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

This medicine contains:

• paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever
• guaifenesin which is an expectorant to help loosen phlegm
• phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily.

These sachets are used for the relief of the symptoms of colds and flu and the pain and congestion of sinusitis, including aches and pains, headache, blocked nose and sore throat, chills and feverishness (high temperature). They can also loosen stubborn mucus (phlegm) and provide relief from chesty coughs.

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

Do not take this medicine if you:

• are allergic to paracetamol, guaifenesin, phenylephrine or any of the other ingredients (listed in section 6)
• have a serious heart condition or cardiovascular disorder(s)
• have high blood pressure (hypertension)
• have an overactive thyroid
• have an enlarged prostate
• have glaucoma, including closed angle glaucoma
• have difficulty passing urine
• are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI’s), or have taken them within the last 14 days – these are medicines such as phenelzine, isocarboxazid and tranylcypromine
• are taking beta-blocking drugs
• are currently taking other decongestant drugs (e.g. ephedrine and xylometazoline) or stimulants (e.g.

L dexamfetamine)

• are taking a cough medicine called a cough suppressant.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

• are pregnant or breast-feeding
• suffer from kidney or liver problems, including alcoholic liver disease
• have diabetes
• have phaeochromocytoma
• have a very bad cough or asthma. See your doctor if your cough lasts for more than 3 days or comes back, or if you have a fever, rash or a headache which won’t go away
• have circulatory disorders such as a condition called Raynaud’s Phe­nomenon, which results from poor circulation in the fingers and toes
• have angina
• have severe stomach or intestinal problems
• have an intolerance to some sugars
• suffer with phenylketonuria, a rare, inherited metabolic disorder.

Other medicines and this medicine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:

• medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine
• medicines to control feeling sick or being sick such as metoclopramide or domperidone
• medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins -you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis
• barbiturates (for epilepsy or to help you sleep), such as phenobarbitone
• tricyclic antidepressants such as imipramine, amitriptyline
• medicines to treat heart or circulatory problems, or to lower blood pressure, (e.g. digoxin, guanethidine, reserpine, methyldopa)
• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)
• medicines to treat migraine (e.g. ergotamine and methysergide)
• zidovudine as this might cause blood problems (low white blood cell count)
• beta blockers (e.g. atenolol) or vasodilators (e.g. hydralazine)
• phenothiazines used as sedatives (e.g. chlorpromazine, pericyazine and fluphenazine)
• if you are going to have blood or urine tests as taking this medicine may affect the results
• if you are going to have a general anaesthetic, as this may cause changes in heart rhythm.

Contains paracetamol.

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

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This medicine with food and alcohol

Do not drink alcohol (beer, wine, spirits etc) while taking this product.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Other important information:

• If you are taking medication, or are under medical care, consult your doctor before using this medicine
• Long term use of this product is not recommended
• This medicine should only be used if you have all of the following symptoms – pain and/or fever, a blocked nose and a chesty cough
• Use medicines which will only treat the symptoms you have
• Do not take with other flu, cold or decongestant products
• This product could cause dizziness. If affected do not drive or operate machinery.

Contains 2 g sucrose (sugar) per sachet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This should be taken into account in patients with diabetes.

Contains aspartame (E951), a source of phenylalanine equivalent to 17 mg per sachet. May be harmful for people with phenylketonuria.

Each sachet contains 117 mg sodium. To be taken into consideration by people on a controlled sodium diet.

3. how to take this medicine

Pour the contents of 1 sachet into a standard mug. Fill the mug to below the brim with approximately 250 ml (8 fluid oz) of hot, but not boiling, water. Stir until dissolved, and allow to cool to a drinkable temperature.

Adults, the elderly and children 16 years and over: 1 sachet every 4 to 6 hours, as required. Do not take more than 4 sachets (4 doses) in any 24 hour period. Leave at least 4 to 6 hours between doses.

Do not give to children under 16 years.

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

Do not take for longer than 3 days, unless advised by your doctor.

If you take more of this medicine than you should 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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

4. 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.

Rare side effects are:

• allergic reactions which may be severe such as skin rash, peeling of the skin, itching, swollen red areas of the skin, sometimes with shortness of breath or swelling of the mouth, lips, tongue, throat or face
• stomach upsets
• difficulty passing urine
• tingling and coolness of the skin
• a faster or slower heart beat
• difficulty sleeping (insomnia)
• nervousness, tremors or convulsions
• a rise in body temperature
• a rise in blood pressure with headache, vomiting (being sick) and irregular heart beat (palpitations).

More rarely, the following side effects can happen :

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

5. how to store this medicine

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 and sachet. The expiry date refers to the last day of the month.

Do not store above 25°C.

6. contents of the pack and other information

What this medicine contains

The active ingredients are paracetamol, guaifenesin and phenylephrine hydrochloride.

Each 5.2 g sachet contains paracetamol 1000 mg, guaifenesin 200 mg and phenylephrine hydrochloride 12.2 mg.

The other ingredients are: sucrose, citric acid, tartaric acid, sodium citrate, acesulfame potassium (E950), aspartame (E951), powdered menthol flavour, lemon flavour and the colour quinoline yellow (E104).

What this medicine looks like and contents of the pack

Each 5.2 g sachet contains off white powder.

This pack contains 5 or 10 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

This leaflet was last revised in July 2018.

PL 12063/0104 D6Q46H9J2