Nossin

Package Leaflet: Information for the Patient

Nossin, 5 mg, Film-Coated Tablets

Levocetirizine Dihydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed for You Only. 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 Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Nossin and What is it Used For
• 2. Important Information Before Taking Nossin
• 3. How to Take Nossin
• 4. Possible Side Effects
• 5. How to Store Nossin
• 6. Package Contents and Other Information
• 1. What is Nossin and What is it Used For

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

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

2. Important Information Before Taking Nossin

When Not to Take Nossin

• If You are Allergic to Levocetirizine Dihydrochloride, Cetirizine, Hydroxyzine, or Any of the Other Ingredients of this Medication (Listed in Section 6).
• If You Have Severe Kidney Impairment (Severe Renal Impairment with a Creatinine Clearance of Less than 10 ml/min)

Warnings and Precautions

Before Taking Nossin, Discuss it with Your Doctor or Pharmacist.
If You Have Difficulty Emptying Your Bladder (Such as Spinal Cord Injury or Prostate Enlargement), Consult Your Doctor.
If You Have Epilepsy or are at Risk of Seizures, Consult Your Doctor, as Nossin May Worsen Seizure Control.
If You are Scheduled to Undergo Allergy Testing, Ask Your Doctor if You Need to Stop Taking Nossin a Few Days Before the Test. This Medication May Affect the Results of Allergy Tests.

Children

Nossin is Not Recommended for Children Under 6 Years of Age, as the Tablet Formulation Does Not Allow for Suitable Dose Adjustment.

Nossin and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking, or Have Recently Taken, and Any Medications You Plan to Take.

Nossin with Food, Drink, and Alcohol

Be Cautious When Taking Nossin with Alcohol or Other Substances that Affect Brain Function.
In Sensitive Patients, Concurrent Use of Nossin with Alcohol or Other Substances that Affect Brain Function May Cause Additional Decreased Alertness and Reaction Ability.
Nossin Can be Taken with or Without Food.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant, Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your Doctor Before Taking this Medication.

Driving and Operating Machinery

Some Patients May Experience Drowsiness or Sedation, Fatigue, and Exhaustion When Taking Levocetirizine.
Be Cautious When Driving or Operating Machinery Until You Know How the Medication Affects You. However, Special Tests Conducted in Healthy Volunteers After Taking Levocetirizine at the Recommended Dose Did Not Show an Effect on Attention, Reaction Ability, or Driving Ability.

Nossin Contains Lactose

Nossin Contains Lactose; If You Have Been Diagnosed with Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication.

3. How to Take Nossin

Always Take this Medication Exactly as Your Doctor Has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist.
The Recommended Dose for Adults and Children Over 6 Years is One Film-Coated Tablet per Day.

Special Patient Groups:

Kidney and Liver Impairment
Patients with Kidney Impairment May Need to Have Their Dose Reduced, Depending on the Severity of the Kidney Disease; the Dose Should Also be Adjusted According to Body Weight in Children; the Doctor Will Determine the Dose.
Patients with Severe Kidney Impairment Should Not Take Nossin.
Patients with Liver Impairment Only Should Take the Usual Recommended Dose.
Patients with Both Liver and Kidney Impairment May Need to Have Their Dose Reduced, Depending on the Severity of the Kidney Disease; the Dose Should Also be Adjusted According to Body Weight in Children; the Doctor Will Determine the Dose.
Elderly Patients (65 Years and Over)
No Dose Adjustment is Needed in Elderly Patients with Normal Kidney Function.

Use in Children

Nossin is Not Recommended for Children Under 6 Years of Age.

How and When to Take Nossin

This Medication is for Oral Use Only.
Nossin Tablets Should be Swallowed Whole with Water. The Medication Can be Taken with or Without Food.

How Long to Take Nossin

The Duration of Treatment Depends on the Type, Duration, and Severity of the Disease Symptoms and is Determined by the Doctor.

Overdose of Nossin

If You Take More Than the Recommended Dose, You May Experience Drowsiness as an Adult. In Children, You May Initially Experience Excitement and Restlessness, Especially Motor Restlessness, Followed by Drowsiness.
If You Suspect an Overdose of Nossin, Consult Your Doctor, Who Will Decide What Actions to Take.

Missing a Dose of Nossin

Do Not Take a Double Dose to Make Up for a Forgotten Dose. Wait Until the Next Scheduled Dose and Take the Recommended Dose as Advised by Your Doctor.

Stopping Nossin Treatment

Stopping Nossin Treatment Should Not Cause Harm. However, Rarely, Itching (Intense Itching) May Occur After Stopping Nossin, Even if These Symptoms Did Not Occur Before Starting Treatment. These Symptoms May Resolve on Their Own. In Some Cases, These Symptoms May be Intense and May Require Restarting Treatment. These Symptoms Should Resolve After Restarting Treatment.
If You Have Any Further Questions About the Use of this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Nossin Can Cause Side Effects, Although Not Everybody Gets Them.
Common Side Effects(May Affect up to 1 in 10 People):
Dry Mouth, Headache, Fatigue, Drowsiness or Sedation.
Uncommon Side Effects(May Affect up to 1 in 100 People):
Feeling of Exhaustion, Abdominal Pain.
Side Effects with Unknown Frequency:Cannot be Estimated from the Available Data.
Other Side Effects Have Also Been Reported, Such as: Palpitations, Increased Heart Rate, Seizures, Tingling, Dizziness, Fainting, Tremors, Taste Disturbances (Altered Taste Perception), Feeling of Spinning or Swaying, Vision Disturbances, Blurred Vision, Painful or Difficult Urination, Inability to Fully Empty the Bladder, Edema, Itching, Rash, Urticaria (Swelling, Redness, and Itching of the Skin), Skin Eruptions, Dyspnea, Weight Gain, Muscle Pain, Joint Pain, Excitement and Aggressive Behavior, Hallucinations, Depression, Insomnia, Recurrent Suicidal Thoughts or Interest in Suicide, Nightmares, Hepatitis, Abnormal Liver Function, Vomiting, Increased Appetite, Nausea, and Diarrhea, as Well as Rotatory Eye Movements (Uncontrolled, Circular Movement of the Eyes).
Itching (Intense Itching) Has Been Reported After Stopping Nossin.
If You Notice the First Symptoms of a Hypersensitivity Reaction, Stop Taking Nossin and Inform Your Doctor.
Hypersensitivity Reaction Symptoms May Include: Swelling of the Mouth, Tongue, Face, and (or) Throat, Difficulty Breathing or Swallowing (Chest Tightness or Wheezing), Urticaria, Sudden Decrease in Blood Pressure Causing Collapse or Shock, Which Can be Fatal.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: 22 49-21-301, Fax: 22 49-21-309, E-mail: ndl@urpl.gov.pl.
Side Effects Can Also be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of this Medication.

5. How to Store Nossin

Keep this Medication Out of the Sight and Reach of Children.
Do Not Use this Medication After the Expiry Date Stated on the Blister Pack and Carton After "EXP". The First Two Digits Indicate the Month, and the Last Four Digits Indicate the Year. The Expiry Date Refers to the Last Day of the Month Stated.
Store in the Original Package to Protect from Moisture.
Medicines Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Nossin Contains

• The Active Substance is Levocetirizine. Levocetirizine is Present as Levocetirizine Dihydrochloride (5 mg), Which Corresponds to 4.2 mg of Levocetirizine.
• The Other Ingredients are: Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate (Tablet Core), and Hypromellose, Titanium Dioxide (E 171), and Macrogol 400 (Coating).

What Nossin Looks Like and Contents of the Package

White or Almost White, Oval, Biconvex Film-Coated Tablets with 'L9CZ' Engraved on One Side and '5' on the Other Side.
The Package Contains: 28 or 30 Film-Coated Tablets.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland
Manufacturer

Synthon B.V.

Microweg 22,
6545CM Nijmegen
Netherlands

Synthon Hispania SL

Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat
Spain

Date of Last Revision of the Package Leaflet: