Famotidine apteo med

Package leaflet: Information for the user

Famotydyna APTEO MED
Famotidinum
20 mg, coated tablets
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 14 days, or if the patient feels worse, contact the doctor.

Contents of the leaflet

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

1. What Famotydyna APTEO MED is and what it is used for

Famotydyna APTEO MED contains the active substance famotidine. Famotydyna APTEO MED is a
gastrointestinal medicine and belongs to a group of drugs known as histamine H₂-receptor antagonists,
which reduce the secretion of hydrochloric acid in the stomach.
Famotydyna APTEO MED is used in adults for the short-term symptomatic treatment of gastric
complaints not associated with organic gastrointestinal disease, such as:
dyspepsia, heartburn, hyperacidity.

2. Important information before using the medicine Famotydyna APTEO MED

When not to use the medicine Famotydyna APTEO MED

• If the patient has a known hypersensitivity (allergy) to famotidine or to any of the other ingredients of the medicine (listed in section 6).
• If the patient has ever experienced a hypersensitivity reaction to another histamine H₂-receptor antagonist, as cross-sensitivity within this class of substances has been observed.
• In patients with renal impairment.

Warnings and precautions
Special caution is required when using the medicine Famotydyna APTEO MED:

• Before starting treatment, the possibility of a malignant tumour should be ruled out. Therefore, if any of the following conditions occur before or during treatment with this medicine, contact a doctor immediately:

  • Recurrent vomiting,
  • Vomiting of food contents or blood,
  • Passing black stools (blood-stained faeces), especially if the patient experiences weight loss, difficulty swallowing, or persistent abdominal pain along with indigestion,
  • If the patient has not previously experienced gastrointestinal symptoms (dyspeptic symptoms), or
  • If such symptoms were present but have recently changed – particularly in middle-aged or elderly individuals.

• Famotidine is primarily excreted by the kidneys. Before starting treatment with Famotydyna APTEO MED, consult a doctor or pharmacist if the patient has impaired kidney function. Famotidine is not suitable for patients with renal impairment who are not under medical supervision.

• In patients with gastric or duodenal ulcer disease, the H. pylori status should be determined. In patients infected with H. pylori, eradication therapy should aim to eliminate Helicobacter pylori (H. pylori) if possible.

Famotydyna APTEO MED and other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to take, including those available without prescription.
Calcium carbonate, used as a medicine to treat high blood phosphate levels (hyperphosphataemia) in dialysed patients.
Famotydyna APTEO MED may reduce the effectiveness of posaconazole oral suspension (a medicine used to prevent and treat certain fungal infections).

• Changes in gastric pH may affect the bioavailability of certain medicines.
• Famotidine may reduce the absorption of ketoconazole and itraconazole (antifungal medicines). Ketoconazole should be administered at least two hours before famotidine.
• Medicines that neutralize gastric hydrochloric acid may reduce the absorption of famotidine and lead to lower serum concentrations of famotidine. Therefore, famotidine should be taken 1–2 hours before antacids.
• Concomitant administration of probenecid (a medicine used in gout) may delay the elimination of famotidine. Concomitant use of famotidine and probenecid should be avoided.
• Concomitant administration of sucralfate (a protective agent used in peptic ulcer disease) should be avoided within two hours of taking famotidine.
• Famotidine may reduce the absorption of the following substances:
  • Rilpivirine (a medicine used in the treatment of HIV infection),
  • Cyanocobalamin (vitamin B₁₂) (a medicine used in anaemia),
  • Dazatinib, erlotinib, gefitinib, and pazopanib (medicines used in cancer treatment).

Famotydyna APTEO MED with food and drink
The medicine can be taken regardless of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Famotydyna APTEO MED may be used during pregnancy only if the physician considers it absolutely necessary.
Breastfeeding
Women who are breastfeeding should either discontinue treatment with Famotydyna APTEO MED or stop breastfeeding, as famotidine passes into human milk.
Use in children
There is insufficient data on the safety and efficacy of famotidine in children and adolescents; therefore, children and adolescents should not take Famotydyna APTEO MED.
Driving and operating machinery
If adverse effects such as dizziness or headache occur during treatment with Famotydyna APTEO MED, the patient should not drive or operate machinery.

3. How to use Famotydyna APTEO MED

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults
The medicine is indicated for the short-term treatment of dyspeptic symptoms in adult patients.
In case of indigestion symptoms, one 20 mg tablet is usually taken once daily. If symptoms recur, one 20 mg tablet may be taken twice daily. The daily dose 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 do not improve after 2 weeks of treatment, seek medical advice immediately.
Use in patients with renal function impairment
Since the 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 the medicine, as it may be necessary to reduce the dose by half or extend the dosing interval to 36–48 hours.
The medicine is contraindicated in patients with renal failure.
Use in elderly patients
There is no need to adjust the dosage in elderly patients.
Use in children and adolescents
This medicine should not be used in children and adolescents.
Taking more than the recommended dose of Famotydyna APTEO MED
If more than the recommended dose is taken, contact a doctor immediately.
Adverse effects observed in cases of overdose are generally those known from clinical experience.
Missing a dose of Famotydyna APTEO MED
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.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following very rare but serious adverse reactions, stop taking Famotydine APTEO MED 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 blistering or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose or genitals may also occur, or extensive detachment of the outer layer of skin. 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 and/or diarrhoea
• interstitial pneumonia

Uncommon (occur in less than 1 in 100 patients)

• dry mouth, nausea, vomiting, gastrointestinal discomfort, bloating, loss of appetite, taste disturbances
• rash, itching
• fatigue, chest tightness

Rare (occur in less than 1 in 1,000 patients)

• increased aminotransferase, gamma-GT, alkaline phosphatase activity, increased bilirubin concentration
• urticaria
• joint pain
• hypersensitivity reactions (anaphylaxis, angioedema, bronchospasm)
• intrahepatic cholestasis (visible symptoms: jaundice)
• atrioventricular block, QT interval prolongation (especially in patients with renal impairment)

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 (thrombocytopenia, leukopenia, agranulocytosis, pancytopenia, neutropenia)
• paraesthesia (tingling, numbness, prickling sensations), somnolence, insomnia, seizures (grand mal)
• alopecia, severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• muscle cramps
• impotence, decreased libido
• reversible psychiatric disorders (such as hallucinations, disorientation, confusion, anxiety and restlessness, depression)

What should be done if adverse reactions occur?
If any of the above adverse reactions or other unusual symptoms occur, consult your doctor. The more detailed the information provided to the doctor regarding your medical history and treatment course, the less likely it is that treatment success will be compromised by adverse effects.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions 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 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 can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Famotydyna APTEO MED

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the specified month.
No special storage conditions apply for this medicine.
Medicines must 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 Famotydyna APTEO MED contains

• The active substance is famotidine. Each tablet contains 20 mg of famotidine.
• The other ingredients are:
  • tablet core: microcrystalline cellulose (type 101), pregelatinized starch, potato starch, hydroxypropylcellulose, microcrystalline cellulose (type 102), magnesium stearate,
  • tablet coating: Opadry Yellow (20A520115) containing: hypromellose 2910, hydroxypropylcellulose, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Famotydyna APTEO MED looks like and contents of the pack
Famotydyna APTEO MED tablets are yellow, square-shaped, slightly rounded coated tablets.
The tablets are packed in aluminium/PVC blisters within a cardboard box. The pack contains 20 or 30 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel.: 22 321 62 40
Importer:
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz