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Teva Max Strength Congestion Relief 12.2mg Capsules Hard

Document: leaflet MORRISON_PL 12063-0075 change

HVIomsons MaxTStrength Congestion Relief 12.2 mg Capsules

Phenylephrine Hydrochloride

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, you may want 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 this medicine and what is it used for?

Your capsules contain the active ingredient, phenylephrine hydrochloride, a decongestant that reduces swelling in the passages of the nose to help you breathe more easily.

Your capsules are used for the relief of nasal congestion, particularly when associated with colds and flu or hayfever.

2.    Is this medicine suitable for you?

Do not take this medicine if you:

•    are allergic to phenylephrine or any of the other ingredients

•    have a serious heart condition or cardiovascular disorder(s)

•    have high blood pressure (hypertension)

•    have diabetes

•    have glaucoma

^_have an overactive thyroid (hyperthyroidism)

•    have an enlarged prostate or other prostate problems

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

•    are taking antidepressant drugs called monoamine oxidase inhibitors (MAOIs), or have taken them within the last 14 days -these are medicines such as phenelzine and isocarboxazid

•    are taking other decongestant medicines

•    are pregnant or breastfeeding.

Please see your doctor or pharmacist before taking this medicine if you:

•    have circulatory problems such as Raynaud’s Phenomenon

•    have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you are taking any of the following medicines, please see your doctor or pharmacist:

•    tricyclic antidepressants such as imipramine and amitriptyline

•    decongestant drugs or stimulants (e.g. ephedrine, amphetamines and xylometazoline

•    medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers, vasodilators (e.g. hydralazine), cardiac glycosides (e.g. digoxin).

Other Important Information:

Do not drink alcohol (beer, wine, spirits etc) while taking this product._ piease turn over *+

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Text revised: June 2015.


^57 How to take this medicine

For oral use, swallow whole with water.

Adults, the elderly and children over 12 years: 1 capsule every 6 hours, as required. Do not take more than 4 capsules in any 24 hour period.

Not recommended for children under 12 years of age.

Do not take for longer than 7 days unless you have been advised to do so by your doctor.

Warning: Do not exceed the stated dose.

Avoid alcohol whilst taking this medicine.

If you take too many capsules by mistake, contact your doctor or pharmacist straight away.

If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.

4. 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.

Possible side effects are:

•    fast heart rate

•    changes in heart rhythm

•    palpitations

•    high blood pressure

•    nausea

•    vomiting

•    headache and occasionally urine retention

|_in males.

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 your medicine

Keep out of the sight and reach of children.

Do not use these capsules after the expiry date on the pack.

Do not store above 25°C. Store in the original packaging to protect from moisture.

6.    What is in this medicine?

Each capsule contains the active ingredient phenylephrine hydrochloride 12.2 mg.

Also contains: maize starch, lactose monohydrate, pregelatinised starch, magnesium stearate.

The capsule shells are made of gelatin and contain the colours quinoline yellow (E104), titanium dioxide (E171).

These capsules are available in a pack size of 12 capsules.

7.    Who makes this medicine?

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

PL12063/0075

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