PROSPAN (EFEJAS EXTR.) HERBAL DROPS 20ML

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 20MG/1ML 20ML

Package leaflet: Information for the user

PROSPAN 20 mg/mL, oral drops, solution

Hedera helix 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.
-   If you have any further questions, ask your pharmacist.
-   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 10 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 oral drops are used to loosen mucus in the case of cough.

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

-   if you are allergic to Hedera helix or any of the other ingredients of this medicine (listed in section 6).
-   if you are in alcohol rehab.
-   PROSPAN is contraindicated for children under 1 year of age.

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. Thus, this medicine can be safely used with other medicines (such as antibiotics).

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

When properly used, the medicine has no effect on driving and using machines.

3.   How to take PROSPAN

Always take 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 a doctor, PROSPAN should be dosed according to the following instructions. Please follow the instructions, otherwise Prospan may be ineffective. Adults and children aged 10 and older: 24 drops (50.4 mg ivy leaf dry extract) 3 times a day, children aged 4-10 years: 16 drops (33.6 mg ivy leaf dry extract) 3 times a day, and children aged 1-4 years: 12 drops (25.2 mg ivy leaf dry extract) 3 times a day.
Drops should always be taken before a meal. In small children, it is recommended to administer drops with small amount of fruit juice.
Duration of treatment depends on the type and severity of symptoms, but it should last for at least one week, even with milder respiratory inflammation.
In order to ensure the efficiency of treatment, administer the medicine for another 2-3 days after the symptoms resolve.
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 (more than triple daily dose) of medicine 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.

4.   Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Very rarely (less than 1 in 10,000 patients), patients may develop allergic reaction.

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.
There are no special conditions. 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 open bottle is 6 months.

6.

Contents of the pack and other information

What PROSPAN contains

-   The active substance is ivy leaf dry extract [5-7.5:1]. 1 mL solution contains 20 mg ivy leaf dry extract (5-7.5:1). (infusion: ethanol 30 percentage by weight)
-   The other ingredients are saccharin sodium, anise oil, cumin oil, peppermint oil, 96% ethanol, purified water.

What PROSPAN looks like and contents of the pack

Prospan is brown, slightly opalescent solution (may contain suspended solids and/or precipitate) with subtle smell of alcohol and fennel.

Marketing Authorisation Holder and Manufacturer

Engelhard Arzneimittel GmbH & Co. KG.
Herzbergstr. 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 6830 700, fax: +372 6701 050

This leaflet was last revised in May 2015.