Famotidin Alkaloid 20 mg and 40 mg film-coated tablets – famotidine for peptic ulcer and reflux disease (GORD)

Famotidin Alkaloid is a film-coated tablet containing famotidine – a substance from the group of H2-receptor antagonists. Famotidine reduces the amount of acid produced in the stomach, so it is used for gastric and duodenal ulcers and for gastro-oesophageal reflux disease (GORD).

The medicine is made by Alkaloid and is authorised in Serbia in two strengths – 20 mg and 40 mg famotidine per tablet. It is dispensed on prescription, and the doctor determines the dose and duration of treatment according to the disease and kidney function.

What is Famotidin Alkaloid used for and how should it be taken?

Key facts about the medicine

What is Famotidin Alkaloid used for?

• treatment and prevention of gastric or duodenal ulcers;
• reducing the chance of a duodenal ulcer coming back;
• treatment of ulcers and relief of symptoms associated with gastric ulcers;
• treatment of gastro-oesophageal reflux disease (GORD) – backflow of food and stomach acid into the oesophagus – and prevention of recurring symptoms;
• treatment of Zollinger-Ellison syndrome (a condition in which a certain type of tumour causes large amounts of stomach acid to be produced).

How is it taken and dosed?

The dose depends on the severity of the disease and on kidney function. Swallow the tablet whole with water, without crushing or chewing; it can be taken with food and drink. Usual dosage according to the leaflet:

• Do not take higher or lower doses than prescribed.
• Take the medicine for as long as your doctor has recommended, even if you feel better earlier.

Special patient groups

• Elderly: no dose adjustment is needed.
• Impaired kidney function: the dose is reduced; according to the SmPC, with creatinine clearance below 10 mL/min the dose is halved, and patients on dialysis take the tablets towards the end of or after dialysis.
• Children: Famotidin Alkaloid should not be prescribed for children.
• Long-term use of high doses: the doctor may request a blood count and liver function tests.

Contraindications – when the medicine must not be used

Do not take Famotidin Alkaloid:

• if you are allergic to famotidine, other H2-receptor antagonists or any ingredient of the medicine;
• if you have ever had an allergic reaction to a similar medicine;
• if you are breast-feeding.

Warnings and precautions

Talk to your doctor before taking the medicine if:

• you have kidney problems;
• there is a possibility of a malignant tumour in your stomach;
• you have an underlying infection, e.g. Helicobacter pylori.

If you have had an ulcer for a long time, do not stop treatment without talking to your doctor. The medicine contains lactose – if you have an intolerance to some sugars, contact your doctor.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take; according to the leaflet this applies particularly to:

• probenecid (gout);
• itraconazole and ketoconazole (fungal infections);
• posaconazole – famotidine may reduce the effect of posaconazole oral suspension;
• atazanavir (HIV infection);
• antacids (medicines for heartburn and indigestion);
• calcium carbonate when used to treat high blood phosphate levels;
• sucralfate (ulcers);
• dasatinib, erlotinib, gefitinib and pazopanib (cancer medicines) – famotidine may reduce their effect.

The tablets can be taken with food and drink.

Pregnancy and breast-feeding

• Pregnancy: famotidine is used during pregnancy only if necessary, as judged by the doctor.
• Breast-feeding: famotidine passes into breast milk – the medicine must not be taken while breast-feeding.

Driving and using machines

Some patients experience dizziness and headache. Do not drive or use machines until you know how the medicine affects you, or if you experience these symptoms.

Possible side effects

Like all medicines, Famotidin Alkaloid can cause side effects, although not everybody gets them.

• Common (up to 1 in 10): headache, dizziness, constipation, diarrhoea.
• Uncommon (up to 1 in 100): dry mouth, altered taste, nausea, vomiting, mild stomach pain or bloating, rash, hives, severe itching, loss of appetite, tiredness.
• Rare (up to 1 in 1,000): cholestasis (bile stasis) with persistent itching.
• Very rare (up to 1 in 10,000): depression, agitation, confusion, hallucinations, disorientation (usually resolve after stopping), insomnia, convulsions and seizures (especially with kidney disease), drowsiness, pins and needles, reduced libido, heart rhythm disorders (AV block, prolonged QT interval), chest tightness, joint pain and muscle cramps, jaundice and hepatitis, reduced blood cell counts, hair loss, impotence.
• Frequency not known: breast enlargement in men.

If any side effect becomes serious, tell your doctor or pharmacist.

Overdose, missed dose and stopping treatment

• Overdose: if you have taken more than you should, talk to a doctor or pharmacist straight away.
• Missed dose: take it as soon as possible; if it is almost time for the next dose, continue with the usual schedule. Do not take a double dose.
• Stopping treatment: it is important not to stop taking the medicine suddenly without first consulting your doctor.

Related information

For additional care and support with heartburn and stomach complaints, see also the category Heartburn (excess acid) – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substance: famotidine – 20 mg or 40 mg per film-coated tablet.
• Tablet core: maize starch; magnesium stearate; lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica.
• Film coating (20 mg): hypromellose; macrogol 4000; titanium dioxide (E171); red and yellow iron oxide (E172). Film coating (40 mg): hypromellose; macrogol 4000; titanium dioxide (E171); red iron oxide (E172).
• Appearance: round, biconvex tablets with a score line; the tablet can be divided into equal doses.
• Pack: 20 mg – 20 tablets (2 blisters of 10); 40 mg – 10 tablets (1 blister).
• Marketing authorisation holder: Alkaloid d.o.o. Beograd, Prahovska 3, Belgrade. Manufacturers: Alkaloid d.o.o. Beograd (manufacturing site Pančevački put 38 “S”, Belgrade) and Alkaloid AD Skopje, North Macedonia.

Storage

• No special storage conditions.
• Keep out of the sight and reach of children.
• Shelf life is 3 years; do not use after the expiry date. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

When is the best time to take Famotidin Alkaloid?

For ulcers one dose is usually taken in the evening at bedtime (40 mg for treatment, 20 mg to prevent a duodenal ulcer from returning), and for reflux disease one dose in the morning and one in the evening. Your doctor sets the exact regimen.

Can Famotidin Alkaloid be taken with food?

Yes. According to the leaflet, the tablets can be taken with food and drink; they are swallowed whole with water.

May I take Famotidin Alkaloid while breast-feeding?

No. Famotidine passes into breast milk and breast-feeding is listed as a contraindication. In pregnancy the medicine is used only if the doctor considers it necessary.

How long does treatment last?

For ulcers treatment usually lasts 4–8 weeks, for reflux with oesophageal erosions 6–8 weeks, and preventive treatment of GORD should not last longer than 6 months. Do not stop the medicine without agreeing it with your doctor.

Sources

• ALIMS – Summary of Product Characteristics, Famotidin Alkaloid® 20 mg and 40 mg film-coated tablets (SmPC, Serbian)
• ALIMS – Package leaflet, Famotidin Alkaloid® 20 mg and 40 mg film-coated tablets (PIL, Serbian, 20 mg authorisation)
• ALIMS – Package leaflet, Famotidin Alkaloid® (PIL, Serbian, 40 mg authorisation)

Sources checked on: 25 October 2026.