PACKAGE LEAFLET: INFORMATION FOR THE USER
PEPCID® Tablets
1. What Pepcid is and what it is used for
Pepcid contains a medicine called famotidine (either 20 mg or 40 mg). This belongs to a group of medicines called ‘H2-blockers’. Pepcid works by
lowering the amount of acid you produce in your stomach.
Pepcid is used for:
• preventing ulcers in your stomach (gastric ulcer) or the first part of your intestine (duodenal ulcer)
• healing ulcers and to give you relief from symptoms. Pepcid may also be used to lower the chance that your duodenal ulcer will come back
• treating ‘gastro-oesophageal reflux disease’ (GORD) caused by stomach acid and food from your stomach going back up into your food pipe
(oesophagus), or for preventing the symptoms from coming back
• ‘Zollinger-Ellison syndrome’ where your stomach produces too much acid.
Talk to your doctor if you have any questions about this.
2. Before you take Pepcid
Do not take Pepcid if:
• you have ever had an allergic reaction to the active ingredient of this medicine or to any of the other ingredients (listed in section 6 below)
• you have ever had an allergic reaction to a similar medicine
• you are or think you may be pregnant
• you are planning to become pregnant
• you are breast-feeding.
Do not take Pepcid if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Pepcid.
Children
Pepcid should not be used in children.
Take special care with Pepcid
Check with your doctor or pharmacist before taking your medicine if you have kidney problems.
Your doctor may check your blood count and liver function, if you have been taking high dose of Pepcid for a long time.
It is important that you do not suddenly stop taking Pepcid without talking to your doctor if you have had ulcer disease for a long time.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular
you should tell your doctor or pharmacist if you are taking any of the following medicines:
• probenecid, used for gout or arthritis caused by gout
• itraconazole or ketoconazole, used for fungal infections
• atazanavir, used for treatment of HIV infection
• antacids, used for treatment of heartburn or acid indigestion
• sucralfate, used for treatment of ulcers.
Driving and using machines
Some patients have experienced adverse reactions such as dizziness and headache while taking Pepcid. Do not drive or operate machinery until
you see how Pepcid affects you and whether you experience these symptoms. (See 4. Possible side effects.)
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3. How to take Pepcid
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Taking this medicine
You should take this medicine by mouth. The number of tablets you take each day will depend upon your condition and whether you have kidney problems.
• Swallow the tablet with water
• Do not take more or less than your doctor has prescribed
• You should keep taking the tablets for as long as your doctor has asked, even though you may feel better very quickly.
• It is important that you do not stop taking the tablets without talking to your doctor.
The usual doses are:
For an ulcer
• Treatment: One 40 mg tablet at night, for 4 to 8 weeks. This may change depending on how you respond to the treatment.
• Prevention: One 20 mg tablet at night.
For ‘gastro-oesophageal reflux disease’ (GORD)
• Prevention of mild symptoms: One 20 mg tablet in the morning and one 20mg tablet at night.
• Treatment of mild symptoms: One 20 mg tablet in the morning and one 20mg tablet at night, for 6 to 12 weeks.
• Treatment of more severe symptoms: One 40 mg tablet in the morning and one 40 mg tablet at night, for 6 to 12 weeks.
For ‘Zollinger-Ellison Syndrome’
• One 20 mg tablet every six hours.
• Some patients may need higher doses for this condition.
If you take more Pepcid than you should
• Please contact your doctor immediately.
If you forget to take Pepcid
• Do not take an extra dose. Take the normal amount of Pepcid the next time you are due to take a dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
For Position Only
(famotidine)
Read all of this leaflet carefully before you start to take 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Pepcid is and what it is used for
2. Before you take Pepcid
3. How to take Pepcid
4. Possible side effects
5. How to store Pepcid
6. Further information
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4. Possible side effects
Like all medicines, Pepcid can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Common (affects less than 1 in 10 people)
• headache, dizziness
• constipation, diarrhea
Uncommon (affects less than 1 in 100 people)
If you have an allergic reaction, stop taking Pepcid and see a doctor straight away. The signs may include:
• swelling of your face, lips, tongue or throat (with difficulty in breathing or swallowing)
• hives
• dry mouth, changes in taste
• feeling sick, vomiting
• mild stomach (abdominal) pain or bloating
• rash
• loss of appetite
• feeling tired
• itching
Very rare (affects less than 1 in 10,000 people)
• wheezing or difficulty swallowing
• feeling depressed, anxious, agitated, confused or seeing or hearing things that are not there (hallucinations) and disorientation. These
usually go away after stopping Pepcid
• difficulty sleeping
• seizures in people with kidney problems
• tingling feeling or numbness
• severe skin reactions known as Stevens-Johnson Syndrome/or toxic epidermal necrolysis
• slow or irregular heart beat
• pneumonia (sometimes severe), painful joints, muscle cramps
• yellowing of your skin or whites of your eyes, (jaundice)
• abnormal liver blood tests
• lowered blood-cell counts (usually seen in a blood test)
• hair loss
• being unable to have an erection (impotence)
Not known
• breast enlargement in men (although this may not have been caused by Pepcid)
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. It will help if you
make a note of what happened, when it started and how long it lasted.
5. How to store Pepcid
Keep your tablets out of the reach and sight of children.
Do not store your tablets above 25°C. Keep them in the original package.
If you have been given a calendar pack, do not remove the tablets from the blister until you are ready to take the medicine.
Do not use Pepcid after the expiry date which is stated on the carton after the letters EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. Further information
What Pepcid contains
• The active ingredient is famotidine. Pepcid tablets are available in two strengths:
− The square-shaped, round-cornered, film-coated, beige-coloured tablet marked 'MSD 963' on one side and plain on the other contain
20 mg famotidine.
− The square-shaped, round-cornered, film-coated, brown-coloured tablet marked 'MSD964' on one side and plain on the other contain
40 mg famotidine.
• The other ingredients are Carnauba wax E903, magnesium stearate E572, pregelatinised starch, hydroxypropylcellulose E463, hypromellose
E464, red iron oxide E172, yellow iron oxide E172, talc, titanium dioxide E171, microcrystalline cellulose E460.
Pepcid tablets are available in calendar blister packs containing 28 tablets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder
Manufacturer(s)
Merck Sharp & Dohme Limited
Merck Manufacturing Division
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