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Document: leaflet SAINSBURYS_PL 12063-0072 change

Sainsbury’s Paracetamol and Phenylephrine Capsules

Patient Information Leaflet

Read all of this leaflet carefully because it contains information you need to know.

This medicine is available without prescription. Nevertheless, 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.

•    If your symptoms worsen or do not improve, you must see a doctor.

1.    What is in your medicine?

Each light blue / dark blue capsule contains the active ingredients: paracetamol 500 mg and phenylephrine hydrochloride 6.1 mg.

The other ingredients in this medicine are: maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc. The capsule shell is made of gelatin and contains the colours titanium dioxide (E171), erythrosine (E127) and indigo carmine (E132).

This product is available in packs of 16 capsules.

2.    Who makes this medicine?

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

3.    What type of drugs are paracetamol and phenylephrine hydrochloride?

Paracetamol is a pain reliever and it reduces your temperature when you have a fever.

Phenylephrine hydrochloride is a decongestant which reduces swelling in the passages of the nose to help you breathe more easily.

4.    What are your capsules for?

Your capsules are for relief of the symptoms of colds and flu including aches and pains, sore throat, headache, blocked nose and fever.

5.    Is this medicine suitable for you?

You should not take these capsules if you:

•    are allergic to paracetamol, phenylephrine, or any of the other ingredients

•    have severe heart disease, high blood pressure or circulatory problems

•    have an overactive thyroid

•    are taking monoamine oxidase inhibitors for depression or have taken them within the last 14 days, these are medicines such as phenelzine and isocarboxazid.

Please see your doctor before taking these capsules if you:

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

•    have diabetes

•    have a condition called Raynaud’s Phenomenon (which results from poor circulation in the fingers or toes).

Pregnancy and breast feeding

As with any other medicine, if you are pregnant or breast feeding, ask your doctor or pharmacist for advice before taking this product.

5.    Is this medicine suitable for you? (continued)

If you are taking any of the following medicines please see your doctor or pharmacist before using this product:

•    metoclopramide or domperidone (to treat nausea and vomiting)

•    colestyramine (to reduce blood cholesterol levels)

•    warfarin or other anti-coagulants (used to thin the blood)

•    medicines to lower blood pressure such as beta blockers (e.g. atenolol) or vasodilators (e.g. hydralazine)

•    barbiturates, medicines to help you sleep such as phenobarbitones

•    tricyclic antidepressants such as imipramine and amytriptyline

•    other decongestants.

If you are taking any other medicines not listed here and you are not sure if it is suitable to take them together with this product, talk to your pharmacist.

Do not drink alcohol (e.g. beer, wine, spirits) while taking this product. Do not take if you are dependent on alcohol.

6.    How to take this medicine

For oral use. Swallow the capsules whole with water. Do not chew.

Adults and children over 12 years:

Take 2 capsules every 4-6 hours as required.

Do not take more than 8 capsules in 24 hours.

Do not give to children under 12 years.

Do not exceed the stated dose.

If symptoms persist or worsen, consult your doctor.

Contains Paracetamol.

Do not take with any other paracetamol-containing products.

7.    What should you do if you take too many capsules?

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.

8.    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.

•    allergic reactions such as skin rash

•    tingling and coolness of the skin

•    a faster or slower heart beat

•    a rise in blood pressure with headache, vomiting and an irregular heart beat.

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

9.    How to store your medicine

•    Do not use these capsules after the expiry date printed on the pack. This expiry date refers to the last day of the month.

•    Do not store above 25°C.

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

Text revised: July 2007.

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