Famotidina Ranigast

Package Leaflet: Information for the Patient

FAMOTIDINE Ranigast

20 mg, coated tablets

Famotidine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 14 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What is Famotydine Ranigast and what is it used for
• 2. Important information before taking Famotydine Ranigast
• 3. How to take Famotydine Ranigast
• 4. Possible side effects
• 5. How to store Famotydine Ranigast
• 6. Contents of the pack and other information

1. What is Famotydine Ranigast and what is it used for

Famotydine Ranigast contains famotidine, which belongs to a group of medicines called H2 receptor antagonists. It inhibits the secretion of hydrochloric acid in the stomach. The indication for use of the medicine is short-term symptomatic treatment of gastrointestinal disorders not related to organic disease of the gastrointestinal tract, such as: indigestion (dyspepsia), heartburn, hyperacidity. The effect of the medicine lasts for 10 to 12 hours.

2. Important information before taking Famotydine Ranigast

When not to take Famotydine Ranigast

• -if the patient is allergic to famotidine or any of the other ingredients of this medicine (listed in section 6);
• -if the patient is allergic to other H2 receptor antagonist medicines;
• -if the patient has renal failure.

Warnings and precautions

Before taking Famotydine Ranigast, the patient should discuss it with a doctor or pharmacist:

• if the patient has kidney function disorders.

Famotydine Ranigast may mask the symptoms of other diseases, including stomach cancer. Therefore, if any of the following conditions occur before or during treatment with the medicine, the patient should immediately consult a doctor:

• recurring vomiting,
• appearance of vomiting with food or blood,
• passing black stools (stool discolored with blood),
• if the patient experiences weight loss, difficulty swallowing, or persistent abdominal pain, along with indigestion,
• if the patient has not had gastrointestinal symptoms (dyspeptic) before or if they have changed recently - especially in people of middle or advanced age. If the symptoms do not improve after 14 days of treatment, the patient should immediately consult a doctor to verify the diagnosis.

Children and adolescents

The safety and efficacy of the medicine in children have not been established. The medicine should not be used in children and adolescents.

Famotydine Ranigast and other medicines

The patient should tell the doctor or pharmacist about all medicines being taken currently or recently, as well as any medicines planned to be taken.

• Famotidine does not interact with warfarin (a medicine that reduces blood clotting), theophylline (a medicine used to treat asthma and other respiratory diseases), phenytoin (an antiepileptic medicine), diazepam (an anxiolytic and sedative medicine), propranolol (a heart medicine), aminophenazone, phenazone (painkillers).
• Changes in gastric pH may affect the bioavailability of some medicines (e.g., reduced absorption of atazanavir (an antiviral medicine used to treat HIV infection)).
• Famotidine may reduce the absorption of ketoconazole and itraconazole (antifungal medicines). Ketoconazole should be administered 2 hours before taking famotidine.
• Antacids may reduce the absorption of famotidine and lead to a decrease in famotidine plasma concentration. Therefore, famotidine should be taken 1-2 hours before taking antacids.
• Concomitant administration of probenecid (a medicine used to treat gout) may delay the elimination of famotidine. Concomitant administration of famotidine and probenecid should be avoided.
• Concomitant administration of sucralfate (a protective medicine used to treat peptic ulcer disease) within 2 hours after taking famotidine should be avoided.
• There is a risk of reduced efficacy of calcium carbonate, used in dialyzed patients as a medicine to reduce high phosphate levels in the blood (hyperphosphatemia), if taken concomitantly with famotidine.
• Particular caution should be exercised when taking famotidine concomitantly with rilpivirine. In such cases, famotidine should be taken once a day. A precise dosing schedule should be followed, with famotidine administered at least 12 hours before or 4 hours after rilpivirine.
• Use of Famotydine Ranigast may reduce the effect of posaconazole oral suspension (an antifungal medicine).
• Use of Famotydine Ranigast may reduce the effect of dasatinib, erlotinib, gefitinib, pazopanib (medicines used to treat cancer).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Famotydine Ranigast may be used in pregnant women only when absolutely necessary.
Breastfeeding
Women who are breastfeeding should stop taking Famotydine Ranigast or breastfeeding, as famotidine passes into breast milk.

Use with food and drink

The medicine can be taken independently of meals.

Driving and using machines

There are no data on contraindications for driving vehicles and operating machinery during the use of famotidine. However, some patients have experienced side effects such as dizziness, which may impair psychophysical fitness. If such side effects occur, the patient should not drive vehicles or operate machinery.

Famotydine Ranigast contains cochineal red (E124)

The medicine may cause allergic reactions.

3. How to take Famotydine Ranigast

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist again.
Adults
Usually, 1 tablet of 20 mg is taken once a day. In case of recurrence of symptoms, 1 tablet of 20 mg can be taken twice a day. The daily dose of the medicine should not exceed 40 mg (2 tablets).
The tablet should be swallowed whole, with a small amount of water.
The medicine should not be taken without consulting a doctor for more than 2 weeks. If the symptoms do not improve after 2 weeks of treatment, the patient should immediately consult a doctor.
Use in patients with renal impairment
Due to the fact that the medicine is mainly excreted by the kidneys, caution should be exercised in patients with renal impairment. Patients with renal impairment should consult a doctor before taking the medicine, as it may be necessary to reduce the dose by half or extend the period between doses to 36-48 hours.
The medicine is contraindicated in patients with renal failure.
Use in elderly patients
There is no need to change the dosage in elderly patients.
Use in children and adolescents
The medicine should not be used in children and adolescents.

Missing a dose of Famotydine Ranigast

In case of missing a dose, it should be taken as soon as possible. However, if it is close to the time for the next dose, the missed dose should not be taken. A double dose should not be taken to make up for the missed dose.

Taking more than the recommended dose of Famotydine Ranigast

In case of taking more than the recommended dose, the patient should immediately consult a doctor.
In case of overdose, the doctor will decide on symptomatic treatment, which consists of removing the unabsorbed medicine from the gastrointestinal tract, monitoring the patient's condition, and providing supportive treatment.
In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of noticing any of the following very rare but serious side effects, the patient should stop taking Famotydine Ranigast and immediately consult a doctor:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, redness, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. Large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals, or shedding of large areas of skin. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver function disorders (hepatitis, cholestatic jaundice).

Other side effects include:

Common(occurring in less than 1 in 10 patients)

• headache, dizziness
• constipation, diarrhea

Uncommon(occurring in less than 1 in 100 patients)

• anorexia
• taste disorders
• dry mouth, nausea, and/or vomiting, feeling of discomfort or fullness in the abdominal cavity, bloating
• rash, itching, urticaria
• fatigue

Rare(occurring in less than 1 in 10,000 patients)

• deficiency of all normal blood cell elements: red blood cells, white blood cells, and platelets
• transient mental disorders, including depression, anxiety, agitation, disorientation, confusion, and hallucinations, decreased libido, insomnia
• seizures, convulsions with loss of consciousness, seizures, drooling, trismus, sometimes rapid eye movements (especially in patients with renal impairment), feeling of unease, drowsiness
• interstitial pneumonia, sometimes leading to death
• liver enzyme activity disorders
• excessive hair loss
• joint pain, muscle cramps
• atrioventricular block, QT interval prolongation (especially in patients with renal impairment)
• impotence
• chest tightness.

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Famotydine Ranigast

The medicine should be stored out of sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Famotydine Ranigast contains

• The active substance of the medicine is famotidine. Each tablet contains 20 mg of famotidine.
• The other ingredients of the medicine are: Tablet core: maize starch, microcrystalline cellulose, magnesium stearate, talc. Tablet coating: hypromellose, titanium dioxide, macrogol 6000, talc, lake of cochineal red (E124).

What Famotydine Ranigast looks like and contents of the pack

Coated tablets, pink, round, biconvex.
Blisters of aluminum/PVC in a cardboard box.
The pack contains 10, 20, or 30 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: 22 364 61 01
Date of last revision of the leaflet:August 2023