Depreger 50mg & 100mg Film-Coated Tablets

  • Name:

    Depreger 50mg & 100mg Film-Coated Tablets

  • Company:
    info
  • Active Ingredients:

    sertraline hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/12/19

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Summary of Product Characteristics last updated on medicines.ie: 4/12/2019

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Gerard Laboratories

Gerard Laboratories

Company Products

Medicine NameActive Ingredients
Medicine Name Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets Active Ingredients Abacavir hydrochloride, Lamivudine
Medicine Name Agerdex 1mg Film Coated Tablets Active Ingredients Anastrozole
Medicine Name Agomelatine Mylan 25 mg film-coated tablets Active Ingredients Agomelatine
Medicine Name Amisulpride 50mg & 200mg Tablets Active Ingredients Amisulpride
Medicine Name Amlodipine Mylan 5mg & 10mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine/Valsartan Mylan 5mg/80mg, 5mg/160mg, 10mg/160mg film-coated tablets Active Ingredients Amlodipine besilate, Valsartan
Medicine Name Areloger 7.5mg & 15mg Tablets Active Ingredients Meloxicam
Medicine Name Aripil 5mg & 10mg Film-coated Tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Atazanavir Mylan 300 mg hard capsules Active Ingredients Atazanavir sulfate
Medicine Name Atenetic 50/12.5mg & 100/25mg Film - coated Tablets Active Ingredients Atenolol, Chlortalidone
Medicine Name Atorvastatin Mylan 10 mg, 20 mg, 40 mg & 80 mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets Active Ingredients Atovaquone, Proguanil Hydrochloride
Medicine Name Azacitidine Mylan 25 mg/mL powder for suspension for injection Active Ingredients azacitidine
Medicine Name Azromax 250mg Film-coated tablets Active Ingredients Azithromycin monohydrate
Medicine Name Baclopar Tablets 10 mg Active Ingredients Baclofen
Medicine Name Bisoprolol Mylan Active Ingredients Bisoprolol Fumarate
Medicine Name Brabio 20mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Brabio 40mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Cifloxager 250 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Cifloxager 500 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciprager 10mg & 20mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprager 40mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprofloxacin Mylan 2mg/1ml solution for infusion Active Ingredients Ciprofloxacin
Medicine Name Clopidogrel Mylan 75 mg film-coated tablets Active Ingredients clopidogrel hydrochloride
Medicine Name Darunavir Mylan 800 mg film-coated tablets Active Ingredients darunavir ethanolate
1 - 0 of 117 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 4 December 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 4 December 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 October 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 14 October 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 5 September 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents

Updated on 5 September 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 29 November 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 29 November 2016 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4. CLINICAL PARTICULARS

4.1 Therapeutic I indications

4.5 Interaction with other medicinal products and other forms of interaction

Special precautions


Other drug interactions, digoxin, atenolol, cimetidine
Co-administration with cimetidine caused a substantial decrease in sertraline clearance. The clinical significance of these changes is unknown. Sertraline had no effect on the beta-adrenergic blocking ability of atenolol. No interaction of sertraline 200 mg daily was observed with digoxin.

Neuromuscular Blockers
SSRIs may reduce plasma cholinesterase activity resulting in a prolongation of the neuromuscular blocking action of mivacurium or other neuromuscular blockers.

Drugs affecting platelet function
The risk of bleeding may be increased when medicines acting on platelet function (e.g. NSAIDs, acetylsalicylic acid and ticlopidine) or other medicines that might increase bleeding risk are concomitantly administered with SSRIs, including sertraline (see section 4.4).

4.8 Undesirable effects

Very

Common

(>1/10)

 

Common

(>1/100 to

<1/10)

 

Uncommon

(>1/1,000 to

<1/100)

 

Rare

(>1/10,000 to

<1/1,000)

 

Very Rare

(<1/10,000)

 

Not Known (cannot be estimated from the available data)

 

Infections and infestations

 

Pharyngitis

 

Upper

Respiratory

Tract Infection,

Rhinitis

Diverticulitis,

Gastroenteritis, Otitis Media

 

 

 

Neoplasms benign, malignant and unspecified (including cysts and polyps)

 

 

 

Neoplasm†

 

 

Blood and lymphatic system disorders

 

 

 

Lymphadenopathy

 

 

Leucopenia,

Thrombocytopenia

Immune system disorders

 

 

Hypersensitivity

Anaphylactoid Reaction

 

Allergy

Endocrine disorders

 

 

Hypothyroidism

 

 

Hyperprolactinaemia,

Inappropriate Antidiuretic Hormone

(ADH) Secretion

Metabolism and nutrition disorders

 

Decreased Appetite,

Increased

Appetite*

 

Diabetes Mellitus, Hypercholesterolaemia, Hypoglycaemia

 

 

Hyponatraemia, Hyperglycaemia

 

Psychiatric disorders

Insomnia

(19%)

 

Depression*,

Depersonalisation, Nightmare,

Anxiety*,

Agitation*,

Nervousness,

Libido

Decreased*,

Bruxism

Hallucination*, Aggression*,

Euphoric

Mood*,

Apathy,

Thinking

Abnormal

 

 

 

Conversion Disorder,

Drug Dependence,

Psychotic disorder*,

Paranoia, Suicidal ideation/behaviour***, Sleep

Walking, Premature

Ejaculation

 

Paroniria

Nervous system disorders

Dizziness

(11%),

Somnolence (13%),

Headache

(21%)*

 

Paraesthesia*,

Tremor,

Hypertonia,

Dysgeusia,

Disturbance in

Attention

 

Convulsion*,

Muscle

Contractions

Involuntary*,

Coordination

Abnormal,

Hyperkinesia,

Amnesia,

Hypoaesthesia*, Speech

Disorder,

Dizziness

Postural, Syncope,

Migraine*

 

 

Coma*,

Choreoathetosis,

Dyskinesia,

Hyperaesthesia,

Sensory Disturbance

 

 

 

 

 

Movement Disorders

(including extrapyramidal

symptoms such as hyperkinesia,

hypertonia, dystonia,

teeth grinding or gait

abnormalities). Also reported were signs and symptoms associated with serotonin syndrome or Neuroleptic Malignant Syndrome: In some cases associated with concomitant use of serotonergic drugs that included agitation,

confusion, diaphoresis,

diarrhoea, fever, hypertension, rigidity and tachycardia.

Akathisia and psychomotor restlessness (see section 4.4). Cerebrovascular Spasm (including reversible Cerebral vasoconstriction syndrome and Call-Fleming syndrome).

Eye disorders

 

Visual

Disturbance

 

Mydriasis*

Glaucoma, Lacrimal

Disorder, Scotoma,

Diplopia,

Photophobia,

Hyphaema

 

 

Vision

Abnormal, Pupils Unequal

 

 

Ear and labyrinth disorders

 

Tinnitus*

Ear Pain

 

 

 

Cardiac disorders

 

Palpitations*

 

Tachycardia

 

Myocardial

Infarction,

Bradycardia, Cardiac

Disorder

 

QTc Prolongation, Torsade de Pointes

Vascular disorders

 

Hot flush*

 

Hypertension*,

Flushing

 

Peripheral Ischaemia, Haematuria

 

 

Abnormal

Bleeding (such as gastrointestinal

bleeding)

Respiratory, thoracic, and mediastinal disorders

 

Yawning*

 

Bronchospasm*, Dyspnoea,

Epistaxis

 

Laryngospasm,

Hyperventilation,

Hypoventilation,

Stridor, Dysphonia,

Hiccups

 

Interstitial Lung Disease

Gastrointestinal disorders

Diarrhoea

(18%),

Nausea

(24%), Dry

Mouth

(14%)

 

Abdominal Pain*

Vomiting*,

Constipation*

Dyspepsia,

Flatulence

 

 

Oesophagitis,

Dysphagia,

Haemorrhoids,

Salivary

Hypersecretion,

Tongue

Disorder,

Eructation

Melaena,

Haematochezia,

Stomatitis, Tongue

Ulceration, Tooth

Disorder, Glossitis,

Mouth Ulceration

 

 

Pancreatitis

 

Hepatobiliary disorders

 

 

 

Hepatic Function

Abnormal

 

 

Serious liver events

(including hepatitis,

jaundice and liver failure)

Skin and subcutaneous tissue disorders

 

Rash*,

Hyperhidrosis

 

Periorbital

Oedema*, Face Oedema,

Purpura*,

Alopecia*,

Cold Sweat,

Dry Skin,

Urticaria*, Pruritus

 

                           

Dermatitis,

Dermatitis Bullous,

Rash Follicular, Hair

Texture Abnormal,

Skin Odour

Abnormal

 

 

 

 

 

 

Rare reports of Severe

Cutaneous Adverse

Reactions (SCAR): e.g. Stevens-Johnson

syndrome and epidermal necrolysis,

Angioedema,

Photosensitivity,

Skin Reaction

 

Musculoskeletal and connective tissue disorders

 

Arthralgia,  Myalgia

 

Osteoarthritis,

Muscular

Weakness,

Back Pain,

Muscle

Twitching

Bone Disorder

 

 

 

 

Muscle Cramps

 

 

 

 

Renal and urinary disorders

 

 

Nocturia,

Urinary

Retention*,

Polyuria,

Pollakiura,

Micturition

Disorder, Urinary Incontinence*

Oliguria,

Urinary Hesitation

 

 

 

 

 

Reproductive system and breast disorders**

Ejaculation

Failure

(14%)

 

Erectile

Dysfunction

 

Vaginal

Haemorrhage, Sexual

Dysfunction,

Female Sexual

Dysfunction, Menstruation Irrelugar Irregular

 

Menorrhagia,

Atrophic

Vulvovaginitis,

Balanoposthitis,

Genital Discharge,

Priapism*,

Galactorrhoea*

 

Gynaecomastia

 

 

 

 

General disorders and administration site conditions

Fatigue

(10%)*

 

Chest Pain*, Malaise*

 

 

Oedema Peripheral,

Chills,

Pyrexia*,

Asthenia*,

Thirst

Hernia, Drug

Tolerance Decreased,

Gait Disturbance

 

 

Investigations

 

 

Alanine

Aminotransferase Aminotransferarase

Increased*, Aspartate

Aminotransferase

Increased*, Weight

Decreased*,

Weight

Increased*

 

Semen

Abnormal, Blood Cholesterol Increased

 

Abnormal Clinical

Laboratory Results, Altered Platelet

Function

Injury, poisoning and procedural complications

 

 

 

Injury

 

 

Surgical and medical procedures

 

 

 

Vasodilation

Procedure

 

 

 

If adverse experience occurred in depression, OCD, panic disorder, PTSD and social anxiety disorder, body term reclassified by depression studies body term.

One case of neoplasm was reported in one patient receiving sertraline compared with no cases in the placebo arm.

* these adverse reactions also occurred in post-marketing experience

** the denominator uses the number of patients in that sex group-combined: sertraline (1118 males, 1424 females) placebo (926 males, 1219 females) For OCD, short term, 1-12 week studies only

*** Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 4.4).

Updated on 28 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 November 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 8 June 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 8 June 2016 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.5 Nature and contents of container

High dDensity Polyethylene polypropylene (HDPE) bottles with polypropylene polyethylene caps (with optional polyethylene filler) in *packages of 14, 15, 20, 28, 30, 50, 60, 98, 100, 250, 300, 500.
PVC/PVdC/aluminium blisters in *packs of 14, 15, 20, 28, 30, 50, 60, 98, 100, 250, 300, 500.
PVC/aluminium blisters in *packs of 14, 15, 20, 28, 30, 50, 60, 98, 100, 250, 300, 500.
*Not all pack sizes may be marketed.

Updated on 8 March 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS)

The development of potentially life-threatening syndromes like serotonin syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) has been reported with SSRIs, including treatment with sertraline. The risk of SS or NMS with SSRIs is increased with concomitant use of

 

other serotonergic drugs (including other serotonergic antidepressants, triptans), with drugs which impair metabolism of serotonin (including MAOIs e.g. methylene blue), antipsychotics, and other dopamine antagonists and with opiate drugs. Patients should be monitored for the emergence of signs and symptoms of SS or NMS syndrome (see section 4.3).

 

Switching from Selective Serotonin Reuptake Inhibitors (SSRIs), antidepressants or anti

 

-obsessional drugs

 

There is limited controlled experience regarding the optimal timing of switching from SSRIs, antidepressants or anti

 

-obsessional drugs to sertraline. Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents such as fluoxetine.

 

Other serotonergic drugs e.g. tryptophan, fenfluramine and 5-HT agonists

Co-administration of sertraline with other drugs which enhance the effects of serotonergic neurotransmission such as tryptophan or fenfluramine or 5-HT agonists, or the herbal medicine, St John’s

 

Wwort (Hypericum perforatum), should be undertaken with caution and avoided whenever possible due to the potential for a pharmacodynamic interaction.

 

QTc prolongation/Torsade de Pointes (TdP)

Cases of QTc prolongation and Torsade de Pointes (TdP) have been reported during post-marketing use of sertraline. The majority of reports occurred in patients with other risk factors for QTc prolongation/TdP. Therefore sertraline should be used with caution in patients with risk factors for QTc prolongation.


 

Paediatric population

 

 

 

Use in children and adolescents under 18 years of age

 

 

 

 

Sertraline should not be used in the treatment of children and adolescents under the age of 18 years, except for patients with obsessive compulsive disorder aged 6-17 years old. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for appearance of suicidal symptoms. In addition,

only limited clinical evidence is available concerning long term safety data in children and adolescents including effects on growth, sexual maturation and cognitive and behavioural developments. A few cases of retarded growth and delayed puberty have been reported post-marketing. The clinical relevance and causality are yet unclear (see section 5.3 for corresponding preclinical safety data)long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking. Physicians must monitor paediatric patients on long term treatment for abnormalities in growth and developmentthese body systems.

 

Abnormal bleeding/

Hhaemorrhage

 

There have been reports of

bleeding abnormalities with SSRIs including cutaneous bleeding abnormalities such as (ecchymoses and purpura) and other haemorrhagic events such as gastrointestinal or gynaecological bleeding, including fatal haemorrhageswith SSRIs. Caution is advised in patients taking SSRIs, particularly in concomitant use with drugs known to affect platelet function (e.g. anticoagulants, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs)) as well as in patients with a history of bleeding disorders (see section 4.5).

 

4.5 Interaction with other medicinal products and other forms of interaction

 

Severe adverse reactions have been reported in patients who have recently been discontinued from an MAOI (e.g. methylene blue) and started on sertraline, or have recently had sertraline therapy discontinued prior to initiation of an MAOI. These reactions have included tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, and hyperthermia with features resembling neuroleptic malignant syndrome, seizures, and death.

 

 

Other serotonergic drugs

 

See section 4.4.

Caution is also advised with fentanyl

 

(used in general anaesthesia or in the treatment of chronic pain), other serotonergic drugs (including other serotonergic antidepressants, triptans) and with other opiate drugs.

 

 

 

Special Pprecautions

 

Drugs that prolong the QT interval

 

 

The risk of QTc prolongation and/or ventricular arrhythmias (e.g. TdP) may be increased with concomitant use of other drugs which prolong the QTc interval (e.g. some antipsychotics and antibiotics) (see section 4.4)

 

 

 

 

 

 

4.8 Undesirable effects

 

Very

Common

(>1/10)

 

 

Common

(>1/100 to

<1/10)

 

 

Uncommon

(>1/1

 

,000 to

 

<1/100)

 

 

Rare

(>1/10

 

,000 to

 

<1/1

 

,000)

Very

rRare

 

(<1/10

 

,000)

Not

kKnown (cannot be estimated from the available data)

Infections and

 

Iinfestations

Pharyngitis

 

 

Upper

Respiratory

Tract Infection,

Rhinitis

 

 

Diverticulitis,

Gastroenteritis, Otitis Media

 

 

Neoplasms benign, malignant and unspecified (including cysts and polyps)

 

 

Neoplasm†

 

 

Blood and lymphatic system disorders

 

 

Lymphadenopathy

 

 

Leucopenia,

Thrombocytop

 

aenia

Immune system disorders

 

 

Hypersensitivity

 

 

 

Anaphylactoid Reaction

 

 

 

Anaphylactoid

Reaction,

Allergic Reaction,

Allergy

 

 

Endocrine disorders

 

 

Hypothyroidism

 

 

 

Hyperprolactinaemia,

Hypothyroidism

and syndrome

of i

 

 

Inappropriate Antidiuretic Hormone

 

(

 

 

ADH) sSecretion

Metabolism and

 

Nnutrition Ddisorders

Anorexia

 

 

Decreased aAppetite,

 

Increased

Appetite*

 

 

Diabetes Mellitus,

 

 

Hypercholesterolaemia, Hypoglycaemia

Hyponatr

 

aemia, Diabetes Mellitus, Hyperglycaemia

Psychiatric

 

Ddisorders

Insomnia

(19%)

 

 

Depression*,

Depersonalisation, Nightmare,

Anxiety*,

Agitation*,

Nervousness,

Libido

 

 

Hallucination*,

 

Aggression*,

 

Euphoric

Mood*,

Apathy,

Thinking

Abnormal

 

 

Conversion Disorder,

Drug Dependence,

Psychotic disorder*,

Aggression*,

Paranoia, Suicidal ideation/behaviour***,

 

 

Very

Common

(>1/10)

 

 

Common

(>1/100 to

<1/10)

 

 

Uncommon

(>1/1

 

,000 to

 

<1/100)

 

 

Rare

(>1/10

 

,000 to

 

<1/1

 

,000)

Very

rRare

 

(<1/10

 

,000)

Not

kKnown (cannot be estimated from the available data)

Decreased*,

Bruxism

 

 

Walking, Premature

Ejaculation

 

 

Nervous

 

Ssystem Ddisorders

Dizziness

(11%),

Somnolence (13%),

Headache

(21%)*

 

 

Paraesthesia*,

Tremor,

Hypertonia,

Dysgeusia,

Disturbance in

Attention

 

 

Convulsion*,

Muscle

Contractions

Involuntary*,

Coordination

Abnormal,

Hyperkinesia,

Amnesia,

Hypoaesthesia*, Speech

Disorder,

Dizziness

Postural,

 

Syncope,

 

Migraine*

 

 

Coma*,

Choreoathetosis,

Dyskinesia,

Hyperaesthesia,

Sensory Disturbance

 

 

Movement Disorders

(including extrapyramidal

symptoms such as hyperkinesia,

hypertonia, dystonia,

teeth grinding or gait

abnormalities)

 

,

 

Syncope

 

 

. Also reported were signs and symptoms associated with serotonin syndrome or Neuroleptic Malignant Syndrome: In some cases associated with concomitant use of serotonergic drugs that included agitation,

 

confusion, diaphoresis,

diarrhoea, fever, hypertension, rigidity and tachycardia.

Akathisia and psychomotor restlessness (see section 4.4). Cerebrovascular Spasm (including reversible Cerebral vasoconstriction syndrome and

 

cCall-fFleming syndrome).

Eye

 

Ddisorders

Visual

Disturbance

 

 

Mydriasis*

 

 

 

Glaucoma, Lacrimal

Disorder, Scotoma,

Diplopia,

Photophobia,

Hyphaema

 

,

 

Mydriasis*

 

 

 

Vision

a

 

 

Abnormal, Pupils Unequal

Ear and

 

Llabyrinth Ddisorders

Tinnitus*

 

 

Ear Pain

 

 

Cardiac

 

Ddisorders

Palpitations*

 

 

Tachycardia

 

 

Myocardial

Infarction,

Bradycardia, Cardiac

Disorder

 

 

QTc Prolongation, Torsade de Pointes

 

 

 

Very

Common

(>1/10)

 

 

Common

(>1/100 to

<1/10)

 

 

Uncommon

(>1/1

 

,000 to

 

<1/100)

 

 

Rare

(>1/10

 

,000 to

 

<1/1

 

,000)

Very

rRare

 

(<1/10

 

,000)

Not

kKnown (cannot be estimated from the available data)

Vascular

 

Ddisorders

Hot flush*

 

 

Hypertension*,

Flushing

 

 

Peripheral Ischaemia

 

, Haematuria

Abnormal

Bleeding (such

As

 

epistaxis, gastrointestinal

 

bleeding

 

or haematuria)

Respiratory,

 

Tthoracic, and Mmediastinal Ddisorders

Yawning*

 

 

Bronchospasm*, Dyspnoea,

Epistaxis

 

 

Laryngospasm,

Hyperventilation,

Hypoventilation,

Stridor, Dysphonia,

Hiccups

 

 

Interstitial Lung Disease

 

 

Gastrointestinal

 

Ddisorders

Diarrhoea

(18%),

Nausea

(24%), Dry

Mouth

(14%)

 

 

Abdominal Pain*

Vomiting*,

Constipation*

Dyspepsia,

Flatulence

 

 

Oesophagitis,

Dysphagia,

Haemorrhoids,

Salivary

Hypersecretion,

Tongue

Disorder,

Eructation

 

 

Melaena,

Haematochezia,

Stomatitis, Tongue

u

 

 

Ulceration, Tooth

 

Disorder, Glossitis,

Mouth Ulceration

 

 

Pancreatitis

 

 

Hepatobiliary

 

Ddisorders

Hepatic Function

Abnormal

 

 

Serious liver events

(including hepatitis,

jaundice and liver failure)

 

 

Skin and

 

Ssubcutaneous Ttissue Ddisorders

Rash*,

Hyperhidrosis

 

 

Periorbital

Oedema*,

 

Face Oedema,

 

Purpura*,

Alopecia*,

Cold Sweat,

Dry

 

sSkin,

 

Urticaria*

 

, Pruritus

Dermatitis,

Dermatitis Bullous,

Rash Follicular, Hair

Texture Abnormal,

Skin Odour

Abnormal

 

 

Rare reports of

 

sSevere

 

Cutaneous

 

aAdverse

 

Reactions (SCAR): e.g. Stevens-Johnson

syndrome and epidermal necrolysis,

Angioedema,

Face Oedema,

Photosensitivity,

Skin Reaction

 

,

 

Pruritus

 

 

 

Musculoskeletal and

 

Cconnective Ttissue Ddisorders

Arthralgia,

 

 

Myalgia

Osteoarthritis,

Muscular

Weakness,

Back Pain,

Muscle

Twitching

 

 

Bone Disorder

 

 

Arthralgia,

Muscle Cramps

 

 

Renal and

 

Uurinary Ddisorders

Nocturia,

Urinary

Retention*,

Polyuria,

Pollakiura,

Micturition

d

 

 

Disorder, Urinary

Oliguria,

 

Urinary

 

Incontinence*,

Urinary Hesitation

 

 

Very

Common

(>1/10)

 

 

Common

(>1/100 to

<1/10)

 

 

Uncommon

(>1/1

 

,000 to

 

<1/100)

 

 

Rare

(>1/10

 

,000 to

 

<1/1

 

,000)

Very

rRare

 

(<1/10

 

,000)

Not

kKnown (cannot be estimated from the available data)

Incontinence*

 

 

 

Reproductive

 

Ssystem and Bbreast Ddisorders**

Ejaculation

Failure

(14%)

 

 

Sexual

Dysfunction,

Erectile

Dysfunction

 

 

Vaginal

Haemorrhage,

 

Sexual

 

Dysfunction,

Female Sexual

Dysfunction,

 

Menstruation Irrelugar

Menorrhagia,

Atrophic

Vulv

 

uovaginitis,

 

Balanoposthitis,

Genital Discharge,

Priapism*,

Galactorrhoea*

 

 

Gynaecomastia

 

,

 

Menstrual

Irregularities

 

 

 

General

 

Ddisorders and Aadministration Ssite Cconditions

Fatigue

(10%)*

 

 

Chest Pain*,

 

Malaise*

Malaise*

 

 

Oedema Peripheral,

 

Chills,

Pyrexia*,

Asthenia*,

Thirst

 

 

Hernia, Drug

Tolerance Decreased,

Gait Disturbance

 

 

Oedema Peripheral

 

 

 

Investigations

 

 

Alanine

Aminotransferarase

Increased*, Aspartate

Aminotransferase

Increased*,

 

 

Weight

 

Decreased*,

Weight

Increased*

 

 

Alanine

Aminotransferarase

Increased*, Aspartate

Aminotransferase

Increased*,

 

 

Semen

 

Abnormal

 

, Blood Cholesterol Increased

Abnormal Clinical

Laboratory Results, Altered Platelet

Function

 

,

 

Increased Serum Cholesterol

 

 

 

Injury, poisoning and procedural complications

 

 

Injury

 

 

Surgical and medical procedures

 

 

Vasodilation

Procedure

 

 

If adverse experience occurred in depression, OCD, panic disorder, PTSD and social anxiety disorder, body term reclassified by depression studies body term.

 

One case of neoplasm was reported in one patient receiving sertraline compared with no cases in the placebo arm.

 

* these adverse reactions also occurred in post

 

-marketing experience

 

** the denominator uses the number of patients in that sex group-combined: sertraline (1118 males, 1424 females) placebo (926 males, 1219 females) For OCD, short term, 1-12 week studies only

*** Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 4.4).

 

 


 

Class effects

 

Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

 

 

 

 

 

 

Uncommon (≥1/1

,000 to <1/100): ECG QT prolonged, suicide attempt, convulsion, extrapyramidal disorder, paraesthesia, depression, hallucination, purpura, hyperventilation, anaemia, hepatic function abnormal, alanine aminotransferase increased, cystitis, herpes simplex, otitis externa, ear pain, eye pain, mydriasis, malaise, haematuria, rash pustular, rhinitis, injury, weight decreased, muscle twitching, abnormal dreams, apathy, albuminuria, pollakiuria, polyuria, breast pain, menstrual disorder, alopecia, dermatitis, skin disorder, skin odour abnormal, urticaria, bruxism, flushing.

 

 

 

Frequency not known: enuresis.

 

 

 

 

Class effects
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

 

 

 

 

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; website: www.hpra.ie; e-mail: medsafety@hpra.ie.FREEPOST, Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2. Tel: +353 1 6764971, Fax: +353 1 6762517 Website: http://www.imb.ie E-mail: imbpharmacovigilance@imb.ie

 

4.9 Overdose

 

Toxicity
On the evidence available, sSertraline has a wide margin of safety dependent on patient population and/or concomitant medicationin overdose. Overdoses of sertraline alone of up to 13.5 g have been reported. Deaths have been reported involving overdoses of sertraline, alone or primarily
in combination with other drugs and/or alcohol. Therefore, any overdosage should be medically treated aggressively.

 

 

 

Symptoms
Symptoms of overdose include serotonin-mediated side effects such as somnolence, gastrointestinal disturbances (such as nausea and vomiting), tachycardia, tremor, agitation and dizziness. Less frequently reported was coma.

 

 

 

QTc prolongation/Torsade de Pointes has been reported following sertraline overdose; therefore, ECG-monitoring is recommended in all ingestions of sertraline overdoses.

 

Treatment

There are no specific antidotes to sertraline. It is recommended to Eestablish and maintain an airway and, if necessary, ensure adequate oxygenation and ventilation, if necessary. Activated charcoal, which may be used with a cathartic, may be as or more effective than lavage, and should be considered in treating overdose. Induction of emesis is not recommended. Cardiac (e.g. ECG) and other vital sign monitoring is also recommended, along with general symptomatic and supportive measures. Due to the large volume of distribution of sertraline, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.

 

 

 

Sertraline overdose may prolong the QT-interval, and ECG-monitoring is recommended in all ingestions of sertraline overdoses.

 

 

 

 

 

 

 

5.1 Pharmacodynamic properties

 

Paediatric population
No data is available for children under 6 years of age.

 

 

5.2 Pharmacokinetic properties

 

 

Absorption
Sertraline exhibits dose proportional pharmacokinetics in the range of 50 to 200 mg. In man, following an oral once-daily dosage of 50 to 200 mg for 14 days, peak plasma concentrations of sertraline occur at 4.5 to 8.4 hours after the daily administration of the drug. Food does not significantly change the bioavailability of sertraline tablets.

 

 

 

Linearity/non-linearity
Sertraline exhibits dose proportional pharmacokinetics in the range of 50 to 200 mg.

 

 

 

 

Pharmacokinetics in specific patient groups

 

Paediatric

patients population with OCD

 

 

Pharmacokinetics of sertraline was studied in 29 paediatric patients aged 6-12 years old, and 32 adolescent patients aged 13-17 years old. Patients were gradual uptitrated to a 200 mg daily dose within 32 days, either with 25 mg starting dose and increment steps, or with 50 mg starting dose or increments. The 25 mg regimen and the 50 mg regimen were equally tolerated. In steady state for the 200 mg dose, the sertraline plasma levels in the 6-12 year old group were approximately 35% higher compared to the 13-17 year old group, and 21% higher compared to adult reference group. There were no significant differences between boys and girls regarding clearance. A low starting dose and titration steps of 25 mg are therefore recommended for children, especially with low bodyweight.

 

Adolescents could be dosed like adults.

 

 

Liver functionHepatic impairment
In patients with liver damage, the half life of sertraline is prolonged and AUC is increased three fold (see sections 4.2 and 4.4).

 

 

 

 

5.3 Preclinical safety data

 

Preclinical data does not indicate any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenesis. Reproduction toxicity studies in animals showed no evidence of teratogenicity or adverse effects on male fertility. Observed foetotoxicity was probably related to maternal toxicity. Postnatal pup survival and body weight were decreased only during the first days after birth. Evidence was found that the early postnatal mortality was due to in-utero exposure after day 15 of pregnancy. Postnatal developmental delays found in pups from treated dams were probably due to effects on the dams and therefore not relevant for human risk.

 

Animal data from rodents and non-rodents does not reveal effects on fertility.

 

Juvenile animal studies
A juvenile toxicology study in rats has been conducted in which sertraline was administered orally to male and female rats on Postnatal Days 21 through 56 (at doses of 10, 40, or 80 mg/kg/day) with a nondosing recovery phase up to Postnatal Day 196. Delays in sexual maturation occurred in males and females at different dose levels (males at 80 mg/kg and females at ≥10 mg/kg), but despite this finding there were no sertraline-related effects on any of the male or female reproductive endpoints that were assessed. In addition, on Postnatal Days 21 to 56, dehydration, chromorhinorrhea, and reduced average body weight gain was also observed. All of the aforementioned effects attributed to the administration of sertraline were reversed at some point during the nondosing recovery phase of the study. The clinical relevance of these effects observed in rats administered sertraline has not been established.

 

 

 

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
No special requirementsNot applicable.

 

 

 

8. MARKETING AUTHORISATION NUMBER(S)

 

 

PA0577/067/001
PA0577/067/002

 

 

 

 




















 

 

Updated on 2 March 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 3 April 2014 PIL

Reasons for updating

  • Change to packaging
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Addition of information on reporting a side effect.

Updated on 3 April 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • 2, pharmaceutical form is changed, the colour is changed to to white to off-white capsule shaped
  • 4.2, patients changed to population
  • 4.2, Withdrawal symptoms seen on discontinuation of sertraline treatment
  • 4.4, Triptans and tramadol added, Contraindications  was deleted
  • 4.4, Under subsection

    Suicide/suicidal thoughts/suicide attempts or clinical worsening, self harm changed to self-harm

  • 4.4, Renal impairment - AUC0-24 or Cmax was formatted correctly

  • 4.4, Diabetes - . 'Insulin and/or oral hypoglycaemic dosage may need to be adjusted' replaced text following 'In patients with diabetes, treatment with an SSRI may alter glycaemic control'

  • 4.4, Grapefruit juice - 'The intake of grapefruit juice should be avoided during treatment with sertraline' replaced previous text

  • 4.5, e.g. added ahead of the drug examples

  • 4.5, 'such as ritonavir'  added in the second last paragraph

  • 4.6, Lactation changed to Breast-feeding

  • 4.6, negligible spelling correction

  • 4.6, fertility - grammar change

  • 4.8, refer to table 1. for changes

  • 4.8, reporting of side effects updated according to new IMB guideline

  • 5.1, Paediatric OCD, sumbols added '+/-'

  • 5.2 - Biotransformation, '

     

    Based on clinical and in vitro data, it can be concluded that sertraline is metabolised by multiple pathways including CYP3A4, CYP2C19 (see section 4.5) and CYP2B6. Sertraline and its major metabolite desmethylsertraline are also substrate of P-glycoprotein in vitro.' was added

  • 5.2 - Renal Impairment, '

    Pharmacogenomics

    Plasma levels of sertraline were about 50 % higher in poor metabolizers of CYP2C19 versus extensive metabolizers. The clinical meaning is not clear, and patients need to be titrated based on clinical response.' was added

  • 6.4 - store in the original packaging

  • 10. date of revision updated

  •  

     

Updated on 10 July 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 10 July 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$04.4 Special warnings and precautions for use$0$0$0$0$0Addition warning added:$0$0Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS)$0$0Grapefruit juice$0$0Interference with urine screening tests$0$0Angle-Closure Glaucoma$0$0$0$0$0$0$0$04.5 Interaction with other medicinal products and other forms of interaction$0$0$0$0$0Caution with use if fentanyl is added$0$0$0$0$0Special Precautions for Phenytoin is updated. Following sentenced added:$0$0It cannot be excluded that other CYP3A4 inducers, e.g. phenobarbital, carbamazepine, St John’s Wort, rifampicin may cause a reduction of sertraline plasma levels.$0$0$0$0$0Interaction with grapefruit juice added$0$0$0$0$0$0$0$04.8 Undesirable effects$0$0$0$0$0Side effecs for adults: Diabetes Mellitus, hyperglycaemia, dystonia, Neuroleptic Malignant Syndrome,Cerebrovascular Spasm, Pupils Unequal, Interstitial Lung Disease - added under Frequency not Known category$0$0$0$0$0Side effect Suicidal ideation/behaviour changed from Frequency not$0$0Known category to Rare frequency$0$0$0$0$0Side effect for paidiatroc patients: enuresis added under Frequency not Known category$0$0$0$0$0$0$0$04.9 Overdose$0$0$0$0$0Following statement added:$0$0Sertraline overdose may prolong the QT-interval, and ECG-monitoring is recommended in all ingestions of sertraline overdoses.$0$0$0$0$0$0$0$010. DATE OF REVISION OF THE TEXT$0$0$0$0$0Date changed to May 2013$0$0$0$0$0$0$0$0(Internal Ref: IT/H/0210/IB/008)$0

Updated on 29 January 2013 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

3. PHARMACEUTICAL FORM
Added -
The tablet can be divided into equal doses.

4.6 Fertility, pregnancy and lactation
Added -
Fertility
Animal data did not show an effect of sertraline in fertility parameters (see section 5.3). Human case reports with some SSRIs have been shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far.

5.3 Preclinical safety data
Added -
Animal data from rodents and non-rodents does not reveal effects on fertility.

6.1 List of excipients
Film Coating:
Changing Triacetin to Glycerol triacetate

10. DATE OF REVISION OF THE TEXT
Change to November 2012


(internal ref: IT/H/0210/IB/007)

Updated on 25 January 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change due to harmonisation of PIL
  • Change to improve clarity and readability
  • Change to information about pregnancy or lactation

Updated on 23 August 2012 PIL

Reasons for updating

  • Addition of manufacturer

Updated on 17 August 2011 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Following paragraph added to section 4.6 Pregnancy and lactation

Epidemiological data have suggested that the use of SSRIs in pregnancy, particular in late
pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn
(PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur.


Following paragraph added to section 4.8 Undesirable effects

Class effects
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an
increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism
leading to this risk is unknown


Changes due to approval of Renewal Application

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization: 05 August 2005
Date of last renewal: 24 March 2011

10. DATE OF REVISION OF THE TEXT

June 2011

Updated on 17 August 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 3 February 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC sections 4.4 and 4.8 have been updated to include the recommended PhVWP warnings on Suicide/ Suicidal behaviour.

 

Updated on 3 February 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to improve clarity and readability

Updated on 3 March 2008 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 SPC has been updated to included warnings on Suicide/ Suicidal behaviour, Withdrawal Symptoms and Akathisia / Psychomotor restlessness.

 The sections affected are : 4.2, 4.4 and 4.8.

 Also updated:

 6.1 – Excipient names updated.

6.3 – Shelf life updted from 2 years to 3 years.

Updated on 15 February 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 March 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 September 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 September 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)