Regulatory Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE PTE LTD
Therapeutic
Pharmacy Only
Formulation Information
TABLET, FILM COATED
**3\. How to take Zyr-NEX** **How much to take** **Always take Zyr-NEX 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** Zyr-NEX for longer than **7 days**, without advice of your doctor or pharmacist. ➔**Contact your doctor** if your symptoms worsen or do not improve after 3 days. **Adults and adolescents 12 years and above** **_Zyr-NEX 5 mg film-coated tablet_** The usual dose of Zyr-NEX is one 5 mg tablet once a day. **Children** Always read the label to make sure the product is appropriate for your child’s age. **Children aged 6 to 12 years** **_Zyr-NEX 5 mg film-coated tablet_** The usual dose of Zyr-NEX is one 5 mg tablet, taken once a day. **Patients with kidney and liver disease** If you have kidney problems, you should talk to your doctor or pharmacist before taking Zyr-NEX. Your doctor will decide on the correct dose of Zyr-NEX depending on the illness and the results of blood tests carried out before treatment. Patients who have severe impairment of kidney function must not take Zyr-NEX (see ‘ _Don't take Zyr-NEX_’, in section 2). **How to take** **_Zyr-NEX film-coated tablets_** Swallow the tablet whole, with some water. Take Zyr-NEX once daily, with or without food. It is best to take Zyr-NEX at bedtime as it can make you feel drowsy. **If you forget to take Zyr-NEX** **Don't take an extra dose to make up for a missed dose.** Just take your next dose at the usual time. **If you take too much Zyr-NEX** If you take more Zyr-NEX than you should **contact your doctor or pharmacist for advice.** If possible, show them the Zyr-NEX pack. Symptoms of overdose in adults may include **drowsiness**. Children may initially show **agitation** and **restlessness**, followed by **drowsiness.** **If you stop taking Zyr-NEX** Rarely pruritus ( _intense itching_) may occur if you stop taking Zyr-NEX, even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
ORAL
Medical Information
**1\. What Zyr-NEX is and what it is used for** The active substance in Zyr-NEX is levocetirizine. Levocetirizine belongs to a group of antiallergic medicines called antihistamines. Zyr-NEX is used to treat symptoms such as sneezing, a runny nose and watery eyes associated with allergic rhinitis (including persistent allergic rhinitis). Zyr-NEX is also used to relieve the rashes and itching of chronic urticaria ( _hives_).
**2\. Before you take Zyr-NEX** **Don't take Zyr-NEX** - if you are **allergic** ( _hypersensitive_) to levocetirizine, cetirizine, hydroxyzine, any piperazine derivatives (closely related active substances of other medicines) or any other ingredients of Zyr-NEX (listed in Section 6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - if you have **severe kidney disease** (severe impairment of kidney function with creatinine clearance below 10 ml/min) - if you use other antiallergic medicines ➔If you think any of these apply to you, **don't take** Zyr-NEX until you have checked with your doctor.
R06AE09
levocetirizine
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
UCB FARCHIM S A
Active Ingredients
Documents
Patient Information Leaflets
1.4.4 Proposed ZyrNex Tablet PIL_NCDS07a(SI)_clean.pdf
Approved: October 19, 2020