Package leaflet: Information for the patient

Famiflux
20 mg, coated tablets
Famotidinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days, or if you feel worse, contact your doctor.

Contents of the leaflet

What Famiflux is and what it is used for
Important information before taking Famiflux
How to take Famiflux
Possible side effects
How to store Famiflux
Contents of the pack and other information

1. What Famiflux is and what it is used for
Famiflux contains famotidine, which belongs to a group of medicines called H₂ receptor antagonists.
It reduces the secretion of hydrochloric acid in the stomach. Famiflux is indicated for short-term
symptomatic treatment in adults of gastric discomfort not associated with organic gastrointestinal
disease, such as: indigestion (dyspepsia), heartburn, and hyperacidity. The effect of the medicine lasts for 10 to 12 hours.

2. Important information before taking Famiflux

When not to take Famiflux

if you are allergic to famotidine or to any of the other ingredients of this medicine (listed in section 6);
if you have had allergic reactions to other H₂-receptor antagonists in the past;
if you have renal insufficiency.

Warnings and precautions
Before starting Famiflux, consult your doctor or pharmacist:

if you have impaired kidney function.

Famiflux may mask symptoms of other diseases, including stomach cancer. Therefore, if any of the following conditions occur before or during treatment, contact your doctor immediately:

recurrent vomiting,
vomiting blood or food contents,
passing black stools (blood-tinged faeces),
if you experience weight loss, difficulty swallowing, or persistent abdominal pain along with indigestion,
if you have not previously experienced gastric discomfort (dyspeptic symptoms), or if existing symptoms have recently changed—particularly applicable to middle-aged or elderly individuals.

If symptoms do not resolve after 14 days of treatment, contact your doctor immediately to re-evaluate the diagnosis.
Children and adolescents
The safety and efficacy of this medicine in children have not been established. Do not use in children and adolescents.
Famiflux with other medicines
Tell 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 conditions), phenytoin (an anticonvulsant), diazepam (an anxiolytic and sedative), propranolol (a cardiovascular medicine), aminophenazone, or phenazone (analgesics).
Changes in gastric pH may affect the bioavailability of certain medicines (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.
Medicines that neutralize gastric acid may reduce the absorption of famotidine and lead to lower serum concentrations. Therefore, famotidine should be taken 1–2 hours before antacids.
Concomitant administration of probenecid (used in gout) may delay the elimination of famotidine. Concomitant use of famotidine and probenecid should be avoided.
Avoid concomitant administration of sucralfate (a protective agent used in peptic ulcer disease) within two hours of taking famotidine.
There is a risk of reduced efficacy of calcium carbonate, used in dialysed patients to lower elevated serum phosphate levels (hyperphosphatemia), when administered simultaneously with famotidine.
The use of Famiflux may reduce the effectiveness of posaconazole oral suspension (a medicine used to prevent and treat certain fungal infections).
The use of Famiflux may reduce the effectiveness of dasatinib, erlotinib, gefitinib, and pazopanib (medicines used in cancer treatment).
Famotidine may reduce the absorption of the following substances:
Rilpivirine (used in the treatment of HIV infection),
cyanocobalamin (vitamin B₁₂) (used in the treatment of anaemia),
most tyrosine kinase inhibitors (except vandetanib, imatinib) (used in cancer treatment).

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Famiflux may be used during pregnancy only if absolutely necessary, as determined by your doctor.
Breastfeeding
Women who are breastfeeding should discontinue either Famiflux or breastfeeding, as famotidine passes into breast milk.
Taking with food and drink
This medicine can be taken regardless of meals.
Driving and operating machinery
There are no data indicating contraindications for driving or operating machinery during famotidine use. However, some patients may experience adverse effects such as dizziness, which may impair psycho-physical performance. If such side effects occur, do not drive or operate machinery.

3. How to take Famiflux

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Adults
For symptoms of indigestion, the usual dose is 1 tablet of 20 mg once daily. If symptoms recur, 1 tablet of 20 mg twice daily may be taken. The daily dose of this medicine should not exceed 40 mg (2 tablets).
The tablet should be swallowed whole with a small amount of water. Do not use this medicine for longer than 2 weeks without consulting a doctor. If symptoms persist after 2 weeks of treatment, seek medical advice immediately.
Use in patients with renal function impairment
Since this medicine is primarily excreted by the kidneys, caution should be exercised in patients with impaired renal function. Patients with renal function impairment should consult a doctor before taking this medicine, as it may be necessary to reduce the dose by half or extend the interval between doses to 36–48 hours.
This medicine is contraindicated in patients with renal failure.
Use in children and adolescents
This medicine should not be used in children and adolescents.
Use in elderly patients
There is no need to adjust the dosage in elderly patients.
Missed dose of Famiflux
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.
Taking more than the recommended dose of Famiflux
If more than the recommended dose has been taken, contact a doctor immediately. In case of overdose, the doctor will decide on symptomatic treatment, which may include removal of unabsorbed medicine from the gastrointestinal tract, monitoring of clinical condition, 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 not everyone experiences them.
If you notice any of the following very rare but serious adverse reactions, stop taking Famiflux immediately and contact your doctor without delay:

sudden wheezing, swelling of the lips, tongue or throat, or body 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, or genital organs may also occur, or extensive peeling of the skin surface. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
yellowing of the skin, dark urine, and fatigue, which may indicate liver function disorders (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, feeling of discomfort or fullness in the abdomen, bloating
rash, itching, urticaria
fatigue

Rare (occur in no more than 1 in 1,000 patients)

gynaecomastia (breast gland enlargement)*

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, restlessness, disorientation, confusion, hallucinations, decreased libido, insomnia
convulsions, epileptic seizures accompanied by 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

Frequency not known (frequency cannot be estimated from available data)

asthenia (state of physical and mental weakness)

*Reversible after discontinuation of treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Famiflux

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Famiflux contains
The active substance is famotidine. Each tablet contains 20 mg of famotidine.
The other ingredients are:
Tablet core: microcrystalline cellulose, type 102, pregelatinized corn starch, microcrystalline cellulose, type 105, talc, magnesium stearate.
Tablet coating: hypromellose type 2910 (5 mPa·s), titanium dioxide (E 171), macrogol, yellow iron oxide (E 172).
What Famiflux looks like and contents of the pack
Film-coated tablets, round, cream-yellow in colour, biconvex on both sides.
Colourless PVC/PVDC/Aluminium blisters in a cardboard box.
The pack contains 10, 20 or 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]