Envil for cough junior

Package leaflet: information for the patient

Envil kaszel junior, 15 mg/5 ml, syrup
Ambroxoli hydrochloridum
Please read the entire leaflet carefully before taking this 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, so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any adverse reactions 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 junior is and what it is used for
2. Important information before taking Envil kaszel junior
3. How to take Envil kaszel junior
4. Possible side effects
5. How to store Envil kaszel junior
6. Contents of the pack and other information

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

Envil kaszel junior contains the active substance ambroxol hydrochloride, which has expectorant and mucolytic effects, helping to loosen and thin mucus in the respiratory tract. The medicine is in the form of an oral syrup.
Indications
Adjunctive treatment of acute and chronic respiratory diseases associated with difficulty in expectorating thick bronchial secretions, such as 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 junior

When not to take Envil kaszel 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 treatment with Envil kaszel junior, 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, as ambroxol may initially worsen cough and increase mucus expectoration.

At the beginning of treatment, excessive amounts of liquid secretion from the respiratory tract may occur.
In such cases, 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 appears (including mucosal lesions, e.g. in the mouth, throat, nose, eyes, or genital organs), treatment with Envil kaszel junior must be discontinued and medical advice must be sought immediately.

Envil kaszel junior and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
Inform the 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;
• antitussives (medicines used to treat dry, exhausting cough), because they may suppress the cough reflex and lead to mucus retention in the airways.

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

Pregnancy and breastfeeding
This section does not apply to Envil kaszel junior syrup, as this medicine is intended for use in children under 12 years of age. However, the following information is relevant regarding the active substance – ambroxol hydrochloride.
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.
Use of this medicine during pregnancy is not recommended, as it may be harmful to the embryo and fetus.
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 vehicles or operate machinery. However, if headache occurs, the patient should not drive, operate machinery, or perform any other tasks requiring concentration.

Envil kaszel junior contains propylene glycol (E1520), benzoic acid (E210), sorbitol liquid, non-crystallizing (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, consult a doctor or pharmacist, 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).

Sorbitol liquid, non-crystallizing (E420)
The medicine contains 2500 mg of sorbitol in each 5 ml of syrup.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance – a rare genetic disorder in which the patient's body cannot break down fructose – has been diagnosed, 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 0.042 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 junior

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a physician or pharmacist. If in doubt, consult a physician 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), doses may be reduced by half.

Method of administration
The medicine should be taken orally.
The medicine should be taken after a meal.
Do not use before going to sleep.
A dosing cup is attached to the package to facilitate dosing; use it to measure the medicine.
The syrup does not contain sugar.

Accidental overdose of Envil kaszel junior
In case of ingestion of a higher than recommended dose, contact a physician immediately.
Symptoms of overdose may include: nausea, fatigue, and excessive mucus secretion from the bronchi.

Missed dose of Envil kaszel junior
Take the syrup 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 doubts concerning 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 junior and contact your doctor immediately if the following occurs:

• anaphylactic shock (skin rash, itching of hands and feet spreading throughout the body, facial, lip or throat swelling causing breathing difficulties, wheezing, shortness of breath, undetectable pulse, significantly lowered blood pressure, sweating, cold extremities, loss of consciousness, cardiac arrest).

Other 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 determined from the available data:

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissue), and itching;
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis);
• heartburn, dyspepsia;
• 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 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
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 junior

Keep the medicine out of sight and reach of children.
Store below 25°C. Do not freeze. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and on the 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Envil kaszel junior contains

• The active substance is ambroxol hydrochloride. 5 ml of syrup contains 15 mg of ambroxol hydrochloride.
• Other ingredients: 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 junior looks like and contents of the pack
Envil kaszel junior is a syrup.
The packaging consists of a brown glass bottle containing 100 ml or 120 ml of syrup, closed with an aluminium cap and including a measuring cup, packed 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