Package Insert: Information for the Patient

Cetirizine Alter 10 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The active ingredient of Cetirizina Alter is cetirizine dihydrochloride.

Cetirizina Alter is an antihistamine medication.

This medication is indicated for adults and children aged 6 years and above for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• relief of urticaria.

Do not take Cetirizina Alter

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 problems urinating (such as spinal cord or 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 thousand (g/l), corresponding to a glass of wine) and the use of cetirizine at the recommended dose. However,there are no available safety data when taking together higher doses of cetirizine and alcohol. Thereforeas 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 interrupt taking Cetirizina Alter a few days before the test. This medication may affect the results of your allergy tests.

Do not administer this medication to children under 6 years old, as this formulation does not allow for the necessary dose adjustment.

Other medications and Cetirizina Alter

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

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 may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Cetirizina Alter should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harmful effects on the fetus. However, the medication should only be administered if necessary and after consulting with the doctor.

Cetirizine passes into breast milk. It cannot be ruled out that there is a risk of adverse reactions in infants. Therefore, do not take Cetirizina Alter during breastfeeding, unless you consult your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that Cetirizina Alter produces attention alterations, decreased reaction capacity, and ability to drive 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 observe your response to the medication.

Cetirizina Alter contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication 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.

Adults and adolescents over 12 years old:

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

Use in children between 6 and 12 years old:

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

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

Patients with renal insufficiency:

Patients with moderate renal insufficiency are recommended to take 5 mg once a day.

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

If your child suffers from 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 medication is too weak or too strong, consult your doctor.

Treatment duration:

The duration of treatment depends on the type, duration, and course of your discomfort 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

After an overdose, the following adverse effects may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, discomfort (feeling unwell), dilated pupils, tingling, irritation, sedation, drowsiness (drowsiness), stupor, abnormal increase in heart rate, tremor, and urinary retention (difficulty emptying the bladder completely).

If you forgot to take Cetirizina Alter

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Cetirizina Alter

In rare cases, pruritus (intense itching) and/or urticaria (hives) may recur if you stop taking cetirizine.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 severe reactions 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 they can start later.

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

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

- Drowsiness (drowsiness)

- Dizziness, headache

- Pharyngitis (sore throat), rhinitis (runny, congested nose) (in children)

- Diarrhea, nausea, dry mouth

- Fatigue

Infrequent side effects(may affect up to 1 in 100 patients)

- Restlessness

- Paresthesia (abnormal skin sensation)

- Abdominal pain

- Pruritus (itching on the skin), rash

- Asthenia (extreme fatigue), malaise (feeling unwell)

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

- Allergic reactions, some severe (very rare)

- Depression, hallucination, aggression, confusion, insomnia

- Convulsions

- Tachycardia (heart beats too quickly)

- 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 in blood)

- Tics (spasms)

- Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)

- Blurred vision, accommodation disorders (difficulty focusing), ocular crises (eyes have an uncontrolled circular movement)

- Angioedema (severe allergic reaction that causes swelling of the face or throat), drug eruption (allergic reaction to the drug)

- Difficulty or inability to urinate (bedwetting, pain, and/or difficulty urinating)

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

- Increased appetite

- Suicidal thoughts (recurring thoughts or obsession with suicide), nightmares

- Amnesia (memory loss), memory deterioration

- Vertigo (sensation of rotation or movement)

- Urinary retention (inability to completely empty the urinary bladder)

- Pruritus (intense itching) and/or urticaria after treatment suspension

- Arthritis (joint pain), myalgia (muscle pain)

- Generalized acute exanthematous pustulosis (rash with pus-filled blisters)

- Hepatitis (inflammation of the liver)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cetirizina Alter

• The active ingredient of Cetirizina Alter is cetirizine dihydrochloride. A coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other components are lactose monohydrate, cornstarch, magnesium stearate, povidone K30, hypromellose, titanium dioxide (E171), and triacetin. See section 2Cetirizina Alter contains lactose.

Appearance of the product and contents of the packaging

Coated tablets with a film coating, white and biconvex.

Packaging with 20 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

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

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)