GRÜNWALDER

GRÜNWALDER Sennalax film-coated tablets

Important notes (mandatory information)

Grünwalder Sennalax. Active ingredient: Senna fruit dry extract.

Indications

For short-term use in case of constipation (obstipation).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Grünwalder Sennalax
Active ingredient: Senna fruit dry extract
Herbal stimulant laxative

Please read the following package leaflet carefully because it contains important information on what you need to consider when using this medicine. If you have any questions, please contact your doctor or pharmacist.

Indications

For short-term use in case of constipation (obstipation). If constipation lasts for more than 1 week, a doctor should be consulted.

Contraindications

When should you not use Grünwalder Sennalax?
In case of known hypersensitivity (allergy) to Alexandrian senna fruits or any other component of the medicine, in case of intestinal obstruction, in case of appendicitis, in case of chronic inflammatory bowel diseases such as Crohn's disease, ulcerative colitis; in case of abdominal pain of unknown cause, in case of severe fluid deficiency with water and salt loss.

What do you need to consider during pregnancy and breastfeeding?
Due to insufficient toxicological studies, not to be used during pregnancy and breastfeeding.

What should be considered in children and the elderly?
Grünwalder Sennalax must not be used in children under 12 years of age.

When should you only use Grünwalder Sennalax after consulting your doctor?
If you are taking certain medicines that strengthen the heart muscle (cardiac glycosides), medicines for heart rhythm disorders (antiarrhythmics), medicines that increase urine output (diuretics), cortisone and cortisone-like substances (adrenal steroids) and liquorice root at the same time.

Precautions for use and warnings

What precautions should be taken?

Special precautions for use

Stimulant laxatives should not be taken for extended periods of time (more than 1-2 weeks) without medical advice.

Special warnings

Taking stimulant laxatives for longer than a short period of time can lead to increased intestinal sluggishness. The preparation should only be used if constipation cannot be relieved by a change in diet or by bulking agents.

Note

In incontinent adults, prolonged skin contact with faeces should be avoided by changing the template when taking Grünwalder Sennalax.

What do you need to consider in road traffic and when working with machinery and when working without a secure hold?
Not applicable.

Interactions

Which other medicines affect the effect of Grünwalder Sennalax and what do you need to consider if you are taking other medicines at the same time?
With prolonged use or misuse, potassium deficiency can increase the effect of certain medicines that strengthen the heart muscle (cardiac glycosides) and influence the effect of medicines for heart rhythm disorders (antiarrhythmics). Potassium losses can be increased by concomitant use of certain medicines that increase urine output (diuretics), cortisone and cortisone-like substances (adrenal corticosteroids) and liquorice root. Please note that this information may also apply to medicines that have been used recently.

Which stimulants, foods and drinks should you avoid?
A high-fibre diet and plenty of fluids should be ensured.

Dosage, type and duration of use

The following information applies unless your doctor has prescribed Grünwalder Sennalax differently. Please follow the instructions for use, otherwise Grünwalder Sennalax will not work properly!

How much and when should you take Grünwalder Sennalax?
The maximum daily intake must not exceed 30 mg of hydroxyanthracene derivatives, therefore you must not take more than 2 Grünwalder Sennalax film-coated tablets per day. Adults and adolescents aged 12 years and over take 1-2 film-coated tablets once a day. The personally correct dosage is the lowest that is required to obtain a soft-formed stool.

How and when should you take Grünwalder Sennalax?
The film-coated tablets are taken unchewed with plenty of liquid in the evening before going to bed.The effect occurs after 8 - 12 hours.

How long should you use Grünwalder Sennalax?

Note

Stimulant laxatives should not be taken for an extended period of time (more than 1-2 weeks) without medical advice.

Application errors and overdose

What should you do if Grünwalder Sennalax has been used in too large quantities (intentionally or accidentally)?
In case of accidental or intentional overdose, painful intestinal cramps and severe diarrhoea with the consequence of water and salt loss and possibly severe gastrointestinal complaints may occur. In case of overdose, please inform a doctor immediately. He will decide which countermeasures (e.g. administration of fluid and salts) are necessary, if any.

What should you do if you have used too little Grünwalder Sennalax or have forgotten to use it?
The application should be continued normally, i.e. without changing the dose.

What should you do if you interrupt or prematurely terminate the treatment?
Premature termination or interruption of treatment is generally harmless. Talk to your doctor or pharmacist.

Side effects

Like all medicines, Grünwalder Sennalax can have side effects. The following frequency information is used to assess side effects

The following categories are used for the frequency information on 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.

What side effects can occur when using Grünwalder Sennalax?
Very rarely, cramp-like gastrointestinal complaints may occur. In these cases, a reduction in dose is necessary. Very rarely, intolerance reactions in the form of itching, hives (urticaria), rash, either localised or on the whole body (so-called local or generalised exanthema), and very rarely shortness of breath and/or drop in blood pressure may occur. With prolonged use or at higher doses (misuse), disturbances of the water and salt balance may occur. Diarrhoea that occurs can lead to potassium losses in particular. Potassium loss can lead to disturbances of heart function and muscle weakness, especially when taken together with medicines that strengthen the heart muscle (cardiac glycosides), medicines that increase urine output (diuretics), cortisone and cortisone-like substances (adrenal corticosteroids). With prolonged use, protein and blood may be excreted in the urine. Furthermore, discolouration of the intestinal mucosa (pseudomelanosis coli) may occur, which usually regresses after discontinuation of the preparation. In the course of treatment, harmless reddening of the urine may occur.

Reporting of

side effects

If you notice any side effects, contact your doctor or pharmacist or the medical professional. 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 to provide more information on the safety of this medicine.

What countermeasures should be taken in case of side effects?
If side effects occur, a reduction in dose or, if necessary, discontinuation of the medicine is necessary. If intolerance reactions (skin rashes), shortness of breath or drop in blood pressure occur, the medicine must be discontinued and your doctor must be consulted immediately.

Notes and information on the shelf life of the medicine

The expiry date of this pack is printed on the blister pack and the folding box. Do not use this pack after this date! Do not store above 30°C. Store dry and in the original packaging! Keep medicines out of the reach of children!

Composition

1 film-coated tablet contains: Active ingredient: 55.2 - 107.2 mg dry extract from Alexandrian senna fruits, adjusted to 13.0 mg hydroxyanthracene derivatives (calculated as sennoside B) (6-12:1), extraction agent: ethanol, 60% (V/V). Other ingredients: pregelatinised starch from maize, highly dispersed silicon dioxide, croscarmellose sodium, microcrystalline cellulose, macrogol 6000, calcium stearate (Ph.Eur.), maltodextrin, shellac, talc, povidone K25, glyceryl diacetate alkanoate (C16 - C18).

Pharmaceutical form and content

Original pack with 30 film-coated tablets.

Pharmaceutical entrepreneur and manufacturer

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

This package leaflet was last revised in February 2014.

Source: Information from the package leaflet
Status: 10/2016
Active ingredient: Senna fruit dry extract. Indications: For short-term use in case of constipation (obstipation).