SENNA LEAVES M filter bags

Important information (mandatory information)

Senna leaves, herbal tea. Areas of application: for short-term use in case of constipation (obstipation).

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Senna leaves, herbal tea for oral administration after preparation of a tea infusion for use in children aged 10 and over and adults
Herbal medicinal product

Read the entire package leaflet carefully as it contains important information for you. This medicine is available without a prescription. However, in order to achieve the best possible treatment results, this medicine must be used as directed.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen or do not improve, you must see a doctor in any case.

This package leaflet contains

1. WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING THIS MEDICINE?
3. HOW TO USE THIS MEDICINE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE THIS MEDICINE?
6. FURTHER INFORMATION

1. WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?

Senna leaves herbal tea is a herbal stimulant laxative. This herbal tea is suitable for short-term use in case of constipation (obstipation).

2. WHAT DO YOU NEED TO KNOW BEFORE USING THIS MEDICINE?

This medicine must not be used:

• if you are hypersensitive (allergic) to senna leaves.
• in case of intestinal obstruction and intestinal narrowing as well as relaxation of the intestinal muscles.
• in acute inflammatory diseases of the intestine, e.g. Crohn's disease, ulcerative colitis or appendicitis.
• in case of abdominal pain of unknown cause.
• in case of severe fluid deficiency in the body with water and salt losses.
• during pregnancy and breastfeeding.
• in children under 10 years of age.

Special care must be taken when using this medicine if the symptoms described in section 1 become more severe. In this case, consult your doctor or pharmacist. Taking stimulant laxatives beyond the short-term use can lead to increased intestinal sluggishness. Senna leaves should only be used if constipation cannot be relieved by a change in diet or by bulking agents. Note: Incontinent adults should avoid prolonged skin contact with faeces by changing the template when drinking tea infusions made from senna leaves. Tea infusions should always be prepared with boiling water. Preparing tea with warm water is not sufficient.

Children

Children under 10 years of age must not drink tea infusions made from senna leaves.

When using this medicine with other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines. With prolonged use or misuse, potassium deficiency may increase the effect of certain medicines that strengthen the heart muscle (cardiac glycosides) and influence the effect of medicines against cardiac arrhythmias. Potassium losses can be increased by concomitant use of certain medicines that increase urine output (diuretics), cortisone and cortisone-like substances (adrenal corticosteroids) or liquorice root.

Pregnancy and breastfeeding

Tea infusions made from senna leaves must not be drunk during pregnancy and breastfeeding due to insufficient toxicological studies.

Driving and operating machinery

There is no experience regarding impairment of driving ability and the ability to operate machinery.

3. HOW TO USE THIS MEDICINE?

Always take Senna leaves exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Dosage and method of administration

The following information applies unless your doctor has prescribed Senna leaves differently. Please adhere to the instructions for use, otherwise the tea infusions made from senna leaves will not work properly! Adults and children aged 10 and over drink 1 cup of a tea infusion prepared as follows twice a day: About ½ teaspoonful (approx. 0.75 g) of senna leaves is poured over with boiling water (approx. 150 ml). After about 10 to 15 minutes, the liquid is poured off through a tea strainer. The individually correct dosage is the lowest required to obtain a soft-formed stool. In some cases, 1 cup of tea infusion may be sufficient. You should drink the tea infusion in the evening before going to bed if possible. The effect usually occurs after 8 - 12 hours.

Duration of use

The stimulant laxative Senna leaves must not be used for a prolonged period (more than 1 - 2 weeks) without medical advice. Please talk to your doctor or pharmacist if you have the impression that the effect of Senna leaves is too strong or too weak.

If you have used more of this medicine than you should

In case of accidental or intentional overdose, painful intestinal cramps and severe diarrhoea with subsequent loss of water and salts as well as possibly severe gastrointestinal symptoms may occur. Overdosage over a longer period of time can lead to liver damage. In case of overdose, please inform a doctor immediately. He will decide which countermeasures (e.g. administration of fluids and salts) may be necessary.

If you forget to use this medicine

Do not make up for the forgotten application, but continue the application as originally planned in such a case.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Senna leaves can have side effects, although not everybody gets them.

Possible side effects

Hypersensitivity reactions such as itching, hives, skin rashes (either localised or all over the body) may occur. In these cases, the herbal tea must be discontinued. In individual cases, cramp-like gastrointestinal symptoms may occur. In these cases, a dose reduction is necessary. Breakdown products can cause intensive yellow or reddish-brown discolouration of the urine, which is temporary and harmless. Prolonged use or misuse can cause:

• increased loss of water and salts (electrolyte losses), especially potassium losses. Potassium loss can lead to heart function disorders and muscle weakness, especially when taken together with cardiac glycosides (medicines that strengthen the heart muscle), diuretics (medicines that increase urine output) and cortisone and cortisone-like substances (adrenal corticosteroids).
• excretion of protein and red blood cells in the urine.
• pigment deposition in the intestinal mucosa (pseudomelanosis coli). This deposition is harmless and usually regresses after discontinuation of senna leaves tea.

Special notes

If intolerance reactions (skin rashes) occur, the herbal tea must be discontinued. If cramp-like gastrointestinal symptoms occur, a dose reduction is necessary.

Reporting of side effects

If you experience 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, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE THIS MEDICINE?

General information: Keep medicines out of the reach of children. Do not use the medicine after the expiry date stated on the carton after "Use by". The expiry date refers to the last day of the month. Storage conditions: Store in the original packaging and protect from light and moisture.

6. FURTHER INFORMATION

What this medicine contains

100 g herbal tea contains the active ingredient: 100 g senna leaves. No other ingredients are included.

What the medicine looks like and contents of the pack

Senna leaves is available in the following pack size: 30 g herbal tea in a cardboard box, 20 g herbal tea in 1 g (20 tea bags).

Pharmaceutical entrepreneur/manufacturer

Bombastus-Werke AG
Wilsdruffer Straße 170
01705 Freital
Germany
Telephone: +49 351 65803-0
Fax: +49 351 65803-99
E-mail: info@bombastus-werke.de

This leaflet was last revised in September 2014.

Source: Information from the package leaflet
Status: 04/2018
Areas of application: for short-term use in case of constipation (obstipation).