Lubrilax gotas 30 ml View larger

Lubrilax gotas 30 ml

Indicated for the symptomatic relief of occasional constipation in adults and children over 6 years old

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6,60 € tax incl.

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 1. What it is Lubrilax and what it is used
The active ingredient of this medicine, picosulfate sodium belongs to a group of medications called stimulant laxatives.
Lubrilax is a medicine that is indicated for the symptomatic relief of occasional constipation in adults and children over 6 years old.
If symptoms worsen, if any deposition after 12 hours does not occur after the maximum daily administration, or if symptoms persist after 6 days of treatment, you should consult your doctor.


 2. What you need to know before you start taking Lubrilax
You should drink daily from 6 to 8 glasses of water when using any type of laxative and to help soften the stool.
Do not take Lubrilax if:
- If you are allergic to picosulfate sodium or any of the other ingredients of this medicine (listed in section 6).
- If you have symptoms such as nausea, vomiting, cramps, stomach pain or lower abdomen, which may indicate the presence of appendicitis or other abdominal problems.
- If you suffer from any acute intestinal inflammatory disease, intestinal obstruction (ileus), gastrointestinal perforation, severe abdominal pain or undiagnosed, severe dehydration, or if you notice blood in stool.
- If you notice sudden changes in bowel habits (frequency and stool consistency) that persist for more than 2 weeks.

Warnings and Precautions
Consult your doctor, pharmacist or nurse before taking Lubrilax.
- Like all laxatives, Lubrilax should not be taken continuously for long periods because their use can lead to habituation and loss of water and electrolytes (diarrhea).
- When given to the elderly for long periods can worsen states of fatigue and / or weakness or cause a decrease in blood pressure and lack of coordination of movements.
- There have been reports of dizziness and / or syncope in patients who have used picosulfate sodium. Based on the information available could be due to syncope efforts during defecation or a reflex response to abdominal pain associated with constipation and not necessarily with the use of sodium picosulfate.
Consult your doctor or pharmacist before taking Lubrilax:
- If constipation also have symptoms of appendicitis such as nausea, vomiting or abdominal cramps, it is recommended to consult a doctor to diagnose you whether or not you have appendicitis.
- If you have chronic constipation, because in that case you should investigate the cause of constipation.

Children
In children under 6 years old administer only under medical judgment.

Lubrilax use with other medicines
Tell your doctor or pharmacist that you are taking, have recently taken or might take any other medicines.
The simultaneous use of diuretics (medicines used to increase urine output) or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of Lubrilax are taken. An electrolyte imbalance can lead to increased sensitivity of cardiac glycosides (medicines used for heart).
Simultaneous administration of antibiotics may reduce the laxative action Lubrilax.

Interference with diagnostic tests:
Taking this medication can also interfere with analytical results preubeas due Aque laxanes prolonged use can lead to decreased blood potassium (hypokalemia).

Taking Lubrilax with food and drink
The drops can be taken alone or dissolved in any beverage (water, milk, fruit juice, etc.) or food (mashed potatoes, baby food, etc.).

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before using this medicine.
There have been no studies on the effect on fertility in humans.

Driving and using machines
There are no specific studies on the ability to drive and use machines. During treatment with this medicine may cause dizziness is and / or syncope due to a vasovagal response (p. Eg. To abdominal cramps). If you have abdominal cramps should avoid potentially hazardous tasks such as driving or operating machinery.

Lubrilax contains propyl parahydroxybenzoate and methyl parahydroxybenzoate
This medicine may cause (possibly delayed) allergic reactions because it contains propyl parahydroxybenzoate and methyl parahydroxybenzoate.
Lubrilax contains sorbitol
If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.
Lubrilax contains sodium
This medicine contains less than 23 mg (1 mmol) of sodium per dose, ie essentially "sodium-free".


 3. How to take Lubrilax
Follow exactly the instructions of medicine administration in this leaflet or as your doctor or pharmacist. If in 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 sodium picosulfate) in one shot. This means a daily maximum of 13 drops (6 mg of sodium picosulfate).
- Use in children 6 to 12 years old: 2 to 9 drops per day (1 to 4 mg of sodium picosulfate) in one shot.
This means a daily maximum of 9 drops (4 mg of sodium picosulfate).
Increasing or decreasing the optimum dosage can be established personal dose. Method of administration:
It should be administered orally.
The drops can be taken alone or dissolved in any beverage (water, milk, fruit juice, etc.) or food (mashed potatoes, baby food, etc.).
Lubrilax should be administered at night to produce evacuation the next morning. It should be administered in a single daily dose.
If symptoms worsen, if any deposition after 12 hours does not occur after the maximum daily administration should consult with your doctor. Should not be used more than 6 days without consulting a doctor.
If it considers that the action of Lubrilax is too strong or too weak, talk to your doctor or pharmacist.

If you take more than you should Lubrilax
mucous stools and diarrhea loss of fluid, potassium and other electrolytes may appear gastrointestinal spasms,.
A much higher than recommended, have been reported cases of ischemia (reduced blood supply) in the colonic mucosa doses.
Like all laxatives, continued use of high doses of laxatives can cause chronic diarrhea, abdominal pain, decreased blood potassium, hyperaldosteronism secondary (excessive production of the hormone aldosterone by the adrenal gland) and kidney stones (kidney stones) . Have also been described in the renal tubule injury, metabolic alkalosis (increased amount of bicarbonate in the blood) and muscle weakness due to decreased blood potassium.
If you have taken more Lubrilax than you should, immediately consult a medical center or call a poison control center +34 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Lubrilax
Do not take a double dose to make up for missed doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


 4. Possible side effects
Like all medicines, Lubrilax can cause side effects, although not everybody gets 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): cramping, abdominal pain, abdominal discomfort.
Uncommon side -effects (may affect up to 1 in 100 people): vomiting, nausea, dizziness.
adverse -effects of unknown frequency (can not be estimated from available data): hypersensitivity (allergic reactions), angioedema (swelling that occurs beneath the surface of the skin), syncope.
Taking medication with sodium picosulfate, active ingredient of this medicine, for long periods of time, may cause an increased loss of water, potassium salts and other salts. This can lead to impaired cardiac function, muscle weakness and fatigue, particularly if taken at the same time as medicines diuretics and corticosteroids.
In addition there have been cases of dizziness and syncope. Dizziness and syncope occurring after taking medication with sodium picosulfate could be due to a vasovagal response (p. Eg. To abdominal spasm, defecation).


 5. Conservation Lubrilax
Keep this medicine out of the sight and reach of children. It does not require any special storage conditions.
Do not use this medicine after the expiry date on the carton after EXP. The expiry date is the last day of that month.


 6. Contents of the pack and other information
Composition of Lubrilax
- The active substance is sodium picosulfate, each ml (17 drops) contains 7.5 mg.
- The other ingredients (excipients) are: sorbitol (E-420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E 216) and purified water.

Looks like and contents of the pack
Lubrilax is available in bottles of 30 ml dropper containing a clear, colorless and odorless solution.

Authorization holder responsible for marketing and manufacturing
NORMON LABORATORIES, S.A.
Round Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (Spain)


Source: Spanish Agency for Medicines and Health Products

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