Patient Information Leaflet

Envil kaszel, 30 mg, tablets
Ambroxoli hydrochloridum
Please read the entire 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 the
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 4 to 5 days, or if your condition worsens, consult your doctor.

Table of Contents

What Envil kaszel is and what it is used for
Important information before taking Envil kaszel
How to take Envil kaszel
Possible side effects
How to store Envil kaszel
Contents of the pack and other information

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

Envil kaszel contains the active substance ambroxol hydrochloride, which has expectorant and mucus-thinning properties in the respiratory tract. The medicine is in the form of tablets.
Indications
Adjunctive treatment in acute and chronic respiratory diseases associated with difficulty in expectorating viscous bronchial secretions, such as pulmonary emphysema, bronchial asthma, bronchiectasis, cystic fibrosis, bronchitis, pneumonia, laryngitis.
If there is no improvement after 4 to 5 days, or if your condition worsens, consult your doctor.

2. Important information before taking Envil kaszel

When not to take Envil kaszel

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 treatment with Envil kaszel, consult a doctor or pharmacist:

if the patient has peptic ulcer disease of the stomach and/or duodenum;
if the patient has impaired kidney and/or liver function;
if the patient has a weakened cough reflex (difficulty expectorating) or impaired ciliary clearance of the bronchi, due to the risk of mucus accumulation;
if the patient has bronchial asthma, because ambroxol may initially worsen cough and cause excessive mucus expectoration.

At the beginning of treatment, increased amounts of liquid secretion from the respiratory tract may occur.
In such a case, coughing should be encouraged to expel the secretion. Suctioning of secretions may be necessary; in this case, the patient should contact a doctor.
Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including lesions of mucous membranes, e.g. oral cavity, throat, nose, eyes, genital organs), treatment with Envil kaszel must be discontinued and the patient should contact a doctor immediately.

Envil kaszel and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to take.

Inform the doctor if the patient is taking:

antibiotics (medicines used to treat infections, e.g.: amoxicillin, erythromycin, ampicillin, doxycycline, and cefuroxime), because ambroxol increases their penetration into the lungs and enhances their effect;
theophylline (a medicine used in the treatment of bronchial asthma), because it enhances the effect of ambroxol;
antitussives (used to treat dry, exhausting cough), because they may suppress the cough reflex and cause mucus retention in the airways.

If the patient is unsure whether they are taking any of the above-mentioned medicines, they should contact a doctor or pharmacist.

Taking Envil kaszel with food and drink
Envil kaszel should be taken after meals.
Do not take the medicine before going to sleep.

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 or pharmacist before using this medicine.
The use of this medicine during pregnancy is not recommended, as it may be harmful to the embryo and fetus.
The use of this medicine during breastfeeding is not recommended, as it passes into breast milk.

Driving and operating machinery
This medicine has no effect on the ability to drive vehicles or operate machinery. However, if headache occurs, the patient should not drive, operate machinery, or perform any other tasks requiring concentration.

Envil kaszel contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact a doctor before taking this medicine.

3. How to take the medicine Envil kaszel

This medicine should always be taken exactly as described in the patient leaflet, or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
The recommended doses are used in the treatment of acute respiratory diseases and in the initial phase of treating chronic conditions. In long-term treatment (beyond 14 days), the doses may be reduced by half.
Adults: 1 tablet three times daily for the first 2 to 3 days, then the dose should be reduced to 1 tablet twice daily.
If symptoms worsen or do not improve within 4 to 5 days, consult your doctor.
Method of administration
The medicine is for oral use.
The medicine should be taken after a meal.
Do not take before going to sleep.
Taking more than the recommended dose of Envil kaszel
If more than the recommended dose has been taken, contact your doctor.
Symptoms of overdose may include nausea, fatigue, and excessive bronchial mucus secretion.
Missed dose of Envil kaszel
Do not take a double dose to make up for a missed dose.
Take the missed dose as soon as possible, and then take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Envil kaszel and contact your doctor immediately if
any of the following occur:

anaphylactic shock (skin rash, itching of hands and feet spreading over the whole body, swelling of the face, lips or throat causing breathing difficulties, wheezing, shortness of breath, undetectable pulse, significantly low blood pressure, sweating, cold extremities, loss of consciousness, cardiac arrest).

The following adverse reactions may occur
Rare: may affect up to 1 in 1,000 people:

hypersensitivity reactions;
rash, urticaria;
pain and burning sensation during urination (dysuria).

Frequency unknown: frequency cannot be estimated from the available data:

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

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 for Monitoring Adverse Drug Reactions 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: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Envil kaszel

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the blister and on the carton. The expiry date refers to the last day of the month indicated.
Markings on the blister
EXP – expiry date
Lot – batch number

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 practice helps protect the environment.

6. Contents of the packaging and other information

What the medicine Envil kaszel contains

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

What Envil kaszel looks like and contents of the pack
Envil kaszel is in the form of tablets.
The medicine pack contains 20, 25 or 50 tablets in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100