IMUPRET

IMUPRET N Coated Tablets

Important notes (mandatory information)

Imupret N Dragees. Areas of application: at the first signs and during a cold, e.g. scratching in the throat, sore throat, difficulty swallowing, coughing.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Imupret N Dragees for use in children aged 12 and over and adults
Traditional herbal medicinal product

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, to achieve the best possible treatment results, Imupret N Dragees must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor in any case.
• If any of the side effects listed significantly affect you or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This leaflet contains

1. WHAT ARE IMUPRET N DRAGEES AND WHAT ARE THEY USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING IMUPRET N DRAGEES?
3. HOW TO TAKE IMUPRET N DRAGEES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE IMUPRET N DRAGEES?
6. FURTHER INFORMATION

1. WHAT ARE IMUPRET N DRAGEES AND WHAT ARE THEY USED FOR?

Imupret N Dragees is a traditional herbal medicinal product. Imupret N Dragees is traditionally used at the first signs and during a cold, e.g. scratching in the throat, sore throat, difficulty swallowing, coughing. Note: Imupret N Dragees is a traditional herbal medicinal product that is registered for the area of application exclusively based on long-standing use.

2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING IMUPRET N DRAGEES?

Imupret N Dragees must not be taken:

• if you are hypersensitive (allergic) to marshmallow root, chamomile flowers, horsetail herb, walnut leaves, yarrow herb, oak bark, dandelion herb or any of the other ingredients of Imupret N Dragees (other ingredients see under section 6 Further information).
• if you are allergic to composite flowers.

Special care should be taken when taking Imupret N Dragees:

• If symptoms of illness persist or if side effects other than those mentioned in the package leaflet occur, you should consult a doctor or other qualified person in a medical profession.
• If symptoms persist for more than a week or if shortness of breath, fever, or purulent or bloody sputum occurs, a doctor should be consulted.

Children

Imupret N Dragees should not be given to children under 6 years of age.

When taking Imupret N Dragees with other medicines

This medicinal product has not been studied in this regard. There are no reports of clinical interactions between Imupret N Dragees and other medicinal products. Imupret N Dragees can reduce or prevent the absorption of alkaloids (e.g. codeine-containing cough suppressants) and other such drugs. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

When taking Imupret N Dragees with food and drink

Not applicable.

Pregnancy and breast-feeding

Safety during pregnancy and breast-feeding has not been studied. Imupret N Dragees is not recommended for pregnant and breast-feeding women.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Imupret N Dragees

This medicinal product contains glucose, lactose and sucrose. Therefore, please only take Imupret N Dragees after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE IMUPRET N DRAGEES?

Always take Imupret N Dragees exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is

Age	Dosage for acute symptoms	Dosage after acute symptoms have subsided
Children under 6 years	Not intended for use
Children aged 6 – 11 years	1 coated tablet 5 – 6 times a day	1 coated tablet 3 times a day
Adolescents aged 12 and over and adults	2 coated tablets 5 – 6 times a day	2 coated tablets 3 times a day

There is insufficient data for specific dosage recommendations in the case of impaired renal/and hepatic function.

Method of administration

The coated tablets are swallowed whole - preferably with a little liquid (e.g. a glass of water).

Duration of use

Imupret N Dragees should not be taken for more than 2 weeks in a row. In any case, please note the information under "Special care should be taken when taking Imupret N Dragees" and the information under "Side effects".

If you have taken more Imupret N Dragees than you should

Poisonings have not been reported to date.

If you forget to take Imupret N Dragees

Do not take double the dose if you have forgotten to take the previous dose.

If you stop taking Imupret N Dragees

Discontinuing the medicinal product is generally harmless.

If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Imupret N Dragees can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Allergic reactions (skin rash, circulatory problems) may occur. Hypersensitivity reactions may occur with chamomile flower-containing preparations, even in persons with hypersensitivity to other plants from the Compositae family (composite flowers, e.g. mugwort, yarrow, chrysanthemum, daisy) due to so-called cross-reactions. Gastrointestinal disorders may occur occasionally. If you observe these or any other side effects, the preparation should be discontinued immediately and a doctor should be consulted.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IMUPRET N DRAGEES?

Keep out of the reach of children. Do not use the medicinal product after the expiry date which is stated on the container (blister pack). The expiry date refers to the last day of the month. Storage conditions: Do not store above 30°C. Store the container (blister pack) in the outer carton in order to protect the contents from light and moisture.

6. FURTHER INFORMATION

What Imupret N Dragees contain

The active ingredients are: 1 coated tablet contains: marshmallow root powder 8 mg, oak bark powder 4 mg, chamomile flowers powder 6 mg, dandelion herb powder 4 mg, horsetail herb powder 10 mg, yarrow herb powder 4 mg and walnut leaves powder 12 mg. The other ingredients are: calcium carbonate, glucose monohydrate, spray-dried glucose syrup, potato starch, lactose monohydrate, corn starch, modified corn starch, montan glycol wax, povidone (K25, K30), native castor oil, shellac, highly dispersed silicon dioxide, stearic acid (vegetable), sucrose, talc, colorants: indigotine (E132), titanium dioxide (E171).

Note for diabetics

One Imupret N Dragee contains an average of 0.02 creditable bread units (BE).

What Imupret N Dragees look like and contents of the pack

Imupret N Dragees are light blue, round, biconvex with a smooth surface. Packs of 50 (N2) and 100 (N3) coated tablets.

Pharmaceutical entrepreneur and manufacturer

BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Telephone: 09181 / 231-90
Telefax: 09181 / 231-265
Internet: www.bionorica.de
E-Mail: info(at)bionorica.de

Co-distributor

PLANTAMED Arzneimittel GmbH
Kerschensteinerstraße 11-15
92318 Neumarkt
Telephone: 09181 / 231-0
Telefax: 09181 / 21850

This package leaflet was last revised in February 2016.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: at the first signs and during a cold, e.g. scratching in the throat, sore throat, difficulty swallowing, coughing.