Famotidine

• Decreases the production of stomach acid
• For intestinal problems such as acid reflux and peptic ulcers
• Can be used during pregnancy and breastfeeding
• Not suitable for use in children

About Famotidine

Famotidine Aurobindo 20 mg works by decreasing the amount of acid made in the stomach. It is used to treat certain conditions resulting from increased gastric acid production. Famotidine is in a class of medicine called histamine-H2 receptor antagonists (H2 blockers).

Famotidine Aurobindo 20 mg is indicated for the treatment of:

• Symptoms of gastroesophageal reflux disease (GERD), such as heartburn.
• Benign gastric ulcers (sores on the lining of the stomach).
• Duodenal ulcers (sores in the duodenum, the first part of the small intestine).
• Recurrent duodenal ulcers (prevention).
• Zollinger-Ellison syndrome (tumours in the pancreas or small intestine that cause increased production of stomach acid).

Use

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Famotidine Aurobindo 20-mg tablets should be swallowed whole with some liquid. They can be taken with or without food.

Dosage

The recommended dose depends on the severity of the disease and the dosage of previously used medicines. The amount to be taken should be determined by a doctor.

The recommended dose in adults is:

Treatment of GERD symptoms (e.g., heartburn):

• 20 mg twice daily.

Benign gastric ulcers and duodenal ulcers:

• 40 mg before bedtime.

The treatment duration is four to eight weeks, although the treatment can be stopped earlier if your doctor determines that the ulcer has healed. If the examination demonstrates that the ulcer has not healed, treatment should be continued for another four weeks.

Prevention of recurrent duodenal ulcers:

• 20 mg once daily in the evening.

The recommended maintenance dose of 20 mg has shown to be effective in clinical trials lasting 12 months.

Zollinger-Ellison syndrome:

For first-time treatment of Zollinger-Ellison syndrome: 20 mg every six hours. Depending on the effect, your doctor may increase this dose until the desired effect is achieved. If treatment with a daily dose of up to 800 mg is not effective, your doctor may consider switching you to a different medicine.

If you have previously taken similar medicines (e.g. other H2 blockers), your doctor may prescribe a stronger starting dose. Ask your doctor for the correct dose.

Treatment should be continued for as long as necessary. For patients with renal impairment, the doctor may adjust the dose. This medicine is not suitable for use in children.

Alcohol/driving

Famotidine may cause side effects such as dizziness, headache and drowsiness. Do not drive if you experience these side effects. This medicine does not interact with alcohol.

If you take more or less Famotidine than you should

Consult a doctor if you have taken too much of this medicine.

If you miss a dose of Famotidine, take the tablet as soon as you remember. Continue your dosing schedule as usual the following day. Never take a double dose to make up for the forgotten one.

Always consult your doctor before stopping treatment with Famotidine.

When not to use Famotidine

Famotidine is not suitable for everyone. Do not use Famotidine if you are hypersensitive to any of the ingredients in this medicine (see section 'What Famotidine contains').

When should this medicine be used with extreme caution?

Consult a doctor on the use of this medicine if:

• You have symptoms that may indicate a malignant condition, such as unintentional weight loss, repeated vomiting, difficulty swallowing, vomiting blood, symptoms of anaemia (paleness and weakness), bloody stools. A doctor will need to investigate these symptoms to determine their cause.
• You have a duodenal ulcer or benign gastric ulcer. Ulcers can be caused by an infection of Helicobacter pylori (H. pylori) bacteria. A doctor will want to investigate this first.
• You have mild gastrointestinal problems. In this case, you should not use this medicine. An alternative medicine may be prescribed to treat your condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. In most cases, Famotidine can be used during pregnancy and while breastfeeding.

Other medicines and Famotidine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines alongside Famotidine Aurobindo 20 mg. Talk to your doctor if you are taking any of the medicines below.

Famotidine should not be used in combination with:

• Probenecid (used to treat gout), because probenecid may affect the elimination of famotidine.
• Atazanavir, ritonavir and tenofovir (anti-HIV medicines).

The effect of this medicine can be decreased by:

• Medicines that neutralise gastric acid (antacids). Since the effect of this medicine is reduced, you should take it at least one to two hours before taking an antacid.
• Sucralfate (used to treat ulcers). As a rule, you should not take sucralfate within two hours of taking this medicine.

This medicine may decrease the effect of:

• Ketoconazole or itraconazole (antifungal medicines). You should take ketoconazole two hours before taking Famotidine.
• Atazanavir or ritonavir (anti-HIV medicines). Consult your doctor before taking these medicines.
• Medicines containing calcium carbonate, when used in patients with high serum phosphate who are undergoing dialysis.

For more warnings about the use of Famotidine, please see the package leaflet.

Side effects

Medicines can cause side effects, although some people may not experience any. The side effects that are known to be associated with this medicine include:

Common (may affect up to 1 in 10 people):

• Headache.
• Dizziness.
• Constipation.
• Diarrhoea.

Uncommon (may affect up to 1 in 100 people):

• Dry mouth.
• Loss of appetite, nausea, vomiting, flatulence or other gastro-intestinal problems.
• Skin irritation and itching.
• Tiredness.

Rare (may affect up to 1 in 1000 people):

• Severe allergic reactions causing breathing problems or dizziness, swelling of the face or neck, breathing difficulties or wheezing.
• Yellow discolouration of the white of the eyes and the skin (jaundice), caused by a blocked duct in your bile duct system.
• Hives.
• Joint pain.
• Elevated lab values (transaminase, gamma-GT, alkaline phosphatase, bilirubin elevations).

For a complete list of possible side effects, see the package leaflet. Consult a doctor if you experience any side effects. It's particularly important that you see a doctor without delay if you experience severe side effects such as an acute allergic reaction.

What Famotidine contains

The active substance in this medicine is famotidine. One film-coated tablet contains 20 mg famotidine.
The other ingredients are:

Tablet core: microcrystalline cellulose, maize starch, pregelatinised maize starch, povidone, talc, magnesium stearate.

Tablet coating: hypromellose, talc, titanium dioxide (E171), propylene glycol.

The manufacturers of Famotidine Aurobindo 20 mg are:

Centrafarm Services B.V. Nieuwe Donk 9
4879 AC Etten-Leur
The Netherlands

STADA Arzneimittel AG Stadastrasse 2-18
61118 Bad Vilbel
Germany

STADA Arzneimittel GmbH Muthgasse 36
1190 Vienna

Austria

Cosmo S.p.A. Via C. Colombo, 1
20020 Lainate
Italy

Package leaflet

Read the package leaflet before use. The official package leaflet of Famotidine Aurobindo 20 mg is available for download here.