Package leaflet: Information for the user

Envil gardło
1.5 mg + 1.0 mg + 17.42 mg, lozenges for sucking
Cetylpyridinii chloridum + Lidocaini hydrochloridum monohydricum + Zinci gluconas
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days, or if your symptoms worsen, you should contact your doctor.

Contents of the leaflet

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

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

Envil gardło is available as lozenges for sucking. It has antiseptic and local anaesthetic properties.
It contains three active substances:

Cetylpyridinium chloride, which has antiseptic, bactericidal and antifungal effects;
Lidocaine hydrochloride monohydrate, which provides local anaesthesia and relieves pain;
Zinc gluconate, which supports the body's immune system.

Indications:
An antiseptic and locally anaesthetic product with zinc, intended for use in inflammatory conditions of the throat and oral cavity.
Envil gardło may be used as an adjunct in the treatment of upper respiratory tract infections associated with sore throat and in tonsillitis (angina).

2. Important information before using Envil gardło

When not to use Envil gardło

if the patient is allergic to cetylpyridinium chloride, lidocaine hydrochloride monohydrate, zinc gluconate (the active ingredients of the medicine), other local anaesthetics from the amide group, or any of the other ingredients of this medicine (listed in section 6);
if the patient has severe liver or kidney impairment;
if the patient suffers from methaemoglobinaemia – a very rare blood disorder in which the blood loses its ability to carry oxygen to the body's cells;
in children under 6 years of age.

Warnings and precautions
Before starting treatment with Envil gardło, consult a doctor or pharmacist:

if the patient has a sore throat accompanied by fever persisting for several days;
if the patient has a sore throat associated with fever, dizziness, nausea, or vomiting.

Children
Envil gardło must not be used in children under 6 years of age.
Envil gardło and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is using:

acetylsalicylic acid (a substance found in medicines used to reduce fever);
sulfonamides (medicines used to treat, among others, bacterial infections);
cimetidine (a medicine used in the treatment of peptic ulcer disease);
-adrenolytics (medicines used to treat, among others, hypertension and ischaemic heart disease, e.g. propranolol);
norepinephrine;
inhalational anaesthetics (medicines used for general anaesthesia);
barbiturates (medicines used to treat insomnia and epilepsy);
rifampicin (an antibiotic used to treat tuberculosis and certain other infections);
phenytoin (a medicine used to treat epilepsy);
skeletal muscle relaxants (e.g. pancuronium);
tetracycline antibiotics (medicines used in bacterial infections);
chelating agents (medicines used, for example, in lead poisoning, such as D-penicillamine);
ibuprofen or indomethacin (analgesic medicines belonging to the group of non-steroidal anti-inflammatory drugs – NSAIDs);
thiazide diuretics (medicines increasing urine production);
corticosteroids (medicines used, among others, in the treatment of rheumatic diseases);
medicines and dietary supplements containing calcium, iron, and copper.

Envil gardło with food and drink
Do not take the medicine during meals or immediately before eating, due to the risk of choking. It is best to take the medicine one hour before or one hour after a meal.
Exercise caution when drinking hot beverages or eating hot food. Due to reduced sensitivity to heat, the risk of thermal injury to the oral mucosa and throat is increased.
During treatment with Envil gardło, do not consume dairy products, as they reduce zinc absorption.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Envil gardło is not recommended for use during pregnancy or in women of childbearing potential who are not using effective contraception.
The medicine must not be used in breastfeeding women.
Driving and operating machinery
There is no data available on the effects of the medicine on the ability to drive or operate machinery.
Envil gardło contains aspartame (E 951), glucose, and sodium
Aspartame
The medicine contains 4.8 mg of aspartame in each tablet.
Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
Glucose (as a component of maltodextrin)
The medicine contains 7.98 mg of glucose in each tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Sodium
The medicine contains 2.712 mg of sodium in each tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Envil gardło

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.
Duration of treatment
Do not use for longer than 5 consecutive days without consulting a doctor.
Method of administration
The tablet should be slowly sucked in the mouth. Do not chew or swallow the tablet.
Recommended dose
Adults: slowly suck one tablet every 1 or 2 hours.
Do not exceed 8 tablets per day.
Children over 6 years of age: slowly suck one tablet every 2 or 3 hours.
Do not exceed 6 tablets per day.
Use in children
Envil gardło should not be used in children under 6 years of age.
Overdose of Envil gardło
If more than the recommended dose has been taken, contact a doctor or pharmacist.
Symptoms of overdose may include:
nausea, vomiting, abdominal pain, diarrhoea, metallic taste in the mouth, headache, collapse (circulatory failure with loss of consciousness), convulsions, coma.
Missed dose of Envil gardło
Do not take 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 all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Uncommon (occur in 1 to 10 people in 1,000):

local skin reactions such as: redness, itching, rash, burning sensation.

Rare (occur in 1 to 10 people in 10,000):

severe skin reactions such as: blistering or acneiform rash, which may spread or become generalized;
urticaria;
photosensitivity;
headache;
gastrointestinal disturbances (nausea, abdominal pain, diarrhoea);
vomiting, metallic taste in the mouth;
inflammation of the oral mucosa.

Very rare (occur in fewer than 1 person in 10,000):

worsening of pre-existing renal insufficiency.

Frequency not known (cannot be estimated from the available data):

convulsions.

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 Adverse Drug Reactions, 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 helps provide more information on the safety of the medicine.

5. How to store Envil gardło

Keep this medicine out of the sight and reach of children.
Store below 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
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. Contents of the packaging and other information

What Envil gardło contains

The active substances in the medicine are: cetylpyridinium chloride, lidocaine hydrochloride monohydrate, zinc gluconate. Each lozenge contains: 1.5 mg cetylpyridinium chloride, 1.0 mg lidocaine hydrochloride monohydrate, and 17.42 mg zinc gluconate (corresponding to 2.5 mg zinc ions).
Other components: microcrystalline cellulose, mannitol (E 421), povidone, aspartame (E 951), citric acid, sodium croscarmellose, talc, magnesium stearate, glycerol (E 422), mint flavouring
(menthol, peppermint oil, spearmint oil, propylene glycol (E 1520), maltodextrin, gum arabic (E 414)).

What Envil gardło looks like and contents of the pack
Envil gardło is a white, flat-shaped lozenge.
The lozenges are packed in blisters. The packaging contains 10, 20 or 60 lozenges in a cardboard box with a leaflet.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel.: +48 42 22-53-100
{logo of the marketing authorisation holder}

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów