Grünwalder Gesundheitsprodukte

Patient information Sennalax®

– please read carefully –

Dear patient,
please read this leaflet very carefully. It contains important information which you should be aware of concerning the use of this medicinal product. If you have any questions, please ask your doctor or pharmacist.

Grünwalder Sennalax®

Active ingredient: dry extract of senna pods

Composition:

1 film tablet contains: Medicinally active ingredient: 55.2 – 107.2 mg dry extract of alexandrine senna pods, standardised to 13.0 mg hydroxyanthracene derivate (calculated as sennoside B) (6-12:1) extraction medium: ethanol, 60 % (V/V) Excipients: preagglutinated corn starch, highly-dispersed silicon dioxide, croscarmellose sodium, microcristalline cellulose, Macrogol 6000, calcium stearate (Ph.Eur.), maltodextrin, shellac, talc, povidon K25, glycerol diacetate alkanoate (C16 – C18)

Pharmaceutical form and contents:

Packs of 30 film tablets
Herbal stimulant laxative

Pharmaceutical company:

Grünwalder Gesundheitsprodukte GmbH
Ruhlandstr. 5
83646 Bad Tölz
Germany
Tel. 08041/806469
Fax 08041/806483

Producer:

Swiss Caps GmbH
Grassingerstr.9
83043 Bad Aibling
Germany

Indications:

For the short term treatment of constipation. A doctor should be consulted if this condition lasts for longer than one week.

Contraindications:

When should you not use Grünwalder Sennalax®?
If there is a known sensitivity (allergy) to alexandrine senna pods or to any of the other ingredients of this product; if there is intestinal obstruction, appendicitis, inflammatory bowel disease such as Morbus Crohn, colitis ulcerosa; stomach pain of unknown origin or severe dehydration with loss of water and tissue salts.

Special considerations for pregnant women and nursing mothers:
The product should not be used by pregnant women and nursing mothers as there are insufficient toxicological test results.

Special considerations for children and old people:
Children under 12 years of age should not use Grünwalder Sennalax®.

When should a doctor be consulted before using Grünwalder Sennalax®?
If certain medication is taken simultaneously, including cardiac drugs such as cardiac glycosides, antiarrhythmic medication, medication which increases urine production (diuretics), cortisone and cortisone-like substances (adrenal steroids) and liquorice root.

Special precautions and interactions with other substances

What precautions must be taken before using Grünwalder Sennalax®?
Special precautions for use: stimulant laxatives should not be taken for a long period (more than 1-2 weeks) without a doctor's permission.
Warning: If a stimulant laxative is taken for a long period this can lead to exacerbation of constipation. The preparation should only be used if the condition cannot be remedied by a change of diet or the use of bulking agents.
Note: in the case of incontinent adults taking Grünwalder Sennalax®.

What special precautions should be taken driving in traffic or whilst working with heavy machinery or under unsafe conditions?
Does not apply

Interactions with other medicines:

Which other medication can influence the effect of Grünwalder Sennalax® and what should you be aware of if taking other medicines simultaneously?
Continuous use or misuse of the product could result in a potassium deficiency which intensifies or compromises the effect of certain cardiac medication such as cardiac glycosides and antiarrhythmic medication. The lack of potassium could also intensify the effect of certain medication which increases urine production (diuretics), cortisone and cortisone-like substances (adrenal steroids) and liquorice.
Please note that the above could also apply if the medication is only taken for a short while.

What foods and drinks should be favoured?
A fibre-rich diet and plenty of fluids should be taken.

Dosage form, method and duration of administration:

The following instructions for taking Grünwalder Sennalax® should be used unless otherwise informed by your doctor. Please follow the instructions carefully otherwise Grünwalder Sennalax® cannot work properly!

What amount of Grünwalder Sennalax® should be taken and how often?
The maximum daily dose should not exceed 30 mg hydroxyanthracene derivate. This is equivalent to no more than 2 film tablets of Grünwalder Sennalax® daily. Adults and children over 12 years 1 film tablet once a day. The correct personal dose is the minimum required to produce a soft stool.

How and when should Grünwalder Sennalax® be taken?
The film tablet/s should be taken at night before bed, swallowed whole with sufficient fluid. The effect is produced after 8-12 hours.

For how long should Grünwalder Sennalax® be taken?
Stimulant laxatives should not be taken for long periods (more than 1- 2 weeks) without a doctor's permission.

Dosage errors and exceeded dosage:

What should be done if the stated dose of Grünwalder Sennalax® is exceeded, either deliberately or by accident??
In cases of deliberate or accidental overdosage, severe colon/stomach cramps and diarrhoea can occur. This results in dehydration, loss of tissue salts and possibly digestive symptoms. Please inform a doctor immediately if the stated dose is exceeded. S/he will decide which counter measures (e.g. administration of fluids and salts) if any are necessary.

What should be done if too little Grünwalder Sennalax® is taken or a dose is forgotten?
Continue normally next time, i.e. without raising the dose.

What should you be aware of if the treatment is interrupted or ended early?
Normally there are no serious consequences if treatment is interrupted or ended early. Ask your doctor or pharmacist.

Side effects:

As with all medicines, Grünwalder Sennalax® can have side effects. The following scale of frequency has been established in the evaluation of side effects.

very often:   more than 1 in 10 cases
often:   more than 1 in 100 cases
occasionally:   more than 1 in 1 000 cases
rarely:   more than 1 in 10 000 cases
very rarely:   less than 1 in 10 000 cases, including isolated / single cases

What side effects can occur in using Grünwalder Sennalax®?
Stomach cramps can occur very rarely. In such cases it is necessary to reduce the dose. Intolerance reactions in the form of itching, nettle rash (urticaria), skin rash - localised / over the entire body (so-called localised / generalised urticaria) can occur very rarely. Very rarely: breathing difficulties or a drop in blood pressure can occur. Longterm treatment or high dosage (misuse) can lead to problems with water and tissue salt balance in the body. If diarrhoea occurs it can lead in particular to loss of potassium which in turn can cause cardiac problems and muscle weakness, particularly if any of the following are taken simultaneously: cardiac medication such as cardiac glycosides, diuretics cortisone and cortisone-like substances (adrenal steroids). Continuous use can lead to the presence of protein and blood in the urine. In addition, discolouration of the colon mucus membrane can occur; this usually fades after the preparation has been discontinued. The urine may acquire a harmless red colouration in the course of normal treatment.

If you notice any side effects which are not described in this leaflet, please inform your doctor or pharmacist.

What measures should be taken if side effects occur?
If side effects occur, the dose should be reduced or if necessary, use of the medication should be discontinued. If intolerance reactions in the form of skin rash, breathing difficulties or drop in blood pressure occur, stop taking the medicine and see your doctor at once.

Expiry information:

The expiry date of this pack is printed on the blister pack and on the outside of the carton. Do not use the product after this date! Keep dry and store below 25°C. Keep all medicines out of the reach of children! Status: July 2005

Grünwalder Sennalax® is only available from pharmacies.

Do you have further questions?

Grünwalder Gesundheitsprodukte GmbH
Ruhlandstr. 5
83646 Bad Tölz
Tel: 08041/806469
Fax:08041/806483
email:

www.gruenwalder.de