CETIRIZINE HYDROCHLORIDE 5MG/5ML ORAL SOLUTION

Active substance: CETIRIZINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET
Cetirizine Hydrochloride 5mg/5ml Oral Solution
Cetirizine hydrochloride
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription, however, you still need to take your medicine 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 a few 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 Hydrochloride 5mg/5ml Oral Solution (”Cetirizine Hydrochloride”) belongs to a group of medicines called antihistamines.
It works by counteracting the effects of histamine which is produced naturally by your body’s defence system, but may be
over-produced in allergic reactions.
Cetirizine Hydrochloride is used to relieve the symptoms of hayfever (seasonal rhinitis) in adults and children over the age
of 2 years, which include:

sneezing

irritated, runny or blocked nose

itchy, red and watering eyes
It is used to relieve the symptoms of other allergies in adults and older children (over the age of 6 years), including:

runny and itchy nose (non-seasonal rhinitis)

pet or house mite allergies

skin allergies such as rash, itching and urticaria (hives)
2.
BEFORE YOU TAKE CETIRIZINE HYDROCHLORIDE
DO NOT TAKE Cetirizine Hydrochloride if you:

are allergic to cetirizine hydrochloride, hydroxyzine or any of the other ingredients of Cetirizine Hydrochloride, or
to any piperazine derivatives (see Section 6 and end of Section 2).

are breast-feeding, as cetirizine hydrochloride can pass into breast milk.

have severe kidney failure (creatinine clearance less than 10 ml/min).
Take special care with Cetirizine Hydrochloride if:

you have kidney problems. Your dose should be adjusted as recommended by a doctor.

you are pregnant.

you suffer from epilepsy or are at risk of convulsions.

you have hereditary intolerance to some sugars.

your symptoms persist, you should get advice from your doctor or pharmacist.
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.
Especially tell your doctor if you are taking:

theophylline which is taken for some heart conditions or breathing disorders like asthma or bronchitis.

central nervous system depressants e.g. barbiturates which are used as sedatives or anaesthetics.
Taking Cetirizine Hydrochloride with food and drink
You must avoid excessive alcohol consumption while you are taking this medicine, as with all antihistamine medicines.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.

Do not take Cetirizine Hydrochloride if you are breast-feeding.

Only take this medicine during pregnancy if advised to do so by your doctor.
Driving and using machines
Cetirizine Hydrochloride does not usually cause drowsiness at the recommended dose. However, individuals react differently,
so do not drive or operate machinery until you know how it affects you.
Important information about some of the ingredients of Cetirizine Hydrochloride
Cetirizine hydrochloride contains:

sorbitol (E420): if you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

propylene glycol, which may cause alcohol-like symptoms.

methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions
(possibly delayed).
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3.
HOW TO TAKE CETIRIZINE HYDROCHLORIDE
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Cetirizine Hydrochloride is to be taken only by mouth, and is not to be taken by children aged under 2 years.
The measuring spoon provided is double-ended. The larger spoon holds 5ml of your medicine, and the smaller spoon holds 2.5ml.
Each 5ml spoonful of solution contains 5mg cetirizine hydrochloride. The usual dose is:
Adults, the elderly and children aged 12 years and above:
Children aged 6 to 11 years:
Children aged 2 to 5 years:

Two 5ml spoonfuls once daily (to a maximum of 10mg
daily).
Either two 5ml spoonfuls once daily, or one 5ml spoonful
twice daily (to a maximum of 10mg daily).
Either one 5ml spoonful once daily or one 2.5ml spoonful
twice daily (to a maximum of 5mg daily).

If you have kidney problems, your dose should be adjusted as recommended by a doctor.
If you take more Cetririzine Hydrochloride than you should:
If you or your child may have taken too much of this medicine, talk to a doctor or pharmacist immediately. You or the child may
feel drowsy or dizzy. In children, agitation or restlessness may occur before drowsiness.
If you forget to take Cetirizine Hydrochloride
If you forget to take a dose, take it as soon as you remember, but wait at least 24 hours before taking the next dose.
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 immediately
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

Nausea

Sore throat

Diarrhoea

Cold-like symptoms of the nose






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

Itching and rash


Feeling agitated


Tingling in the hands and feet

Headache
Pain in the abdomen
Dry mouth
Dizziness

Feeling weak or generally unwell
Diarrhoea

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

Convulsions

Increased weight

Urticaria (hives)

Aggression, confusion, depression, hallucination (hearing or seeing things), sleeplessness
Very rare side effects (affects less than 1 in 10,000 people)

Blurred vision, difficulty focussing


Fainting


Recurring rash


Bed wetting, pain and/or difficulty passing water

Tremor, tics


Muscle spasms in the neck and shoulders


Rotation of the eyes
Unusual bleeding or bruising
Bad taste in the mouth
Involuntary movements and/or jerking of the limbs
Swelling of the skin particularly around the face

If any of these side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.
HOW TO STORE CETIRIZINE HYDROCHLORIDE
Keep out of the reach and sight of children, and do not store above 25˚C. Do not use Cetirizine Hydrochloride after the expiry
date which is stated on the label. The expiry date refers to the last day of that month. Use within 6 months after opening.
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 contains

The active ingredient is cetirizine hydrochloride: 5mg in each 5ml of solution.

The other ingredients are: liquid sorbitol (E420), glycerol, propylene glycol, sodium acetate, acetic acid, saccharin
sodium, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), banana flavour and purified water.
What Cetirizine Hydrochloride looks like and contents of the pack
Cetirizine Hydrochloride 5mg/5ml Oral Solution is a clear or almost clear colourless solution, with the taste and smell of
banana. It is available in pack sizes of 60ml, 75ml, 80ml, 100ml, 150ml and 200ml amber glass bottles, and includes a
combined 5ml / 2.5ml measuring spoon.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/0068
This leaflet was last updated in 08/2011.

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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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