Leaflet: information for the patient

Tuscalman 15 mg Suppositories for children

Noscapine hydrochloride

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Noscapine is a central antitussive that acts by temporarily reducing the urge to cough.

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

Do not use Tuscalman

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• in children under 2 years.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tuscalman

This medication may cause drowsiness.

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

Inform your doctor of your current and past medical problems, especially diabetes and any allergy you may suffer.

Use of Tuscalman with other medications

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

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

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

Inform your doctor about all sedative medications 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 indicated above. Contact your doctor when you experience these symptoms.

Pregnancy and breastfeeding

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

This medication is indicated for children aged 2 to 12 years, so it does not apply.

Driving and operating machinery

This medication is indicated for children aged 2 to 12 years, so it does not apply.

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

Remember to take your medication.

Your doctor will indicate the duration of treatment with Tuscalman. Do not discontinue treatment prematurely, as the same symptoms will reappear.

This medication and its administration method have been prescribed exclusively for you. Do not give it to anyone else or use it for other types of disorders.

The recommended dose is:

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

Children:

Children aged 2 to 6 years: 1 suppository every 8-12 hours.

Children aged 6 to 12 years: 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Tuscalman

Do not use a double dose to compensate for the missed doses. Limit yourself to using the next dose as usual.

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

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

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

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Adverse Effect Communication

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects not listed in this prospectus. You can also communicate them directly through theSpanish System for Pharmacovigilance of Medications for Human Use: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 store at a temperature above 25°C. In hot weather, it is recommended to store the suppositories in the refrigerator (between 2°C and 8°C).

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tuscalman

• The active principle is noscapine hydrochloride. Each suppository contains 15 mg of noscapine hydrochloride.
• The other components are suppo-cire and colloidal silica.

Appearance of the product and content of the packaging

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

Each package contains 20 suppositories.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio Farmaceutico SIT S.r.l.

Via Cavour 70

27035 Mede (Pavia) Italy

Responsible for manufacturing

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 medication by contacting the local representative of the holder of the marketing authorization:

DESMA Laboratorio Farmacéutico SL

Paseo de la Castellana 121, escalera Izquierda 3ºB

28046 Madrid, Spain

Last review date of this leaflet: May 2024

Other sources of information:

The detailed and updated information about this medication is available on the

website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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