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CETIRIZINE HYDROCHLORIDE 1 MG | ML ORAL SOLUTION
Active substance(s): CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride 1 mg/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 Cetirizine
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.
If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist. See section 4.
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. How to store Cetirizine
6. Contents of the pack and other information
1. WHAT CETIRIZINE IS AND WHAT IT IS USED FOR
Cetirizine is an antihistamine. Antihistamines help to relieve the symptoms of some allergies.
In children 2 to 6 years, Cetirizine is used:
to relieve the nasal symptoms of hay fever (runny and itchy nose)
In adults and children 6 years and above, Cetirizine is used:
to relieve the nasal symptoms of hay fever and non-seasonal rhinitis (runny and itchy
to relieve the symptoms of other allergies e.g. pet or house dust mite allergies
for skin allergies such as rash, itching and urticaria (hives).
In adults and children 12 years and above Cetirizine is also used:
to relieve the symptoms of allergic eye conditions.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE
DO NOT take Cetirizine and talk to your doctor if you:
are allergic (hypersensitive) to cetirizine or similar products (e.g. hydroxyzine, cyclizine,
meclozine) or to any of the other ingredients in this medicine
are undergoing dialysis for kidney problems
have a hereditary fructose intolerance.
Warnings and precautions
Tell your doctor before you start to take this medicine if you:
have kidney problems, as the dose may need to be adjusted
are epileptic or at risk of convulsions.
have urinary retention problem
Allergy tests: If you are going to have an allergy skin test stop taking this medicine 3 days
before the test.
Not recommended in children aged less than 2 years of age.
Other medicine and Cetirizine
Talk to your doctor if you are taking any of the following:
Due to the profile of cetirizine, no interactions with other drugs are expected.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Important information about some of the ingredients of Cetirizine
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
Propyl parahydroxybenzoate E216 and methyl parahydroxybenzoate E218 may cause
allergic reactions (possibly delayed).
Cetirizine with food and drink
DO NOT take large amounts of alcohol whilst taking Cetirizine, as Cetirizine may
increase the effects of alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or planning to become pregnant, ask your doctor for advice before
taking this medicine.
DO NOT take Cetirizine if you are breast-feeding.
Driving and using machines
When taken at the recommended dose, Cetirizine is not expected to affect your ability to
drive or operate machinery. However, there are exceptions and you should take care when
using this medicine for the first time. If this product makes you feel drowsy, DO NOT
drive or operate machinery. This effect will be worse if you are also taking sedatives or
3. HOW TO TAKE CETIRIZINE
If your doctor has prescribed this medicine, always take Cetirizine exactly as your doctor has
told you. Otherwise, follow the instructions below. If you are not sure how to take this
medicine talk to your doctor or pharmacist.
Use the spoon provided to make sure you have the correct dose.
The usual dosage instructions are given below:
Adults and children over 12 years of age
10 mg once daily as 10 ml oral solution (two full measuring spoons) once daily.
Children aged 6 – 12 years (for hay fever, runny and itchy nose due to allergy and
5 mg twice daily as 5 ml oral solution (one full measuring spoon) twice daily.
Children aged 2 – 6 years (for hay fever only)
2.5 mg twice daily as 2.5 ml oral solution (a half-measuring spoon) twice daily.
Children under 2 years of age
Cetirizine is not recommended for use.
Patients with moderate to severe kidney problems
In patients with kidney impairment, the dose may need to be reduced as recommended by
a doctor. Please talk to you doctor or pharmacist.
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 has
accidentally swallowed any of the solution, contact your nearest hospital casualty department
or your doctor immediately.
The effects of an overdose may cause confusion, diarrhoea, dizziness, tiredness, headache, a
general feeling of being unwell, dilated pupils, itching, restlessness, drowsiness, sleepiness, a
state of semi unconsciousness, faster heartbeat, shaking or problems urinating. Please take
this leaflet, any remaining solution and the container with you to the hospital or doctor so that
they know which solution was taken.
If you forget to take Cetirizine
If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take
the next one. DO NOT take a double dose to make up for a forgotten 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 can cause side effects, although not everybody gets them.
Stop taking the solution and tell your doctor immediately or go to the casualty department
at your nearest hospital if the following happens:
a severe allergic reaction (swelling of the face, lips, mouth or throat leading to severe
difficulty in breathing or swallowing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or
The following side effect has been reported with Cetirizine. Tell your doctor if you notice
abnormal liver function tests (diagnosed by blood and/or urine tests).
The following side effects have been reported at the approximate frequencies shown:
Common (affecting fewer than one person in 10 but more than one person in 100)
tiredness or sleepiness
dizziness or headache
nausea or diarrhoea
dry mouth or difficulty in swallowing accompanied by earache and swollen glands, sore
runny and itchy nose.
Uncommon (affecting less than one person in 100 but more than one person in 1,000):
lethargy or feeling weak and/or unwell
pins and needles
skin itchiness or rashes.
Rare (affecting less than one person in 1,000 but more than one person in 10,000):
fits or unusual movements of your arms and/or legs
aggression or depression
difficulty in sleeping
red and/or blotchy skin rash.
Very rare (affecting less than one person in 10,000):
bleeding and bruising easily (could indicate problems with your blood)
sight problems including difficulty focusing and blurred vision
unusual movements of the eyeball
decreased sense of taste
pain in passing water
inflammatory skin eruption
unusual movements or contractions in the face
abnormal muscle rigidity or movements
Side effects with frequency not known
Partial or total loss of memory
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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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
5. HOW TO STORE CETIRIZINE
Keep out of the sight and reach of children. There are no special storage conditions. Do not
transfer to another container. Do not use Cetirizine after the expiry date that is stated on the
outer packaging. The expiry date refers to the last day of that month.
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
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cetirizine solution contains:
The active ingredient is cetirizine hydrochloride. Each 1 ml of solution contains 1 mg of
The other ingredients are glycerol, propylene glycol, sorbitol solution (E420), methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium acetate, glacial
acetic acid, saccharin sodium, banana flavour and purified water.
What Cetirizine solution looks like and contents of the pack:
Cetirizine solution is a clear, colourless solution with a banana flavour.
The product is available in pack sizes of 70 ml, 75 ml, 100 ml, 150 ml and 200 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK
Limited, Eastbourne, BN22 9AG.
Marketing Authorisation holder:
TEVA UK Limited, Eastbourne, BN22 9AG.
Company responsible for manufacture: Teva Czech Industries s.r.o., Opava, Czech
This leaflet was last revised: July 2014
*Only the company responsible for batch release will be shown on the mock-up.
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.