Cetirizine Hydrochloride 10mg Tablets

Document: leaflet MAH BRAND_PL 08553-0193 change

PACKAGE LEAFLET INFORMATION FOR THE USER

PollenasE Allergy & Hayfever Relief lOmg Tablets

Read all this leaflet carefully before you start taking this medicine, referred to as Allergy & Hayfever Relief in this leaflet 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 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 your doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet:

1. What Allergy & Hayfever Relief Tablets are and what they are used for

2. What you need to know before you take Allergy & Hayfever Relief Tablets

3. How to take Allergy & Hayfever Relief Tablets

4. Possible side effects

5. How to store Allergy & Hayfever Relief Tablets

6. Contents of the pack and other information

1. What Allergy & Hayfever Relief Tablets are and what they are used for

The active ingredient (which makes this medicine work) is called cetirizine hydrochloride, which belongs to a family of medicines called antihistamines. Allergy & Hayfever Relief Tablets are used for the relief of symptoms of hay fever and other allergic conditions (e.g. sneezing, runny or itchy nose) or for skin rashes (chronic nettle rash, idiopathic urticaria) in adults and children over 6 years of age.

2. What you need to know before you take Allergy & Hayfever Relief Tablets

Do not take Allergy & Hayfever Relief Tablets if you:

• Are allergic to cetirizine hydrochloride, or any of the ingredients of this medicine (listed in section 6), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines)

• Suffer from severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min)

• Have problems of urinary retention

• If you have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Warnings and precautions:

• If you have liver or kidney problems, 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 predisposition factors of urinary retention (e.g.: spinal cord lesion, prostatic hyperplasia) ask your doctor or pharmacist for advice

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

• If you are scheduled for allergy testing, ask your doctor if you should stop taking Allergy & Hayfever Relief Tablets for several days before testing. This medicine may affect your allergy test results.

Children and Allergy & Hayfever Relief Tablets

The use of this medicine is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.

Other medicines and Allergy & Hayfever Relief Tablets

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

Allergy & Hayfever Relief Tablets with food and drink and alcohol

Food does not affect absorption of Allergy & Hayfever Relief Tablets.

No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 g/l corresponding to one glass of wine) and cetirizine used at the recommended doses. However there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore as it is the case with all antihistamines, it is recommended to avoid taking Allergy & Hayfever Relief Tablets with alcohol.

Pregnancy and breastfeeding

You should not take these tablets if you are pregnant without first consulting your doctor or pharmacist.

Do not take these tablets if you are breast-feeding.

Driving and using machines

Do not drive or operate machinery if the tablets make you feel drowsy. At the recommended dose, these tablets do not cause drowsiness in the majority of people.

Allergy & Hayfever Relief Tablets contain lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

3. How to take Allergy & Hayfever Relief Tablets

The tablets should be swallowed with water.

Adults, elderly patients and children 12 years and over: 1 tablet daily.

Children aged 6 to 12 years: Half a tablet twice daily.

Children under 6 years: Not recommended.

If you have kidney problems (or liver and kidney problems together) please ask your doctor for advice: you may need to take a lower dose. The new dose will be determined by your doctor.

Duration of treatment

The duration of the treatment depends on the type, duration and course of your complaints. Please ask your pharmacist for advice.

If you take more than you should

If you accidentally take too much medicine, contact your doctor or nearest casualty department at once.

If you forget to take a tablet

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

4. Possible side effects

Like all medicines Allergy & Hayfever Relief Tablets can cause side effects, although not everybody gets them.

The following side effects are very rare but you must stop taking the tablets and speak to your doctor immediately if you notice them:

• Allergic reactions including sudden wheeziness, difficulty in breathing or dizziness, rash itchiness and fever, swollen throat, face, eyelids or lips. This reaction might start soon after you first take the medicine, or it might start later.

• bruising or bleeding more easily than normal.

The following side effects have also been reported.

Common side effects (affects less than 1 in 10 people)

• Tiredness, feeling sleepy • Pain in the abdomen

• Headache • Dizziness

• Dry mouth • Sore throat

• Nausea • Cold-like symptoms of the nose

• Diarrhoea (children only) (children only).

Uncommon side effects (affects less than 1 in 100 people)

• Itching and rash • Feeling agitated

• Asthenia (extreme fatigue) or • Diarrhoea.

feeling generally unwell

• Tingling in the hands and feet

Rare side effects (affects less than 1 in 1000 people)

• Tachycardia (heart beating too fast)

• Oedema (generalised swelling due to water retention)

• Abnormal liver function test results (your doctor will know what to do)

• Convulsions (fits)

• Weight increased

• Aggression, confusion, depression, hallucination (hearing or seeing things), sleeplessness

• Urticaria (hives).

Very rare side effects (affects less than 1 in 10,000 people)

• Blurred vision, difficulty focusing

• Oculogyration (eyes having uncontrolled circular movements)

• Low levels of blood platelets causing unusual bleeding or bruising

• Bad taste in mouth

• Tremor, tics (habit spasm)

• Involuntary movements and/or jerking of the limbs

• Muscle spasms in the neck and shoulders

• Swelling of the skin particularly around the face or throat

• Fainting

• A recurring rash

• Abnormal elimination of urine (bedwetting, pain and/or difficulty passing water).

Not known frequency of side effects

• Memory loss and forgetfulness.

• Increased appetite

• Vertigo

• Urinary retention.

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. How to store Allergy & Hayfever Relief Tablets

Keep this medicine out of the sight and reach of children. Do not take the tablets after the expiry date, which is stated on the blister and carton. The expiry date refers to the last day of that month. 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. Contents of the pack and other information

What Allergy & Hayfever Relief Tablets contain

Each tablet contains 10mg of cetirizine hydrochloride (the active ingredient). They also contain: lactose, microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate, talc, hypromellose, titanium dioxide (E171), macrogol 4000 and sodium citrate.

What Allergy & Hayfever Relief Tablets look like and contents of the pack

The tablets are white circular bi-convex, film-coated tablets marked C on one side and a breakline on the other.

Available in cartons containing 7, 14, 21, 28, 30 and 60 tablets.

Not all pack sizes may be marketed

Marketing authorisation holder and manufacturer

Dr. Reddy’s Laboratories (UK) Ltd 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

Revision date: November 2015