Alcetir

Package Leaflet: Information for the Patient

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

1. What is Alcetyr and What is it Used For

The Active Substance of Alcetyr is Levocetirizine Dihydrochloride.
Alcetyr is an Antihistamine Medication.
It is Used to Treat Symptoms Associated With:

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

2. Important Information Before Taking Alcetyr

When Not to Take Alcetyr:

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

Warnings and Precautions

Before Taking Alcetyr, Discuss with Your Doctor or Pharmacist:

• If You Have Difficulty Urinating (Due to Spinal Cord Injury or Prostate Enlargement).
• If You Have Epilepsy or a Risk of Seizures, as Alcetyr May Worsen Seizure Activity.
• If You are Scheduled to Undergo Allergy Testing. Alcetyr May Affect the Results of Allergy Tests, So You Should Ask Your Doctor if You Should Stop Taking Alcetyr a Few Days Before the Test.

Children

Alcetyr is Not Recommended for Children Under 6 Years of Age, as the Film-Coated Tablets Do Not Allow for Appropriate Dose Adjustment.

Alcetyr 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.

Alcetyr with Food, Drink, and Alcohol

Caution is Advised When Taking Alcetyr with Alcohol or Other Substances that Affect Brain Function.
In Sensitive Patients, Concurrent Use of Cetirizine or Levocetirizine with Alcohol or Other Substances that Affect Brain Function May Cause Additional Decreased Alertness and Reaction Ability.
Alcetyr Can be Taken with or Without Food.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant, Breastfeeding, or Think You May be Pregnant, or are Planning to Have a Baby, Ask Your Doctor for Advice Before Taking this Medication.

Driving and Using Machines

Some Patients Taking Alcetyr May Experience Drowsiness, Fatigue, and Tiredness. Caution is Advised 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.

Alcetyr Contains Lactose

This Medication Contains Lactose. If You Have Been Diagnosed with Intolerance to Some Sugars, You Should Consult Your Doctor Before Taking Alcetyr.

3. How to Take Alcetyr

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, Adolescents, and Children Over 6 Years is One Film-Coated Tablet per Day.

Use in Children

The Recommended Dose for Children Aged 6 Years and Above is One Film-Coated Tablet per Day. Alcetyr is Not Recommended for Children Under 6 Years of Age.

Recommendations for Special Patient Groups:

In Patients with Renal Impairment, the Dose of Alcetyr May be Reduced Depending on the Severity of the Kidney Disease, and in Children, the Dose Will be Adjusted According to Body Weight; the Dose Will be Determined by the Doctor.
Patient with Severe Renal Insufficiency Should Not Take Alcetyr.
Patient with Hepatic Impairment Should Take the Usual Recommended Dose.
In Patients with Both Hepatic and Renal Impairment, a Lower Dose May be Necessary Depending on the Severity of the Kidney Disease. In Children, the Dose Will be Adjusted According to Body Weight; the Dose Will be Determined by the Doctor.
In Elderly Patients, Dose Adjustment is Not Necessary, Provided Their Renal Function is Normal.

When and How to Take Alcetyr?

This Medication is for Oral Use Only.
Swallow the Tablets Whole with Water. Alcetyr Can be Taken with or Without Food.

How Long to Take Alcetyr?

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

Taking More Than the Recommended Dose of Alcetyr

In Case of Overdose, Adults May Experience Drowsiness.
In Children, Initial Excitement and Restlessness, Especially Motor, May Occur, Followed by Drowsiness.
If You Suspect That You Have Taken More Than the Recommended Dose of Alcetyr, Contact Your Doctor, Who Will Decide What Actions Should be Taken.

Missing a Dose of Alcetyr

If You Miss a Dose of Alcetyr, or Take a Lower Dose Than Recommended, Do Not Take a Double Dose to Make Up for the Missed Dose. Take the Next Dose at the Usual Time.

Stopping Alcetyr Treatment

Stopping Treatment with Alcetyr Should Not Have Any Negative Effects. In Rare Cases, After Stopping Treatment, Itching (Intense Itching) May Occur, 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 Resumption of Treatment. These Symptoms Should Resolve After Resuming 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, Alcetyr Can Cause Side Effects, Although Not Everybody Gets Them.
Common: May Affect Up to 1 in 10 People
Dry Mouth, Headache, Fatigue, and Drowsiness or Drowsiness.
Uncommon: May Affect Up to 1 in 100 People
Feeling of Exhaustion and Abdominal Pain.
Frequency Not Known: Frequency Cannot be Estimated from the Available Data
Other Side Effects, Such as: Palpitations, Rapid Heart Rate, Seizures, Tingling, Dizziness, Fainting, Shaking, Taste Disorders (Taste Disturbances), Feeling of Spinning or Swaying, Vision Disorders, Blurred Vision, Rotatory Eye Movements (Uncontrolled Rotatory Eye Movement), Painful or Difficult Urination, Inability to Completely Empty the Bladder, Edema, Itching (Itching), Rash, Urticaria (Swelling, Redness, and Itching of the Skin), Skin Eruptions, Shortness of Breath, Weight Gain, Muscle Pain, Joint Pain, Aggressive Behavior or Excitement, Hallucinations, Depression, Insomnia, Recurring Suicidal Thoughts or Interest in Suicide, Nightmares, Hepatitis, Liver Function Disorders, Vomiting, Increased Appetite, Nausea, Diarrhea Have Also Been Reported.
Itching (Intense Itching) After Stopping Treatment.
If You Notice the First Symptoms of a Hypersensitivity Reaction, Stop Taking Alcetyr and Seek Medical Attention Immediately. Symptoms of a Hypersensitivity Reaction May Include:
Swelling of the Mouth, Tongue, Face, and (or) Throat, Difficulty Breathing or Swallowing (Chest Tightness or Wheezing) with Urticaria, Sudden Decrease in Blood Pressure Leading to Fainting 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: (22) 49 21 301, Fax: (22) 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side Effects Can Also be Reported to the Marketing Authorization Holder.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Alcetyr

Keep this Medication Out of the Sight and Reach of Children.
Do Not Use this Medication After the Expiration Date Stated on the Carton and Blister After: EXP.
The Expiration Date Refers to the Last Day of the Month.
There are No Special Precautions for Storage.
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 Alcetyr Contains

• The Active Substance is Levocetirizine Dihydrochloride. Each Film-Coated Tablet Contains 5 mg of Levocetirizine Dihydrochloride.
• The Other Ingredients are: Lactose Monohydrate, Microcrystalline Cellulose, Colloidal Anhydrous Silica, Magnesium Stearate, Hypromellose (15 cP), Titanium Dioxide (E 171), Talc, Macrogol 400.

What Alcetyr Looks Like and Contents of the Package

White or Almost White, Biconvex, Oval Film-Coated Tablets with a Score Line, with "5" Engraved on One Side and Smooth on the Other Side.
PVC/PVDC/Aluminum Blister Pack, in a Cardboard Box.
The Package Contains 28 Film-Coated Tablets.

Marketing Authorization Holder:

Artespharm Sp. z o.o.
Solec Street 81 B, Apt. A-51,
00-382 Warsaw, Poland

Importer:

Mako Pharma Sp. z o.o.
Wiśniowa Street 9,
05-092 Kiełpin

Date of Last Revision of the Package Leaflet: