FAMOPSIN 20mg Film-coated tablet (2018)
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Περιεχόμενα
1. Name of the medicinal product
Famopsin 20 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains famotidine 20 mg. <u>Excipient(s) with known effect:</u> This product contains lactose 67.4 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. Light brown, round, film-coated tablets. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4.1. Therapeutic indications
Prevention of relapses of duodenal ulcers. Duodenal ulcer. Benign gastric ulcer. ZollingerEllison syndrome. Symptomatic treatment of mild 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 before going to sleep. Prophylactic treatment of recurrent duodenal ulcers 20 mg of famotidine in the ...
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 H<sub>2</sub>-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
<b>Pharmacotherapeutic group:</b> Drugs for acid related disorders; Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) <b>ATC Code:</b> 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
<u>Core:</u> Cellulose, microcrystalline Lactose monohydrate Maize starch Povidone Sodium starch glycolate (Type A) Silica, colloidal anhydrous Magnesium stearate <u>Film-coating:</u> 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 30 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)
11971
9. Date of first authorization / renewal of the authorization
Date of first authorization: 12 October 1988 Date of latest renewal: 10 December 2010
10. Date of revision of the text
04/09/2018
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