Leaflet: information for the user

Angituss 6 mg/ml syrup

Levodropropizina

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 4 days.

1. What is Angituss 6 mg/ml syrup and what it is used for

2. What you need to know before starting to take Angituss 6 mg/ml syrup

3. How to take Angituss 6 mg/ml syrup

4. Possible side effects

5. Storage of Angituss 6 mg/ml syrup

6. Contents of the pack and additional information

Angituss syrup contains levodropropizine and belongs to a group of medicines called antitussives.

Angituss syrup is indicated for:

Treatment of unproductive cough forms, such as irritative cough or nervous cough in adults, adolescents, and children over 2 years old.

You should consult a doctor if it worsens or does not improve after 4 days of treatment.

Do not take Angituss syrup

• If you are allergic to levodropropizine or any of the other components of this medication (listed in section 6).
• If you have excessive mucus secretion in the bronchi or have impaired mucus elimination function (Kartagener syndrome, bronchial ciliary dyskinesia).
• During pregnancy and lactation.
• Children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Angituss syrup:

• If you have liver and kidney insufficiency.
• If you are diabetic.

Children

Do not administer to children under 2 years old.

Other medications and Angituss syrup

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No interactions or incompatibilities with other medications have been observed. However, caution is necessary in the case of concurrent administration of anxiolytic drugs (which reduce anxiety), such as benzodiazepines, particularly in sensitive patients, as it may cause an increase in sedative effect.

Use of Angituss syrup with food

Since there is no available information on the effect of food on the absorption of the product, it should be taken outside of meals.

Pregnancy and lactation

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

This medication is not recommended during pregnancy, nor in fertile women who are not using contraceptive methods. Levodropropizine is excreted in breast milk. Therefore, its use is not recommended during lactation.

Driving and operating machinery

This medication may, although rarely, cause drowsiness. If you experience drowsiness, do not drive vehicles or operate hazardous machinery.

Angituss syrup contains saccharose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and propylene glycol (E-1520)

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 4.0g of saccharose per 10ml dose.

This medication may cause allergic reactions (possibly delayed) due to the presence of methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medication contains 2.25 mg of propylene glycol per ml.

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

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: 10 ml every 6-8 hours. Do not administer more than 3 times a day.

Adolescents:

Unless the doctor establishes another regimen, but in no case will more than 10 ml be administered 3 times a day.

Pediatric population

Children 2-6 years:only under medical supervision

The dose is calculated according to the patient's weight, administering 1 mg per kg/dose, every 6-8 hours. Not more than 3 doses in 24 hours. The amount of medication to be administered is indicated in the table below:

Antitussives are symptomatic medications and should only be used while symptoms persist.

It is not recommended to use the medication for more than 7 days.

Elderly patients do not require adjustments or modifications to the dosing regimen. Your doctor will monitor you while you are on treatment.

How to take:

This medication is taken orally

Measure the amount of medication to be taken using the dosing cup provided in the packaging.

Once used, wash the dosing cup with water.

Do not take with food.

If the patient worsens or symptoms persist after 4 days of treatment, discontinue and consult the doctor.

If you take more Angituss syrup than you should

You may experience mild and transient tachycardia (increased heart rate). Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

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

The detected adverse effects include:

Frequently (affecting less than 1 in 10 patients but more than 1 in 100)

- Gastrointestinal disorders: nausea, heartburn, indigestion, diarrhea, vomiting, and abdominal pain.

- Nervous system disorders: fatigue and/or asthenia, clumsiness, drowsiness, headache, and vertigo.

- Cardiac disorders: palpitations

Rarely (affecting less than 1 in 1,000 patients but more than 1 in 10,000)

- Skin and subcutaneous tissue disorders: rarely, cases of cutaneous allergy have been observed.

- Respiratory, thoracic, and mediastinal disorders: dyspnea (difficulty breathing)

Unknown frequency

- Eye disorders: visual disturbances

- Cardiac disorders: precordial pain (chest pain).

Reporting Adverse Effects

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

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

No special storage conditions are required.

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

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

Composition of Angituss syrup

- The active ingredient is levodropropizine. Each ml contains 6 mg of levodropropizine.

- The other components (excipients) are: citric acid monohydrate, cherry aroma (contains propylene glycol E-1520), sodium hydroxide, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), saccharose and purified water.

Appearance of the product and contents of the packaging

Transparent liquid with a cherry odor that is presented in a dark-colored glass bottle of 120 and 200 ml with a safety cap and a plastic graduated measuring cup.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

Alfasigma España S.L.

Avenida Diagonal, 490

08006 Barcelona

Spain

Responsible for manufacturing

Dompe Farmaceutici SPA

Via Campo di Pile, L’aquila

67100 – Italy

Or

Pharmaloop, S.L.

Bolivia, 15. Industrial Zone Azque

28806 Alcala de Henares (Madrid), Spain

Last review date of this leaflet: August 2023

Other sources of information

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