PRIADEL Prolonged-release tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Priadel 400mg Prolonged-release Tablets.

2. Qualitative and quantitative composition

Each tablet contains 400 mg lithium carbonate. For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Prolonged-release tablet. White, circular, bi-convex tablets engraved PRIADEL on one side and a scoreline on the other. The tablets can be divided into equal halves.

4.1. Therapeutic indications

In the management of acute manic or hypomanic episodes. In the management of episodes of recurrent depressive disorders where treatment with other antidepressants has been unsuccessful. In the prophylaxis ...

4.2. Posology and method of administration

Dosage must be individualized depending on serum lithium levels and clinical response. The dosage necessary to maintain serum lithium levels within the therapeutic range varies from patient to patient. ...

4.3. Contraindications

Hypersensitivity to lithium or to any of the excipients Cardiac insufficiency Severe renal insufficiency Addisons disease Untreated hypothyroidism Lactation Brugada syndrome or family history of Brugada ...

4.4. Special warnings and precautions for use

General When considering Priadel therapy, it is necessary to ascertain whether patients are receiving lithium in any other form. If so, check serum levels before proceeding.The minimum clinically effective ...

4.5. Interaction 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 ...

4.6. Fertility, pregnancy and lactation

Pregnancy Lithium therapy should not be used during pregnancy, especially during the first trimester, unless considered essential. It may be harmful to the foetus in human pregnancy. Cardiac, especially ...

4.7. Effects on ability to drive and use machines

Since lithium may slow reaction time, and considering the adverse reactions profile of lithium (see section 4.8), patients should be warned of the possible hazards when driving or operating machinery. ...

4.8. Undesirable effects

Side effects are usually related to serum lithium concentration and are infrequent at levels below 1.0 mmol/l. The adverse reactions usually subside with a temporary reduction or discontinuation of lithium ...

4.9. Overdose

Symptoms of lithium intoxication include: Gastrointestinal disorders: increasing anorexia, diarrhoea and vomiting. Nervous system disorders: Encephalopathy, cerebellar syndrome with symptoms such as muscle ...

5.1. Pharmacodynamic properties

Mood-stabilizing agent ATC code: N05AN01 (antipsychotics) Lithium is an alkali metal available for medical use as lithium carbonate or lithium citrate. The exact mechanism of action of lithium ...

5.2. Pharmacokinetic properties

Lithium is rapidly absorbed from the gastrointestinal tract. Steady-state lithium levels may not be obtained until 4-6 days. Time to peak serum level for controlled release Priadel tablets is about 2 hours ...

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1. List of excipients

Glycerol distearate Mannitol (E421) Acacia powder Sodium laurilsulfate Magnesium stearate Maize starch Sodium starch glycolate Type A

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Tablet containers: Do not store above 25°C. Dispense in an airtight container. Keep the container tightly closed. Blister strips: Do not store above 25°C. Store in the original package to ...

6.5. Nature and contents of container

Polypropylene tablet containers of 100 and 1000 tablets with a snap on low density polyethylene lid. PVC/PVdC/aluminium blister strips, each strip containing 10 tablets. Ten strips are packed in a cardboard ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Essential Pharma Limited, Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara, CBD 1070, Malta

8. Marketing authorization number(s)

PA22587/001/002

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 01 April 1978 Date of last renewal: 01 August 2009

10. Date of revision of the text

March 2021

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