PROSPAN (EFEJAS EXTR.) COUGH SYRUP 100ML

ATC code: R05CA 

Active substances: Hederae Helicis Folii Extractum Siccum

Vendor, principal: Engelhard Awd. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

PROSPAN 7MG/1ML 100ML

Package leaflet: Information for the user

Prospan, 7 mg/mL syrup Hedera helix dry extract

Read all of this leaflet carefully before you start 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 told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

1.   What Prospan is and what it is used for
2.   What you need to know before you take Prospan
3.   How to take Prospan
4.   Possible side effects
5.   How to store Prospan
6.   Contents of the pack and other information
1. What Prospan is and what it is used for
Prospan syrup is used to loosen mucus in the case of cough.

2. What you need to know before you take Prospan Do not take Prospan syrup:

- if you are allergic to Hedera helix or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Prospan.

Children and adolescents

See section 3.

Other medicines and Prospan

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
There are no reports of possible side effects during concomitant use of Prospan and other medicines.

Prospan with food and drink

No specific precautions apply.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Not applicable.

Prospan contains sorbitol

2.5 mL of syrup contains 0.963 g sugar substitute sorbitol = 0.08 BU (bread units).
According to dosage instructions, each dose releases up to 2.9 mL sorbitol.
Health risks are present in patients with hereditary problems with fructose intolerance. In that case, treatment must be performed only after consulting with a doctor.

3. How to take Prospan

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by doctor, the following dosage instructions will apply to Prospan. Please follow the instructions, otherwise Prospan may be ineffective.
Children aged under 6 years: 2.5 mL of syrup twice a day (35 mg ivy leaf dry extract), children aged 6 to 12 years: 5 mL of syrup twice a day (70 mg ivy leaf dry extract), children aged 12 years and older and adults: 5 mL of syrup 3 times a day (105 mg ivy leaf dry extract).
The volume of measuring cup is 10 mL. Cup has scoring at 2.5 mL intervals (graduations at 2.5 mL, 5 mL, 7.5 mL and 10 mL).
The medicine should be taken in the morning, (midday) and evening. Shake well before use.
Duration of treatment depends on the type and severity of disease symptoms. Treatment should last for at least one week, even with milder respiratory inflammation.
The medicine should be administered for another 2-3 days after symptoms resolve to ensure effectiveness of the treatment.
If you feel that the effect of Prospan is too strong or too weak, talk to your doctor or pharmacist.

If you take more Prospan than you should

You should not exceed recommended dose. Taking significantly higher doses of medicine (more than triple daily dose) may cause nausea, vomiting and diarrhoea.

If you forget to take Prospan

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In very rare cases (less than 1 in 10,000 patients) users may develop allergic reaction.
In very rare cases, the medicine can have laxative effect due to sorbitol content.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prospan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Shelf-life of opened bottle is 3 months.

What Prospan contains

-   The active substance is ivy leaf extract. 1 mL of solution contains 7 mg of ivy leaf dry extract.
-   The other ingredients are potassium sorbate, citric acid anhydrous, xanthan gum, cherry flavouring, 70 % (crystallised) sorbitol solution, purified water.

What Prospan looks like and contents of the pack

Brown glass bottle with screw cap. The package contains measuring cup, placed over the bottle. The volume of measuring cup is 10 mL. Cup has scoring at 2.5 mL intervals (graduations at 2.5 mL, 5 mL, 7 mL and 10 mL).
Glass bottle contains 100 or 200 mL syrup.
Prospan syrup contains natural herbal extract, which may cause variations in the colour of the preparation. This does not affect therapeutic effect of the preparation.

Marketing Authorisation Holder and Manufacturer

Engelhard Arzneimittel GmbH & Co. KG.
Herzbergerst. 3 61138 Niederdorfelden Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
AS Sirowa Tallinn Salve 2C 11612 Tallinn Phone: +372 6 830 700

This leaflet was last revised in February 2014.