LUBRILAX 7.5 mg/ml ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the Patient

Lubrilax 7.5 mg/ml Oral Solution Drops

Sodium Picosulfate

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet.
• You should consult a doctor if your symptoms worsen, if you do not have a bowel movement after 12 hours following the maximum daily intake, or if you do not improve after 6 days of treatment.

Package Leaflet Contents:

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

1. What is Lubrilax and what is it used for

The active ingredient of this medication, sodium picosulfate, belongs to a group of medications called stimulant laxatives.

Lubrilax is a medication indicated for the symptomatic relief of occasional constipation in adults and children over 6 years of age.

If your symptoms worsen, if you do not have a bowel movement after 12 hours following the maximum daily intake, or if your symptoms persist after 6 days of treatment, you should consult your doctor.

2. What you need to know before taking Lubrilax

It is recommended to drink 6 to 8 glasses of liquid daily when using any type of laxative to help soften the stools.

Do not take Lubrilax

• If you are allergic to sodium picosulfate or any other component of this medication (listed in section 6).
• If you have symptoms such as nausea, vomiting, cramps, stomach pain, or lower abdominal pain, which may indicate the presence of appendicitis or other abdominal problems.
• If you have acute inflammatory intestinal disease, intestinal obstruction (ileus), gastrointestinal perforation, severe abdominal pain, or if you notice blood in your stool.
• If you notice sudden changes in bowel habits (frequency and consistency of stools) that persist for more than 2 weeks.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Lubrilax.

• Like all laxatives, Lubrilax should not be taken continuously for extended periods, as its use can lead to habituation, as well as water and electrolyte loss (diarrhea).
• When administered to elderly patients for extended periods, it may worsen fatigue and/or weakness or cause a decrease in blood pressure and lack of coordination.
• There have been reports of dizziness and/or fainting in patients who have used sodium picosulfate. Based on available information, these may be due to a vasovagal response (e.g., to abdominal spasms) or a reflex response to abdominal pain related to constipation, and not necessarily to the use of sodium picosulfate.

Consult your doctor or pharmacist before taking Lubrilax:

• If you have symptoms of appendicitis, such as nausea, vomiting, or abdominal cramps, it is recommended that you consult a doctor to diagnose whether you have appendicitis.
• If you have chronic constipation, as the cause of constipation should be investigated in this case.

Children

In children under 6 years of age, administer only under medical supervision.

Using Lubrilax with other medications

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

The simultaneous use of diuretics (medications used to increase urine elimination) or adrenocorticosteroids may increase the risk of electrolyte imbalance if excessive doses of Lubrilax are taken. An electrolyte imbalance can lead to increased sensitivity to cardiac glycosides (medications used for the heart).

The simultaneous administration of antibiotics may reduce the laxative effect of Lubrilax.

Interference with diagnostic tests:

Taking this medication may also interfere with laboratory test results, as prolonged use of laxatives can lead to a decrease in potassium levels in the blood (hypokalemia).

Taking Lubrilax with food and beverages

The drops can be taken alone or dissolved in any type of beverage (water, milk, fruit juice, etc.) or food (purées, mush, etc.).

Pregnancy, breastfeeding, and fertility

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.

No studies have been conducted on the effect on fertility in humans.

Driving and using machines

There are no specific studies on the ability to drive vehicles and operate machinery.

During treatment with this medication, dizziness and/or fainting may occur due to a vasovagal response (e.g., to abdominal spasms). If you experience abdominal spasms, you should avoid potentially hazardous tasks such as driving or operating machinery.

Lubrilax contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218)

May cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).

Lubrilax contains sorbitol

This medication contains 350 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

Lubrilax contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per dose, which is essentially "sodium-free".

3. How to take Lubrilax

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Use in adults and children over 12 years:

9 to 13 drops per day (4 to 6 mg of sodium picosulfate), in a single dose.

This means a maximum daily dose of 13 drops (6 mg of sodium picosulfate).

Use in children from 6 to 12 years:

2 to 9 drops per day (1 to 4 mg of sodium picosulfate), in a single dose.

This means a maximum daily dose of 9 drops (4 mg of sodium picosulfate).

By increasing or decreasing the dosage, the optimal personal dose can be established.

Method of administration:

It should be administered orally.

The drops can be taken alone or dissolved in any type of beverage (water, milk, fruit juice, etc.) or food (purées, mush, etc.).

Lubrilax should be administered at night, to produce evacuation the following morning. It should be administered in a single dose per day.

If your symptoms worsen, if you do not have a bowel movement after 12 hours following the maximum daily intake, you should consult your doctor. Do not use for more than 6 consecutive days without consulting your doctor.

If you think the effect of Lubrilax is too strong or too weak, inform your doctor or pharmacist.

If you take more Lubrilax than you should

Gastrointestinal spasms, mucous and diarrheic stools, fluid loss, potassium, and other electrolytes may occur.

At much higher doses than recommended, cases of ischemia (reduced blood flow) in the colon mucosa have been reported.

Like all laxatives, prolonged use of high doses of laxatives can lead to chronic diarrhea, abdominal pain, decreased potassium levels in the blood, secondary hyperaldosteronism, and kidney stones. Renal tubule lesions, metabolic alkalosis (increased bicarbonate levels in the blood), and muscle weakness due to decreased potassium levels in the blood have also been reported.

If you have taken more Lubrilax than you should, go immediately to a medical center or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lubrilax

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

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

4. Possible side effects

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

Very common side effects (may affect at least 1 in 10 patients):

• diarrhea

Common side effects (may affect more than 1 in 10 people)

• colic
• abdominal pain
• abdominal discomfort

Uncommon side effects (may affect up to 1 in 100 people)

• vomiting
• nausea
• dizziness

Side effects of unknown frequency (cannot be estimated from available data)

• hypersensitivity (allergic reactions)
• angioedema (inflammation under the skin surface)
• skin reactions
• syncope

Taking medications with sodium picosulfate, the active ingredient of this medication, for long periods may cause increased water loss, potassium, and other salts. This can lead to alterations in cardiac function, muscle weakness, and fatigue, particularly if taken with diuretic and corticosteroid medications.

Additionally, cases of dizziness and fainting have been reported. Dizziness and fainting that occur after taking medications with sodium picosulfate may be due to a vasovagal response (e.g., to abdominal spasms, defecation).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (Website: www.notificaram.es).

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

5. Storage of Lubrilax

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Lubrilax Composition

• The active ingredient is sodium picosulfate, each ml (17 drops) contains 7.5 mg.
• The other ingredients (excipients) are: sorbitol (E-420), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and purified water.

Product Appearance and Package Contents

Lubrilax is presented in 30 ml drop bottles containing a clear, colorless, and odorless solution.

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: November 2009

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