Entus Max

Package Leaflet: Information for the Patient

Entus Max, 30 mg/5 ml, Syrup

Ambroxol Hydrochloride

Read the package 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 package leaflet for the patient, or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• 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 there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Entus Max 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

Supportive treatment in acute and chronic respiratory diseases with difficulty in expectorating viscous bronchial secretions, such as chronic bronchitis, asthma, bronchiectasis, mucoviscidosis, bronchitis, laryngitis. If there is no improvement or the patient feels worse after 4 to 5 days, they should consult their doctor.

2. Important information before taking Entus Max

When not to take Entus Max

• 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 Max, 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 mucociliary 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 them. It may be necessary to aspirate the secretions, in which case the patient should consult their doctor. Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash appears (including changes in mucous membranes, such as the mouth, throat, nose, eyes, genitals), the patient should stop taking Entus Max and immediately consult their doctor.

Entus Max and other medicines

The patient should tell 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, irritating cough), as they may inhibit the cough reflex and cause secretions to accumulate in the respiratory tract.

Taking Entus Max with food and drink

Entus Max should be taken after a meal. The patient should not take the medicine before bedtime.

Pregnancy and breastfeeding

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 Max contains ethanol, propylene glycol, benzoesic acid, liquid sorbitol, 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 cause 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.

Liquid sorbitol, 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 a rare genetic disorder, fructose intolerance, they should consult their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and 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 it is considered "sodium-free".

3. How to take Entus Max

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist. If in 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.

Adults and adolescents over 12 years of age:

5 ml of syrup 3 times a day for the first 2 to 3 days of treatment, then 5 ml of syrup 2 times a day. If symptoms worsen or do not improve after 4 to 5 days, the patient should consult their doctor.

Method of administration

The medicine should be taken orally. The medicine should be taken after a meal. The patient should not take the medicine before bedtime. A measuring cup is attached to the packaging to facilitate dosing. The syrup does not contain sugar.

Taking more than the recommended dose of Entus Max

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

Missing a dose of Entus Max

The patient should take the syrup as soon as possible and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Entus Max can cause side effects, although not everybody gets them.

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

• anaphylactic shock (rash on the skin, itching of the hands and feet, 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 possible side effects

Rare (may affect up to 1 in 1,000 people):

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

Frequency not known (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 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 Post-Marketing Surveillance 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, more information can be gathered on the safety of the medicine.

5. How to store Entus Max

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 or 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 pack and other information

What Entus Max contains

• -The active substance of the medicine is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
• -The other ingredients are: liquid sorbitol, 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 Max looks like and contents of the pack

Entus Max 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: