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ALLERTEK 10MG TABLETS

Active substance(s): CETIRIZINE HYDROCHLORIDE

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TEVA UK Ref: 231-30-20239-F LEA ALLERTEK (CETIRIZINE) 10mg TAB RATIOPHARM
Version:

1

06 August 2015

Patient Information Leaflet

AllerTek 10mg Tablets
cetirizine dihydrochloride
Read all of this leaflet carefully before you start taking this medicine.
• This medicine is available without prescription. However, you still need to use this
medicine 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 7 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. This includes any side effects not listed
in the leaflet. See section 4.

In this leaflet:
1. What AllerTek 10mg Tablets are and what they are used for
2. What you need to know before you take AllerTek 10mg Tablets
3. How to take AllerTek 10mg Tablets
4. Possible side effects
5. How to store AllerTek 10mg Tablets
6. Contents of the pack and other information

1. What AllerTek 10mg Tablets are and what they are used for
Cetirizine dihydrochloride is an antihistamine for the treatment of allergic diseases.
This medicine acts by blocking the effect of histamine, which is involved in the
development of the allergic reaction.
Cetirizine dihydrochloride is used for the treatment of symptoms in the following
allergic diseases:
Adults and children over 6 years:
Seasonal and non-seasonal allergic rhinitis (sneezing, itchy, runny and blocked up
nose), allergic inflammation of the eyes (itchy, red and watering eyes) and urticaria
(swelling, redness and itchiness of the skin).

2. What you need to know before you take AllerTek 10mg Tablets
Do not take this medicine and tell your doctor
• If you are allergic (hypersensitive) to cetirizine dihydrochloride or any of the other
ingredients of this medicine, or to hydroxyzine or piperazine derivatives (closely
related active substances of other medicines).
• If you have severe kidney disease (severe renal failure with creatinine clearance
below 10 ml/min).
You should not take this medicine
If you have hereditary problems of galactose intolerance, the Lapp lactase deficiency
or glucose-galactose malabsorption.
Warnings and precautions
Take special care with this medicine and tell your doctor
• If you are receiving long-term treatment with this medicine. There is an increased
risk of tooth decay due to dryness of the mouth. So it is important that you brush
your teeth regularly to help prevent tooth decay.
• If you have liver or kidney problems (your doctor will decide whether you need to
take a lower dose).
• If you are an epileptic patient or a patient at risk of convulsions.
• If you have urinary retention problem
Children
This medicine is not intended for use in children under 6 years of age. This product is
also available as a solution that would be more suitable for this age group.
Other medicine and Cetirizine
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
If you are having an allergy test you must stop taking your tablets three days before
the test as the tablets may affect the results.
This medicine can increase the effect of medicines that are used to treat the central
nervous system.
Cetirizine with food and drink This medicine can influence the effect of alcohol. You
are advised to avoid drinking large amounts of alcohol whilst taking this medicine.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You should let your doctor know if you are pregnant or think you might be pregnant
before taking this medicine. Your doctor will decide if this medicine is suitable for
you.
Breast-feeding
You should therefore not take this medicine if you are breast-feeding, because
cetirizine passes into breast milk.
Driving and using machines
This medicine can make you feel drowsy and therefore affect the ability to drive or
use machines safely. Therefore avoid driving or using dangerous machines until you
know how this medicine affects you.
Important information about some of the ingredients of AllerTek 10mg Tablets
This medicine contains lactose. If you have been told by your doctor, that you have
an intolerance to some sugars, contact your doctor before taking this medicinal
product.

3. How to take AllerTek 10mg Tablets
Always take this medicine exactly as prescribed in this package leaflet. You should
check with your doctor or pharmacist if you are not sure.
The usual dose for adults and children over 12 years:
1 tablet (10 mg) daily.
The usual dose for children between 6 and 12 years:
½ a tablet (5 mg) twice a day (morning and evening).
The usual dose for children under 30 kg:
½ tablet (5 mg) once daily.
Patients with moderate to severe kidney impairment:
Patients with moderate renal impairment are recommended to take ½ tablet (5mg)
once daily.
Do not exceed the stated dose.
The tablet should preferably be swallowed with liquid (e.g. a glass of water). If the
tablets make you drowsy you may take them in the evening. The tablets can be taken
with or without food.
If you have the impression that the effects of this medicine are too strong or too
weak, talk to your doctor or pharmacist.

REG0070190

If you take more AllerTek 10mg Tablets than you should
If you take a larger dose than recommended, consult your doctor immediately.

Version 3.3

Approved

Page 1 of 3

Version:

TEVA UK Ref: 231-30-20239-F LEA ALLERTEK (CETIRIZINE) 10mg TAB RATIOPHARM
1

06 August 2015

You may feel dizzy, drowsy, sleepy, have a headache, have difficulty with muscle
coordination, a racing heart-beat, be excitable (children in particular), have a dry
mouth, muscle tremor, flushed face and neck, diarrhoea, and difficulty passing urine.
If you forget to take AllerTek 10mg Tablets
Do not take a double dose to make up for a forgotten tablet/dose.
The treatment should be continued as normal.
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.
If any of the following happen, stop taking this medicine and tell your doctor
immediately or go to the casualty department at your nearest hospital:
Anaphylactic shock (sudden life-threatening allergic reaction). Symptoms include
rash, itching or hives on the skin; swelling of the face, lips, mouth, tongue or other
parts of the body; difficulty swallowing, shortness of breath, wheezing or trouble
breathing.
These are very serious side effects. If you have them, you may have had a serious
allergic reaction. You may need urgent medical attention or hospitalisation. All of
these very serious side effects are very rare (fewer than 1 in 10,000 patients treated).
Stop taking this medicine and seek medical attention as soon as possible if you
experience any of the following side effects:
Fixed drug eruption (a skin reaction that erupts every time the drug is taken, in the
same place on the body. The skin rash is usually preceded by itching or burning, then
erupts as a raised dusky red or purple-tinged patch of skin. The affected skin may
blister as well. Common locations are the hands and feet, lips, and genitalia) (this
side effect is very rare (fewer than 1 in 10,000 patients treated)) or hypersensitivity
(excessive, undesirable - damaging, discomfort-producing and sometimes fatal
reactions produced by the normal immune system) (this side effect is rare (fewer
than 1 in 1,000 patients treated)).
Other possible side effects:
Common (occurs in less than 1 in 10 patients receiving this medicine):
Mouth dryness, drowsiness, dizziness, headache, sleepiness in children and adults,
nausea (feeling sick), diarrhoea in children, pharyngitis (swelling of the throat),
rhinitis (runny nose).
Uncommon (occurs in less than 1 in 100 patients receiving this medicine):
Agitation, diarrhoea, asthenia (unusual tiredness or weakness), malaise (generally
feeling unwell), paresthesia (tingling or numbness of the hands or feet / pins and
needles), itching, rash, abdominal pain
Rare (occurs in less than 1 in 1000 patients receiving this medicine):
Abnormal liver function leading to increased levels of some liver enzymes (detected
by a blood test), tachycardia (heart beating too fast), weight gain, aggression,
confusion, depression, hallucination, insomnia (inability to sleep), oedema (swelling
of the hands, ankles, or feet), convulsions (fits), movements disorders, hives.
Very rare (occurs in less than 1 in 10,000 patients receiving this medicine):
Oculogyric crisis (a convulsive condition of the eyes in which the eyeballs become
fixed, normally upwards), especially in children, accommodation disorder (difficulty
focussing the eye), blurred vision, thrombocytopenia (low levels of blood platelets
leading to an increased tendency to bleed or bruise more easily than normal), tic,
urinary disorders such as painful or difficult urination, inability to control the flow of
urine, and involuntary urination (bed wetting), fainting, tremor, dysgeusia (distortion
or decrease in the sense of taste), dystonia (unusual muscle tone causing distortion
of the body), dyskinesia (uncontrollable twitching, jerking or writhing movements).
Not known (frequency cannot be estimated from the available data):
Amnesia (memory loss), memory impairment, vertigo, increased appetite, urinary
retention.
In very rare cases people have thoughts about committing suicide and if you feel this
way then stop taking these tablets and see your doctor.
If any of the side effects gets 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
medicine.

5. How to store AllerTek 10mg Tablets
Do not store above 25°C. Store in the original package.
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 carton and on
the blister after ‘Exp:’. 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 environment.

6. Contents of the pack and other information
What AllerTek 10mg Tablets contain
The active substance is cetirizine dihydrochloride. One tablet contains 10 mg.
The other ingredients are:
Tablet core:
Lactose monohydrate,
Microcristalline cellulose,
Colloida anhydrous silica,
Magnesium stearate.
Tablet coat:
Titanium dioxide (E171),
Hypromellose,
Macrogol 400.
What AllerTek 10mg Tablets look like and contents of the pack
White to off-white film-coated tablets, with a break-line on one side.
Blister packs containing 7 or 14 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89070 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany.
This leaflet was last revised in July 2015.

REG0070190

Version 3.3

Approved

20239-F

Page 2 of 3

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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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