PARACETAMOL ASCORBIC ACID PHENYLEPHRINE HYDROCHLORIDE 750/60/10 MG BLACKCURRANT FLAVOURED POWDER - Patient leaflet, side effects, dosage

Package leaflet: Information for the user

Paracetamol, Ascorbic acid, Phenylephrine Hydrochloride 750/60/10mg blackcurrant flavoured

Powder for Oral solution.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – Ask your pharmacist if you need more information or advice.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

• – You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

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

• 2. What you need to know before you take this medicine

• 3. Howtotake thismedicine

• 4. Possible side effects

• 5. How to store this medicine

• 6. Contents of the pack and other information..­.............­......

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

Paracetamol is an analgesic (a painkiller) and antipyretic (it reduces body temperature when you have a fever). Phenylephrine hydrdochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily. Ascorbic acid (Vitamin C) is a common ingredient of flu and cold products. It is included to help replace the vitamin C which may be lost in the initial stages of flu and colds.

2. what you need to know before you take this medicine

IMPORTANT:

• Do not take with any other Paracetamol-containing products. Do not take with any other flu, cold or decongestant products.

Do not take this medicine if:

• You are allergic to Paracetamol, Ascorbic acid, Phenylephrine hydrochloride or any of the other ingredients listed above.
• You have kidney or liver problems, overactive thyroid, diabetes or are under the care of your doctor for high blood pressure or heart disease.
• You are taking tricyclic antidepressants (e.g. imipramine or amitriptyline) or drugs for heart problems (including beta-blockers) or you are taking (or have taken within the last two weeks) drugs called monoamine oxidase inhibitors (MAOIs) prescribed by your doctor or hospital for depression.

.......

• If you have glaucoma or phaeochromocytoma.
• This medicinal product contains 2.7 g of sucrose. When taken according to the dosage recommendations this supplies up to 10.8 g sucrose daily. Unsuitable in rare disorders of sugar metabolism (hereditary fructose intolerance, glucoase-galactose malabsorption or sucrase-isomaltase deficiency).

Take special Care with this medicine:

• This product may cause dizziness. If affected, do not drive or operate machinery.

Ask your doctor before you take this medicine:

• If you have a blood vessel disease such as Raynaud’s Phe­nomenon.
• If you have an enlarged prostate.
• If you have diabetes mellitus. Each dose contains 2.7 g of sucrose.
• If you are on a controlled-sodium diet. Each dose contains 0.12 g of sodium.

If you are taking other medicines:

Talk to your doctor or pharmacist before taking this medicine if you are taking any prescribed medicines particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick] or colestyramine (to lower blood cholesterol) or drugs to lower blood pressure; appetite suppressants or stimulants; drugs to treat depression such as tricyclic antidepressants (e.g. amitriptyline) or heart disease (e.g. digoxin); 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 ofbleeding. But you can still take occasional doses of this medicine at the same time as anticoagulants.

If you are pregnant or breast feeding:

Do not take this medicine if you are pregnant or breast feeding unless advised by a doctor.............

3. how to take this medicine

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

Empty contents of one sachet into a mug. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.

Adults (including the elderly) and children ages 12 years and over:

The contents of one sachet to be taken every four to six hours as necessary. Do not take more than four sachets in any 24 hours.

Do not give to children under 12 years of age unless your doctor tells you to.

Do not take for more than 5 days without asking your doctor

If symptoms persist consult your doctor.

If you take more than you should

It will be harmful to take more than the doses stated on the pack and in this leaflet. 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.

4. possible side effects

Like all medicines, this medicine can have side effects but not everybody gets them.

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

• Allergic reactions which may be severe such as skin rash and itching sometimes with swelling ofthe mouth or face or shortness ofbreath.
• Skin rash or peeling or mouth ulcers.
• Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin.
• Unexplained bruising or bleeding.
• Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
• Visual disturbances. This is rare but is more likely in those with glaucoma.
• Usually fast pulse rate or a sensation of an unusually fast or irregular heartbeat
• Difficulty passing water. This is more likely to occur in men with an enlarged prostate gland.

These reactions are rare.

The following side effects may occur. Tell your doctor if you get them:

• Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, diarrhoea or sickness.

If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or pharmacist.

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

...........

5. how to store this medicine

Store in a dry place. Do not store above 25°C.

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines 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 this medicine contains

• – Each 5 g of powder for oral solution contains Paracetamol 750 mg, Ascorbic Acid 60 mg and Phenylephrine Hydrochloride 10 mg as the active ingredients.

• – The powder for oral solution also contains caster sugar, citric acid, saccharin sodium, sodium citrate, blackcurrant flavours and blackcurrant colours.

• – Sodium content 0.12 g per sachet. Carbohydrate content 2.7 g per sachet.

What this medicine looks like and contents of the pack

Each sachet contains 5 g ofpowder for oral solution. Five or ten sachets are contained in a box.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation is GlaxoSmithKline Consumer Heathcare (UK) Trading Limited, 980 Great West Road, Brentford, TW8 9GS, U.K.

The manufacturer is SmithKline Beecham SA Carretera De Ajalvir, KM 2500, Alcala De Henares (Madrid), E-28806, Spain...... ________

This leaflet was prepared in October 2015.

4