Galpharm Paracetamol Guaifenesin Phenylephrine Hydrochloride 250 Mg/100 Mg/5 Mg Hard Capsules

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Galpharm Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 250 mg / 100 mg / 5 mg Capsules - Leaflet

Marketing

Authorisation number

PL 12063/0125

Version Number

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 capsules 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

• are pregnant or breastfeeding

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Galpharm Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 250 mg / 100 mg / 5 mg Capsules - Leaflet

Marketing

Authorisation number

PL 12063/0125

Version Number

• tricyclic antidepressants such as imipramine, amitriptyline

• 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

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.

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Galpharm Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 250 mg / 100 mg / 5 mg Capsules - Leaflet

Marketing

Authorisation number

PL 12063/0125

Version Number

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.

3) How to take this medicine

Swallow the capsules whole with water. Do not chew.

Adults, the elderly and children 12 years and over:

2 capsules every 4 hours as required. Do not take more than 8 capsules 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

• 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 and coolness of the skin

• a faster or slower heart beat

• difficulty sleeping (insomnia)

• nervousness or tremors

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

Pack Copy Specification

Galpharm Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 250 mg / 100 mg / 5 mg Capsules - Leaflet

Marketing

Authorisation number

PL 12063/0125

Version Number

• 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 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: 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 all medicines out of the sight and reach of children.

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

Do not store above 25°C.

6) What is in this medicine?

Each blue / purple hard capsule contains the active ingredients: paracetamol 250 mg, guaifenesin 100 mg and phenylephrine hydrochloride 5 mg.

The other ingredients are: maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc. The capsule shell is made of gelatin and contains the colours erythrosine (E127), brilliant blue FCF (E133) and titanium dioxide (E171).

This product is available in pack sizes of 8 or 16 capsules.

Pack Copy Specification

Galpharm Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 250 mg / 100 mg / 5 mg Capsules - Leaflet

Marketing

Authorisation number

PL 12063/0125

Version Number

7) Who makes this medicine?

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

Text revised: 10/2015

PL 12063/0125