KRÄUTERLAX

KRÄUTERLAX Dr.Henk 15 mg herbal tablets for laxatives

Important notes (mandatory information)

KRÄUTERLAX Herbal Dragees for Laxative, coated tablets. Active ingredient: Aloe dry extract. 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.


PACKAGE LEAFLET: INFORMATION FOR THE USER

KRÄUTERLAX Herbal Dragees for Laxative, coated tablets
Active ingredient: Aloe dry extract
Herbal stimulant laxative

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist or healthcare professional.

• Keep the package leaflet. You may want 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, pharmacist or healthcare professional. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 7 days, contact your doctor.

What is in this leaflet

1. WHAT ARE KRÄUTERLAX HERBAL DRAGEES FOR LAXATIVE AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KRÄUTERLAX HERBAL DRAGEES FOR LAXATIVE?
3. HOW TO TAKE KRÄUTERLAX HERBAL DRAGEES FOR LAXATIVE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KRÄUTERLAX HERBAL DRAGEES FOR LAXATIVE BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE KRÄUTERLAX HERBAL DRAGEES FOR LAXATIVE AND WHAT ARE THEY USED FOR?

KRÄUTERLAX Herbal Dragees for Laxative is a herbal stimulant laxative. Area of application: For short-term use in case of constipation (obstipation). If you do not feel better or if you feel worse after 7 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KRÄUTERLAX HERBAL DRAGEES FOR LAXATIVE?

KRÄUTERLAX Herbal Dragees for Laxative must not be taken:

• if you are allergic to aloe or any of the other ingredients of this medicine listed in section 6.
• in case of intestinal obstruction, narrowing of the intestine (intestinal stenosis), relaxation of the intestinal muscles (intestinal atony), appendicitis, chronic inflammatory bowel diseases, such as Crohn's disease, ulcerative colitis.
• in case of abdominal pain of unknown cause.
• if you have severe fluid deficiency with water and salt loss.

Children under 12 years of age must not take KRÄUTERLAX Herbal Dragees for Laxative.

Warnings and precautions

Please talk to your doctor or pharmacist or healthcare professional before taking KRÄUTERLAX Herbal Dragees for Laxative if you:

• take certain medicines that strengthen the heart muscle (cardiac glycosides),
• medicines for heart rhythm disorders (antiarrhythmics),
• medicines that increase urine output (diuretics),
• take cortisone and cortisone-like substances (adrenal corticosteroids) and liquorice root,
• if you suffer from stool congestion in the colon (coprostasis) or from gastrointestinal complaints of unknown cause such as abdominal pain, nausea and vomiting, because these complaints can be an indication of an impending or already existing intestinal obstruction (ileus).
• if you suffer from impaired kidney function, you should bear in mind that taking KRÄUTERLAX Herbal Dragees for Laxative can increase electrolyte imbalances.

Taking stimulant laxatives beyond the short-term use 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: Incontinent adults should avoid prolonged skin contact with faeces by changing the template when taking KRÄUTERLAX Herbal Dragees for Laxative.

Children and adolescents

Children under 12 years of age must not take KRÄUTERLAX Herbal Dragees for Laxative.

Taking KRÄUTERLAX Herbal Dragees for Laxative with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or intend to take any other 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 for heart rhythm disorders (antiarrhythmics). The effect can also be influenced by certain medicines for normalising the heart rhythm (quinidine) and medicines that can trigger heart rhythm disorders as a side effect (induce QT prolongation). 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.

Taking KRÄUTERLAX Herbal Dragees for Laxative with food, drinks and alcohol

No special precautions are required.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Due to insufficient toxicological studies, KRÄUTERLAX Herbal Dragees for Laxative must not be used during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

KRÄUTERLAX Herbal Dragees for Laxative contains lactose and sucrose

This medicine contains lactose and sucrose. Please only take it after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE KRÄUTERLAX HERBAL DRAGEES FOR LAXATIVE?

Always take KRÄUTERLAX Herbal Dragees for Laxative exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist or healthcare professional. Check with your doctor or pharmacist if you are not sure. The maximum daily intake must not exceed 30 mg of hydroxyanthracene derivatives; this corresponds to 2 coated tablets. The recommended dose is: Adults and children over 12 years of age take 1-2 coated tablets once a day. The personally correct dosage is the lowest that is required to obtain a soft-formed stool. The effect occurs after 8 -12 hours.

Method of administration

The coated tablets should be taken unchewed with plenty of liquid after dinner.

Duration of use

Stimulant laxatives must not be taken 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 KRÄUTERLAX Herbal Dragees for Laxative is too strong or too weak.

If you have taken more KRÄUTERLAX Herbal Dragees for Laxative than you should

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 notify a doctor immediately. He will decide which countermeasures (e.g. administration of fluid and salts) may be necessary. Higher doses of anthranoid-containing medicines such as KRÄUTERLAX Herbal Dragees for Laxative taken over a long period of time can lead to liver damage.

If you forget to take KRÄUTERLAX Herbal Dragees for Laxative

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

If you stop taking KRÄUTERLAX Herbal Dragees for Laxative

There are no special instructions to be observed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or healthcare professional.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following frequency categories are used to evaluate side effects

The following frequency categories are used to evaluate 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

Very rarely, cramp-like gastrointestinal complaints may occur. In these cases, a reduction in the dose is necessary. Very rarely, hypersensitivity reactions (allergies) may occur in the form of itching, hives (urticaria) and, especially on the face, skin and mucous membrane swelling (Quincke's oedema). In the course of treatment, a harmless red colouring of the urine may occur. With prolonged use or at higher dosage (misuse), disturbances of the water and electrolyte balance may occur. Diarrhoea that occurs can lead to potassium losses in particular. Potassium loss can lead to disturbances of the heart function and to 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). With prolonged use, protein and blood may be excreted in the urine. Furthermore, a discolouration of the intestinal mucosa (pseudomelanosis coli) may occur, which usually regresses after discontinuation of the preparation.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or healthcare 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, Dept. 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.

5. HOW SHOULD KRÄUTERLAX HERBAL DRAGEES FOR LAXATIVE BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after . The expiry date refers to the last day of the month. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Storage conditions: Do not store above 30°C. Store the container in the outer carton in order to protect the contents from moisture.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What KRÄUTERLAX Herbal Dragees for Laxative contains

The active ingredient is: Aloe dry extract. 1 coated tablet contains: 41.25 - 52.5 mg Aloe dry extract (1.8 - 2.2:1) corresponding to 15 mg hydroxyanthracene derivatives, calculated as aloin. Extraction agent: Water. The other ingredients are: Lactose, highly dispersed silicon dioxide, cellulose powder, croscarmellose sodium, magnesium stearate (Ph. Eur), sucrose, talc, maize starch, copovidone, carmellose sodium, carnauba wax, colouring agent: E171. 1 coated tablet contains 0.03 BE

How KRÄUTERLAX Herbal Dragees for Laxative looks like and contents of the pack

White, round, biconvex coated tablets. Pack of 10 KRÄUTERLAX Herbal Dragees for Laxative, pack of 30 KRÄUTERLAX Herbal Dragees for Laxative.

Pharmaceutical entrepreneur and manufacturer

DOLORGIET GmbH & Co. KG
Otto-von-Guericke-Straße 1
53757 Sankt Augustin/Bonn
Phone: 02241/317-0
Fax: 02241/317 390
E-mail: info@dolorgiet.de

This leaflet was last revised in September 2013.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Aloe dry extract. Areas of application: for short-term use in case of constipation (obstipation).