Ambroksol Orifarm

Leaflet attached to the packaging: patient information

Ambroksol Orifarm, 30 mg/5 ml, syrup

Ambroxol hydrochloride

Cough syrup with a banana flavor

Please read the contents of the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects 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 Ambroksol Orifarm and what is it used for
• 2. Important information before using Ambroksol Orifarm
• 3. How to use Ambroksol Orifarm
• 4. Possible side effects
• 5. How to store Ambroksol Orifarm
• 6. Package contents and other information

1. What is Ambroksol Orifarm and what is it used for

Ambroksol Orifarm is a syrup medicine that contains ambroxol hydrochloride (a derivative of bromhexine) as the active substance. It belongs to a group of medicines that stimulate the production of bronchial mucus and reduce its viscosity.
Ambroksol Orifarm is used in:

• acute and chronic respiratory diseases with difficulty in expectorating thick mucus from the respiratory tract, such as: acute and chronic bronchitis, inflammatory conditions of the nose and throat, cystic fibrosis.

2. Important information before using Ambroksol Orifarm

When not to use Ambroksol Orifarm

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient has bronchial asthma.

Warnings and precautions

Before starting to use Ambroksol Orifarm, the patient should discuss it with their doctor or
pharmacist.
The medicine should be used with particular caution in patients with a weakened cough reflex or
impaired bronchial mucociliary clearance.
In patients with bronchial asthma, the medicine may initially exacerbate coughing.
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. in the mouth, throat, nose, eyes, genitals), the use of Ambroksol Orifarm should be discontinued and the patient should contact their doctor immediately.
The medicine should be used with caution in patients with severe liver failure, gastric or duodenal ulcer, and intestinal ulceration.
In patients with renal failure, the doctor will recommend a reduction in the daily dose depending on the degree of renal function or an extension of the interval between doses.
The medicine should not be administered directly before bedtime.
The administration of Ambroksol Orifarm to bedridden patients should be consulted with a doctor.
If expectoration of thinned mucus does not occur within 30 minutes of administration, it should be aspirated.

Ambroksol Orifarm and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ambroksol Orifarm should not be used at the same time as cough suppressants (e.g. codeine), due to their cough-suppressing effect.
Ambroksol Orifarm administered simultaneously with antibiotics (e.g. amoxicillin, ampicillin, cefuroxime, doxycycline, erythromycin) increases their penetration into the lungs and enhances their effect.
Ambroksol Orifarm and theophylline mutually enhance their effects.

Pregnancy, breastfeeding, and fertility

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 using this medicine.
The medicine may be used by pregnant or breastfeeding women only in cases of absolute necessity.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

Ambroksol Orifarm contains sorbitol, benzoic acid (E 210), and flavoring agents (banana essence), including propylene glycol (E 1520) and sulfites.

Sorbitol

The medicine contains 1.66 g of sorbitol in 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, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect. Caloric value: 2.6 kcal/g sorbitol.

Benzoic acid

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

Propylene glycol

The medicine contains 4.35 mg of propylene glycol in 5 ml of syrup.

Sulfites

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Ambroksol Orifarm

This medicine should always be used exactly as described in this patient leaflet or as directed by
their doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Recommended dose
Children aged
1 to 2 years: 1.25 ml of syrup (7.5 mg of ambroxol) - 2 times a day;
2 to 5 years: 1.25 ml of syrup (7.5 mg of ambroxol) - 3 times a day;
6 to 12 years: 2.5 ml of syrup (15 mg of ambroxol) - 2 to 3 times a day.
Children over 12 years and adults
5 ml of syrup (30 mg of ambroxol) up to 3 times a day for the first 2 to 3 days, then 5 ml of syrup 2 times a day.
The recommended dosage applies to acute respiratory conditions.
In chronic diseases, the dose should be reduced by half.
The medicine should be used with caution in children aged 1 to 5 years.
Ambroksol Orifarm should not be used at night.
If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Using a higher dose of Ambroksol Orifarm than recommended

Overdose symptoms are: nausea, fatigue, excessive mucus production.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Ambroksol Orifarm

A double dose should not be used to make up for a missed dose.
If the medicine is taken regularly and it has not been long since the missed dose, it should be taken as soon as possible.
If it is almost time for the next scheduled dose, the missed dose should be skipped and the next dose taken at the scheduled time.

4. Possible side effects

Like all medicines, Ambroksol Orifarm can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people):

• hypersensitivity reactions;
• allergic reactions, such as: skin reactions, redness and (or) burning of mucous membranes, facial swelling, shortness of breath, chills;
• rash, urticaria;
• abdominal pain, constipation, heartburn, indigestion, nausea, and vomiting.

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 tissue) and pruritus;
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

During long-term use, the following may occur: dryness of the mucous membranes of the mouth and respiratory tract, watery discharge from the nose, increased salivation, urinary disorders.
There have also been reports of occasional fatigue and (or) tiredness in patients taking ambroxol at a dose of 60-120 mg per day.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181 C, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ambroksol Orifarm

Store in a temperature below 25°C. Do not freeze. Protect from light.
After opening the bottle, the medicine should not be stored for more than 3 months.
The medicine should be stored out of sight and reach of children.
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. Package contents and other information

What Ambroksol Orifarm 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 85%; benzoic acid (E 210); propionic acid; banana essence (contains, among others: propylene glycol (E 1520), methyl heptinocarbonate, eugenol, citral, isoeugenol, sulfites); purified water.

What Ambroksol Orifarm looks like and what the package contains

The medicine is a banana-flavored syrup.
Package: a brown glass bottle containing 150 ml of syrup, closed with an HDPE cap with an LDPE dropper and an HDPE ring or an HDPE cap with an LDPE dropper and an HDPE ring, and a measuring cup placed in a cardboard box.

Marketing authorization holder

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
[email protected]

Manufacturer

Orifarm Manufacturing Poland Sp. z o.o.
ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland
Date of last revision of the leaflet:07/2023