Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. No interaction studies have been performed with other medicinal products. To date, no interactions have been reported with other medicinal products.

If you accidentally take a double or triple dose of the medicine at one time (for example 4-12 chewable tablets), this should not lead to any side effects. In this case, continue taking as directed. In case of significant drug overdose, adverse reactions may be exacerbated (see section 4. Adverse reactions). In this case, please consult your doctor or pharmacist.

Pregnancy, breast-feeding, fertility:

Ask your doctor or pharmacist for advice before taking any medicine.

Famotidine Sopharma is not used during pregnancy and lactation.

Driving and using machines:

No special instructions required.

Possible side effects:

Like all medicines, Famotidine can cause side effects, although not everybody gets them.
Famotidine is well tolerated.

• The following side effects are rare: headache, dizziness, diarrhea or constipation.
• Very rare:
  • general disorders – loss of appetite, fatigue, fever;
  • heart disorders – arrhythmia, palpitations;
  • gastrointestinal disorders – nausea, vomiting, abdominal discomfort, dry mouth, changes in liver enzymes;
  • disorders of the musculoskeletal system – muscle cramps, joint pain;
  • disorders of the nervous system – dizziness, confusion, insomnia, drowsiness;
  • skin disorders – itching, rash, dry skin;

If any of the side effects gets serious, or if you notice any side effects not listed, please tell your doctor or pharmacist.

FAMOTIDINE tablets 20 mg. * 30 SOPHARMA

PACKAGE LEAFLET: USER
INFORMATION Famotidine Sopharma 20 mg film-coated
tablets Famotidine Sopharma 20 mg film-coated tablets
Famotidine
Read all of this leaflet carefully as it contains important information for you.
This medicine can only be obtained without a doctor’s prescription. However, in order to get the best treatment results, you should carefully follow the instructions for use of the medicinal product.

• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
• You should seek medical attention if your symptoms worsen or do not improve after 2 weeks.

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

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

Famotidine Sopharma contains famotidine – the strongest H₂-receptor blocker, which inhibits increased acid secretion of the gastric glands.
Famotidine Sopharma is used to treat the symptoms of acid reflux (return of gastric juice to the esophagus) such as: burning, heartburn and pain behind the sternum.
Burning, heartburn and pain behind the sternum can occur after eating or lying down, as well as after heavy physical work. Symptoms can be controlled by short-term treatment with a drug without a doctor’s prescription. If your symptoms persist or your condition worsens, your doctor needs to reassess your treatment.

2. What you need to know before you take Famotidine Sopharma

Do not take Famotidine Sopharma:

• if you are hypersensitive to the active substance or any of the other ingredients listed in point 6;
• if you have impaired liver function;
• if you have impaired kidney function;
• if you are pregnant or breast-feeding;
• children under 12 years of age due to a lack of sufficient data on effectiveness and safety.

Take special care when using Famotidine Sopharma:

• Before starting treatment with Famotidine Sopharma, tell your doctor or pharmacist about any health problems you have or have had, the existence of allergies or hypersensitivity to other antacids.
• If you have or have recently had the following symptoms: unwanted weight loss, repeated vomiting or vomiting of blood, or black stools. Your doctor will order additional tests to diagnose or rule out malignancy.
• If you are elderly or have had complications such as bleeding or an ulcer from taking nonsteroidal anti-inflammatory drugs (NSAIDs).
• If you are taking NSAIDs.
• If you have or have had problems with your liver or kidneys.

It is not recommended to use Famotidine Sopharma in children under 12 years of age due to a lack of sufficient data on effectiveness and safety.

Other medicines and Famotidine Sopharma
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Famotidine Sopharma may reduce the absorption of ketoconazole (a medicine used to treat fungus) due to a change in acidity in the stomach. If ketoconazole is needed, the difference between the two doses should be at least 2 hours.
Concomitant intake of Famotidine Sopharma with antacids may reduce its action.

It is recommended to take Famotidine Sopharma during
meals or after meals, as food increases its absorption.

Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine. Famotidine Sopharma is not used in pregnancy and lactation.

There
are no restrictions on the use of Famotidine Sopharma when driving and using machines as it has no influence on active attention and reflexes.

Important information about some of the ingredients of Famotidine Sopharma Famotidine Sopharma
contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, ask your doctor for advice before taking this product.

3. How to take Famotidine Sopharma

The usual dose is:
Adults
Twice a day 20 mg in the morning and evening, for 2 weeks.

For children from 12 to 18 years
A tablet a day.
In children under 12 years of age, it is not used due to a lack of data on effectiveness and safety.

In elderly patients
No change in dosage is required.

Famotidine Sopharma tablets should be swallowed whole, with a little water. If symptoms have not resolved after taking Famotidine Sopharma for two weeks, contact your doctor as your symptoms may have another cause.

Check with your doctor or pharmacist if you are not sure.

If you take more Famotidine Sopharma
than you should In case of any overdose, contact your doctor. It is necessary to discontinue the product and use symptomatic treatment.

If you forget to take one dose of Famotidine Sopharma
Do not take a double dose to make up for a forgotten dose. Continue to take the medicine according to the established scheme.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Famotidine Sopharma can cause side effects, although not everybody gets them.
Famotidine Sopharma is well tolerated.

The following side effects have been observed during treatment with Famotidine:
Uncommon (affects 1 to 10 patients in 1000):

• excessive amount of gas in the intestines.

Rare (affects 1 to 10 patients in 10,000 treated):

• headache, dizziness, diarrhoea or constipation.

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

• general disorders – loss of appetite, fatigue, slight fever;
• cardiac disorders – arrhythmia, bradycardia;
• gastrointestinal disorders – nausea, vomiting, dry mouth, changes in liver enzymes;
• disorders of the musculoskeletal system – muscle cramps, joint pain;
• disorders of the nervous system – confusion, agitation, depression, drowsiness;
• skin disorders – itching, rash, dry skin;
• changes in laboratory indicators indicating damage to the hematopoietic system;
• Alopecia.

If
you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Famotidine Sopharma

Store in original packages in a dry and protected from direct sunlight place at a temperature below 25 ° C.
Store out of the reach of children!
Do not use Famotidine Sopharma after the expiry date which is stated on the package. The expiry date refers to the last day of that month. Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. These measures will help to protect the environment.

6. Contents of the pack and other information

What Famotidine Sopharma contains

• The active substance is famotidine 20 mg.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, talc, magnesium stearate, sodium starch glycolate (type A), hydroxypropylmethylcellulose, opadrai YS-IR-7002.

What Famotidine Sopharma looks like and contents of the
pack White, round, biconvex, film-coated tablets of 10 pieces in a PVC/aluminium foil blister in 3 blisters per pack

Marketing Authorisation Holder:
SOPHARMA AD, Bulgaria

Manufacturer:
SOPHARMA AD, Bulgaria