CETIRIZINE CIPLA 1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Cetirizine Cipla 1 mg/ml Oral Solution 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

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

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

Cetirizine, the active substance of this solution, is an antihistamine. This medicine works by blocking the effect of histamine, which is involved in the development of allergic reactions.

Cetirizine Cipla Oral Solution is used for the treatment in adults and pediatric patients 2 years of age and older who have hay fever (seasonal allergic rhinitis), year-round allergies, such as to dust or pets (perennial allergic rhinitis), and urticaria (hives, itching, and redness of the skin).

Antihistamines like Cetirizine Cipla Oral Solution relieve the symptoms and discomforts associated with these conditions, such as sneezing, runny or itchy nose, nasal stuffiness, itchy or watery eyes, and skin rashes.

You should consult your doctor if your symptoms worsen or do not improve after 3 days.

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

Do not take Cetirizine Cipla

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

If you experience any of the above symptoms, talk to your pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizine Cipla.

If you have kidney problems, 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 convulsions, consult your doctor.

No clinically significant interactions have been observed between alcohol (with a blood level of 0.5 per thousand, corresponding to one glass of wine) and the use of cetirizine at the recommended dose. However, there are no safety data available when taking higher doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine Oral Solution with alcohol.

Children

Do not give this medicine to children under 2 years of age.

Other medicines and Cetirizine Cipla

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

Due to the profile of cetirizine, no interactions with other medicines are expected.

Taking Cetirizine Cipla with food, drinks, and alcohol

Avoid alcoholic beverages while taking this medicine.

Food does not affect the absorption of cetirizine.

Pregnancy and breastfeeding

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

The use of cetirizine oral solution should be avoided in pregnant women. Accidental use of the medicine in pregnant women does not produce any harmful effect on the fetus. However, the medicine should only be administered if necessary and after consulting with the doctor.

Cetirizine is excreted in breast milk. A risk of adverse reactions in the breastfed infant cannot be excluded. Therefore, you should not take cetirizine oral solution during breastfeeding, unless you have consulted your doctor.

Allergy testing

If you are going to have an allergy test, tell your doctor if you should stop taking the oral solution of cetirizine dihydrochloride for several days before the test. This medicine may affect the results of allergy tests.

Driving and using machines

Clinical studies have not shown evidence that cetirizine produces alterations in attention, decreased ability to react, and ability to drive at the recommended dose.

You should carefully observe your response after taking cetirizine oral solution if you intend to drive, engage in potentially hazardous activities, or use machinery. Do not exceed the recommended dose.

Cetirizine Cipla Oral Solution contains sorbitol, sodium, methyl parahydroxybenzoate, and propyl parahydroxybenzoate.

• This medicine contains 500 mg of sorbitol in each ml of solution, equivalent to 500 mg/ml.
• Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.
• Sorbitol may cause gastrointestinal upset and a mild laxative effect.
• The oral solution contains the preservatives methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).
• This medicine contains less than 1 mmol of sodium (23 mg) per ml; i.e., it is essentially "sodium-free".

3. How to take Cetirizine Cipla

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

Remember that the solution can be swallowed as is.

The dose should be measured using the measuring spoon included with this pack. The spoon has measurement marks that allow you to choose either 2.5 ml (half a spoon) or 5 ml (one whole spoon):

Do not take or administer more cetirizine oral solution than the amounts shown below.

If you do not feel better within a few days, consult your doctor.

The recommended dose is:

Children from 2 to 6 years:

2.5 mg twice a day: 2.5 ml of oral solution (half a spoon) twice a day.

Children from 6 to 12 years:

5 mg twice a day: 5 ml of oral solution (one spoon) twice a day.

Adults and adolescents over 12 years of age:

10 mg once a day: 10 ml of oral solution (2 spoons) once a day.

Use in children

Cetirizine oral solution is not suitable for children under 2 years of age.

Renal impairment

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

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 oral solution is too weak or too strong, consult your doctor.

Method of administration

For oral use.

Duration of treatment

The duration of treatment depends on the type, duration, and course of your complaints. Consult your doctor or pharmacist.

If you take more Cetirizine Cipla than you should

If you have accidentally taken more Cetirizine Cipla than the recommended or prescribed dose, consult your doctor immediately. Your doctor will decide what measures to take if necessary.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone: 91 562 04 20. Remember to bring the pack with you.

After an overdose, the adverse effects described in section 4 may occur with greater intensity. The following adverse effects have been reported:

confusion,

diarrhea,

dizziness,

fatigue,

headache,

weakness,

pupil dilation,

tingling,

irritation,

sedation,

somnolence,

stupor,

abnormal increase in heart rate,

tremors,

urinary retention.

If you forget to take Cetirizine Cipla

If you forget to take a dose, you should take one as soon as you remember, but you must wait at least 24 hours before taking the next dose.

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

If you stop taking Cetirizine Cipla

On rare occasions, itching and/or hives may reappear if you stop taking cetirizine oral solution.

If you have any further questions on the use of this product, 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 very rare, but you must stop taking the medicine and consult your doctor immediately if you notice any of the following symptoms:

• A severe allergic reaction, including skin rash, itching, and fever, throat inflammation, face, eyelids, or lip swelling. This reaction may start soon after you start taking the medicine or could start later.

The following side effects have also been reported.

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

• Fatigue, somnolence, abdominal pain,
• headache, dizziness,
• dry mouth, sore throat,
• nausea, cold-like symptoms (only in children).
• diarrhea (only in children),

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

• Itching and rash, tingling in hands and feet,
• diarrhea, feeling agitated.
• feeling weak or unwell,
  • abdominal pain

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

• rapid heartbeat,
• edema (generalized swelling due to water retention),
• abnormal liver function test results (your doctor will know what to do),
• seizures,
• weight gain,
• aggression, confusion, depression, hallucinations (hearing or seeing things), sleep disturbances.

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

• low platelet count in the blood
• blurred vision, difficulty concentrating

• eye rotation

• bad taste in the mouth,
• fainting,
• bedwetting, pain and/or difficulty urinating,
• unusual bleeding or bruising,
• tremors, tics,
• involuntary movements and/or jerking of the limbs,
• muscle spasms in the neck and shoulders,
  • drug rash (appearance of red or scaly skin at the same site after taking this medicine).

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

• increased appetite,
• vertigo,
• suicidal thoughts (recurring thoughts of suicide or concern about suicide), nightmares
• urinary retention (inability to fully empty the bladder)..
• liver inflammation (hepatitis).
  • memory loss, memory impairment
  • joint pain
  • acute generalized exanthematous pustulosis (a red and scaly rash with bumps under the skin and blisters).

Some cases of memory loss and/or impairment have also been reported.

In very rare cases, people have thought about committing suicide, and if you feel this way, stop taking the oral solution and go see your doctor.

Reporting of side effects

If you experience 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 through the Spanish Medicines Monitoring System website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine Cipla

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 on the label of the bottle, after EXP. The expiry date is the last day of the month shown.

Do not use after 6 months from the opening of the bottle.

This medicine does not require any special storage conditions.

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.

6. Contents of the pack and other information

Composition of Cetirizine Cipla

• The active substance is cetirizine dihydrochloride. Each ml of oral solution contains 1 mg of cetirizine dihydrochloride.
• The other ingredients are:

methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), 70% non-crystallizing sorbitol solution (E420), glycerol, trisodium citrate (sodium citrate), citric acid, propylene glycol, monoammonium glycyrrhizinate, purified water, pineapple flavor No. 1 (012080), and sweet orange flavor (SC406296).

Appearance of the product and pack contents

Cetirizine Cipla Oral Solution is a clear, colorless, flavored solution.

Cetirizine Cipla 1 mg/ml Oral Solution is packaged in a 200 ml amber glass or polyethylene terephthalate bottle, with a child-resistant cap and a measuring spoon with a CE mark of 2.5 ml / 5 ml of transparent plastic.

Marketing authorization holder and manufacturer

Cipla Europe NV

De Keyserlei 58-60

Box-19, 2018

Antwerp, Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorization holder

Cipla Europe NV, Spanish branch

C/Guzmán el Bueno, 133 Edif Britannia

28003, Madrid

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Cetirizine Cipla, 1 mg/ml, oral solution

Ireland: Anti-Hist Allergy 1 mg/ml Oral Solution

Spain: Cetirizine Cipla 1 mg/ml oral solution EFG

Date of last revision of this leaflet:September 2024

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/