Famogast

Package Leaflet: Information for the Patient

Famogast, 40 mg, Coated Tablets

Famotidine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Famogast and what is it used for

Famogast contains famotidine, which blocks histamine H2 receptors located in the stomach lining cells. Famogast inhibits the secretion of hydrochloric acid (also stimulated by food). The action of the medicine lasts for 10 to 12 hours.

Indications for Use

• Duodenal ulcer disease.
• Prevention of duodenal ulcer recurrence after healing of its active form.
• Diseases associated with excessive hydrochloric acid secretion (Zollinger-Ellison syndrome).
• Gastric ulcer disease.
• Treatment of gastroesophageal reflux disease.
• Prevention of gastroesophageal reflux disease recurrence and the occurrence of erosions or ulcers in the course of gastroesophageal reflux disease.

2. Important Information Before Taking Famogast

When Not to Take Famogast:

• -if you are allergic to famotidine or any of the other ingredients of this medicine (listed in section 6);
• -if you are allergic to other H2 receptor antagonist medicines.

Warnings and Precautions

Before starting to take Famogast, discuss it with your doctor.
Particular caution should be exercised when taking Famogast:

• if you have a stomach ulcer. The doctor will rule out the malignant nature of the ulcer (as famotidine treatment may mask the symptoms of stomach cancer);
• if you have severe kidney failure. Famotidine is mainly excreted by the kidneys, so in these patients, the doctor will reduce the daily dose of the medicine (see section 3. How to take Famogast);
• in the case of long-term use, the doctor will decide on the need to monitor blood morphology and liver function;
• in the case of long-term ulcer disease, you should avoid sudden discontinuation of the medicine after symptom relief.

Children

The safety and efficacy of the medicine in children have not been established.

Famogast and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as about medicines you plan to take.

• Famotidine does not interact with warfarin (a blood thinner), theophylline (a medicine used to treat asthma and other respiratory diseases), phenytoin (an antiepileptic medicine), diazepam (an anxiolytic and sedative), 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 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 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 ulcer disease) within 2 hours after famotidine administration 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 administered concomitantly with famotidine.
• Particular caution should be exercised when taking famotidine with rilpivirine. In such cases, famotidine should be taken once a day. A precise dosing schedule should also be used, with famotidine administered at least 12 hours before or 4 hours after rilpivirine administration.
• Taking Famogast may reduce the effect of posaconazole in oral suspension (an antifungal medicine used to prevent and treat certain fungal infections).
• Taking Famogast may reduce the effect of dasatinib, erlotinib, gefitinib, pazopanib (medicines used to treat cancer).

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.
Pregnancy
Famogast should only be used in pregnant women if it is absolutely necessary.
Breastfeeding
Women who are breastfeeding should stop taking Famogast or breastfeeding, as famotidine passes into breast milk.

Famotidine with Food and Drink

The medicine can be taken with or without food.

Driving and Using Machines

There are no data on contraindications for driving vehicles and operating machinery during famotidine treatment. However, some patients have experienced adverse reactions from the central nervous system (e.g., dizziness), which may impair psychophysical fitness.
If such adverse reactions occur, do not drive vehicles or operate machinery.

Famogast Contains Carmoisine (E124)

The medicine may cause allergic reactions.

3. How to Take Famogast

This medicine should always be taken as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Famogast is intended for oral use.
The tablet has a dividing line on both sides. The tablet can be divided into equal doses.

Adult Administration

• Duodenal ulcer disease 40 mg before bedtime for 4 to 8 weeks. In most patients, healing is achieved after 4 weeks of therapy. If necessary, the doctor may extend the treatment to 8 weeks.
• Prevention of duodenal ulcer recurrence 20 mg of the medicine directly before bedtime.
• Diseases associated with excessive hydrochloric acid secretion (Zollinger-Ellison syndrome) Initially 20 mg every 6 hours. The maintenance dose will be adjusted individually by the doctor, depending on the patient's condition and response to treatment.
• Gastric ulcer disease Usually 40 mg orally once a day before bedtime. Healing is achieved after 4 to 8 weeks of therapy.
• Gastroesophageal reflux disease Treatment of symptoms in gastroesophageal reflux disease: 20 mg twice a day for 6 to 12 weeks. If gastroesophageal reflux disease has led to erosions or ulcers of the esophagus: adults - usually 40 mg twice a day for 6 to 12 weeks.
• Prevention of gastroesophageal reflux disease recurrence and the occurrence of erosions or ulcers in the course of gastroesophageal reflux disease

20 mg twice a day.

Pediatric Administration

The safety and efficacy of the medicine in children have not been established.

Administration in Elderly Patients

Same as in younger patients.

Administration in Patients with Renal Impairment

To avoid excessive accumulation of the medicine in patients with moderate or severe renal impairment, the famotidine dose may be reduced to half the dose or the interval between administrations may be extended to 36-48 hours, depending on the patient's clinical response.

Missing a Dose of Famogast

If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Taking More Than the Recommended Dose of Famogast

If you take more than the recommended dose, contact your doctor immediately.
In case of overdose, the doctor will decide on symptomatic treatment, consisting of removing the unabsorbed medicine from the gastrointestinal tract, monitoring the patient's condition, and providing supportive treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

If You Notice Any of the Following Very Rare but Serious Side Effects, Stop Taking Famogast and Contact Your Doctor Immediately:

• 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 or bleeding in the area of the lips, eyes, mouth, nose, or 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 abdomen, bloating
• rash, itching, urticaria
• fatigue

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

• pancytopenia (reduction of all blood cell elements)
• transient mental disorders, including depression, anxiety, agitation, disorientation, confusion, and hallucinations, decreased libido, insomnia
• seizures, convulsions with loss of consciousness, 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 after placebo administration.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 to gather more information on the safety of the medicine.

5. How to Store Famogast

Keep the medicine out of the sight and reach of children.
Store in 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.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Famogast Contains

• The active substance of the medicine is famotidine. Each tablet contains 40 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, carmoisine lake (E124).

What Famogast Looks Like and Contents of the Pack

Coated tablets, pink, round, biconvex, with a dividing line on both sides. The tablet can be divided into equal doses.
Aluminum/PVC blisters in a cardboard box.
The pack contains 30 or 60 coated tablets.

Marketing Authorization Holder and Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: 22 364 61 01
Date of the last revision of the leaflet:August 2023