Regulatory Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE PTE LTD
Therapeutic
General Sale List
Formulation Information
SOLUTION
**How to take Zyrtec-R?** **How much to take** **Always take Zyrtec-R 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-R** 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. **_Zyrtec-R Film-Coated Tablet 10 mg_** **Children aged from 6 to 12 years:** Half of the tablet twice daily. **Adolescents 12 years and above, and adults:** 1 tablet once daily. Half of the tablet as a starting dose may be used if this leads to satisfactory control of the symptoms. Do not take more than one 10 mg tablet in 24 hours. Swallow the tablet whole, with a glass of water. You can divide the tablet into two equal doses. **Zyrtec-R film-coated tablets are not recommended for children under 6 years,** as the formulation does not allow for appropriate dose adaptation. _**Zyrtec-R Oral Solution 1 mg/mL**_ **Children aged from 2 to 6 years**: 2.5 mL oral solution (half of a spoon) twice daily. **Children aged from 6 to 12 years**: 5 mL oral solution (1 full spoon) twice daily. **Adolescents 12 years and above, and adults**: 10 mL of oral solution (2 full spoons) once daily. 5 mL oral solution (1 full spoon) starting dose may be used if this leads to satisfactory control of the symptoms. Do not take more than the recommended dose. **Zyrtec-R oral solution is not recommended for infants and children under 2 years**. A measuring spoon is supplied with the pack so you can measure your dose accurately. If you are not supplied with a measuring spoon, talk to your doctor or pharmacist. **Patients with kidney and liver disease:** Your doctor will decide on the correct dose of **Zyrtec-R** 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-R** (see “ _Don’t take **Zyrtec-R**_”). If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly.
ORAL
Medical Information
**What Zyrtec-R is and what it is used for** **Zyrtec-R** contains active ingredient: cetirizine dihydrochloride. Cetirizine belongs to a group of anti-allergic medicines called antihistamines. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions. **Zyrtec-R** is used to treat symptoms associated with allergic conditions, such as: - Runny, itchy nose - Sneezing - Watery, itchy eyes - Itchy skin rash
**Don’t take Zyrtec-R:** - If you are **allergic** ( _hypersensitive_) to cetirizine, hydroxyzine, any piperazine derivatives (closely related active ingredients of other medicines), or to any ingredients of **Zyrtec-R** (listed in section _What does **Zyrtec-R** contain_ – _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 less than 10 ml/min). - If you use other anti-allergy medicines. - If you are breastfeeding (see _Pregnancy and breast-feeding_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - If you have a rare galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (tablets). - If you have a rare fructose intolerance (oral solution). ➔ If you think any of these applies to you, **don’t take Zyrtec-R** until you have checked with your doctor or pharmacist.
Pending
xpending
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
AESICA PHARMACEUTICALS S.R.L
Active Ingredients
Documents
Patient Information Leaflets
Zyrtec PIL.pdf
Approved: January 12, 2023