Rökan Plus 80 mg film-coated tablets, 30 pcs

Instructions for use for Rökan Plus 80 mg film-coated tablets, 30 pcs

Important notes (compulsory information):

Rökan plus 80 mg film tablet. Active substance: Ginkgo-biloba leaves dry extract. Areas of application: - To symptomatic treatment of brain organic mental performance losses. The application takes place in the context of a therapeutic overall concept when decrease is progressed or Loss of acquired mental abilities (demential syndrome) with the main complaints: memory disorders, concentration disorders, depression, dizziness, ear-rise, headache, for extending the painless walking distance in arterial sealing disease in the limbs, so-called "shop window disease" (Claudicatio Intermittens in Stage II after Fontaine) in the context of physical-therapeutic measures, in particular walking training, - Dizziness due to circulatory disorders and age-related reflection processes (Vertigo vascular and involutive genesis), - for the supportive treatment of earrings as a result of circulatory disorders and age-related reflection operations (tinnitus vascular and involutive genesis).

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


LEAFLET: INFORMATION FOR THE USER

Rökan plus 80 mg film-coated tablet, for adults from 18 years
Active substance: Ginkgo-biloba leaves dry extract

Read the entire leaflet / use information carefully because it contains important information for you. This medicine is also available without medical prescription. However, in order to achieve the best possible treatment success, Rökan plus 80 mg must be applied in accordance with properly.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If your clinic image is worsening or no improvement occurs, you must consult a doctor.

This leaflet contains:

1. What is Rökan plus 80 mg and what is it applied for?
2. What do you need to know before taking Rökan plus 80 mg?
3. How is Rökan plus 80 mg to take?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Rökan plus 80 mg?
6. How is Rökan plus 80 mg composed and which packs are there?
7. Who is Rökan Plus 80 mg?

1. What is Rökan plus 80 mg and what is it used for?

Rökan Plus 80 mg contains an extract of ginkgo leaves.

Rökan plus 80 mg is applied:

• For the symptomatic treatment of brain organic mental performance losses. The application takes place in the context of a therapeutic overall concept when decrease is progressed or Loss of acquired mental abilities (demential syndrome) with the main complaints: memory disorders, concentration disorders, depression, dizziness, ear-rise, headache. The individual response to the medication can not be predicted. Before the treatment is started with this medicine, it should be clarified whether the clinical signs are not based on a specifically treated basic disease.
• To extend the painless walking distance with arterial locking sickness in the limbs, so-called "shop window disease" (Claudicatio intermittent in Stage II after Fontaine) in the context of physical-therapeutic measures, in particular walking training.
• Dizziness due to circulatory disorders and age-related reflection processes (Vertigo vascular and involutive genesis).
• For the supportive treatment of earries as a result of circulatory disorders and age-related reflection operations (Tinnitus vascular and involutive genesis). Frequently occurring dizziness and ear grooves must basically require clarification by a doctor. In suddenly occurring hearing loss or hearing loss should immediately Doctor be visited.

2. What do you need to consider 80 mg before taking Rökan plus?

Rökan plus 80 mg must not be taken:

• if you are hypersensitive (allergic) to Ginkgo Biloba or any of the other ingredients,
• during pregnancy.

Special care when taking Rökan plus 80 mg is required:
What should be considered in children?
To apply this medicine in this age group, there are no sufficient investigations. It should therefore not be used in children and adolescents under Lö years.

What do you need to consider in pregnancy and lactation?
Since there are individual indications that ginkgo-containing preparations could increase bleeding, this medicine may not be taken during pregnancy. This medicine should not be used during lactation, as there are no sufficient investigations. It is not known if the ingredients of the extract go into breast milk.

What else do you need to look out for?
In sickly increased bleeding tendency (hemorrhagic diathesis) As well as simultaneous treatment with blood clotting drugs, this medicine should only be applied after consultation with a doctor. Since there are individual notes that ginkgo-containing preparations could increase bleeding, this medicine should be deducted prior to surgery. Please inform your doctor in time when you take Rökan plus 80 mg so that it can decide on the further procedure. If you have known a canceling (epilepsy), please consult with your doctor before taking Rökan Plus 80 mg.

This medicine contains lactose:
Please take Rökan plus 80 mg after consultation with your doctor if you are known to suffer from any intolerance to certain sugars.

Interactions with other medicines:
At the same time, while taking this medicine with blood clotting drugs (such as phenprocoumone, warfarin, clopidogrel, acetylsalicylic acid and other non-steroidal anti-rheumatics), their effort can not be excluded. As for all medicines, even for Rökan plus 80 mg, an influence on the metabolism of different other medicines can not be excluded, which could influence the efficiency and / or duration of effect of the affected medicines. Sufficient investigations are not available. Please consult with your doctor or pharmacist.

When taking Rökan plus 80 mg together with food and beverages, no special features should be observed.

3. How to take Rökan plus 80 mg?

Always take Rökan Plus 80 mg exactly as directed in this leaflet. Please ask your doctor or pharmacist if you are not sure.

Type of application:
To take. Unless otherwise prescribed by the doctor, the usual dose is:

• To symptomatic treatment of brain organic performance disorders: adults from 18 years should be 2-3 times a day 1 Take film tablet (corresponding to 2-3 times daily 80 mg ginkgo extract).
• To extend the painless walking distance with peripheral arterial locking sickness: adults from 18 years should Take 1 film tablet 2 times a day (2 times a day 80 mg ginkgo extract).
• For dizziness and supportive treatment of earries: adults from 18 years should be 2 times a day 1 Take a film tablet (according to 2 times a day, 80 mg ginkgo extract).

The taking is 3 times a day's application in the morning, at noon and evening, with 2 times daily application in the morning and in the evening. Do not take film-coated tablets in the loungers. Please take the film-coated tablets so far with sufficient fluid (preferably a glass of drinking water). The intake can be done independently of meals. Please talk to your doctor or pharmacist if you have the Eindruck have that the effect of this medicine is too strong or too weak.

Children and adolescents:
Rökan plus 80 mg is not intended for use in persons under 18 years.

How long should you use Rökan plus 80 mg?

• For brain organic performance interference: The treatment period should be at least 8 weeks. After a treatment period of 3 months, the doctor must be checked whether the continuation of treatment is still justified.
• In the case of peripheral arterial sealing disease: the improvement of the housing power sets a treatment time of at least 6 weeks ahead.
• In dizziness: the application over a longer period of time than 6 Up to 8 weeks does not improve the treatment result.
• In case of earries: The supportive treatment should be done over a period of at least 12 weeks. Should be after 6 Months have not succeeded, this is no longer expected for prolonged treatment.

If you take a larger amount of Rökan plus 80 mg than you should:
Overdose phenomena are not known yet. The side effects mentioned below are increasingly occurring when they take a greater amount of Rökan plus 80 mg. Please notify your doctor. This can decide on necessary measures via if necessary.

If you forget to take Rökan Plus 80 mg:
Next time, take about twice the amount, but continue taking how to prescribe from your doctor or described in this use information.

4. Which side effects are possible?

Like all medicines, this medicine can have side effects. The enumeration includes all known side effects under treatment with ginkgo leaves dry extract, even under higher dosage or long-term therapy. The assessment of side effects is based on the following frequency information:

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

For the frequency of adverse effects known to Ginkgo-Biloba-containing medicines, no secured information is possible, as these side effects have become known by individual reports of patients, physicians or pharmacists. Thereafter, taking this medicine may cause side effects:

• Bleeding may occur at individual organs, especially if coagulation-resistant drugs such as phenprocoumone, acetylsalicylic acid or other non-steroidal antirheumatic acid (see also under interactions). For hypersensitive persons, it can cause severe hypersensitivity reactions (allergic shock) come; In addition, allergic skin reactions can (Skull, skin threshold, itching) occur. If they are affected by one of the abovementioned side effects, they do not take Rökan plus 80 mg again and contact their doctor immediately, so that he can decide on the severity and possibly necessary measures.
• Furthermore, it can lead to light gastrointestinal discomfort, headache, dizziness or for reinforcement of existing dizziness problems. Please inform your doctor or pharmacist if one of these listed side effects are significantly affected.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Rökan plus 80 mg?

Store drug out of reach of children. You may be the medicine after the on the outer carton or container (Pushing packing) no longer use specified expiration date.

6. How is Rökan plus 80 mg composed and which packs are there?

1 film tablet contains:
Active substance: 80 mg dry extract from ginkgo-biloba leaves (35-67: 1), Complete agent: acetone 60% (m / m). The extract is quantified to 17.6-21.6 mg of flavonoids calculated as flavonoid glycosides, as well as 4.0-5.6 mg terpenlactone, including 2.24-2.72 MG ginkgolide A, B and C and 2.08-2.56 mg bilobalide, and contains below 0.4 μg ginkgols per film tablet. Other ingredients: Croscarmello sodium; Hochdisperses silicon dioxide; Hypromellosis; Lactose monohydrate; Macrogol 1500; Magnesium stearate (Ph. EUR.); Corn starch; Microcrystalline cellulose; Simeticon-Alpha-Hydro-Omega Octadecyl Oxypoly (Oxyethylene) -5 Sorbic acid (pH. EUR.) - Water; Talc; Titanium dioxide; Iron (III) oxide; Iron oxides and Hydroxides.

Rökan plus 80 mg is in packs with 30 (Ni), 60 (N2), 120 (N3) Film tablets available.

Pharmaceutical entrepreneur and manufacturer
Dr. Willmar Schwabe GmbH & Co. Kg
Willmar-Schwabe-Str. 4
76227 Karlsruhe
Telephone: 0800 000 52 58
Fax: 0800 100 95 49
www.schwabe.de

Status of Information: May 2014.

Source: Information of the leaflet
Status: 08/2016