TOPAL TABLETS

Active substance: MAGNESIUM CARBONATE LIGHT

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texte corp 8

210 x 157 mm

Ceuta Healthcare own label- will be marketed version

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 Topal contains
Each tablet contains dried aluminium hydroxide 30mg, magnesium carbonate
(light) 40mg and alginic acid 200mg.
The other ingredients are sucrose, lactose monohydrate, silica gel, povidone,
citric acid monohydrate, sodium hydrogen carbonate, caramel flavour, vanillin,
strawberry flavour, magnesium stearate.
What Topal looks like and contents of the pack
Topal tablets are round, off-white or light cream coloured, flat faced bevel-edged
chewable tablets, with a score line on one face.
Each box of Topal contains PVC/Aluminium blisters as cards containing 14
tablets.
A box of 14 tablets contains one blister card
A box of 28 tablets contains two blister cards
A box of 42 tablets contains three blister cards
Not all pack sizes may be marketed
MARKETING AUTHORISATION HOLDER
PIERRE FABRE LIMITED
Hyde Abbey House - 23 Hyde Street - Winchester
Hampshire - SO23 7DR - United Kingdom
Tel: 01962 874400
MANUFACTURER
PIERRE FABRE MEDICAMENT PRODUCTION
45, place Abel-Gance - 92100 Boulogne - France
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please
call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name Reference Number
Topal chewable tablets 00603/0021
This is a service provided by the Royal National Institute of
the Blind.
This leaflet was last approved in
January 2011
Imported into the U.K. by:
CEUTA HEALTHCARE LTD
Bournemouth - Dorset - BH2 6HS
Tel : 01202 780 558

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Topal™ chewable tablets
(Dried Aluminium hydroxide 30 mg, Magnesium carbonate (light) 40 mg,
Alginic acid 200 mg)
Read all of this leaflet carefully because it contains important information for
you.
This medicine is available without prescription. However, you still need to use
Topal carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after
5 days.
• 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 Topal is and what it is used for
2. Before you use Topal
3. How to take Topal
4. Possible side effects
5. How to store Topal
6. Further information
1. WHAT TOPAL IS AND WHAT IT IS USED FOR
Topal chewable tablets belong to a group of medicines called antacids, which
means they reduce the effect of stomach acid.
Topal chewable tablets are used to relieve the pain and discomfort of
heartburn and acid indigestion. They can also be used to treat the symptoms
of conditions such as hiatus hernia, reflux œsophagitis (inflamed food pipe) and
gastritis (inflamed stomach).

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Ceuta Healthcare own label- will be marketed version

2. BEFORE YOU USE TOPAL
Do not use Topal
• if you are allergic (hypersensitive) to aluminium hydroxide, magnesium
carbonate, alginic acid, or any of the other ingredients of Topal.
Take special care with Topal
Medicines are not always suitable for everyone. Speak to the pharmacist before
taking this medicine if any of the following applies to you:
• You have kidney disease
• You are on a low phosphate diet.
• You are diabetic
• You have an intolerance to some sugars.
• You are on a controlled sodium diet.
• You have alkalosis (an imbalance of body fluids)
• You have hypermagnesaemia (too much magnesium in your blood).
Taking other medicines
Please tell your pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription as Topal can
reduce the effectiveness in your body of some medicines taken at the same time.
Some of these include medicines:
• Used to treat infections, such as antituberculosis drugs (ethambutol, isoniazide), tetracycline antibiotics, quinolone antibiotics (ciprofloxacin), and
ketoconazole for an anti-fungal infection.
• Non-steroidal anti-inflammatory drugs (NSAIDs), which are painkillers (such
as aspirin, indometacin, diflunisal),
• Bisphosphonates (a group of medicines used to treat bone disorders)
• Digoxin (a medicine use to treat heart conditions)
• Penicillamine (for rheumatoid arthritis),
• Chloroquine (to treat malaria),
• Antihistaminics H2, (medicines used to treat stomach acid and ulcer problems),
• Glucocorticoids (steroid drugs used to treat some allergic, inflammatory or
auto-immune disorders)
• Phenothiazinic neuroleptics, such as chlorpromazine and sulpiride used to
treat mental illness such as psychosis
• Iron salts (iron supplements)
• Thyroid hormones (medicines used to regulate the activity of your thyroid).
It is recommended that you do not take Topal at the same time as these medicines
but take it at least 2 hours later.
Pregnancy and Breast-feeding
If you are pregnant, think you might be pregnant, planning to get pregnant or
are breast-feeding, you should not use Topal unless your doctor has told you that
it is safe to do so.
Important information about some of the ingredients of Topal
Topal contains lactose and sucrose (types of sugar). If you are diabetic or if you

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have been told by your doctor that you have an intolerance to some sugars,
please contact your doctor or your pharmacist before taking this medicine.
One tablet of this medicine contains 11 mg of sodium; take this into account if
you are on a controlled sodium diet.
3. HOW TO TAKE TOPAL
Adults including the elderly
The usual dose is one to three tablets four times a day, preferably taken after
meals with the last dose taken at bedtime. The tablets should be chewed.
Children
The usual dose is half a tablet to one and a half tablets four times a day, preferably taken after meals with the last dose taken at bedtime. The tablets should be
chewed.
If your symptoms do not improve after 5 days you should contact your doctor
or pharmacist.
If you take more Topal than you should
If you accidentally take too many tablets contact your doctor at once or go to the
nearest hospital casualty department. Always take the medicine package with
you, whether there are any tablets left or not.
If you forget to use Topal
If you forget to take a dose, take it as soon as you remember unless it is time for
your next dose. Do not take a double dose to make up for a missed dose.
If you have any further questions on how to take this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Topal can cause side effects, although not everybody gets
them.
The side-effects seen with Topal are:
• Constipation, diarrhoea.
• Decreased phosphate levels and symptoms of hypophosphatemia such
as muscle weakness, tingling sensations, tremors and bone weakness.
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 TOPAL
Keep out of the reach and sight of children.
Do not use Topal after the expiry date which is stamped on the blister and the
outer carton. The expiry date refers to the last day of that month.
Do not store above 30 °C. Keep the blisters in the outer carton in order to protect
from moisture.

19/10/09 13:53:27

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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