Teva Max Strength Cold & Flu Day & Night Capsules Hard
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If any of these apply to you, get advice from a doctor or pharmacist without using Sudafed Day & Night Capsules.
Talk to your doctor or pharmacist...
SlIDAFED
DAY & NIGHT
CAPSULES
Paracetamol, Caffeine & Phenylephrine
■ This medicine is used for the relief of symptoms associated with colds and flu, including stuffy nose, headache, fever, sore throat, aches and pains.
■ This medicine is for use by adults and children aged 12 years and over.
■ Do not use this medicine:
n There are some people who should not use this medicine. To find out if you are one of them see section 2 ►
□ If you have ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6 ►
■ Speak to your doctor:
n If you suffer from any of the conditions mentioned in section 2. See section 2 ►
□ If you are taking any other medicines. See section 2 ►
■ Follow the dosage instructions carefully. There are different capsules for day and night time doses. See section 3 ►
Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.
1 What the medicine is for
Sudafed Day & Night Capsules are used for the relief of symptoms associated with colds and flu, including stuffy nose, headache, fever, sore throat, aches and pains.
The Day Capsules can also relieve tiredness and drowsiness. The Night Capsules contain paracetamol, an analgesic and antipyretic which helps to relieve pain and fever and phenylephrine hydrochloride, which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily.
The Day Capsules contain paracetamol and phenylephrine hydrochloride (as above) but also contain caffeine, which provides relief from fatigue (tiredness) associated with colds and flu. Caffeine can also increase pain relief from paracetamol.
This medicine is for use in adults and children aged 12 years and over.
2 Before taking this medicine
This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Do not use this medicine...
■ If you have ever had a bad reaction to any of the ingredients.
■ If you have severe heart disease or cardiovascular disorder(s).
■ If you have high blood pressure.
■ If you have an overactive thyroid gland.
■ If you have a history of stomach ulcers.
■ If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs).
■ If you are taking any other medicines containing paracetamol.
■ If you have liver or kidney problems.
■ If you are taking alcohol.
■ If you have a blood circulation problem (including Raynaud's Phenomenon).
■ If you suffer from diabetes.
■ If you are taking any other medicines, including:
n tricyclic antidepressants (drugs used to treat mood disorders).
n barbiturates (a kind of sleeping tablet), n sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).
n antihypertensives (drugs used to treat high blood pressure such as beta blockers or vasodilators), n colestyramine (used to lower blood cholesterol), n metoclopramide or domperidone (used to treat nausea and vomiting).
n anticoagulants (drugs used to thin the blood, such as warfarin).
If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist.
If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.
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If you are pregnant or breast-feeding:
■ Ask your doctor or pharmacist for advice Before taking this medicine if you are pregnant or breastfeeding.
3 How to take this medicine
Check the table that follows to see how much medicine to take.
■ For oral use only.
■ Swallow the capsules whole with water. Do not chew.
■ Do not take more than the stated dose shown.
■ ■ Children under 12 years old
Do not give to children under 12 years old.
o Adults and children aged 12 years and over
Age Dosage
Adults and Day time: 2 red / yellow Day Capsules children aged every 4-6 hours, up to 3 times a day.
12 years Night time: 2 dark blue / light blue Night
and over Capsules to be taken at night.
■ Leave at least 4 hours between doses.
■ Do not take more than 6 Day Capsules and 2 Night Capsules in 24 hours.
■ If symptoms persist or worsen, talk to your doctor.
Note: Does not contain a sleep aid.
_i If anyone has too much
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.
rlf you forget to take the medicine
If you forget to take a dose, take the next dose when needed provided that the last dose was taken at least 4 hours ago. Do not take a double dose.
4 Possible side-effects
Sudafed Day & Night Capsules can have side-effects, like all medicines, although these don't affect everyone and are usually mild.
If you experience any of the following, stop using the medicine and talk to your doctor:
■ Allergic reactions such as skin rash.
■ Raised blood pressure with headache, vomiting and palpitations.
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■ An increase or decrease in heart rate.
■ You may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.
Other effects which may occur include:
■ Nausea.
■ Difficulty sleeping.
■ Tingling and coolness of the skin.
If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.
5 Storing this medicine
Do not store above 25°C.
Keep the product out of the reach and sight of children.
Do not use after the end of the month shown as an expiry date on the packaging.
6 Further information
What's in this medicine?
The active ingredients in Sudafed Day & Night Capsules are: Day Capsule: Paracetamol 500 mg, caffeine 25 mg and phenylephrine hydrochloride 6.1 mg per capsule.
Night Capsule: Paracetamol 500 mg and phenylephrine hydrochloride 6.1 mg per capsule.
Other ingredients are:
Day Capsules: 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 (El71), patent blueV (El31) and erythrosine (E127).
Night Capsules: 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).
What the medicine looks like
Sudafed Day & Night Capsules are red / yellow capsules (Day) and dark blue / light blue capsules (Night) and are available in packs containing 12 Day Capsules and 4 Night Capsules. Marketing Authorisation holder and manufacturer:
Wrafton Laboratories Limited, Braunton, Devon,
EX33 2DL, UK.
Distributor: McNeil Products Ltd, Maidenhead, Berkshire,
SL6 3UG, UK.
Sudafed is a registered trade mark.
This leaflet was revised October 2009.
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