Famotidine 40mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Famotidine 40 mg film-coated tablets Famotidine
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Famotidine is and what it is used for
2. Before you take Famotidine Tablets
3. How to take Famotidine Tablets
4. Possible side effects
5. How to store Famotidine Tablets
6. Further information
1. What Famotidine is and what it is used for
Famotidine belongs to the group of medicines called H2-receptor antagonists, which work by reducing the amount of acid you produce in your stomach.
Famotidine is used:
• for the treatment of duodenal ulcers and benign gastric ulcers.
• for the treatment of inflammatory conditions of the oesophagus caused by gastric acid reflux.
• for Zollinger-Ellison syndrome, a disorder characterised by excessive production of gastric acid.
2. Before you take Famotidine Tablets
Do not take Famotidine Tablets
• if you are allergic (hypersensitive) to famotidine or any of the other ingredients of Famotidine..
If you have ever had an allergic reaction to other medicines that belong to the same group of medicines (H2-receptor antagonists) as Famotidine.
Take special care with Famotidine
• Famotidine can mask the symptoms of a malignant gastric disorder and accordingly delay the required treatment. Your doctor should therefore exclude the possibility that you have a disorder of this type, before treatment with Famotidine is commenced.
• Tell your doctor if you have kidney problem, as it may be necessary to prescribe a lower dose for you.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking any of the following medicines:
• Ketoconazole and itraconazole (for fungal infections)
• Probenecide (for gout)
• Atazanavir (a medicine used to treat HIV)
• Agents which neutralise acid (e.g. aluminium hydroxide, magnesium hydroxide)
• Sucralfate (for gastric and duodenal ulcers)
Taking Famotidine Tablets with food and drink
Take Famotidine independent of meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy:
Experience with use during pregnancy is limited. Ask your doctor for advice.
Breast feeding:
Do not breast feed while you are taking Famotidine..
Driving and using machines
If you experience side effects such as dizziness and headache while taking Famotidine you should not drive or use any tools or machines.
Important information about some of the ingredients of Famotidine
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before you taking this medicinal product.
3. How to take Famotidine Tablets
Always take Famotidine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults:
For gastric and duodenal ulcer
The usual dose is 40 mg at bedtime for 4 - 8 weeks.
Maintenance dose for prevention of ulcer recurrence: 20 mg at bedtime.
For inflammatory conditions of the oesophagus caused by gastric acid reflux
The usual dose is 20 mg twice daily.
In severe cases the dose can be increased to 40 mg twice daily for 6 - 8 weeks.
The usual dose for long-term treatment is 20 mg twice daily. Treatment should not be continued for longer than 6 months.
For Zollinger-Ellison syndrome
The dosage should be adjusted for each individual patient. The usual starting dose is 20 mg every 6 hours. In impaired kidney function:
In case of severely impaired kidney function the dose is reduced by half.
Use in children:
Famotidine is not recommended for use in children.
Mode of administration
Take the tablets with a sufficient quantity of liquid (e.g. one glass of water).
The tablets can be divided but must not be crushed or chewed.
If you take more Famotidine Tablets than you should
If you have taken too much Famotidine contact a doctor or hospital.
If you forget to take Famotidine Tablets
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Famotidine Tablets
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Famotidine Tablets can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking Famotidine HEXAL and contact your doctor immediately:
• if you experience sudden high fever, severe sore throat or mouth and ulcers in the mouth, pale skin, tiredness, breathlessness, dark urine, more frequent infections, tingling and numbness of hands and feet that may be a sign for reduced number of blood platelets or white blood cells, seriously reduced number of a certain type of white blood cells (agranulocytosis), reduction of all blood cells
• if you experience serious breathlessness, or sudden worsening of breathlessness, possibly with a cough or fever indicating an inflammation of the lungs (sometimes fatal)
• if you experience severe skin reactions with rash, red skin, blistering of the lips, eyes or mouth, skin peeling, and fever (Stevens Johnson Syndrom, toxic epidermal necrolysis sometimes fatal)
• if you experience allergic reactions including swelling of the face, lips, tongue and/or throat, severe hypersensitivity reactions (anaphylaxis), difficulties with breathing, joint pain
Some patients experienced the following side effects whilst taking Famotidin HEXAL:
Common (occur in less than 1 in 10patients):
• headache, dizziness
• constipation, diarrhoea
Uncommon (occur in less than 1 in 100 patients):
• nausea, vomiting
• mild abdominal pain
• flatulence
• tiredness
• dry mouth
• loss of appetite
• disturbed sense of taste
• rash, itching, nettle rash (urticaria)
Very rare (occur in less than 1 in 10,000 patients):
• changes in liver enzyme values
• jaundice, hepatitis
• hallucinations, disorientation, confusion, anxiety disorders, restlessness
• depression
• impotence, reduced libido
• creeping sensation under the skin
• drowsiness, insomnia
• epileptic seizure
• convulsions in patients with impaired kidney function
• loss of hair
• tension in the chest
• muscle cramps
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.
5. How to store Famotidine Tablets
Keep out of the reach and sight of children.
Do not use Famotidine Tablets after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original packaging. Keep the blister in the outer carton.
6. Further information
What Famotidine Tablets contains
The active substance is: Famotidine 40 mg
One film-coated tablet contains famotidine 40 mg.
The other ingredients are: Microcrystalline cellulose, lactose monohydrate, Macrogol 4000, magnesium stearate, hypromellose, sodium starch glycolate (type A), colloidal anhydrous silicone dioxide, pregelatinised starch, talc, titanium dioxide (E 171).
What Famotidine looks like and contents of the pack
The tablets are white, oval with a score line on one side.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St. Neots
Cambridgeshire PE19 8ET UK
Product Licence Number: PL 11311/0227
This leaflet was last revised in 11/2012