Wrafton Laboratories Limited Confidential Product Information

1.3    Product Information

1.3.1    SmPC, Labelling and Package Leaflet

Pack Copy Specification - Patient Information Leaflet

Paracetamol/Guaifenesin/Phenylephrine Hydrochloride Wrafton 500 mg/200 mg/10 mg Powder for Oral Solution

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.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

•    You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

What is in this leaflet?

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

2.    Is this medicine suitable for you?

3.    How to take this medicine

4.    Possible side effects

5.    How to store your medicine

6.    What is in this medicine?

7.    Who makes this medicine?

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 short term symptomatic relief of colds and flu including aches and pains, headache, blocked nose and sore throat, chills and fever, and for 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

•    are pregnant or breastfeeding

•    have liver or kidney disease

•    have a serious heart condition or cardiovascular disorder(s) or blood problems such as anaemia (low red blood cell count)

•    have high blood pressure (hypertension)

•    have an overactive thyroid

•    have diabetes

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

•    have closed angle glaucoma

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

•    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 tricyclic antidepressants such as imipramine or amitriptyline

•    are taking beta blockers (e.g. atenolol) or vasodilators (e.g. hydralazine)

•    are taking other paracetamol-containing products

•    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:

•    have a very bad cough or asthma. See your doctor if your cough lasts for more than 5 days or comes back

•    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 autoimmune disorder called myasthenia gravis where muscles become easily tired and weak

•    have an enlarged prostate gland, as this may cause more difficulty in passing urine

•    have severe stomach or intestinal problems

•    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 before taking this medicine:

•    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

•    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 methylsergide)

•    zidovudine as this might cause blood problems (low white blood cell count)

•    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.

Other important information:

•    Do not use for longer than 5 days, except on medical advice

•    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

•    Do not drink alcohol when using this product

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

Information about some of the ingredients in this medicine:

Contains 2.1 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. May be harmful for people with phenylketonuria.

Each sachet contains 129 mg sodium. To be taken into consideration by patients 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. Drink all of the yellow solution within 1% hours.

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 exceed the stated dose. If your symptoms persist for more than 5 days or worsen, you must see a doctor or pharmacist.

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. 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.

Common side effects (affecting less than 1 in 10 people but more than 1 in 100 people) are:

•    difficulty sleeping (insomnia)

•    diarrhoea, nausea (feeling sick)

•    nervousness, tremors, irritability, restlessness or excitability

•    a rise in blood pressure with headache, dizziness, vomiting (being sick) and irregular heart beat (palpitations).

Rare side effects (affecting less than 1 in 1,000 people but more than 1 in 10,000 people) 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. 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

•    allergic reactions such as skin rash, breathing difficulties stomach pain or discomfort

•    liver problems

•    a faster or slower heart beat

•    eye disorders

•    problems or pain passing water.

Very rarely (affecting less than 1 in 10,000 people), 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.

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 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 <national reporting system listed in Appendix V>. 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 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)    What is in this medicine?

Each 4.4 g sachet of off-white powder with a characteristic citrus/menthol odour, contains the active ingredients: paracetamol 500 mg, guaifenesin 200 mg and phenylephrine hydrochloride 10 mg.

The other ingredients are: sucrose, citric acid (E330), tartaric acid (E334), sodium cyclamate (E952), sodium citrate (E331), acesulfame potassium (E950), aspartame (E951), powdered menthol flavour, lemon flavour, lemon juice flavour and quinoline yellow (E104).

This product is available in pack sizes of 5, 6 or 10 sachets although not all pack sizes may be marketed.

7)    Who makes this medicine?

The manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

MA Holder: Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

Text Revised: June 2016

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