CETIRIZINE SANDOZ 10 mg/ml ORAL SOLUTION DROPS

Introduction

Leaflet: Information for the user

Cetirizine Sandoz 10 mg/ml oral drops in EFG solution

Cetirizine dihydrochloride

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Cetirizine Sandoz is and what it is used for
2. What you need to know before taking Cetirizine Sandoz
3. How to take Cetirizine Sandoz
4. Possible side effects
5. Storage of Cetirizine Sandoz
6. Package contents and additional information

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

The active ingredient of Cetirizine Sandoz is cetirizine dihydrochloride.

Cetirizine Sandoz is an antiallergic medication.

Cetirizine Sandoz 10 mg/ml oral drops in solution are indicated for adults and children from 2 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 Cetirizine Sandoz

Do not use Cetirizine Sandoz:

• if you have severe kidney disease (severe renal insufficiency with creatinine clearance below 10 ml/min),
• if you know you are allergic to cetirizine dihydrochloride, to any of the other components of this medication (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances to other medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cetirizine Sandoz.

If you are a patient with renal insufficiency, consult your doctor, if necessary, to take a lower dose. Your doctor will determine the new dose.

If you have problems urinating (such as spinal cord or prostate and 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 (g/l), corresponding to a glass of wine) and the use of cetirizine at the recommended dose. However, safety data are not available when taking higher doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid taking cetirizine with alcohol.

If you are scheduled to undergo an allergy test, consult your doctor if you should stop taking cetirizine a few days before the test. This medication may affect the results of your allergy tests.

Using Cetirizine Sandoz with other medications

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Taking Cetirizine Sandoz with food, drinks, and alcohol

Food does not affect the absorption of cetirizine.

Pregnancy, breastfeeding, and fertility

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

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

Cetirizine is excreted in breast milk. Therefore, you should not take cetirizine during breastfeeding, unless you consult your doctor.

Driving and using machines

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

If you plan to drive, perform potentially hazardous activities, or use machinery, you should not exceed the recommended dose. You should observe your response to the medication. If you are a sensitive patient, you may find that the simultaneous use of alcohol or other central nervous system depressants may also affect your attention and reaction capacity.

Cetirizine Sandoz contains propylene glycol

This medication contains 125 mg of propylene glycol per ml of solution.

Cetirizine Sandoz contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml of solution; i.e., it is essentially "sodium-free".

3. How to take Cetirizine Sandoz

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

Adults and adolescents from 12 years of age:

The recommended dose is 10 mg, once a day as 20 drops.

Use in children between 6 and 12 years:

The recommended dose is 5 mg, twice a day, as 10 drops twice a day.

Use in children between 2 and 6 years:

The recommended dose is 2.5 mg, twice a day, administered as 5 drops.

Patient with renal insufficiency:

It is recommended that patients with moderate renal insufficiency take 5 mg, as 10 drops 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 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 Cetirizine Sandoz than you should

If you have taken more cetirizine than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

After an overdose, the side effects described below may occur with greater intensity. Side effects such as confusion, diarrhea, dizziness, fatigue, weakness, headache, pupil dilation, tingling, irritation, sedation, somnolence, stupor, abnormally rapid heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Sandoz

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

If you stop taking Cetirizine Sandoz

Rarely, itching (intense itching) and/or urticaria may reappear if you stop taking cetirizine.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following side effects are rare or very rare, but you should stop taking the medication 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 can start soon after taking the medication for the first time or may start later.

The frequency of the possible side effects listed below is defined as follows:

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

• Somnolence (drowsiness).
• Dizziness, headache.
• Pharyngitis, rhinitis (in children).
• Diarrhea, nausea, dry mouth.
• Fatigue.

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

• Agitation.
• Paresthesia (strange skin sensation).
• Abdominal pain.
• Itching (skin itching), rash.
• Asthenia (extreme fatigue), malaise.

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

• Allergic reactions, some severe (very rare).
• Depression, hallucination, aggression, confusion, insomnia.
• Seizures.
• Tachycardia (rapid heart rate).
• Abnormal liver function.
• Urticaria (hives).
• Edema (swelling).
• Weight gain.

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

• Thrombocytopenia (low platelet count in blood).
• Tics (spasms).
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder).
• Blurred vision, accommodation disorders (difficulty fixing gaze), ocular gyration (uncontrolled circular eye movement).
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash.
• Difficulty or lack of control when urinating (bedwetting, pain and/or difficulty urinating).

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

• Increased appetite.
• Suicidal thoughts (recurrent or obsessive thoughts of suicide), nightmares.
• Amnesia, memory impairment.
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to fully empty the urinary bladder).
• Itching (intense itching) and/or urticaria after treatment suspension
• Joint pain
• Blistering rash
• Hepatitis (liver inflammation)

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cetirizine Sandoz

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Storage conditions after the first opening of the package: 12 months at room temperature

Do not use this medication after the expiration date shown on the package and on the bottle after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Cetirizine Sandoz

• The active ingredient of Cetirizine Sandoz is cetirizine dihydrochloride. One ml (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride. The other components are: glycerol (E422), propylene glycol (E-1520), sodium acetate trihydrate, and purified water.

Appearance of the product and package contents

Cetirizine Sandoz is presented as a clear, colorless liquid, free of undissolved particles by visual inspection.

Package with a 20 ml bottle of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto Von Guericke Allee 1.

Barleben 39179

Germany

Date of the last revision of this leaflet: January 2020

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