Package Insert: Information for the User

Cetirizine Sandoz 10 mg/ml Oral Solution EFG

Cetirizine Dihydrochloride

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 package insert. See section 4.

The active ingredient of Cetirizina Sandoz is cetirizine dihydrochloride.

Cetirizina Sandoz is an antihistamine medication.

Cetirizina Sandoz10 mg/mloral drops in solution is indicated in adults andchildrenfrom 2 years old, for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• relief of chronic urticaria.

Do not use Cetirizina Sandoz:

• if you have a severe kidney disease (severe renal insufficiency with a 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 principles of other medications).

Warnings and precautions

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

If you have 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 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 at the 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 avoid taking cetirizine with alcohol.

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

Use of Cetirizina Sandoz with other medications

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

Taking Cetirizina Sandoz with food, drinks, and alcohol

Foods do not affect the absorption of cetirizine.

Pregnancy, breastfeeding, and fertility

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 should be avoided in pregnant women.The accidental use of this medication in pregnant women does not produce any harmful effects 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, do not take cetirizine during breastfeeding, unless you consult your doctor.

Driving and operating machines

Clinical studies have not shown evidence that cetirizine produces attention alterations, reaction ability decrease, and driving ability at the recommended dose.

If you intend to drive, perform potentially hazardous activities or use machinery, do 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 affect your attention and reaction ability in addition.

Cetirizina Sandoz contains propylene glycol

This medication contains 125 mg of propylene glycol in each ml of solution.

Cetirizina Sandoz contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor again.

Adults and adolescents 12 years and older:

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

Use in children 6 to 12 years:

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

Use in children 2 to 6 years:

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

Patients with renal insufficiency:

Patients with moderate renal insufficiency are recommended to take 5 mg, as 10 drops once a day.

If you have severe renal disease, please contact your doctor or pharmacist, who may adjust the dose accordingly.

If your child has renal 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 too strong, consult your doctor.

Treatment duration

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 Sandoz than you should

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

After an overdose, the following adverse effects may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, weakness, headache, dilated pupil, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor, and urinary retention.

If you forgot to take Cetirizina Sandoz

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

If you stop taking Cetirizina Sandoz

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

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 rare or very rare, but you should stop taking the medicine 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 may start soon after taking the medicine for the first time, or they may start later.

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

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

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

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

• Restlessness.
• Paresthesia (strange sensation of the skin).
• Abdominal pain.
• Pruritus (itching on the skin), 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 (heart beats too quickly).
• 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 focusing), nystagmus (eyes have an uncontrolled circular movement).
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash.
• Difficulty or inability to urinate (bedwetting, pain, and/or difficulty urinating).

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

• Increased appetite.
• Suicidal thoughts (recurring thoughts or obsession with suicide), nightmares.
• Amnesia, memory deterioration.
• Dizziness (sensation of rotation or movement)
• Urinary retention (inability to completely empty the urinary bladder).
• Pruritus (intense itching) and/or urticaria after treatment suspension
• Joint pain
• Rash with blisters that have pus
• Hepatitis (liver inflammation)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special conditions are required for conservation.

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

Do not use this medication after the expiration date that appears on the packaging and on the bottle after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Cetirizina Sandoz

• The active ingredient of Cetirizina Sandoz is cetirizine dihydrochloride. One milliliter (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 contents of the packaging

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

Packaging with a 20 ml bottle of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto Von Guericke Allee 1.

Barleben 39179

Germany

Last review date of this leaflet: January 2020

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