FAMOPSIN 40mg Film-coated tablet (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Famopsin 40 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains famotidine 40 mg. Excipient(s) with known effect: This product contains lactose 155.1 mg. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet. Yellow, round, scored, film-coated tablets with Remedicas logo on one side. The tablet can be divided into equal doses.

4.1. Therapeutic indications

Duodenal ulcer. Benign gastric ulcer. Zollinger-Ellison syndrome. Treatment of mild to moderate reflux oesophagitis.

4.2. Posology and method of administration

Posology Adults and the elderly Duodenal ulcers and benign gastric ulcers 40 mg of famotidine once in the evening before going to bed. Zollinger-Ellison syndrome If no preceding treatment with medicines ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with a history of hypersensitivity to other H2-receptor antagonists.

4.4. Special warnings and precautions for use

Gastric neoplasm Gastric malignancy should be excluded prior to initiation of therapy of gastric ulcer with famotidine. Symptomatic response of gastric ulcer to famotidine therapy does not preclude the ...

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

No drug interactions of clinical importance have been identified. Famotidine does not interact with the cytochrome P450-linked drug metabolizing enzyme system. Compounds metabolized by this system which ...

4.6. Pregnancy and lactation

Pregnancy Famotidine is not recommended for use in pregnancy, and should be prescribed only if clearly needed. Before a decision is made to use famotidine during pregnancy, the physician should weigh the ...

4.7. Effects on ability to drive and use machines

Some patients have experienced adverse reactions such as dizziness and headache while taking famotidine. Patients should be informed that they should avoid driving vehicles or operating machinery or doing ...

4.8. Undesirable effects

Tabulated list of adverse reactions Frequencies are defined as 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 ...

4.9. Overdose

The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see section 4.8). Patients with Zollinger-Ellison syndrome have tolerated doses up ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for acid related disorders; Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) ATC Code: A02BA03 Mechanism of action Famotidine is a competitive ...

5.2. Pharmacokinetic properties

Famotidine kinetics is linear. Absorption Famotidine is quickly absorbed after oral administration. Distribution Peak plasma concentrations are achieved in approximately 1-3.5 hours after administration ...

5.3. Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity and toxicity to reproduction.

6.1. List of excipients

Core: Cellulose, microcrystalline Lactose monohydrate Maize starch Povidone Sodium starch glycolate (Type A) Silica, colloidal anhydrous Magnesium stearate Coating: Hypromellose Macrogol ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and moisture.

6.5. Nature and contents of container

PVC/Aluminium blisters. Pack-sizes of 10, 50 and 100 film-coated tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

11972

9. Date of first authorization / renewal of the authorization

Date of first authorization: 12 October 1988 Date of latest renewal: 03 October 2012

10. Date of revision of the text

04/09/2018

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