Leaflet: information for the patient

Lubrilax 7.5 mg/ml oral drops in solution

Picosulfate sodium

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if you worsen, if no bowel movement occurs after 12 hours following the maximum daily dose, or if you do not improve after 6 days of treatment.

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

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

If symptoms worsen, if no bowel movement occurs after 12 hours following the maximum daily dose, or if symptoms persist after 6 days of treatment, you should consult your doctor.

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

Do not take Lubrilax

• If you are allergic to sodium picosulfate or any of the other components of this medication (listed in section 6).
• If you experience symptoms such as nausea, vomiting, cramps, stomach pain, or lower abdominal pain that may indicate the presence of appendicitis or other abdominal problems.
• If you have an acute inflammatory intestinal disease, intestinal obstruction (ileus), gastrointestinal perforation, severe abdominal pain, or undiagnosed, severe dehydration, or if you observe blood in your stool.
• If you observe sudden changes in bowel habits (frequency and consistency of stool) 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 prolonged periods as its use may cause habituation, as well as water and electrolyte loss (diarrhea).
• When administered to elderly individuals for prolonged periods, it may worsen states of fatigue and/or weakness or produce a decrease in blood pressure and lack of movement coordination.
• Cases of dizziness and/or syncope have been described in patients who have used sodium picosulfate. Based on available information, they may be due to syncope during defecation or a reflex response to abdominal pain related to constipation and not necessarily due to the use of sodium picosulfate.

Consult your doctor or pharmacist before taking Lubrilax:

• If, in addition to constipation, you have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps, it is recommended that you visit a doctor to diagnose whether you have or do not have appendicitis.
• If you have chronic constipation, as in that case, the cause of constipation should be investigated.

Children

In children under 6 years, administer only under medical advice.

Use of 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 adreno-corticoids may increase the risk of electrolyte imbalance if excessive doses of Lubrilax are taken. An electrolyte imbalance may lead to increased sensitivity to cardiac glycosides (heart medications).

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

Interference with diagnostic tests:

The taking of this medication may also interfere with analytical test results, as the prolonged use of laxatives may lead to a decrease in blood potassium (hypokalemia).

Taking Lubrilax with food and drinks

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

Pregnancy, breastfeeding, and fertility

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.

No studies have been conducted on the effect on human fertility.

Driving and operating machinery

No specific studies have been conducted on the ability to drive vehicles and operate machinery.

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

Lubrilax contains parahydroxybenzoic acid propyl ester (E-216) and parahydroxybenzoic acid methyl ester (E-218)

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid propyl ester (E-216) and parahydroxybenzoic acid methyl ester (E-218).

Lubrilax contains sorbitol

This medication contains 350 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (IHF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) 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".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Use in adults and children over 12 years old:

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

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

Use in children from 6 to 12 years old:

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

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

Increasing or decreasing the dosage may establish the optimal personal dose.

Administration form:

It must be administered orally.

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

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

If symptoms worsen, if no stool is produced after 12 hours after the maximum daily dose administration, consult your doctor. Do not use for more than 6 consecutive days without consulting a doctor.

If you estimate that Lubrilax's action is too strong or too weak, inform your doctor or pharmacist.

If you take more Lubrilax than you should

Abdominal spasms, mucous and diarrheal stools, fluid loss, potassium and other electrolyte loss may appear.

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

Like all laxatives, the continued use of high doses of laxatives can produce chronic diarrhea, abdominal pain, decreased blood potassium, secondary aldosteronism (excessive production of aldosterone hormone by the adrenal gland), and kidney stones (stones in the kidney). Renal tubular lesions, metabolic alkalosis (increased blood bicarbonate), and muscle weakness due to decreased blood potassium have also been described.

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

If you forgot to take Lubrilax

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

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

Like all medications, Lubrilax can produce adverse effects, although not all people will experience them.

Very frequent adverse effects (may affect at least 1 in 10 patients):

• diarrhea

Frequent adverse effects (may affect more than 1 in 10 people)

• cramps
• abdominal pain
• abdominal discomfort

Rare adverse effects (may affect up to 1 in 100 people)

• vomiting
• nausea
• dizziness

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

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

The long-term use of medications with picosulfate of sodium, the active ingredient of this medication, may cause an increase in water loss, potassium and other salt loss. This may lead to cardiac function alterations, muscle weakness, and fatigue, particularly when taken with diuretics and corticosteroids at the same time.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 (Website: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.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Lubrilax

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

Appearance of the product and content of the container

Lubrilax is presented in 30 ml dropper bottles containing a transparent, colorless and odorless solution.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet: November 2009

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