Patient leaflet - Paracetamol 1000 mg soluble tablets

1. What Paracetamol Soluble Tablets are and what they are used for

Paracetamol Soluble Tablets are used for the relief of headache, tension headache, migraine, backache, rheumatic and muscle pain, toothache and period pain. They also relieve sore throat and the fever, aches and pains of colds and ﬂu.

The active ingredient is paracetamol which is a pain killer and also reduces your temperature when you have a fever.

2. What you need to know before you take Paracetamol Soluble Tablets

Breathing problems. These are more likely if you have experienced them before when taking other painkillers Do not take Paracetamol Soluble Tablets:

Paracetamol Soluble Tablets contain Lactose monohydrate, Sodium, Sorbitol and Sulfurous acid.

If you have ever had an allergic reaction to paracetamol or to any of the other ingredients (listed in Section 6).
If you are taking other medicines containing paracetamol.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If you are under the age of 16 years.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol Soluble Tablets:

Talk to your doctor or pharmacist if you need 1 or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

If you have liver or kidney disease, including alcoholic liver disease.
If you have been told by your doctor that you have an intolerance to some sugars.
May rarely cause severe hypersensitivity reactions and bronchospasm.
If you are on a controlled sodium diet. Each tablet contains 330 mg of sodium.

3. How to take Paracetamol Soluble Tablets

Always take this medicine exactly as described in this leaﬂet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Other medicines and Paracetamol Soluble Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or colestyramine (to lower blood cholesterol).

The recommended dose is as follows:

Adults:

If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Paracetamol Soluble Tablets at the same time as anticoagulants.

Take ½ to 1 tablets dissolved in a tumbler of water every 4 hours as needed.

Do not take more than 4 tablets in 24 hours.

Use in children and adolescents

Flucloxacillin (antibiotic), due to a serious risk of blood and ﬂuid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Not recommended in children under the age of 16 years.

The tablet can be divided into equal doses.

If you take more Paracetamol Soluble Tablets than you should: Talk to a doctor at once if you or your child take too much of this medicine even if you or they feel well. This is because too much paracetamol can cause delayed, serious liver damage.

E ects of paracetamol on laboratory tests

Uric acid and blood sugar tests may be a ected.

If your symptoms continue or your headache becomes persistent, see your doctor.

Pregnancy and breast-feeding

Talk to your doctor before taking Paracetamol Soluble Tablets if you are pregnant.

4. Possible side e ects

Like all medicines this medicine can cause side e ects, although not everybody gets them.

If necessary, Paracetamol Soluble Tablets can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible.

Stop taking the medicine and tell your doctor immediately if you experience:

Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath.

Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Skin rash or peeling, or mouth ulcers.

You can take this product whilst breast feeding.

such as ibuprofen and aspirin.

U nexplained bruising or bleeding.
Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

Reporting of side e ects

If you get any side e ects, talk to your doctor or pharmacist. This includes any possible side e ects not listed in this leaﬂet. You can also report side e ects via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store. By reporting side e ects you can help provide information on the safety of this medicine.

5. How to store Paracetamol Soluble Tablets

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

Do not use Paracetamol Soluble Tablets after expiry date which is stated on the label after EXP. The expiry date refers to last day of that month.

Do not store above 30°C. Keep the polypropylene tube tightly closed. Store in the original container to protect from moisture and light.

Do not use the product if you notice visible signs of deterioration, like brown or black spots on the tablets, bulging of tablets or discoloration of the tablets.

Medicines should not be disposed 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. Contents of the pack and other information

What Paracetamol Soluble Tablets contains:

The active substance is Paracetamol. Each Soluble tablet contains 1000 mg of Paracetamol.

The other ingredients are; Povidone, Ascorbic acid, Citric acid, Lactose monohydrate (see section 2),

Sorbitol (see section 2), Sodium hydrogen carbonate (see section 2), Sodium saccharin (see section 2),

L-Leucine, sulfurous acid (see section 2), magnesium stearate and lemon ﬂavour.

What Paracetamol Soluble Tablets looks like and content of the pack:

Paracetamol 1000 mg Soluble Tablets are white round, single scored soluble tablets.

Polypropylene tube pack: 10 tablets

The Paracetamol 1000 mg Soluble Tablets are packed in a polypropylene tube containing 10 soluble tablets enclosed in an outer carton. Carton contains 1 tube with silica gel.

Marketing Authorisation Holder:

Nevik Limited

116 Rye House,

161 High Street,

Ruislip 4 8JY,

United Kingdom

Manufacturer:

Copea Pharma Limited

25 Compass Road

Spindus Road

Compass Industrial Park

Liverpool

L24 1YA