Envil gardvo

Leaflet attached to the packaging: patient information

Envil throat

1.5 mg + 1.0 mg + 17.42 mg, lozenges
Cetylpyridinium chloride + Lidocaine hydrochloride monohydrate + Zinc gluconate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Envil throat and what is it used for
• 2. Important information before taking Envil throat
• 3. How to take Envil throat
• 4. Possible side effects
• 5. How to store Envil throat
• 6. Package contents and other information

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

Envil throat is a lozenge that has antiseptic (disinfecting) and local anesthetic effects.
It contains three active substances:

• cetylpyridinium chloride, which has disinfecting, antibacterial, and antifungal effects;
• lidocaine hydrochloride monohydrate, which has a local anesthetic effect, relieving pain;
• zinc gluconate, which supports the body's immune system.

Indications for use:

An antiseptic and local anesthetic product with zinc for use in inflammatory conditions of the throat and mouth.
Envil throat may be used as an adjunct in the treatment of upper respiratory tract infections associated with sore throat and tonsillitis (angina).

2. Important information before taking Envil throat

When not to take Envil throat

• if the patient is allergic to cetylpyridinium chloride, lidocaine hydrochloride monohydrate, zinc gluconate (active substances of the medicine), other local anesthetics 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 failure;
• if the patient has methemoglobinemia - a very rare blood disease 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 taking Envil throat, the patient should discuss it with their doctor or pharmacist:

• if the patient has a throat infection and a persistent fever;
• if the patient has a sore throat with fever, dizziness, nausea, or vomiting.

Children

Envil throat should not be used in children under 6 years of age.

Envil throat with other medicines

The patient should inform their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking:

• acetylsalicylic acid (a substance found in medicines used to lower fever);
• sulfonamides (medicines used to treat bacterial infections);
• cimetidine (a medicine used to treat stomach and duodenal ulcers);
• β-adrenolytics (medicines used to treat high blood pressure and coronary heart disease, e.g., propranolol);
• norepinephrine;
• inhalation anesthetics (medicines used for general anesthesia);
• barbiturates (medicines used to treat insomnia and epilepsy);
• rifampicin (an antibiotic used to treat tuberculosis and some other infections);
• phenytoin (a medicine used to treat epilepsy);
• muscle relaxants (e.g., pancuronium);
• tetracycline antibiotics (medicines used to treat bacterial infections);
• chelating agents (medicines used to treat lead poisoning, such as D-penicillamine);
• ibuprofen or indomethacin (pain relievers belonging to the group of nonsteroidal anti-inflammatory drugs - NSAIDs);
• thiazide diuretics (medicines that increase urine production);
• corticosteroids (medicines used to treat rheumatic diseases);
• medicines and dietary supplements containing calcium, iron, and copper.

Envil throat with food and drink

The medicine should not be taken while eating or immediately before eating, due to the risk of choking.
The medicine is best taken 1 hour before or 1 hour after a meal.
Care should be taken when drinking hot beverages and eating hot foods.
Due to decreased sensitivity to heat, the risk of burning the mucous membrane of the mouth and throat increases.
During treatment with Envil throat, dairy products should not be consumed, as they reduce zinc absorption.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Envil throat is not recommended for use during pregnancy or in women of childbearing age who are not using effective contraception.
The medicine should not be used in breastfeeding women.

Driving and operating machinery

There is no data on the effect of the medicine on the ability to drive and operate machinery.

Envil throat contains aspartame, mannitol, and sodium

Aspartame
The medicine contains 4.8 mg of aspartame in each lozenge.
Aspartame is a source of phenylalanine.
It may be harmful to patients with phenylketonuria.
This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
Mannitol
The medicine may have a mild laxative effect.
Sodium
The medicine contains 2.712 mg of sodium in each lozenge.
The medicine contains less than 1 mmol (23 mg) of sodium in one lozenge, which means the medicine is considered "sodium-free".

3. How to take Envil throat

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.

Duration of treatment

Do not take the medicine for more than 5 consecutive days without consulting a doctor.

Method of administration

The lozenge should be slowly sucked in the mouth.
It should not be chewed or swallowed.

Recommended dose

Adults: slowly suck one lozenge every 1 or 2 hours.
Do not exceed the dose of 8 lozenges per day.
Children over 6 years of age: slowly suck one lozenge every 2 or 3 hours.
Do not exceed the dose of 6 lozenges per day.

Use in children

Envil throat should not be used in children under 6 years of age.

Overdose of Envil throat

In case of overdose, the patient should contact their doctor or pharmacist.
The following symptoms of overdose may occur:
nausea, vomiting, abdominal pain, diarrhea, metallic taste in the mouth, headache, collapse (cardiac arrest with loss of consciousness), seizures, coma.

Missed dose of Envil throat

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Envil throat can cause side effects, although not everybody gets them.
Uncommon(occurring in 1 to 10 people per 1,000):

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

Rare(occurring in 1 to 10 people per 10,000):

• severe skin reactions, such as: blistering or pustular rash, which may spread or become generalized;
• hives;
• increased sensitivity to sunlight;
• headache;
• gastrointestinal disorders (nausea, abdominal pain, diarrhea);
• vomiting, metallic taste in the mouth;
• inflammation of the oral mucosa.

Very rare(occurring less frequently than in 1 person per 10,000):

• worsening of existing kidney failure.

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

• seizures.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 gather more information on the safety of the medicine.

5. How to store Envil throat

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Package contents and other information

What Envil throat contains

• The active substances of the medicine are: cetylpyridinium chloride, lidocaine hydrochloride monohydrate, zinc gluconate.
  One lozenge contains: 1.5 mg of cetylpyridinium chloride, 1.0 mg of lidocaine hydrochloride monohydrate, and 17.42 mg of zinc gluconate (which corresponds to 2.5 mg of zinc ions).
• The other ingredients are: levomenthol, microcrystalline cellulose, mannitol, povidone, aspartame, citric acid, sodium croscarmellose, talc, magnesium stearate, glycerol.

What Envil throat looks like and what the package contains

Envil throat is a white, flat lozenge.
The lozenges are packaged in blisters.
The package contains 10, 20, or 60 lozenges in a cardboard box with a leaflet.

Marketing authorization holder

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

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
Date of last revision of the leaflet:24.08.2021