Document: leaflet MAH BRAND_PL 15513-0017 change

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■    This medicine is used to relieve the symptoms of

hay fever and similar allergic conditions.

■    This medicine is for use by adults and children

aged 12 - 65 years.

■    Do not take this medicine:

■    There are some people who should not use this medicine. See Section 2 to find out if you are one of them c

■    If you have ever had a bad reaction to any of the ingredients. See Section 6 for the list of ingredients c

■    Speak to your doctor:

■    If you suffer from any of the conditions mentioned in section 2. See Section 2 c

■    If you are taking any other medicines.

See Section 2 c

■    Follow the dosage instructions carefully.

See Section 3 c

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

Benadryl Allergy Relief Plus Decongestant Capsules are a medicine which are used to relieve the symptoms of hay fever and similar allergic conditions. The capsules contain pseudoephedrine

hydrochloride, which is a decongestant that relieves nasal and sinus congestion and acrivastine which is an antihistamine that helps relieve allergy symptoms such as sneezing, runny nose and watery eyes.

2 Before taking this medicine

This medicine is suitable for most adults under 65 years old and children aged 12 years and over. If you are in any doubt, talk to your doctor or pharmacist.

□ Do not take this medicine...

■    If you have very high blood pressure or severe heart disease.

■    If you have ever had a bad reaction to any of the ingredients, or to the antihistamine triprolidine.

■    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 the antibacterial agent,

furazolidone.

■    If you have kidney problems.

If any of these apply to you, get advice from a

doctor or pharmacist without taking Benadryl

Allergy Relief Plus Decongestant Capsules.

^, Talk to your doctor or pharmacist.

■    If you have high blood pressure or heart disease.

■    If you have diabetes.

■    If you have an over active thyroid gland.

■    If you have glaucoma (increased pressure in the eye).

■    If you have prostate problems (difficulty with passing water or needing to pass water often).

■    If you are taking alcohol.

■    If you are taking any other medicines,

3 How to take this medicine

Check the table below to see how much medicine to take.

■ For oral use only.

o Children under 12 years old

This medicine is not recommended for children aged under 12 years old.

o Adults and Children 12 - 65 years old

Age	Dose
Adults and children 12 - 65 years old	■ 1 capsule up to 3 times a day
■    Do not give more than 3 doses in 24 hours. ■    If symptoms persist talk to your doctor.

Adults over 65 years

This medicine is not recommended for adults aged over 65 years old.

If anyone has too much

If anyone has too much contact a doctor or your nearest Accident and Emergency Department (Casualty) taking this leaflet and pack with you.

If you forget to take the medicine

If you forget to take a dose, take the next dose when needed provided that you only take a maximum of 3 capsules in 24 hours.

Do not take a double dose.

4    Possible side-effects

Benadryl Allergy Relief Plus Decongestant Capsules can have side-effects, like all medicines, although these don't affect everyone and are usually mild.

If you experience the following, stop taking this medicine and talk to your doctor:

■    A few people have had hallucinations, but this is rare.

■    Occasionally people get skin rashes that are sometimes itchy.

■    A few men, especially men with prostate problems, may have trouble passing water.

Other effects which may occur include:

■    Restlessness, having trouble getting to sleep or bad dreams.

If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.

Reporting of side-effects

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5    Storing this medicine

Store below 25⁰C.

Keep the product dry and store in its original packaging.

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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Further Information

What's in this medicine?

The active ingredients in Benadryl Allergy Relief Plus Decongestant Capsules are: 60 mg

Pseudoephedrine hydrochloride and 8 mg acrivastine in each capsule.

Other ingredients are: Lactose, sodium starch glycollate, magnesium stearate, gelatin, titanium dioxide and patent blue V.

What the medicine looks like

Benadryl Allergy Relief Plus Decongestant Capsules are blue and opaque-white capsules available in blister packs of 12 capsules.

Product Licence holder:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

Manufacturer:

Janssen-Cilag, Domaine de Maigremont, 27100 Val de Reuil, France.

This leaflet was revised March 2013.

Benadryl is a registered trade mark.

McJVeiTs

Products Lid.

COLOURS:

Main body text (PIL’s only)

145 x 210 mm

A print out of this image should not be used for exact colour matching but to check if the layout, spelling, text and colour references are correct. Please check thoroughly.