Patient Information Leaflet

Guaiacalcium complex 0.144 g/100 ml + 2 g/100 ml syrup
dropropizine + potassium guaiacolsulfonate
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 your symptoms worsen after a few days.

Contents of this leaflet:

What Guaiacalcium complex is and what it is used for
What you need to know before taking Guaiacalcium complex
How to take Guaiacalcium complex
Possible side effects
How to store Guaiacalcium complex
Contents of the pack and other information

1. What Guaiacalcium complex is and what it is used for

Guaiacalcium complex contains dropropizine and potassium guaiacolsulfonate.
This medicine is used to relieve cough.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you should know before taking Guaiacalcium complex

Do not take Guaiacalcium complex

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
during pregnancy or breastfeeding (see Pregnancy and breastfeeding);
in children under 13 years of age.

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

if you have liver disease;
if you suffer from epilepsy;
if you have alcohol-related problems;
if you have suffered trauma or suffer from brain disorders.

Children and adolescents
This medicine may only be used in children above 13 years of age.
Other medicines and Guaiacalcium complex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Guaiacalcium complex and alcohol
The alcohol contained in this medicine may alter or increase the effect of other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding.
Driving and using machines
This medicine may rarely cause drowsiness. You should not drive, operate complex machinery, or perform any other potentially dangerous activities until you know whether this medicine impairs your ability to carry out such activities.
Guaiacalcium complex contains ethanol
This medicine contains 6.3% vol. ethanol (alcohol), e.g. up to 0.76 g per dose, equivalent to 20 ml of beer or 7.9 ml of wine per dose.
It may be harmful for alcoholics.
This should be taken into consideration in pregnant or breastfeeding women and in children (for whom the product is contraindicated anyway), as well as in high-risk groups such as patients with liver disease or epilepsy.
For athletes, the use of medicines containing ethyl alcohol may lead to a positive result in anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.
Guaiacalcium complex contains methyl 4-hydroxybenzoate. It may cause allergic reactions (including delayed reactions).
Guaiacalcium complex contains sucrose. This medicine contains 6 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus.

3. How to use Guaiacalcium complex

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose in adults and in adolescents over 13 years of age is 1 tablespoon, 2 or 3 times daily.
Method of administration: during the cold season, it is advisable to take the syrup warm, diluting the dose in hot water, hot tea, or hot milk.
Duration of treatment: use only for short-term treatment periods.
Do not exceed the recommended doses without medical advice.
If you take more Guaiacalcium complex than you should
In case of accidental ingestion/overdose of Guaiacalcium complex, contact a doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cases of nausea and other mild gastrointestinal and intestinal disturbances have rarely been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website: http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Guaiacalcium complex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Guaiacalcium complex contains
The active substances are dropropizine and potassium guaiacolsulfonate.
100 ml of syrup contain:

Active substances: Dropropizine 0.144 g, Potassium guaiacolsulfonate 2 g.
Other components: Aconite root fluid extract, cherry laurel (aromatic distilled water), grindelia fluid extract, balsam of Tolu fluid extract, ethanol 95%, natural caramel, aromatic extract, sucrose, methyl parahydroxybenzoate, purified water.

Description of the appearance of Guaiacalcium complex and contents of the pack
Guaiacalcium complex is supplied in a 200 ml dark glass bottle with an aluminum cap.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
DMS Farmaceutici S.p.A. - Via Provinciale per Lecco, 78 - 22038 Tavernerio (CO)