Envil for cough

Package leaflet: Information for the patient

Envil kaszel, 30 mg/5 ml, syrup
Ambroxoli hydrochloridum
Please read carefully the entire leaflet 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
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any 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

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

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

Envil kaszel contains the active substance ambroxol hydrochloride, which has an expectorant effect and thins mucus in the respiratory tract. The medicine is in the form of an oral syrup.
Indications
Adjunctive treatment in acute and chronic respiratory diseases associated with difficulty in expectorating viscous bronchial secretions, e.g.: pulmonary emphysema, bronchial asthma, bronchiectasis, cystic fibrosis, bronchitis, 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, discuss this with your 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 respiratory secretions may appear.
In such a case, coughing should be encouraged to expel the mucus. 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 mucosal lesions, e.g. in the mouth, throat, nose, eyes, or genital organs), treatment with Envil kaszel must be discontinued and medical advice must be sought immediately.

Envil kaszel with other medicines
Tell 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.
Tell your doctor if the patient is taking:

• antibiotics (medicines used to treat infections, such as: 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;
• cough suppressants (used to treat dry, exhausting cough), because they may suppress the cough reflex and lead to mucus accumulation in the airways.

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

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 or has negligible effect on the ability to drive and operate machinery. However, if headache occurs, the patient should not drive, operate machinery, or perform any other tasks requiring concentration.

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

Propylene glycol (E1520)
The medicine contains 152.03 mg of propylene glycol in each 5 ml of syrup.

Benzoic acid (E210)
The medicine contains 10 mg of benzoic acid in each 5 ml of syrup.

Non-crystallizing liquid sorbitol (E420)
The medicine contains 2500 mg of sorbitol in each 5 ml of syrup.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—the patient should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Sodium
The medicine contains 0.168 mg of sodium in each 5 ml of syrup.
The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup, meaning it is considered "sodium-free".

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

3. How to take Envil kaszel medicine

This medicine should always be taken exactly as described in this patient information 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 tract diseases and in the
initial phase of treatment of chronic conditions.
In long-term treatment (beyond 14 days), the doses may be reduced by half.
Adults and adolescents over 12 years of age:
5 ml of syrup 3 times daily during the first 2 to 3 days of treatment, then 5 ml of syrup 2 times
daily.
If symptoms worsen or do not improve within 4 to 5 days, consult your doctor.
Method of administration
The medicine should be taken orally.
The medicine should be taken after meals.
Do not use before going to sleep.
A measuring device is provided with the packaging to facilitate accurate dosing; it should be used to
measure the dose.
The syrup does not contain sugar.
Accidental overdose of Envil kaszel medicine
In case of taking more than the recommended dose, contact your doctor immediately.
Symptoms of overdose may include: nausea, fatigue, excessive mucus secretion from the bronchi.
Missed dose of Envil kaszel medicine
Take the missed dose as soon as possible, then take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you have any further questions regarding 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 everybody will experience them.
You must stop taking Envil kaszel and contact your doctor immediately if you experience:

• anaphylactic shock (skin rash, itching of hands and feet spreading throughout the body, swelling of the face, lips or throat causing breathing difficulties, wheezing, shortness of breath, undetectable pulse, significantly lowered 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 during urination (dysuria).

Frequency not known: 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 of Monitoring Adverse Drug Reactions at 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Envil kaszel

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and carton.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Envil kaszel contains

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

What Envil kaszel looks like and contents of the pack
Envil kaszel is a syrup.
The packaging consists of an amber glass bottle containing 100 ml or 120 ml of syrup, closed with an aluminium cap and supplied with a measuring cup, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacia Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100