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CETIRIZINE HYDROCHLORIDE 5 MG/5 ML SOLUTION

Active substance(s): CETIRIZINE HYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE / 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 before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4,

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
In this leaflet:
1. What Cetirizine hydrochloride is and what it is used for
2. What you need to know before you take Cetirizine hydrochloride
3. How to take Cetirizine hydrochloride
4. Possible side effects
5. How to store Cetirizine hydrochloride
6. Contents of the pack and other 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 urticaria.

2. What you need to know 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 allergic to Cetirizine hydrochloride, to any of the other ingredients (listed in section 6), to hydroxyzine or to any piperazine derivatives
(closely related active substances of other medicines)
Warning and precautions
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 have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice
If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 per mille(g/l) corresponding to one glass of wine)
and cetirizine used at the normal doses.
However, there are no data avaible on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all
antihistamines, it is recommended to avoid taking Cetirizine hydrochloride with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine dihydrochloride for several days before testing. This
medicine may affect your allergy test results.
Other medicines and Cetirizine Hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Cetirizine hydrochloride with food and drink
Food does not affect absorption of cetirizine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this
medicine. 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 medicine should be administered if necessary and after medical advice.
Cetirizine passes into breast milk. Therefore, you should not take Cetirizine hydrochloride during breast-feeding unless you have contacted a
doctor.
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. You should closely observe your response to the drug after you have taken Cetirizine hydrochloride if you are intending to
drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if
you are not sure.
The solution can be swallowed as such.
Adults and adolescents above 12 years old:
The recommended dose is 10 mg once daily as 10 ml oral solution (2 full measuring spoon)
Use in children between 6 and 12 years old:
The recommended dose is 5 mg twice daily as 5 ml (one full measuring spoon) twice daily.
Use in children between 2 and 6 years old
The recommended dose is 2.5 mg twice daily as 2.5 ml oral solution (a half measuring spoon) twice daily
Patients with renal impairment
Patients with moderate renal impairment are recommended to take 5 mg as once daily.
If you suffer from severe kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly.
If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose according to your child’s needs.
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. Please ask your doctor or pharmacist for advice.

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
Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Citerizine 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, this medicine can cause side effects, although not everybody gets them.
The following side effects are rare or very rare, but you must stop taking the medicine and speak to your doctor straight away if you
notice these symptoms:

Allergic reactions, including severe reactions and angioedema (serious allergic reaction which causes swelling of the face or throat).
This reaction may start soon after you first take the medicine, or it might start later.
Common side effects (may affect up to 1 in 10 patients)
Somnolence (sleepiness)
Dizziness, headache
Pharyngitis, rhinitis (in children)
Diarrhea, nausea, dry mouth
Fatigue
Uncommon side effects (may affect up to 1 in 100 patients)
Agitation
Paresthesia (abnormal feelings of the skin)
Abdominal pain
Pruritus (itchy skin), rash
Asthenia (extreme fatigue), malaise
Rare side effects (may affect up to 1 in 1000 patients)
-

Allergic reactions, some severe (very rare)
Depression, hallucination, aggression, confusion, insomnia
Convulsions
Tachycardia (heart beating too fast)
Liver function abnormal
Urticaria (hives)
Oedema (swelling)
Weight increased

Very rare side effects (may affect up to 1 in 10,000 patients)
Thrombocytopenia (low levels of blood platelets)
Tics (habit spasm)
Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeusia (altered taste)
Blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes having uncontrolled circular movements)
Angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption
Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)
Not known frequency of side effects (frequency cannot be estimated from the available data)
Increased appetite
Amnesia, memory impairment
Vertigo (sensation of rotation or movement)
Urinary retention (inability to completely empty the urinary bladder)
Pruritus (intense itching) and/or urticaria upon discontinuation
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 or pharmacist, 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and bottle. The expiry date refers to the last day of the month.
Do not use after 2 months of first opening the bottle.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These
measures will help to protect the environment.

6. Contents of the pack and other information

What Cetirizine hydrochloride solution contain
The active substance 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.
10 mg Cetirizine hydrochloride 5mg/5ml solution (2 measuring spoons) contain: 2.5 g glucose equivalent (sorbitol).
What Cetirizine hydrochloride solution looks like and contents of the pack
Clear, colourless, pineapple and orange flavoured solution with a sweet taste. Pack with bottles containing volumes of 75 ml, 100 ml, and 200 ml
solutions. Not all pack sizes may be marketed.
Marketing Authorisation Holder Chanelle Medical, Loughrea, Co Galway, Ireland.
Manufacturer Chanelle Medical, Loughrea, Co. Galway, Ireland.
Distributor Chanelle Medical UK Ltd.
This leaflet was last revised in: 01/2017

LC1959

Client

Chanelle

Colours used:

Date

17.1.17

Black

Product

CETIRIZINE

Pack Code
Scale / Size

1:1 / 190 x 300mm

Software

Illustrator CC

Proof No

2
Minimum Text 8pt

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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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