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Paracetamol Seltzer

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PATIENT INFORMATION LEAFLET PARACETAMOL SELTZER

Paracetamol and Sodium Bicarbonate

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 further questions, please ask your doctor or pharmacist

• Do not pass this medicine 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 paracetamol seltzer is and what it is used for

2. Before you take paracetamol seltzer

3. How to take paracetamol seltzer

4. Possible side effects

5. How to store paracetamol seltzer

6. Further information

WHAT PARACETAMOL SELTZER IS AND WHAT IT IS USED FOR

The name of your medicine is Paracetamol Seltzer (called paracetamol seltzer throughout this leaflet). This medicine contains two different medicines called paracetamol and sodium bicarbonate. Paracetamol belongs to a group of medicines called analgesics (painkillers). It is used to treat pain (including headache, toothache and period pain). Sodium bicarbonate is an antacid which helps to relieve the symptoms of an upset stomach.

2. BEFORE YOU TAKE PARACETAMOL SELTZER

Do not take paracetamol seltzer and tell your doctor if:

• You are allergic (hypersensitive) to paracetamol or sodium bicarbonate or any of the other ingredients in your medicine (listed in Section 6: Further information)

Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue

• The person going to take the tablets is under 12 years of age. Paracetamol Seltzer must not be given to children under 12 years of age

Do not take paracetamol seltzer if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking paracetamol.

Take special care and check with your doctor before taking paracetamol seltzer if:

• You have severe kidney or liver problems

• You have liver problems caused by alcohol

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol seltzer can affect the way some other medicines work. Also, some other medicines can affect the way paracetamol seltzer works.

While taking paracetamol seltzer you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Tell your doctor if you are taking any of the following medicines:

• Medicines used to thin the blood such as warfarin

• Medicines for liver problems such as barbiturates

• Medicines for the treatment of mental disorders such as lithium

• Salicylates such as aspirin

• Anticonvulsants such as carbamazepine

• Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick (vomiting)

• Cholestyramine - for lowering blood cholesterol levels

• Non-steroidal anti-inflammatory medicines such as indomethacin, ibuprofen or diclofenac - used to treat pain and inflammation

• Methotrexate for rheumatoid arthritis, psoriasis

• Amphetamines

• Quinidine - an anti-arrhythmic drug.

If you are taking any of the following medicines you should leave at least two hours between taking Paracetamol Seltzer and the other medicine:

• Antibiotics such as tetracyclines or rifampicin

• Ketoconazole for fungal infections

• Chloroquine for malaria and autoimmune diseases including rheumatoid arthritis and lupus erythematosus

• Phenothiazines for treatment of nervous and emotional disorders

• Phenytoin for epilepsy

• Penicillamine for rheumatoid arthritis

• Bisphosphonates such as alendronate, etidronate.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking paracetamol seltzer.

Taking paracetamol with food and drink

You should not drink alcohol while you are taking these tablets. Taking alcohol with paracetamol can increase your chances of getting side effects

Pregnancy and breast-feeding

Talk to your doctor before taking these tablets if:

• You are pregnant, think you may be pregnant or plan to get pregnant

• You are breast-feeding or planning to breast-feed

Important information about some of the ingredients of your paracetamol seltzer tablets

• Sodium: There is 388mg of sodium per effervescent tablet. This may be harmful to people on a low sodium or low salt diet.

• Sorbitol: This is a type of sugar. If you have been told by you doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.

3. HOW TO TAKE PARACETAMOL SELTZER

Always take paracetamol seltzer exactly as instructed on this leaflet. You should check with your pharmacist if you are not sure.

• Do not take more than the recommended dose

• If you need to use this medicine for more than three days at a time, see your doctor Adults and children over 12

• The usual dose of paracetamol seltzer is 2 effervescent tablets, taken together

• Dissolve the effervescent tablets in a full glass of water before taking

• Wait at least 4 hours before taking another dose

• Do not take more than 8 tablets in any 24-hour period

Children

Paracetamol Seltzer should not be given to children under 12 years of age.

If you take more paracetamol seltzer than you should

• Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of

the risk of delayed, serious liver damage

• Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken

If you have forgotten to take paracetamol seltzer

If you forget to take a dose at the right time, take it as soon as you remember. However, do not take two doses at or near the same time. Remember to leave at least 4 hours between doses.

POSSIBLE SIDE EFFECTS

As with all medicines, paracetamol seltzer can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking paracetamol and see a doctor or go to a hospital straight away if:

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)

This may mean you are having an allergic reaction to paracetamol seltzer

Talk to your doctor straight away if you notice the following serious side effect:

• Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This has only been reported in a very small number of people taking paracetamol.

These people had usually been taking paracetamol for a long time.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

• Excess burping (belching)

• Excess wind (flatulence)

• Feeling sick (nausea)

• A bloated or swollen stomach (abdominal distension)

• Irritability, muscle twitching, muscle cramp, hand tremor or light-headedness (alkalosis)

• You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia)

If any of the side effects gets serious, lasts longer than a few days or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PARACETAMOL SELTZER

• Keep this medicine in a safe place out of the reach and sight of children.

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

• Store your medicine in the original packaging in order to protect from moisture.

• Do not store above 25 °C.

• Ask your pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish. This will help protect the environment.

6. FURTHER INFORMATION

What Paracetamol Seltzer Tablets contain

• The active substance of Paracetamol Seltzer is paracetamol. Each tablet contains 500mg of paracetamol and 1222.2 mg of sodium hydrogen carbonate (Sodium bicarbonate).

• The other ingredients are, sorbitol, saccharin sodium, sodium lauryl sulphate, citric acid, sodium carbonate, povidone, and dimeticone.

What Paracetamol Seltzer Tablets look like and contents of pack

Paracetamol Seltzer are flat, white tablets with bevelled edges, which are scored on one side and plain on the reverse. Paracetamol Seltzer Tablets come in pack sizes of 24.

The Marketing Authorisation Holder is

Winthrop Pharmaceuticals, PO Box 611, Guildford, Surrey, GU1 4YS Or

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.

The Manufacturer is

Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle upon Tyne, NE3 3TT, UK This leaflet was last updated in March 2011