Zyrtec contains active ingredient: cetirizine. Cetirizine belongs to a group of anti-allergic medicines called antihistamines.

Zyrtec is used to treat symptoms associated with allergic conditions, such as:

• nasal and ocular symptoms of seasonal and perennial allergic rhinitis,
• itchy rashes 

Do not take Zyrtec:

·       if you are allergic (hypersensitive) to cetirizine, hydroxyzine, any piperazine derivatives (closely related active ingredients of other medicines), or to any other ingredients of Zyrtec (listed in Section 6)

·       if you have severe kidney disease (severe impairment of kidney function with estimated GFR below 15ml/min)

·       if you use other antiallergic medicines

 If you think any of these apply to you, don’t take Zyrtec until you have checked with your doctor.

Take special care with Zyrtec

Talk to your doctor or pharmacist before using Zyrtec:

·       if you have kidney problems (your doctor may lower your dose of Zyrtec)

·       if you have difficulty passing urine or you have conditions that make you more likely to be unable to empty your bladder, such as spinal cord injury or enlarged prostate

·       if you have epilepsy or you are at risk of convulsions (fits)

·       if you are pregnant of breast-feeding (see Pregnancy and breast-feeding later in Section 2)

 Check with your doctor if you think any of these may apply to you.

Zyrtec film-coated tablets are not recommended for children under 6 years, as this formulation does not allow for appropriate dose adaptation.

While you are taking Zyrtec

·       Avoid alcohol while you are taking Zyrtec.

·       Zyrtec may affect your allergy test results. If you are scheduled for allergy testing, ask your doctor if you should stop taking Zyrtec for several days before testing.

·       Contact your doctor if you have high temperature (fever), shivering or chills, as you may require other type of treatment.

Conditions you need to look out for

Zyrtec can make some existing conditions worse, or cause severe allergic reactions or urinary retention. Some people may have suicidal thoughts when taking Zyrtec. You must look out for certain symptoms while you are taking Zyrtec, to reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.

Other medicines and Zyrtec

Tell your doctor or pharmacist if you're taking any other medicines, if you’ve taken any recently, or if you start taking new ones. This includes medicines bought without a prescription.

Some medicines may affect how Zyrtec works, or make it more likely that you’ll have side effects. Zyrtec can also affect how some other medicines work. These include:

·       medicines acting on the brain, for example other antihistamines such as hydroxizine, clemastine, medicines used to treat anxiety such as diazepam or sleeping pills such as zolpidem (concurrent administration of Zyrtec with other agents acting on the brain may cause additional reductions in alertness and impairment of performance, see ‘Food and drink with Zyrtec’ later in Section 2).

   Tell your doctor or pharmacist if you are taking any of these.

Food and drink with Zyrtec

Avoid alcohol when you are taking Zyrtec. In sensitive patients, the concurrent administration of Zyrtec and alcohol may cause additional reductions in alertness and impairment of performance.

Pregnancy and breast-feeding

Zyrtec should be avoided in pregnant women.

·       Tell your doctor if you are pregnant or planning to become pregnant.

·       If you do become pregnant during treatment with Zyrtec, tell your doctor.

The ingredients in Zyrtec can pass into breast milk. If you are breast-feeding, you must check with your doctor before you take Zyrtec.

Driving and using machines

Zyrtec at the recommended dose is unlikely to affect your ability to drive or use machines. However, some patients being treated with Zyrtec may feel drowsy, tired or weak (see ‘Possible side effects’ in Section 4).

è  Don’t drive or use machines unless you are sure you’re not affected.

How much to take

Always take Zyrtec exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Don’t take more than the recommended dose

Don’t take Zyrtec for longer than 7 days, without advice of your doctor or pharmacist.

è Contact your doctor if your symptoms worsen or do not improve after 3 days.

Adults and adolescents above 12 years old

Zyrtec 10 mg film-coated tablets

The usual dose of Zyrtec is one 10 mg tablet, once a day.

Children between 6 and 12 years old

Zyrtec 10 mg film-coated tablet

The usual dose of Zyrtec is half tablet (5 mg) twice a day.

Children between 2 and 6 years old

Zyrtec film-coated tablets are not recommended for children under 6 years, as this formulation does not allow for appropriate dose adaptation.

Patients with kidney and liver disease:

Your doctor will decide on the correct dose of Zyrtec depending on the illness and the results of blood tests carried out before treatment. Patients who have end stage impairment of kidney function must not take Zyrtec (see ‘Don’t take Zyrtec’, in section 2).

If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly.

How to take

Zyrtec 10 mg film-coated tablets

Swallow the tablet whole, with a glass of water. You can divide the tablet into two equal doses.

If you forget to take Zyrtec

Don't take an extra dose to make up for a missed dose. Just take your next dose at the usual time.

è If you are not sure what to do, ask your doctor or pharmacist.

If you take too much Zyrtec

If you take too much Zyrtec, contact your doctor or pharmacist for advice. If possible, show them the Zyrtec pack.

If you take too much Zyrtec you may be more likely to have side effects such as: confusion, diarrhoea, dizziness, tiredness, headache, malaise, dilating of pupil, itching, restlessness, sedation, somnolence (feeling drowsy), stupor, abnormal rapid heart rate, tremor, urinary retention.

If you stop taking Zyrtec

Rarely, pruritus (intense itching) and/or urticaria may occur if you stop taking Zyrtec.

Like all medicines, Zyrtec can cause side effects, but not everybody gets them

Conditions you need to look out for:

Severe allergic reactions. Signs include:

•        raised and itchy rash (hives)

•        swelling, sometimes of the face or mouth (angioedema), causing difficulty in swallowing or breathing

•        collapse or loss of consciousness

Urinary retention. Signs include:

•        pain when passing urine or inability to pass urine

Suicidal thoughts. Some people had suicidal thoughts when taking Zyrtec.

è Contact a doctor immediately if you get these symptoms. Stop taking Zyrtec.

Common side effects

These may affect up to 1 in 10 people:

• Somnolence (sleepiness)
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhoea (in children), nausea, dry mouth
• Fatigue

Uncommon side effects

These may affect up to 1 in 100 people:

• Agitation
• Paraesthesia (tingling or numbness of the hands or feet)
• Diarrhoea
• Stomach pain
• Pruritus (itching), rash
• Asthenia (unusual weakness), malaise

Rare side effects

These may affect up to 1 in 1,000 people:

• Hypersensitivity
• Aggression, confusion, depression, hallucination, insomnia (sleeplessness)
• Convulsions
• Tachycardia (fast heart beat)
• Liver function abnormal (reflected in the blood tests)
• Urticaria
• Oedema (swelling)

• Increased weight

Very rare side effects

These may affect up to 1 in 10,000 people:

• Thrombocytopenia (low blood platelets count)
• Anaphylactic shock (see ‘Severe allergic reactions’ earlier in section 4)
• Tics (uncontrolled body movement)
• Dysgeusia (taste disturbance or loss of taste), dyskinesia (uncontrollable movements), dystonia (uncontrolled muscle spasm), syncope (fainting), tremor
• Accommodation disorder (difficulty focusing), blurred vision, oculogyration (eyes having uncontrolled circular movements)
• Angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption
• Dysuria (pain when passing urine) (see ‘Urinary retention’ earlier in section 4), enuresis (bed wetting)

Other side effects

Have occurred but their exact frequency is unknown:

• Increased appetite
• Suicidal ideation (see ‘Suicidal thoughts’ earlier in section 4), nightmare
• Amnesia, memory impairment
• Vertigo (spinning sensation)
• Inflammation of the liver
• Urinary retention (difficulty passing urine) (see ‘Urinary retention’ earlier in section 4)
• Joint pain
• Rash with blisters containing pus
• Intense itching (pruritus) upon discontinuation.

è   Tell your doctor or pharmacist if any of the side effects listed becomes severe or troublesome, or if you notice side effects not listed in this leaflet.

·         Keep out of the reach and sight of children.

·         Do not use Zyrtec after the expiry date which is stated on the pack after ‘Exp’.

·         Store Zyrtec at below 30 ⁰C in dry place.

·         If your doctor tells you to stop taking Zyrtec, it is important to return any remnants which are left over to your pharmacist.

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.