LAXOBERAL

LAXOBERAL tablets

Important notes (mandatory information)

Laxoberal Laxative Tablets. Active ingredient: Sodium picosulfate. 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

Laxoberal Laxative Tablets 5 mg tablets, for use in adults and children aged 4 years and over
Active ingredient: Sodium picosulfate
Laxative

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take 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 experience any side effects, talk to your doctor or pharmacist. This also applies to any 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 LAXOBERAL LAXATIVE TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING LAXOBERAL LAXATIVE TABLETS?
3. HOW SHOULD LAXOBERAL LAXATIVE TABLETS BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD LAXOBERAL LAXATIVE TABLETS BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE LAXOBERAL LAXATIVE TABLETS AND WHAT ARE THEY USED FOR?

Laxoberal Laxative Tablets are a laxative. Laxoberal Laxative Tablets are used for constipation and for conditions that require easier bowel movements. Like other laxatives, Laxoberal Laxative Tablets 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 LAXOBERAL LAXATIVE TABLETS?

Laxoberal Laxative Tablets must not be taken:

• if you are allergic to sodium picosulfate, related active ingredients from the triarylmethane group or any of the other ingredients of Laxoberal Laxative Tablets listed in section 6;
• in the case of intestinal narrowing with impaired intestinal passage or in the case of intestinal obstruction;
• in the case of severe, acute abdominal pain with or without fever (e.g. appendicitis), possibly in conjunction 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;
• in the case of a rare congenital lactose intolerance (see below, section "Laxoberal Laxative Tablets contain lactose").

Constipation, combined with other symptoms 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 symptoms, you must not take Laxoberal Laxative Tablets 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 Laxoberal Laxative Tablets under medical supervision.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Laxoberal Laxative Tablets. If your symptoms have occurred spontaneously, persist for a long time and/or are accompanied by symptoms such as blood in the stool or fever, you should consult your doctor for advice and examination before starting treatment with Laxoberal Laxative Tablets, as bowel movement disorders can be signs of a serious illness. Laxoberal Laxative Tablets should not be taken continuously daily or for extended periods of time without prior medical consultation. If Laxoberal Laxative Tablets 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 Laxoberal Laxative Tablets. 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.

Children

Laxoberal Laxative Tablets should not be used in children under 4 years of age. Please only use Laxoberal Laxative Tablets in your child after consulting your doctor if you know that your child suffers from an intolerance to certain sugars.

Taking Laxoberal Laxative Tablets 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 Laxoberal Laxative Tablets may be lost if antibiotics (medicines for bacterial infections) are taken at the same time. Excessive use of Laxoberal Laxative Tablets 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 breast-feeding

If you are pregnant or breast-feeding, if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking/using this medicine. There are no meaningful clinical studies on use during pregnancy. Use during pregnancy should be avoided if possible. It has been shown that neither the active form nor the breakdown products pass into breast milk. Laxoberal Laxative Tablets can therefore be used during breast-feeding.

Driving and using machines

When Laxoberal Laxative Tablets are used at the intended dosage, impairment is not normally 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.

Laxoberal Laxative Tablets contain lactose

One tablet contains approx. 70 mg lactose (milk sugar). This corresponds to an amount of approx. 140 mg lactose calculated on the basis of the maximum recommended daily dose for adults. Please only take Laxoberal Laxative Tablets after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD LAXOBERAL LAXATIVE TABLETS BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual single dose for adults is: 1 - 2 tablets (equivalent to 5-10 mg sodium picosulfate). Children aged 4 years and over take a single dose of 1/2 - 1 tablet (equivalent to 2.5 - 5 mg sodium picosulfate). It is recommended to start with the lowest dosage. The dose can be adjusted up to the maximum recommended dose to enable regular bowel movements. The maximum daily dose of 2 tablets (for adults) or 1 tablet (for children aged 4 years and over) should not be exceeded. Laxoberal Laxative Tablets are best taken in the evening with sufficient liquid. The laxative effect normally occurs after 10 - 12 hours. Please note the time until the effect occurs and do not try to force a bowel movement by straining hard. Laxoberal Laxative Tablets should not be taken continuously daily or for extended periods of time without prior medical consultation.

If you have taken more Laxoberal Laxative Tablets than you should

Acute overdose of Laxoberal Laxative Tablets can lead to diarrhoea and abdominal discomfort. The countermeasures depend on the symptoms. Within a short time after ingestion, the effect of the medicine can be reduced or prevented by induced vomiting or gastric lavage. In the case of severe water and mineral loss, these must be balanced out as instructed by the doctor. The administration of antispasmodic agents 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 picosulfate was considerably higher than the dosage recommended for the treatment of constipation.

Note

Laxoberal Laxative Tablets, like other laxatives, are generally 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, metabolically induced 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 frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Skin and subcutaneous tissue:

• Not known: Skin reactions such as swelling of the skin and/or mucous membrane (angioedema), e.g. in the area of the face and throat, possibly with shortness of breath, drug-induced skin rash (drug exanthema), skin rash (exanthema), skin itching (pruritus).

Immune system:

• Not known: allergic reactions.

Nervous system:

• Uncommon: Dizziness.
• Not known: short-term unconsciousness (syncope) This is presumably due to circulatory reactions due to abdominal pain or the laxative process itself (see section 2 under "Warnings and precautions").

Gastrointestinal tract:

• Very common: Diarrhoea.
• Common: Abdominal discomfort, abdominal pain, abdominal cramps.
• Uncommon: Nausea, vomiting.

In the case of improper use of Laxoberal Laxative Tablets (too high a dose for too long), water, potassium and other electrolytes may be lost. This can cause disorders of heart function and muscle weakness, especially if 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 Laxoberal Laxative Tablets and consult your doctor for advice.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any 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 LAXOBERAL LAXATIVE TABLETS 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 on the label of the tablet tube after "Use by". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you have finished using it. In this way, you help to protect the environment. Storage conditions: Keep the tablet tube tightly closed.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Laxoberal Laxative Tablets contain

The active ingredient is sodium picosulfate. 1 tablet contains 5.18 mg sodium picosulfate monohydrate (equivalent to 5 mg sodium picosulfate). The other ingredients are: Lactose monohydrate, magnesium stearate, maize starch, hydrolysed starch, soluble starch, highly dispersed silicon dioxide.

What Laxoberal Laxative Tablets look like and contents of the pack

White tablets for oral administration. The tablets can be divided into equal halves. Laxoberal Laxative Tablets are available in packs of 50 tablets.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main

Postal address

Postfach 80 08 60
65908 Frankfurt am Main
Telephone: 0 800 56 56 010
Telefax: 0 800 56 56 011

Manufacturer

Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France

This package leaflet was last revised in June 2017.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Sodium picosulfate. Areas of application: for constipation and for conditions that require easier bowel movements.