Priadel 400mg Prolonged Release Tablets

  • Name:

    Priadel 400mg Prolonged Release Tablets

  • Company:
    info
  • Active Ingredients:

    Lithium Carbonate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 27/11/2018

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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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 27 November 2018 SmPC

Reasons for updating

  • Previous version of SmPC reinstated

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

Updated on 27 November 2018 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 22 November 2018 PIL

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 22 November 2018 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Diltiazem

An increased risk of depression has been reported when beta-blockers are co-administered with diltiazem (see section 4.8 Undesirable Effects).

  

Digitalis glycosides

Association with beta blockers may increase atrio-ventricular conduction time.

Anaesthetic drugs

Celiprolol therapy must be reported to the anaesthetist prior to general anaesthesia (see also section 4.4: Anaesthesia).  Celiprolol, as other β-blockers, attenuates the reflex tachycardia and increases the risk of hypotension.

 

Interactions with inhibitors/inducers of P-glycoprotein

Concomitant use with drugs that inhibit P-gp (e.g. verapamil, erythromycin, clarithromycin, ciclosporin, quinidine, ketoconazole and itraconazole) are likely to result in increased plasma concentrations of celiprolol. Co-administration of celiprolol 100mg and the P-gp-inhibitor itraconazole 200mg resulted in an 80& increase in celiprolol AUC.

 

Sympathomimetic agents

Sympathomimetic agents may counteract the effects of beta blockers.

 

Sinus arrest may occur when beta blockers, including Selectol, are used in combination with other drugs known to induce sinus arrest (see Section 4.8, Undesirable effects).

4.6       Fertility, pregnancy and lactation

 

  • Cardiac disorders
    Uncommon: palpitations
    Not known: bradycardia;, cardiac failure and arrhytmia; sinus arrest in predisposed patients (e.g., elderly patients or patients with pre-existing bradycardia, sinus node dysfunction or atrioventricular block).
     
  • Vascular disorders

 

4.9       Overdose

 

Symptoms

Bradycardia, hypotension, bronchospasm, and acute cardiac failure and sinus arrest have   been reported with beta-blocker overdosage.

Treatment

 

Updated on 30 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 30 November 2017 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8

 

Added under sub title:-Musculoskeletal and connective tissue disorders:

 

rhabdomyolysis.

 

Added:-

Eye disorders

Eye irritation (reversible in most cases); optic disc swelling, in some cases without increased intracranial pressure; papilloedema leading to possible visual impairment (generally reversible); exophthalmos (not always associated with thyroid disorders)

Updated on 27 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 November 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 November 2016 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 8 June 2015 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)

Free text change information supplied by the pharmaceutical company

Section 4.4 and 4.8 updated to include information on 'Renal tumours'.

Updated on 2 June 2015 PIL

Reasons for updating

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

Updated on 16 December 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to further information section

Updated on 10 December 2014 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 4.8 – Undesirable effects - how to report a side effect
  • 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

Section 4.4: 'General' updated to include:
At the first sign of toxicity, the patient should consult a physician and lithium levels should be checked.

Section 4.5: Under the paragraph 'Serum lithium levels 'Calcitonin' has been added. 
Under 'Antipsychotic drugs the co-adminstration of lithium may increase the risk of Neuroleptic Malignant Syndrome, which may be fatal.

Section 4.8: Nervous system disorders updated:

Nervous system disorders: tremor especially fine hand tremors, vertigo, dysarthria, impaired consciousness, myoclonus, abnormal reflexes, convulsions (see section 4.4 & section 4.5), benign intracranial hypertension (see section 4.4).

Vertigo, impaired consciousness, abnormal reflexes, convulsions (see section 4.4 & section 4.5), extrapyramidal disorders, encephalopathy, cerebellar syndrome (usually reversible), nystagmus. The above symptoms may result in fall (frequency not known).

Peripheral neuropathy may occur on long-term treatment and is usually reversible at cessation of lithium.


Renal and urinary disorders updated:

Long term treatment with lithium may result in permanent changes in kidney histology, formation of renal microcysts and impairment of renal function.


Psychiatric disorders updated to include 'delirium (frequency not known).

General disorders and adminstration site conditions updated to include:

Urticaria and angioedema, attributed to some excipients.


Reporting of suspected adverse reactions paragraph included.

Section 4.9 updated:

Symptoms of lithium intoxication include:

·         Gastrointestinal disorders: increasing anorexia, diarrhoea and vomiting.

·         Nervous system disorders: Encephalopathy, cerebellar syndrome with symptoms such as muscle weakness, lack of coordination, drowsiness or lethargy, giddiness, ataxia, nystagmus, coarse tremor. tTinnitus, blurred vision, dysarthria, coarse tremor, twitching, myoclonus, extrapyramidal disorders.

·         Other: ECG changes (flat or inverted T waves, QT prolongation), AV block, dehydration and electrolyte disturbances.

Updated on 12 September 2013 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Type 1B No. C.1.3.a to update the SPC section 4.9 as committed to in PSUR submission.

Updated on 22 February 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 24 August 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7 updated with the addition of T/A SANOFI

Updated on 3 May 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 14 March 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Change: Update to Section 3 to include the statement: 'The tablets can be divided into equal halves'.

Updated on 10 December 2010 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 4.3 - 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 4.6 - 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 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Sections 4.2 updated with regard to text relating to individualizing dosage from patient to patient and reference to using minimum effective dose also include. Instructions to monitor lithium levels changed from four to a maximum of 5 days after treatment to four to a maximum of 7  days after starting teatment, serum levels should be measured. Section added with regard to patients with renal impairment with instruction included to closely monitor these patients and adjust dose accordingly along with the inclusion of a contrainidcation for use in patients with severe renal insufficiency.  Additional updates made to this section see SPC for full details

Section 4.3: updated to include contraindication in brugada syndrome or family history of Brugada syndrome, some editorial changes made to wording of other contraindications i.e. cardiac failure changed to cardiac insufficiency & clinically significant renal impariment changed to severe renal insufficiency.

Section 4.4:
General section updated to include instruction to use the minimim effective dose of lithium and to provide clear instructions regarding the symptoms of impending toxicity to patients receiveding long term lithium therapy.

Monitoring section updated to include : Lithium therapy is contraindicated in patients with severe renal insufficiency or cardiac insufficiency (see section 4.3).

Renal, cardiac and thyroid functions should be re-assessed regularly during treatment with lithium.

For monitoring recommendations of lithium serum levels see section 4.2.


Renel impairment section udpated to:  Since lithium is primarily excreted via the renal route, significant accumulation of lithium may occur in patients with renal insufficiency. Therefore, if patients with mild or moderate renal impairment are being treated with lithium, serum lithium levels should be closely monitored (see section 4.2) and the dose should be adjusted accordingly. If very regular and close monitoring of serum lithium levels and plasma creatinine levels is not possible, lithium should not be prescribed in this population. Lithium is contraindicated in patients with severe renal insufficiency, (see section 4.3).

Patients should also be warned to report if polyuria or polydipsia develop. In patients who develop polyuria and/or polydipsia (see section 4.8), renal function should be monitored in addition to the routine serum lithium assessment.


Fluid and electrolyte section updated to include: if episodes of nausea......occur, lithium dosage should be closely monitored and dosage adjustments made as necessary.

the following sections have been added to section 4.4:
  • Risk of convulsions

The risk of convulsions may be increased in case of co-administration of lithium with drugs that lower the epileptic threshold, or in epileptic patients (see section 4.5 & section 4.8).

 

  • Benign intracranial hypertension

There have been case reports of benign intracranial hypertension (see section 4.8). Patients should be warned to report persistent headache and/or visual disturbances.

 

  • QT prolongation

As a precautionary measure, lithium should be avoided in patients with congenital long QT syndrome, and caution should be exercised in patients with risk factors for QT interval prolongation (e.g. uncorrected hypokalemia, bradycardia), and in patients concomitantly treated with drugs that are known to prolong the QT interval (see section 4.5 & section 4.8).

 

  • Brugada syndrome

Lithium may unmask or aggravate Brugada syndrome, a hereditary disease of the cardiac sodium channel with characteristic electrocardiographic changes (right bundle branch block and ST segment elevation in right precordial leads), which may lead to cardiac arrest or sudden death. Lithium should not be administered to patients with Brugada syndrome or a family history of Brugada syndrome (see section 4.3). Caution is advised in patients with a family history of cardiac arrest or sudden death.

 

Section regarding Elderly is updated to include:  Caution is also advised since lithium excretion may be reduced in the elderly due to age related decrease in renal function (see also section 4.2 & section 5.2).

 And section re Children added:

  • Children

The use in children is not recommended.



Section 4.5: updated to the following
 

4.5       Interactions with other medicinal products and other forms of interaction

 

Serum lithium levels may be increased if one of the following drugs is co-administered. When appropriate, either lithium dosage should be adjusted or concomitant treatment stopped.

·        Thiazide diuretics may reduce lithium renal clearance, potentially leading to lithium intoxication. If a thiazide diuretic has to be used, lithium dosage should first be reduced. Loop diuretics seem less likely to increase lithium levels.

·        Other drugs affecting electrolyte balance, e.g. steroids, may alter lithium excretion and should therefore be avoided.

·        Non-steroidal anti-inflammatory drugs (NSAIDs) including cyclo-oxygenase (COX) 2 inhibitors

·        Angiotensin-converting enzyme (ACE) inhibitors

·        Angiotensin II receptor antagonists

·        Metronidazole may reduce lithium renal clearance

·        Tetracyclines

 

Serum lithium levels may be decreased due to an increase in lithium renal clearance in case of concomitant administration of one of the following drugs:

·        Osmotic diuretics and carbonic anhydrase inhibitors

·        Xanthine (theophylline, caffeine)

·        Sodium bicarbonate

 

Co-administration of the following drugs may increase the risk of neurotoxicity:

·        Calcium channel blockers may lead to a risk of neurotoxicity with symptoms such as ataxia, confusion and somnolence. Lithium concentrations may be increased.

·        Antipsychotic drugs such as haloperidol, thioridazine, fluphenazine, chlorpromazine and clozapine may lead in rare cases to neurotoxicity with symptoms such as confusion, disorientation, lethargy, tremor, extra-pyramidal symptoms and myoclonus. Increased lithium levels were present in some of the reported cases. Discontinuation of both drugs is recommended at the first signs of neurotoxicity.

·        Carbamazepine may lead to dizziness, somnolence, confusion and cerebellar symptoms such as ataxia.

·        Methyldopa

·        Triptan derivatives and/or serotoninergic antidepressants such as SSRIs (such as fluoxatine and fluvoxamine) may result in occurrence of serotonin syndrome, which requires immediate treatment discontinuation.

Seritonin syndrome: The Serotonin Syndrome is a potentially life-threatening adverse drug reaction, which is caused by an excess in serotonin (e.g. from overdose or concomitant  use of serotonergic drugs), necessitating hospitalisation or even causing death. Symptoms may include:

-         Mental status change (agitation, confusion, hypomania, eventually coma);

-         Neuromuscular abnormalities (myoclonus, tremor, hyperreflexia, rigidity, akathisia);

-         Autonomic hyperactivity (hypo or hypertension, tachycardia, shivering, hyperthermia, diaphoresis);

-         Gastrointestinal symptoms (diarrhoea).

Strict adherence to the recommended doses is an essential factor for the prevention of the occurrence of this syndrome.

·         Caution is advised if lithium is co-administered with other drugs that prolong the QT interval (see also Section 6 and Section 11) e.g. Class IA (e.g. quinidine, disopyramide) or Class III (e.g. amiodarone) antiarrhythmic agents, cisapride, antibiotics such as erythromycin, antipsychotics such as thioridazine or amisulpride. This list is not exhaustive.

·        Caution is advised if lithium is co-administered with drugs that lower the epileptic threshold (see section 4.4), e.g. antidepressants such as SSRIs, tricyclic antidepressants, antipsychotics, anaesthetics, theophylline. This list is not comprehensive.

 

Section 4.6: updated to include

Neonates may show signs of lithium toxicity necessitating fluid therapy in the neonatal period, including symptoms such as lethargy, flaccid muscle tone, or hypotonia. Neonates born with low serum lithium concentrations may have a flaccid appearance that returns to normal without any treatment.Careful clinical observation of the neonate exposed to lithium during pregnancy is recommended and lithium levels may need to be monitored as necessary.


Remainder of section 4.6 updated to the following:

4.6.1        Women of child-bearing potential

 

Women of childbearing potential should use effective contraceptive methods during treatment with lithium.

It is advisable that women treated with lithium should adopt adequate contraceptive methods. In case of a planned pregnancy, it is strongly recommended to discontinue lithium therapy.

 

4.6.2        Lactation

 

Lithium is secreted in breast milk, and there have been reports of neonates showing signs of lithium toxicity (see section 4.6.1). Therefore lithium should not be used during breast feeding (see section 4.3). A decision should be made whether to discontinue lithium therapy or to discontinue breast feeding, taking into account the importance of the drug to the mother and the importance of breast feeding to the infant. Therefore, bottle-feeding is recommended (see section 4.3 Contraindications).


Section 4.7 updated to included warning to patients of possible hazards when driving or operating machinery.

Section 4.8 updated as follows:

4.8       Undesirable effects

 

Side effects are usually related to serum lithium concentration and are less common in patients with plasma lithium concentrations infrequent at levels below 1.0 mmol/l. The adverse reactions usually subside with a temporary reduction or discontinuation of the lithium treatment. Mild gastrointestinal effects such as nausea, a general discomfort and vertigo, may occur initially, but frequently disappear after the first few days of lithium administration. Fine hand tremors, polyuria and mild thirst may persist.

 

 

DermatologySkin and subcutaneous tissue disorders: acne, aggravation or occurrence of psoriasis, allergic rashes, alopecia, cutaneous ulcers.

Musculoskeleta and connective tissue disordersl: muscle weakness

Central nNervous system disorders: tremor especially fine hand tremors, vertigo, speech disorderdysarthria, impaired consciousness, myoclonyus, and abnormal reflexes, convulsions (see section 4.4 & section 4.5), benign intracranial hypertension (see section 4.4), extrapyramidal disorders have been reported.  Memory impairment may occur during long term use.

Gastrointestinal disorders: abdominal discomfort, taste disorder, nausea, vomiting, diarrhoea, salivary hypersecretion, dry mouth.

Endocrine disorders: long term adverse effects may include thyroid function disturbances such as euthyroid goitre and/or hypothyroidism. Rarely hyperthyroidism may also occur. Lithium-induced hypothyroidism may be managed successfully with concurrent levothyroxine. Hypercalcaemia, hypermagnesaemia, hyperparathyroidism have been reported.

Metabolic and Nutritional disorders: Weight increase.

CardiovascularCardiac disorders: QT prolongation, sometimes associated with ventricular tachycardia or torsades de points, which may result in ventricular fibrillation or cardiac arrest and sudden death. Other cardiac arrhythmia mainly bradycardia, sinus node dysfunction, ECG changes such as reversible flattening or inversion of T-waves, AV block,.  Ccardiomyopathy.

HaematologicalBlood and lymphatic disorders: leucocytosis

Renal and urinary disorders: polydipsia and/or polyuria, and nephrogenic diabetes insipidus have been reported (see section 4.4). This is usually due to lithium blocking the effect of ADH and is reversible on lithium withdrawal.

However, lLong term treatment with lithium may also result in permanent changes in kidney histology and impairment of renal function.

High serum concentrations of lithium including episodes of acute lithium toxicity may aggravate these changes. The minimum clinically effective dose of lithium should always be used. In patients who develop polyuria and/or polydipsia, renal function should be monitored, e.g. with measurement of blood urea, serum creatinine and urinary protein levels in addition to the routine serum lithium assessment.

 

Rare cCases of nephrotic syndrome have been reported.

 

Psychiatric disorders: Confusion.

 

General disorders and administration site conditions: Peripheral oedema.

Section 4.9 updated:to include some editorial updates, additional symptom and additional information regarding treating overdose.

Section 5 updated: with regarding to pK properties.

Some additional editorial updates have been made to the SPC.

Updated on 18 November 2010 PIL

Reasons for updating

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

Updated on 11 March 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Addition of statement on halving of tablet.

Updated on 18 December 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 31 August 2009 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

Update Section 4.5 & 4.8 - Amendment of typographical errors.

Updated on 28 November 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 28 November 2007 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Update section
7 - Change MA holder to sanofi-aventis Ireland Ltd.
8 - Update PA number
10 - Update date of revision

Updated on 24 May 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 24 May 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 24 May 2007 PIL

Reasons for updating

  • New PIL for medicines.ie