Dulcolax 2.5 Mg 50 Soft Capsules ingredient sodium picosulfate

• Active substance: Sodium picosulphate. Each DULCOLAX® 2.5 milligram soft gelatin capsule contains 2.5930 mg sodium picosulphate monohydrate equivalent to 2.5 milligrams of sodium picosulfate.

• Excipients: propylene glycol, macrogol 400, gelatin, glycerol, pure water.

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When you go to the doctor or hospital during the use of this medicine, tell your doctor that you are taking this medicine.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is DULCOLAX® and what is it used for? 2. Things to consider before using DULCOLAX® 3. How to use DULCOLAX®? 4. What are the possible side effects? 5. Storage of DULCOLAX®

Headers are included.

1. What is DULCOLAX® and what is it used for?

• DULCOLAX® is produced in the form of soft gelatin capsules.

• DULCOLAX® is available in glass bottles containing 50 soft gelatin capsules.

• Sodium picosulphate, the active ingredient of DULCOLAX®, belongs to a group of drugs called triarylmethane.

Sodium picosulphate is a locally effective, softening agent; shows its effect only in the intestines. No obvious absorption. Increases bowel movements, increases water and electrolyte aggregation in the intestine. As a result, the faeces are softened, the time of passage through the intestines is shortened and the defecation warning is realized.

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• DULCOLAX® is for use in cases of constipation and in cases where excretion needs to be facilitated.

2. Things to consider before using

DULCOLAX® DO NOT use DULCOLAX® if: -to sodium picosulphate or any of the excipients in DULCOLAX®

If you are allergic; - If there is intestinal nodes (ileus); - If there is obstruction in the intestines; - If there are acute (acute) severe reports of the abdomen, such as acute appendicitis; - If you have an inflammatory bowel disease; -associated with nausea and vomiting, which may be indicative of serious conditions mentioned above

severe abdominal pain; - If your body has excessive water loss.

USE DULCOLAX® CAREFULLY: As with

all softening agents, DULCOLAX® should not be used continuously or for long periods of time without investigating the cause of constipation.

Prolonged or excessive use may lead to fluid and electrolyte imbalance and potassium deficiency in the blood.

Dizziness and / or fainting have been reported in patients receiving DULCOLAX®. Our knowledge of these phenomena suggests that events may be due to constipation rather than sodium picosulphate application (fainting due to pressure due to defecation during defecation or pain caused by constipation, otherwise a defecation defecation).

Children should not be given DULCOLAX® without a doctor's control.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Use of DULCOLAX® with food and drink: DULCOLAX® should be swallowed with enough water.

Pregnancy Consult your doctor or pharmacist before using the medicine.

There are no adequate and well-controlled studies on pregnant women. As a result of long-term experience, no data were found for the undesirable or harmful effects during pregnancy. However, as with all medications, DULCOLAX® should be taken only under the supervision of a physician during pregnancy.

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If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine. Studies have shown that DULCOLAX® does not pass into breast milk. Therefore DULCOLAX® can be used safely during the breastfeeding period.

The use of tools and machinery DULCOLAX® has not been studied for its effects on the ability to drive and use machines.

In combination with other drugs

When diuretic drugs and hormones called adreno-corticosteroids are used, taking DULCOLAX® in overdoses may increase the risk of electrolyte imbalance.

Electrolyte imbalance can lead to increased sensitivity to digoxin, heart failure drugs such as digitoxin.

When used in combination with antibiotics, DULCOLAX® may reduce the stool softening effect.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medicine or have recently used it.

3. How to use DULCOLAX®?

Instructions for appropriate use and dose / frequency of administration: Always take DULCOLAX® exactly as instructed by your doctor. If you're not sure, you should ask your doctor or pharmacist.

By a physician Unless advised otherwise, the following dosage is recommended:

adults and 10 children over: 2-4 capsules (5-10 mg) of 4 - children aged 10: 1-2 capsules (2.5 to 5 mg)

4 years The recommended dose for children below 250 micrograms per kilogram, based on body weight.

Method and method of application: DULCOLAX® must be taken overnight to defecate the next morning. The capsules should be swallowed with sufficient amount of water.

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Different age groups: Use in children: DULCOLAX® is used in children. Use in elderly: There is no additional data on the use of DULCOLAX® in the elderly.

Specific use conditions: DULCOLAX® has no special use in renal or hepatic insufficiency.

Talk to your doctor or pharmacist if you have an impression that DULCOLAX® is too strong or too weak.

If you have used more DULCOLAX® than you should use: If you have used more than DULCOLAX®, talk to a doctor or pharmacist.

It is important to follow the dose prescribed by your doctor. If you accidentally take more capsules, ask your doctor immediately without delay or contact the nearest hospital's emergency department.

When taken in high doses, diarrhea, cramp style pain in the abdomen, potassium and other electrolyte losses may occur.

Damage in the large intestine inner membrane has been reported at doses far greater than the routine doses used to treat constipation.

As with other softening drugs, DULCOLAX® can also lead to chronic (chronic) diarrhea, abdominal pain, decreased blood potassium levels, secondary hyperaldosteronism (increased production of aldosterone hormone that controls sodium and potassium in the blood) and kidney stones when taken continuously in overdose. In addition to the long-term abuse of softening drugs, it has also been reported that kidney damage, metabolic alkalosis (increased basic substances in the body), and muscle weakness due to potassium deficiency.

If you forget to use DULCOLAX®: If you forget to take your medicine, skip that day and take your normal dose the next day. Do not take two doses on the same day.

Do not take double doses to compensate for forgotten doses.

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

4. What are the possible side effects?

Like all medicines, DULCOLAX® may have side effects in people who are sensitive to the substances contained in its contents.

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Stop DULCOLAX® if you have any of the following and IMMEDIATELY tell your doctor or contact your nearest hospital emergency department:

- Face, mouth and throat swelling (angioneurotic edema) andaccompanied by dyspneaaccompany them

severe allergic reactions that may bethat may(hypersensitivity );

These are all very serious side effects. If you have one of these, you have a serious allergy to DULCOLAX®. You may need urgent medical attention or hospitalization. All of these very serious side effects are very rare.

If you notice any of the following, report to your doctor immediately or contact your nearest hospital emergency department:

- Cramp style pains in the abdomen

These are all serious side effects. Emergency medical intervention may be required. Serious side effects are very rare.

If you notice any of the following, tell your doctor:

- Skin reactions - Abdominal pain, restlessness in the abdomen - Diarrhea, vomiting, nausea

These are mild side effects of DULCOLAX®.

If you encounter any side effects not mentioned in these instructions for use, please inform your doctor or pharmacist.

5. Storage of

DULCOLAX® Keep DULCOLAX® out of the reach of children and in its packaging. Store at room temperature below 25 ° C in a dry place.

Use in accordance with expiration dates. Do not use DULCOLAX® after the expiration date of the packaging.

Do not use DULCOLAX® if you notice any defects in the product and / or its packaging.

Registration Owner: Boehringer Ingelheim Pharmaceuticals Eski Büyükdere Cad., USO Center No: 61, K: 13-14 34398 - Maslak, ISTANBUL

Tel: (0 212) 329 1100 Fax: (0 212) 329 1101

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Manufacturer: Pharmaton SA Via Mulini, CH- 6934 Bioggio, Switzerland

These instructions for use are approved on __ / __ / ___.

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