Cetirizine Alter 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Cetirizine Alter 10 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine.
- 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 only and must not be given to other people, even if they have the same symptoms as you, since 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 Cetirizine Alter is and what it is used for
- What you need to know before taking Cetirizine Alter
- How to take Cetirizine Alter
- Possible side effects
- How to store Cetirizine Alter
- Contents of the pack and other information
1. What Cetirizina Alter is and what it is used for
The active substance of Cetirizina Alter is cetirizine dihydrochloride.
Cetirizina Alter is an antiallergy medicine.
This medicine is 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 Cetirizina Alter
Do not take Cetirizina Alter
- 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
Consult your doctor or pharmacist before taking Cetirizina Alter.
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, 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), corresponding 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 cetirizine with alcohol.
If you are scheduled for an allergy test, consult your doctor whether you should stop taking Cetirizina Alter a few days before the test. This medicine may affect the results of your allergy tests.
Do not administer this medicine to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.
Other medicines and Cetirizina Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.
Taking Cetirizina Alter with food, drinks, and alcohol
Food does not affect the absorption of cetirizine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
The use of Cetirizina Alter should be avoided in pregnant women. Accidental use of the medicine in pregnant women is not expected to cause any 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 ruled out. Therefore, you should not take Cetirizina Alter during breastfeeding unless advised by your doctor.
Driving and using machines
Clinical studies have not shown evidence that Cetirizina Alter causes disturbances in 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.
Cetirizina Alter contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Cetirizina Alter
Follow exactly the instructions for use 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.
Adults and adolescents over 12 years of age:
The recommended dose is 10 mg once daily as 1 tablet.
Use in children between 6 and 12 years of age:
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: please 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 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 this medicine 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 Alter than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 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 Alter
Do not take a double dose to make up for the missed dose.
If you stop taking Cetirizina Alter
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, 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 inform your doctor immediately if you experience 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 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 count 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 eyes), oculogyric crisis (eyes have uncontrollable 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 unknown frequency (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 stopping treatment
- Arthralgia (joint pain), myalgia (muscle pain)
- Generalized pustular eruption (rash with pus-filled blisters)
- Hepatitis (liver inflammation)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Alter
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 refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cetirizine Alter
- The active substance in Cetirizine Alter is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
- The other components are lactose monohydrate, corn starch, magnesium stearate, povidone K30, hypromellose, titanium dioxide (E171), and glyceryl triacetate. See section 2 Cetirizine Alter contains lactose.
Nature of the product and contents of the pack
Film-coated, white, lens-shaped tablets.
Pack containing 20 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Alter, S.A.
C/Mateo Inurria, 30
28036 Madrid
Spain
Manufacturers
Laboratorios Alter, S.A.
C/Mateo Inurria, 30
28036 Madrid
Spain
or
Laboratorios Alter, S.A.
C/ Zeus, 6
Polígono Industrial R2
28880 Meco (Madrid)
Spain
Date of the most recent review of this leaflet:
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)