Entus max

Patient Information Leaflet

Entus Max, 30 mg/5 ml, syrup
Ambroxoli hydrochloridum
Please read this 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 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.

Contents of the leaflet

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

Entus Max contains the active substance ambroxol hydrochloride, which has expectorant and mucolytic properties, helping to liquefy and clear respiratory secretions. The medicine is in the form of an oral syrup.
Indications
For adjunctive treatment of acute and chronic respiratory tract diseases associated with impaired expectoration of viscous bronchial secretions, such as pulmonary emphysema, bronchial asthma, bronchiectasis, cystic fibrosis, bronchitis, and laryngitis.
If there is no improvement after 4 to 5 days, or if the patient feels worse, medical advice should be sought.

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, 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, 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 appear.
In such cases, coughing should be induced to help 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 lesions of mucous membranes, e.g. in the mouth, throat, nose, eyes, genital organs), treatment with Entus Max must be discontinued immediately and the patient should contact a doctor without delay.

Entus Max and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
Inform your doctor if the patient is taking:

• antibiotics (medicines used to treat infections, e.g.: amoxicillin, erythromycin, ampicillin, doxycycline, and cefuroxime), as ambroxol increases their penetration into the lungs and enhances their effect;
• theophylline (a medicine used in the treatment of bronchial asthma), as it enhances the effect of ambroxol;
• antitussives (used to treat dry, exhausting cough), as they may suppress the cough reflex and lead to mucus retention in the airways.

Taking Entus Max with food and drink
Entus Max should be taken after meals.
Do not take the medicine before going to sleep.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 a negligible effect on the ability to drive vehicles or operate machinery. However, if headache occurs, do not drive, operate machinery, or perform any other activities requiring concentration.

Entus Max contains ethanol, propylene glycol, benzoic acid, non-crystallizing liquid sorbitol, and sodium

Ethanol
This medicine contains 1.68 mg of ethanol (alcohol) per dose (5 ml), equivalent to 0.34 mg/ml (0.03% w/v). 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.

Propylene glycol
The medicine contains 149.35 mg of propylene glycol in each 5 ml of syrup.

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

Non-crystallizing liquid sorbitol
The medicine contains 1742.2 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 metabolize fructose—has been diagnosed, the patient should contact 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 the medicine is considered "sodium-free".

3. How to take Entus Max

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Recommended doses are used in the treatment of acute respiratory tract diseases and during the initial phase of treating chronic conditions. For long-term treatment (beyond 14 days), doses may be reduced by half.
Adults and adolescents over 12 years of age:
5 ml of syrup three times daily during the first 2 to 3 days of treatment, followed by 5 ml of syrup twice daily.
If symptoms worsen or do not improve within 4 to 5 days, consult a doctor.
Method of administration
The medicine should be taken orally.
Take the medicine after meals.
Do not take before sleep.
A measuring device is provided with the package to assist in accurate dosing.
The syrup is sugar-free.
Overdose of Entus Max
In case of ingestion of a higher than recommended dose, contact a doctor immediately.
Symptoms of overdose may include nausea, fatigue, and excessive bronchial mucus secretion.
Missed dose of Entus Max
Take the missed dose as soon as possible, then continue with 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 about 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 gets them.
You must stop taking Entus Max and contact your doctor immediately if any of the following occur:

• anaphylactic shock (skin rash, itching of hands and feet spreading throughout the body, swelling of the face, lips or throat causing difficulty breathing, 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 (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and pruritus;
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised 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 the medicine Entus Max

Keep the medicine out of sight and reach of children.
Store 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 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Entus Max contains

• The active substance is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: liquid non-crystallising sorbitol, glycerol, sodium saccharin, benzoic acid, propylene glycol, hydroxyethylcellulose, natural orange flavour 72 VP 100 g/100 (containing ethanol), levomenthol, purified water.

What Entus Max looks like and contents of the pack
Entus Max is a syrup.
The packaging consists of a brown glass bottle containing 120 ml of syrup, closed with an aluminium cap and including a measuring cup, placed 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