FAMOGAST

Package leaflet: Information for the patient

Famogast, 40 mg, coated tablets
Famotidinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Famogast is and what it is 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 Famogast is and what it is used for
Famogast contains famotidine, which blocks histamine H\textsubscript{2} receptors located in the mucosal cells of the stomach wall. Famogast inhibits the secretion of hydrochloric acid (including food-stimulated secretion). The effect of the medicine lasts for 10 to 12 hours.

Indications

• Duodenal ulcer disease.
• Prevention of recurrence of duodenal ulcer disease after healing of its active form.
• Conditions associated with excessive secretion of hydrochloric acid (Zollinger-Ellison syndrome).
• Gastric ulcer disease.
• Treatment of gastroesophageal reflux disease.
• Prevention of recurrence of gastroesophageal reflux disease and prevention of erosions or ulcers associated with 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 have a history of allergy to other drugs from the group of H\textsubscript{2} receptor antagonists.

Warnings and precautions
Before starting treatment with Famogast, discuss it with your doctor.
Exercise special caution when using Famogast:

• if you have gastric ulcer. Your doctor will exclude a malignant nature of the ulcer (treatment with famotidine may mask symptoms of gastric cancer);
• if you have severe renal impairment. Famotidine is primarily excreted via the kidneys; therefore, your doctor will reduce the daily dose accordingly (see section 3. How to take Famogast);
• during long-term treatment, your doctor may decide to monitor blood morphology and liver function;
• in case of long-standing ulcer disease, abrupt discontinuation of the medicine after symptom relief should be avoided.

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

Famogast with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

• Famotidine does not interact with warfarin (an anticoagulant), theophylline (used in the treatment of asthma and other respiratory disorders), phenytoin (an anticonvulsant), diazepam (an anxiolytic and sedative), propranolol (a beta-blocker), aminophenazone, or phenazone (analgesics).
• Changes in gastric pH may affect the bioavailability of certain drugs (e.g., reduced absorption of atazanavir (an antiviral used in HIV treatment)).
• Famotidine may reduce the absorption of ketoconazole and itraconazole (antifungal agents). Ketoconazole should be administered at least two hours before famotidine.
• Antacids (agents that neutralize gastric acid) may reduce the absorption of famotidine and lead to lower serum concentrations. Therefore, famotidine should be taken 1 to 2 hours before antacids.
• Concomitant administration of probenecid (used in gout) may delay the elimination of famotidine. Concurrent use of famotidine and probenecid should be avoided.
• Avoid concomitant administration of sucralfate (a cytoprotective agent used in ulcer treatment) within two hours after taking famotidine.
• There is a risk of reduced efficacy of calcium carbonate, used in dialysis patients to reduce elevated serum phosphate levels (hyperphosphatemia), when administered simultaneously with famotidine.
• Exercise special caution when using famotidine concomitantly with rilpivirine. In such cases, famotidine should be administered once daily. A strict dosing schedule should be followed, with famotidine administered at least 12 hours before or 4 hours after rilpivirine.
• The use of Famogast may reduce the efficacy of posaconazole oral suspension (an antifungal agent used for prophylaxis and treatment of certain fungal infections).
• The use of Famogast may reduce the efficacy of dazatinib, erlotinib, gefitinib, and pazopanib (anticancer agents).

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Famogast may be used during pregnancy only if, in the opinion of the doctor, it is absolutely necessary.

Breastfeeding
Women who are breastfeeding should discontinue either Famogast or breastfeeding, as famotidine passes into breast milk.

Famotidine with food and drink
This medicine can be taken independently of meals.

Driving and operating machinery
There are no data on contraindications regarding driving or operating machinery while taking famotidine. However, some patients have experienced central nervous system adverse effects (e.g., dizziness), which may impair psychomotor performance. If such adverse effects occur, do not drive or operate machinery.

Famogast contains carmine red (E124)
This medicine may cause allergic reactions.

3. How to use Famogast

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist.
Famogast is intended for oral use.
The tablet has a score line on both sides. The tablet can be divided into equal doses.

Use in adults

• Duodenal ulcer disease: 40 mg at bedtime for 4 to 8 weeks. Healing occurs within 4 weeks in most patients. If necessary, the doctor may extend treatment up to 8 weeks.
• Prevention of recurrent duodenal ulcer: 20 mg of the medicine at bedtime.
• Conditions associated with excessive gastric acid secretion (Zollinger-Ellison syndrome): Initially 20 mg every 6 hours. Maintenance dosage will be individually adjusted by the doctor depending on the patient's condition and response to treatment.
• Gastric ulcer: Usually 40 mg orally once daily at bedtime. Healing occurs within 4 to 8 weeks of therapy.
• Gastroesophageal reflux disease: Treatment of symptoms in gastroesophageal reflux disease: 20 mg twice daily for 6 to 12 weeks. If erosions or ulcers of the esophagus have occurred in the course of gastroesophageal reflux disease: adults - usually 40 mg twice daily for 6 to 12 weeks.
• Prevention of recurrent gastroesophageal reflux disease and prevention of occurrence of erosions or ulcers in gastroesophageal reflux disease:
  20 mg twice daily.

Use in children
The safety and efficacy of this medicine in children have not yet been established.

Use in elderly patients
As in younger patients.

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

Missed dose of Famogast
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. Do not take a double dose to make up for a missed dose.

Overdose of Famogast
In case of an overdose, contact a doctor immediately. In the event of overdose, the doctor will decide on symptomatic treatment, which may include removal of the unabsorbed medicine from the gastrointestinal tract, monitoring of clinical status, and supportive therapy.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following very rare but serious adverse reactions occur, stop taking Famogast and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, rash, redness, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blister formation or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs, or detachment of large areas of skin may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine and fatigue, which may indicate liver dysfunction (hepatitis, cholestatic jaundice).

Other adverse reactions include:
Common (occur in less than 1 in 10 patients)

• headache, dizziness
• constipation, diarrhoea

Uncommon (occur in less than 1 in 100 patients)

• anorexia
• taste disturbances
• dry mouth, nausea and/or vomiting, discomfort or fullness in the abdomen, bloating
• rash, itching, urticaria
• fatigue

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

• deficiency of all normal blood cells: red blood cells, white blood cells and platelets
• transient psychiatric disorders including depression, anxiety, agitation, disorientation, confusion, delirium and hallucinations, decreased libido, insomnia
• seizures, epileptic fits associated with loss of consciousness, convulsions, salivation, trismus, sometimes rapid eye movements (especially in patients with renal impairment), paraesthesia, somnolence
• interstitial pneumonia, sometimes leading to death
• disturbances in liver enzyme activity
• excessive hair loss
• joint pain, muscle cramps
• atrioventricular block, QT interval prolongation (especially in patients with renal impairment)
• impotence
• chest tightness

Rare cases of gynaecomastia were observed in controlled clinical trials; however, these cases were not more frequent than with placebo.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Famogast

Keep this medicine 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 stated month.
The marking on the package following the abbreviation EXP indicates the expiry date, and the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Famogast contains

• The active substance is famotidine. Each tablet contains 40 mg of famotidine.
• Other components of the medicine are:
  Tablet core: pregelatinized starch, microcrystalline cellulose, magnesium stearate, talc.
  Tablet coating: hypromellose, titanium dioxide, macrogol 6000, talc, carmine lake (E124).

What Famogast looks like and contents of the pack
Film-coated tablets, pink in colour, round, biconvex, with a dividing line on both sides.
The tablet can be divided into equal doses.
Aluminium/PVC blisters in a cardboard box.
The pack contains 30 or 60 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Pelplinska Street 19, 83-200 Starogard Gdanski, Poland
Tel. 22 364 61 01