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Benadryl Allergy One A Day 10mg Tablets

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Document: leaflet MAH BRAND 2_PL 15513-0118 change

FOR POSITION ONLY



ONEADAY

10 mg TABLETS

Cetirizine dihydrochloride


■    This medicine is used to relieve the symptoms of hay fever and other allergic conditions such as pet or dust allergies and skin reactions.

■    This medicine is for use by adults and children aged 12 years and over.

■    A doctor must be contacted if symptoms worsen or do not improve after 3 days

Read the leaflet carefully before use. Keep this leaflet, you might need it again.

1 What the medicine is for

Benadryl Allergy One a Day 10 mg Tablets is a medicine which is used to relieve the symptoms of hay fever and other allergic conditions such as pet or dust al lergies. The tablets contain 10 mg cetirizine dihydrochloride which is an antihistamine that helps relieve allergy symptoms such as sneezing, runny nose and watery eyes. It can also be used to treat allergic skin reactions. These include urticaria, also known as hives, where the skin looks blotchy, with white raised wheals (bumps) surrounded by redness.

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 adults and children aged 12 years and over, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

n Do not take this medicine...

■    If you have ever had a bad reaction to cetirizine dihydrochloride, to hydroxyzine or piperazine derivatives or any other ingredients of this medicine (See section 6).

■    If you have serious kidney problems.

A Talk to your doctor or pharmacist

■    If you are an epileptic or at risk of convulsions (fits).

If this applies to you, talk to a doctor or pharmacist.

A Warnings and precautions

If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor. If you have difficulty passing urine, you should ask your doctor for advice.

A If you are pregnant or breast-feeding

■    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Benadryl Allergy One a Day 10 mg Tablets during breast feeding because cetirizine passes into breast milk.

A Special warnings about this medicine

■    In most people this product does not cause drowsiness. However, there are rare


I


exceptions and you should take care when you use this product for the first time. If this product makes you feel drowsy, do not drive or operate machinery.

■    As with all antihistamines, it is advisable to avoid excessive alcohol consumption when taking this medicine.

■    You should stop taking this product for 3 days before undergoing a skin allergy test because antihistamines can affect the results of the test.

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

3 How to take this medicine

■    For oral use only.

■    Swallow with a glass of water.

■    Do not take more than the stated dose shown in the table.

o Children under 12 years old

This medicine is not recommended for children

aged under 12 years old.

Q Adults and children aged 12 years and above


Age    Dose

Adults and children    Take 1 tablet

aged 12 years and above    once a day

■    Do not take more than 1 tablet in 24 hours.

■    If symptoms persist talk to your doctor.


A


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.

turn over ►


A 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 1 tablet in 24 hours. Do not take a double dose.

4 Possible side-effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following, stop taking this medicine and seek immediate medical help:

■    Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing

■    Bruising or bleeding more easily than normal

■    Convulsions (fits)

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

■    Confusion

■    Hallucinations

■    Abnormal liver function tests

■    Rapid heartbeat

■    Loss of consciousness

Other effects which may occur include:

Common: affects 1 to 10 users in 100

■    Headache or dizziness

■    Drowsiness or tiredness

■    Restlessness

■    Dry mouth, sore throat

■    Upset stomach, abdominal pain, diarrhoea, nausea

■    Runny nose


Uncommon: affects 1 to 10 users in 1,000

■    Agitation

■    Weakness

■    Feeling of general discomfort or uneasiness

■    Pins & needles

■    Itching

■    Rash or hives

■    Abdominal pain

Rarely: affects 1 to 10 users in 10,000

■    Aggression, depression

■    Weight gain

■    Swelling

■    Dystonia/dyskinesia (movement disorders) including tremor, muscle spasm and tics

■    Sleeplessness

Very rarely: affects less than 1 user in 10,000

■    Taste disorder

■    Blurred vision, eye movement disorder

■    Involuntary movement and/jerking of the limbs, muscle spasms in the neck and shoulders

■    Difficult, painful or involuntary urination Not known

■    Vertigo, increased appetite

■    Amnesia, memory impairment

In very rare cases people have thought about committing suicide and if you feel this way then stop taking the tablets and see your doctor.

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.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.


5    Storing this medicine

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions. Do not use this medicine after the expiry date stated on the carton and blister. 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 ingredient in Benadryl Allergy One a Day 10 mg Tablets is: 10 mg Cetirizine dihydrochloride in each tablet.

Other ingredients are: Microcrystalline cellulose, lactose, colloidal anhydrous silica and magnesium stearate.

The film coating contains

hydroxypropylmethylcellulose (E464), titanium dioxide (El 71) and macrogol 400.

What the medicine looks like and contents of the pack

Benadryl Allergy One a Day 10 mg Tablets are white oblong film-coated tablets, with a break-line and Y-Y logo available in packs of 7, 14 and 30.

Not all pack sizes may be marketed.

Product licence holder and manufacturer:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

This leaflet was revised June 2015.

Benadryl is a registered trade mark.

McNeiT}    15-0229

,    PrOftuds UzL ^

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