PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetrex 5 mg/5ml Solution

Cetirizine dihydrochloride

What is in this leaflet:

1.    What Cetrex 5 mg/ 5 ml Solution is and what it is used for

2.    What you need to know before you take Cetrex 5 mg/ 5 ml Solution

3.    How to take Cetrex 5 mg/ 5 ml Solution

4.    Possible side effects

5.    How to store Cetrex 5 mg/ 5 ml Solution

6.    Contents of the pack and other information

1.    What Cetrex 5 mg/ 5 ml Solution is and what it is used for

Cetirizine dihydrochloride is the active ingredient of Cetrex. Cetrex is an antiallergic medication.

In adults and children aged 6 years and above, Cetrex 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 Cetrex 5 mg/ 5 ml Solution

Do not take Cetrex 5 mg/ 5 ml Solution

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

-    if you are known to be hypersensitive to the active substance of Cetrex 5 mg/5 ml, to any of its excipients (other constituents), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines)

-    if you have rare hereditary problems of fructose intolerance

Take special care with Cetrex 5 mg/ 5 ml Solution

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

No interactions suceptible 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.

If you have predisposition factors of urinary retention (eg: spinalcord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention. Allergy Testing

If you are due to have an allergy test, ask your doctor if you should stop taking Cetrex for several days before testing. This medicine may affect your allergy test results.

Other medicines and Cetrex 5 mg/ 5 ml Solution

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.

Taking Cetrex 5 mg/ 5 ml Solution with food and drink

Food does not affect noticeably the absorption of cetirizine.

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before taking any medicine.

As with other drugs, use of Cetrex 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 Cetrex 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 Cetrex 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.

Important information about some of the ingredients of Cetrex 5 mg/ 5 ml Solution

Cetrex 5 mg/ 5 ml solution contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

Cetrex 5 mg/ 5 ml contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These ingredients may cause allergic reactions (possibly delayed).

3.    How to take Cetrex 5 mg/ 5 ml Solution

These guidelines apply unless your doctor has given you different instructions on how to use Cetrex. Please follow these instructions, otherwise Cetrex may not be fully effective.

The solution can be swallowed as such.

Adults and adolescents above 12 years old:

10 mg once daily as 10 ml oral solution (2 full measuring spoons)

Children between 6 and 12 years old:

5 mg twice daily as 5 ml (one full measuring spoon) twice daily.

Children under 6 years old:

Not recommended

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 Cetrex 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 Cetrex 5 mg/ 5 ml Solution than you should

If you think you have taken an overdose of Cetrex 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 Cetrex 5 mg/ 5 ml Solution

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

If you stop taking Cetrex

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

4.    Possible side effects

Like all medicines, Cetrex 5 mg/ 5 ml Solution can cause side effects, although not everybody gets them.

The following side effect is very rare, but you must stop taking the medicine 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 (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 (children only).

•    Diarrhoea (children only)

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

•    Itching and rash

•    Tingling in the hands and feet

•    Diarrhoea

•    Feeling agitated.

•    Feeling weak or generally unwell

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)

•    Convulsions

•    Increased weight

•    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 focussing

•    Rotation of the eyes

•    Bad taste in the mouth

•    Fainting

•    Bed wetting, pain and/or difficulty passing water

•    Unusual bleeding or bruising

•    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

•    A recurring rash.

Not known side effects

•    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 the oral solution and see your doctor.

At the first signs of a hypersensitivity reaction, stop taking Cetrex. Your doctor will then assess the severity and decide on any further measures that may be necessary.

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, Website: 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 Cetrex 5 mg/ 5 ml Solution

Keep out of the reach and sight of children.

The expiry date is stated on the label. “Exp” is short for expiry. Do not take your medicine after this date.

Once opened, the content of the bottle should be used within 2 months.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Cetrex 5 mg/ 5 ml Solution contain

The active substance of Cetrex oral solution is Cetirizine. 10 ml (equals to 2 measuring spoons) contain 10 mg of cetirizine dihydrochloride.

The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sorbitol, glycerol, sodium citrate, propylene glycol, monoammonium glycerrhizinate, pineapple flavour, sweet orange flavour and citric acid.

What Cetrex 5 mg/ 5 ml Solution looks like and contents of the pack

Cetrex 5 mg/ 5 ml Solution is a clear, colourless, pineapple and sweet orange flavoured solution with a sweet taste.

Cetrex 5 mg/ 5 ml Solution is available in 70 ml bottles.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is Chanelle Medical, Loughrea, Co Galway, Ireland.

The manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.

The distributor is Chanelle Medical UK Ltd.

This leaflet was last approved in: 03/2015