Xyzal Levocetirizine dihydrochloride 5 mg Film-Coated Tablets

The active ingredient, levocetirizine dihydrochloride, is an antihistamine for systemic use. It is used for the treatment of signs of illness (symptoms) associated with:

• allergic rhinitis (including persistent allergic rhinitis)
• chronic nettle rash of unknown origin (chronic idiopathic urticaria).

Do not take XYZAL:

• if you or your child are hypersensitive (allergic) to levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or any other substances with a similar chemical structure or to one of the other ingredients of XYZAL (listed in section 6 ‘What XYZAL contains’)
• if you or your child have a severe impairment of kidney function.

Warnings and precautions:

Take special care if you have predisposing factors of urinary retention (inability to completely empty your bladder) (e.g. spinal cord lesions, prostatic hyperplasia (enlarged prostate)) as XYZAL may increase the risk of urinary retention. Tell your doctor if you have a history of epilepsy (seizures/fits/convulsions). Pruritus (intense itching) and/or urticaria may occur if you stop taking XYZAL. XYZAL may affect your allergy test results. If you are scheduled for allergy testing, ask your doctor if you should stop taking XYZAL for several days before testing.

Children and adolescents:

XYZAL Oral Solution is not indicated for use in children under 2 years. The use of XYZAL tablets is not recommended in children under 6 years of age.

Other medicines and XYZAL:

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Tell your doctor if you are using:

• theophylline (used to treat respiratory diseases such as asthma)
• ritonavir (used to treat HIV/AIDS)
• 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 XYZAL with other medicines acting on the brain may cause additional reductions in alertness and impairment of performance).

XYZAL with food and alcohol:

You may take XYZAL with or without food. XYZAL film-coated tablets should be taken with liquid. Caution is advised if XYZAL is taken at the same time as alcohol. In sensitive patients, the simultaneous use of XYZAL and alcohol or agents affecting the central nervous system may have effects on alertness, impairment of performance and ability to drive and use machines.

Pregnancy and breastfeeding:

It is not recommended to use XYZAL if you are pregnant or breastfeeding your baby. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking XYZAL.

Always take XYZAL 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. The usual dose is:

Adults or children aged 6 years and older:

• XYZAL film-coated tablets: The daily recommended dose is one tablet. The tablets should be swallowed whole with water and may be taken with or without food.
• XYZAL ORAL SOLUTION: The daily recommended dose is 10 mL (2 medicine measurefuls) once daily.

Children from the age of 2 to 6 years:

• XYZAL ORAL SOLUTION: 2,5 mL solution twice daily. The administration of XYZAL to infants and toddlers aged less than 2 years is not recommended.

If you have the impression that the effect of XYZAL is too strong or too weak, talk to your doctor or pharmacist.

Instruction for use of XYZAL ORAL SOLUTION:

For oral use only. A dosing syringe is supplied with the pack (see diagram for how to use). The solution can be taken undiluted or diluted in a glass of water. XYZAL can be taken with or without food.

Handling of the dosing syringe: Dip the dosing syringe into the bottle and draw the plunger up to the mark which corresponds to the dose in milliliters (mL) prescribed by your doctor. For use in children below 6 years of age, the daily dose of 5 mL is measured by removing 2,5 mL of solution from the bottle twice daily (please cautiously refer to the syringe graduation). Remove the dosing pipette from the bottle and empty its contents into a spoon or into a glass of water by pressing the plunger down. The oral intake of the medicine should be performed right after dilution.

Rinse the plunger with water after every use.

If you take more XYZAL than you should: If you take more XYZAL than you should, drowsiness can occur in adults. Children may initially show excitation and restlessness followed by drowsiness. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison centre.

If you forget to take XYZAL: Do not take a double dose to make up for forgotten individual doses, just continue taking the amounts stated in the dosage instructions.

Effects when treatment with XYZAL is stopped: Stopping treatment with XYZAL earlier than foreseen should have no detrimental effects.

XYZAL can have side effects. Not all side effects reported for XYZAL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking XYZAL, please consult your doctor, pharmacist or health care provider for advice.

If the following happens, stop taking XYZAL and tell your doctor immediately, or go to the casualty department at your nearest hospital:

• swelling of the mouth, tongue, face and/or throat, which may cause breathing or swallowing difficulties
• rash or itching
• sudden fall in blood pressure leading to collapse or shock, which may be fatal.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to XYZAL. You may need urgent medical attention or hospitalisation.

Other side effects include:

Frequent side effects:

• dry mouth
• headache
• tiredness and somnolence/drowsiness
• diarrhoea and constipation (in children).

Less frequent side effects:

• exhaustion
• abdominal pain
• nausea and vomiting.

Side effects – frequency unknown:

• fits (seizures), tingling or numbness of the hands or feet, dizziness, fainting, tremor, taste disturbance
• visual disturbances, blurred vision, oculogyration (eyes having uncontrolled circular movements)
• spinning sensation
• irregular heartbeat, seizures, visual disturbances, fainting, tremor, abnormal taste, dizziness
• swelling, pruritus (itchiness), rash, urticaria (swelling, redness and itchiness of the skin)
• shortness of breath, weight increase, appetite increase, muscular pain, aggressive or agitated behavior, insomnia, thoughts of suicide, nightmares
• liver inflammation, abnormal liver function
• small patches of swelling and redness of the skin, which may blister
• itching, rash
• intense itching (pruritus) upon discontinuation.
• joint pain
• painful urination, inability to empty bladder
• swelling caused by fluid.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of XYZAL.

Store all medicines out of reach of children. Store at or below 30 °C. Protect XYZAL tablets from moisture. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems e.g. toilets.