Envil kashel

Leaflet attached to the packaging: patient information

Envil cough, 30 mg, tablets

Ambroxol hydrochloride

Please 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 the patient leaflet, or as advised by a doctor or pharmacist.

• The 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 any possible side effects not listed in the 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 medicine and what is it used for
• 2. Important information before taking Envil cough medicine
• 3. How to take Envil cough medicine
• 4. Possible side effects
• 5. How to store Envil cough medicine
• 6. Package contents and other information

1. What is Envil cough medicine and what is it used for

Envil cough medicine contains the active substance – ambroxol hydrochloride, which has expectorant and mucolytic properties in the respiratory tract. The medicine is in the form of tablets.

Indications for use

As an adjunct in acute and chronic respiratory diseases with difficulty in expectorating viscous bronchial secretions, such as chronic bronchitis, asthma, bronchiectasis, cystic fibrosis, bronchitis, pneumonia, laryngitis.
If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

2. Important information before taking Envil cough medicine

When not to take Envil cough medicine

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

Warnings and precautions

Before starting to take Envil cough medicine, the patient should discuss it with their doctor or pharmacist:

• if the patient has stomach or duodenal ulcers;
• if the patient has kidney or liver function disorders;
• if the patient has a weakened cough reflex (difficulty in expectorating) or disorders of ciliary clearance of the bronchi, due to the possibility 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 appear.
In such a case, the patient should induce coughing to expectorate it. 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 appears (including changes in mucous membranes, e.g. mouth, throat, nose, eyes, genitals), the patient should stop taking Envil cough medicine and immediately contact their doctor.

Envil cough medicine and other medicines

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

• antibiotics(medicines 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 medicine 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.

If the patient is unsure whether they are taking any of the above medicines, they should consult their doctor or pharmacist.

Taking Envil cough medicine with food and drink

Envil cough medicine should be taken after a meal.
The medicine 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 medicine.
The use of this medicine is not recommended during pregnancy, as it may be harmful to the fetus.
The use of this medicine is not recommended during breastfeeding, as it passes into breast milk.

Driving and operating machinery

The medicine does not affect the ability to drive or operate machinery. If the patient experiences headache, they should not drive, operate machinery, or perform other activities that require concentration.

Envil cough medicine contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Envil cough medicine

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

Recommended dose

Recommended doses are used to treat acute respiratory diseases and in the initial period of treatment of chronic conditions. In long-term treatment (over 14 days), the dose can be reduced to half.
Adults:1 tablet 3 times a day for the first 2 to 3 days, then the dose should be reduced to 1 tablet 2 times a day.
If symptoms worsen or do not improve after 4 to 5 days, the patient should contact their doctor.

Method of administration

The medicine should be taken orally.
The medicine should be taken after a meal.
The medicine should not be taken before bedtime.

Taking a higher dose of Envil cough medicine than recommended

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

Missing a dose of Envil cough medicine

A double dose should not be taken to make up for a missed dose.
The patient should take the medicine as soon as possible, and the next dose should be taken at the usual time.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Envil cough medicine can cause side effects, although not everybody gets them.

The patient should stop taking Envil cough medicine and immediately contact 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 making breathing difficult, wheezing, shortness of breath, unpalpable pulse, significantly lowered 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:

• hypersensitivity 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 polymorphic erythema, 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 any side effects not listed in the 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
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: ndl@urpl.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 medicine.

5. How to store Envil cough medicine

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
Markings on the blister
EXP – expiry date
Lot – batch number
Medicines should not be disposed of via wastewater or household waste. 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 cough medicine contains

• The active substance of the medicine is ambroxol hydrochloride. 1 tablet contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: ludipress (povidone, crospovidone, lactose monohydrate), magnesium stearate.

What Envil cough medicine looks like and what the package contains

Envil cough medicine is in the form of tablets.
The package contains 20, 25, or 50 tablets in a cardboard box.

Marketing authorization holder and manufacturer

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

Date of last update of the leaflet: