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CETIRIZINE HYDROCHLORIDE 5 MG/5 ML SOLUTION

Active substance(s): CETIRIZINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizine hydrochloride 5 mg/5ml Solution
Cetirizine dihydrochloride

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Cetirizine hydrochloride carefully to get the best results from it.

Keep this 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 3 days.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cetirizine hydrochloride is and what it is used for
2. Before you take Cetirizine hydrochloride
3. How to take Cetirizine hydrochloride
4. Possible side effects
5. How to store Cetirizine hydrochloride
6. Further Information

1. What Cetirizine hydrochloride is and what it is used for

Cetirizine dihydrochloride is the active ingredient of Cetirizine hydrochloride. Cetirizine hydrochloride is an antiallergic medication.
In adults and children aged 2 year and above, Cetirizine dihydrochloride 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. Before you take Cetirizine hydrochloride

Do not take Cetirizine hydrochloride
if you have a severe kidney disease (severe renal failure with creatinine clearance below10 ml/min)
if you are known to be hypersensitive to the active substance of Cetirizine hydrochloride, 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 Cetirizine hydrochloride
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 Cetirizine dihydrochloride for several days before testing. This
medicine may affect your allergy test results.
Taking other medicines
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 Cetirizine hydrochloride with food and drink
Food does not affect noticeabily the absorption of cetirizine.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
As with other drugs, use of Cetirizine hydrochloride 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 Cetirizine hydrochloride 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 Cetirizine hydrochloride 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 Cetirizine hydrochloride
Cetirizine hydrochloride contains sorbitol; If you have been told by your doctor that you have an intolerance to some sugars, please contact your
doctor before taking this medicinal product.
Cetirizine hydrochloride contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) that may cause allergic reactions
(possibly delayed).

3. How to take Cetirizine hydrochloride

How and when should you take Cetirizine hydrochloride?
These guidelines apply unless your Doctor has given you different instructions on how to use Cetirizine hydrochloride.
Please follow these instructions, otherwise Cetirizine hydrochloride 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 spoon)
Children between 6 and 12 years old:
5 mg twice daily as 5 ml (one full measuring spoon) twice daily..
Children between 2 and 6 years old
2.5 mg twice daily as 2.5 ml oral solution (a half measuring spoon) twice daily
Patients with moderate to severe renal impairment
Patients with moderate renal impairment are recommended to take 5 mg as once daily.
If you feel that the effect of Cetirizine hydrochloride 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 Cetirizine hydrochloride than you should
If you think you have taken an overdose of Cetirizine hydrochloride 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 Cetirizine hydrochloride
Do not take a double dose to make up for forgotten dose
If you stop taking Cetirizine hydrochloride
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetirizine hydrochloride 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.
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 Cetirizine hydrochloride 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. Further information

What Cetirizine hydrochloride solution contain
The active substance of Cetirizine hydrochloride 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 Cetirizine hydrochloride solution looks like and contents of the pack
Cetirizine Hydrochloride 5 mg/5 ml Solution is a clear, colourless, pineapple and sweet orange flavoured solution with a sweet taste.
Cetirizine Hydrochloride 5 mg/5 ml Solution is available in 75 ml, 100 ml, and 200 ml bottles.
Not all pack sizes may be marketed.
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

LB1959

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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