ANGITUSS 6mg/mL SYRUP

Introduction

Leaflet: information for the user

Angituss 6 mg/ml syrup

Levodropropizine

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

Follow the administration instructions of the medicine contained in this leaflet or as 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 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 it worsens or does not improve after 4 days.

Contents of the leaflet

1. What is Angituss 6 mg/ml syrup and what is it used for
2. What you need to know before taking 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. Package contents and additional information

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

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

Angituss syrup is indicated for:

Treatment of non-productive forms of cough, such as irritative or nervous cough in adults, adolescents, and children over 2 years of age.

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

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

Do not take Angituss syrup

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

Warnings and precautions

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

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

Children

Do not administer to children under 2 years of age.

Other medicines and Angituss syrup

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

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

Using Angituss syrup with food

Since there is no information available 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is not recommended during pregnancy or in women of childbearing age who are not using contraceptive methods. Levodropropizine is excreted in breast milk. Therefore, its use is not recommended during the lactation period.

Driving and using machines

This medicine may, although rarely, cause drowsiness. If it causes drowsiness, do not drive vehicles or operate hazardous machinery.

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

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medicine contains 2.25 mg of propylene glycol per ml.

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

3. How to take Angituss 6 mg/ml syrup

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of 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 should more than 10 ml be administered 3 times a day.

Pediatric population

Children from 2-6 years: only under medical control

The dose is calculated according to the patient's weight, administering 1 mg per kg per dose, every 6-8 hours. No more than 3 doses in 24 hours. The amount of medicine to be administered is indicated in the following table:

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

It is not advisable to use the medicine for more than 7 days.

Elderly patients do not require adjustments or modifications to the dosage regimen. Your doctor will monitor you while you are being treated.

How to take:

This medicine is taken orally

Measure the amount of medicine to be taken using the dosing cup included in the package.

Once used, wash the cup with water.

Do not take with food.

If the patient worsens or symptoms persist after 4 days of treatment, it should be discontinued and the doctor consulted.

If you take more Angituss syrup than you should

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The detected side effects include:

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

• Gastrointestinal disorders: nausea, pyrosis, dyspepsia, diarrhea, vomiting, and abdominal pain.
• Nervous system disorders: fatigue and/or asthenia, clumsiness, drowsiness, headache, and vertigo.
• Cardiac disorders: palpitations

Rarely (affects less than 1 in 1000 patients but more than 1 in 10,000)

• Skin and subcutaneous tissue disorders: rare cases of skin allergy have been observed.
• Respiratory, thoracic, and mediastinal disorders: dyspnea (difficulty breathing)

Frequency not known

• Eye disorders: visual disturbances
• Cardiac disorders: precordial pain (chest pain).

Reporting side effects

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

5. Storage of Angituss 6 mg/ml syrup

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

No special storage conditions are required.

Do not use this medicine after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other components (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and mint flavor

Appearance of the product and package contents

Angileptol are sucking tablets, white, round, and with the Greek letter σ on one of the faces.

They come in packages containing 15 and 30 sucking tablets.

Other presentations

Angileptol Mint-eucalyptus flavor

Angileptol Honey-lemon flavor

Marketing authorization holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

ManufacturerPharmaloop, S.L

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), SPAIN

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), ITALY

Date of the last revision of this leaflet:September 2021

Other sources of information

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