ENVIL 1.5 mg/2.5 mg Aerosol

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
2. What is Envil Katar and What is it Used for
3. Important Information Before Using Envil Katar
   1. When Not to Use Envil Katar
   2. Warnings and Precautions
   3. Children
   4. Envil Katar and Other Medications
   5. Envil Katar with Food, Drink, and Alcohol
   6. Pregnancy and Breastfeeding
   7. Driving and Operating Machinery
   8. Envil Katar Contains Methyl Parahydroxybenzoate and Propyl Parahydroxybenzoate
4. How to Use Envil Katar
   1. Recommended Dose
   2. Do Not Use the Medication More than 5 Times a Day or for More than 3 Days.
   3. Using a Higher than Recommended Dose of Envil Katar
   4. Missing a Dose of Envil Katar
5. Possible Side Effects
   1. Reporting Side Effects
6. How to Store Envil Katar
7. Contents of the Package and Other Information
   1. What Envil Katar Contains
   2. What Envil Katar Looks Like and What the Package Contains
   3. Marketing Authorization Holder and Manufacturer
   4. Date of the Last Update of the Package Leaflet:

Package Leaflet: Information for the Patient

Envil Katar, (1.5 mg + 2.5 mg)/mL, Nasal Spray, Solution
Mepyramine Maleate + Phenylephrine Hydrochloride

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

This Medication Should Always be Used Exactly as Described in this Package Leaflet or as Directed by a Doctor or Pharmacist.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or You Feel Worse after 3 Days, Consult a Doctor.

Table of Contents of the Package Leaflet

• 1. What is Envil Katar and What is it Used for
• 2. Important Information Before Using Envil Katar
• 3. How to Use Envil Katar
• 4. Possible Side Effects
• 5. How to Store Envil Katar
• 6. Contents of the Package and Other Information

1. What is Envil Katar and What is it Used for

Envil Katar Contains Two Active Substances: Mepyramine Maleate and Phenylephrine Hydrochloride.
Mepyramine has Antihistamine and Anti-Allergic Effects, and Phenylephrine Reduces Nasal Congestion and Facilitates Nasal and Sinus Passage.
In Addition, the Excipient Chlorhexidine has Antibacterial Properties.
Envil Katar Relieves Rhinitis, Facilitates Nasal and Sinus Passage, Eases Breathing, and has Antibacterial Effects.
Envil Katar is Indicated for the Treatment of:

• Rhinitis (Runny Nose) in Nasal Mucosa Inflammation, Including Allergic Rhinitis;
• Sinusitis.

If There is no Improvement or You Feel Worse after 3 Days, Consult a Doctor.

2. Important Information Before Using Envil Katar

When Not to Use Envil Katar

• If You are Allergic to Mepyramine Maleate, Phenylephrine Hydrochloride, or any of the Other Ingredients of this Medication (Listed in Section 6);
• If You Have Asthma or Atrophic Rhinitis (Dry Nasal Mucosa);
• In Children Under 6 Years of Age;
• During Pregnancy and Breastfeeding.

Warnings and Precautions

Before Starting to Use Envil Katar, Discuss it with Your Doctor or Pharmacist:

• In Case of Using the Medication in Children;
• If You are an Elderly Person;
• If You Have Heart Disease;
• If You Have High Blood Pressure;
• If You Have Diabetes;
• If You Have a Pheochromocytoma;
• If You Have Hyperthyroidism;
• If You Have Prostatic Hyperplasia;
• If You Have Narrow-Angle Glaucoma;
• If You are Taking or Have Taken Medications Used to Treat Depression, Called Monoamine Oxidase Inhibitors (Selegiline, Moclobemide, Amiflamine), Envil Katar can be Used Only After at Least 14 Days have Passed Since the End of Therapy with these Medications, Unless Otherwise Directed by a Doctor.

Long-Term Use of the Medication may Cause Nasal Congestion and Drug-Induced Rhinitis.

Children

Do Not Use in Children Under 6 Years of Age.

Envil Katar and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take.
If You are Taking any of the Following Medications, it may be Necessary to Change the Dose or Discontinue Treatment:

• Barbiturates, Sedatives, and Hypnotics, Atropine, Tricyclic Antidepressants (Imipramine, Opipramol, Amitriptyline, Doxepin, Mianserin) - Envil Katar may Enhance their Effects;
• Certain β-Adrenolytics, Such as Esmolol, may Enhance the Effect of Phenylephrine, a Component of Envil Katar, which may Cause Severe Hypertension in Some Patients;
• Monoamine Oxidase Inhibitors, Such as Selegiline, Moclobemide, Amiflamine, Prolong and Enhance the Effect of Envil Katar.

Envil Katar with Food, Drink, and Alcohol

Envil Katar can be Used Independently of Food and Drink.
Envil Katar may Enhance the Effect of Alcohol.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You may be Pregnant, or are Planning to Have a Child, Consult a Doctor Before Using this Medication.
Envil Katar Should Not be Used During Pregnancy and Breastfeeding.

Driving and Operating Machinery

Envil Katar has a Minor or Moderate Influence on the Ability to Drive and Operate Machinery.
If You Experience Headache, Dizziness, Drowsiness, Do Not Drive or Operate Machinery.

Envil Katar Contains Methyl Parahydroxybenzoate and Propyl Parahydroxybenzoate

The Medication may Cause Allergic Reactions (Possible Late Reactions).
The Medication may Cause Minor Skin, Eye, and Mucous Membrane Irritation.

3. How to Use Envil Katar

This Medication Should Always be Used Exactly as Described in this Package Leaflet or as Directed by a Doctor or Pharmacist.
In Case of Doubt, Consult a Doctor or Pharmacist.
The Medication is Administered Intranasally.
Shake Before Use.

Recommended Dose

Adults, Adolescents, and Children Over 6 Years of Age:
2 Sprays into Each Nostril Every 4 to 6 Hours.

Do Not Use the Medication More than 5 Times a Day or for More than 3 Days.

If There is no Improvement or You Feel Worse after 3 Days, Consult a Doctor.
Long-Term Use of the Medication may Cause Nasal Congestion and Drug-Induced Rhinitis.
Children Under 6 Years of Age:
Do Not Use the Medication in Children Under 6 Years of Age.

Using a Higher than Recommended Dose of Envil Katar

In Case of Using a Higher than Recommended Dose, Consult a Doctor.
In Case of Overdose, the Following may Occur: Headache, Dizziness, Sleep Disturbances, Difficulty Urinating, Heart Rhythm Disturbances.

Missing a Dose of Envil Katar

Do Not Use a Double Dose to Make Up for a Missed Dose.
In Case of any Further Doubts Regarding the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Envil Katar can Cause Side Effects, Although not Everybody Gets them.
The Following Side Effects may Occur During the Use of Envil Katar:

• Tachycardia (Rapid Heart Rate), Palpitations (Irregular, Rapid Heartbeat), Arrhythmia (Heart Rhythm Disturbances);
• Headache, Dizziness, Drowsiness, Sedation, Insomnia, Weakness;
• Diarrhea, Nausea, Constipation, Vomiting;
• Hypertension;
• Nasal Mucosa Irritation and Congestion, Dryness of the Mucous Membranes, Drug-Induced Rhinitis.
  The Frequency of the Above Side Effects Cannot be Determined from the Available Data.

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 Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.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 the Medication.

5. How to Store Envil Katar

Store the Medication Out of Sight and Reach of Children.
Do Not Use this Medication After the Expiration Date Stated on the Carton and Label.
Store in a Temperature Below 25°C.
Medications Should Not be Disposed of via Wastewater or Household Waste.
Ask Your Pharmacist How to Dispose of Medications that are no Longer Needed.
This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Envil Katar Contains

• The Active Substances of the Medication are: Mepyramine Maleate and Phenylephrine Hydrochloride.
  1 mL of Nasal Spray Contains 1.5 mg of Mepyramine Maleate and 2.5 mg of Phenylephrine Hydrochloride.
  A Single Spray Contains 0.15 mg of Mepyramine Maleate and 0.25 mg of Phenylephrine Hydrochloride.
• The Other Ingredients are: Glycerol, Sodium Chloride, Chlorhexidine, Methyl Parahydroxybenzoate, Propyl Parahydroxybenzoate, Polysorbate 20, Purified Water.

What Envil Katar Looks Like and What the Package Contains

Envil Katar is a Nasal Spray.
A 30 mL Polyethylene Bottle with an Atomizer in a Carton Containing 15 mL or 20 mL of the Medication, or a 20 mL Polyethylene (HDPE) Bottle with a Spray Pump (Low-Density Polyethylene LDPE, Polypropylene PP, Silicone, Stainless Steel) with a Nasal Applicator (Polypropylene PP) in a Carton Containing 10 mL, 15 mL, or 20 mL of the Medication.

Marketing Authorization Holder and Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: (42) 22-53-100

Date of the Last Update of the Package Leaflet: