ZIRTEK ALLERGY

Active substance: CETIRIZINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PATIENT INFORMATION LEAFLET
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 it 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 3 days.
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.

Zirtek Allergy Solution
1 mg/ml oral solution
Cetirizine dihydrochloride
In this leaflet:

1. What Zirtek is and what it is used for
2. Before you take Zirtek
3. How to take Zirtek
4. Possible side effects
5. How to store Zirtek
6. Further information.

1. WHAT ZIRTEK IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek.
Zirtek is an antiallergic medicine.

In adults and children aged 2 years and above, Zirtek is used
• for the relief of nasal and ocular symptoms of seasonal and perennial

allergic rhinitis (hayfever and year-round allergies affecting the nose and
eyes).
• for the relief of chronic nettle rash (chronic idiopathic urticaria).

2. BEFORE YOU TAKE ZIRTEK

Do not take Zirtek:
• if you have a severe kidney disease (severe renal failure with creatinine
clearance below 10 ml/min);

• if you are known to be hypersensitive to the active substance of Zirtek, to

Important information about some of the ingredients of Zirtek

You should not take Zirtek 1 mg/ml oral solution:
• if you have rare hereditary problems of fructose intolerance.
Take special care with Zirtek
• If you are a patient with renal insufficiency, please ask your doctor for

3. HOW AND WHEN SHOULD YOU TAKE ZIRTEK?

any of its excipients (other constituents), to hydroxyzine or to any
piperazine derivatives (closely related active substances of other
medicines).

advice; if necessary, you will 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.
No clinically significant interactions have been observed between alcohol
(at the blood level of 0.5 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 Zirtek with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop
taking Zirtek for several days before testing. This medicine may affect your
allergy test results.

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.

Taking Zirtek with food and drink

Food does not affect absorption of Zirtek.

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine.
As with other drugs, use of Zirtek 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.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness
and driving capabilities after taking Zirtek at the recommended dose.
You should closely observe your response to the drug after you have taken
Zirtek if you are intending to drive, engage in potentially hazardous activities
or operate machinery. You should not exceed the recommended dose.

Zirtek oral solution 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.
Zirtek oral solution contain methyl (4-hydroxybenzoate) E 218, propyl
(4-hydroxybenzoate) E 216 that may cause allergic reactions (possibly
delayed).
These guidelines apply unless your doctor has given you different
instructions on how to use Zirtek. Please follow these instructions, otherwise
Zirtek may not be fully effective. The solution may be swallowed as such.

Adults and adolescents above 12 years old:

10 mg once daily as 10 ml oral solution (2 full measuring spoons).

Children between 6 and 12 years old:

5 mg twice daily as 5 ml (one full measuring spoon) twice daily.

Children between 2 and 6 years old:

2.5 mg twice daily as 2.5 ml oral solution (a half measuring spoon) twice
daily.

Patients with moderate to severe kidney impairment

Patients with moderate kidney impairment are recommended to take 5 mg or
5 ml once daily.
If you feel that the effect of Zirtek 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 pharmacist for advice.

If you take more Zirtek Allergy Solution than you should

If you think you have taken an overdose of Zirtek 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 a dose

Do not take a double dose to make up for forgotten dose.

If you stop taking Zirtek

If you have any other questions about taking this medicine, ask your
pharmacist.

• Convulsions
• Weight increased
• Aggression, confusion, depression, hallucination (hearing or seeing

4. POSSIBLE SIDE EFFECTS

• Urticaria (hives).

Like all medicines Zirtek Allergy Solution can cause side effects, although
not everybody gets them.
The following side effect is 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 cause swelling of the face and throat).
These reactions may start soon after you first take the medicine, or it
might start later.
The frequency of possible side effects listed below is defined using the
following convention:
Common (affects 1 to 10 patients in 100)
Uncommon (affects 1 to 10 patients in 1000)
Rare (affects 1 to 10 patients in 10,000)
Very rare (affects less than 1 patient in 10,000)
Not known (frequency cannot be estimated from available data)
The following side effects have also been reported.
Common side effects (affects less than 1 in 10 people)
• Tiredness, feeling sleepy
• Headache
• Nausea
• Sore throat
• Dry mouth
• Diarrhoea
• Dizziness
• Cold-like symptoms of the nose (children only).
Uncommon side effects (affects less than 1 in 100 people)
• Itching and rash
• Asthenia (extreme fatigue) or generally unwell
• Feeling agitated
• Tingling in the hands and feet
• Pain in the abdomen.
Rare side effects (affects less than 1 in 1000 people)
• Tachycardia (heart beating too fast)
• Oedema (generalised swelling due to water retention)
• Abnormal liver function test results (your doctor will know what to do)

things), sleeplessness

Very rare side effects (affects less than 1 in 10,000 people)
• Blurred vision, difficulty focussing
• Oculogyration (eyes having uncontrolled circular movements)
• Fainting
• Low level of blood platelets causing unusual bleeding or bruising
• A recurring rash.
• Bad taste in the mouth
• Abnormal elimination of urine (bedwetting, pain and/or difficulty passing
water)
• Tremor, tics (habit spasm)
• Involuntary movements and/or jerking of the limbs
• Muscle spasms in the neck and shoulders
• Swelling of the skin particularly around the face or throat.
Not known frequency of side effects
• Memory loss and forgetfulness
If you develop one of the side effects described above, please inform
your doctor or pharmacist. At the first signs of a hypersensitivity
reaction, stop taking Zirtek. Your doctor will then assess the severity
and decide on any further measures that may be necessary.
If you think you have any side effects not mentioned in this leaflet,
please inform your doctor or pharmacist.

acetic acid, purified water.
10 ml Zirtek oral solution (=2 measuring spoons) contain: 3.15 g glucose
equivalents (sorbitol).

What Zirtek Allergy Solution looks like and contents of pack

Clear colourless liquid with slightly sweet taste and a banana flavour
solution. Pack with a bottle containing 60 ml, 75 ml, 100 ml, 150 ml or
200 ml solution. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United
Kingdom
This leaflet was last updated July 2011
If this leaflet is difficult to see or read or you would like it in a different
format, please contact UCB Pharma Ltd, UK

5. HOW TO STORE ZIRTEK ALLERGY SOLUTION

Keep out of the reach and sight of children. Do not use Zirtek after the
expiry date which is stated on the box and bottle.
Do not use after 3 months of first opening the bottle. This medicine does not
require any special storage conditions.

6. FURTHER INFORMATION

What Zirtek Allergy Solution contains

The active substance of Zirtek is cetirizine. 10 ml (equals to 2 measuring
spoons) contain 10 mg of cetirizine dihydrochloride.
The other ingredients are sorbitol (E 420), glycerol, propylene
glycol, saccharin sodium, methyl (4-hydroxybenzoate) / propyl
(4-hydroxybenzoate) = E 218 / E 216, flavouring agent, sodium acetate,

CIA70972A

Expand view ⇕

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
(web1)