Tiocalmina

Package leaflet: Information for the patient

TIOCALMINA 1.2 g / 100 ml + 0.1 g / 100 ml syrup

potassium sulfoguaiacolate + dropropizine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Tiocalmina is and what it is used for
2. What you need to know before taking Tiocalmina
3. How to take Tiocalmina
4. Possible side effects
5. How to store Tiocalmina
6. Package contents and other information

1. What Tiocalmina is and what it is used for

Tiocalmina contains dropropizine and potassium guaiacolsulfonate.
Dropropizine has antitussive activity; potassium guaiacolsulfonate has an expectorant action, facilitates the expulsion of bronchial and tracheal secretions, and reduces bronchial secretion and coughing.
Tiocalmina is used as a cough suppressant, i.e. to relieve cough of any origin, including irritative cough and smoker's cough.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Tiocalmina

Do not take Tiocalmina

• if you are allergic to dropropizine, potassium guaiacolsulfonate, or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant or breastfeeding (see section 2. Pregnancy and breastfeeding),
• if you have diabetes.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tiocalmina.
Due to the presence of ethanol (alcohol), use special caution if any of the following apply to you:

• you have a liver disease;
• you have/have had problems related to alcohol abuse;
• you have epilepsy.

Children and adolescents
Tiocalmina can be used in children and adolescents.
Other medicines and Tiocalmina
Tell your doctor or pharmacist if you/your child are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you suspect you are pregnant or are planning a pregnancy, consult your doctor before taking this medicine.
Pregnancy

• Do not use Tiocalmina during pregnancy
  Breastfeeding
• Do not use Tiocalmina if you are breastfeeding with breast milk

Driving and operating machinery
Since Tiocalmina may cause fatigue and drowsiness, exercise particular caution when driving or operating machinery.
Tiocalmina contains sucrose, ethanol, and methyl 4-hydroxybenzoate
This medicine contains 4.4 g of sucrose (sugar) per dose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 346 mg of alcohol (ethanol) per dose (1 tablespoon), equivalent to 24 mg/ml. The amount of alcohol in 1 tablespoon of this medicine is equivalent to less than 9 ml of beer or 4 ml of wine.
The amount of alcohol in this medicine does not appear to have an effect on adults and adolescents, and its effects in children are not clear. Some effects may occur in very young children, for example, feeling drowsy.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
If you have alcohol dependence, speak with your doctor before taking this medicine.
This medicine contains 22.5 mg of p-hydroxybenzoate per dose, equivalent to 150 mg/100 ml.

3. How to take Tiocalmina

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
How much to take
Adults
The recommended dose is 1 tablespoon 2 to 4 times daily.
Children
The recommended dose is 1 tablespoon twice daily.
Do not exceed the recommended doses without medical advice.
Duration of treatment
Take Tiocalmina only for short treatment periods.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.
Method of administration
Take Tiocalmina undiluted or diluted in your preferred beverage (hot or cold), preferably taken away from meals.

CHILD-RESISTANT SAFETY CAP
To open, press down on the closure cap and turn it simultaneously in the direction indicated by the arrow.
If you take more Tiocalmina than you should
In case of accidental ingestion or overdose of Tiocalmina, contact your doctor immediately or go to the nearest hospital.
If you forget to take Tiocalmina
Do not take a double dose to make up for the missed dose.
If you stop treatment with Tiocalmina
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of Tiocalmina:

• nausea,
• stomach and intestinal disturbances

These side effects are rare and usually temporary. If they occur, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tiocalmina

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the box and on the
vial after Exp.
The expiry date refers to the last day of that month.
This date applies to the product in its original, unopened packaging, stored correctly.
The shelf life after first opening the vial is 6 months (record the date of first opening in the designated space on the carton).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Tiocalmina contains

• The active substances are sulfoguaiacolyl potassium 1.2 g, dropropizine 0.1 g (present in 100 ml of syrup).
• The other components are sucrose, 96% ethanol, methyl p-hydroxybenzoate (see section 2. Tiocalmina contains sucrose, ethanol and methyl p-hydroxybenzoate), orange sweet essence flavouring, citric acid monohydrate, purified water.

Description of the appearance of Tiocalmina and contents of the pack
Tiocalmina is a syrup for oral administration.
It is available in a 200 g pack.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLIFARMA BENESSERE S.r.l. – Via del Poggio Laurentino, 2 – 00144 ROME, ITALY

Manufacturers
Istituto De Angeli S.r.l. – Loc. Prulli 103/C – Reggello 50066 (FI)
Aeffe Farmaceutici S.r.l. – Via Torino 448 – Brandizzo 10032 (TO)