REGULAX

REGULAX Picosulfate Drops

Important notes (mandatory information)

Regulax Picosulphate Drops. Active ingredient: Sodium picosulphate. Areas of application: for constipation and for conditions that require easier bowel movements.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Regulax Picosulphate Drops 7.23 mg/ml, drops for oral administration, solution
Active ingredient: Sodium picosulphate

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 your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get 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 you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT ARE REGULAX PICOSULPHATE DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING REGULAX PICOSULPHATE DROPS?
3. HOW SHOULD YOU TAKE REGULAX PICOSULPHATE DROPS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD REGULAX PICOSULPHATE DROPS BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE REGULAX PICOSULPHATE DROPS AND WHAT ARE THEY USED FOR?

Regulax Picosulphate Drops are a laxative. Regulax Picosulphate Drops are used for constipation and for conditions that require easier bowel movements. Like other laxatives, Regulax Picosulphate Drops should not be taken daily or for an extended period of time without a medical diagnosis of the cause of the constipation.

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING REGULAX PICOSULPHATE DROPS?

Regulax Picosulphate Drops must not be taken:

• if you are allergic to sodium picosulphate, related active ingredients from the group of triarylmethanes or any of the other ingredients of this medicine listed in section 6;
• in the case of intestinal narrowing with impaired intestinal passage, intestinal obstruction, acute abdominal complaints such as appendicitis, severe abdominal pain associated with nausea and vomiting;
• in the case of acute inflammatory diseases of the gastrointestinal tract;
• in the case of significant fluid deficiency in the body.

Children under 4 years of age must not take Regulax Picosulphate Drops. Constipation, combined with other complaints such as abdominal pain, vomiting and fever, can be signs of a serious illness (intestinal obstruction, acute inflammation in the abdominal area). In the case of such complaints, you must not take Regulax Picosulphate Drops or other medicines and should consult your doctor immediately. In the case of conditions that are associated with disorders of the water and mineral salt balance (e.g. severely impaired renal function), you must only take Regulax Picosulphate Drops under medical supervision.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Regulax Picosulphate Drops. Children from 4 years of age should only take Regulax Picosulphate Drops on doctor's orders. Special care must be taken when taking Regulax Picosulphate Drops if your complaints have occurred spontaneously, persist for a longer period of time and/or are accompanied by symptoms such as blood in the stool or fever. In this case, you should consult your doctor for advice and examination before starting treatment with Regulax Picosulphate Drops, because disorders or impairments of bowel movements can be signs of a serious illness. Regulax Picosulphate Drops should not be taken continuously daily or for extended periods of time without prior medical diagnosis. If Regulax Picosulphate Drops are discontinued, the symptoms may recur. After long-term use for chronic constipation, the recurrence of symptoms may also be associated with a worsening of the constipation. Dizziness and short-term fainting spells (syncope) have been reported in patients who have taken sodium picosulphate. According to the corresponding case reports, these are presumably syncopes that are either due to the laxative process itself, to straining or to circulatory reactions due to abdominal pain.

Taking Regulax Picosulphate Drops together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. The laxative effect of Regulax Picosulphate Drops may be lost if antibiotics (medicines against bacterial infections) are taken at the same time. Excessive use of Regulax Picosulphate Drops carries the risk of an imbalance of potassium and other salts in the blood. This risk may be increased if other medicines (e.g. diuretics or adrenal cortex hormones [corticosteroids]) are taken at the same time. This can lead to disorders of heart function and muscle weakness and increase the sensitivity to certain medicines for strengthening heart function (cardiac glycosides).

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are no meaningful clinical studies on the use during pregnancy. Use during pregnancy should be avoided if possible.

Breastfeeding

It has been shown that the active ingredient does not pass into breast milk. Regulax Picosulphate Drops can therefore be used during breastfeeding.

Driving and using machines

When Regulax Picosulphate Drops are used in the intended dosage, impairment is normally not to be expected. However, if symptoms such as dizziness, short-term unconsciousness (syncope) or abdominal cramps occur, the ability to participate in road traffic and to operate machines may be impaired.

Regulax Picosulphate Drops contains sorbitol

Please only take Regulax Picosulphate Drops after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD YOU TAKE REGULAX PICOSULPHATE DROPS?

Always take 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. Unless otherwise prescribed by your doctor, the recommended dose for adults and older children is: 14 - 27 drops (corresponding to 5 - 10 mg sodium picosulphate). Children from 4 years of age take a single dose of 7 - 14 drops (corresponding to 2.5 - 5 mg sodium picosulphate) as prescribed by the doctor.

Method of administration

Regulax Picosulphate Drops are best taken in the evening. They can be taken with or without liquid. The laxative effect normally occurs after 10 to 12 hours. Please note the duration until the effect occurs and do not try to force a bowel movement by straining hard.

Duration of use

Regulax Picosulphate Drops should not be taken continuously daily or for extended periods of time without prior medical diagnosis. Please talk to your doctor or pharmacist if you have the impression that the effect of Regulax Picosulphate Drops is too strong or too weak.

If you have taken a larger amount of Regulax Picosulphate Drops than you should

Acute overdose of Regulax Picosulphate Drops can lead to diarrhoea, abdominal discomfort, loss of fluid, potassium and other minerals. The countermeasures depend on the symptoms. The effect of the medicine can be reduced or prevented by induced vomiting or gastric lavage within a short time after ingestion. In the case of severe loss of water and minerals, these must be balanced out as instructed by the doctor. The administration of antispasmodics may be useful under certain circumstances. Furthermore, isolated cases of reduced or interrupted blood flow to the colonic mucosa have been reported, in which the dosage of sodium picosulphate was considerably higher than the recommended dosage for the treatment of constipation.

Note

In general, Regulax Picosulphate Drops, like other laxatives, are known to lead to chronic diarrhoea, abdominal pain, reduced potassium levels, excessive secretion of aldosterone and kidney stones in the case of chronic overdose. Damage to the kidney tissue, metabolic increase in base concentrations in the blood and muscle weakness due to reduced potassium levels have also been reported in connection with chronic laxative abuse.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of 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

Immune system disorders

Frequency not known: Allergic reactions (including skin reactions and swelling of the skin and/or mucous membrane [angioedema], e.g. in the area of the face and throat, possibly with shortness of breath).

Nervous system disorders

Uncommon: Dizziness.
Frequency not known: Short-term unconsciousness (syncope). The available information indicates that these complaints are due to severe straining during bowel movements or to a circulatory reaction due to pain in the abdomen (see section 2. »Warnings and precautions«).

Gastrointestinal disorders

Very common: Diarrhoea.
Common: Flatulence, abdominal pain or abdominal cramps.
Uncommon: Nausea, vomiting.

Improper use of Regulax Picosulphate Drops (for too long, at too high a dose) can lead to the loss of water, potassium and other electrolytes. This can cause disorders of heart function and muscle weakness, especially when diuretics or adrenal cortex hormones (corticosteroids) are taken at the same time.

Measures to be taken if you are affected by side effects

If side effects occur, you should stop taking Regulax Picosulphate Drops and consult your doctor for advice.

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 REGULAX PICOSULPHATE DROPS 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 and the label after »Use by:«. The expiry date refers to the last day of the month indicated. Note on shelf life after first opening: Regulax Picosulphate Drops can be stored for 6 months after the bottle has been opened for the first time.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Regulax Picosulphate Drops contain

The active ingredient is: Sodium picosulphate. 1 ml solution (= 20 drops) contains 7.5 mg sodium picosulphate monohydrate (corresponding to 7.23 mg sodium picosulphate). The other ingredients are: Sorbitol solution 70 % (non-crystallising) (Ph. Eur.), propylene glycol, purified water. Note for diabetics: Suitable for diabetics: contains sugar substitutes; 1 ml corresponds to 0.03 BE.

What Regulax Picosulphate Drops look like and contents of the pack

Regulax Picosulphate Drops are a clear, colourless solution for oral administration. Regulax Picosulphate Drops are available in packs of 20 ml (N1) and 50 ml (N3).

Pharmaceutical entrepreneur and manufacturer

Krewel Meuselbach GmbH
Krewelstr. 2
53783 Eitorf
Telephone: 02243 / 87-0
Telefax: 02243 / 87-175
E-mail: Info@krewel-meuselbach.de

This package leaflet was last revised in August 2013.

Source: Information from the package leaflet
Status: 12/2016
Active ingredient: Sodium picosulphate. Areas of application: for constipation and for conditions that require easier bowel movements.