The Co-Operative Max Strength Cold & Flu Capsules
Galpharm Max Strength Cold & Flu Capsules
Paracetamol, Phenylephrine, Caffeine
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 barefully 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 7 days.
What is in this leaflet?
1. What is Galpharm Max Strength Cold & Flu Capsules and what is it used for
2. What you need to know before you take Galpharm Max Strength Cold & Flu Capsules
3. How to take Galpharm Max Strength Cold & Flu Capsules
4. Possible side effects
6. How to store Galpharm Max Strength Cold & Flu Capsules 6. Contents of the pack and other information
1. What is Galpharm Max Strength Cold & Flu Capsules 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 » phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily
* caffeine which helps to increase the pain relief from paracetamol and makes you more alert.
These capsules are used for the relief of the symptoms of colds and flu, including aches and pains, sore throat, headache, fatigue (tiredness) and drowsiness, nasal congestion (blocked nose) and feverishness (high temperature).
2. What you need to know before you take Galpharm Max Strength Cold & Flu Capsules
Do not take this medicine if you:
|» are allergic to paracetamol, caffeine, phenylephrine or any of the other l_ ingredients listed in section 6
• are under 12 years of age
• have a serious heart condition or cardiovascular disorder(s)
• have high blood pressure (hypertension)
• have a history of stomach ulcers
• have an overactive thyroid
• 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 and isocarboxazid
• are taking tricyclic antidepressants, such as imipramine, amitriptyline.
Please see your doctor or pharmacist before taking this medicine if you:
• are pregnant or breastfeeding
• suffer from kidney or liver problems, including alcoholic liver disease or have alcohol dependence
• have diabetes
• have circulatory disorders such as a condition called Raynaud's Phenomenon, which results from poor circulation in the fingers and toes.
Other medicines and Galpharm Max Strength Cold & Flu Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
• 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 migraines such as ergotamine or methylsergide
• medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers (e.g. atenolol) or vasodilators (e.g. hydralazine)
• other decongestant drugs such as ephedrine or xylometazoline.
Galpharm Max Strength Cold & Flu Capsules contain paracetamol.
Do not take anything else containing paracetamol while taking this medicine.
Please turn over
Galpharm Max Strength Cold & Flu Capsules with food, drink and alcohol Do not drink alcohol (beer, wine, spirits etc) while taking this product.
3. How to take Galpharm Max Strength Cold & Flu Capsules
Swallow the capsules whole with water.
Do not chew.
Adults, the elderly and children aged 12 years and over: 2 capsules every 4 hours, as required. Do not take more than 8 apsules in any 24 hour period.
Children and adolescents
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.
Taking this medicine with food and drink:
(7ou should avoid too much caffeine in drinks like coffee and tea. If you are also consuming other medicines or food that contains caffeine (coffee, tea, cola drinks, chocolate) you may have a high caffeine intake and might have ifficulty sleeping, start shaking and/or have n uncomfortable feeling in the chest.
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 nd 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, pr anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.
Unknown side effects are:
• bronchospasm
!• restlessness, anxiety, nervousness, irritability, agitation.
Rare side effects are:
» allergic reactions such as skin rash
• nausea (feeling sick) or vomiting (being sick) or diarrhoea
» headache, tremor, dizziness
• difficulty sleeping (insomnia)
|» fast, slow or irregular heart beat (palpitations)
• high blood pressure ,• glaucoma
|» problems or pain passing urine
• sudden weight loss, loss of appetite and l_ yellowing of the eyes and skin.
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.
Very rare cases of serious skin reactions have been reported.
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.aov.uk/vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Galpharm Max Strength Cold & Flu Capsules
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the pack.
Do not store above 25°C.
6. Contents of the pack and other information
Each red / yellow capsule contains the active ingredients: paracetamol 500 mg, caffeine 25 mg and phenylephrine hydrochloride 6.1 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: quinoline yellow (E104), titanium dioxide (E171), patent blue V (E131) and erythrosine (E127).
This product is available in a pack size of 16 capsules.
The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.
Text revised: February 2016.
PL 12063/0066
2752954