What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 08553/0194.


Pollenase Allergy & Hayfever Relief 10mg Tablets (GSL)

PACKAGE LEAFLET INFORMATION FOR THE USER

Pollenase Allergy & Hayfever Relief 10mg Tablets

Read all this leaflet carefully before you start taking this medicine, referred to as Allergy & Hayfever Relief Tablets 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 a doctor if you do not feel better or if you feel worse after a few 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 to treat people who have hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin). Antihistamines like Allergy & Hayfever Relief Tablets relieve the unpleasant symptoms and discomfort associated with these conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.

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 to any of the ingredients listed in section 6, to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines)
  • suffer from severe kidney failure (creatinine clearance less than 10ml/min)
  • have problems of urinary retention
  • you are breast-feeding

If any of the above applies to you talk to your pharmacist.

Warnings and precautions:

  • If you have liver or kidney problems please ask your pharmacist for advice.
  • If you have predisposition factors of urinary retention (eg: spinal cord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention.,
  • If you suffer from epilepsy or are at risk of convulsions, you should ask your pharmacist for advice.

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 this medicine.

Avoid alcohol while you are taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or trying to become pregnant ask your pharmacist for advice before taking Allergy & Hayfever Relief Tablets.

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

Allergy Testing

If you are due to have an allergy test, 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.

Driving and using machines

Some people have reported that they feel drowsy or dizzy while they are taking Allergy & Hayfever Relief Tablets. If you are affected do not drive or use machines.

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

Remember. Take the tablet with a glass of water. Do not take more than one tablet each day. If you do not feel better within a few days, consult your doctor.

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

Adults and children aged 12 years and over: Take one tablet daily. 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.

Allergy & Hayfever Relief Tablets are not suitable for children under 6.

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

If you forget to take a tablet, you should take one as soon as you remember, but wait at least 24 hours before taking your next tablet.

4. Possible side effects

Like all medicines Cetirizine Hydrochloride 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 straight away if you notice these symptoms:

  • A severe allergic reaction including rash, itchiness and fever, swollen throat, face, eyelids or lips. This reaction may start soon after you first take the medicine or it might start later.
  • bruising or bleeding more easily than normal.
  • convulsions or fits.

The following side effects have also been reported.

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

  • Tiredness, feeling sleepy
  • Headache
  • Dry mouth
  • Nausea
  • Diarrhoea (children only)
  • Pain in the abdomen
  • Dizziness
  • Sore throat
  • Cold like symptoms of the nose (children only)

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

  • Itching and rash
  • Diarrhoea
  • Feeling weak or generally unwell
  • Tingling in the hands and feet
  • Feeling agitated.

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

  • Fast heart beat
  • Oedema (generalised swelling due to water retention)
  • Abnormal liver function test results (your doctor will know what to do)
  • Increased weight
  • Aggression, confusion, depression, hallucination (hearing or seeing things), sleepiness
  • Urticaria (hives).

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

  • Blurred vision, difficulty focussing
  • Rotation of the eye
  • Bad taste in the mouth
  • Tremor, tics
  • Involuntary movements and/or jerking of the limbs
  • Muscle spasms in the neck and shoulders
  • Swelling of the skin particularly around the face
  • Fainting
  • A recurring rash
  • Bed wetting, pain and/or difficulty passing water.

Not known side effects

  • Increased appetite
  • Vertigo
  • Urinary retention
  • Memory loss and/or 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: http://yellowcard.mhra.gov.uk/

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 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

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 14 and 30 tablets.

Marketing authorisation holder and manufacturer

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

Revision date November 2014

Allergy & Hayfever Relief 10mg Tablets PL 08553/0194

© Dr. Reddy's Laboratories (UK)Ltd