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Pepcidtwo Chewable Tablets

Patient Information Leaflet

Pepcidtwo Chewable tablets

Famotidine, magnesium hydroxide, calcium carbonate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist have told you.

•    Ask your pharmacist if you need more information or advice.

•    This medicine is used to provide fast and long-lasting relief from heartburn, indigestion and excess acid.

•    This medicine is for use by adults and children aged 16 years and over.

   Do not take this medicine:

•    There are some people who should not use this medicine. To find out if you are one of them. See Section 2

•    If you have ever had a bad reaction to any of the ingredients. For the list of ingredients. See Section 6

   Speak to your doctor:

•    If you suffer from any of the conditions mentioned in Section 2

•    If you are taking any other medicines. See Section 2

   Follow the dosage instructions carefully. These are shown in the dosage table. See

Section 3

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse after 6 days.

Keep the leaflet: you might need it again.

1    What the medicine is for

Pepcidtwo chewable tablets is a medicine which is used to provide fast and long-lasting (up to 12 hours) relief from heartburn, indigestion and excess acid. The tablets contain antacids (calcium carbonate and magnesium hydroxide) to neutralise acid, as well as famotidine which belongs to a group of medicines known as H2 blockers that help balance the amount of acid produced.

This medicine is for use in adults and children aged 16 years and over.

2    Before taking this medicine

This medicine is suitable for most adults and children aged 16 years and over, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

Do not take this medicine...

• If you have ever had a bad reaction to any of the ingredients.

• If you have ever had a bad reaction to other H2 antagonists such as cimetidine and ranitidine.

•    If you have liver or kidney problems.

If any of these apply to you, get advice from a doctor or pharmacist without taking Pepcidtwo chewable tablets.

Warnings and precautions

! Talk to your doctor or pharmacist before taking this medicine.

•    If you have difficulty swallowing or persistent stomach pains.

•    If you have lost weight without trying to whilst suffering from indigestion.

•    If you have high calcium or magnesium levels in the blood.

•    If you are over 50 and have indigestion for the first time, or your symptoms have recently changed.

•    If you have any other illness.

•    If you have been told by your doctor that you have an intolerance to some sugars.

•    If you are taking any other medicines including:

non-steroidal anti-inflammatory (NSAID) painkillers.

If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist.

If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

Other medicines and Pepcidtwo chewable tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines such as:

•    Itraconazole (medicine used to treat fungal infections)

•    Tetracycline hydrochloride; doxycycline (antibiotic used to treat bacterial infections)

•    Ciprofloxacin (antibiotic used to treat bacterial infections)

•    Penicillamine (drug used to treat rheumatoid arthritis)

•    Zinc sulfate (drug used to treat zinc deficiency)

! If you are pregnant or breast-feeding

•    Do not take this medicine if you are pregnant, think you are pregnant or planning to become pregnant or breast-feeding. Talk to your doctor about a suitable treatment.

! Some of the ingredients can cause problems

•    Pepcidtwo chewable tablets contain sucrose, glucose and lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

•    This medicinal product contains small amounts of ethanol (alcohol) less than 100 mg per dose.

3 How to take this medicine

Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist

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

Check the table below to see how much medicine to take.

•    For oral use only.

•    Do not use more than the stated dose shown in the table.

! Children under 16 years

This medicine is not recommended for children under 16 years old.

! Adults and children aged 16 years and over

Age

Dose

Adults and children aged 16 years and over

Chew one tablet to relieve your symptoms. Repeat the dose if symptoms return.

• Do not take more than 2 tablets in 24 hours.

•    If you are over 50 and have indigestion for the first time or your symptoms have recently changed you should talk to your doctor or pharmacist before taking this medicine.

•    If your symptoms get worse, come back, or the tablets have no effect, talk to your doctor or pharmacist.

•    If symptoms persist for more than 6 days talk to your doctor or pharmacist. You should not keep treating yourself with these tablets without taking advice, as it may be a sign that you have a different medical condition.

! If anyone takes too much of this medicine

If anyone takes too many Pepcidtwo chewable tablets, contact your doctor or nearest Accident and Emergency department (Casualty) taking this leaflet with you.

! If you forget to take the medicine

You should only take this medicine as required following the dosage instructions above carefully. If you forget to take a dose, take the next dose when needed provided that you only take a maximum of 2 tablets in 24 hours. Do not take a double dose.

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4 Possible side-effects

Pepcidtwo chewable tablets can have side-effects, like all medicines, although these don't affect everyone and are usually mild.

If you experience any of the following, stop using the medicine and seek immediate medical help:

•    Allergic reactions such as skin rash, itching, shortness of breath or swollen face.

•    Fits or numbness.

If you experience any of the following, stop using the medicine and talk to your doctor:

•    Itchiness, hives or swelling.

•    Yellowing of the eye and or skin (jaundice), which may be a sign of liver problems.

•    Unexplained bruising, bleeding or getting more infections, which may be due to lowering of blood cell counts.

•    Vomiting or stomach pain.

Other effects which may occur include:

Common (may affect up to 1 in 10 people):

•    Headache.

Uncommon (may affect up to 1 in 100 people):

•    Dizziness

•    Dry mouthor changes in taste.

•    Diarrhoea and nausea.

•    Abdominal discomfort and pain.

•    Tiredness.

•    Excessive intestinal gas.

•    Sore or painful mouth and throat.

•    Unusual weakness.

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

•    Constipation.

•    Decrease or loss of appetite.

•    Drowsiness.

•    Joint pain.

•    Increased breast size in men.

•    Liver enzyme abnormalities or worsening liver disease.

•    Generally feeling unwell.

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

•    Hair loss.

Other effects which may occur but it is unknown how often:

•    Nervousness.

•    Bloating.

Changes in stool frequency and consistency. Indigestion or burping.

Thirst.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5 Storing this medicine

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use your medicine after the end of the month shown as the expiry date on the packaging.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Further information What's in this medicine?

The active ingredients in Pepcidtwo chewable tablets are: Calcium carbonate 800 mg, Magnesium hydroxide 165 mg and Famotidine 10 mg.

Other ingredients are: Pregelatinised maize starch, sodium lauryl sulphate, dextrates, confectioner's sugar (sucrose and maize starch), lactose monohydrate, cellulose acetate, magnesium stearate, hypromellose (E464), hydroxypropyl cellulose (E463), peppermint flavour (peppermint oil, modified food starch, maltodextrine, citric acid (E330), sodium ascorbate (E301), water), cream flavour (sweet orange oils, ethanol, esters of acetic and butanoic acids, aliphatic alcohols and ketones, phenols, aliphatic and aromatic aldehydes, benzaldehyde, dextrin, maltodextrine, glucose, corn starch, calcium silicate, powdered vanilla extract, heliotropine, vanillin, silicone dioxide, water), red ferric oxide (E172).

What the medicine looks like

Pepcidtwo chewable tablets are rose coloured, round, flat chewable tablets.

They are supplied in packs of 6 or 12 tablets. Not all pack sizes may be marketed. Marketing Authorisation holder:

McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

Manufacturer:

Janssen-Cilag SpA, Via Constant Janssen, Borgo San Michele, Latina, Italy. This leaflet was revised March 2016.

Pepcidtwo is a registered trade mark.

7 What you can do to help stop these symptoms

Heartburn and indigestion symptoms can be caused or aggravated by:

•    Eating late in the evening.

•    Overeating, or very large meals.

•    Bending or stooping soon after eating.

•    Exercise immediately after eating.

•    Pressure on the stomach, e.g. tight fitting clothing.

Try to lose excess weight as the pressure it causes on the stomach can produce heartburn.

Try to cut down or stop smoking. Smoking can make the muscles at the entrance to the stomach relax, which can cause heartburn.