Levocetirizine Genoptim

Package Leaflet: Information for the User

Levocetirizine Genoptim, 5 mg, Film-Coated Tablets

Levocetirizine Dihydrochloride

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this Leaflet, You May Need to Read it Again.
• If You Have any Further Questions, Ask Your Doctor or Pharmacist.
• This Medicinal Product has been Prescribed for You. Do Not Pass it on to Others. It may Harm them, even if their Symptoms are the Same as Yours.
• If You Experience any Side Effects, including any not Listed in this Leaflet, Tell Your Doctor or Pharmacist.

Table of Contents of the Leaflet

• 1. What is Levocetirizine Genoptim and What is it Used for
• 2. Important Information Before You Take 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 is Levocetirizine Genoptim and What is it Used for

The Active Substance of Levocetirizine Genoptim is Levocetirizine Dihydrochloride. Levocetirizine Genoptim is an Antihistamine Medicinal Product.
It is Used to Treat Symptoms of Allergic Conditions, Such as:

• - Allergic Rhinitis (Including Chronic Allergic Rhinitis);
• - Urticaria.

If After 3 Days There is no Improvement or the Patient Feels Worse, Consult a Doctor.

2. Important Information Before You Take Levocetirizine Genoptim When Not to Use Levocetirizine Genoptim:

Do Not Take Levocetirizine Genoptim:

• - If You are Allergic to Levocetirizine Dihydrochloride or to any Other Antihistamine or to any of the Other Ingredients of this Medicinal Product (Listed in Section 6).
• - If You Have Severe Kidney Problems (Severe Renal Impairment with a Creatinine Clearance of Less than 10 ml/min).

Warnings and Precautions

Before Taking Levocetirizine Genoptim, Consult a Doctor or Pharmacist.
Levocetirizine Genoptim is Not Recommended for Children Under 6 Years of Age, as the Film-Coated Tablets do Not Allow for the Necessary Dose Adjustment.
If it is Likely that the Patient is Unable to Empty the Bladder (Due to Conditions Such as Spinal Cord Injuries or Prostatic Hyperplasia), Consult a Doctor.

Other Medicinal Products and Levocetirizine Genoptim

Tell Your Doctor or Pharmacist About all Medicinal Products You are Taking or Have Recently Taken, as well as any Medicinal Products You Plan to Take.

Levocetirizine Genoptim with Food, Drink, and Alcohol

Caution is Advised When Taking Levocetirizine Genoptim with Alcohol.
In Sensitive Patients, Concurrent Use of Cetirizine or Levocetirizine and Alcohol or Other Central Nervous System Depressants may Have an Additive Effect on the Central Nervous System, Although the Racemic Cetirizine Used in this Medicinal Product Did Not Show an Increased Effect of Alcohol.

Pregnancy, Breast-Feeding, and Fertility

If You are Pregnant, Breast-Feeding, or Think You May be Pregnant, or are Planning to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking this Medicinal Product.

Driving and Using Machines

Some Patients Taking Levocetirizine may Experience Drowsiness, Fatigue, and Tiredness.
If You Plan to Drive, Perform Potentially Hazardous Activities, or Operate Machinery, You Should First Establish Your Reaction to the Medicinal Product. However, Special Tests Conducted with Healthy Volunteers Who Took Levocetirizine at the Recommended Dose Did Not Show an Effect on Attention, Reaction Time, or Ability to Drive.

3. How to Take Levocetirizine Genoptim

Always Take this Medicinal Product Exactly as Your Doctor has Told You.
If You are Not Sure, Consult Your Doctor or Pharmacist.
The Recommended Dose for Adults and Children Over 6 Years is One Tablet Once Daily.
In Patients with Renal Impairment, the Dose of Levocetirizine Genoptim may be Reduced Depending on the Severity of the Renal Disease. The Dose will be Determined by Your Doctor.
Patient with Hepatic Impairment Should be Treated with the Usual Recommended Dose.
In Patients with Both Hepatic and Renal Impairment, a Lower Dose may be Necessary Depending on the Severity of the Renal Disease. In Children, the Dose will be Determined Based on Body Weight; the Dose of the Medicinal Product will be Determined by Your Doctor.
Levocetirizine Genoptim is Not Recommended for Use in Children Under 6 Years of Age.
Swallow the Tablets Whole with Water. The Medicinal Product can be Taken with or Without Food.

Overdose of Levocetirizine Genoptim

In Case of Significant Overdose in Adults, Drowsiness may Occur. In Children, Initial Excitement and Restlessness, Especially Motor, may be Followed by Drowsiness.
If You Think You Have Taken More than the Recommended Dose of Levocetirizine Genoptim, Consult a Doctor Who Will Decide What Measures Should be Taken.

Missed Dose of Levocetirizine Genoptim

Do Not Take a Double Dose to Make up for a Forgotten Dose. Wait Until it is Time for the Next Dose and Take the Recommended Dose.

Stopping Treatment with Levocetirizine Genoptim

Stopping Treatment with Levocetirizine Genoptim Earlier than Recommended Should Not Cause any Harm, i.e., the Symptoms of the Disease will Reappear Gradually, and their Intensity will Not be Greater than Before the Start of Treatment with Levocetirizine Genoptim.
If You Have any Further Questions on the Use of this Medicinal Product, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medicinal Products, Levocetirizine Genoptim can Cause Side Effects, although Not Everybody gets them.
Common (May Affect up to 1 in 10 People) Side Effects are Usually Mild to Moderate and Include Dry Mouth, Headache, Fatigue, and Drowsiness or Dizziness.
Uncommon (May Affect up to 1 in 100 People) Side Effects Include Feeling of Exhaustion and Abdominal Pain.
Other Side Effects with Frequency Not Known (Cannot be Estimated from the Available Data) Include: Rapid Heartbeat, Fast Heart Rate, Seizures, Tingling, Dizziness, Fainting, Shaking, Taste Disturbances, Feeling of Spinning or Movement, Vision Disturbances, Blurred Vision, Rotational Eye Movements (Uncontrolled Rotational Eye Movement), Painful or Difficult Urination, Inability to Completely Empty the Bladder, Swelling, Itching (Itch), Rash, Urticaria (Swelling, Redness, and Itching of the Skin), Skin Eruptions, Shortness of Breath, Weight Gain, Muscle Pain, Aggressive or Restless Behavior, Hallucinations, Depression, Insomnia, Recurring Thoughts of or Preoccupation with Suicide, Viral Hepatitis, Liver Function Disorders, Nausea and Vomiting, Increased Appetite.
In Case of the First Symptoms of Hypersensitivity Reaction, Stop Taking Levocetirizine Genoptim and Consult a Doctor Immediately. Symptoms of a Hypersensitivity Reaction may Include: Swelling of the Mouth, Tongue, Face, and (or) Throat, Difficulty Breathing or Swallowing, and Urticaria (Angioedema), Sudden Decrease in Blood Pressure Leading to Fainting or Shock, which can be Life-Threatening.
If You Experience any Side Effects, including any not Listed in this Leaflet, Tell Your Doctor or Pharmacist.

Reporting of Side Effects

If You Experience any Side Effects, including any not Listed in this Leaflet, Tell Your Doctor, Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department for Monitoring of Adverse Reactions of Medicinal Products, 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]
By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medicinal Product.

5. How to Store Levocetirizine Genoptim

Keep this Medicinal Product out of the Sight and Reach of Children.
Do Not Use this Medicinal Product After the Expiry Date Stated on the Carton After “EXP”. The Expiry Date Refers to the Last Day of that Month.
There are no Special Precautions for Storage.
Medicinal Products Should 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 Film-Coated Tablet Contains 5 mg of Levocetirizine Dihydrochloride.
• The Other Ingredients are: Croscarmellose Sodium, Microcrystalline Cellulose, Silica Colloidal Anhydrous, 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 Film-Coated Tablets are White or Almost White, Oval, 2.9 mm to 3.5 mm Thick, 7.8 mm to 8.2 mm Long, and 4.3 mm to 4.7 mm Wide, with a Smooth Surface on Both Sides.
Levocetirizine Genoptim 5 mg Film-Coated Tablets are Available in OPA/Aluminium/PVC/Aluminium Blisters, Packaged in Cardboard Boxes.
Pack Sizes: 7 and 28 Film-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 Member States of 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

Date of Last Revision of the Leaflet: