ULCEDINE Film coated table (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Ulcedine 20 mg film coated tablets. Ulcedine 40 mg film coated tablets.
2. Qualitative and quantitative composition
Ulcedine 20mg film coated tablets contain 20mg of famotidine. Ulcedine 40mg film coated tablets contain 40mg of famotidine. <u>Excipient with known effect:</u> lactose. Each Ulcedine 20mg film coated tablet ...
3. Pharmaceutical form
Film coated tablet. Ulcedine 20mg film coated tablets are round, brown film coated tablets for oral administration. Ulcedine 40mg film coated tablets are round, brown, film coated tablets for oral administration. ...
4.1. Therapeutic indications
Benign gastric ulcer. Duodenal ulcer and prevention of duodenal ulcer relapses. Treatment of gastro-oesophageal reflux disease and prevention of relapse of symptoms and ulceration associated with gastro-oesophageal ...
4.2. Posology and method of administration
Posology Adults Benign gastric ulcer One 40mg tablet at night. Treatment should last four to eight weeks, unless endoscopy reveals complete healing earlier. Duodenal ulcer One 40mg tablet at night. Treatment ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Symptoms associated with carcinoma of the stomach can be masked by treatment with a histamine H<sub>2</sub>-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. Pregnancy and lactation
Pregnancy Ulcedine 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. Breast-feeding ...
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
Ulcedine is generally well tolerated. The following adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon ...
4.9. Overdose
There has not been any report of overdosage. 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
<b>Pharmacotherapeutic group:</b> H<sub>2</sub>-receptor antagonists, Drugs for acid related disorders <b>ATC code:</b> A02BA03 Ulcedine is a highly specific and potent competitive H<sub>2</sub>-receptors ...
5.2. Pharmacokinetic properties
Ulcedine 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
The film coated tablets also contain microcrystalline cellulose, lactose, croscarmellose sodium, silicon dioxide, magnesium stearate, titanium dioxide (E172), hydroxypropylmethyl cellulose, polyethylene ...
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, in 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. Ulcedine 20mg is available in cartons of 30 and 100 tablets and Ulcedine 40mg in cartons of 20 and 100 tablets. For ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Codal-Synto Ltd., 21 Constantinoupoleos St., 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Ulcedine 20mg film coated tablets: 19961 Ulcedine 40mg film coated tablets: 20001
9. Date of first authorization / renewal of the authorization
<u>Ulcedine 20mg film coated tablets:</u> Date of first authorization: 29/12/2005 / Renewal: 09/10/2012 <u>Ulcedine 40 mg film coated tablets:</u> Date of first authorization: 29/12/2005 / Renewal: 23/04/2014 ...
10. Date of revision of the text
10/2018
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