Ambroxol teva

Ambrosol Teva, 15 mg/5 ml, syrup
Ambroxoli hydrochloridum
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by the doctor, pharmacist, or nurse.

• 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 possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement within 4 to 5 days, or if you feel worse, consult your doctor.

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 (mucus-thinning agent). It increases the amount of mucus in the respiratory tract, reduces its viscosity, and accelerates mucus clearance from the airways, thus facilitating expectoration and relieving cough.
Ambrosol Teva is indicated for the treatment of acute and chronic lung and bronchial diseases associated with impaired mucus expectoration and mucus transport.
If there is no improvement within 4 to 5 days, or if symptoms worsen, 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 conditions of intolerance to excipients (see also 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 suffers from gastric or duodenal ulcer, as the medicine may adversely affect the gastric mucosa,
• if the patient has impaired liver or kidney function, medical advice should be sought before taking the medicine,
• if the patient has a weakened cough reflex or impaired ciliary clearance of the bronchi, due to the risk of mucus accumulation in the airways,
• severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash appears (including lesions of mucous membranes, e.g. in the mouth, throat, nose, eyes, genital organs), treatment with Ambrosol Teva should be discontinued and immediate medical advice sought,
• liquefaction of large amounts of secretions in immobilized or severely ill patients and in young children should be accompanied by suctioning. Cough suppressants should not be administered to such patients, as this may lead to dangerous accumulation of bronchial secretions,
• bronchial secretions should be expectorated thoroughly,
• in patients with bronchial asthma, ambroxol may initially exacerbate coughing.

Ambrosol Teva and other medicines
Inform your doctor or pharmacist about any medicines currently taken or recently taken, as well as any medicines planned for future use. 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 medicines that inhibit mucus secretion, as this may lead to dangerous accumulation of bronchial secretions due to a weakened cough reflex. Antitussives impair the 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
The active substance passes through the placental barrier. Use of Ambrosol Teva is not recommended during pregnancy, especially during the first three months of pregnancy.
Ambroxol hydrochloride passes into breast milk. Use of Ambrosol Teva is not recommended during breastfeeding.

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 intolerance to certain sugars has previously been diagnosed in the patient (or his/her child), or if hereditary fructose intolerance, a rare genetic disorder in which the body cannot metabolize fructose, has been diagnosed, 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 is 2.6 kcal/g of sorbitol.

3. How to use Ambrosol Teva

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

Recommended dosage:
Adults and adolescents over 12 years of age: 20 ml of syrup twice daily.
This dose is recommended for acute respiratory tract inflammatory conditions and for the initial treatment of chronic conditions during the first 14 days of therapy.

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

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

The above dosing is recommended during the initial treatment period; the dose 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 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 during treatment with Ambrosol Teva for acute respiratory diseases symptoms do not improve, medical advice should be sought. If symptoms worsen or do not resolve within 4 to 5 days, consult your doctor.

Taking more Ambrosol Teva than recommended
After taking more than the recommended dose of Ambrosol Teva, 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.

If an overdose is taken, seek immediate medical advice from a doctor or pharmacist.

No specific symptoms of overdose in humans have been observed to date. Based on cases of accidental overdose and/or reports of improper use, symptoms consistent with known adverse effects of the medicine used at recommended doses have been observed, which may require symptomatic treatment.

Missing a dose of Ambrosol Teva
If you miss a dose, take it as soon as possible, then return to 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 only be used 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 1,000 people):

• hypersensitivity reactions
• rash
• urticaria

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

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucosa or submucosal tissue), and itching
• severe skin-related adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis)
• dryness of the 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 those 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 to provide more information on the safety of the 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 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ambrosol Teva contains

• The active substance is ambroxol hydrochloride. 5 ml of syrup (1 measuring spoon) contains 15 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), strawberry flavour, purified water.

What Ambrosol Teva looks like and contents of the pack
Ambrosol Teva, 15 mg/5 ml is a clear syrup with a strawberry odour. 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, tel.: (22) 345 93 00

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