Prospect: information for the user

Bohm Evacuant Solution powder for oral solution in sachets

Macrogol 4000, Sodium Chloride, Potassium Chloride, Anhydrous Sodium Sulfate,

Sodium Hydrogenocarbonate, Sodium Phosphate.

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Bohm Evacuant Solution and for what it is used

2. What you need to know before starting to take Bohm Evacuant Solution

3. How to take Bohm Evacuant Solution

4. Possible adverse effects

5. Storage of Bohm Evacuant Solution

6. Contents of the package and additional information

Bohm Evacuative Solution belongs to a group of medications called osmotic laxatives that induce intestinal evacuation.

Bohm Evacuative Solution is indicated in adults for:

- Cleansing of the digestive system prior to a colonoscopy, surgery, radiological test, and other examinations of the digestive or genitourinary system.

- Treatment of chronic constipation of non-organic cause (not originating from the body), which has previously been treated, without satisfactory results, with a high-fiber and high-water diet and an increase in daily physical exercise.

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 medication, as listed in section 6.
• If you have a stomach or intestinal ulcer.
• If you have delayed stomach emptying.
• If you have difficulty or obstruction of intestinal transit.
• If you have an inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and megacolon.
• If you have a condition where it is dangerous to increase intestinal peristalsis, such as intestinal perforation.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Solución Evacuante Bohm.

• If you have difficulty swallowing, gastroesophageal reflux (backflow of stomach contents into the esophagus), or are unconscious, monitor the administration of Solución Evacuante Bohm when used for gastrointestinal cleansing, especially if using a nasogastric tube, to prevent vomiting or aspiration of the solution into the lungs.
• If you experience severe bloating or abdominal pain, administration should be done more slowly or temporarily interrupted until symptoms subside.
• If you have severe colitis or rectal and anal inflammation (proctitis), use this medication with caution.
• Do not use additional ingredients (e.g., flavor enhancers, sweeteners) with the solution.
• If you are diabetic, inform your doctor about the fasting required prior to taking this medication.
• If you experience sudden abdominal pain or rectal bleeding while taking Solución Evacuante Bohm Oral Powder for Intestinal Preparation, contact your doctor or seek immediate medical attention.

Children and adolescents

This medication is not recommended for use in this population.

Use of Solución Evacuante Bohm with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Avoid using other medications while taking Solución Evacuante Bohm. Medication administered during the use of Solución Evacuante Bohm or within one hour after its administration may be eliminated through the gastrointestinal tract and not absorbed.

Pregnancy, breastfeeding, and fertility

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

As a precaution, it is recommended to avoid using Solución Evacuante Bohm during pregnancy.

No adverse effects are anticipated in infants/children due to the insignificant absorption of Solución Evacuante Bohm by lactating mothers.

Driving and operating machinery

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

Solución Evacuante Bohm contains Sodium and Potassium

Patients with renal insufficiency or low-potassium diets should note that this medication contains 390 mg (9.98 mmol) of potassium per liter of solution.

Patients with low-sodium diets should note that this medication contains 2,950 mg (128.33 mmol) of sodium per liter of solution.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose is:

- Pre-cleansing of the digestive system prior to a colonoscopy, surgery, radiological test, and other digestive or genitourinary system examinations:

16 sachets, taking 1 sachet dissolved in 200-250 ml of water (a glass) every 10-15 minutes, until the total volume has been ingested or the stool is clear. Do not take any food for 3 or 4 hours before administering the solution and do not ingest solid food in the 2 hours before using it.

The solution administration is done orally, and a nasogastric tube may be used in patients who are reluctant or unable to drink the solution.

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

- Chronic constipation treatment of non-organic cause:

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

In elderly patients, it is recommended to start with 1 sachet per day.

As with all laxatives, it is not recommended to use Solución Evacuante Bohm for a prolonged period.

Do not use Solución Evacuante Bohm for more than six days without consulting your doctor.

Instructions for correct administration

This medication is administered orally.

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

It is recommended to prepare the solution at the time of consumption.

Nasogastric administration will be done at a rate of 20-30 ml per minute (1.2 to 1.8 liters per hour).

If you take more Solución Evacuante Bohm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the product and amount ingested.

If you forgot to take Solución Evacuante Bohm

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

These adverse reactions are transient and resolve quickly.

With an unknown frequency (cannot be estimated from available data) may appear urticaria, nasal discharge and skin irritation as a manifestation of an allergic reaction.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Bohm Evacuant Solution.

• The active principles 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 Aroma 5949.

Appearance of the product and contents of the packaging

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 colorless and particle-free.

Each package contains 16 single-dose sachets for the preparation of 4 liters of solution.

Each clinical package contains 496 single-dose sachets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS BOHM, S.A.

C/ Molinaseca 23-25. Cobo Calleja Industrial Estate.

28947 Fuenlabrada – Madrid (Spain).

Last review date of this leaflet October 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es