Ambroxol Normon 3 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ambroxol Normon 3 mg/ml oral solution EFG

ambroxol hydrochloride

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Ambroxol Normon is and what it is used for
2. What you need to know before taking Ambroxol Normon
3. How to take Ambroxol Normon
4. Possible adverse effects
5. Storage of Ambroxol Normon
6. Contents of the pack and other information

1. What Ambroxol Normon is and what it is used for

Ambroxol Normon belongs to a group of medicines called mucolytics. Ambroxol, the active substance in this medicine, works by reducing the viscosity of mucus, making it less thick and easier to expel.

This medicine is used to treat acute and chronic respiratory tract conditions that require the breakdown and elimination of mucus.

You should consult a doctor if you worsen or do not improve after 5 days of treatment.

2. What you need to know before taking Ambroxol Normon

Do not take Ambroxol Normon

If you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Ambroxol Normon.

Serious skin reactions have been reported following ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as in the mouth, throat, nose, eyes, and genitals), stop using Ambroxol Normon and consult your doctor immediately.

If you have problems with bronchial function, you should avoid taking mucolytics.

If you have liver or kidney problems, or a history of stomach or duodenal ulcer, consult your doctor before using this medicine, as your dose may need to be reduced.

Patients with known histamine intolerance should avoid treatment with this medicine during prolonged therapy. Symptoms of intolerance include headache, rhinitis, and itching.

Other medicines and Ambroxol Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking this medicine together with cough suppressants (antitussives) may lead to accumulation of pulmonary secretions due to reduced cough reflex.

Administration of this medicine together with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases the concentration of the antibiotic in lung tissue.

Taking Ambroxol Normon with food and drink

Do not take with meals; take with a glass of water. Drinking more fluids may enhance the activity of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Ambroxol should only be used during pregnancy, especially during the first trimester, if prescribed by your doctor.

Breastfeeding mothers should only take this medicine if instructed by their doctor.

Driving and using machines

No effects on the ability to drive or operate machinery have been observed.

Ambroxol Normon contains sorbitol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), benzyl alcohol, and sodium.

This medicine contains 350 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has advised you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

This medicine contains 0.0008 mg of benzyl alcohol per ml.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.

This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

This medicine contains less than 23 mg of sodium (1 mmol) per ml; thus, it is essentially "sodium-free".

3. How to take Ambroxol Normon

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your pharmacist again.

The recommended dose is:

Adults and adolescents from 12 years of age:

The normal dose is 10 ml (30 mg) three times a day (every 8 hours).

Use in children

Children under 2 years of age

Contraindicated.

Children from 2 to 5 years of age

The normal dose is 2.5 ml up to three times a day.

Children from 6 to 12 years of age

The normal dose is 5 ml up to three times a day.

Patients with kidney and/or liver disease: If you suffer from kidney and/or liver disease, your doctor may prescribe a lower than usual dose.

How to take it:

This medicine is taken orally.

Measure the amount of medicine to take using the dosing device provided in the package. Drink directly from the dosing device and then take a glass of liquid (preferably water). After each dose, wash the dosing device.

Do not take with food.

If symptoms worsen or persist beyond 5 days of treatment, or if fever, skin rashes, persistent headache, or sore throat occur, you must consult a doctor.

If you take more Ambroxol Normon than you should

If you take more medicine than you should, you may experience short-term restlessness and diarrhea.

Accidental or intentional overdose may lead to increased salivation, nausea, vomiting, and low blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ambroxol Normon:

Do not take a double dose to make up for the missed dose.

If symptoms persist, resume taking the medicine as indicated in section 3, “How to take Ambroxol Normon”.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Uncommon side effects (may affect up to 1 in 100 patients): nausea, vomiting, stomach pain, fever.

Rare side effects (may affect up to 1 in 1,000 people): hypersensitivity reactions, rash, urticaria.
Frequency not known (cannot be estimated from available data): anaphylactic reactions such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues), and pruritus. Serious skin adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

At the first sign of an allergic reaction, stop taking the medicine and consult your doctor or pharmacist.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambroxol Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via drains or in household waste. Dispose of packaging and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of packaging and unused medicines. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Ambroxol Normon

• The active substance is ambroxol hydrochloride. Each ml of solution contains 3 mg of ambroxol hydrochloride.

- The other components (excipients) are: Tartaric acid, citric acid monohydrate, disodium edetate, hydroxyethylcellulose, methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), sodium citrate, sorbitol (E-420), strawberry flavor (contains benzyl alcohol), and purified water.

Appearance of the product and contents of the container

Ambroxol Normon 3 mg/ml oral solution EFG is presented as a solution. It is slightly viscous, transparent or slightly opalescent, practically colorless or slightly colored, with a strawberry odor.

Each container holds 200 ml in a topaz-colored polyethylene terephthalate bottle.

A dosing device is included, marked for: 2.5, 5, 7.5, 10, and 15 ml.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This patient information leaflet was approved in January 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

http://cima.aemps.es/cima/dochtml/p/63790/P_63790.html