Alercina 10 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Alercina 10 mg tablets
cetirizine dihydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration of this medicine contained in this leaflet or those provided by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- 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.
- You should consult a doctor if you worsen or do not improve after 3 days.
Leaflet contents
- What Alercina is and what it is used for
- What you need to know before taking Alercina
- How to take Alercina
- Possible side effects
- How to store Alercina
- Contents of the pack and other information
1. What alercina is and what it is used for
The active substance in al ercina is cetirizine dihydrochloride.
Alercina is an antiallergic medicinal product.
It is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis in adults, adolescents, and children from 6 years of age.
You should consult a doctor if symptoms worsen or do not improve after 3 days.
2. What you need to know before taking alercina
Do not take alercina
- if you are allergic to cetirizine, hydroxyzine, or piperazine derivatives (active substances closely related to other medicines), or to any of the other ingredients of this medicine (listed in section 6).
- if you have severe renal disease (severe renal insufficiency with creatinine clearance below 10 ml/min).
Warnings and precautions
Consult your doctor or pharmacist before starting to take alercina.
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 are an epileptic patient or a patient at risk of seizures, consult your doctor.
No interactions likely to have a significant impact have been observed between alcohol (with a blood level of 0.5 per mille, corresponding to one glass of wine) and the use of cetirizine at normal doses. However, as with all antihistamines, it is recommended to avoid concomitant consumption of alcohol during treatment.
Other medicines and alercina
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking alercina with food and drinks
Taking this medicine with food and drinks does not affect its efficacy.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
You should not take this medicine during breastfeeding, as cetirizine passes into breast milk.
Driving and using machines
Clinical studies have not shown evidence that alercina 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, do not exceed the recommended dose. You should closely monitor your response to the medicine.
If you are a sensitive patient, you may find that the concomitant use of alcohol or other central nervous system depressants may further affect your attention and reaction capacity.
If you experience dizziness or drowsiness while taking this medicine, you should not drive.
Alercina contains lactose.
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take alercina
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age
1 tablet of 10 mg, once daily.
Children between 6 and 12 years of age
Half a tablet (5 mg), twice daily.
Patients with moderate to severe renal impairment
Patients with moderate renal impairment are advised to take half a tablet (5 mg) once daily.
How to take
The tablets should be swallowed with a glass of liquid.
You should consult a doctor if your condition worsens or does not improve after 3 days of treatment.
If you take more alercina 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 medication and the amount ingested.
After an overdose, you may experience confusion, diarrhea, dizziness, fatigue, headache, weakness, pupillary dilation, tingling, irritation, sedation, somnolence, stupor, abnormally increased heart rate, tremor, and urinary retention.
If you forget to take alercina
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have occurred:
Frequent (may affect up to 1 in 10 people): fatigue, dizziness, headache, diarrhoea, dry mouth, nausea, somnolence, pharyngitis, rhinitis.
Uncommon (may affect up to 1 in 100 people): asthenia (extreme fatigue), malaise, paraesthesia (abnormal sensation of the skin), abdominal pain, agitation, pruritus, rash.
Rare (may affect up to 1 in 1,000 people): oedema (swelling), seizures, movement disorders, aggression, confusion, depression, hallucination, insomnia, allergic reactions, some severe (very rare), tachycardia (heart beating too fast), abnormal liver function, urticaria, weight gain.
Very rare (may affect up to 1 in 10,000 people): syncope, tremor, dysgeusia (taste disturbance), tic, thrombocytopenia (low platelet levels in blood), accommodation disorders, blurred vision, ocular rotation (eyes have uncontrolled circular movement), oedema, drug-induced rash, abnormal urination.
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 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 alercina
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Alercina
The active substance is cetirizine dihydrochloride. Each tablet contains 10 mg of cetirizine dihydrochloride.
The other components are:
- Tablet core: lactose monohydrate, povidone K 30 (E-1201), crospovidone, magnesium stearate (E-470b) and talc (E-553b).
- Tablet coating: hypromellose (E-464), macrogol 400 and titanium dioxide (E-171).
Appearance of the product and pack contents
Alercina is a coated tablet, cylindrical, biconvex, scored, white in colour and marked with the code “C”.
It is presented in PVC-PVDC/aluminum blisters, and is available in cartons containing 7 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Date of the most recent review of this leaflet: June 2023
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es