Ambroxol teva

Ambrosol Teva, 30 mg/5 ml, syrup
Ambroxoli hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 4 to 5 days, or if your condition worsens, consult a doctor.

Table of contents of the leaflet:

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

1. What Ambrosol Teva is and what it is used for

Ambrosol Teva syrup contains ambroxol hydrochloride as the active substance, which acts as an expectorant and mucolytic agent (liquefies mucus). It increases the volume of respiratory tract secretions, reduces their viscosity, and accelerates mucus transport in the airways, thus facilitating expectoration and relieving cough.
Ambrosol Teva is indicated in acute and chronic lung and bronchial diseases associated with difficulty in expectorating mucus and impaired mucus transport.
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 using Ambrosol Teva

When not to use Ambrosol Teva

• if the patient is allergic (hypersensitive) to ambroxol hydrochloride, bromhexine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has been diagnosed with rare inherited intolerance to excipients (see also the section "Ambrosol Teva contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, propylene glycol, sorbitol");
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with Ambrosol Teva, consult a doctor:

• if the patient has gastric or duodenal ulcer disease, as the medicine may adversely affect the gastric mucosa;
• if the patient has impaired liver or kidney function, medical advice should be sought before using this medicine;
• if the patient has a weakened cough reflex or impaired ciliary clearance of the bronchi, due to the risk of mucus retention in the airways;
• severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including mucosal lesions, e.g. in the mouth, throat, nose, eyes, genital organs), discontinue Ambrosol Teva and contact a doctor immediately;
• liquefaction of large amounts of secretions in immobilized or severely ill patients and in young children must be accompanied by suctioning. Cough suppressants should not be administered to such patients, as this may lead to dangerous accumulation of secretions in the respiratory tract;
• bronchial secretions should be expectorated thoroughly;
• in patients with bronchial asthma, ambroxol may initially increase coughing.

Ambrosol Teva 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 plans to take.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in bronchopulmonary secretions and sputum.
Ambroxol should not be administered simultaneously with antitussive medicines, e.g. codeine, or with agents that inhibit mucus secretion, as this may lead to dangerous accumulation of bronchial secretions due to suppressed cough reflex. Antitussive medicines impair expectoration of liquefied mucus by suppressing the cough reflex.
No clinically significant adverse interactions with other medicines have been reported.

Taking Ambrosol Teva with food and drink
The syrup can be taken with or without food.

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 a doctor or pharmacist before using this medicine.
The active substance of the medicine crosses the placental barrier. Use of Ambrosol Teva during pregnancy, especially during the first trimester, is not recommended.
Ambroxol hydrochloride passes into breast milk. Use of Ambrosol Teva during breastfeeding is not recommended.

Driving and operating machinery
There is no data available on the effect of the medicine on the ability to drive or operate machinery.
No studies have been conducted on the effect of the medicine on the ability to drive or operate machinery.

Ambrosol Teva contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
Due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate, this medicine may cause allergic reactions (including delayed-type reactions).

Ambrosol Teva contains propylene glycol (E1520)
The medicine contains 150 mg of propylene glycol in 5 ml of syrup, corresponding to 3.6 g of propylene glycol in 120 ml of syrup and 6 g of propylene glycol in 200 ml of syrup.

Ambrosol Teva contains sorbitol (E420)
5 ml of syrup contains 2.25 g of sorbitol. Sorbitol is a source of fructose. If the patient (or the patient's child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot metabolize fructose, the patient should consult a doctor before taking the medicine or giving it to the child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect. The caloric value of sorbitol is 2.6 kcal/g.

3. How to use Ambrosol Teva

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dosage:
Adults and adolescents over 12 years of age:
10 ml of syrup twice daily.
This dosage is recommended for acute respiratory tract inflammatory conditions and for the initial phase of chronic conditions, during the first 14 days of treatment.

Children aged 6 to 12 years:
5 ml of syrup 2 to 3 times daily.

Children aged 2 to 6 years:
2.5 ml of syrup 3 times daily.

The above dosage is recommended during the initial treatment phase; the dosage may be reduced by half after 14 days of treatment.

The syrup may be taken with or without food.

Do not use in children without consulting a doctor.

If you feel that the effect of Ambrosol Teva is too strong or too weak, consult your doctor.

Do not use this medicine before going to sleep.

The medicine should be measured using the provided measuring spoon.

If symptoms do not improve during treatment with Ambrosol Teva for acute respiratory diseases, medical advice should be sought.
If symptoms worsen or do not improve after 4 to 5 days, consult your doctor.

Taking more Ambrosol Teva than recommended
If more Ambrosol Teva is taken than recommended, symptoms listed in section 4 "Possible side effects" may occur. Symptomatic treatment is advised.

In young children and patients with weakened cough reflex (elderly, unconscious), ensure removal of bronchial secretions from the airways.

In case of overdose, seek immediate medical advice from a doctor or pharmacist. Specific symptoms of overdose have not been observed in humans. Based on accidental overdose cases and (or) reports of improper use, symptoms corresponding to known adverse effects of the medicine used at recommended doses have been observed, which may require symptomatic treatment.

If you forget to take Ambrosol Teva
If you miss a dose, take it as soon as possible and then continue with the recommended dosing schedule.
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping Ambrosol Teva
Ambrosol Teva should be taken only when necessary and treatment should be discontinued once symptoms have resolved.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Ambrosol Teva may cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:

Common (may affect up to 1 in 10 people):

• nausea
• sensation of numbness in the oral cavity, tongue and throat (reduced sensation in the mouth and throat)
• altered taste perception (taste disturbances)

Uncommon (may affect up to 1 in 100 people):

• diarrhoea
• indigestion
• abdominal pain (epigastric pain)
• dryness of the oral mucosa
• vomiting

Rare (may affect up to 1 in 1000 people):

• hypersensitivity reactions
• rash
• urticaria

Frequency not known (frequency cannot be estimated from available data):

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of skin, subcutaneous tissue, mucous membranes or submucosal tissues), and itching
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis)
• dry throat

If any of the above adverse reactions occur, discontinue use of Ambrosol Teva immediately and seek medical advice without delay.

Reporting of adverse reactions
If any adverse reactions occur, including any 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
Phone: +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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ambrosol Teva

Keep the medicine out of sight and reach of children.
Store below 25°C. Protect from light.
Shelf life after first opening of the container: 28 days.
Do not use Ambrosol Teva after the expiry date stated on the label of the bottle and carton
after the words "Expiry date:". 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 package and other information

What Ambrosol Teva contains

• The active substance is ambroxol hydrochloride. 5 ml of syrup (1 measuring spoon) contains 30 mg of ambroxol hydrochloride.
• Other ingredients are: sorbitol solution 70% (E420), glycerol (E422), citric acid monohydrate (E330), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), raspberry flavour, purified water.

What Ambrosol Teva looks like and contents of the pack
Ambrosol Teva 30 mg/5 ml is a clear raspberry-scented syrup. The syrup is contained in a brown/orange glass bottle. The bottle contains 120 ml or 200 ml of syrup and is closed with an aluminium or polypropylene cap with a polyethylene foam seal and a polyethylene tamper-evident ring, or with an HDPE cap with a polyethylene tamper-evident ring. The bottle is placed in a cardboard box together with a measuring spoon (graduated markings: 1.25, 2.5 and 5 ml).

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland, tel.: (22) 345 93 00

Manufacturer
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
Balkanpharma Troyan AD, 1 Krayrechna Str., 5600 Troyan, Bulgaria