Ambroxol orifarm

Patient Information Leaflet

Ambroksol Orifarm, 30 mg/5 ml, syrup
Ambroxoli hydrochloridum
Expectorant syrup with banana flavour
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 4 to 5 days, consult your doctor.

Contents of the leaflet

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

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

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

• Acute and chronic respiratory tract disorders associated with difficulty in expectorating thick mucus, such as acute and chronic bronchitis, inflammatory conditions of the nose and throat, and 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 to any of the other ingredients of this medicine (listed in section 6).
• If the patient has bronchospasm.

Warnings and precautions
Before starting treatment with Ambroksol Orifarm, consult your doctor or
pharmacist.
Ambroksol Orifarm should be used with particular caution in patients with weakened cough reflex or
impaired ciliary clearance of the bronchi.
In patients with bronchial asthma, the medicine may initially increase coughing.
Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including mucosal lesions, e.g. in the oral cavity, throat, nose, eyes, or genital organs), discontinue use of Ambroksol Orifarm and contact a doctor immediately.
Use with caution in patients with severe hepatic insufficiency, gastric or duodenal ulcer disease, or intestinal ulceration.
In patients with renal insufficiency, the doctor will recommend reducing the daily dose depending on the degree of renal function or extending the interval between doses.
Administration of the medicine immediately before bedtime is not recommended.
Administration of Ambroksol Orifarm to bedridden patients should be discussed with a doctor.
If no expectoration of liquefied secretions occurs within 30 minutes after administration, the secretions should be suctioned.

Ambroksol Orifarm 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.
Do not use Ambroksol Orifarm simultaneously with antitussive medicines (e.g. codeine) due to their cough-suppressant effect.
When administered concomitantly with antibiotics (e.g. amoxicillin, ampicillin, cefuroxime, doxycycline, erythromycin), Ambroksol Orifarm increases their penetration into the lungs and enhances their effect.
Ambroksol Orifarm and theophylline mutually enhance each other's effects.

Pregnancy, breastfeeding and fertility
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.
This medicine may be used during pregnancy and breastfeeding only if clearly needed.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

Ambroksol Orifarm contains sorbitol, benzoic acid (E 210), and flavouring components (banana flavouring), including propylene glycol (E 1520) and sulphites.

Sorbitol
The medicine contains 1.66 g of sorbitol in 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 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 a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect. Calorific value: 2.6 kcal/g of 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.

Sulphites
The medicine may rarely cause severe allergic 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 a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Children aged
1 to 2 years: 1.25 ml of syrup (7.5 mg ambroxol) twice daily;
2 to 5 years: 1.25 ml of syrup (7.5 mg ambroxol) three times daily;
6 to 12 years: 2.5 ml of syrup (15 mg ambroxol) two to three times daily.
Children over 12 years of age and adults
5 ml of syrup (30 mg ambroxol) up to three times daily for the first 2 to 3 days, then 5 ml of syrup
twice daily.
The recommended dosage applies to acute respiratory conditions.
In chronic conditions, the dose should be reduced by half.
Ambroksol Orifarm 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 after 4 to 5 days, or if the patient feels worse, consult a doctor.
Taking more Ambroksol Orifarm than recommended
Symptoms of overdose include: nausea, fatigue, excessive mucus secretion.
In case of overdose, seek immediate advice from a doctor or pharmacist.
Missing a dose of Ambroksol Orifarm
Do not take a double dose to make up for a missed dose.
If the medicine is taken regularly and only a short time has passed since the missed dose,
take it as soon as possible.
If it is almost time for the next scheduled dose, take the next dose at the regular time.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience 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 (cannot be estimated from the available data):

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressive 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).

With long-term use, the following may rarely occur: dryness of the oral and respiratory mucosa, watery nasal discharge, increased salivation, and urinary disturbances.

There have also been sporadic reports of fatigue and/or tiredness in patients receiving ambroxol at a dose of 60–120 mg per day.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181 C, 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 to provide more information on the safety of the medicine.

5. How to store Ambroksol Orifarm

Store below 25°C. Do not freeze. Protect from light.
After opening the bottle, do not store the medicine for longer than 3 months.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging. 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 Ambroksol Orifarm contains

• The active substance is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
• Other ingredients are: sorbitol liquid, non-crystallizing; glycerol 85%; benzoic acid (E 210); propionic acid; banana flavour (containing, among others: propylene glycol (E 1520), methyl heptin carbonate, eugenol, citral, isoeugenol, sulphites); purified water.

What Ambroksol Orifarm looks like and contents of the pack
The medicine is a banana-flavoured syrup.
Pack: amber glass bottle containing 150 ml of syrup, closed with an HDPE screw cap with an LDPE dropper and HDPE security ring, or an HDPE screw cap with an LDPE dropper and security ring, and a measuring cup, all contained in a cardboard box.

Marketing Authorisation Holder
Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orifarm Healthcare Sp. z o.o.
Przyokopowa Street 31
01-208 Warsaw
Poland
[email protected]

Manufacturer
Orifarm Manufacturing Poland Sp. z o.o.
Księstwa Łowickiego Street 12
99-420 Łyszkowice
Poland