LAXOBERAL

LAXOBERAL Laxative Drops 7.5 mg/ml for oral use

Important notes (mandatory information)

Laxoberal Laxative Drops. 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 Drops 7.5 mg/ml Drops for oral administration, solution for use in adults and children aged 4 years and over
Active ingredient: Sodium picosulfate

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 includes any possible side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What this package leaflet contains

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

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

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

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING LAXOBERAL LAXATIVE DROPS?

Laxoberal Laxative Drops 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 this medicine 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 conditions of the gastrointestinal tract;
• in the case of significant fluid deficiency in the body;
• in the case of a rare congenital fructose intolerance (see below, section "Laxoberal Laxative Drops contain sorbitol").

Constipation, combined with other symptoms such as abdominal pain, vomiting and fever, can be signs of a serious condition (intestinal obstruction, acute inflammation in the abdominal area). In the case of such symptoms, you must not take Laxoberal Laxative 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 kidney function), you must only take Laxoberal Laxative Drops under medical supervision.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Laxoberal Laxative Drops. 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 Drops, because disorders or impairments of bowel movements can be signs of a serious condition. Laxoberal Laxative Drops should not be taken continuously daily or for extended periods of time without prior medical consultation. If Laxoberal Laxative 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 Laxoberal Laxative Drops. 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 Drops should not be used in children under 4 years of age. Please only use Laxoberal Laxative Drops in your child after consulting your doctor if you know that your child suffers from an intolerance to certain sugars.

Taking Laxoberal Laxative Drops 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 Drops may be lost if antibiotics (medicines for bacterial infections) are taken at the same time. Excessive use of Laxoberal Laxative 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 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 taking 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 Drops can therefore be used during breast-feeding.

Driving and using machines

When Laxoberal Laxative Drops are used in the intended dosage, no impairment is 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 Drops contain sorbitol

This medicine contains approx. 450 mg sorbitol per 1 ml solution. This corresponds to a quantity of approx. 600 mg sorbitol calculated on the maximum recommended daily dose for adults. Please only take Laxoberal Laxative Drops after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD LAXOBERAL LAXATIVE DROPS BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual single dose for adults is: 10 - 18 drops (equivalent to 5 - 10 mg sodium picosulfate). Children aged 4 years and over take a single dose of 5 - 9 drops (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 18 drops (for adults) or 9 drops (for children aged 4 years and over) should not be exceeded. Laxoberal Laxative Drops are best taken in the evening. They can be taken with or without 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. Hold the bottle with the dropper pointing downwards. Do not shake! If the drops do not start flowing immediately, please tap the bottom of the bottle gently. Laxoberal Laxative Drops should not be taken continuously daily or for extended periods of time without prior medical consultation.

If you have taken more Laxoberal Laxative Drops than you should

Acute overdose of Laxoberal Laxative Drops 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 antispasmodics may be useful under certain circumstances. Furthermore, isolated cases of reduced or interrupted blood flow to the colon 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 Drops, 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 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 Drops (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 Drops and consult your doctor for advice.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 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 on the bottle label 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 bottle tightly closed. Shelf life after first opening: Laxoberal Laxative Drops can be stored for 12 months after the bottle has been opened for the first time.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Laxoberal Laxative Drops contain

The active ingredient is sodium picosulfate. 1 ml solution (approx. 14 drops) contains 7.78 mg sodium picosulfate monohydrate (equivalent to 7.5 mg sodium picosulfate). The other ingredients are: sodium benzoate, sorbitol solution 70 % (non-crystallising), sodium citrate dihydrate, citric acid monohydrate, purified water.

What Laxoberal Laxative Drops look like and contents of the pack

Colourless to slightly yellowish, clear solution for oral administration. Laxoberal Laxative Drops are available in packs of 15 ml, 30 ml and 50 ml solution.

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: 0800 56 56 010
Telefax: 0800 56 56 011

Manufacturer

Istituto de Angeli, s.r.l.
Località Prulli, 103/C
50066 Reggello (Firenze)
Italy

This package leaflet was last revised in June 2017.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Sodium picosulfate. Areas of application: for constipation and for conditions that require easier bowel movements.