NORMONLAX POWDER FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Normonlax Powder for Oral Solution

Macrogol 3350/Sodium Chloride/Sodium Bicarbonate/Potassium Chloride

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 Normonlax and what is it used for
2. What you need to know before taking Normonlax
3. How to take Normonlax
4. Possible side effects
5. Storage of Normonlax
6. Package Contents and Additional Information

1. What is Normonlax and what is it used for

The name of this medication is Normonlax powder for oral solution. It 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.

Normonlax helps you have a proper intestinal transit even when you have been constipated for a long time. Normonlax is also effective in resolving fecal impaction, a complication of severe constipation.

2. What you need to know before taking Normonlax

Do not take Normonlax

• 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.
• If you are allergic to macrogol 3350, sodium chloride, sodium bicarbonate, and potassium chloride or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Normonlax if:

• You have epilepsy or a history of seizures.
• You have heart failure, severe kidney problems, or are taking medications for high blood pressure.

When taking Normonlax, you should continue to drink plenty of fluids. The liquid content of Normonlax does not replace your usual fluid intake.

If you experience vomiting (with blood) followed by sudden chest, neck, or abdominal pain, difficulty swallowing, or difficulty breathing when taking Normonlax, stop taking the medication and contact your doctor immediately.

Cardiac Conditions

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

If you experience sudden abdominal pain or rectal bleeding when taking Normonlax for intestinal preparation, contact your doctor or go to a doctor immediately.

Other Medications and Normonlax

Some medications, such as antiepileptics, may not be as effective when taken with Normonlax. Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Pregnancy, Breastfeeding, and Fertility

Normonlax can be taken during 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.

Driving and Using Machines

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

Normonlax contains Potassium, Sodium, and Sorbitol

Patients with kidney failure or those on low-potassium diets should note that this medication contains 26.39 mg (0.675 mmol) of potassium per sachet.

This medication contains 186.87 mg of sodium (the main component of table salt/cooking salt) in each sachet. This is equivalent to 9.3% of the maximum recommended daily sodium intake for an adult.

This medication contains 0.760 mg of sorbitol in each sachet.

3. How to take Normonlax

Follow the exact instructions for administration of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Taking this medication

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.

Constipation:

A dose of Normonlax corresponds to one 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 Normonlax for fecal impaction, your doctor must confirm that you have this condition.

A dose of 8 sachets per day is necessary 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 six hours and for 3 days if necessary. If you have heart problems, do not take more than 2 sachets in one hour.

Preparing Normonlax

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

Duration of Treatment

Constipation:

Treatment usually lasts about 2 weeks. If you need to take Normonlax 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 Normonlax for more than 2 weeks. If you need to take Normonlax 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 Normonlax than you should

You may experience excessive diarrhea, which can lead to dehydration. If this happens, stop treatment with Normonlax 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 Normonlax

Take your dose as soon as you remember. Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

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

Tell your doctor immediately and stop treatment with Normonlax if you experience:

-A 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, swelling of hands, feet, or ankles, headaches, and high or low potassium levels in the blood.
• Esophageal rupture caused by vomiting, frequency not known.

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

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

If any of these side effects are particularly bothersome or last more than a few days, or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

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 Normonlax

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

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

No special storage conditions are required.

Once you have dissolved Normonlax in water, if you do not take it immediately, store the solution in the refrigerator (between 2°C and 8°C). Discard any solution that has not been used within 24 hours.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Normonlax

Each Normonlax sachet contains the following active ingredients:

Macrogol 3350 13.125 g

Sodium Chloride 0.3507 g

Sodium Bicarbonate 0.1785 g

Potassium Chloride 0.0466 g

The other ingredients are: lemon-lime flavor, orange flavor, sodium saccharin, and anhydrous colloidal silica.

The lemon-lime flavor consists of the following components: natural flavoring preparations, natural flavoring substances, flavoring substances, maltodextrin, mannitol (E421), gluconolactone (E575), sorbitol (E420), gum arabic (E414), and anhydrous colloidal silica (E551).

The orange flavor consists of the following components: flavoring preparations, flavoring substances, natural flavoring substances, maltodextrin, gum arabic (E414), and α-tocopherol (E307).

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

Sodium 65 mmol/l

Potassium 5.4 mmol/l

Chloride 53 mmol/l

Bicarbonate 17 mmol/l

Appearance of the Product and Package Contents

Normonlax is a white crystalline powder. Normonlax is available in cartons with 20 or 30 sachets. Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Date of the Last Revision of this Package Leaflet:December 2024

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