Superdrug Headache And Upset Stomach Relief

Document: leaflet BOOTS 2_PL 12063-0033 change

Boots Headache and Upset Stomach Relief

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1. What is this medicine and what is it used for?

This medicine contains:

• paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever

• citric acid, sodium bicarbonate, sodium carbonate and potassium bicarbonate provide the effervescence (fizzing) and have an antacid action in the stomach.

These sachets are used for the relief of headache with queasy / upset stomach and acid indigestion, particularly when you have too much to eat or drink.

2. Is this medicine suitable for you?

Do not take this medicine if you:

• are allergic to paracetamol, citric acid, sodium bicarbonate, sodium carbonate, potassium bicarbonate or any of the other ingredients

• suffer from kidney or liver problems, including alcoholic liver disease

• or the patient is under the age of 16 years

• are on a low potassium or sodium (salt) diet.

Please see your doctor or pharmacist before taking this medicine if you:

• are pregnant or breast feeding

• suffer with phenylketonuria, a rare inherited, metabolic disorder

• are taking any other medication, including those available without prescription.

If you are taking any of the following medicines please see your doctor:

• medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine

• medicines to control feeling sick or being sick such as metoclopramide or domperidone

• medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins - you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis.

• Contains paracetamol.

• Do not take anything else containing paracetamol while taking this medicine. Other important information:

Do not drink alcohol (beer, wine, spirits etc) while taking this product.

Information about some of the ingredients in this medicine:

Contains aspartame (E951), a source of phenylalanine equivalent to 28 mg per sachet. May be harmful for people with phenylketonuria.

Each sachet contains 288 mg of sodium. To be taken into consideration by patients on a controlled sodium diet.

Each sachet contains 287 mg of potassium. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Contains sunset yellow (E110), this may cause allergic reactions.

3. How to take this medicine

Dissolve the contents of the sachet in a (150 - 200 ml) glass of water and drink before the fizzing stops.

Adults, the elderly and children aged 16 years and over:

1 sachet every 4 hours as required. Do not take more than 4 sachets in any 24 hour period.

Do not give to children under 16 years.

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

4. Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.

Rare side effects are:

• allergic reactions such as swelling of the face, lips and tongue, difficulty breathing and a skin rash.

More rarely, the following side effects can happen:

• you may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.

• Very rare cases of serious skin reactions have been reported

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. How to store your medicine

Keep all medicines out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack.

6. What is in this medicine?

Each 4.1 g sachet of powder contains the active ingredients: paracetamol 1000 mg, anhydrous citric acid 1185 mg, sodium bicarbonate 808 mg, potassium bicarbonate 715 mg, anhydrous sodium carbonate 153 mg.

The other ingredients are: ascorbic acid, orange flavour [including maltodextrin, gum arabic (E414), triacetin and 0.45% alpha-tocopherol (E307)], acesulfame potassium (E950), aspartame (E951) and colours quinoline yellow (E104) and sunset yellow (E110).

This product is available in a pack size of <5 / 10 *Delete as appropriate> sachets.

7. Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, United Kingdom.

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PL 12063/0033