Zyrtec 10 mg/ml oral solution drops
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Zyrtec 10 mg/ml oral drops solution
Cetirizine dihydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Zyrtec is and what it is used for
- What you need to know before taking Zyrtec
- How to take Zyrtec
- Possible side effects
- How to store Zyrtec
- Contents of the pack and other information
1. What Zyrtec is and what it is used for
The active substance of Zyrtec is cetirizine dihydrochloride.
Zyrtec is an antiallergic medicinal product.
Zyrtec 10 mg/ml oral drops solution is indicated in adults and pediatric patients from 2 years of age:
- for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
- for the relief of urticaria.
2. What you need to know before starting to take Zyrtec
Do not take Zyrtec
- if you have severe kidney disease (requiring dialysis);
- if you are allergic to cetirizine dihydrochloride, or to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances closely related to other medicines).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Zyrtec.
If you are a patient with renal insufficiency, consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.
If you have difficulty urinating (such as spinal cord disorders, prostate problems, or bladder issues), please consult your doctor.
If you are an epileptic patient or a patient at risk of seizures, consult your doctor.
No clinically significant interactions have been observed between alcohol (with a blood level of 0.5 per mille (g/l), equivalent to one glass of wine) and cetirizine at the recommended dose. However, safety data are not available when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking Zyrtec with alcohol.
If you are scheduled to undergo an allergy test, consult your doctor about whether you should stop taking Zyrtec a few days before the test. This medicine may affect the results of your allergy tests.
Other medicines and Zyrtec
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Zyrtec with food, drinks, and alcohol
Food does not affect the absorption of Zyrtec.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of Zyrtec should be avoided in pregnant women. Accidental use of the medicine in pregnant women is not expected to cause harmful effects on the fetus. However, the medicine should only be administered if necessary and after consultation with a doctor.
Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take Zyrtec during breastfeeding unless advised by your doctor.
Driving and using machines
Clinical studies have not shown evidence that Zyrtec causes impairment of attention, reduced reaction capacity, or impaired driving ability at the recommended dose.
If you intend to drive, perform potentially hazardous activities, or operate machinery, do not exceed the recommended dose. You should closely monitor your response to the medicine.
Zyrtec 10 mg/ml oral solution drops contain methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), propylene glycol (E 1520), and sodium
This medicine contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).
This medicine contains 350 mg of propylene glycol (E 1520) in each ml.
This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially "sodium-free".
3. How to take Zyrtec
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor again.
The drops should be dispensed into a spoon or diluted in water, and taken orally. If used diluted, especially when administering to children, consider the volume of water in which the drops are added, to ensure it matches the amount of liquid the patient can ingest. The diluted solution should be taken immediately.
When counting the drops, hold the bottle vertically (upside down). If no drops come out and the required number of drops has not been dispensed, turn the bottle upright, then hold it upside down again and continue counting the drops.
Adults and adolescents aged 12 years and older:
The recommended dose is 10 mg once daily, equivalent to 20 drops.
Use in children between 6 and 12 years of age:
The recommended dose is 5 mg twice daily, equivalent to 10 drops twice daily.
Use in children between 2 and 6 years of age:
The recommended dose is 2.5 mg twice daily, administered as 5 drops twice daily.
Patients with renal impairment:
Patients with moderate renal impairment are advised to take 5 mg (10 drops) once daily.
If you have severe renal disease, please contact your doctor, who may appropriately adjust the dose.
If your child has renal disease, please contact your doctor, who may adjust the dose according to your child's needs.
If you notice that the effect of Zyrtec is too weak or too strong, consult your doctor.
Duration of treatment:
The duration of treatment depends on the type, duration, and course of your symptoms and will be determined by your doctor.
If you take more Zyrtec than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Poison Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
After an overdose, the adverse effects described below may occur with increased intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, tingling, irritation, sedation, somnolence (drowsiness), stupor, abnormal tachycardia, tremor, and urinary retention (difficulty completely emptying the bladder).
If you forget to take Zyrtec
Do not take a double dose to make up for the missed dose.
If you stop taking Zyrtec
In rare cases, pruritus (intense itching) and/or urticaria (hives) may reappear if you stop taking Zyrtec.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects are rare or very rare, but you must stop taking the medicine and tell your doctor immediately if you notice any of them:
- Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat).
These reactions may start soon after first taking the medicine, or may begin later.
The frequency of the possible adverse effects listed below is defined as follows:
Frequent adverse effects (may affect up to 1 in 10 patients)
- Somnolence (drowsiness)
- Dizziness, headache
- Pharyngitis (sore throat), rhinitis (runny nose, nasal congestion) (in children)
- Diarrhea, nausea, dry mouth
- Fatigue
Uncommon adverse effects (may affect up to 1 in 100 patients)
- Agitation
- Paresthesia (abnormal sensation of the skin)
- Abdominal pain
- Pruritus (itching), rash
- Asthenia (extreme fatigue), malaise (feeling unwell)
Rare adverse effects (may affect up to 1 in 1,000 patients)
- Allergic reactions, some severe (very rare)
- Depression, hallucination, aggression, confusion, insomnia
- Seizures
- Tachycardia (heart beating too fast)
- Abnormal liver function
- Urticaria (hives)
- Edema (swelling)
- Weight gain
Very rare adverse effects (may affect up to 1 in 10,000 patients)
- Thrombocytopenia (low platelet levels in blood)
- Tics (spasms)
- Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disturbance)
- Blurred vision, accommodation disorders (difficulty focusing vision), oculogyric crisis (eyes have uncontrolled circular movement)
- Angioedema (severe allergic reaction causing swelling of the face or throat), drug rash (drug allergy)
- Difficulty or lack of control when urinating (bedwetting, pain and/or difficulty urinating)
Adverse effects with unknown frequency (frequency cannot be estimated from available data)
- Increased appetite
- Suicidal thoughts (recurrent thoughts or obsession with suicide), nightmares
- Amnesia (memory loss), memory impairment
- Dizziness (sensation of spinning or movement)
- Urinary retention (inability to completely empty the urinary bladder)
- Pruritus (intense itching) and/or urticaria after discontinuation of treatment
- Arthralgia (joint pain), myalgia (muscle pain)
- Generalized pustular exanthema (rash with pus-filled blisters)
- Hepatitis (inflammation of the liver)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Zyrtec
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and bottle after EXP. The expiry date is the last day of the month indicated.
Do not use more than 3 months after first opening the container.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Pack contents and other information
Composition of Zyrtec
- The active substance is cetirizine dihydrochloride. One ml (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
- The other components are glycerol (E 422), propylene glycol (E 1520), sodium saccharin, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), sodium acetate, glacial acetic acid, purified water.
Appearance of the product and contents of the pack
Zyrtec is supplied as a clear, colourless liquid.
Original pack containing a bottle of 10, 15, or 20 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
UCB Pharma, S.A.
Plaza de Manuel Gómez Moreno, s/n,
Edificio Bronce, Planta 5,
28020 Madrid
Spain
Manufacturer
Aesica Pharmaceuticals S.r.l.
Via Praglia 15
I-10044 Pianezza (TO) – Italy
<Nextpharma SAS, 17 Route de Meulan, 78520 Limay, France.>
<UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom>
<Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ozarów Mazowiecki, Poland>
<ExtractumPharma Co. Ltd., 6413 Kunfehértó, IV. körzet 6., Hungary.>
<UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway>
<UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark>
<UCB Pharma SA Chemin Du Foriest 1, Braine-L'alleud, 1420, Belgium>
This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria: Zyrtec 10 mg/ml – Tropfen
Belgium: Zyrtec
Bulgaria: Zyrtec
Czech Republic: Zyrtec
Denmark: Zyrtec
Estonia: Zyrtec
Finland: Zyrtec
France: Zyrtec
Greece: Ziptek
Hungary: Zyrtec 10 mg/ml belsoleges oldatos cseppek
Ireland: Zirtek oral drops 10 mg/ml
Italy: Zirtec 10 mg/ml gocce orali soluzione
Latvia: Zyrtec
Lithuania: Zyrtec
Luxembourg: Zyrtec
Norway: Zyrtec
Poland: Zyrtec
Romania: Zyrtec
Slovakia: Zyrtec
Spain: Zyrtec 10 mg/ml oral drops solution
Date of the latest revision of this leaflet: 09/2023
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es