Paracetamol/Guaifenesin/Phenylephrine Hcl Wrafton 1000 Mg/200 Mg/12.2 Mg Powder For Oral Solution

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Document: leaflet MAH BRAND_PL 12063-0086 change

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PGP Max Sachets - Leaflet

Marketing

Authorisation number

PL 12063/0086

Paracetamol, Guaifenesin, Phenylephrine

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, 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.

1) What is this medicine and what is it 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) Is this medicine suitable for you?

Do not take this medicine if you:

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

• have a serious heart condition or cardiovascular disorder(s)

• have high blood pressure (hypertension)

• have diabetes

• have an overactive thyroid

• have glaucoma

• have difficulty passing urine, an enlarged prostate or other prostate problems

• have phaeochromocytoma (a rare tumour of adrenal gland tissue)

• suffer from liver or kidney problems

• have porphyria, which is a type of blood disorder that causes skin or nervous system problems

• are pregnant or breastfeeding

• are taking tricyclic antidepressants such as imipramine or amitriptyline

Pack Copy Specification

PGP Max Sachets - Leaflet

Marketing

Authorisation number

PL 12063/0086

• 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 currently taking other decongestant drugs (e.g. ephedrine and xylometazoline) or stimulants (e.g. dexamfetamine).

Please see your doctor or pharmacist before taking this medicine if you:

• suffer from alcoholic liver disease or alcohol dependence

• have circulatory disorders such as a condition called Raynaud’s Phenomenon, which results from poor circulation in the fingers and toes

• have angina

• have an intolerance to some sugars

• suffer with phenylketonuria, a rare, inherited metabolic disorder.

If you are taking any of the following medicines please see your doctor:

• 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 phenobarbitones

• medicines to treat heart or circulatory problems, or to lower blood pressure, (e.g. digoxin, guanethidine, reserpine, methyldopa)

• 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 a general anaesthetic, as this may cause changes in heart rhythm.

Contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine. Other important information:

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

If you are taking medication, or are under medical care, consult your doctor before using this medicine. Do not take with other flu, cold or decongestant products.

Long term use of this product is not recommended.

Pack Copy Specification

PGP Max Sachets - Leaflet

Marketing

Authorisation number

PL 12063/0086

Information about some of the ingredients in this medicine:

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.

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 patients on a controlled sodium diet.

3) How to take this medicine

For oral use. 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 12 years and over:

1 sachet every 4 hours, as required. Do not take more than 4 sachets (4 doses) in any 24 hour period.

Do not give to children under 12 years.

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

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:

• 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.

Very rare cases of serious skin reactions have been reported.

• breathing problems, these are more likely if you have experienced them before when taking other painkillers such as aspirin or ibuprofen

• stomach upsets, nausea, vomiting, diarrhoea

• tingling or coolness of the skin

• a faster or slower heart beat

• difficulty sleeping (insomnia)

Pack Copy Specification

PGP Max Sachets - Leaflet

Marketing

Authorisation number

PL 12063/0086

• nervousness or tremors

• a rise in blood pressure with headache, and irregular heartbeat (palpitations)

• restlessness

• dizziness, headache

• anxiety, irritability

• problems or pain passing water

• hallucinations

• eye disorders

• pins and needles and cold feelings in your extremities.

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

If you have previously experienced an allergic reaction (hypersensitivity) when taking decongestants, appetite suppressant and stimulants, you may be at increased risk of developing an allergic reaction when taking this product.

Reporting 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: www.mhra.gov.uk/yellowcard.

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

5) How to store your medicine

Keep 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) What is in this medicine?

Each 5.2 g sachet of off-white powder, taken as a hot drink, contains the active ingredients: 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).

This product is available in pack sizes of 5 or 10 sachets.

7) Who makes this medicine?

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

Pack Copy Specification

PGP Max Sachets - Leaflet

Marketing

Authorisation number

PL 12063/0086

Text Revised: October, 2014 PL 12063/0086