DULCOLAX NP

DULCOLAX NP Drops

Important notes (mandatory information)

Dulcolax NP drops. Active ingredient: Sodium picosulfate monohydrate. 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

Dulcolax NP 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 monohydrate
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 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 DULCOLAX NP DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DULCOLAX NP DROPS?
3. HOW TO TAKE DULCOLAX NP DROPS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DULCOLAX NP DROPS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE DULCOLAX NP DROPS AND WHAT ARE THEY USED FOR?

Dulcolax NP drops are a laxative. Dulcolax NP drops are used for constipation and for conditions that require easier bowel movements. Like other laxatives, Dulcolax NP 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 CONSIDER BEFORE TAKING DULCOLAX NP DROPS?

Dulcolax NP drops must not be taken:

• if you are allergic to sodium picosulfate, related active ingredients from the group of triarylmethanes or any of the other ingredients of this medicine listed in section 6;
• in case of intestinal narrowing with impaired intestinal passage or in case of intestinal obstruction;
• in case of severe, acute abdominal pain with or without fever (e.g. appendicitis), possibly in connection with nausea and vomiting;
• in case of acute inflammatory diseases of the gastrointestinal tract;
• in case of significant fluid deficiency of the body;
• in case of a rare congenital fructose intolerance (see below, section "Dulcolax NP drops contain sorbitol").

Constipation, combined with other symptoms such as abdominal pain, vomiting and fever, can be a sign of a serious illness (intestinal obstruction, acute inflammation in the abdominal area). In case of such symptoms, you must not take Dulcolax NP drops or other medicines and should consult your doctor immediately. In case of conditions that are associated with disorders of the water and mineral balance (e.g. severely impaired renal function), you must only take Dulcolax NP drops under medical supervision.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Dulcolax NP drops. If your symptoms have occurred spontaneously, persist for a longer period of 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 Dulcolax NP drops, as disturbances or impairments of bowel movements can be signs of a serious illness. Dulcolax NP drops should not be taken continuously daily or for extended periods of time without prior medical consultation. If Dulcolax NP 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 Dulcolax NP. 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

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

Taking Dulcolax NP 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. If antibiotics (medicines against bacterial infections) are taken at the same time, the laxative effect of Dulcolax NP drops may be lost. In case of excessive use of Dulcolax NP drops, there is a 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 the heart function and muscle weakness and increase the sensitivity to certain medicines for strengthening the 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 the use during pregnancy. Use during pregnancy should be avoided if possible. It has been shown that neither the active form nor the degradation products pass into breast milk. Dulcolax NP drops can therefore be used during breast-feeding.

Driving and using machines

When using Dulcolax NP drops 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.

Dulcolax NP drops contain sorbitol

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

3. HOW TO TAKE DULCOLAX NP DROPS?

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: 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. Dulcolax NP drops are best taken in the evening. They can be taken with or without liquid. The laxative effect usually occurs after 10 - 12 hours. Please note the duration until the effect occurs and do not try to force a bowel movement by straining hard.

Application

Hold the bottle with the dropper vertically downwards. Do not shake! If the dripping process does not start immediately, please tap the bottom of the bottle lightly.

Dulcolax NP drops should not be taken continuously daily or for extended periods of time without prior medical consultation.

If you have taken more Dulcolax NP drops than you should

Acute overdose of Dulcolax NP drops can lead to diarrhoea, abdominal discomfort, loss of fluid, potassium and other minerals. 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 case of severe loss of water and minerals, these must be balanced according to the doctor's instructions. 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 picosulfate was considerably higher than the dosage recommended for the treatment of constipation.

Note

In general, Dulcolax NP drops, like other laxatives, are known to lead to chronic diarrhoea, abdominal pain, reduced potassium levels, excessive secretion of aldosterone and kidney stones in case of chronic overdose. Damage to the kidney tissue, metabolically induced increase of 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 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.

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 disorders:

• Not known: allergic reactions.

Nervous system disorders:

• 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 disorders:

• Very common: diarrhoea.
• Common: abdominal discomfort, abdominal pain, abdominal cramps.
• Uncommon: nausea, vomiting.

In case of improper use of Dulcolax NP drops (too high a dose for too long), loss of water, potassium and other electrolytes may occur. This can cause disorders of the 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 Dulcolax NP drops 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 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 about the safety of this medicine.

5. HOW TO STORE DULCOLAX NP DROPS?

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 specified month. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment. Storage conditions: Keep the bottle tightly closed. Shelf life after first opening: Dulcolax NP drops can be stored for 12 months after first opening the bottle.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dulcolax NP drops contain

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

What Dulcolax NP drops look like and contents of the pack

Colourless to slightly yellowish, clear solution for oral administration. Dulcolax NP drops are available in packs of 15 ml and 30 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: 02/2018
Active ingredient: Sodium picosulfate monohydrate. Areas of application: for constipation and for conditions that require easier bowel movements.