Famiflux

Leaflet attached to the packaging: patient information

Famiflux

20 mg, coated tablets
Famotidine

Read the 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Famiflux and what is it used for

Famiflux 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 in adults 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 Famiflux

When not to take Famiflux

• 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 impairment.

Warnings and precautions

Before taking Famiflux, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney problems.

Famiflux may mask the symptoms of other diseases, including stomach cancer. For this reason, if any of the following conditions occur before starting or during treatment with the medicine, the patient should immediately contact their 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 (dyspeptic) symptoms 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 contact their doctor to verify the diagnosis.

Children and adolescents

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

Famiflux and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or 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 decreased serum famotidine concentrations. 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 stomach ulcers) 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 phosphate binder, if administered concomitantly with famotidine.
• The use of Famiflux may reduce the effect of posaconazole in oral suspension (an antifungal medicine used to prevent and treat certain fungal infections).
• The use of Famiflux may reduce the effect of dasatinib, erlotinib, gefitinib, pazopanib (medicines used to treat cancer).
• Famotidine may reduce the absorption of the following compounds:
• Rilpivirine (a medicine used to treat HIV infection),
• cyanocobalamin (vitamin B12) (a medicine used to treat anemia),
• most tyrosine kinase inhibitors (except vandetanib, imatinib) (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 their doctor or pharmacist before taking this medicine.
Pregnancy
Famiflux may be used in pregnant women only when absolutely necessary.
Breastfeeding
Women who are breastfeeding should stop taking Famiflux or breastfeeding, as famotidine passes into breast milk.

Using the medicine 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 famotidine treatment. However, some patients have experienced side effects such as dizziness, which may impair physical and mental performance. If such side effects occur, the patient should not drive vehicles or operate machinery.

3. How to take Famiflux

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist again.
Adults
In case of indigestion symptoms, usually 1 tablet of 20 mg per day is taken. 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 their 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 their doctor before taking the medicine, as it may be necessary to reduce the dose by half or extend the interval between doses to 36-48 hours.
The medicine is contraindicated in patients with renal failure.
Use in children and adolescents
The medicine should not be used in children and adolescents.
Use in the elderly
No dose adjustment is necessary in elderly patients.

Missing a dose of Famiflux

In case of missing a dose, the patient should take it as soon as possible.
If it is almost time for the next dose, the patient should not take the missed dose. The patient should not take a double dose to make up for the missed dose.

Taking more than the recommended dose of Famiflux

In case of taking more than the recommended dose, the patient should immediately contact their 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.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Famiflux 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 Famiflux and immediately contact their doctor:

• sudden wheezing, swelling of the lips, tongue, and 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 may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems (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 no more than 1 in 1,000 patients)

• gynecomastia (breast enlargement)*

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

• pancytopenia (reduction of all blood cell types: 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, salivation, trismus, sometimes rapid eye movements (especially in patients with renal impairment), feeling of unease, drowsiness
• interstitial lung disease, sometimes leading to death
• liver enzyme disorders
• 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 the available data)

• asthenia (physical and mental weakness)

*Reversible after discontinuation of treatment.

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 Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides
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 Famiflux

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
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 packaging and other information

What Famiflux contains

The active substance of the medicine is famotidine. Each tablet contains 20 mg of famotidine.
The other ingredients of the medicine are:
Core: microcrystalline cellulose, type 102, corn starch, microcrystalline cellulose, type 105, talc, magnesium stearate.
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

Coated tablets, round, cream-yellow, convex on both sides.
Colorless PVC/PVDC/Aluminum blisters 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

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
email: [email protected]

Date of last revision of the leaflet: