Famotidine Teva

PACKAGE LEAFLET

Package leaflet: information for the patient

Famotidine Teva 40 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Famotidine Teva is and what it is used for
2. What you need to know before taking Famotidine Teva
3. How to take Famotidine Teva
4. Possible side effects
5. How to store Famotidine Teva
6. Contents of the pack and other information

1. What Famotidine Teva is and what it is used for

Famotidine Teva is a medicine containing the active substance famotidine.
Famotidine Teva is a gastrointestinal medicine and belongs to a group of medicines called
histamine H-_receptor antagonists, which reduce gastric acid production.
Famotidine Teva is used to treat the following conditions in adults when a reduction in gastric acid
production is indicated:

• Duodenal ulcers
• Benign gastric ulcers (gastric ulcers)
• Zollinger-Ellison syndrome

Consult a doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Famotidine Teva

Do not take Famotidine Teva:

• if you are allergic to famotidine or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction to another H₂-receptor antagonist, as similar reactions may occur with this medicine.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Famotidine Teva.

• Immediately inform your doctor if you notice any of the following symptoms:
  • unintentional weight loss;
  • repeated episodes of vomiting;
  • difficulty swallowing;
  • vomiting blood;
  • paleness and feeling weak (anaemia);
  • presence of blood in stools.

Your doctor may consider it necessary to carry out certain tests to rule out malignancy, as famotidine may relieve symptoms of cancer and could therefore delay diagnosis. If symptoms persist despite treatment, further investigations will be considered.

• If you have impaired kidney function. Your doctor may prescribe a lower dose of Famotidine Teva (see section 3 “How to take Famotidine Teva”).

Famotidine is not appropriate for minor gastrointestinal disorders, such as stomach upset due to stress or anxiety.

• If you suffer from duodenal ulcers or benign gastric ulcers, your doctor may suspect that the cause is a bacterial infection with H. pylori. In such cases, you will require specific treatment under medical supervision to eliminate these bacteria.

Use in children
There is insufficient experience regarding the safety and efficacy of famotidine in children.
Therefore, Famotidine Teva is not recommended for use in children.

Other medicines and Famotidine Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
When taking substances whose absorption is influenced by gastric acidity, possible changes in absorption should be taken into account.
Inform your doctor or pharmacist if you are taking any of the following medicines:

Do not take Famotidine Teva

• if you are concurrently taking probenecid (a medicine used to treat gout), as probenecid may delay the elimination of famotidine;
• in combination with atazanavir, ritonavir, and tenofovir (medicines used to treat human immunodeficiency virus [HIV] infection).

The effect of Famotidine Teva may be reduced by

• medicines that neutralize gastric acid (antacids). Because of the reduced effect of Famotidine Teva, it should be taken at least 1–2 hours before the antacid;
• sucralfate (a medicine used to treat ulcers). Normally, sucralfate should not be taken within 2 hours of taking Famotidine Teva.

Famotidine Teva may reduce the effect of

• ketoconazole or itraconazole (medicines used to treat fungal infections). Take ketoconazole 2 hours before taking Famotidine Teva;
• atazanavir with ritonavir (medicines taken for HIV infection). Consult your doctor;
• calcium carbonate, when used as a medicine for high phosphate levels in the blood (hyperphosphataemia) in dialysis patients;
• Famotidine Teva may decrease the effect of posaconazole oral suspension (an oral medicine used to prevent and treat certain fungal infections);
• Famotidine Teva may decrease the effect of dasatinib, erlotinib, gefitinib, pazopanib (medicines used to treat cancer).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Data on the use of Famotidine Teva in pregnant women are lacking or limited. If you are pregnant, you should take Famotidine Teva only if your doctor considers that the benefit to you outweighs the potential risk to the unborn child.
Famotidine, the active substance in Famotidine Teva, is excreted in breast milk.
Since there is no information on the effects of famotidine in infants and since disturbances in gastric acid production cannot be ruled out, breastfeeding should be discontinued during treatment. If considered necessary by your doctor, treatment with Famotidine Teva should be discontinued.

Driving and using machines
During treatment with famotidine, some patients have experienced adverse reactions such as dizziness and headache, which could impair the ability to drive or operate machinery. If you experience side effects such as dizziness or headache while taking Famotidine Teva, you must not drive or operate machinery.

Famotidine Teva contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially “sodium-free”.

3. How to take Famotidine Teva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
Acute duodenal ulcers and benign peptic ulcers
The recommended dose is 40 mg of famotidine once daily in the evening.
Treatment duration should be 4-8 weeks. However, it may be shortened if endoscopic evidence of ulcer healing is observed. If there is no endoscopic evidence of ulcer healing after 4 weeks, treatment should continue for another 4 weeks.
Zollinger-Ellison syndrome
Treatment should be initiated with 20 mg of famotidine every 6 hours in patients who have not previously been treated with antisecretory drugs. The dosage depends on the level of gastric acid secretion and the patient's clinical response. Daily doses of up to 800 mg of famotidine have been used for up to one year without observing increased adverse effects or loss of efficacy. Patients previously treated with another H2-receptor antagonist may immediately switch to a higher initial dose of famotidine than that recommended for treatment-naïve patients; this initial dose depends on the severity of symptoms and the dosage of the previous medication. Depending on the individual dose required, consideration should be given to using famotidine 40 mg film-coated tablets.
Treatment should continue for as long as medically necessary.
Dosing in patients with impaired renal function
Famotidine is primarily eliminated via the kidneys. Therefore, a 50% reduction in the daily dose of Famotidine Teva is recommended in patients with severe renal impairment (creatinine clearance below 30 mL/min or serum creatinine above 3.0 mg/100 mL). Famotidine Teva should be administered at the end of dialysis or afterwards, as part of the active substance is removed during dialysis.
How to take Famotidine Teva
The tablets should be swallowed whole with a little liquid (e.g. a glass of water).
They may be taken independently of meals.
If you feel that the effect of Famotidine Teva is too strong or too weak, inform your doctor or pharmacist.
Take this medicine exactly as directed in this leaflet or as prescribed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Use in children and adolescents
There is insufficient experience regarding the safety and efficacy of famotidine in children.
Therefore, Famotidine Teva is not recommended for use in children.
The break line is only intended to help you split the tablet if you have difficulty swallowing it whole.
If you take more Famotidine Teva than you should
Seek immediate medical advice. Adverse effects observed in cases of overdose are consistent with clinical experience.
If you forget to take Famotidine Teva
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following effects, stop taking the medicine and contact your doctor immediately or go to
the nearest hospital emergency department:
Very rare side effects (may affect up to 1 in 10,000 people)

• Severe allergic/hypersensitivity reactions causing difficulty breathing or dizziness (anaphylaxis), swelling of the face or throat (angioedema), difficulty breathing or wheezing (bronchospasm)

The following side effects have been reported:
Common (may affect up to 1 in 10 people)

• Headache, dizziness
• Constipation, diarrhoea

Uncommon (may affect up to 1 in 100 people)

• Reduced appetite
• Dry mouth, nausea, vomiting, abdominal discomfort, abdominal distension, flatulence, taste disturbance
• Skin rash, itching
• Tiredness, chest discomfort

Rare (may affect up to 1 in 1,000 people)

• Hypersensitivity (including anaphylaxis, angioedema, bronchospasm)
• Intrahepatic cholestasis (sign: jaundice)
• Urticaria
• Joint pain (arthralgia)
• Abnormal liver enzyme
• Gynaecomastia (enlargement of male breast tissue)

Very rare (may affect up to 1 in 10,000 people)

• Blood cell count abnormalities (leucopenia, thrombocytopenia, agranulocytosis, pancytopenia), which may cause, for example, weakness, tiredness, sudden fever, sore throat, bruising or nosebleeds
• Mental disorder, depression, anxiety, agitation, disorientation, confusion, hallucination
• Seizure, generalized tonic-clonic seizures (particularly in patients with impaired renal function), paraesthesia, somnolence, insomnia (difficulty sleeping)
• Atrioventricular block with intravenous administration of H-receptor antagonists
• Interstitial lung disease (sometimes fatal)
• Alopecia, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema
• Muscle spasms
• Erectile dysfunction, decreased libido

Not known (frequency cannot be estimated from the available data)

• Neutropenia

If any of the above side effects occur, or if you experience any other unusual symptoms, seek advice from your doctor. The more information your doctor has about your medical history and the more accurately you report your treatment course, the less likely it is that the success of treatment will be compromised by side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Famotidine Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if it appears damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Famotidina Teva contains

• The active substance is famotidine.

Famotidina Teva 40 mg: each tablet contains 40 mg of famotidine.

• The other components are:

Tablet core
Microcrystalline cellulose, pregelatinized starch, hydroxypropylcellulose, magnesium stearate
Film coating of the tablet
Famotidina Teva 40 mg film-coated tablets:
Graft copolymer of poly(vinyl alcohol) and polyethylene glycol, talc, titanium dioxide (E171), glycerol monocaprilocaprate, poly(vinyl alcohol), quinoline yellow aluminium lake
Description of the appearance of Famotidina Teva and contents of the pack
Famotidina Teva 40 mg film-coated tablets are yellow, round, film-coated tablets with a score line on one side and smooth on the other, with a diameter of 9.6 mm ± 0.2 mm.
Unit-dose blister packs and perforated divisible blisters in PVC/PE/PVDC/aluminium, packed in cardboard boxes.
Pack sizes of 10, 20 or 30 x 1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Manufacturer
Remedica Ltd., Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus