Zenaro 5mg 7 Tablets
ZENARO 5 MG
1. What Zenaro is and what it is used for
Zenaro contains levocetirizine dihydrochloride, which belongs to the group of antihistamines and is used to treat the symptoms associated with:
-allergic rhinitis, including chronic allergic rhinitis,
-hives (skin swelling, redness and burning).
The product is for adults and children over 6 years of age.
2. What you need to know before taking Zenaro
Do not take Zenaro:
if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of this medicine (listed in section 6).
if you have severe kidney function impairment (severe kidney failure with creatinine clearance below 10 ml / min).
Warnings and precautions
Talk to your doctor or pharmacist before taking Zenaro if you have difficulty emptying your bladder (due to spinal cord injury or an enlarged prostate).
Zenaro use is not recommended in children under 6 years of age as film-coated tablets do not give an opportunity for dose adjustment.
Other medicines and Zenaro
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Zenaro with food, drinks and alcohol
Caution is advised if Zenaro is taken concomitantly with alcohol or other agents acting on the brain. In sensitive patients, coadministration of Zenaro and alcohol or other agents acting on the brain may result in decreased alertness and impaired ability to work.
Zenaro can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and operating machines
Some patients treated with Zenaro may experience drowsiness, fatigue and exhaustion. Be careful when driving or operating machines until you know how this medicine works. However, special tests in healthy volunteers have shown that there is no disturbance in concentration, alertness, the ability to respond or drive after the use of levocetirizine at the recommended doses.
Zenaro contains lactose monohydrate.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
3. How to take Zenaro
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Posology: The recommended dose in adults and children over 6 years of age is 1 film-coated tablet per day.
Special dosing instructions
Patients with impaired renal function may take a lower dose according to the severity of the kidney disease, and in children the dose depends on their body weight; the dose will be determined by your doctor.
Patients with serious kidney problems should not take Zenaro.
Patients who have impaired liver function should take the usual prescribed dose.
Patients who have both impaired renal and hepatic function may receive the lowest dose, depending on the severity of the kidney disease, and in children the dose will also be determined on the basis of body weight; the dose will be determined by your doctor.
Zenaro is not recommended for use in children below 6 years of age.
No dosage adjustment is necessary in elderly patients if their kidney function is not impaired.
You should contact a doctor if your symptoms get worse or do not improve after 3 days, or if any of the side effects gets serious, or if you notice any other side effects listed in this leaflet.
The tablets should be swallowed whole with water and can be taken with or without food.
How long to take Zenaro
The length of treatment depends on the type, duration and appearance of your complaints and is determined by your doctor.
If you take more Zenaro than you should
If you take more than you should, you may experience drowsiness (in adults). In children this can be preceded by excitement and anxiety and followed by drowsiness.
If you think you have taken a higher dose of Zenaro, tell your doctor who will decide what measures to take, if any.
If you forget to take Zenaro
If you forget to take Zenaro or take a lower dose than prescribed, do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you stop taking Zenaro
Stopping treatment with Zenaro earlier than expected will not harm you.
Disease complaints can recur but are lighter than those prior to treatment with Zenaro.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking the medicine and seek immediate medical attention at the first signs of hypersensitivity (allergic) to Zenaro. Symptoms of hypersensitivity include: swelling of the mouth, face and / or throat, or difficulty swallowing along with skin reactions such as local redness, swelling and itching, difficulty breathing, sudden lowering of blood pressure, resulting in collapse or shock; can be fatal.
The following side effects have been reported during treatment with levocetirizine (the active ingredient of the product):
Common (may affect up to 1 in 10 people):
Dry mouth, fatigue, headache, drowsiness.
Uncommon (may affect up to 1 in 100 people):
Exhaustion, abdominal pain.
Not known (can not be estimated from the available data):
Palpitation, painful or difficulty in passing urine, inability to empty the bladder completely , swelling, itching, rash, urticaria (swelling, redness and itching of the skin), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive behavior or agitation, hallucinations, depression, insomnia, frequent thoughts of suicide, hepatitis, impaired liver function, vomiting, increased appetite, nausea and diarrhea.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly by:
As you report side effects, you can contribute to gathering more information on the safety of this medicine.
5. How to store Zenaro
Keep out of the reach and sight of children.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the pack after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewage system or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Package Contents and Additional Information
What Zenaro contains
The active substance is levocetirizine dihydrochloride 5 mg in each film-coated tablet.
The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycollate (type A), colloidal anhydrous silica, magnesium stearate, hypromellose 2910/5, macrogol 6000, talc, titanium dioxide (E171).
What Zenaro looks like and contents of the pack
Zenaro are off-white, oblong, biconvex, film-coated tablets with an embossed "e" on one side.
1 or 4 blisters, each containing 7 film-coated tablets