Prospect: information for the user

Ambroxol Normon 3 mg/ml oral solution EFG

ambroxol hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in the prospect. See section 4

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

2.What you need to knowbeforestarting totake Ambroxol Normon

3.How to take Ambroxol Normon

4.Possible adverse effects

5Storage of Ambroxol Normon

6.Contents of the package and additional information

Ambroxol Normon belongs to a group of medicines called mucolytics. The active ingredient ambroxol in this medicine acts by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

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

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

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.

Severe skin reactions have been reported associated with the administration of ambroxol. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genitals), stop using Ambroxol Normon and consult your doctor immediately.

If you have problems with bronchial function, 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 dosage.

Patients with known histamine intolerance should avoid long-term treatment with this medication. Symptoms of intolerance are: headache, rhinitis, and itching.

Other medications and Ambroxol Normon

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

The concurrent use of this medication with cough suppressants (antitussives) may cause the accumulation of pulmonary secretions due to the reduction of the cough reflex.

The administration of this medication with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases the concentration of antibiotics in pulmonary tissue.

Use of Ambroxol Normon with food and beverages

Do not take with meals and take with a glass of water. Taking 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 intend 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 advises it.

Mothers breastfeeding should only take it if your doctor advises it.

Driving and operating machinery

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

Ambroxol Normon contains sorbitol,parahydroxybenzoate of methyl (E-218), parahydroxybenzoate of propyl (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 indicated that you (or your child) suffer from intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

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

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 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 your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children.

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

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

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubts, consult your pharmacist again.

The recommended dose is:

Adults and adolescents 12 years and older:

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

Use in children

Children under 2 years:

It is contraindicated.

Children 2 to 5 years:

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

Children 6 to 12 years:

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

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

How to take:

This medication is takenby mouth.

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

Do not take with meals.

If symptoms worsen or persist after 5 days of treatment, or if you experience: fever, skin eruptions, 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 notice short-term agitation and diarrhea.

Accidental or intentional overdose may cause an increase in saliva production, nausea, vomiting, and low blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological 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 symptoms continue, take the medication in the same way as indicated in the section 3 “How to take Ambroxol Normon”.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Infrequent may affect up to 1 in 100 patients: nausea, vomiting, stomach pain, fever.

Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, exanthema, urticaria. Unknown frequency (cannot be estimated from available data): anaphylactic reactions, such as anaphylactic shock, angioedema (rapid progression of skin, subcutaneous tissues, mucous membranes, or submucosal tissues swelling) and pruritus. Severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalized acute exanthematous pustulosis).

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

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ambroxol Normon

- The active ingredient is ambroxol hydrochloride. Each milliliter 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.

Appearance of the product and contents of the packaging

Ambroxol Normon 3 mg/ml oral solution EFG is presented in the form of a solution. Its appearance is slightly viscous, transparent or slightly opaque, practically colorless or slightly colored and with a strawberry odor.

Each package contains 200 ml in a polyethylene terephthalate bottle of topaz color.

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

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

This prospectus was approved in January 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning with your smartphone the QR code included in the prospectus and packaging. You can also access this information at the following internet address:

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