TOMEL Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Tomel 25 mg film-coated tablets. Tomel 100 mg film-coated tablets. Tomel 150 mg film-coated tablets. Tomel 200 mg film-coated tablets. Tomel 300 mg film-coated tablets.

2. Qualitative and quantitative composition

For 25 mg strength Each tablet contains 25 mg quetiapine (as quetiapine fumarate). Excipient(s) with known effect: Each tablet contains 1.000 mg lactose monohydrate. For 100 mg strength Each tablet ...

3. Pharmaceutical form

Film-coated tablets. For 25 mg strength: Peach coloured, round, biconvex film-coated tablets. For 100 mg strength: Yellow coloured, round, biconvex film-coated tablets with breakline on one ...

4.1. Therapeutic indications

Tomel is indicated for: treatment of schizophrenia. treatment of bipolar disorder:For the treatment of moderate to severe manic episodes in bipolar disorder For the treatment of major depressive episodes ...

4.2. Posology and method of administration

Posology Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition. Tomel can be administered ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal ...

4.4. Special warnings and precautions for use

As quetiapine has several indications, the safety profile should be considered with respect to the individual patients diagnosis and the dose being administered. Paediatric population Quetiapine is not ...

4.5. Interaction with other medicinal products and other forms of interaction

Given the primary central nervous system effects of quetiapine, quetiapine should be used with caution in combination with other centrally acting medicinal products and alcohol. Caution should be exercised ...

4.6. Fertility, pregnancy and lactation

Pregnancy First trimester The moderate amount of published data from exposed pregnancies (i.e. between 300-1000 pregnancy outcomes), including individual reports and some observational studies do not suggest ...

4.7. Effects on ability to drive and use machines

Given its primary central nervous system effects, quetiapine may interfere with activities requiring mental alertness. Therefore, patients should be advised not to drive or operate machinery, until individual ...

4.8. Undesirable effects

The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine (≥10%) are somnolence, dizziness, headache, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, ...

4.9. Overdose

Symptoms In general, reported signs and symptoms were those resulting from an exaggeration of the active substances known pharmacological effects, i.e. drowsiness and sedation, tachycardia, hypotension ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antipsychotics; Diazepines, oxazepines and thiazepines ATC code: N05AH04 Mechanism of action Quetiapine is an atypical antipsychotic agent. Quetiapine and the active ...

5.2. Pharmacokinetic properties

Absorption Quetiapine is well absorbed and extensively metabolised following oral administration. The bioavailability of quetiapine is not significantly affected by administration with food. Steady-state ...

5.3. Preclinical safety data

There was no evidence of genotoxicity in a series of in vitro and in vivo genotoxicity studies. In laboratory animals at a clinically relevant exposure level the following deviations were seen, which as ...

6.1. List of excipients

Tablet core: Calcium hydrogen phosphate anhydrous Lactose monohydrate Cellulose microcrystalline Sodium starch glycolate Povidone Magnesium stearate Water purified Film-coating: For 25 mg ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

The tablets for Tomel 25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablets are packed in white opaque PVC/PE/PVDC/Al blisters containing 28, 30, 60 tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

8. Marketing authorization number(s)

Tomel 25 mg film-coated tablets: 021144 Tomel 100 mg film-coated tablets: 021145 Tomel 150 mg film-coated tablets: 021146 Tomel 200 mg film-coated tablets: 021147 Tomel 300 mg film-coated tablets: 021148 ...

9. Date of first authorization / renewal of the authorization

Date of first authorization: 10/11/2011 Date of latest renewal: 04/05/2017

10. Date of revision of the text

06/07/2021

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