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CETIRIZINE HYDROCHLORIDE 10MG TABLETS

Active substance(s): CETIRIZINE HYDROCHLORIDE / CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE / CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aspar Hayfever and Allergy Relief
Cetirizine hydrochloride 10 mg Tablets
(One a day)
Cetirizine hydrochloride
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 pharmacists have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or
advice.
• If any get side effects, talk to your doctor or
pharmacist. This includes side effects not listed in this
leaflet, See section 4.
• You must contact a doctor if you do not feel better or if
you feel better worse after 3 days.
What is in this leaflet:
1. What Cetirizine hydrochloride Tablets is and what it is
used for
2. What you need to know before you take Cetirizine
hydrochloride Tablets
3. How to take Cetirizine hydrochloride Tablets
4. Possible side effects
5. How to store Cetirizine hydrochloride Tablets
6. Contents of the pack and other information
1. WHAT CETIRIZINE HYDROCHLORIDE TABLETS IS
AND WHAT IT IS USED FOR
Cetirizine hydrochloride is the active ingredient of
Cetirizine hydrochloride Tablets.
Cetirizine hydrochloride Tablets are an anti allergy
medication.
In adults and children aged 6 years and above, Cetirizine
hydrochloride Tablets are 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 TABLETS
Do not take Cetirizine hydrochloride Tablets:
• if you have severe kidney problems (severe renal
failure with creatinine clearance below 10 ml/min);
• if you are allergic to Cetirizine hydrochloride, to any of
the other ingredients (listed in section 6), to
hydroxyzine or to piperazine derivatives (closely
related active ingredients 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 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 recommended doses. However, there are no data
available 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 tablets with alcohol.

If you are scheduled for allergy testing, ask your doctor if
you should stop taking Cetirizine hydrochloride tablets for
several days before testing. This medicine may affect your
allergy test results.
Children
Do not give this medicine to children below the age of 6
years because the tablet formulation does not allow the
necessary dose adjustments.
Other medicines and Cetirizine hydrochloride tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Cetirizine hydrochloride tablets with food and drink
Food does not affect absorption of Cetirizine hydrochloride
tablets.
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 Tablets 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 only be
administered if necessary and after medical advice.
Cetirizine passes into breast milk. Therefore, you should
not take Cetirizine hydrochloride tablets during breastfeeding 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 tablets at the recommended dose. You
should closely observe your response to the drug after you
have taken Cetirizine hydrochloride tablets if you are intending
to drive, engage in potentially hazardous activities or operate
machinery. You should not exceed the recommended dose.
Cetirizine hydrochloride Tablets contain lactose; 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.
3. HOW TO TAKE CETIRIZINE HYDROCHLORIDE
TABLETS
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 tablets need to be swallowed with a glass of liquid.
The tablet can be divided into 2 equal doses.
Adults and adolescents above 12 years old:
The recommended dose is 10 mg once as 1 tablet daily.
Use in Children between 6 to 12 years old:
The recommended dose is 5mg twice daily as half tablet
twice daily.
Patients with renal impairment
Patients with moderate renal impairment are
recommended to take 5mg 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 tablets
are 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 Tablets than
you should
If you think you have taken an overdose of Cetirizine
hydrochloride tablets 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,
dilated pupils, itching, restlessness, sedation, stupor,
abnormal rapid heart rate, tremors and urinary retention
have been reported.
If you forget to take Cetirizine hydrochloride Tablets
Do not take a double dose to make up for a forgotten dose.

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 tablets
and see your doctor.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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

4. POSSIBLE SIDE EFFECTS

By reporting side effects you can help provide more
information on the safety of this medicine.

If you stop taking Cetirizine hydrochloride Tablets
Rarely, pruritus (intense itching) and/or urticaria may return
if you stop taking Cetirizine hydrochloride Tablets.

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 them:
• Allergic reactions, including severe reactions and
angioedema (serious allergic reaction which causes
swelling of the face or throat).
These reactions 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)

V I C T O R

D E S I G N

5. HOW TO STORE CETIRIZINE HYDROCHLORIDE
TABLETS
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 blister and the carton. The expiry date refers
to the last day of that month.
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 you no longer use. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cetirizine hydrochloride Tablets contains
• The active substance is Cetirizine hydrochloride.
Each film-coated tablet contains 10 mg of Cetirizine
hydrochloride.


The other ingredients are lactose monohydrate,
microcrystalline cellulose, maize starch, colloidal
anhydrous silica, magnesium stearate, talc,
hypromellose, titanium dioxide (E171), macrogol 4000
and sodium citrate.

What Cetirizine hydrochloride Tablets looks like and
contents of the pack
White, circular film-coated tablets, marked ‘A’ on one side
with a break line on the other side.
Pack available in blister pack containing 7 tablets.
Marketing Authorisation Holder
Chanelle Medical,
Loughrea, Co. Galway, Ireland.
Manufacturer
Chanelle Medical,
Loughrea, Co. Galway, Ireland.
Distributor
The distributor is
Aspar Pharmaceuticals., Ltd.
This leaflet was revised 01/2017
LD2630

tel/fax: 01275 342028 • email: mail@victor-design.com

Distributor:

Aspar Pharmaceuticals Limited

Product:

Cetirizine HCL 10 mg PIL

Reference:

PIL-ASP_CEThcl-10

PL number:

n/a

A/W version:

Version 16

Dimensions:

150 x 260 mm (taken from profile supplied)

Inks used:

Black

Date:

17.01.17

Expand Transcript

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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