Cetirizine Almus 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cetirizine Almus 10 mg film-coated tablets EFG
cetirizine dihydrochloride
Read the entire 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Cetirizine Almus is and what it is used for
- What you need to know before taking Cetirizine Almus
- How to take Cetirizine Almus
- Possible side effects
- How to store Cetirizine Almus
- Contents of the pack and other information
1. What Cetirizina Almus is and what it is used for
The active substance of Cetirizina Almus is cetirizine dihydrochloride.
Cetirizina Almus is an antiallergic medicinal product.
Cetirizina Almus is indicated in adults, adolescents and children from 6 years of age for:
- relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- relief of chronic urticaria.
2. What you need to know before taking Cetirizina Almus
Do not use Cetirizina Almus
- if you have severe kidney disease (requiring dialysis);
- if 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 (active substances closely related to other medicines).
Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizina Almus.
If you have kidney impairment, consult your doctor; if necessary, you will be prescribed a lower dose. Your doctor will determine the new dose.
If you have difficulty urinating (such as spinal cord problems, prostate or bladder issues), 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 mille (g/l), equivalent to one glass of wine) and cetirizine at the recommended dose. However, safety data are not available when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina Almus with alcohol.
If you are scheduled for allergy testing, consult your doctor whether you should stop taking Cetirizina Almus a few days before the test. This medicine may affect the results of your allergy tests.
Do not administer this medicine to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.
Use of Cetirizina Almus with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Taking Cetirizina Almus with food, drinks, and alcohol
Food does not significantly affect the extent of absorption of cetirizine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
The use of Cetirizina Almus should be avoided in pregnant women. Accidental use of the medicine in pregnant women is not expected to cause harmful effects on the fetus. However, the medicine should only be administered if necessary and after consultation with a doctor.
Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded.
Therefore, you should not take Cetirizina Almus while breastfeeding, unless advised otherwise by your doctor.
Driving and use of machines
Clinical studies have not shown evidence that cetirizine causes disturbances in attention, reduced reaction capacity, or impaired ability to drive at the recommended dose.
If you intend to drive, perform potentially hazardous activities, or operate machinery, you should not exceed the recommended dose. You should closely monitor your response to the medicine.
Cetirizina Almus contains lactose and propylene glycol
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains between 0.69 and 1.38 mg of propylene glycol in each tablet.
3. How to take Cetirizina Almus
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The tablets must be swallowed with a glass of liquid.
The tablets may be divided into two equal doses.
Adults and adolescents over 12 years of age:
The recommended dose is 10 mg once daily as 1 tablet.
Children between 6 and 12 years of age:
The recommended dose is 5 mg twice daily, as half a tablet twice daily.
Patients with renal impairment:
Patients with moderate renal impairment are recommended to take 5 mg once daily.
If you have severe kidney disease, please contact your doctor or pharmacist, who can appropriately adjust the dose.
If your child has kidney disease, please contact your doctor or pharmacist, who can 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 Cetirizina Almus than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 reported include confusion, diarrhea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, tingling, irritation, sedation, somnolence (drowsiness), stupor, abnormally increased heart rate, tremor, and urinary retention (difficulty completely emptying the bladder).
If you forget to take Cetirizina Almus
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Cetirizina Almus
In rare cases, pruritus (intense itching) and/or urticaria (hives) may reappear if you stop taking cetirizine.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse 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 severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat).
These reactions may begin soon after first taking the medicine, or they may begin later.
The frequency of the possible adverse effects listed below is defined as follows:
Frequent adverse effects (may affect up to 1 in 10 people)
- Somnolence (drowsiness)
- Dizziness, headache
- Pharyngitis (sore throat), rhinitis (runny nose, nasal congestion) (in children)
- Diarrhea, nausea, dry mouth
- Fatigue
Uncommon adverse effects (may affect up to 1 in 100 people)
- Agitation
- Paresthesia (abnormal sensation of the skin)
- Abdominal pain
- Pruritus (itching), rash
- Asthenia (extreme fatigue), malaise (feeling unwell)
Rare adverse effects (may affect up to 1 in 1,000 people)
- Allergic reactions, some severe (very rare)
- Depression, hallucination, aggression, confusion, insomnia
- Seizures
- Tachycardia (heart beating too fast)
- Abnormal liver function
- Urticaria (hives)
- Edema (swelling)
- Weight gain
Very rare adverse effects (may affect up to 1 in 10,000 people)
- Thrombocytopenia (low platelet levels in blood)
- Tics (spasms)
- Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disturbance)
- Blurred vision, accommodation disorders (difficulty focusing eyes), oculogyric crisis (eyes have uncontrolled circular movements)
- Angioedema (severe allergic reaction causing swelling of the face or throat), drug rash (allergy to the medicine)
- Difficulty or lack of control when urinating (bedwetting, pain and/or difficulty urinating)
Adverse effects with unknown frequency (frequency cannot be estimated from available data)
- Increased appetite
- Suicidal thoughts (recurring thoughts or obsession with suicide), nightmares
- Amnesia (loss of memory), memory impairment
- Vertigo (sensation of spinning or movement)
- Urinary retention (inability to completely empty the urinary bladder)
- Pruritus (intense itching) and/or urticaria after discontinuation of treatment
- Arthralgia (joint pain), myalgia (muscle pain)
- Generalized pustular eruption (rash with pus-filled blisters)
- Hepatitis (inflammation of the liver)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es.
By reporting adverse 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 stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cetirizine Almus 10 mg film-coated tablets
- The active substance is cetirizine dihydrochloride. Each tablet contains 10 mg of cetirizine dihydrochloride.
- The other components are: anhydrous colloidal silica, 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 container
Film-coated tablets, white, elliptical, scored on one side.
Pack containing 20 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]
Manufacturer
Teva Pharma, S.L.U.
Polígono Malpica c/C, 4
50016 Zaragoza, Spain
Date of the most recent revision of 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/