Prospect: information for the patient

Tuscalman 3 mg/ml Syrup

Noscapine hydrochloride

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Contents of the package and additional information

Noscapine is a central antitussive agent 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 take Tuscalman

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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.

Taking 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 carefully 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 breastfeeding

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

Since there are not enough 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 to breast milk, so it is not recommended to use it during breastfeeding.

Driving and operating machinery

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

Tuscalman contains saccharose, sorbitol, and sodium benzoate

This medication contains saccharose. If your doctor has indicated that you suffer from an intolerance to certain sugars, consult with him before taking this medication.

Patients with diabetes mellitus should note that this medication contains 5.130 g of saccharose per 10 ml.

This medication contains 87.15 mg of sorbitol in each ml.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from 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 (or your child) before taking this medication.

This medication contains 1 mg of sodium benzoate per ml.

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 as symptoms will reappear.

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

Tuscalman should be taken preferably after meals.

The recommended dose is:

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

Use in children and adolescents:

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

Children 6 to 12 years old: 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.

Overdose treatment consists of inducing vomiting through the administration of emetics or gastric lavage.

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 take Tuscalman

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products 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.

Store in the original packaging to protect it from light.

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

Do not use this medication after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

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

Composition of Tuscalman

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

Appearance of the product and content of the packaging

Tuscalman is presented in the form of a dark yellow solution.

Each package contains 150 ml.

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 of this prospect was in: 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/