ALERCINA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alercina 10 mg Tablets

cetirizine dihydrochloride

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the Package Leaflet

1. What Alercina is and what it is used for
2. What you need to know before taking Alercina
3. How to take Alercina
4. Possible side effects
5. Storage of Alercina
6. Package Contents and Additional Information

1. What Alercina is and what it is used for

The active ingredient of Alercina is cetirizine dihydrochloride.

Alercina is an antiallergic medicine.

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 it worsens or does 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 ingredients closely related to other medicines) or to any of the other components of this medicine (listed in section 6).
• if you have severe kidney 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 take a lower dose. Your doctor will determine the new dose.

If you are an epileptic patient or a patient at risk of convulsions, consult your doctor.

No interactions likely to have a significant impact have been observed between alcohol (with a blood level of 0.5 per thousand, corresponding to a glass of wine) and the use of cetirizine at normal doses. However, as with all antihistamines, it is recommended to avoid concurrent consumption of alcohol during treatment.

Other Medicines and Alercina

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

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 alterations in attention, decreased reaction capacity, and ability to drive at the recommended dose.

If you plan to drive, perform potentially hazardous activities, or use machinery, do not exceed the recommended dose. You should closely observe your response to the medicine.

If you are a sensitive patient, you may find that simultaneous use of alcohol or other central nervous system depressants may also affect your attention and reaction capacity.

If during treatment with this medicine you notice dizziness or drowsiness, you should not drive.

Alercina contains Lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to Take Alercina

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and Adolescents over 12 years

1 tablet of 10 mg, 1 time a day.

Children between 6 and 12 years

Half a tablet (5 mg), 2 times a day.

Patients with Moderate to Severe Renal Insufficiency

It is recommended that patients with moderate renal insufficiency take half a tablet (5 mg) 1 time a day.

How to take

The tablets should be swallowed with a glass of liquid.

You should consult a doctor if it 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

After an overdose, you may notice confusion, diarrhea, dizziness, fatigue, headache, weakness, pupil dilation, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor, and urinary retention.

If you forget to take Alercina

Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have occurred:

Common(may affect up to 1 in 10 people): fatigue, dizziness, headache, diarrhea, dry mouth, nausea, drowsiness, pharyngitis, rhinitis.

Uncommon(may affect up to 1 in 100 people): asthenia (extreme fatigue), malaise, paresthesia (abnormal skin sensation), abdominal pain, agitation, pruritus, rash.

Rare(may affect up to 1 in 1,000 people): edema (swelling), convulsions, movement disorders, aggression, confusion, depression, hallucination, insomnia, allergic reactions, some severe (very rare), tachycardia (heart beats too fast), abnormal liver function, urticaria, weight gain.

Very Rare(may affect up to 1 in 10,000 people): syncope, tremor, dysgeusia (taste disorder), tic, thrombocytopenia (low blood platelet levels), accommodation disorders, blurred vision, ocular gyration (eyes have uncontrolled circular movement), edema, drug eruption, abnormal urine elimination.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es. By reporting side 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 special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Alercina Composition

The active ingredient is cetirizine dihydrochloride. Each tablet contains 10 mg of cetirizine dihydrochloride.

The other ingredients 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).

Product Appearance and Package Contents

Alercina are film-coated, cylindrical, biconvex, scored tablets, white in color, and marked with the code “C”.

They are presented in PVC-PVDC/Aluminum blisters and are available in packs with 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 Last Revision of this Package Leaflet:June 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es