CETIRIZINE ALTER 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Cetirizine Alter 10 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take the medicine.

• 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Cetirizine Alter is and what it is used for
2. What you need to know before taking Cetirizine Alter
3. How to take Cetirizine Alter
4. Possible side effects
5. Storage of Cetirizine Alter
6. Package contents and additional information

1. What Cetirizine Alter is and what it is used for

The active ingredient of Cetirizine Alter is cetirizine dihydrochloride.

Cetirizine Alter is an antiallergic medicine.

This medicine is indicated for 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 Cetirizine Alter

Do not take Cetirizine Alter

• if you have severe kidney disease (requiring dialysis);
• if you are allergic to cetirizine dihydrochloride or to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances to other medicines);

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cetirizine Alter.

If you have kidney failure, consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.

If you have problems urinating (such as spinal cord or prostate and bladder problems), please consult your doctor.

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

No clinically significant interactions have been observed between alcohol (with a blood level of 0.5 per thousand (g/l), corresponding to a glass of wine) and the use of cetirizine at the recommended dose. However, safety data are not available when taking higher doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid taking cetirizine with alcohol.

If you are scheduled to undergo an allergy test, consult your doctor if you should stop taking Cetirizine Alter a few days before the test. This medicine may affect the results of your allergy tests.

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 Cetirizine Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Cetirizine 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 may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

The use of Cetirizine Alter should be avoided in pregnant women. Accidental use of the medicine in pregnant women should not produce any harmful effect on the fetus. However, the medicine should only be administered if necessary and after consulting a doctor.

Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take Cetirizine Alter during breastfeeding, unless you consult your doctor.

Driving and using machines

Clinical studies have not shown evidence that Cetirizine Alter 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.

Cetirizine Alter contains lactose

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

3. How to take Cetirizine Alter

Follow the administration instructions of this medicine indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The tablets should be swallowed with a glass of liquid.

Adults and adolescents over 12 years:

The recommended dose is 10 mg once a day as 1 tablet.

Use in children between 6 and 12 years:

The recommended dose is 5 mg twice a day, as half a tablet twice a day.

Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.

Patients with kidney failure:

It is recommended that patients with moderate kidney failure take 5 mg once a day.

If you have severe kidney disease, please contact your doctor, who may adjust the dose accordingly.

If your child has kidney 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 Cetirizine Alter 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 taken.

After an overdose, the adverse effects described below may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, paresthesia, irritation, sedation, somnolence, stupor, abnormal increase in heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Alter

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

If you stop taking Cetirizine Alter

Rarely, pruritus and/or urticaria may reappear if you stop taking cetirizine.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects are rare or very rare, but you should stop taking the medicine and tell your doctor immediately if you notice any of them:

• Allergic reactions, including serious and angioedema (severe allergic reaction that causes swelling of the face or throat).

These reactions can start soon after taking the medicine for the first time or may start later.

The frequency of the possible side effects listed below is defined as follows:

Common side effects(may affect up to 1 in 10 patients)

• Somnolence (drowsiness)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (runny or stuffy nose) (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

Uncommon side 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

Rare side effects(may affect up to 1 in 1,000 patients)

• Allergic reactions, some serious (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Seizures
• Tachycardia (rapid heart rate)
• Abnormal liver function
• Urticaria (hives)
• Edema (swelling)
• Weight gain

Very rare side effects(may affect up to 1 in 10,000 patients)

• Thrombocytopenia (low platelet count)
• Tics (involuntary muscle contractions)
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)
• Blurred vision, accommodation disorders (difficulty focusing), oculogyric crisis (involuntary and repetitive eye movements)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash
• Urinary retention (inability to empty the bladder completely)

Side effects with unknown frequency(frequency cannot be estimated from available data)

• Increased appetite
• Suicidal thoughts (recurring or obsessive thoughts of suicide), nightmares
• Amnesia (memory loss), memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to empty the bladder completely)
• Pruritus (intense itching) and/or urticaria after stopping treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Acute generalized exanthematous pustulosis (rash with pus-filled blisters)
• Hepatitis (inflammation of the liver)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es.

By reporting side 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 expiration date stated on the packaging and blister after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection 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

Composition of Cetirizine Alter

• The active ingredient of Cetirizine Alter is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are lactose monohydrate, cornstarch, magnesium stearate, povidone K30, hypromellose, titanium dioxide (E171), and glycerol triacetate. See section 2 Cetirizine Alter contains lactose.

Appearance of the product and package contents

White, lenticular, film-coated tablets.

Package with 20 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Date of the last revision of this leaflet:July 2024.

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