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Benadryl Allergy One A Day 10mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Benadryl Allergy One a Day 10mg Tablets

Cetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse after 3 days.


What is in this leaflet:

1.    What Benadryl Allergy One a Day 10mg Tablets is and what it is used for

2.    What you need to know before you take Benadryl Allergy One a Day 10mg Tablets

3.    How to take Benadryl Allergy One a Day 10mg Tablets

4.    Possible side effects

5.    How to store Benadryl Allergy One a Day 10mg Tablets

6.    Contents of the pack and other information

1. WHAT Benadryl Allergy One a Day 10mg Tablets IS AND WHAT IT IS USED FOR

Cetirizine dihydrochloride is the active ingredient of Benadryl Allergy One a Day 10mg Tablets. This is an antiallergic medication.

In adults and children aged 6 year and above, Benadryl Allergy One a Day 10mg Tablets is indicated

-    for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

-    for the relief of chronic nettle rash (chronic idiopathic urticaria).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Benadryl Allergy One a Day 10mg

Tablets

Do not take Benadryl Allergy One a Day 10mg Tablets

-    if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min);

-    if you are allergic to cetirizine dihydrochloride, to hydroxyzine, to piperazine derivatives (closely related active substances of other medicines) or any of the other ingredients of this medicine (listed in section 6).

You should not take Benadryl Allergy One a Day 10mg Tablets 10 mg tablets:

-    if you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Warnings and precautions Talk to your doctor or pharmacist before taking Benadryl Allergy One a

Day 10mg Tablets.

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.

If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.

You should stop taking this product three days before an allergy skin test because antihistamines can affect the results of the test.

No interactions susceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses. However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.

Other medicines and Benadryl Allergy One a Day 10mg Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Due to the profile of cetirizine, no interactions with other drugs are expected.

Benadryl Allergy One a Day 10mg Tablets with food and drink

Food does not affect noticeably the absorption of cetirizine.

Pregnancy and 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.

As with other drugs, use of Benadryl Allergy One a Day 10mg Tablets should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the administration of the medicine should be discontinued.

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

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking this medicine at the recommended dose.

If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose. You should closely observe your response to the drug. If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.

Benadryl Allergy One a Day 10mg Tablets contains lactose

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

3. HOW TO TAKE Benadryl Allergy One a Day 10mg Tablets

How and when should you take Benadryl Allergy One a Day 10mg Tablets?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Please follow these instructions, otherwise Benadryl Allergy One a Day 10mg Tablets may not be fully effective.

Tablets need to be swallowed with a glass of liquid.

Adults and adolescents above 12 years old:

10 mg once daily as 1 tablet.

Children between 6 and 12 years old:

5 mg twice daily as a half tablet twice daily.

Patients with moderate to severe renal impairment

Patients with moderate renal impairment are recommended to take 5 mg once daily.

If you feel that the effect of Benadryl Allergy One a Day 10mg Tablets is too weak or too strong, please consult your doctor.

Duration of treatment:

The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.

If you take more Benadryl Allergy One a Day 10mg Tablets than you should

If you think you have taken an overdose of this medicine please inform your doctor.

Your doctor will then decide what measures, if any, should be taken.

After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.

If you forget to take Benadryl Allergy One a Day 10mg Tablets

Do not take a double dose to make up for a forgotten dose.

If you stop taking Benadryl Allergy One a Day 10mg Tablets

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common (may affect up to 1 in 10 people):

fatigue, dry mouth, nausea, diarrhoea, dizziness, headache, somnolence, pharyngitis, rhinitis Uncommon (may affect up to 1 in 100 people):

abdominal pain, asthenia (extreme fatigue), malaise, paresthesia (abnormal feelings of the skin), agitation, pruritus, rash

Rare (may affect up to 1 in 1,000 people):

tachycardia (heart beating too fast), oedema (swelling), allergic reactions, some severe (very rare), liver function abnormal, weight increased, convulsions, aggression, confusion, depression, hallucination, insomnia, urticaria

Very rare (may affect up to 1 in 10,000 people):

thrombocytopenia (low levels of blood platelets), accommodation disorder, blurred vision, oculogyration (eyes having uncontrolled circular movements), syncope, tremor, dysgeusia (altered taste), dystonia/dyskinesia (movement disorders), abnormal elimination of urine, tics, oedema, fixed drug eruption

Not known (frequency cannot be estimated from the available data): vertigo (dizziness), increased appetite, amnesia (memory loss), memory impairment, urinary retention (difficulty passing urine)

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 or pharmacist. This includes any possible side effects not listed in this leaflet. At the first signs of a hypersensitivity reaction, stop taking the

medicine. Your doctor will then assess the severity and decide on any further measures that may be necessary.

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. HOW TO STORE Benadryl Allergy One a Day 10mg Tablets

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

Do not use this medicine after the expiry date which is stated on the carton.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. FURTHER INFORMATION

What Benadryl Allergy One a Day 10mg Tablets contain

-    The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg cetirizine dihydrochloride.

-    The other ingredients are microcrystalline cellulose, lactose, macrogol 400, magnesium stearate, hypromellose, colloidal silicon dioxide, titanium dioxide (E 171).

What Benadryl Allergy One a Day 10mg Tablets look like and contents of the pack

White, oblong, film-coated tablet, with breakline and Y-Y logo

Pack with 7, 14, 20, 21, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

McNeil Products Limited Foundation Park Roxborough Way Berkshire SL6 3UG United Kingdom

This leaflet was last revised in October 2014.

This leaflet was authorised in the Member States of the EEA under the following names:

Name in the Member State

Belgium Czech Republic Denmark France ACTIFED Germany Reacti Italy

Luxembourg

Netherlands


Name of the medicinal product

Reactine 10 mg filmomhulde tablet Livoreactine 10mg

Benaday, filmovertrukne tabletter, 10 mg

Allergie Cetirizine 10mg, comprimes pellicules secables ne

Reactidiem "10mg compresse rivestite con film" 7 compresse Reactine 10 mg comprime pellicule Reactine 10 mg filmomhulde tablet

Reactine 10 mg

Slovakia Livo Spain Reacti United Kingdom


ne Cetirizina 10 mg comprimidos recubiertos con pelicula Benadryl Allergy One a Day 10mg Tablets

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