ZIRTEC ORAL DROPS 10 mg/ 20 ml

ZIRTEK solution 10 mg / ml x 20 ml.
Leaflet: information for the user
Zyrtec 10 mg/ml oral drops, solution Zyrfec 10 mg/ml oral drops, solution
Cetirizine dihydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.
If you need any further information or advice, ask your pharmacist. If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

If you do not feel better after 3 days or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Zyrtec is and what it is used for
2. What you need to know before you take Zyrtec
3. How to take Zyrtec
4. Possible side effects
5. How to store Zyrtec
6. Contents of the pack and other information
1. What Zyrtec is and what it is used for
Zyrtec contains the active ingredient cetirizine dihydrochloride.
Zyrtec is an antiallergic medication.
Zyrtec 10 mg/ml oral drops, solution is indicated in adults and children aged 2 years and over:

for the relief of nasal and ocular symptoms associated with conjunctivitis in seasonal and perennial allergic rhinitis, for the relief of urticaria.

2. What you need to know before you take Zyrtec Do not take Zyrtec

if you have severe kidney impairment (severe renal failure and creatinine clearance below 10 ml/min);
if you are allergic to cetirizine dihydrochloride, to any of the other ingredients (listed in section b), to hydroxyzine or to other piperazine derivatives (similar active ingredients of other medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zyrtec.
If you have kidney failure, please ask your doctor for advice; if necessary, you will take a lower dose. Your doctor will determine the new dose. If you have problems urinating (such as problems with the spinal cord, prostate or bladder), please ask your doctor for advice.
If you have epilepsy or are at risk of convulsions, you should ask your doctor for advice.
No clinically significant interactions have been observed between alcohol (at a blood alcohol concentration of 0.5 ppm (g/l), corresponding to a glass of wine) and cetirizine used at recommended doses. There are no data available on the safety of higher doses of cetirizine and alcohol taken concomitantly. Therefore, as with all antihistamines, it is recommended to avoid taking Zyrtec with alcohol.
If you have a scheduled allergy test, ask your doctor about stopping Zyrtec for a few days before the test. This medicine may affect your allergy test results.
Other medicines and Zyrtec
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Zyrtec with food and drink
Food does not affect the absorption of Zyrtec.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before using this medicine.
The use of Zyrtec during pregnancy should be avoided.
Accidental use by pregnant women should not cause harm to the fetus, but the drug should still be used only when necessary and after consulting a doctor.
Cetirizine passes into breast milk. A risk of adverse reactions in nursing infants cannot be excluded.
Do not take Zyrtec while breastfeeding unless you have consulted a doctor.
Driving and using machines
Clinical trials have not shown any impairment of attention, alertness or driving ability after taking Zyrtec at the recommended dose. If you intend to drive, perform potentially hazardous activities or operate machinery, you should carefully monitor the effects of the drug after taking Zyrtec.
Do not exceed the recommended dose.
Zyrtec oral drops, solution contain methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).
3. How to take Zyrtec
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your pharmacist.
The drops should be poured into a spoon or diluted in water, and taken orally. Dilution should be carried out, taking into account, especially when administered to children, that the volume of water,
The following side effects are rare or very rare, but you should stop taking the medicine and tell your doctor as soon as you notice them:
 – Allergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes swelling of the face or throat).
These reactions may start immediately after you first take a medicine or later.
Common side effects (may affect up to 1 in 10 people)
 – Drowsiness
 – Dizziness, headache Pharyngitis, rhinitis (in children)
 – Diarrhea, nausea, dry mouth Fatigue
Uncommon side effects (may affect up to 1 in 100 people) Anxiety
 – Paresthesia (abnormal sensations on the skin)
 – Abdominal pain Itching, rash
 – Asthenia (complete exhaustion), malaise
Rare side effects (may affect up to 1 in 1,000 people)
 – Allergic reactions, some of which are severe (very rare)
 – Depression, hallucinations, aggression, confusion, insomnia Convulsions
 – Tachycardia (rapid heartbeat)
 – Impaired liver function
 – Urticaria
 – Edema (swelling)
 – Weight gain
Very rare side effects (may affect up to 1 in 10,000 patients)
 – Thrombocytopenia (low levels of platelets in the blood)
 – Tics (acquired spasm)
 – Syncope, dyskinesia (involuntary movements), dystonia (abnormally prolonged muscle contractions), tremor, diegeusia (altered taste)
 – Blurred vision, accommodation disorder, oculogyration (uncontrolled circular eye movements)
 – Angioedema (severe allergic reaction that causes swelling of the face or throat), fixed drug rash.
 – Pathological urine output (nocturnal urination, pain and/or difficulty urinating)
Side effects with unknown frequency (frequency cannot be estimated from the available data)
 – Increased appetite
 – Suicidal ideation (recurrent thoughts or ideas about suicide), nightmares
 – Amnesia, memory impairment
 – Vertigo (sensation of spinning or movement)
 – Urinary retention (inability to completely empty the bladder)
 – Pruritus (severe itching) and/or urticaria after stopping the medication
 – Joint pain
 – Rash with blisters containing pus
 – Hepatitis (liver inflammation)
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
Executive Agency for Medicines
8 Damyan Gruev Street
1303 Sofia
Tel.:+35 928903417
website: www.bda.bg
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store Zyrtec
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
Do not use more than 3 months after first opening the bottle.
This medicine does not require any special storage conditions.
6. Contents of the pack and other information
What Zyrtec contains
 – The active substance is: cetirizine dihydrochloride. One ml (equivalent to 20 drops) contains 10 mg cetirizine dihydrochloride. One drop contains 0.5 mg cetirizine dihydrochloride.
 – The other ingredients are: glycerol, propylene glycol, saccharin sodium, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium acetate, glacial acetic acid, purified water.
What Zyrtec looks like and contents of the pack
Zyrtec is a clear and colorless liquid.
The packaging is a bottle containing volumes of 10, 15 or 20 ml.
Not all types of packaging can be released for sale.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
UCB Pharma GmbH, Germany Manufacturer:
Aesica Pharmaceuticals Srl, Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UCB Bulgaria EOOD,
tel.: (02) 962 30 49