PYRILAX

PYRILAX 10 mg Suppositories

Important notes (mandatory information)

Pyrilax 10 mg suppositories. Active ingredient: Bisacodyl. Areas of application: for constipation, for conditions that require easier bowel movements, and for bowel movements during treatment measures and measures for detecting diseases (therapeutic and diagnostic interventions) on the bowel.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Pyrilax 10 mg suppositories
Active ingredient: Bisacodyl

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

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. 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, contact your doctor.

What this package leaflet contains

1. WHAT IS PYRILAX AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING PYRILAX?
3. HOW IS PYRILAX USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD PYRILAX BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS PYRILAX AND WHAT IS IT USED FOR?

Pyrilax is a laxative. Pyrilax is used for a short period of time for constipation, for conditions that require easier bowel movements, and for bowel movements during treatment measures and measures for detecting diseases (therapeutic and diagnostic interventions) on the bowel.

2. WHAT SHOULD YOU CONSIDER BEFORE USING PYRILAX?

Pyrilax must not be used:

• if you are allergic to bisacodyl or any of the other ingredients of this medicine listed in section 6,
• in the case of intestinal obstruction or narrowing,
• in acute abdominal conditions (e.g. inflammations such as "appendicitis"),
• if you suffer from constipation that is accompanied by other symptoms such as abdominal pain, nausea, vomiting or fever. A serious condition may be present. Contact your doctor immediately.
• if there are disturbances in the water and electrolyte balance (e.g. significant loss of body fluids),
• in children under 10 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using Pyrilax:

• if you suffer from chronic constipation or have long-lasting or recurring symptoms
• if you suffer from chronic inflammatory bowel diseases
• if you have anal fissures or inflammation of the rectum (ulcerative proctitis)
• pain and irritation in this area may occur.

Increased fluid loss can lead to dehydration. Under certain circumstances (e.g. in patients with impaired renal function or in the elderly), this can have harmful effects on health. In such cases, the use of Pyrilax should be discontinued and continued only under medical supervision. Note: Laxatives should only be used for a short period of time. Regular or prolonged excessive use can lead to disturbances in the fluid or electrolyte balance and to potassium deficiency and, as a consequence, to renewed constipation, muscle weakness or disturbances in heart function. In general, treatment with laxatives is only recommended if you have not been able to achieve sufficient success by changing your diet (by increasing your intake of fibre and drinking sufficient fluids) and by changing your lifestyle (with sufficient physical exercise).

Children and adolescents

Children and adolescents should not use laxatives without a doctor's recommendation.

Use of Pyrilax together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Pyrilax can increase the loss of potassium caused by other medicines, e.g. certain diuretics or cortisone preparations that are taken orally. The sensitivity to so-called "cardiac glycosides" (medicines for treating heart failure) may be increased due to potassium losses. The effectiveness of some medicines that are taken orally, such as contraceptives ("the pill"), medicines for high blood sugar (antidiabetics), antibiotics, medicines for epilepsy and medicines to inhibit blood clotting, may be reduced, especially if diarrhoea occurs in connection with the use of Pyrilax.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. The effectiveness of contraceptives that are taken orally ("the pill") may be reduced, especially if diarrhoea occurs in connection with the use of Pyrilax (see section 2. "Use of Pyrilax together with other medicines"). Pyrilax should not be used in high doses, for a long period of time and only on the advice of a doctor during pregnancy. Pyrilax should not be used during breast-feeding, as sufficient information on possible passage into breast milk is not available.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Please note that side effects may occur that could theoretically impair the ability to drive and operate machinery.

Pyrilax contains hard fat

When using Pyrilax, the use of latex condoms at the same time may reduce the tear resistance and thus impair the safety of such condoms due to the auxiliary substance hard fat.

3. HOW IS PYRILAX USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage

Short-term use for constipation

For adults and children over 10 years of age, the usual dose is: one Pyrilax suppository (corresponding to 10 mg bisacodyl) once a day to achieve an immediate onset of action.

Conditions that require easier bowel movements

For these conditions, the same dosage as above applies for a short period of time, unless your doctor has recommended a different dosage.

For bowel movements during treatment measures and measures for detecting diseases on the bowel

For bowel movements during treatment measures and measures for detecting diseases (therapeutic and diagnostic interventions) on the bowel, this medicine should only be used under medical supervision. For adults and children over 10 years of age, it is recommended to take 10 mg bisacodyl in the morning and 10 mg bisacodyl in the evening as a dragée or tablet one day before the operation/examination. On the morning of the operation/examination day, 1 Pyrilax suppository (corresponding to 10 mg bisacodyl) is used. To ensure complete bowel emptying, you should strictly follow your doctor's instructions.

Use in children

Since the use of laxatives in children requires medical clarification, please consult a doctor before use in such cases. Pyrilax suppositories are not suitable for children under 10 years of age.

Method of administration

Pyrilax suppositories are used rectally (i.e. inserted into the rectum) once a day as needed. To improve the lubricity, the suppository may be warmed in the hand or briefly immersed in warm water. The onset of action is after 10 to 30 minutes. Suppositories are not for oral use!

How to remove a suppository from the foil wrapper

First, tear off a suppository from the strip after bending the perforation several times or cut it off with scissors. The loose foil sheets at the tip of the suppository are grasped with the thumb and forefinger of each hand and carefully pulled apart (until the suppository can be removed from the foil wrapper).

Duration of use

As a rule, a single application should be sufficient. Pyrilax may only be used for a short period of time without a doctor's prescription. If daily use is required, a doctor should be consulted after one week at the latest. In the case of chronic constipation or longer-lasting or recurring symptoms, a doctor should be consulted (see section 2. "Warnings and precautions"). Please talk to your doctor or pharmacist if you have the impression that the effect of Pyrilax is too strong or too weak.

If you have used more Pyrilax than you should

An overdose can lead to diarrhoea and abdominal cramps as well as to loss of fluid, potassium and other electrolytes. Contact a doctor immediately. Regular use or use of higher than recommended doses of Pyrilax without medical supervision constitutes misuse, which can lead to serious side effects and should be avoided under all circumstances.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• Abdominal pain
• Diarrhoea
• Abdominal cramps
• Nausea
• Pain, local irritation and bleeding of the rectum, especially in the case of tears in the intestinal mucosa and ulcers in the rectal area

Uncommon side effects (may affect up to 1 in 100 people):

• Vomiting
• Blood in the stool
• Abdominal discomfort
• Rectal discomfort
• Dizziness

Rare side effects (may affect up to 1 in 1,000 people):

• Hypersensitivity reactions

Frequency of side effects not known (cannot be estimated from the available data):

• Loss of water
• Swelling of the skin and mucous membranes (angioedema)
• severe immediate allergic reaction
• Inflammation of the colon (colitis)
• short-term loss of consciousness (syncope)

In the case of prolonged or high-dose use of Pyrilax, increased losses of fluid, potassium and other salts may occur. Likewise, the intestinal sluggishness may be increased. Pyrilax should therefore only be used for a short period of time.

Reporting of side effects

If you get 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, 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 PYRILAX BE STORED?

Keep this medicine out of the reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the suppository strip and the folding box after "use by". The expiry date refers to the last day of the month indicated. 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pyrilax contains

The active ingredient is bisacodyl. One suppository contains 10 mg bisacodyl. The other ingredients are: Highly dispersed silicon dioxide, maize starch, hard fat.

What Pyrilax looks like and contents of the pack

Pyrilax are white or almost white torpedo-shaped suppositories with a concave base, heat-sealed in cast strips of white PE-coated PVC foil with an embossed batch designation. Pyrilax is available in packs of 6 suppositories (N1).

Pharmaceutical entrepreneur and manufacturer

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

This package leaflet was last revised in December 2014.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Bisacodyl. Areas of application: for constipation, for conditions that require easier bowel movements, and for bowel movements during treatment measures and measures for detecting diseases (therapeutic and diagnostic interventions) on the bowel.