AMBROXOL NORMON 3 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Ambroxol Normon 3 mg/ml Oral Solution EFG

ambroxol hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in the package leaflet. See section 4.

Package Leaflet Contents

1. What is Ambroxol Normon and what is it used for
2. What you need to know before taking Ambroxol Normon
3. How to take Ambroxol Normon
4. Possible side effects

5 Storage of Ambroxol Normon

1. Package Contents and Additional Information

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

Ambroxol Normon belongs to the group of medications called mucolytics. The active ingredient ambroxol acts by reducing the viscosity of mucus, making it more fluid and easier to eliminate.

This medication is used to treat acute and chronic respiratory tract conditions that require dissolution and elimination of mucus.

You should consult a doctor if your symptoms 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 any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ambroxol Normon.

There have been reports of severe skin reactions associated with the administration of ambroxol. If you experience a skin rash (including lesions of the mucous membranes, such as 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 ulcers, consult your doctor before using this medication, as you may need to reduce the dose.

Patients with known histamine intolerance should avoid treatment with this medication for long periods. The symptoms of intolerance are: headache, rhinitis, and itching.

Other Medications and Ambroxol Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Taking this medication with cough suppressants (antitussives) may cause accumulation of pulmonary secretions due to decreased cough reflex.

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

Using Ambroxol Normon with Food and Drinks

Do not take with meals and take with a glass of water. Drinking more liquids may increase the activity of this medication.

Pregnancy, Breastfeeding, and Fertility

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

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

Breastfeeding mothers should only take it if their doctor recommends it.

Driving and Using Machines

No effects on the ability to drive and use machines have been observed.

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

This medication contains 350 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

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

This medication 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 can 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 can accumulate in your body and cause adverse effects (metabolic acidosis).

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

This medication should not be used for more than one week in children under 3 years of age, unless recommended by your doctor or pharmacist.

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

3. How to take Ambroxol Normon

Follow the instructions for administration of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your pharmacist again.

The recommended dose is:

Adults and adolescents from 12 years:

The normal dose is 10 ml (30 mg), 3 times a day (every 8 hours).

Use in Children

Children under 2 years

It is contraindicated.

Children from 2 to 5 years

The normal dose is 2.5 ml up to 3 times a day.

Children from 6 to 12 years

The normal dose is 5 ml up to 3 times a day.

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

How to take:

This medication is taken orally.

Measure the amount of medication to be taken with the dosing device included in the box. Drink directly from the dosing device and take a glass of liquid (preferably water). After each dose, wash the dosing device.

Do not take with meals.

If your symptoms worsen or persist after 5 days of treatment, or if you experience: fever, skin rash, persistent headache, or sore throat, consult a doctor.

If you take more Ambroxol Normon than you should

If you take more medication than you should, you may experience short-term agitation and diarrhea.

Accidental or intentional overdose may cause increased saliva production, nausea, vomiting, and decreased blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication 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 your symptoms continue, take the medication again as indicated in section 3 "How to take Ambroxol Normon".

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

At the first symptom of an allergy, stop taking the medication and consult your doctor or pharmacist.

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

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ambroxol Normon

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Ambroxol Normon Composition

-The active ingredient 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, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate, sorbitol (E-420), strawberry flavor (contains benzyl alcohol), and purified water.

Product Appearance and Package Contents

Ambroxol Normon 3 mg/ml Oral Solution EFG is presented as a solution. Its appearance is slightly viscous, transparent or slightly opaque, practically colorless or slightly colored, and has a strawberry flavor.

Each package contains 200 ml in a topaz-colored polyethylene terephthalate bottle.

A dosing device with measurements for 2.5, 5, 7.5, 10, and 15 ml is included.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This package leaflet was approved in January 2022

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

You can access detailed and up-to-date information on this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address:

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