Bohm evacuant solution powder for oral solution in sachets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Solución Evacuante Bohm Powder for Oral Solution in Sachets

Macrogol 4000, Sodium Chloride, Potassium Chloride, Anhydrous Sodium Sulfate,
Sodium Hydrogen Carbonate, Sodium Phosphate.

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Solución Evacuante Bohm is and what it is used for
2. What you need to know before taking Solución Evacuante Bohm
3. How to take Solución Evacuante Bohm
4. Possible adverse effects
5. How to store Solución Evacuante Bohm
6. Contents of the pack and other information

1. What Solución Evacuante Bohm is and what it is used for

Solución Evacuante Bohm belongs to a group of medicines called osmotic laxatives that induce intestinal evacuation.

Solución Evacuante Bohm is indicated in adults for:

• Bowel cleansing prior to a colonoscopy, surgery, radiological examination, and other digestive or genitourinary tract procedures.
• Treatment of chronic constipation of non-organic cause (not originating within the body), which has previously been treated, without satisfactory results, with a high-fiber and high-fluid diet and increased daily physical activity.

2. What you need to know before starting to take Solución Evacuante Bohm

Do not take Solución Evacuante Bohm:

• If you are allergic to Macrogol 4000, sodium chloride, potassium chloride, anhydrous sodium sulfate, sodium hydrogen carbonate, sodium phosphate, or any of the other components of this medicine listed in section 6.
• If you have a stomach or intestinal ulcer.
• If you have delayed gastric emptying.
• If you have impaired or obstructed intestinal transit such as intestinal obstruction or ileus.
• If you have an inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or megacolon.
• If you have any condition where increasing intestinal peristalsis could be dangerous, such as intestinal perforation.

Warnings and precautions

Consult your doctor or pharmacist before taking Solución Evacuante Bohm.

• If you have difficulty swallowing, suffer from esophageal reflux (backflow of stomach contents into the esophagus), or are unconscious, administration of Solución Evacuante Bohm should be closely supervised when used for gastrointestinal cleansing, especially if a nasogastric tube is used, to prevent vomiting or aspiration of the solution into the lungs.
• If you experience severe bloating or abdominal pain, administration should be slowed down or temporarily interrupted until symptoms resolve.
• This medicine should be used with caution if you have severe colitis or inflammation of the rectum and anus (proctitis).
• Additional ingredients (e.g., flavor enhancers, sweeteners) must not be added to the solution.
• If you are diabetic, inform your doctor, as you will need to fast prior to taking this medicine.
• If you experience sudden abdominal pain or rectal bleeding while taking Solución Evacuante Bohm Powder for Oral Solution in sachets for bowel preparation, contact your doctor immediately or seek medical attention.

Children and adolescents

Its use is not recommended in this population.

Use of Solución Evacuante Bohm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Avoid taking other medicines while using Solución Evacuante Bohm. Medications taken during or up to one hour after administration of Solución Evacuante Bohm may be flushed through the gastrointestinal tract and not absorbed.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist.

As a precautionary measure, it is preferable to avoid using Solución Evacuante Bohm during pregnancy.

No effects are expected in breastfed infants, as absorption of Solución Evacuante Bohm in breastfeeding mothers is negligible.

Driving and use of machines

Solución Evacuante Bohm does not affect the ability to drive or operate machinery.

Solución Evacuante Bohm contains Sodium and Potassium

Patients with renal impairment or those on potassium-restricted diets should be aware that this medicine contains 390 mg (9.98 mmol) of potassium per liter of solution.

Patients on sodium-restricted diets should be aware that this medicine contains 2,950 mg (128.33 mmol) of sodium per liter of solution.

3. How to take Bohm Evacuant Solution

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

The recommended dose is:

• Bowel cleansing prior to colonoscopy, surgery, radiological examination, and other gastrointestinal or genitourinary examinations:

16 sachets, taking 1 sachet dissolved in 200–250 ml of water (one glass) every 10–15 minutes, until the entire volume has been consumed or stools become clear. No food should be taken during the 3 to 4 hours prior to administration of the solution, and in no case should solid food be ingested within 2 hours before taking the solution.

Administration of the solution is performed orally; a nasogastric tube may be used in patients reluctant or unable to drink the solution.

The first bowel movement should occur approximately one hour after starting administration of the solution.

• Treatment of chronic non-organic constipation:

1 or 2 sachets per day, each dissolved in 250 ml (one glass) of water.

In elderly patients, one sachet per day is initially recommended.

As with all laxatives, prolonged use of Bohm Evacuant Solution is not recommended.

Do not use Bohm Evacuant Solution for more than six days without consulting your doctor.

Instructions for correct administration

This medicine is administered orally.

To prepare the solution, pour the contents of one sachet into a glass, add water up to approximately 250 ml, and stir until the powder is completely dissolved.

It is recommended to prepare the solution immediately before consumption.

Administration via nasogastric tube should be performed at a rate of 20–30 ml per minute (1.2 to 1.8 liters per hour).

If you take more Bohm Evacuant Solution than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, indicating the product and amount ingested.

If you forget to take Bohm Evacuant Solution

Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

The adverse effects that occur frequently (may affect up to 1 in 10 patients) are: Nausea, feeling of abdominal fullness, and abdominal bloating.

The adverse effects that occur less frequently (may affect up to 1 in 100 patients) are: Abdominal cramps, vomiting, and anal irritation.

These adverse reactions are transient and resolve quickly.

With unknown frequency (cannot be estimated from available data), urticaria, runny nose, and skin irritation may occur as manifestations of an allergic reaction.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bohm Evacuant Solution

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Once the solution has been prepared, it is recommended to take it immediately.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solución Evacuante Bohm.

• The active substances are: Macrogol 4000, Sodium chloride, Potassium chloride, Anhydrous sodium sulfate, Sodium hydrogen carbonate, Sodium phosphate.
• The other components are: Potassium acesulfame (E-950), Hesperidin (E-959), Orange flavour 5949.

Appearance of the medicine and contents of the pack

White crystalline powder in individual sachets. Each single-dose sachet contains 17.73 g of product to prepare 250 ml of solution.

The prepared solution is colourless and free from particles.

Each pack contains 16 single-dose sachets to prepare 4 litres of solution.

Each clinical pack contains 496 single-dose sachets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS BOHM, S.A.
C/ Molinaseca 23-25. Polígono Industrial Cobo Calleja.
28947 Fuenlabrada – Madrid (Spain).

Date of latest review of this leaflet: October 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es