Envil kashel iunior

Leaflet attached to the packaging: patient information

Envil cough junior, 15 mg/5 ml, syrup

Ambroxol hydrochloride

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 according to
the doctor's or pharmacist's instructions.

• The leaflet should be kept, so that it can be read again if necessary.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 4 to 5 days there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet

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

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

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

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, laryngitis.
If after 4 to 5 days there is no improvement or the patient feels worse, the doctor should be consulted.

2. Important information before taking Envil cough junior

When not to take Envil cough junior

• 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 junior, the doctor or pharmacist should be consulted:

• 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 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 appear.
In such a case, coughing should be induced to expectorate it. It may be necessary to aspirate the secretions, then the patient should consult a doctor.
Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash appears (including changes in the mucous membranes, e.g. mouth, throat, nose, eyes, genitals), the use of Envil cough junior should be discontinued and the doctor should be consulted immediately.

Envil cough junior and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as about medicines the patient plans to take.
The doctor should be informed if the patient is 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.

Taking Envil cough junior with food and drink

Envil cough junior should be taken after a meal.
The medicine should not be taken before bedtime.

Pregnancy and breastfeeding

This subsection does not apply to Envil cough junior, syrup, as this medicine is intended for use in children up to 12 years of age. However, the following information is relevant to the active substance - ambroxol hydrochloride.
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a 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 has no influence or negligible influence on the ability to drive and use machines. If headache occurs, the patient should not drive vehicles, operate machinery, or perform other activities that require concentration.

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

Propylene glycol (E1520)

The medicine contains 152.03 mg of propylene glycol in each 5 ml of syrup.
Before administering the medicine to a child under 4 weeks of age, the doctor or pharmacist should be consulted, especially if the child is taking other medicines containing propylene glycol or alcohol.

Benzoic acid (E210)

The medicine contains 10 mg of benzoic acid in each 5 ml of syrup.
Benzoic acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

Liquid, non-crystallizing 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 some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Sodium

The medicine contains 0.042 mg of sodium in each 5 ml of syrup.
The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, which means the medicine 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 cough junior

This medicine should always be taken exactly as described in this patient leaflet, or according to the doctor's or pharmacist's instructions. In case of doubt, the doctor or pharmacist should be consulted.

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 (more than 14 days), the dose can be reduced to half.

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.
A measuring cup is attached to the packaging to facilitate dosing, with which the medicine should be measured.
The syrup does not contain sugar.

Taking a higher dose of Envil cough junior than recommended

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

Missing a dose of Envil cough junior

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

4. Possible side effects

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

Stop taking Envil cough junior and consult a doctor immediately if:

• anaphylactic shock (rash on the skin, itching of the hands and feet covering the entire 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).

Other 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 any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed.
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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Envil cough junior

The medicine 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 medicine after the expiry date stated on the label and carton.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Envil cough junior contains

• The active substance of the medicine is ambroxol hydrochloride. 5 ml of syrup contains 15 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 junior looks like and what the packaging contains

Envil cough junior is a syrup.
The packaging of the medicine is a brown glass bottle containing 100 ml, 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: