Zyrtec 10 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Zyrtec 10 mg film-coated tablets
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 should not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 in Zyrtec is cetirizine dihydrochloride.
Zyrtec is an antiallergic medicinal product.
Zyrtec 10 mg film-coated tablets are indicated in adults and children aged 6 years and older for:
- relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
- relief of urticaria.
2. What you need to know before taking 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 components of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances closely related to other medicines).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Zyrtec.
If you are a patient with renal impairment, consult your doctor; if necessary, you will be given a lower dose. Your doctor will determine the new dose.
If you have difficulty urinating (such as due to spinal cord problems, or prostate, bladder issues), please consult your doctor.
If you are an epileptic patient or 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 for allergy testing, 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.
Zyrtec film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Children
Do not give this medicine to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.
Other medicines and Zyrtec
Tell 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 before using this medicine.
The use of Zyrtec should be avoided in pregnant women. Accidental use of the medicine during pregnancy 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 while breastfeeding unless advised by your doctor.
Driving and using machines
Clinical studies have not shown evidence that Zyrtec causes impairment of attention, reduced reaction ability, or affects driving performance at the recommended dose.
If you intend to drive, perform potentially hazardous activities, or operate machinery, you should not exceed the recommended dose. You should closely monitor your response to the medicine.
3. How to take Zyrtec
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The tablets must be swallowed with a glass of liquid.
The tablets can be divided into two equal doses.
Adults and adolescents over 12 years of age:
The recommended dose is 10 mg once daily as 1 tablet.
Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.
Use in children aged 6 to 12 years:
The recommended dose is 5 mg twice daily, as half a tablet twice daily.
Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.
Patients with renal impairment:
Patients with moderate renal impairment are advised to take 5 mg once daily.
If you have severe kidney disease, please contact your doctor, who can appropriately adjust the dose.
If your child has kidney disease, please contact your doctor, who can 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 Toxicology Information Service at phone number: 91 562 04 20, indicating the medicine and the amount ingested.
After an overdose, the adverse effects described below may occur with greater intensity. Adverse effects reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, tingling, irritation, sedation, somnolence (drowsiness), stupor, abnormally increased heart rate, 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 forgotten 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 begin soon after taking the medicine for the first time, or they 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 skin sensation)
- 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 contractions), tremor, dysgeusia (taste disturbance)
- Blurred vision, accommodation disorders (difficulty focusing vision), oculogyric crisis (eyes have uncontrolled circular movements)
- 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 frequency not known (frequency cannot be estimated from available data)
- Increased appetite
- Suicidal thoughts (recurring thoughts or obsession with suicide), nightmares
- Amnesia (memory loss), memory impairment
- Vertigo (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 eruption (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 Medicines: 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.
No special storage conditions are required.
6. Contents of the pack and other information
Composition of Zyrtec
- The active substance is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
- The other components are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate, Opadry Y-1-7000 (hydroxypropylmethylcellulose (E 464), titanium dioxide (E 171), macrogol 400).
Appearance of the product and contents of the pack
Film-coated white, oblong, scored tablets with the logo Y-Y.
Pack sizes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
UCB Pharma, S.A.
Plaza de Manuel Gómez Moreno, s/n,
Edificio Bronce, planta 5
28020 Madrid
Spain
Manufacturers
Aesica Pharmaceuticals S.r.l.,
Via Praglia 15, I-10044
Pianezza (TO) – Italy
<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 B.V., Hoge Mosten 2 A1, 4822 NH, Breda, The Netherlands>
<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 authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Zyrtec 10 mg - Filmtabletten
Belgium: Zyrtec
Bulgaria: Zyrtec
Cyprus: Zyrtec
Czech Republic: Zyrtec
Denmark: Zyrtec
Estonia: Zyrtec
Finland: Zyrtec
France: Zyrtec
Germany: Zyrtec
Greece: Ziptek
Hungary: Zyrtec 10mg filmtabletta
Ireland: Zirtek tablets
Italy: Zirtec 10 mg compresse rivestite con film
Latvia: Zyrtec
Lithuania: Zyrtec
Luxembourg: Zyrtec
Malta: Zyrtec
Netherlands: Zyrtec
Norway: Zyrtec
Poland: Zyrtec
Portugal: Zyrtec
Slovakia: Zyrtec
Slovenia: Zyrtec 10 mg filmsko obložene tablete
Spain: Zyrtec 10 mg comprimidos recubiertos con película
United Kingdom (Northern Ireland): Zirtek allergy tablets
Date of the most recent 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