Skip to Content

UK Edition. Click here for US version.

DEXCEL CETIRIZINE HAYFEVER & ALLERGY RELIEF 10 MG TABLETS

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Cetirizine
Hayfever and Allergy Relief
10 mg Tablets
(Cetirizine hydrochloride)
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
This medicine is available without prescription. However, you
still need to use Cetirizine Hayfever and Allergy Relief 10 mg
Tablets carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- You must contact a doctor if your symptoms worsen or do not
improve after 3 days.
- If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Cetirizine Hayfever and Allergy Relief 10 mg Tablets
are and what they are used for
2. What you need to know before you take Cetirizine Hayfever
and Allergy Relief 10 mg Tablets
3. How to take Cetirizine Hayfever and Allergy Relief 10 mg
Tablets
4. Possible side effects
5. How to store Cetirizine Hayfever and Allergy Relief 10 mg
Tablets
6. Content of the pack and other information
1. WHAT CETIRIZINE HAYFEVER AND ALLERGY RELIEF
10 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Cetirizine hydrochloride is the active ingredient of Cetirizine
Hayfever and Allergy Relief 10 mg Tablets. Cetirizine Hayfever
and Allergy Relief 10 mg Tablets is an antiallergic medication.
In adults and children aged 6 years and above, Cetirizine
Hayfever and Allergy Relief 10 mg Tablets are indicated
- for the relief of symptoms of hay fever (seasonal allergic
rhinitis) and allergies such as dust or pet allergies (perennial
allergic rhinitis), such as sneezing, itchy, runny and blocked
nose, red and watery eyes.
- for the relief of swelling, redness and itchiness of the skin
(symptoms of chronic idiopathic urticaria, which is also
known as chronic nettle rash).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CETIRIZINE HAYFEVER AND ALLERGY RELIEF 10 MG
TABLETS
Do not take Cetirizine Hayfever and Allergy Relief 10 mg
Tablets
- if you have a severe kidney disease (severe renal failure with
creatinine clearance below 10 ml/min).
- if you are known to be allergic (hypersensitive) to the active
substance of Cetirizine Hayfever and Allergy Relief 10 mg
Tablets or any of the other ingredients of these tablets (these
are listed below, in section 6 “Further information”).
- if you are known to be allergic (hypersensitive) to hydroxyzine
(a closely related active substance of other medicines).
- if you are known to be allergic (hypersensitive) to drugs
from the piperazine family, for example buclizine, cyclizine,
meclozine, levocetirizine.
Warnings and precautions
Check with your doctor before taking Cetirizine Hayfever and
Allergy Relief 10 mg Tablets:
- if you have problems with your kidneys
- if you have predisposition factors of urinary retention (eg:
spinalcord lesion, prostatic hyperplasia) as cetirizine
increases the risk of urinary retention
- you suffer from epilepsy or are at risk of convulsions
Take special care with Cetirizine Hayfever and Allergy
Relief 10 mg Tablets
If you have kidney problems, please ask your doctor for
advice; if necessary, you may have to take a lower dose. The
new dose will be determined by your doctor.

If you are an epileptic patient or a patient at risk of convulsions,
you should ask your doctor for advice.
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 Hayfever and Allergy
Relief 10 mg Tablets
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription.
Due to the profile of cetirizine, no interactions with other drugs
are expected.
Taking Cetirizine Hayfever and Allergy Relief 10 mg
Tablets with food and drink
Food does not noticeably affect the absorption of cetirizine.
No interactions having a noticeable impact have been
observed between alcohol (at the blood level of 0.5 per
millilitre corresponding to one glass of wine) and cetirizine
used at the normal doses. However, as it is the case with all
antihistamines, it is recommended to avoid consumption of
alcohol while taking this medicine.
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 Hayfever and Allergy Relief 10 mg 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 Hayfever and Allergy Relief 10 mg Tablets
during breast-feeding unless you have contacted a doctor.
Allergy skin test
If you are going to have an allergy skin test stop taking
Cetirizine Hayfever and Allergy Relief 10 mg Tablets for three
days before the test. This medicine may affect your allergy
test results.
Driving and using machines
Clinical studies have produced no evidence of impaired
attention, alertness and driving capabilities after taking
Cetirizine Hayfever and Allergy Relief 10 mg Tablets at the
recommended dose.
If you intend to drive, operate machinery, or perform other
tasks that need your full attention, you should not exceed
the recommended dose and you should closely observe your
response to the drug. If you are a sensitive patient, you may
find that the simultaneous use of alcohol or other nervous
depressant agents may additionally affect your attention and
ability to react.
Cetirizine Hayfever and Allergy Relief 10 mg Tablets
contains lactose
Cetirizine Hayfever and Allergy Relief 10 mg 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 HAYFEVER AND ALLERGY
RELIEF 10 MG TABLETS
Always take Cetirizine Hayfever and Allergy Relief 10 mg
Tablets exactly as your doctor has told you. Check with
your doctor if you are not sure.
Tablets need to be swallowed with a glass of liquid.

Children aged 6 to 12 years
The recommended dose is 5 mg twice daily as half a tablet
twice a day.
Adults and children aged 12 years and over:
The recommended dose is 10 mg once daily as one tablet.
Patients with moderate to severe renal impairment:
Patients with moderate renal impairment are recommended to
take 5 mg once daily as a half tablet.
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 Hayfever and Allergy
Relief 10 mg Tablets 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 Hayfever and Allergy Relief 10
mg Tablets than you should
If you think you have taken an overdose of Cetirizine Hayfever
and Allergy 10 mg 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, dilating (widening) of the pupil,
itching, restlessness, sedation, somnolence, stupor, abnormal
rapid heart rate, tremors and urinary retention have been
reported.
If you forget to take Cetirizine Hayfever and Allergy Relief
10 mg Tablets
If you forget to take a tablet, take it as soon as you remember,
but wait at least 24 hours before taking the next tablet. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Cetirizine Hayfever and Allergy Relief
10 mg Tablets
Rarely, pruritus (intense itching) and/or urticaria may return
if you stop taking Cetirizine Hayfever and Allergy Relief 10
mg Tablets.
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 Hayfever and Allergy Relief 10
mg Tablets can cause side effects, although not everybody
gets them.
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 develop one of the very rare side effects described
below, please inform your doctor straight away.
At the first signs of a severe allergic (hypersensitivity)
reaction (symptoms include: rash, itchiness and fever,
difficulty breathing, swelling of the neck, throat, tongue,
face, eyelids or lips) stop taking the tablets and contact
your doctor immediately.
This reaction may start soon after you first take the
medicine or it might start later. Your doctor will then
assess the severity and decide on any further measures
that may be necessary.
The following side effects have also been reported.
Common side effects (may affect up to 1 in 10 patients)
- Fatigue, somnolence (sleepiness)
- Dizziness, headache,
- Dry mouth, nausea (feeling sick), diarrhoea (children only)
- Pharyngitis (sore throat), rhinitis (swelling and irritation
inside the nose (children only))
Uncommon side effects (may affect up to 1 in 100 patients)
- Pruritus (itching), rash
- Abdominal pain
- Agitation

- Asthenia (feeling of weakness), malaise (feeling of being
generally unwell)
- Paraesthesia (abnormal feelings of the skin), tingling in the
hands and feet
Rare side effects (may affect up to 1 in 1,000 patients)
- Tachycardia (heart beating fast)
- Oedema (generalised swelling due to water retention)
- Liver function abnormal (your doctor will know what to do)
- Convulsions
- Weight increased
- Aggression, confusion, depression, hallucination (hearing or
seeing things), insomnia (difficulty sleeping)
- Urticaria (swelling,redness and itchiness of the skin)
Very rare side effects (may affect up to 1 in 10,000patients)
- Thrombocytopenia (low level of blood platelets), which
increases risk of bleeding or bruising
- Accommodation disorder (impaired ability of the eye to
focus), blurred vision, oculogyration (eyes moving in an
uncontrolled circular manner)
- Syncope (fainting), dyskinesia (involuntary movements),
dystonia (abnormal prolonged muscular contractions),
tremor, dysgeusia (altered taste)
- Tics (sudden abnormal repetitive muscle movement)
- Swelling of the skin particularly around the face, fixed drug
eruption (may look like round or oval patches of redness and
swelling of the skin)
- 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 (loss of memory), 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
Reporting of suspected adverse reactions
If you think you have any side-effects not mentioned in
this leaflet, please inform 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 at: 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 HAYFEVER AND ALLERGY
RELIEF 10 MG TABLETS
Keep out of the sight and reach of children.
Do not use Cetirizine Hayfever and Allergy Relief 10 mg
Tablets after the expiry date which is stated on the box and
blister.
This medicine does not require any special storage conditions.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Cetirizine Hayfever and Allergy Relief 10 mg Tablets
contain
- The active substance of Cetirizine Hayfever and Allergy
Relief 10 mg Tablets is cetirizine hydrochloride. One filmcoated tablet contains 10 mg cetirizine hydrochloride.
- The other ingredients are: pregelatinized starch, lactose,
maize starch, povidone, magnesium stearate, macrogol
6000, basic polymethacrylate, titanium dioxide (E171), talc.
What Cetirizine Hayfever and Allergy Relief 10 mg Tablets
look like and contents of the pack
White, capsule shaped film-coated tablets with a score on one
side.
There are 7 or 14 tablets in a pack.
Not all pack sizes may be marketed.
Marketing Authorization Holder / Manufacturer:
Dexcel®-Pharma Ltd.,7 Sopwith Way, Drayton Fields,
Daventry, Northamptonshire, NN11 8PB,UK.
This leaflet was last revised in January 2017.

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.

Hide