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CETIRIZINE HYDROCHLORIDE 5MG/5ML ORAL SOLUTION
Active substance(s): CETIRIZINE HYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride 5 mg/5 ml Oral Solution
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
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 hay fever (seasonal rhinitis) in
adults and children over the age of 2 years, which include:
• 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)
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
• 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
• 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
• you are due to have an allergy test, as this medicine may affect your allergy test
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
Taking Cetirizine Hydrochloride with food and drink
You must avoid excessive alcohol consumption while you are taking this medicine, as with all
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
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).
• This medicinal product contains small amounts of ethanol (alcohol), less than 100mg
per 10 ml.
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 5 ml of your medicine,
and the smaller spoon holds 2.5 ml.
Each 5 ml spoonful of solution contains 5 mg 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 5 ml spoonfuls once daily (to a maximum
of 10 mg daily).
Either two 5 ml spoonfuls once daily, or one 5
ml spoonful twice daily to a maximum of 10
Either one 5 ml spoonful once daily or one 2.5
ml spoonful twice daily (to a maximum of 5
If you have kidney problems, your dose should be adjusted as recommended by a doctor.
If you take more Cetirizine 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.
Possible side effects
Like all medicines, Cetirizine Hydrochloride can cause side effects, although not everybody gets
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.
• In very rare cases people have thoughts about committing suicide and if you feel this way
then stop taking the tablets and see your doctor.
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
Cold-like symptoms of the nose
Uncommon side effects (affects less than 1 in 100 people)
Itching and rash
Feeling weak or generally unwell
Tingling in the hands and feet
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
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
Rotation of the eyes
Unusual bleeding or bruising
Bad taste in the mouth
Bed wetting, pain and/or difficulty passing water
Involuntary movements and/or jerking of the limbs
Muscle spasms in the neck and shoulders
Swelling of the skin particularly around the face
Not Known (frequency cannot be estimated from the available data)
Photosensitivity (allergic reaction caused by the sun)
Bronchospasm (difficulty breathing)
Lack of coordination
Palpitations (feeling your heartbeat)
Alopecia (hair loss)
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 at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Cetirizine Hydrochloride
Keep this medicine out of the sight and reach 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
What Cetirizine Hydrochloride contains
• The active ingredient is cetirizine hydrochloride: 5 mg in each 5 ml 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 5 mg/5 ml Oral Solution is a clear or almost clear colourless solution,
with the taste and smell of banana. It is available in pack sizes of 60 ml, 70 ml, 80 ml, 100 ml,
150 ml and 200 ml amber glass bottles, and includes a combined 5ml / 2.5ml measuring spoon.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
This leaflet was last updated in: November 2015
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.