Ambrosol Teva

Patient Information Leaflet: User Information

Ambrosol Teva, 15 mg/5 ml, Syrup

Ambroxol Hydrochloride
Read this leaflet carefully, as it contains important information for the patient..
This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor, pharmacist, or nurse.

• 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 possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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 Ambrosol Teva and what is it used for
• 2. Important information before using Ambrosol Teva
• 3. How to use Ambrosol Teva
• 4. Possible side effects
• 5. How to store Ambrosol Teva
• 6. Contents of the pack and other information

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

Ambrosol Teva syrup contains the active substance ambroxol hydrochloride, which has expectorant and mucolytic properties (thins mucus). It increases the amount of mucus in the airways, reduces its viscosity, accelerates the transport of secretions in the airways, making it easier to cough up and relieving cough.
The indication for the use of Ambrosol Teva is acute and chronic respiratory diseases, characterized by difficulty in coughing up viscous bronchial secretions, such as:

• acute and chronic bronchitis,
• bronchial asthma,
• cystic fibrosis,
• pulmonary emphysema,
• bronchiectasis.

2. Important information before using Ambrosol Teva

When not to use Ambrosol Teva

Warnings and precautions

Before starting treatment with Ambrosol Teva, the patient should consult a doctor:

The liquefaction of a large amount of secretions in immobilized patients and those in severe condition, as well as in small children, must be associated with its aspiration. In such patients, cough-suppressing medications should not be administered, as this may lead to the accumulation of secretions in the airways.
Bronchial secretions should be thoroughly coughed up.
In patients with bronchial asthma, ambroxol may initially exacerbate cough.
Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash occurs (including changes in the mucous membranes, e.g., oral cavity, throat, nose, eyes, genitals), the use of Ambrosol Teva should be discontinued and a doctor should be consulted immediately.

Ambrosol Teva and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription.
Ambroxol should not be administered simultaneously with cough medicines, such as codeine or medicines that suppress mucus production.
Ambroxol increases the penetration of some antibiotics (e.g., amoxicillin, cefuroxime, erythromycin, doxycycline) into lung tissue.

Using Ambrosol Teva with food and drink

The medicine should be taken after a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Pregnancy
The active substance of the medicine passes through the placental barrier. The use of Ambrosol Teva is not recommended during pregnancy, especially in the first three months of pregnancy.
Breastfeeding
Ambroxol hydrochloride passes into breast milk. The use of Ambrosol Teva is not recommended during breastfeeding.

Driving and using machines

There are no data on the effect of the medicine on the ability to drive and use machines.
No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

Ambrosol Teva contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

Due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate, the medicine may cause allergic reactions (possible late-type reactions).

Ambrosol Teva contains propylene glycol

The medicine contains 150 mg of propylene glycol in 5 ml of syrup, which corresponds 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

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

3. How to use Ambrosol Teva

Ambrosol Teva should always be used in accordance with the doctor's recommendations.
In case of doubt, the patient should consult a doctor or pharmacist.
The medicine should be taken orally, after a meal.
The medicine should not be taken directly before bedtime.
Adults and children over 12 years of age:
Initially, for 2 to 3 days, 30 mg of ambroxol hydrochloride (10 ml of syrup, i.e., 2 measuring spoons) should be taken 3 times a day; then the dose should be reduced to 30 mg (10 ml of syrup, i.e., 2 measuring spoons) 2 times a day.
Children from 6 to 12 years of age:
15 mg of ambroxol hydrochloride (5 ml of syrup, i.e., 1 measuring spoon) 2 to 3 times a day.
Children from 2 to 6 years of age:
7.5 mg of ambroxol hydrochloride (2.5 ml of syrup, i.e., half a measuring spoon) 3 times a day.
The medicine should not be used in children without consulting a doctor.
If the treatment lasts longer than 7 to 14 days, the dose should be reduced.
If the symptoms worsen or do not improve after 4 to 5 days, the patient should consult a doctor.
The medicine does not contain sucrose.
If the patient feels that the effect of Ambrosol Teva is too strong or too weak, they should consult a doctor.

Using a higher dose of Ambrosol Teva than recommended

So far, there have been no specific symptoms of overdose in humans.
After taking a higher dose of Ambrosol Teva than recommended, the side effects listed in section 4 "Possible side effects" may occur. Symptomatic treatment is recommended.
In small children and patients with a weakened cough reflex (elderly, unconscious patients), it is necessary to ensure the removal of bronchial secretions from the airways.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Ambrosol Teva

In case of missing a dose, the patient should take it as soon as possible and then return to the recommended dosing schedule.
A double dose should not be taken to make up for the missed dose.
In case of any further doubts about the use of the medicine, the patient should consult a doctor.

4. Possible side effects

Like all medicines, Ambrosol Teva can cause side effects, although not everybody gets them.
The following side effects may occur:

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

• taste disorders (e.g., change in taste), nausea, numbness (hypoesthesia) in the oral cavity and throat.

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

• vomiting, diarrhea, abdominal pain, indigestion, dryness of the oral mucosa.

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

• hypersensitivity reactions,
• rash, urticaria,
• heartburn.

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

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membrane, or submucosal tissue swelling) and itching;
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
• dryness in the throat.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient 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, 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 Ambrosol Teva

Store in a place out of sight and reach of children.
Store at a temperature below 25°C. Protect from light.
Shelf life after first opening the package: 28 days.
Ambrosol Teva should not be used after the expiry date stated on the label and carton after "Expiry date:". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 of the medicine is ambroxol hydrochloride. 5 ml of syrup (1 measuring spoon) contains 15 mg of ambroxol hydrochloride.
• Other ingredients of the medicine are: liquid sorbitol 70% (E420), glycerol (E422), citric acid monohydrate (E330), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), strawberry flavor, 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 odor. The syrup is in a brown/orange glass bottle. The bottle contains 120 ml or 200 ml of syrup, is closed with an aluminum or polypropylene cap with a polyethylene foam seal and a polyethylene ring, or an HDPE cap with a polyethylene ring, and is placed in a cardboard box with a measuring spoon ( graduation 1.25; 2.5 and 5 ml).

Marketing authorization 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 Krakow
Balkanpharma Troyan AD, 1 Krayrechna Str., 5600 Troyan, Bulgaria

Date of last revision of the leaflet: August 2021