Cetirizine Normon 10 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Cetirizina Normon 10 mg film-coated tablets EFG
cetirizine dihydrochloride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms, as it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Cetirizina Normon is and what it is used for
- What you need to know before taking Cetirizina Normon
- How to take Cetirizina Normon
- Possible side effects
- How to store Cetirizina Normon
- Contents of the pack and other information
1. What Cetirizina Normon is and what it is used for
The active substance of Cetirizina Normon is cetirizine dihydrochloride.
Cetirizina Normon is an antiallergic medicinal product.
Cetirizina Normon is indicated in adults and children from 6 years of age for:
- relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- relief of urticaria.
2. What you need to know before taking Cetirizina NORMON
Do not use Cetirizina NORMON
- if you have severe kidney disease (severe renal insufficiency with creatinine clearance below 10 ml/min);
- if you are allergic to cetirizine dihydrochloride, 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
Talk to your doctor or pharmacist before starting to use Cetirizina NORMON.
If you are a patient with renal insufficiency, consult your doctor; if necessary, you will be given a lower dose. Your doctor will determine the new dose.
If you have problems urinating (such as spinal cord, prostate, or bladder problems), 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 concomitant alcohol consumption during treatment.
If you are scheduled to undergo an allergy test, consult your doctor whether you should stop taking Cetirizina NORMON a few days before the test. This medicine may affect the results of your allergy tests.
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 Cetirizina NORMON
Inform your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicines.
Taking Cetirizina NORMON with food, drinks, and alcohol
Food does not affect the absorption of Cetirizina NORMON.
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 Cetirizina NORMON 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 consulting with your doctor.
Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take Cetirizina NORMON during breastfeeding unless advised by your doctor.
Driving and using machines
Clinical studies have not shown evidence that Cetirizina NORMON 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, you should not exceed the recommended dose. You should closely monitor your response to the medicine.
3. How to take Cetirizina Normon
Follow exactly the instructions for use of this medicine as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The tablets must be swallowed with a glass of liquid.
The tablet may 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.
Children between 6 and 12 years of age:
5 mg twice daily, as half a tablet twice daily.
Other pharmaceutical forms of this active ingredient may be more suitable for children: please ask your doctor or pharmacist.
Patients with renal impairment:
Patients with moderate renal impairment are recommended to take 5 mg once daily.
If you suffer from severe renal disease, please contact your doctor or pharmacist, who can appropriately adjust the dose.
If your child suffers from renal disease, please contact your doctor or pharmacist, who can adjust the dose according to your child's needs.
If you notice that the effect of cetirizine 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 Cetirizina Normon than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology 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 greater intensity. Adverse effects reported include confusion, diarrhea, 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 Cetirizina Normon
Do not take a double dose to make up for the missed dose.
If you stop taking Cetirizina Normon
In rare cases, pruritus (intense itching) and/or urticaria (hives) may reappear if you stop taking cetirizine.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Cetirizina Normon may 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 inform 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 occur shortly after first taking the medicine, or they may begin later.
Frequent adverse effects (may affect up to 1 in 10 patients)
- Somnolence (drowsiness)
- Dizziness, headache
- Pharyngitis, rhinitis (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 (skin itching), rash
- Asthenia (extreme fatigue), malaise
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, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disturbance)
- Blurred vision, accommodation disorders (difficulty focusing vision), ocular flutter (eyes have uncontrolled circular movement)
- Angioedema (severe allergic reaction causing swelling of the face or throat), drug-induced rash
- 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 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
-
Joint pain
-
Blistering rash containing pus
-
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 Cetirizine NORMON
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
6. Additional information
Composition of Cetirizina Normon
- The active substance in Cetirizina Normon is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
- The other components are microcrystalline cellulose, macrogol 6000, magnesium stearate, hypromellose, talc, pregelatinized corn starch, titanium dioxide (E-171).
Appearance of the medicinal product and contents of the pack
Film-coated tablets, white or almost white, round, biconvex, marked with C/T on one side and unmarked on the other, and scored on one side.
Pack containing 20 tablets.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos - Madrid (SPAIN)
Date of the most recent review of this leaflet: January 2023
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67862/P_67862.html