Cetirizine Cipla 1 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cetirizine Cipla 1 mg/ml oral solution 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Cetirizina Cipla oral solution is used to treat adults and pediatric patients aged 2 years and older who have hay fever (seasonal allergic rhinitis), year-round allergies such as to dust or pets (perennial allergic rhinitis), and urticaria (swelling, redness, and itching of the skin).

Antihistamines such as Cetirizina Cipla oral solution relieve the symptoms and unpleasant discomfort associated with these conditions, such as sneezing, itchy nose, runny and blocked nose, itchy eyes, red and watery eyes, and skin rashes.

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

2. What you need to know before taking Cetirizina Cipla

Do not take Cetirizina Cipla

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

If you experience any of the symptoms listed above, speak with your pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting Cetirizina Cipla

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 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 the use of 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 oral solution with alcohol.

Children

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

Other medicines and Cetirizina Cipla

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

Due to the profile of cetirizine, interactions with other medicines are not expected.

Taking Cetirizina 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 plan to become pregnant, consult your doctor or pharmacist before using 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 effects on the fetus. However, the medicine should only be administered if necessary and after consulting with your doctor.

Cetirizine is excreted in breast milk. A risk of adverse reactions in breastfed infants cannot be ruled out. Therefore, you should not take cetirizine oral solution during breastfeeding unless advised by your doctor.

Allergy testing

If you are scheduled for allergy testing, consult your doctor about whether you should stop taking dihydrochloride cetirizine oral solution several days before the test. This medicine may affect the results of allergy tests.

Driving and using machines

Clinical studies have shown no evidence that cetirizine causes impairment of attention, reduced reaction capacity, or impaired driving ability at the recommended dose.

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

Cetirizina 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 informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine.
• 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), which may cause allergic reactions (possibly delayed).
• This medicine contains less than 1 mmol of sodium (23 mg) per ml; thus, it is essentially “sodium-free”.

3. How to take Cetirizine Cipla

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Please remember that the solution can be swallowed directly as it is.

The dose should be measured using the dosing spoon provided with this package. The spoon has measurement markings allowing you to measure either 2.5 ml (half a spoon) or 5 ml (one full spoon):

Do not take or administer more cetirizine oral solution than the amounts indicated 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 daily: 2.5 ml of oral solution (half a spoonful) twice daily.

Children aged 6 to 12 years:

5 mg twice daily: 5 ml of oral solution (one spoonful) twice daily.

Adults and adolescents over 12 years of age:

10 mg once daily: 10 ml of oral solution (two spoonfuls) once daily.

Use in children

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

Renal impairment

Patients with moderate renal impairment are advised to take 5 mg once daily.

If you suffer from severe kidney disease, please contact your doctor or pharmacist, who can appropriately adjust the dose. If your child suffers from kidney disease, please contact your doctor or pharmacist, who will 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 symptoms. 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, contact the Toxicology Information Service at telephone: 91 562 04 20. Remember to bring the package with you.

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

confusion,

diarrhea,

dizziness,

fatigue,

headache,

weakness,

pupil dilation,

tingling,

irritation,

sedation,

drowsiness,

stupor,

abnormally increased heart rate,

tremor,

urinary retention.

If you forget to take Cetirizine Cipla

If you forget to take a dose, take it 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 missed doses.

If you stop taking Cetirizine Cipla

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

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 very rare, but you should 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, swelling of the throat, face, eyelids or lips. This reaction may begin shortly after starting the medicine, or it may begin later.

The following adverse effects have also been reported.

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

• Tiredness, drowsiness, • Abdominal pain,
• Headache, • Dizziness,
• Dry mouth, • Sore throat,
• Nausea, • Nasal flu-like symptoms (in children only).
• Diarrhea (in children only),

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

• Itching and rash, • Tingling in hands and feet,
• Diarrhea, • Feeling restless.
• Feeling weak or generally unwell,
  • Abdominal pain

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

• Fast 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 (seeing or hearing things), trouble sleeping.

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

• Low platelet levels in the blood,

• Blurred vision, difficulty concentrating,

• Eye rolling

• Bad taste in the mouth,

• Fainting,

• Bedwetting, pain and/or difficulty urinating,

• Unusual bleeding or bruising,

• Tremor, 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).

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

• Increased appetite,
• Dizziness,
• Suicidal thoughts (recurring thoughts about suicide or preoccupation with suicide), nightmares
• Urinary retention (inability to completely empty the bladder).
• Inflammation of the liver (hepatitis).
  • Memory lapses, memory impairment
  • Joint pain
  • Generalized exanthematous pustulosis (a red, scaly rash with bumps under the skin and blisters).

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

In very rare cases, some people have had thoughts of suicide. If you experience this, stop taking the oral solution and see your doctor immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse 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 stated on the carton and on the label of the bottle, after EXP. The expiry date refers to the last day of the month indicated.

Do not use more than 6 months after opening the bottle.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps 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 components are:

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

Appearance of the product and contents of the pack

Cetirizine Cipla oral solution is a clear, colourless, flavoured solution.

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

Marketing Authorisation Holder and Manufacturer

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

Further information about this medicine can be obtained from the local representative of the Marketing Authorisation Holder

Cipla Europe NV, Spanish branch
C/Guzmán el Bueno, 133, Edif. Britannia
28003, Madrid, Spain

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

Ireland: Anti-Hist Allergy 1 mg/ml Oral Solution
Spain: Cetirizine Cipla 1 mg/ml oral solution EFG

Date of the most recent review of this leaflet: November 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/