LEVOCETIRIZINE SANDOZ

Package Leaflet: Information for the Patient

LEVOCETIRIZINE SANDOZ 5 mg film-coated tablets

Levocetirizine (as dihydrochloride)
Read this leaflet carefully before using 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. Never give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT LEVOCETIRIZINE SANDOZ IS AND WHAT IT IS USED FOR

Levocetirizine is an antiallergic medicine used to treat symptoms associated with allergic conditions, such as:

• hay fever
• perennial allergies, such as those to dust or animal fur
• chronic urticaria

2. WHAT YOU NEED TO KNOW BEFORE TAKING LEVOCETIRIZINE SANDOZ

Do not take Levocetirizine Sandoz

• if you are allergic (hypersensitive) to levocetirizine or to any of the other ingredients of this medicine (listed in section 6, ‘’Contents of the pack and other information’’).
• if you have severe renal impairment (creatinine clearance less than 10 ml/min)

Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine Sandoz.
Inform and consult your doctor if:

• you suffer from epilepsy or are at risk of seizures for any other reason
• you have renal impairment. You may require a lower dose and should discuss your condition with your doctor
• you may have difficulty emptying your bladder (in conditions such as spinal cord injury or enlarged prostate)
• you are planning to undergo allergy testing. Ask your doctor whether you should stop taking Levocetirizine Sandoz several days before the test. This medicine may affect the results of allergy testing.

Children
Levocetirizine Sandoz is not recommended in children under 6 years of age, since the coated tablets currently available do not allow for dose adjustment.
Other medicines and Levocetirizine Sandoz
The effects of other medicines may be influenced by levocetirizine, or may in turn influence the effects of levocetirizine.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Levocetirizine Sandoz with food, drinks and alcohol
Levocetirizine may be taken regardless of food intake.
Taking levocetirizine together with alcohol requires caution. In sensitive patients, the effect of alcohol may be stronger or different than expected.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
In some patients, levocetirizine may cause drowsiness, fatigue and weakness. If you experience any of these symptoms, refrain from driving and operating any machinery.
Levocetirizine Sandoz contains lactose.
These tablets contain lactose; if your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE LEVOCETIRIZINE SANDOZ

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The tablet should be swallowed whole with water or another liquid.
The usual dose for adults and children aged 6 years and older is one tablet per day. Children under 6 years of age must not take Levocetirizine Sandoz 5 mg.
If you have mild to moderate renal impairment, your doctor may prescribe a lower dose depending on the severity of your kidney disease.
The duration of treatment depends on the type, duration, and course of your symptoms. Your doctor or pharmacist will determine how long you should take this medicine.
If you take more Levocetirizine Sandoz than you should
If you take more levocetirizine than prescribed, drowsiness may occur in adults. In children, initial agitation and restlessness may occur, followed by drowsiness.
Contact your doctor or pharmacist immediately. They may perform gastric lavage or take other measures to relieve symptoms.
If you forget to take Levocetirizine Sandoz
Do not take a double dose to make up for a missed dose. Skip the missed dose and take the next one at your usual time.
If you stop taking Levocetirizine Sandoz
Premature discontinuation of treatment with Levocetirizine Sandoz 5 mg should not cause any adverse effects. However, the symptoms for which you took levocetirizine may reappear.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, levocetirizine may cause side effects, although not everyone experiences them.

Common side effects (may occur in 1 out of 10 people):
Somnolence, headache, dry mouth, fatigue

Uncommon side effects (may occur in 1 out of 100 people):
Weakness, abdominal pain

Not known (frequency cannot be estimated from available data):
Palpitations, increased heart rate, seizures, paraesthesia, dizziness, syncope, tremor, dysgeusia (distortion of taste sensation), sensation of spinning or movement, visual disturbances, blurred vision, oculogyric crisis (eyes with uncontrollable circular movements), painful or difficult urination, inability to completely empty the bladder, edema, pruritus, rash, urticaria (swelling, redness, and itching of the skin), skin eruption, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, suicidal thoughts or recurrent suicidal ideation, hepatitis, hepatic dysfunction, vomiting, increased appetite, nausea, diarrhea.

Pruritus (intense itching) after discontinuation.

In case of first signs of hypersensitivity reactions, stop taking Levocetirizine Sandoz and contact your doctor.
Hypersensitivity reactions may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (feeling of chest tightness or labored breathing), urticaria, sudden drop in blood pressure which may lead to collapse or shock, which can be fatal.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, speak to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LEVOCETIRIZINE SANDOZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after
EXP.
The expiry date refers to the last day of the month.
Store the medicine in the original packaging to protect it from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Levocetirizine Sandoz contains
The active substance is levocetirizine.
Each tablet contains 5 mg of levocetirizine dihydrochloride.
The other excipients are: microcrystalline cellulose, lactose (as monohydrate), magnesium stearate,
hypromellose (E 464), titanium dioxide (E 171) and macrogol 400.

Description of the appearance of Levocetirizine Sandoz film-coated tablets and pack contents
Film-coated tablets, white to off-white, oval-shaped, biconvex, with "L9CZ" engraved on one side and "5" on the other.
The tablets are packed in blisters made of ALU/PVC/PVDC or in OPA/ALU/PVC/ALU blisters, placed in cardboard cartons.
Available pack sizes:
6, 7, 10, 14, 15, 18, 20, 21, 28, 30, 30x1, 40, 50, 56, 60, 70, 90, 100, 112 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
SANDOZ S.p.A. Largo U. Boccioni, 1 21040 Origgio (VA)

Responsible manufacturer for batch release
Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands
Synthon Hispania S.L., Castelló 1 Polígono Las Salinas, 08830 Sant Boi de Llobregat, Spain
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1 39179 Barleben - Germany

This medicinal product has been authorised in the Member States of the European Economic Area
under the following names:
Belgium Levocetirizine Sandoz 5 mg film-coated tablets
France Levocetirizine Sandoz 5 mg, film-coated tablet
Germany Levocetirizin HEXAL® bei Allergien
Italy Levocetirizina Sandoz
Netherlands Levocetirizine diHCl Sandoz 5 mg, film-coated tablets
United Kingdom Levocetirizine dihydrochloride 5 mg Tablets

This patient information leaflet was last approved on