CETIRIZINE ALMUS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cetirizine Almus 10mg film-coated tablets EFG

cetirizine dihydrochloride

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 and other information:

1. What is Cetirizine Almus and what is it used for
2. What you need to know before you take Cetirizine Almus
3. How to take Cetirizine Almus
4. Possible side effects

5 Storage of Cetirizine Almus

1. Contents of the pack and further information

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

The active substance of Cetirizine Almus is cetirizine dihydrochloride.

Cetirizine Almus is an antiallergic medicine.

Cetirizine Almus is indicated in adults, adolescents and children from 6 years for:

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

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

Do not take Cetirizine Almus

• if you have severe renal impairment (requiring dialysis);
• if you know that you are allergic (hypersensitive) to the active substance, to any of the excipients (listed in section 6) of this medicine, to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizine Almus.

If you have 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 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 Almus with alcohol.

If you are scheduled to undergo an allergy test, consult your doctor if you should stop taking Cetirizine Almus 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, as this formulation does not allow for the necessary dose adjustment.

Use of Cetirizine Almus with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Taking Cetirizine Almus with food, drinks and alcohol

Food does not significantly affect the degree of absorption of cetirizine.

Pregnancy, breastfeeding and fertility

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 Almus 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 breast-fed infants cannot be excluded.

Therefore, you should not take Cetirizine Almus during breastfeeding, unless you have consulted your doctor.

Driving and using machines

Clinical studies have not shown evidence that cetirizine produces alterations in attention, decreased 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 Almus contains lactose andpropylene glycol

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

This medicine contains between 0.69 and 1.38 mg of propylene glycol in each tablet.

3. How to take Cetirizine Almus

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

The tablets should be swallowed with a glass of liquid.

The tablets can be divided into 2 equal doses.

Adults and adolescents over 12 years:

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

Children between 6 and 12 years:

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

Patient with renal insufficiency:

It is recommended that patients with moderate renal insufficiency take 5 mg once a day.

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

If your child suffers from 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 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 Almus than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Tel: 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, malaise, pupil dilation, paresthesia, irritation, sedation, somnolence, stupor, abnormal increased heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Almus

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

If you stop taking Cetirizine Almus

On rare occasions, pruritus and/or urticaria may reappear if you stop taking cetirizine.

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 (severe allergic reaction that causes swelling of the face or throat).

These reactions may start soon after taking the medicine for the first time, or they 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 people)

• Somnolence (drowsiness)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (runny, stuffy nose) (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 (rapid 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 in blood)
• Tics (muscle spasms)
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)
• Blurred vision, accommodation disorders (difficulty focusing), oculogyric crisis (involuntary circular movement of the eyes)
• 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 unknown frequency(frequency cannot be estimated from the available data)

• Increased appetite
• Suicidal thoughts (recurring or obsessive thoughts of suicide), nightmares
• Amnesia (memory loss), memory impairment
• Vertigo (feeling of spinning or movement)
• Urinary retention (inability to empty the bladder completely)
• Pruritus 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine Almus

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 shown.

No special storage conditions are required.

Store in the original package.

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 to protect the environment.

6. Contents of the pack and further information

Composition of Cetirizine Almus 10mg film-coated tablets

• The active substance is cetirizine dihydrochloride. Each tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: colloidal anhydrous silica, crospovidone, magnesium stearate, lactose monohydrate, microcrystalline cellulose, propylene glycol, polyethylene glycol stearate, hypromellose, titanium dioxide.

Appearance and packaging

White, elliptical, film-coated tablets with a score line on one side.

Package with 20 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Almus Pharmaceutical, S.A.U. Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica c/C, 4

50016 Zaragoza

Date of last revisionof this leaflet:August 2023

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/