Tuscalman 15 mg suppositories for children
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Tuscalman 15 mg Suppositories for children
Noscapine hydrochloride
Read the entire leaflet carefully before you start using this medicine, because 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 only for you; do not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
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What Tuscalman is and what it is used for.
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What you need to know before using Tuscalman.
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How to use Tuscalman.
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Possible side effects.
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How to store Tuscalman.
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Contents of the pack and other information
1. What Tuscalman is and what it is used for
Noscapine is a centrally-acting antitussive that works by temporarily reducing the cough reflex.
Tuscalman is indicated for the symptomatic treatment of all forms of non-productive cough (dry cough).
2. What you need to know before using 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; therefore, it is advisable to avoid consuming alcoholic beverages during treatment.
Inform your doctor about your current and past medical conditions, especially diabetes and any allergies you may have.
Use of Tuscalman with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Concomitant use of Tuscalman and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Tuscalman together 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 dosage carefully. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine is indicated for children aged 2 to 12 years; therefore, this section does not apply.
Driving and using machines
This medicine is indicated for children aged 2 to 12 years; therefore, this section does not apply.
3. How to use Tuscalman
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medication.
Your doctor will indicate how long you should continue treatment with Tuscalman. Do not stop treatment prematurely, as symptoms may return.
This medicine and its method of administration have been prescribed exclusively for you. Never give it to other people, and do not use it for other types of disorders.
Recommended dose:
Tuscalman 15 mg Suppositories for children must be administered exclusively by 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Tuscalman
Do not use a double dose to make up for a missed dose. Simply take the next dose as usual.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
The most frequent adverse effects are: drowsiness, headache, nausea, and allergic-type reactions such as inflammation of the nasal mucosa, redness of the eyes, skin rash, and skin itching.
These effects are generally mild and usually not clinically significant.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide 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. During 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other 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 silicon dioxide.
Nature of the product and contents of the pack
Tuscalman 15 mg Suppositories for children are presented as white-colored 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
DESMA Laboratorio Farmacéutico SL
Paseo de la Castellana 121, Left staircase, 3rd floor, B
28046 Madrid, Spain
Date of the most recent revision of this leaflet: May 2024
Other sources of information:
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.gob.es/