TUSCALMAN 3 mg/ml SYRUP

Introduction

Patient Information Leaflet

Tuscalman 3 mg/ml Syrup

Noscapine hydrochloride

Read this leaflet carefully before starting to take 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 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 this leaflet. See section 4.

Contents of the leaflet:

1. What Tuscalman is and what it is used for.
2. What you need to know before taking Tuscalman.
3. How to take Tuscalman.
4. Possible side effects.
5. Storage of Tuscalman.

Package contents and additional information.

1. What Tuscalman is and what it is used for

Noscapine is a centrally acting antitussive that temporarily reduces the cough impulse.

Tuscalman is indicated for the symptomatic treatment of all forms of non-productive cough (dry cough).

2. What you need to know before taking Tuscalman

Do not take Tuscalman

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• in children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tuscalman. This medicine may cause drowsiness.

It may enhance the effects of alcohol, so it is advisable to avoid consuming alcoholic beverages during treatment.

Inform your doctor about your current and past medical problems, especially diabetes and any allergies you may have.

Taking Tuscalman with other medicines

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

The concomitant use of Tuscalman and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Tuscalman with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

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.

Since there are no sufficient data to confirm its safety, as a precaution, it is not recommended to take it during pregnancy.

There are no data on the passage of Tuscalman into breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

Since this medicine may affect your reaction ability, it is recommended to pay special attention if you drive vehicles or operate hazardous machinery, and do not exceed the recommended daily dose advised by your doctor.

Tuscalman contains sucrose, sorbitol, and sodium benzoate

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 5.130 g of sucrose per 10 ml.

This medicine contains 87.15 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 disease in which the patient cannot break down fructose, consult with your doctor before taking this medicine.

This medicine contains 1 mg of sodium benzoate per ml.

3. How to take Tuscalman

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of treatment with Tuscalman.

Do not stop treatment before, as the same symptoms will reappear.

This medicine and its administration have been prescribed exclusively to you. Do not give it to others, nor use it for other types of disorders.

Tuscalman should be taken preferably after meals.

The recommended dose is:

AdultThe recommended dose is 2 dessert spoons (2 x 5 ml) every 5-6 hours.

Use in children and adolescents:

Children from 2 to 6 years: Half a dessert spoon (2.5 ml) every 5-6 hours.

Children from 6 to 12 years: 1 dessert spoon (5 ml) every 5-6 hours.

If you take more Tuscalman than you should

The most frequent symptom in case of overdose is excessive drowsiness.

Treatment of overdose consists of inducing vomiting by administering emetics or gastric lavage.

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 medicine and the amount ingested.

If you forget to take Tuscalman

Do not take a double dose to make up for forgotten doses. Just take the next dose as usual.

4. Possible side effects

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

The most frequent side effects are: drowsiness, headache, nausea, and allergic reactions such as nasal mucosa inflammation, eye redness, skin rash, and itching.

These effects are generally mild and do not usually present significant importance.

Reporting side effects

If you experience any 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 Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tuscalman

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

Store in the original packaging to protect it from light.

Once the package is opened, it expires after 6 months.

Do not use this medicine after the expiration date shown on the package 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 packages and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Tuscalman composition

• The active substance is noscapine hydrochloride. Each ml contains 3 mg of noscapine hydrochloride.
• The other ingredients are sucrose, crystallized sorbitol liquid, elderberry syrup, sodium benzoate, citric acid, peppermint essence, cherry essence, and water.

Appearance of the product and package contents

Tuscalman is presented as a dark yellow solution.

Each package contains 150 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Farmaceutico SIT, S.r.l.

Via Cavour 70

27035 Mede (Pavia)

Italy

Manufacturer

Laboratorio Farmaceutico S.I.T. Specialità Igienico Terapeutichi S.r.l

Via Provinciale per Lecco, 78.

22038 Tavernerio (Como)

Italy

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

DESMA Laboratorio Farmacéutico SL

Paseo de la Castellana 121, escalera Izquierda 3ºB

28046 Madrid, Spain

This leaflet was last revised in:May 2024

Other sources of information

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS)

http://www.aemps.gob.es/