TUSCALMAN 15 mg SUPPOSITORIES FOR CHILDREN

Introduction

Package Leaflet: Information for the Patient

Tuscalman 15 mg Suppositories Children

Noscapine hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult 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 side effects not mentioned in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

1. Contents of the pack and further 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 starting to use Tuscalman

Do not use Tuscalman

• if you are allergic to the active substance or to any of the other components 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 use 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 allergy you may suffer from.

Use of 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 along with sedative medicines, your doctor must limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and carefully 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 such 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.

This medicine is indicated for children from 2 to 12 years of age, so it is not applicable.

Driving and using machines

This medicine is indicated for children from 2 to 12 years of age, so it is not applicable.

3. How to use 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. You should never give it to others or use it for other types of disorders.

The recommended dose is:

Tuscalman 15 mg Suppositories Children should be applied exclusively via the rectal route.

Children:

Children from 2 to 6 years of age: 1 suppository every 8-12 hours.

Children from 6 to 12 years of age: 1 suppository every 5 hours.

If you use more Tuscalman than you should

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

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 forgot to use Tuscalman

Do not use a double dose to make up for forgotten doses. Just use 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.

If you consider that any of the side effects you suffer from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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.

Do not store above 25°C. In periods of high temperature, it is recommended to store the suppositories in the refrigerator (between 2°C and 8°C).

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging 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 packaging and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of Tuscalman

• The active substance is noscapine hydrochloride. Each suppository contains 15 mg of noscapine hydrochloride.
• The other components are suppocire and colloidal silica.

Appearance of the product and contents of the pack

Tuscalman 15 mg Suppositories Children are presented in the form of white suppositories.

Each pack contains 20 suppositories.

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

Date of the last revision of this package leaflet: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 Health Products (AEMPS)

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