Levocetirizine genoptim

Package leaflet: Information for the user

Levocetirizine Genoptim, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Table of contents

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

1. What Levocetirizine Genoptim is and what it is used for

The active substance in Levocetirizine Genoptim is levocetirizine dihydrochloride. Levocetirizine Genoptim is an antiallergic medicine.
It is used to treat symptoms associated with:

• • allergic rhinitis (including perennial allergic rhinitis);
• • urticaria.

If there is no improvement after 3 days, or if the patient feels worse, medical advice should be sought from a doctor.

2. Important information before using Levocetirizine Genoptim When not

to use Levocetirizine Genoptim:

• • if the patient is allergic to levocetirizine dihydrochloride or antihistamines or any of the other ingredients of this medicine (listed in section 6).
• • if the patient has severe kidney function impairment (severe renal insufficiency with creatinine clearance less than 10 ml/min).

Warnings and precautions
Before starting treatment with Levocetirizine Genoptim, consult a doctor or
pharmacist.
The use of Levocetirizine Genoptim is not recommended in children under 6 years of age, since the coated tablets do not allow for appropriate dose adjustment.
If it is likely that the patient is unable to empty the bladder (due to conditions such as spinal cord injury or benign prostatic hyperplasia), medical advice should be sought.
Other medicines and Levocetirizine Genoptim
Inform your doctor or pharmacist about all medicines currently used or recently used, as
well as any medicines the patient plans to use.
Levocetirizine Genoptim with food, drink and alcohol
Caution is advised when using Levocetirizine Genoptim concomitantly with alcohol.
In sensitive patients, concomitant use of cetirizine or levocetirizine and alcohol or other centrally acting medicines may affect the central nervous system, although the racemic form of cetirizine used in the medicine did not show potentiation of alcohol effects.
Pregnancy, breastfeeding and fertility
During pregnancy or breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
In some patients treated with levocetirizine, somnolence, drowsiness, fatigue and exhaustion may occur. If the patient intends to drive, perform potentially hazardous activities or operate machinery, they should first assess their individual response to the medicine. However, specific tests conducted in healthy volunteers after administration of levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability or driving performance.

3. How to use Levocetirizine Genoptim

This medicine should always be used as directed by the physician. In case of doubts, consult a
physician or pharmacist.
The recommended dose for adults and children aged 6 years and older is one tablet per day.
In patients with renal impairment, the dose may be reduced depending on the severity of kidney
disease. The dose will be determined by the physician.
Patients with hepatic impairment alone should usually receive the recommended dose.
In patients with both hepatic and renal impairment, a lower dose may be necessary depending on
the severity of renal disease. In children, the dose will be adjusted based on body weight; the dose
is determined by the physician.
Levocetirizine Genoptim is not recommended for use in children under 6 years of age.
Tablets should be swallowed whole with water. The medicine may be taken with or without food.
Use of a higher than recommended dose of Levocetirizine Genoptim
In cases of significant overdose in adults, drowsiness may occur. In children, initial excitation and
restlessness, especially motor restlessness, may occur, followed by drowsiness.
If an overdose of Levocetirizine Genoptim is suspected, consult a physician who will decide what
actions should be taken.
Missed dose of Levocetirizine Genoptim
Do not take a double dose to make up for a missed dose. Wait until the next scheduled dose and
take the dose recommended by the physician.
Discontinuation of Levocetirizine Genoptim
Discontinuing treatment with Levocetirizine Genoptim earlier than recommended should not
cause harmful effects; that is, disease symptoms will gradually reappear, and their severity will not
be greater than before starting treatment with Levocetirizine Genoptim.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Frequent (may affect 1 to 10 in 100 patients), mainly mild or moderate adverse reactions reported include dry mouth, headache, fatigue, drowsiness or somnolence.
Uncommon (may affect 1 to 10 in 1,000 patients) adverse reactions observed include feeling of exhaustion and abdominal pain.
Other adverse reactions have also been reported with unknown frequency (frequency cannot be estimated from the available data), such as: palpitations, rapid heartbeat, convulsions, tingling sensations, dizziness, fainting, tremor, taste disturbances (disturbances in taste perception), sensation of spinning or movement, visual disturbances, blurred vision, rotatory eye movements (involuntary circular movements of the eyeballs), painful or difficult urination, inability to completely empty the urinary bladder, swelling, itching, rash, urticaria (skin swelling, redness and itching), skin eruptions, shortness of breath, weight gain, muscle pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurring thoughts about or preoccupation with suicide, viral hepatitis, liver function abnormalities, vomiting, increased appetite and nausea.

If the first symptoms of hypersensitivity reactions occur, treatment with Levocetirizine Genoptim should be discontinued and medical advice should be sought immediately. Symptoms of hypersensitivity reactions may include: swelling of the lips, tongue, face and (or) throat, difficulty breathing or swallowing, and urticaria (angioedema), sudden drop in blood pressure leading to collapse or shock, which may lead to death.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected]
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Levocetirizine Genoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month.
No special precautions for storage of this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Levocetirizine Genoptim contains

• The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are: sodium croscarmellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, Opadry White (03K58884) (containing hypromellose 6 cps, titanium dioxide (E 171) and triacetin).

What Levocetirizine Genoptim looks like and contents of the pack
Levocetirizine Genoptim 5 mg coated tablets are white or almost white, oval-shaped, with a thickness of 2.9 mm to 3.5 mm, length of 7.8 mm to 8.2 mm, and width of 4.3 mm to 4.7 mm, smooth on both sides.
Levocetirizine Genoptim 5 mg coated tablets are available in blisters made of OPA/Aluminium/PVC/Aluminium, packed in cardboard boxes.
Pack sizes: 7 and 28 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
PharmSol Europe Limited
Victoria Centre Unit 2
Lower Ground Floor Valletta Road
Mosta, MST 9012 Malta

Manufacturer/Importer
Fair-Med Healthcare GmbH
Maria-Goeppert-Straße 3, 23562 Lübeck, Germany
Strandhaven Ltd T/A Somex Pharma
High Road, Ilford, Essex, IG3 8RA
United Kingdom

This medicinal product is authorised in the European Economic Area under the following names:
Germany: Levocetirizin Fairmed 5mg Filmtabletten
Poland: Levocetirizine Genoptim
Portugal: Levocetirizina Fair-Med
United Kingdom: Levocetirizine dihydrochloride 5mg film coated tablets