Document: leaflet MAH BRAND_PL 08977-0037 change

• leaflet MAH BRAND 2_PL 08977-0037
• leaflet MAH BRAND_PL 08977-0037

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ASPAR

Cold Relief Capsules

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Patient Information Leaflet for

Cold Relief Capsules

Read this leaflet carefully before taking these capsules. It does not contain all the information about your medicine that you may need to know, so please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Cold Relief Capsules.

BCold Relief Capsules are used for the short term relief of colds, chills and flu.

The symptoms include shivers, fever, blocked nose, painful sinuses, catarrh, sore throat, aches, pains and headaches.

This medicine contains three active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever.

Phenylephrine is a decongestant which unblocks your nose and sinuses helping you breathe more easily. Caffeine acts as a mild stimulant.

2. Check BEFORE YOU TAKE

Do not take these capsules if you:

• Are allergic to paracetamol, phenylephrine hydrochloride or caffeine or any of the other ingredients listed in section 6.

•    Have kidney or liver problems.

•    Have phaeochromocytoma or glaucoma.

•    Are taking tricyclic antidepressants.(e.g. imipramine or amitriptyline)

•    Are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) (e.g.moclobemide) prescribed for depression.

•    Have heart or circulatory problems or high blood pressure (hypertension).

•    Have an overactive thyroid gland.

•    Have diabetes.

•    Are taking beta blockers (e.g. atenolol).

Do not take anything else containing paracetamol while taking this medicine.

Do not take with any other flu, cold or decongestant products.

Take special care and tell your doctor if you:

•    Have been told by your doctor that you have an intolerance to some sugars.

•    Have a blood vessel disease such as Raynaud's Phenomenon.

•    Have an enlarged prostate.

•    Have heart or circulation disease.

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

•    Colestyramine (medicines used to lower blood cholesterol)

•    Ergotamine or methylsergide (medicines used to treat migraines)

•    Debrisoquine (medicines used to lower blood pressure)

•    Metoclopramide and domperidone (medicines for nausea(feeling sick) and vomiting (being sick))

•    Blood thinning medicines such as Warfarin

•    Tricyclic antidepressants such as amitriptyline (medicines used to treat depression)

•    Digoxin (medicines used to treat heart disease)

•    Appetite suppressants or stimulants

Pregnancy and breast-feeding

Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding. Driving and using machines

These capsules may cause dizziness. If affected do not drive or operate machinery.

3. How to take these capsules

Adults (including elderly) and children over 12 years:

Take two capsules every 4 to 6 hours as needed. Swallow the capsules whole with a drink of water. Do not chew.

•    Do    not give these    capsules to children under 12 years. • Avoid too much caffeine in drinks like coffee    and

•    Do    not take more    frequently than every 4 hours.    tea. High caffeine intake can cause difficulty

•    Do    not take more    than 12 capsules in 24 hours.    sleeping, shaking and an uncomfortable feeling

•    Do    not take more    than the recommended dose.    in the chest.

•    Do not take for more than 7 days without asking your doctor.

If you take more capsules than you should or if you miss a dose

•    Seek medical attention IMMEDIATELY if you accidentally take too many capsules, even if you feel well, because of the risk of delayed serious liver damage.

•    If you miss a dose, do not take a double dose to make up for the missed dose

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Cold Relief Capsules can cause side effects but Stop taking this medicine and tell your doctor

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

•    Skin rash or peeling, or mouth ulcers.

•    Difficulty breathing. This is more likely if you have experienced this before when taking other painkillers such as ibuprofen or aspirin.

•    Reoccurring fevers or infections.

•    Unexplained bruising or bleeding.

These reactions are rare.

The following side effects may occur. Please tell your doctor if you get them.

Diarrhoea or sickness Irritability and anxiety Raised blood pressure

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.ulkyellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storing your medicine

•    Keep out of the reach and sight of children.

•    Do not store above 25°C. Store in the original packaging to protect from light and moisture.

•    Do not use this medicine after the ‘expiry’ date printed on the packaging.

6. More about your medicine

The active ingredients in Cold Relief Capsules are Paracetamol 300mg, Caffeine 25mg and Phenylephrine Hydrochloride 5mg. They are green and yellow hard gelatin capsules. The other ingredients are starch, colloidal anhydrous silica (aerosil 200), magnesium stearate, gelatin, Indigotine-FD & C Blue2 (E132), Yellow Iron oxide (E172) and Titanium Dioxide (E171).

The product licence holder and manufacturer is Aspar pharmaceuticals Ltd, Capitol Way, Colindale, London NW9 0EQ. PL 08977/0037 Cold relief Capsules are sold in packs of 16.