Package leaflet: Information for the user Teva Cetirizine Hydrochloride 1 mg/ml

Oral Solution

Read all of this leaflet carefully before you start using 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.

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

•    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.

What is in this leaflet:

1.    What Cetirizine is and what it is used for

2.    What you need to know before you take Cetirizine

3.    How to take Cetirizine

4.    Possible side effects

5.    Contents of the pack and other information

1. What Cetirizine is and what it is used for

•    Each 1 ml of solution contains 1 mg of cetirizine hydrochloride. Cetirizine belongs to a group of drugs called antihistamines which help to relieve the symptoms of some allergies.

•    Your medicine is used to relieve the symptoms of hay fever, non-seasonal rhinitis (runny and itchy nose) and other allergies e.g. pet or house dust mite allergies. It can also be taken for skin allergies such as rash, itching and urticaria (hives).

This medicine may be given to children aged 2 - 6 years to relieve hay fever symptoms.

•    If you are allergic to Cetirizine or any of the other ingredients of this medicine (listed in section 6).

•    If you have severe kidney problems Warnings and precautions

Talk to your doctor or pharmacist before taking Cetirizine.

•    Mild or moderate kidney problems

•    If you have predisposition factors of urinary retention (eg: spinal cord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention

•    If you are an epileptic patient or a patient at risk of fits (convulsions).

Other precautions you should take:

•    Cetirizine must be discontinued 3 days before any allergy testing.

Other medicines and Cetirizine:

Due to the profile of cetirizine, no interactions with other drugs are expected Cetirizine with alcohol:

•    Avoid drinking large amounts of alcohol.

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

•    Talk to your doctor before taking Cetirizine if you are pregnant

•    Do not take if you are breast-feeding.

Driving and using machines:

•    Cetirizine may affect your reaction time. If you feel drowsy do not drive, or operate machinery. This effect will be worse if you are also taking sedatives or drink alcohol.

Cetirizine contains:

•    Sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicines.

•    E216 and E218 may cause allergic reactions (possibly delayed).

3. How to take Cetirizine

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.

If your doctor has prescribed this medicine, always follow your doctor’s instructions. Otherwise follow the instructions below. If you do not understand these instructions, or you are in any doubt, ask your doctor or pharmacist.Use the spoon provided to make sure you have the correct dose.

Use in children and adolescents

Adults and children aged 12 years and over:

Two 5 ml spoonfuls once daily.

If drowsiness occurs, take your medicine in the evening.

Children aged 6 - 12 years:

Either two 5 ml spoonfuls once daily, or one 5 ml spoonful morning and evening.

Children aged 2 - 6 years:

Either one 5 ml spoonful daily, or half a spoonful (2.5 ml) morning and evening.

Children under 2 years of age:

Not recommended.

Patients with moderate to severe renal impairment:

If you have kidney problems, you may only need half the recommended dose.

If you take more Cetirizine than you should

If you (or someone else) swallow a lot of the solution all together, or if you think a child swallowed any of the solution, contact your nearest hospital casualty department immediately.

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

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

If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one.

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

4. Possible side effects

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

If the following happens(frequency rare or very rare), stop taking cetirizine and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    A severe allergic reaction (swelling of the face, lips, mouth or throat which maycause difficulty swallowing or breathing, hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. The following side effects have been reported at the approximate frequencies shown:

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

•    Sleepiness

•    Headaches

•    Pain in the abdomen

•    Dizziness

•    Dry mouth

•    Sore throat

•    Nausea

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

•    Diarrhoea (children only)

Uncommon (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

•    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)

•    Increased appetite

•    Vertigo

•    Urinary retention

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 Cetirizine and see your doctor.

Reporting of side effects

If you get 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.

5. How to store Cetirizine

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

Do not transfer to another container.

Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. 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 Cetizine contains

The name of your medicine is Teva Cetirizine Hydrochloride 1 mg/ml Oral Solution.

The active substance is cetirizine hydrochloride.

The other ingredients are glycerol, propylene glycol, sorbitol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium acetate, acetic acid, saccharin sodium, banana flavour and purified water.

What Cetirizine looks like and contents of the pack

Clear colourless solution with a banana odour.

Pack sizes: 75, 150 and 200 ml fill bottles (glass).

Measuring device: 5 ml plastic measuring spoon graduated at 2.5 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Teva pharma B.V.

Swensweg 5,

2031 GA Haarlem,

The Netherlands.

Company responsible for manufacture:

Pharmachemie B.V., Haarlem, The Netherlands*.

Or

TEVA UK Ltd, Leeds LS27 0JG, England*.

Or

Teva Czech, s.r.o, Opava, Czech Republic.*

* Only the paragraph containing details of the current Batch release site will be included in the printed version of the PIL.

This leaflet was last revised in June 2015

PL 14776/0072