Teva Max Strength Cold & Flu Day & Night Capsules Hard
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Paramed Max Strength Cold & Flu Day & Night Capsules
Paracetamol, Phenylephrine & Caffeine
Patient Information Leaflet
Read all of this leaflet carefully because it contains information you need to know.
This medicine is available without prescription. Nevertheless, 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 your symptoms worsen or do not improve, you must see a doctor.
1. What is in your medicine?
Each blister pack contains 6 day capsules and 2 night capsules.
Day Capsules: These are red / yellow capsules. Each capsule contains the active ingredients: paracetamol 500 mg, caffeine 25 mg and phenylephrine hydrochloride 6.1 mg.
The other ingredients of the day capsules 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 (El 71), patent blue V(E131) and erythrosine (E127).
Night Capsules: These are dark blue / light blue capsules. Each capsule contains the active ingredients: paracetamol 500 mg and phenylephrine hydrochloride 6.1 mg.
The other ingredients of the night capsules are: maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc. The capsule shell is made of gelatin and contains the colours titanium dioxide (E171), erythrosine (E127) and indigo carmine (E132).
This product is available in packs containing 12 Day capsules and 4 Night capsules.
2. Who makes this medicine?
The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL UK.
3. What type of drugs are paracetamol, caffeine and phenylephrine hydrochloride?
• paracetamol is a pain reliever and it reduces temperature when you have a fever.
• caffeine is included to provide relief from fatigue (tiredness) associated with colds and flu. Caffeine can also increase pain relief from paracetamol
• phenylephrine hydrochloride is a decongestant which reduces swelling in the passages of the nose to help you breathe more easily.
4. What are your capsules for?
Your Day and Night capsules are for the relief of the symptoms of colds and flu, including aches and pains, sore throat, headache, blocked nose and fever.
The Day capsules can also relieve tiredness and drowsiness.
5. Is this medicine suitable for you?
You should not take these capsules if you:
• are allergic to paracetamol, caffeine, phenylephrine or any of the other ingredients
• have severe heart disease, high blood pressure or circulatory problems
• have a history of stomach ulcers
• have an overactive thyroid
• are taking monoamine oxidase inhibitors for depression or have taken them within the last 14 days, these are medicines such as isocarboxazid and phenelzine.
5. Is this medicine suitable for you? (continued)
Please see your doctor or pharmacist before taking these capsules if you:
• suffer from kidney or liver problems, including alcoholic liver disease
• have diabetes
• have a condition called Raynaudls Phenomenon (which results from poor circulation in the fingers or toes).
Pregnancy and breast feeding
As with any other medicine, if you are pregnant or breast feeding, ask your doctor or pharmacist for advice before taking this product.
If you are taking any of the following medicines please see your doctor or pharmacist before using this product:
• metodopramide or domperidone (to treat nausea and vomiting)
• colestyramine (to reduce blood cholesterol levels) ■ tricyclic antidepressants, such as imipramine
and amitriptyline
• warfarin or other anti-coagulants (used to thin the blood)
• medicines used to lower blood pressure, such as beta blockers (e.g. atenolol) or vasodilators (e.g. hydralazine)
• barbiturates (for epilepsy or to help you sleep), such as phenobarbitones
• other decongestants.
If you are taking any other medicines not listed here and you are not sure if it is suitable to take them together with this product, talk to your pharmacist. Do not drink alcohol (e.g. beer, wine, spirits) while taking this product. Do not take if you are dependent on alcohol.
Contains Paracetamol.
Do not take with any other paracetamol-containing products.
6. How to take this medicine
For oral use. Swallow the capsules whole with water. Do not chew.
Adults and children over 12 years:
2 Day capsules every 4-6 hours during the daytime, as required, followed by 2 Night capsules at bedtime. Leave at least 4 hours between doses. Do not take more than 8 capsules in 24 hours.
Do not give to children under 12 years.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Note: Does not contain a sleep aid.
7. What should you do if you take too many capsules?
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.
8. Possible side-effects
Most people do not have any side-effects while taking this medicine. Flowever, 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 such as skin rash
• tingling and coolness of the skin
• a faster or slower heart beat
• a rise in blood pressure with headache, vomiting and sometimes an irregular heart beat
■ (Day capsules only) nausea, difficulty sleeping
• you may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.
9. How to store your medicine
• Do not use these capsules after the end of the month shown as an expiry date printed on the pack. Keep the capsules in the original pack.
• Do not store above 25°C.
• Keep all medicines out of the reach and sight of children.
Text revised: July 2007.
PL12063/0073 2720113
