Cetirizina cipla 1 mg/ml solucion oral efg

Package Leaflet: Information for the User

Cetirizine Cipla 1 mg/ml Oral Solution EFG

Cetirizine dihydrochloride

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

• Keep this leaflet, as 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Cetirizine Cipla

3. How to take Cetirizine Cipla

4. Possible side effects

5. Storage of Cetirizine Cipla

6. Contents of the pack and additional information

Cetirizine, the active ingredient of this solution, is an antihistamine. This medication acts by blocking the effect of histamine, which is involved in the development of allergic reactions.

Cetirizina Cipla oral solution is used for the treatment in adults and pediatric patients 2 years or older who have hay fever (seasonal allergic rhinitis), allergies throughout the year, such as dust or pet allergies (perennial allergic rhinitis), and urticaria (skin swelling, redness, and itching).

Antihistamines like Cetirizina Cipla oral solution alleviate the symptoms and discomfort associated with these conditions, such as sneezing, irritated nose, stuffy and runny nose, itchy eyes, red and watery eyes, and skin eruptions.

You should consult your doctor if it worsens or does not improve after 3 days.

Do not take Cetirizina Cipla

• If you are allergic to cetirizine orhydroxyzine or to any piperazine derivative (closely related active principles of other drugs),or to any of the other components of this medication (listed in section 6).
• If you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10ml/min)
• If you are breastfeeding

Consult your pharmacist if you experience any of the above symptoms.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cetirizina Cipla

If you have kidney 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 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 0.5 per thousand (g/l), corresponding to a glass of wine) and the use of cetirizine atthe 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 avoidtaking Cetirizina oral solution withalcohol.

Children

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

Other medications and Cetirizina Cipla

Inform your doctor or pharmacist if you are taking, have taken recently or may take any other medication, including those purchased without a prescription.

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

Taking Cetirizina Cipla with food, drinks, and alcohol

Avoid alcoholic beverages while taking this medication.

Food does not affect the absorption of cetirizine.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Cetirizine oral solution should be avoided in pregnant women. Accidental use of the medication in pregnant women does not cause any harmful effects on the fetus. However, the medicationshould only be administered if necessary and after consulting with the doctor.

Cetirizine is excreted in breast milk. A risk of adverse reactions in infants cannot be ruled out. Therefore, do not take cetirizine oral solution during lactation, unless you consult your doctor.

Allergy tests

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

Driving and operating machinery

Clinical studies have not shown evidence that cetirizine produces attention impairments, reaction capacity reduction, and ability to drive at the recommended dose.

You should closely monitor your response after taking cetirizine oral solution if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Cetirizina Cipla oral solution contains sorbitol, sodium, methyl parahydroxybenzoate, and propyl parahydroxybenzoate.

• This medication contains 500mg of sorbitol in each ml of solution equivalent to 500mg/ml.
• Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (IHF), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.
• Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
• The oral solution contains the preservatives methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) that may cause allergic reactions (possibly delayed).
• This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially “sodium-free”.

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

Remember that the solution can be taken as is.

The dose must be measured using the spoon included with this package. The spoon has measurement marks that allow you to choose either 2.5 ml (half a spoon) or 5 ml (a full 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 aged 2 to 6 years:

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

Children aged 6 to 12 years:

5 mg twice a day: 5 ml of oral solution (a full spoonful) twice a day.

Adults and adolescents over 12 years of age:

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

Use in children

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

Renal insufficiency

Patients with moderate renal insufficiency 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.

Administration form

For oral use

Treatment duration

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

If you take more Cetirizina Cipla than you should

If you have accidentally taken more Cetirizina Cipla than the recommended or prescribed dose, consult your doctor immediately. Your doctor will decide on the necessary measures.

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

drowsiness,

stupor,

abnormal increase in heart rate,

trembling,

urinary retention.

If you forgot to take Cetirizina Cipla

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

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

If you interrupt treatment with Cetirizina Cipla

In rare cases, itching (intense itching) and/or urticaria may recur if you stop taking cetirizine oral solution.

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 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, face, eyelid, or lip inflammation. This reaction may start shortly after starting the medicine, or it may start later.

Also, the following side effects have been reported.

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

• Fatigue, drowsiness,• Abdominal pain,

• Headache,• Dizziness,

• Dry mouth,• Sore throat,

• Nausea,• Common cold-like nasal symptoms (only in children).

• Diarrhea (only in children),

Less frequent side effects(may affect 1 in 100 people)

• Itching and hives,• Tingling in hands and feet,

• Diarrhea,• Feeling agitated.

• Feeling weak or generally unwell,

• Abdominal pain

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

• Rapid heartbeat,

• Generalized edema (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), insomnia.

Very rare side effects(may affect 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, or difficulty urinating,

• Unusual bleeding or bruising,

• Tremors, tics,

• Involuntary movements and/or limb jerks,

• Muscle spasms in the neck and shoulders,

• Drug-induced rash (appearance of red or scaly skin in the same area after taking this medicine).

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

• Increased appetite,

• Dizziness,

• Suicidal thoughts (recurring thoughts of suicide or concern about suicide), nightmares

• Urinary retention (inability to completely empty the bladder).

• Liver inflammation (hepatitis).

• Forgetting, memory deterioration
• Joint pain
• Acute generalized pustular psoriasis (a red, scaly rash with bumps under the skin and blisters).

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 box and on the bottle label, after CAD. The expiration date is the last day of the month indicated.

Do not use after 6 months from opening the bottle.

This medication does not require special storage conditions.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Cetirizina Cipla Composition

• The active ingredient is cetirizine dihydrochloride. Each milliliter of oral solution contains 1 mg of cetirizine dihydrochloride
• The other components are:

methyldroxybenzoate (E218), propylhydroxybenzoate (E216), 70% non-crystallizable sorbitol solution (E420), glycerol, trisodium citrate (sodium citrate), citric acid, propylene glycol, monoammonium glycirrate, purified water, pineapple flavor No 1 (012080) and sweet orange flavor (SC406296).

Product appearance and packaging contents

Cetirizina Cipla oral solution is a clear, colorless, and fragrant solution.

Cetirizina Cipla 1 mg/ml oral solution is packaged in a 200 ml amber glass bottle or polyethylene terephthalate bottle, with a child-resistant cap and a 2.5 ml / 5 ml plastic transparent measuring spoon marked with CE.

Marketing authorization holder and manufacturer

Cipla Europe NV

De Keyserlei 58-60

Box-19, 2018

Antwerp, Belgium

For more information about this medication, please contact the local representative of the marketing authorization holder

Cipla Europe NV subsidiary in Spain

C/Guzmán el Bueno, 133 Edif Britannia

28003, Madrid

This medication is authorized in the European Economic Area member states with the following names:

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

IrelandAnti-Hist Allergy 1 mg/ml Oral Solution

Spain: Cetirizina Cipla 1 mg/ml oral solution EFG

Last review date of this leaflet:September 2024

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