Amlodipine Mylan 5mg & 10mg Tablets

  • Name:

    Amlodipine Mylan 5mg & 10mg Tablets

  • Company:
    info
  • Active Ingredients:

    Amlodipine besilate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/09/18

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 17/9/2018

Click on this link to Download PDF directly

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 Areloger 7.5mg & 15mg Tablets Active Ingredients Meloxicam
Medicine Name Aripil 5mg & 10mg Film-coated Tablets Active Ingredients Donepezil Hydrochloride
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 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
Medicine Name Depreger 50mg & 100mg Film-Coated Tablets Active Ingredients sertraline hydrochloride
Medicine Name Diaclide MR 30 mg Modified-release Tablets Active Ingredients Gliclazide
Medicine Name Diaclide MR 60mg modified-released tablets Active Ingredients Gliclazide
1 - 0 of 116 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 18 September 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Updated on 17 September 2018 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

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 29 May 2018 SmPC

Reasons for updating

  • 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 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 May 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 26 July 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 26 July 2016 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8  Undesirable effects

Tabulated list of adverse reactions
The following adverse reactions have been observed and reported during treatment with amlodipine with the following frequencies:
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).

System organ class

Frequency

Adverse reactions

Blood and lymphatic system disorders

Very rare

Leukocytopenia, thrombocytopenia

Immune system disorders

 

Very rare

Allergic reactions

Metabolism and nutrition disorders

Very rare

Hyperglycaemia

Psychiatric disorders

Uncommon

Depression,  mood changes (including anxiety), insomnia

Rare

Confusion

Nervous system disorders

Common

Somnolence, dizziness, headache (especially at the beginning of the treatment)

Uncommon

Tremor, dysgeusia, syncope, hypoesthesia, paresthesia

Very rare

Hypertonia,

peripheral neuropathy

Not known

Extrapyramidal disorder

Eye disorders

Common

Visual disturbance (including diplopia)

Ear and labyrinth disorders

Uncommon

Tinnitus

Cardiac disorders

Common

Palpitations

Uncommon

Arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation)

Very rare

Myocardial infarction

Vascular disorders

Common

Flushing

Uncommon

Hypotension

Very rare

Vasculitis

Respiratory, thoracic and mediastinal disorders

Common

Dyspnoea

Uncommon

Cough, rhinitis

Gastrointestinal disorders

Common

Abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation)

Uncommon

Vomiting, dry mouth

Very rare

Pancreatitis, gastritis, gingival hyperplasia

Hepatobiliary disorders

Very rare

Hepatitis, jaundice, hepatic enzymes increased*

Skin and subcutaneous tissue disorders

Uncommon

Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticaria

Very rare

Angioedema, erythema multiforme,  exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity

Musculoskeletal and connective tissue disorders

Common

Ankle swelling, muscle cramps

Uncommon

Arthralgia, myalgia, back pain

Renal and urinary disorders

Uncommon

Micturition disorder, nocturia, increased urinary frequency

Reproductive system and breast disorders

Uncommon

Impotence, gynaecomastia

General disorders and administration site conditions

Very common

Oedema

Common

Fatigue, asthenia

Uncommon

Chest pain, pain, malaise

Investigations

Uncommon

Weight increase, weight decrease


*mostly consistent with cholestasis

Exceptional cases of extrapyramidal syndrome have been reported.

Updated on 19 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 July 2016 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 19 July 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 15 December 2015 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 11 December 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 10 December 2015 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

revision date updated to match the licence

Updated on 9 December 2015 PIL

Reasons for updating

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

Updated on 30 September 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

section 4.1

Therapeutic indications


section 4.2

Patients with hepatic impairment


Patients with renal impairment


section 4.3

4.3     Contraindications

 

hypersensitivity to the active substanc,...

section 4.4-headers

section 4.5

Tacrolimus

There is a risk of increased tacrolimus blood levels when co-administered with amlodipine but the pharmacokinetic mechanism of this interaction is not fully understood. In order to avoid toxicity of tacrolimus, administration of amlodipine in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.

 

Ciclosporin

No drug interaction studies have been conducted with ciclosporin and amlodipine in healthy volunteers or other populations with the exception of renal transplant patients, where variable

trough concentration increases (average 0% - 40%) of ciclosporin were observed.

 

Consideration should be given for monitoring ciclosporin levels in renal transplant patients on amlodipine, and ciclosporin dose reductions should be made as necessary.


 

In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin or warfarin.


section 4.8 -table udpated & reporting of side effects added

section 5.1 headers updated

section 5.2

Pharmacokinetic properties

Absorption

The bioavailability of amlodipine is not affected by food intake.


 

Distribution

The volume of distribution is approximately 21 l/kg. In vitro studies have shown that approximately 97.5% of circulating amlodipine is bound to plasma proteins.

 

Biotransformation

Amlodipine is extensively metabolised by the liver to inactive metabolites with 10% of the parent compound and 60% of metabolites excreted in the urine

Elimination

The terminal plasma elimination half life is about 35-50 hours and is consistent with once daily dosing.[RTQ1] 

 

Hepatic impairment

Very limited clinical data are available regarding amlodipine administration in patients with hepatic impairment. Patients with hepatic insufficiency have decreased clearance of amlodipine resulting in a longer half-life and an increase in AUC of approximately 40-60%.[RTQ2] 


 

section 6.1 -uppercase to lower case




Updated on 29 September 2015 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 29 September 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 21 July 2015 PIL

Reasons for updating

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

Updated on 11 August 2014 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 31 July 2014 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Introduction of new pack/pack size

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

section 6.5 Nature and contents of container: pack size 90 added for blisters

Updated on 20 February 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • 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 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2:For the full list of excipients, see section 6.1.
Section 3:
The tablet can be divided into equal doses.
Section 4.3:
·         hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1
Section 4.4:
Calcium channel blockers, including amlodipine,
Section 4.5:
Effects of other medicinal products on amlodipine CYP3A4 inhibitors: Concomitant use of amlodipine

Simvastatin: Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

Section 6.6:Any unused medicinal product or waste material should be disposed of in accordance with local requirements

Updated on 15 February 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 14 February 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 1 August 2012 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes made to each of the following sections:
4.1,1.2,4.4,4.5,4.6,4.7,4.8,4.9,5.1,5.2,5.3

Changes made in-line with an Article 30 referral

Updated on 17 April 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Addition of manufacturer

Updated on 17 April 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 21 February 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 February 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 21 June 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 20 June 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 22 April 2011 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 16 March 2011 PIL

Reasons for updating

  • New PIL for new product