ULCERAN Film-coated tablet (2018)

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Περιεχόμενα

1. Name of the medicinal product

Ulceran 20 mg film-coated tablets. Ulceran 40 mg film-coated tablets.

2. Qualitative and quantitative composition

Ulceran tablets 20 mg contain 20 mg of famotidine. Ulceran tablets 40 mg contain 40 mg of famotidine. Excipient with known effect: lactose. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet. Ulceran tablets 20 mg are round, brown, film-coated tablets. Ulceran tablets 40 mg are round, brown, film-coated tablets.

4.1. Therapeutic indications

Ulceran tablets are indicated for the treatment of the following conditions: Benign gastric ulcer. Duodenal ulcer and prevention of duodenal ulcer relapses. Treatment of gastro-oesophageal reflux disease ...

4.2. Posology and method of administration

Method of administration Ulceran tablets are for oral administration only. They should be swallowed whole with a little water. Posology Adults Benign gastric ulcer: One 40mg tablet at night. Treatment ...

4.3. Contraindications

Hypersensitivity to famotidine or to any of the excipients listed in section 6.1. Since cross-sensitivity has been documented in this class, Ulceran should not be administered to patients with a history ...

4.4. Special warnings and precautions for use

Symptoms associated with carcinoma of the stomach can be masked by treatment with a histamine H2-antagonist, which may delay diagnosis of the carcinoma. If gastric ulcer is suspected, the possibility ...

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

Clinically important drug interactions have not been identified. Famotidine does not interact with the cytochrome P450 linked drug metabolising system. Aminopyrine, diazepam, phenazone, phenytoin, propranolol, ...

4.6. Fertility, pregnancy and lactation

Pregnancy Ulceran is not recommended for use in pregnancy. It should be prescribed only if use is essential, and the physician should weigh the potential benefits against the potential risks. Breastfeeding ...

4.7. Effects on ability to drive and use machines

As dizziness, headaches or fatigue may occur, patients should make sure they are not affected before driving or operating machines.

4.8. Undesirable effects

Ulceran is generally well tolerated. The adverse reactions are displayed by frequency using the following convention: very common (≥1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare ...

4.9. Overdose

There has not been any report of over dosage. The procedure in such case is to remove unabsorbed material from the gastro-intestinal tract, clinically monitor the patient and therapy should be symptomatic ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), H2-receptor antagonists ATC code: A02BA03 Ulceran is a highly specific and potent ...

5.2. Pharmacokinetic properties

Ulceran is orally administered. Famotidine preparations reach the peak plasma concentration within 1 to 3 hours after administration and the peak plasma concentration of a 40 mg dose is 0.076 to 0.1 mcg/ml. ...

5.3. Preclinical safety data

No further relevant data.

6.1. List of excipients

Microcrystalline cellulose Lactose Croscarmellose sodium Silicon dioxide Magnesium stearate Titanium dioxide Hydroxypropylcellulose Polyethylene glycol 400 Iron oxides yellow, black and red, E172

6.2. Incompatibilities

None known.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C in the original package, in order to protect from light.

6.5. Nature and contents of container

Polyvinylchloride-aluminium blisters with a patient information leaflet in a carton and securitainers are available. 20 mg: 20, 30, 100 packs are available and securitainers of 250 and 500 tablets ...

6.6. Special precautions for disposal and other handling

None.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

Ulceran 20 mg: 11010 Ulceran 40 mg: 11011

9. Date of first authorization / renewal of the authorization

Ulceran 20 mg: 14.01.1987 / 20.03.2009 Ulceran 40 mg: 14.01.1987 / 20.03.2009

10. Date of revision of the text

09/2018

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