Patient Information Leaflet

Normonlax Powder for Oral Solution

Macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride

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

• Keep this leaflet, as you may need to read it again.

If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Normonlax and what it is 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. Contents of the pack and additional information

The name of this medication is Normonlax powder for oral solution. It is a laxative for the treatment of constipation in adults, adolescents, and elderly people. It is not recommended for children under 12 years of age.

Normonlax helps you have an adequate 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.

Do not take Normonlax

• Ifyour 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.
• Ifyou are allergic to macrogol 3350, sodium chloride, sodium bicarbonate and potassium chloride or 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 medication for high blood pressure.

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

If you experience vomiting (with blood) followed by sudden chest, neck or abdominal pain, difficulty swallowing or difficulty breathing while 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 abdominal pain or sudden rectal bleeding while taking Normonlax for bowel preparation, contact your doctor or seek immediate medical attention.

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 taken recently 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Normonlax does not affect the ability to drive or operate machinery.

Normonlax contains potassium, sodium and sorbitol

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

This medication contains186.87 mgof sodium (main component of table salt/for cooking) in each sachet. This is equivalent to 9.3% of the recommended daily maximum sodium intake for an adult.

This medication contains 0.760 mg of sorbitol in each sachet.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Administration of this medication

This medication can be taken at any time without the need to accompany it with 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 a 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, it must be confirmed by the doctor that you are in this condition.

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

How to prepare Normonlax

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

Duration of treatment

Constipation:

The treatment usually lasts for 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 may 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:

The 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 occurs, stop the Normonlax treatment and drink plenty of liquid. 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Normonlax

Take your dose as soon as you remember. Do not take a double dose to compensate for the missed doses.

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

Inform your doctor immediately and discontinue 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 adverse effects include:

• Allergic reactions that may cause skin rash, itching, skin redness, or urticaria, hand, foot, or ankle inflammation, headaches, and high or low potassium levels in the blood.
• Esophageal rupture caused by vomiting, unknown frequency.

You may experience indigestion, stomach pain, or rumbling sounds.

You may also feel bloated, have gas, nausea, or vomiting, and experience anal pain and mild diarrhea when starting to take Normonlax. These adverse effects usually improve if you reduce the amount of Normonlax you take.

If any of these adverse effects are especially bothersome or last more than a few days, or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on 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 and the box after CAD. 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 drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Normonlax

Each packet of Normonlax contains the following active principles:

Macrogol 3350 13,125 g

Sodium chloride 0,3507 g

Sodium bicarbonate 0,1785 g

Potassium chloride 0,0466 g

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

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

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

When one packet is dissolved in 125 ml of water contains:

Sodium 65 mmol/l

Potassium 5,4 mmol/l

Chloride 53 mmol/l

Bicarbonate 17 mmol/l

Appearance of the product and contents of the packaging

Normonlax is a white crystalline powder. Normonlax is presented in boxes with 20 or 30 packets. Some packaging sizes may only be marketed.

Holder of the marketing authorization and responsible manufacturer

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Date of the last review of this leaflet:December 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).