ACOLORA POWDER FOR ORAL SOLUTION IN SACHET

Introduction

Package Leaflet: Information for the Patient

Acolora Powder for Oral Solution in Sachet

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Acolora and what is it used for
2. What you need to know before taking Acolora
3. How to take Acolora
4. Possible side effects
5. Storage of Acolora
6. Contents of the pack and further information

1. What is Acolora and what is it used for

Acolora powder for oral solution in sachet is a laxative for the treatment of constipation in adults, adolescents, and the elderly. It is not recommended for children under 12 years of age.

Acolora helps you have an easy bowel movement, even if you have been constipated for a long time. Acolora is also effective in resolving fecal impaction, a complication of severe constipation.

2. What you need to know before taking Acolora

Do not take Acolora:

• If you are allergic to the active substances or any of the other components of this medication (listed in section 6).
• If your doctor has told you that you have:
• intestinal obstruction
• intestinal perforation
• severe inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or toxic megacolon.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acolora:

• If you have epilepsy or a history of seizures.
• If you have heart failure, severe kidney problems, or are taking medications for high blood pressure.
• If you experience vomiting (with blood) followed by sudden chest, neck, or abdominal pain, difficulty swallowing, or difficulty breathing when taking Acolora, stop taking the medication and contact your doctor immediately.
• If you experience sudden abdominal pain or rectal bleeding when taking Acolora for bowel preparation, contact your doctor or seek medical attention immediately.

When taking Acolora, you should continue to drink plenty of fluids. The liquid content of Acolora once dissolved in water does not replace your normal fluid intake.

Cardiac conditions

Follow the instructions in section 3 if you are taking Acolora for fecal impaction.

Other medications and Acolora

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

Some medications, such as antiepileptics, may not be as effective when taken with Acolora.

If you need to thicken liquids to swallow them safely, Acolora may neutralize the effect of the thickener.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Acolora can be taken during pregnancy and breastfeeding.

Driving and using machines

Acolora does not affect your ability to drive or use machines.

Acolora contains sodium, potassium, and sucrose

• Consult your doctor or pharmacist if you need to take 3 or more sachets per day for an extended period, especially if you have been advised to follow a low-salt diet.

Acolora contains 187.92 mg of sodium (the main component of table salt) per sachet, which is equivalent to 9.4% of the maximum recommended daily sodium intake for an adult.

• This medication contains 24.4 mg of potassium per sachet, which should be taken into account in patients with kidney failure or those on a low-potassium diet.

• This medication contains sucrose (4.6 mg of sucrose per sachet). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Acolora

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

This medication can be taken at any time without the need for food.

Dissolve the contents of each sachet in 125 ml (1/2 glass) of water and take it.

Adults, adolescents, and the elderly

• Constipation:

A dose of Acolora corresponds to 1 sachet dissolved in 125 ml (1/2 glass) of water.

Take this amount 1 to 3 times a day, depending on the degree of constipation you have.

• Fecal impaction:

Before taking Acolora for fecal impaction, your doctor must confirm that you have this condition.

A dose of 8 sachets per day is required for the treatment of fecal impaction. Each sachet should be dissolved in 125 ml (1/2 glass) of water. The 8 sachets should be taken over a period of 6 hours and for 3 days if necessary. If you have heart problems, do not take more than 2 sachets in 1 hour.

How to prepare:

Open the sachet and pour the contents into a glass. Add approximately 125 ml (1/2 glass) of water and stir well until the powder is completely dissolved, resulting in a turbid solution, and then drink it. If you are taking Acolora for fecal impaction, it will be easier to dissolve the 8 sachets in 1 liter of water.

Duration of treatment:

• Constipation:

Treatment usually lasts for 2 weeks. If you need to take Acolora for a longer period, consult your doctor. If your constipation is caused by a disease such as Parkinson's or multiple sclerosis, or if you are taking medications that can cause constipation, your doctor may recommend that you take Acolora for more than 2 weeks. If you need to take Acolora for a longer period, consult your doctor.

For long-term treatments, the dose can usually be reduced to 1 or 2 sachets per day.

• Fecal impaction:

Treatment may last up to 3 days.

If you take more Acolora than you should

You may experience excessive diarrhea, which can lead to dehydration. If this occurs, stop treatment with Acolora and drink plenty of fluids. If you are concerned, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Acolora:

Take your dose as soon as you remember.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Frequency not known (frequency cannot be estimated from the available data)

Stop taking Acolora and contact your doctor immediately if you experience any of the following side effects:

• Severe allergic reaction that causes difficulty breathing or swelling of the face, lips, tongue, or throat.
• Seizures.

• Other side effects include:

Allergic reactions that can cause skin rash, itching, redness of the skin, or hives, inflammation of hands, feet, or ankles, headaches, high or low potassium levels in the blood, and esophageal rupture caused by vomiting.

• In some cases, you may experience indigestion, stomach pain, or rumbling.

You may also feel bloated, have gas, nausea, or vomiting, and you may experience anal pain or have mild diarrhea when you start taking Acolora. These side effects usually improve if you reduce the amount of Acolora you take.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Acolora

Sachet: No special storage conditions are required.

Reconstituted solution: Can be stored in the refrigerator (between 2°C and 8°C) for up to 6 hours. Discard any solution that has not been used within 6 hours.

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

Do not use this medication after the expiration date stated on the sachet and carton after EXP.The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Acolora

• The active substances are macrogol 3350, sodium chloride, potassium chloride, and sodium hydrogen carbonate.

Each sachet of Acolora contains:

Macrogol 3350 13.125 g

Sodium chloride 0.3507 g

Sodium hydrogen carbonate 0.1785 g

Potassium chloride 0.0466 g

• The other components are: lemon flavor (contains sucrose and citral) and sodium saccharin.

• When one sachet is dissolved in 125 ml of water, it contains:

Sodium 65.4 mmol/liter

Chloride 53.0 mmol/liter

Potassium 5.0 mmol/liter

Hydrogen carbonate 17.0 mmol/liter

Appearance of the product and pack contents

Acolora is a white powder.

Acolora is available in cartons containing 20 or 30 sachets.

Marketing authorization holder and manufacturer

LAINCO, S.A.

Avda. Bizet 8-12

08191 RUBÍ (Barcelona)

Spain

Date of the last revision of this package leaflet: January 2025

Detailed and up-to-date information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es