Entus Iunior

Leaflet attached to the packaging: patient information

Entus Junior, 15 mg/5 ml, syrup

Ambroxol hydrochloride

Please read carefully the contents of the 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 doctor or pharmacist.

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

Table of contents of the leaflet

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

1. What is Entus Junior and what is it used for

Entus 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, they should consult a doctor.

2. Important information before taking Entus Junior

When not to take Entus 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 Entus Junior, 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 cases, the patient should induce coughing 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 mucous membranes, e.g. oral cavity, throat, nose, eyes, genitals), the patient should stop taking Entus Junior and immediately consult a doctor.

Entus Junior 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, exhausting cough), as they may inhibit the cough reflex and cause secretions to accumulate in the respiratory tract.

Taking Entus Junior with food and drink

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

Pregnancy and breastfeeding

This subsection does not apply to Entus Junior syrup, as this medicine is intended for use in children from 2 to 12 years old. However, the following information is relevant to the active substance - ambroxol hydrochloride. 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 using machines

The medicine has no or negligible influence on the ability to drive and use machines. If the patient experiences headache, they should not drive vehicles, operate machinery, or perform other activities that require concentration.

Entus Junior contains ethanol, propylene glycol, benzoesic acid, sorbitol, liquid, non-crystallizing, and sodium

Ethanol

This medicine contains 1.68 mg of ethanol (per 5 ml dose), which is equivalent to 0.34 mg/ml (0.03% v/v). The amount of ethanol in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of ethanol in this medicine will not have noticeable effects.

Propylene glycol

The medicine contains 149.35 mg of propylene glycol per 5 ml of syrup.

Benzoesic acid

The medicine contains 10 mg of benzoesic acid per 5 ml of syrup.

Sorbitol, liquid, non-crystallizing

The medicine contains 1742.2 mg of sorbitol per 5 ml of syrup. Sorbitol is a source of fructose. If the patient 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, they should consult their 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 0.168 mg of sodium per 5 ml of syrup. The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup, which means the medicine is considered "sodium-free".

3. How to take Entus Junior

This medicine should always be taken exactly as described in this patient leaflet, or as directed 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 (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. If symptoms worsen or do not improve after 4 to 5 days, the patient should consult their doctor. The syrup does not contain sugar.

Taking a higher dose of Entus Junior than recommended

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

Missing a dose of Entus Junior

The patient should take the syrup 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 a missed dose. 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, Entus Junior can cause side effects, although not everybody gets them.

The patient should stop taking Entus Junior and immediately consult their doctor if they experience:

• anaphylactic shock (rash on the skin, itching of 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 oral cavity due to lack of saliva production.

Reporting side effects

If the patient experiences any side effects, including any not listed in this 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Entus Junior

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not store in the refrigerator, do not freeze. Store in the original packaging. 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 patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Entus Junior contains

• -The active substance of the medicine is ambroxol hydrochloride. 5 ml of syrup contains 15 mg of ambroxol hydrochloride.
• -The other ingredients are: sorbitol, liquid, non-crystallizing, glycerol, sodium saccharin, benzoesic acid, propylene glycol, hydroxyethyl cellulose, natural orange flavor 72 VP 100 g/100 (contains ethanol), levomenthol, purified water.

What Entus Junior looks like and what the packaging contains

Entus Junior is a syrup. The packaging of the medicine is a brown glass bottle containing 120 ml of syrup, closed with an aluminum cap with a measuring cup, placed 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 revision of the leaflet: