Envil kashel

Package Leaflet: Information for the Patient

Envil Cough, 30 mg/5 ml, Syrup

Ambroxol Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Envil Cough and what is it used for
• 2. Important information before taking Envil Cough
• 3. How to take Envil Cough
• 4. Possible side effects
• 5. How to store Envil Cough
• 6. Contents of the pack and other information

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

Envil Cough contains the active substance ambroxol hydrochloride, which has expectorant and mucolytic properties in the respiratory tract. The medication is in the form of a syrup for oral use.

Indications

Supportive treatment in acute and chronic respiratory diseases with difficulty in expectorating viscous bronchial secretions, e.g., chronic bronchitis, asthma, bronchiectasis, mucoviscidosis, bronchitis, laryngitis.
If there is no improvement or the patient feels worse after 4 to 5 days, they should consult their doctor.

2. Important information before taking Envil Cough

When not to take Envil Cough

• if the patient is allergic to ambroxol hydrochloride or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Before starting treatment with Envil Cough, the patient should discuss it with their doctor or pharmacist:

• if the patient has gastric or duodenal ulcers;
• if the patient has kidney or liver function disorders;
• if the patient has a weakened cough reflex (difficulty in expectorating) or impaired mucociliary clearance of the bronchi, due to the risk of secretions accumulating;
• if the patient has asthma, as ambroxol may initially exacerbate cough and cause excessive expectoration of secretions.

At the beginning of treatment, an excessive amount of fluid secretions from the respiratory tract may occur.
In such cases, the patient should be encouraged to cough to expel the secretions. It may be necessary to aspirate the secretions, in which case the patient should consult their doctor.
Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash occurs (including changes in mucous membranes, such as the mouth, throat, nose, eyes, genitals), the patient should stop taking Envil Cough and immediately consult their doctor.

Envil Cough and other medications

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

• antibiotics(medications used to treat infections, such as amoxicillin, erythromycin, ampicillin, doxycycline, and cefuroxime), as ambroxol increases their penetration into the lungs and enhances their effect;
• theophylline(a medication used to treat asthma), as it enhances the effect of ambroxol;
• cough suppressants(used to treat dry, irritating cough), as they may inhibit the cough reflex and cause secretions to accumulate in the respiratory tract.

Taking Envil Cough with food and drink

Envil Cough should be taken after a meal.
The medication should not be taken before bedtime.

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 medication.
The use of this medication is not recommended during pregnancy, as it may be harmful to the fetus.
The use of this medication is not recommended during breastfeeding, as it passes into breast milk.

Driving and using machines

The medication has no or negligible influence on the ability to drive and use machines. If dizziness occurs, the patient should not drive vehicles, operate machinery, or perform other activities that require concentration.

Envil Cough contains propylene glycol (E1520), benzoic acid (E210), liquid, non-crystallizing sorbitol (E420), sodium, and ethanol

Propylene glycol (E1520)

The medication contains 152.03 mg of propylene glycol in each 5 ml of syrup.

Benzoic acid (E210)

The medication contains 10 mg of benzoic acid in each 5 ml of syrup.

Liquid, non-crystallizing sorbitol (E420)

The medication contains 2500 mg of sorbitol in each 5 ml of syrup.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medication or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.

Sodium

The medication contains 0.168 mg of sodium in each 5 ml of syrup.
The medication contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, which means the medication is considered "sodium-free".

Etanol

This medication contains 0.02 micrograms of alcohol (ethanol) in 5 ml of syrup. The amount of alcohol in 5 ml of this medication is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medication will not produce noticeable effects.

3. How to take Envil Cough

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose

Recommended doses are used in the treatment of acute respiratory diseases and in the initial period of treatment of chronic conditions.
In long-term treatment (more than 14 days), the dose can be reduced to half.

Adults and adolescents over 12 years of age:

5 ml of syrup 3 times a day for the first 2 to 3 days of treatment, then 5 ml of syrup 2 times a day.
If symptoms worsen or do not improve after 4 to 5 days, the patient should consult their doctor.

Method of administration

The medication should be taken orally.
The medication should be taken after a meal.
The medication should not be taken before bedtime.
A measuring cup is attached to the packaging to facilitate dosing, with which the medication should be measured.
The syrup does not contain sugar.

Taking a higher dose of Envil Cough than recommended

In case of taking a higher dose of the medication than recommended, the patient should consult their doctor.
Overdose symptoms may occur: nausea, fatigue, excessive secretion of mucus from the bronchi.

Missing a dose of Envil Cough

The patient should take the syrup as soon as possible and take the next dose at the usual time.
A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Envil Cough can cause side effects, although not everybody gets them.

The patient should stop taking Envil Cough and immediately consult their doctor if they experience:

• anaphylactic shock (rash on the skin, itching of the hands and feet covering the whole body, swelling of the face, lips, or throat that makes breathing difficult, wheezing, shortness of breath, unnoticeable pulse, significantly low blood pressure, sweating, cold limbs, loss of consciousness, cardiac arrest).

The following side effects may occur

Rarely:may occur in up to 1 in 1,000 people:

• allergic reactions;
• rash, urticaria;
• pain and burning during urination (dysuria).

Frequency not known:frequency cannot be estimated from the available data

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membrane, or submucosal tissue), and itching;
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
• heartburn, indigestion;
• nausea, vomiting;
• diarrhea, constipation;
• skin changes, fever, shortness of breath, chills, facial swelling, headache;
• dryness of the mucous membrane of the mouth due to lack of saliva production (xerostomia).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they 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 to gather more information on the safety of the medication.

5. How to store Envil Cough

The medication should be stored out of sight and reach of children.
Store in a temperature below 25°C. Do not freeze. Store in the original packaging to protect from light.
Do not use this medication after the expiry date stated on the label and carton.
The expiry date refers to the last day of the month stated.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Envil Cough contains

• The active substance of the medication is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
• Other ingredients are: hydroxyethylcellulose, sorbitol, liquid, non-crystallizing (E420), glycerol (E422), propylene glycol (E1520), sodium saccharin (E954), benzoic acid (E210), Tutti-Frutti AR1459 flavor (contains, among others, propylene glycol, linalool, ethanol), purified water.

What Envil Cough looks like and what the pack contains

Envil Cough is a syrup.
The medication packaging is a brown glass bottle containing 100 ml or 120 ml of syrup, closed with an aluminum cap with a measuring cup, in a cardboard box.

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 last revision of the leaflet: