Ranigast is a drug used in peptic ulcer disease and gastro-esophageal reflux disease. This medicine contains the active ingredient famotidine in a dose of 20 mg, which belongs to a group of medicines called H2 receptor antagonists.

Famotidine inhibits the secretion of hydrochloric acid, also stimulated by food and pentagastrin, and reduces the concentration of pepsin in gastric juice.

Usually 1 tablet is taken once or maximum twice a day. The daily dose of the drug should not exceed 40 mg. The action of Famotydyna Ranigast tablets lasts for 10 to 12 hours.

Symptoms

Short-term symptomatic treatment of stomach problems unrelated to organic gastrointestinal disease, such as:

• indigestion,
• heartburn,
• hyperacidity.

Active substance: Famotidinum

Composition

The active substance is famotidine. Each tablet contains 20 mg of famotidine.

The other ingredients are:

• Tablet core: pregelatinized starch, powdered cellulose, magnesium stearate, talc.
• Tablet coating: hypromellose, titanium dioxide, macrogol 6000, talc, cochineal red lake (E124).

Dosage

• In case of symptoms, the usual dose is one tablet of Famotydyna Ranigast 20 mg per day.
• In case of recurrence of symptoms, one tablet of 20 mg can be used twice a day.
• The daily dose of Famotydyna Ranigast should not exceed 40 mg (2 tablets).
• The tablet should be swallowed whole with a little water.
• The drug should not be used without consulting a doctor for more than 2 weeks. If symptoms persist after 2 weeks of treatment, consult a doctor immediately.

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.

Use of the drug in children and adolescents

The drug should not be used in children and adolescents.

When should you not take Ranigast?

• if you are allergic to famotidine or any of the other ingredients of this medicine;
• if you have a history of allergy to other H2 receptor antagonists;
• if you have kidney failure.

Contents

The package of Famotydyna Ranigast contains 20 tablets and a leaflet.

Storage

Below 25°C

Manufacturer

POLPHARMA

Warnings

Talk to your doctor or pharmacist before taking Famotydyna Ranigast:

• if you have kidney problems.

Famotydyna Ranigast may mask the symptoms of other diseases, including stomach cancer. Therefore, if you experience any of the following conditions, contact your doctor immediately before or while taking this medicine:

• recurrent vomiting
• the onset of vomiting with food or blood,
• passing black stools (blood-stained faeces)
• if you experience weight loss, difficulty swallowing or persistent stomach pain together with indigestion,
• if you have not had any stomach problems (dyspeptic) before or if you have had it recently, but it has changed recently – especially in middle-aged or elderly people.

If the symptoms do not improve after 14 days of treatment, you should immediately contact your doctor to verify the diagnosis.

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.
• Famotydyna Ranigast may be used during pregnancy only when the doctor thinks it is absolutely necessary.
• Breast-feeding women should stop taking Famotydyna Ranigast or breast-feeding, as famotidine passes into breast milk.

Driving Vehicles

Some patients have experienced side effects such as dizziness, which may impair psychophysical fitness. If affected, you should not drive or operate machinery.

Overdosage

If you take more than the prescribed dose of the drug, contact your doctor immediately.

In the event of an overdose, the physician will decide on symptomatic treatment, which includes removing unabsorbed drug from the gastrointestinal tract, monitoring the clinical condition and applying supportive measures.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Interactions with other drugs

Tell the doctor or pharmacist about all the drugs taken by the patient now or recently, and about the drugs that the patient plans to take.

• Famotidine does not interact with warfarin (a drug that reduces blood clotting), theophylline (a drug used to treat asthma and other respiratory conditions), phenytoin (an anti-epileptic drug), diazepam (an anxiolytic and sedative drug), propranolol (a heart drug), aminophenazone, phenazone (painkillers).
• Changes in gastric pH can affect the bioavailability of some medicines (e.g. reduced absorption of atazanavir (an antiviral medicine used to treat HIV infection)).
• Famotidine can reduce the absorption of ketoconazole and itraconazole (antifungal drugs). Ketoconazole should be administered two hours before famotidine.
• Antacids may reduce the absorption of famotidine and lead to a reduction in serum famotidine levels. Therefore, famotidine should be taken 1-2 hours before administration of antacids.
• Administration of probenecid (a gout drug) may delay the excretion of famotidine. Concurrent administration of famotidine and probenecid should be avoided.
• Co-administration of sucralfate (a protective medicine to treat ulcers) within two hours of administration of famotidine should be avoided.
• Calcium carbonate, used in dialysis patients as a medicine to reduce excessively high levels of phosphate in the blood (hyperphosphataemia), is at risk of losing its effectiveness if it is given at the same time as famotidine.

Side effects

Like all medicines, Famotydyna Ranigast can cause side effects, although not everybody gets them.

If you notice any of the following very rare but serious side effects, stop taking Famotydyna Ranigast and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, rash, redness, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling. It is also possible for large blisters and bleeding around the lips, eyes, mouth, nose and genitals, or for large areas of the epidermis to creep. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems (hepatitis, cholestatic jaundice).

Other side effects include:

Common (occurs in less than 1 in 10 patients):

• headache, dizziness;
• constipation, diarrhea.

Uncommon (affects less than 1 in 100 patients):

• anorexia;
• taste disturbance;
• dry mouth, nausea and / or vomiting, abdominal discomfort or fullness, gas
• rash, itching, hives;
• tiredness.

Very rare (affects less than 1 in 10,000 patients):

• deficiency of all normal blood counts: red blood cells, white blood cells and platelets;
• transient mental disorders including depression, anxiety, agitation, disorientation, confusion and hallucinations, decreased libido, insomnia;
• convulsions, seizures with loss of consciousness, convulsions, drooling, trismus, sometimes rapid eye movements (especially in patients with impaired renal function), misguided feeling, drowsiness;
• interstitial pneumonia, sometimes fatal;
• disturbances in the activity of liver enzymes;
• excessive hair loss;
• joint pain, muscle cramps;
• AV block, QT prolongation (especially in patients with renal impairment);
• impotence;
• tightness of the chest.

Rare cases of gynaecomastia have been observed in controlled clinical trials, however these events were not more frequent than with placebo.