CETIRIZINE UXA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cetirizine Uxa 10 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Cetirizine Uxa and what is it used for
2. What you need to know before you take Cetirizine Uxa
3. How to take Cetirizine Uxa
4. Possible side effects
5. Storing Cetirizine Uxa
6. Contents of the pack and other information

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

The active substance of Cetirizine Uxa is cetirizine dihydrochloride. Cetirizine is an antiallergic medicine.

Cetirizine is indicated in adults and children aged 6 years and above for:

• Relief of symptoms of seasonal and perennial allergic rhinitis and conjunctivitis
• Relief of urticaria

2. What you need to know before you take Cetirizine Uxa

Do not take Cetirizine Uxa

• If you have severe kidney disease (severe renal impairment with creatinine clearance below 10 ml/min)
• If you are allergic to cetirizine dihydrochloride, or any of the other ingredients of this medicine (listed in section 6), or to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines)

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizine Uxa:

• If you have kidney problems, 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)
• If you are an epileptic patient or a patient at risk of convulsions

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 Uxa with alcohol.

If you are going to have an allergy test, ask your doctor if you should stop taking Cetirizine Uxa a few days before the test. This medicine may affect the results of your allergy tests.

Children

Do not give this medicine to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.

Taking Cetirizine Uxa with other medicines

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

Taking Cetirizine Uxa with food, drinks, and alcohol

Food does not affect the absorption of Cetirizine Uxa.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

The use of cetirizine 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 Uxa is excreted in breast milk. Therefore, you should not take Cetirizine Uxa during breastfeeding, unless you have consulted your doctor.

Driving and using machines

Clinical studies have not shown evidence that Cetirizine Uxa produces alterations in attention, reduced reaction capacity, and ability to drive at the recommended dose.

If you intend 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 Uxa contains lactose

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

3. How to take Cetirizine Uxa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The tablets should be swallowed with a glass of liquid.

The tablet can be divided into equal doses.

Adults and adolescents over 12 years:

The recommended dose is 10 mg once daily as 1 tablet.

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

Use in children between 6 and 12 years:

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: ask your doctor or pharmacist.

Patients with renal impairment:

It is recommended that patients with moderate renal impairment take 5 mg once daily.

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

If your child has kidney disease, please contact your doctor or pharmacist, who may adjust the dose according to your child's needs.

If you notice that the effect of Cetirizine Uxa 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 Uxa 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, the adverse effects described below may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, weakness, pupil dilation, tingling, irritation, sedation, somnolence, stupor, abnormally fast heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Uxa

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

If you stop taking Cetirizine Uxa

In rare cases, itching (intense itching) and/or urticaria (hives) may reappear if you stop taking Cetirizine Uxa.

If you have any further questions on 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 must stop taking the medicine and tell your doctor immediately if you notice any of them:

• Allergic reactions, including serious and angioedema (a 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.

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

• Somnolence (drowsiness)
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

Uncommon side effects(may affect up to 1 in 100 people):

• Agitation
• Paresthesia (abnormal skin sensation)
• Abdominal pain
• Pruritus (itching), rash
• Asthenia (extreme fatigue), malaise

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

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

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

• Thrombocytopenia (low platelet count)
• Tics (involuntary muscle contractions)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)
• Blurred vision, accommodation disorders (difficulty focusing), oculogyric crisis (uncontrolled circular eye movements)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash
• Difficulty or lack of control when urinating (bedwetting, pain, and/or difficulty urinating)

Side effects with frequency not known(frequency cannot be estimated from the available data):

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

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Health 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. Storing Cetirizine Uxa

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

No special storage conditions are required.

6. Contents of the pack and other information

Composition of Cetirizine Uxa

• The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride (8.4 mg of cetirizine base).
• The other ingredients are lactose monohydrate, corn starch, dried corn starch, pregelatinized starch (from corn), talc, magnesium stearate, hypromellose, macrogol, and titanium dioxide (E 171).

Appearance of the product and pack contents

Film-coated tablets with a capsule shape (10.0 mm x 4.0 mm), white or almost white, scored on one side and engraved with "10" on the other side.

Cetirizine Uxa is available in packs of 20 tablets in PVC-Alu blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

UXAfarma S.A.

Avda. San Francisco Javier 24

41018 Sevilla, Spain

Manufacturers

Laboratorio Fundación DAU

C/ de la Lletra C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona, Spain

Date of last revision: June 2025

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