PATIENT LEAFLET: INFORMATION

_FOR THE USER_

CETEC10mg FILM-COATED TABLETS _(Cetirizine hydrochloride)_

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 have told you.

•    Keep the leaflet. You may need to read it again.

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

•    You must contact a doctor if your symptoms worsen or do not improve after few days. What is in this leaflet:

1.    What Cetec tablets are and what they are used for

2.    What you need to know before you take Cetec tablets

3.    How to take Cetec tablets

4.    Possible side effects

5.    How to store Cetec tablets

6.    Contents of the pack and other information

1. What Cetec tablets are and what they are used for

•    The name of your medicine is Cetec 10mg film-coated tablets, referred as Cetec tablets in this leaflet.

•    The active ingredient, Cetirizine hydrochloride belongs to a group of medicines

called antihistamines.

•    It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions.

•    Cetec 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).

•    Cetec tablets also 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 Cetec tablets_

Do not take if you:

•    have severe kidney failure (creatinine clearance less than 10 ml/min) and are on dialysis

•    are known to be allergic (hypersensitive) to cetirizine hydrochloride or any of the other ingredients (listed in section 6) or to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines)

Warnings and precautions

Talk to your doctor or pharmacist before taking

Cetec tablets if:

•    you have kidney problems

•    you suffer from epilepsy or at risk of convulsions

•    you have predisposition factors of urinary

retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention.

•    you want to use for children less than 6 years of age

Other medicines and Cetec tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

•    If you are pregnant or likely to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.

•    Do NOT take this medicine during breast feeding because cetirizine passes into breast milk.

Cetec tablets with food, drink and alcohol

It is recommended to avoid alcohol while taking this medicine

Driving and using machines

Some people have reported that they feel drowsy or dizzy while they are taking Cetec. If you are affected do not drive or use machines.

Cetec tablets contain Lactose

•    If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.

|    3. How to take Cetec tablets |

•    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

•    The tablet can be divided into equal halves. The usual doses are as follows:

Adults and children aged 12 years and over:

Take one tablet daily. If the tablets make you feel drowsy or dizzy, taking half a tablet twice a day may be better than taking one tablet once a day.

Children aged 6 to 12:

Take half a tablet twice a day. Cetec tablets are not suitable for children under 6.

If you have kidney problems you should talk to your doctor or pharmacist for advice before taking these tablets as a lower dose may be required.

If you take more Cetec tablets than you should

If you accidentally take too many tablets, tell your doctor immediately or contact your nearest Hospital Casualty/Accident & Emergency department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

If you forget to take Cetec tablet

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

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.

Cetec Insert

SAME SIZE ARTWORK

240 x 120 mm

Front

|    4. Possible Side Effects |

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

The following side effects have also been reported:

Common side effects (may affect up to 1 in 10 people)

•    Tiredness, feeling sleepy

•    Pain in the abdomen

•    Headache

•    Dizziness

•    Dry mouth

•    Sore throat

•    Nausea

•    Cold-like symptoms of the nose (children only)

•    Diarrhoea (children only)

Uncommon side effects (may affect up to 1 in 100 people)

•    Itching and rash

•    Tingling in the hands and feet

•    Diarrhoea

•    Feeling agitated

•    Feeling weak or generally unwell

Rare side effects (may affect up to 1 in

1.000    people)

•    Fast heart beat

•    Oedema (generalised swelling due to water retention)

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

•    Convulsions, movement disorders

•    Increased weight

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

•    Urticaria (hives)

Very rare side effects (may affect up to 1 in

10.000    people)

•    Blurred vision, difficulty focussing

•    Rotation of the eyes

•    Unusual bleeding or bruising

•    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 (frequency cannot be estimated from the available data)

•    Increased appetite

•    Vertigo

•    Urinary retention

•    inflammation of the liver (hepatitis)

Some cases of memory loss and/or impairment have also been reported. 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. 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.

I 5. How to store Cetec tablets I

•    Keep out of the sight and reach of children

•    Do not store above 25⁰C. Store in the original package.

•    Do not use the tablets after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wasterwater 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 Cetec tablets Contain

•    Each tablet contains 10mg of the active ingredient cetirizine hydrochloride.

•    The other ingredients are: lactose monohydrate, maize starch, pregelatinised starch, purified talc, magnesium stearate,

hypromellose, titanium dioxide (E171) and macrogol.

What Cetec tablets look like and the contents of the pack

•    Cetec tablets are white to off white capsule shaped film coated tablets with a breakline and 'B' and 'L' embossed on either side of the breakline and '10' embossed on the other side.

•    Cetec tablets are available in packs of 7, 14 and 30 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address:

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG,

United Kingdom

Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Cetec 10mg film-coated tablets;

PL 17907/0046

This leaflet was last revised in August 2014

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V18 28-08-2014 DO

SAME SIZE ARTWORK

240 x 120 mm

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