Prospecto: information for the user

Cetirizine Almus 10mg film-coated tablets EFG

cetirizine dihydrochloride

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it 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 prospectus. See section 4.

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

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

3.How to take Cetirizine Almus

4.Possible adverse effects

5Storage of Cetirizine Almus

6. Contents of the pack and additional information

The active ingredient of Cetirizina Almus is cetirizine dihydrochloride.

Cetirizina Almus is an antihistamine medication.

Cetirizina Almus is indicated in adults, adolescents, and children aged 6 years and above for:

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

Do not use Cetirizina Almus

-if you have a severe kidney disease (requiring dialysis);

• if you know you are allergic (hypersensitive) to the active ingredient, to any of the excipients (listed in section 6) of this medication, to hydroxyzine or to piperazine derivatives (closely related active ingredients of other drugs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cetirizina Almus.

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 problems 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 0.5per 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. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina Almus with alcohol.

If you are planning to undergo an allergy test, consult your doctor if you should interrupt taking Cetirizina Almus 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.

Use of Cetirizina Almus with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Taking Cetirizina 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 intend to become pregnant, consult your doctor before using this medication.

The use of Cetirizina Almus should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harm to the fetus. However, the medication should only be administered if necessary and after consulting with the doctor.

Cetirizine passes into breast milk. A risk of adverse reactions in infants cannot be ruled out.

Therefore, do not take Cetirizina Almus during breastfeeding, unless you consult your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that cetirizine produces attention impairments, 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 must closely observe your response to the medication.

Cetirizina Almus contains lactose andpropylene glycol

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

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.

The tablets can be divided into 2 equal doses.

Adults and adolescents over 12 years old:

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

Children between 6 and 12 years old:

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

Patients with renal insufficiency:

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

Treatment duration:

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 Cetirizina Almus 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 pupil, tingling, irritation, sedation, drowsiness (drowsiness), stupor, abnormal increase in heart rate, tremor, and urinary retention (difficulty emptying the bladder).

If you forgot to take Cetirizina Almus

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

If you interrupt treatment with Cetirizina Almus

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 may 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 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:

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)

• Agitation
• 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
• Seizures
• 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(the eyes have an uncontrolled circular movement)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash (allergy to the medication)
• 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
• Dizziness (sensation of spinning or movement)
• Urinary retention (inability to completely empty the urinary bladder)
• Pruritus (intense itching) and/or urticaria after treatment suspension
• Arthralgia (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, pharmacist, or nurse, even if it is a side effect that does not appear in this prospectus.You can also report them directly through theSSpanish System for Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es.

By reporting side effects, you can contribute to providing more information about 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 the blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Store in the original packaging..

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

Composition of Cetirizina Almus 10mg film-coated tablets

• The active ingredient is cetirizine dihydrochloride. Each tablet contains 10mg of cetirizine dihydrochloride.
• The other components are: silicon dioxide anhydrous, crospovidone, magnesium stearate, lactose monohydrate, microcrystalline cellulose, propylene glycol, polyethylene glycol stearate, hydroxypropyl methylcellulose (hypromellose), titanium dioxide.

Appearance of the product and contents of the packaging

Film-coated tablets,white, elliptical, scored on oneside.

Packaging with 20 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

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

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible for Manufacturing

Teva Pharma, S.L.U.

Malpica Industrial Estate c/C, 4

50016 Zaragoza

Last review date of this leaflet:August 2023

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