Cetirizine 10 mg film-coated tablets

(Cetirizine hydrochloride)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Cetirizine 10 mg Tablets 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 side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctoror pharmacist.

In this leaflet:

  1. What Cetirizine 10 mg Tablets are and what they are used for
  2. Before you take Cetirizine 10 mg Tablets
  3. How to take Cetirizine 10 mg Tablets
  4. Possible side effects
  5. How to store Cetirizine 10 mg Tablets
  6. Further information

1. WHAT CETIRIZINE 10 MG TABLETS ARE AND WHAT THEY ARE USED FOR

Cetirizine hydrochloride is the active ingredient of Cetirizine 10 mg Tablets.

Cetirizine 10 mg Tablets is an antiallergic medication.

In adults and children aged 6 year and above, Cetirizine 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. BEFORE YOU TAKE CETIRIZINE 10 MG TABLETS

Do not take Cetirizine 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 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 (closely related active substances of other medicines).
  • if you are known to be allergic (hypersensitive) to drugs from the piperazine family, for example buclizine, cyclizine, meclozine, levocetirizine.

You should not take Cetirizine 10 mg Tablets:

  • if you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains lactose).

Take special care with Cetirizine 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.

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.

Due to the profile of cetirizine, no interactions with other drugs are expected.

Taking Cetirizine 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

Ask your doctor for advice before taking any medicine.

As with other drugs, use of Cetirizine 10 mg Tablets should be avoided by pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the administration of the medicine should be discontinued.

You should not take Cetirizine 10 mg Tablets during breast-feeding because cetirizine passes into breast milk.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine 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.

Important information about some of the ingredients of Cetirizine 10 mg Tablets

Cetirizine 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.

Allergy skin test

If you are going to have an allergy skin test stop taking Cetirizine 10 mg Tablets for three days before the test.

3. HOW TO TAKE CETIRIZINE 10 MG TABLETS

How and when should you take Cetirizine 10 mg Tablets?

These guidelines apply unless your doctor has given you different instructions on how to use Cetirizine 10 mg Tablets.

Please follow these instructions, otherwise Cetirizine 10 mg Tablets may not be fully effective.

Tablets need to be swallowed with a glass of liquid.

Adults and adolescents above 12 years old:

10 mg once daily as one tablet.

Children between 6 and 12 years old:

5 mg twice daily as half a tablet.

Patients with kidney problems:

Patients with moderate renal impairment are recommended to take 5 mg once daily as a half tablet.

If you feel that the effect of Cetirizine 10 mg Tablets is too weak or too strong, please consult your doctor.

If you take more Cetirizine 10 mg Tablets than you should

If you think you have taken an overdose of Cetirizine 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 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 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 10 mg Tablets can cause side effects, although not everybody gets them.

The following side effects have been reported in post marketing experience. The frequencies are defined as such: (common: 1 patient out of 100 to less than 1 out of 10, uncommon: 1 out of 1,000 to less than 1 out of 100, rare: 1 out of 10,000 to less than 1 out of 1,000, very rare: less than 1 out of 10,000, not known: cannot be estimated from the available data).

  • Blood and lymphatic disorder: very rare: thrombocytopenia (low levels of blood platelets)
  • Body as a whole: common: fatigue
  • Cardiac disorders: rare: tachycardia (heart beating fast)
  • Eye disorders: very rare: accommodation disorder (impaired ability of the eye to focus), blurred vision, oculogyration (eyes moving in an uncontrolled circular manner)
  • Gastro-intestinal disorders: common: dry mouth, nausea (feeling sick), diarrhoea uncommon: abdominal pain
  • General disorders and administration site conditions: uncommon: asthenia (feeling of weakness), malaise (feeling of being generally unwell) rare: oedema (swelling)
  • Immune system disorders: rare: allergic reactions, some severe (very rare)
  • Hepatobiliary disorders: rare: liver function abnormal
  • Investigations: rare: weight increased
  • Nervous system disorders: common: dizziness, headache uncommon: paraesthesia (abnormal feelings of the skin) rare: convulsions, movements disorders very rare: syncope (fainting), tremor, dysgeusia (altered taste) frequency not known: loss of memory, memory impairment
  • Psychiatric disorders: common: somnolence (sleepiness) uncommon: agitation rare: aggression, confusion, depression, hallucination, insomnia (difficulty in sleeping) very rare: tics (sudden abnormal repetitive muscle movement)
  • Renal and urinary disorders: very rare: abnormal elimination of urine
  • Respiratory system disorders: common: pharyngitis (sore throat), rhinitis (swelling and irritation inside the nose)
  • Skin and subcutaneous tissue disorders: uncommon: pruritus (itching), rash rare: urticaria (swelling, redness and itchiness of the skin) very rare: oedema (swelling), fixed drug eruption

If you develop one of the side effects described above, please inform your doctor. At the first signs of an allergic (hypersensitivity) reaction, stop taking Cetirizine 10 mg Tablets and contact your doctor immediately. Symptoms of an allergic (hypersensitivity) reaction include difficulty breathing, swelling of the face, neck, tongue or throat. 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.

5. HOW TO STORE CETIRIZINE 10 MG TABLETS

Keep out of the reach and sight of children.

Do not use Cetirizine 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. FURTHER INFORMATION

What Cetirizine 10 mg Tablets contain

  • The active substance of Cetirizine 10 mg Tablets is cetirizine hydrochloride. One film-coated 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 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, 10 or 30 tablets in a pack.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK.

This leaflet was last revised in May 2012.

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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