Package leaflet: Information for the patient

Envil katar, (1.5 mg + 2.5 mg)/mL, nasal spray, solution
Mepyramini maleas + Phenylephrini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if your condition worsens, contact your doctor.

Table of contents

What Envil katar is and what it is used for
Important information before using Envil katar
How to use Envil katar
Possible side effects
How to store Envil katar
Contents of the pack and other information

1. What Envil katar is and what it is used for

Envil katar contains two active substances: mepyramine maleate and phenylephrine hydrochloride.
Mepyramine has antihistamine and antiallergic properties, while phenylephrine reduces congestion of the mucous membrane, clears the nasal passages and sinus openings.
Additionally, the excipient cetalkonium chloride has antibacterial properties.
Envil katar relieves nasal discharge, clears the nose and sinus openings, facilitates breathing, and exerts antibacterial action.
Envil katar is indicated for the treatment of:

Rhinitis (nasal discharge) in inflammation of the nasal mucosa, including allergic rhinitis (allergy);
Sinusitis.

If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

2. Important information before using the medicine Envil katar

When not to use the medicine Envil katar

if the patient is allergic to mepiramine maleate, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
if the patient has asthma or atrophic rhinitis (dry nasal mucosa);
in children under 6 years of age;
during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with the medicine Envil katar, discuss this with a doctor or pharmacist:

when using the medicine in children;
if the patient is elderly;
if the patient has heart disease;
if the patient has hypertension;
if the patient has diabetes;
if the patient has a pheochromocytoma;
if the patient has hyperthyroidism;
if the patient has benign prostatic hyperplasia;
if the patient has narrow-angle glaucoma;
if the patient is taking or has recently taken medicines used to treat depression called monoamine oxidase inhibitors (selegiline, moklobemide, amiflamine), the medicine Envil katar may be used only after at least 14 days have passed since stopping treatment with these medicines, unless otherwise advised by a doctor.

Prolonged use of the medicine may lead to nasal mucosa hyperaemia and rebound rhinitis (medication-induced rhinitis).
Children
Do not use in children under 6 years of age.
Interaction of Envil katar with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient intends to take.
If the patient is taking any of the following medicines, dosage adjustment or discontinuation of treatment may be necessary:

barbiturates, hypnotics and sedatives, atropine, tricyclic antidepressants (imipramine, opipramol, amitriptyline, doxepin, mianserine) – the medicine Envil katar may enhance their effects;
certain β-blockers, such as esmolol, may enhance the effect of phenylephrine, a component of Envil katar, which may lead to severe hypertension in some patients;
monoamine oxidase inhibitors, such as selegiline, moklobemide, amiflamine, prolong and intensify the effect of the medicine Envil katar.

Envil katar with food, drink and alcohol
The medicine Envil katar can be taken regardless of meals.
The medicine Envil katar may enhance the effects of alcohol.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
The medicine Envil katar must not be used during pregnancy and breastfeeding.
Driving and operating machinery
The medicine Envil katar has a minor or moderate effect on the ability to drive and operate machinery. If headache, dizziness or drowsiness occur, the patient should not drive or operate machinery.
Envil katar contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions). It may cause mild irritation of the skin, eyes and mucous membranes.

3. How to use Envil katar

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is for nasal use.
Shake well 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 medicine more than 5 times daily or for longer than 3 days.
If there is no improvement after 3 days, or if symptoms worsen, consult a doctor.
Prolonged use of the medicine may lead to nasal mucosal hyperemia and rebound rhinitis.
Children under 6 years of age:
This medicine should not be used in children under 6 years of age.
Overdose of Envil katar
In case of overdose, consult a doctor.
Symptoms of overdose may occasionally include headache, dizziness, sleep disturbances, difficulty in urination, and cardiac arrhythmias.
Missed dose of Envil katar
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur during treatment with Envil katar:

tachycardia (increased heart rate), palpitations (irregular, rapid heartbeat), arrhythmia (heart rhythm disturbances);
headache, dizziness, drowsiness, sedation, insomnia, fatigue;
diarrhoea, nausea, constipation, vomiting;
arterial hypertension;
irritation and hyperaemia of nasal mucosa, dryness of mucous membranes, drug-induced rhinitis.
The frequency of occurrence of the above-mentioned adverse reactions cannot be determined based on the available data.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables the collection of further information on the safety of the medicine.

5. How to store Envil katar

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and label. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Envil katar contains

The active substances are: mepyramine maleate and phenylephrine hydrochloride. 1 mL of nasal aerosol contains 1.5 mg of mepyramine maleate and 2.5 mg of phenylephrine hydrochloride. A single sprayed dose contains 0.15 mg of mepyramine maleate and 0.25 mg of phenylephrine hydrochloride.
Other ingredients: glycerol, sodium chloride, cetalkonium chloride, methyl parahydroxybenzoate, propyl parahydroxybenzoate, polysorbate 20, purified water.

What Envil katar looks like and contents of the pack
Envil katar is a nasal aerosol.
A 30 mL polyethylene bottle with an atomizer in a cardboard box containing 15 mL or 20 mL of the medicinal product, or a 20 mL high-density polyethylene (HDPE) bottle with a spray pump (low-density polyethylene LDPE, polypropylene PP, silicone, stainless steel) and a nasal applicator (polypropylene PP) in a cardboard box containing 10 mL, 15 mL or 20 mL of the medicinal product.

Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100