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_Lactuosa level

Lactulosa Level

Lactulose.

Laxative action.

Indicated:

  • In treatment of habitual chronic constipation.
  • In hepatic encephalopathy (also known as hepatic coma).


    Plastic jars with 200 ml

    Not financed by the S.N.S apart from when therapeutically necessary.

    N.C. 653453.3

Constipation:

The daily dose will be taken in conjunction with breakfast. It may take 2-3 days to reach the desired effect, as lactose does not break down until it reaches the colon.

Systematic portal encephalopathy (alteration of the functioning of the brain as a result of a hepatic illness).

Adults:
Start with 30-50ml 3 times (corresponding to 60 – 100 g of lactulose) per day.
A dosage regime which produces 2-3 soft stools per day should be adopted, the pH of the stools should be of between 5.0 and 5.5.
There are no special recommendations for elderly patients and patients with renal or hepatic insufficiency.

MEDICATION GUIDE
Lactulosa Level 667,5 mg/ml oral solution

Read the whole of this medication guide in detail, because it contains information that will be important to you.
This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use Lactulosa Level with care to obtain the best results.
-Keep this leaflet; you may need to read it again.
-If you have any doubts, consult your doctor or pharmacists.
This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours.

In this leaflet:
1. What are Lactulosa Level and what are they used for?
2. Before using Lactulosa Level
3. How to use Lactulosa Level
4. Possible adverse effects
5. Storage of Lactulosa Level

1. WHAT IS LACTULOSA LEVEL AND WHAT IS IT USED FOR?

Lactulosa Level belongs to the group of medicines called laxatives.

It is used in the treatment of constipation.

It is also used to treat a liver problem called hepatic encephalopathy, which is also known as ‘hepatic coma’.

2. BEFORE TAKING LACTULOSA LEVEL

Do not take Lactulosa Level
-    If you are allergic (hypersensitive) to lactulose or any of the other components of Lactulosa Level.
-    If you suffer from inflammatory intestinal illnesses (like ulcerative colitis or Crohn’s illness), intestinal obstruction, digestive perforation or risk of digestive perforation, or painfaul abdominal syndromes with an undetermined cause.
-    If you suffer from a rare hereditary illness of the metabolism called glactosemia (an in increase in the blood of a sugar called galactose).

Children, especially young ones, should be seen by a doctor before using this medication.

Be especially careful with Lactulosa Level
Inform your doctor before taking Lactulosa Level if you suffer from gastrocardiac syndrome (Roehmeld’s syndrome).

If you suffer symptoms such as meteorism or swelling after using it, stop the treatment and consult your doctor.

In these cases your doctor will closely monitor the treatment.

Long term use of unadjusted doses (above 2 or 3 soft stools per day) or incorrect use can provoke diarrhoea and disturbances of the electrolyte equilibrium.

If you are an elderly patient or if your general condition is weak and take lactulose for more than 6 months, your doctor will periodically revise the electrolytes in your blood.

In patients with systematic portal enthephalopathy, the concomitant administration of other laxatives must be avoided, because it impedes the personalisation of the dosage of the medication.

Please do not use Lactulosa Level for more than 2 weeks without medical assessment.

Children
Lactulosa Level normally must not be given to young children or those breast feeding, as it can alter the normal reflections for the expulsion of faeces.

In exceptional circumstances your doctor can prescribe Lactulosa Level for a child, child breast feeding or newborn. In these cases your doctor will closely monitor the treatment.

If your doctor has told you that you are intolerant to certain sugars contact him/her before taking this medication.

During treatment with laxatives you must drink enough liquids (approx 2l/day, equivalent to 6/8 glasses).

Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used other medicines, including those acquired without prescription.

Lactulose  can increase the loss of potassium caused by other medication such as thiazides (diuretic medicines), steroids (anti-inflammatory) or anphotericine B (for the treatment of fungi). This loss of potassium can increase the effect of cardiotonic glucosoides (used for some heart conditions).

If the dose of lactulose is increased an increase in the acidity of the colon may result (increased pH). As a result some medicines may be inactivated, as occurs with mesalazine (used in the treatment of ulcerative colitis and Chron’s sickness).

Taking Lactulosa Level with food and drink
Lactulosa Level can be taken with a drink like water or fruit juices. While you drink laxatives you must drink abundant liquids (1.5-2 litres/day, so 6-8 glasses).

Pregnancy and while breast feeding
Consult your doctor or pharmacist before taking any medication.

You can take Lactulosa Level during pregnancy and while breast feeding , so long as you follow the indicated dosage.

Driving and the use of machines
No problems driving or using machines have been described when taking Lactulosa Level.

Important information about the ingredients of Lactulosa Level
Lactulosa Level can contain lactose, epylactose, galactacose, tagatose and fructose. If your doctor has indicated you are intolerant to certain sugars, consult with him/her before using this medicine.

The 30ml dose habitually used against constipation should not cause a problem to diabetics. The dose used in hepatic encephalopathy is habitually much higher and it may be necessary for diabetics to bear this in mind.

3. HOW TO TAKE LACTULOSA LEVEL

Follow the administration instructions for Lactulosa Level indicated by your doctor exactly. Consult your doctor or pharmacist if you have doubts.

Take your dose at the same time every day. The dose can be administered once a day, for example with breakfast, or divided into two daily doses.

Swallow the medicine quickly, do not maintain it in the mouth.

You can take Lactulosa Level oral solution without diluting it or diluted in a little liquid (water or fruit juice).

During treatment with laxatives you will need to drink enough liquids (approx 2l/day, equivalent to 6-8 glasses).

Constipation:

The daily dose will be taken in conjunction with breakfast. It may take 2-3 days to reach the desired effect, as lactose does not break down until it reaches the colon.

Systematic portal encephalopathy (alteration of the functioning of the brain as a result of a hepatic illness).

Adults:
Start with 30-50ml 3 times (corresponding to 60 – 100 g of lactulose) per day.
A dosage regime which produces 2-3 soft stools per day should be adopted, the pH of the stools should be of between 5.0 and 5.5.
There are no special recommendations for elderly patients and patients with renal or hepatic insufficiency.

If you take more Lactulosa Level than you should
In the case of overdose, you may suffer from diarrhoea and abdominal pain. Contact your doctor or chemist if you take more Lactulosa Level than you should.

In case the case of overdosing or accidental ingestion, immediately consult your doctor or chemist, or phone the Toxicology Information Service, telephone 915620420, indicating the medicine and quantity used.

Take this medication guide and the remaining solution so that the health staff can know exactly what you have taken.

If you forget to take Lactulosa Level
Do not take a double dose to compensate the forgotten ones. Do not worry if you forget a dose of Lactulosa Level, simply take the next one at the usual hour.

If you interrupt the treatment with Lactulosa Level
The desired effect of the medicine may not be achieved.

If you have any doubt about this or another product, contact your doctor or chemist.

4. POSSIBLE SIDE EFFECTS

Aswith all medicines, Lactulosa Level can produce side effects, although not everyone suffers from them.

The following side effects have been communicated.

Very frequent
-    Flatulence can be produced (gases), especially during the first days of treatment.
This normally disappears in a couple of days.
-    If you use a greater dose than recommended, you may suffer from abdominal pain and diarrhoea.

Frequent
-    Nausea (dizziness).
-    Vomiting

If you consider any of the side effects you suffer to be serious, or if you appreciate any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. CONSERVATION OF LACTULOSA LEVEL

Keep out of reach and sight of children.

Do not keep at temperatures above 25 ºC. Do not refrigerate or freeze.

Do not use Lactulosa Level after the date of expiry that appears on the container after CAD. The date of expiry is the last day of the month indicated.

Medicines must not be disposed of in the drains or thrown away. Leave unwanted medicines and containers at the SIGRE point in a chemist. Ask your pharmacist how to dispose of any containers or unneeded medicines. This way you will help look after the environment.

6. ADDITIONAL INFORMATION

Composition of Lactulosa Level
-    The principal ingredient is lactulose. 1milliletre of oral solution contains 667.5 mg of lactulose.
-    The other components are citric acid, sodium hydroxide and water.

Appearance of the product and contents of the container
Lactulosa Level is a transparent liquid, colourless or yellow or slightly brown.

Lactulosa Level is available in plastic jars of 200 or 800ml with a screw top.

It is possible that only certain sizes of container are commercialised.

Holder of the authorisation for the commercialisation and fabrication of the product.

LABORATORIOS ERN, S.A. Pedro IV, 499 - 08020 Barcelona, España
Tel: 93 314 80 11   Fax: 93 314 40 96

Responsable for fabrication.
Laboratorios ERN, S.A. Gorcs i LLadó, 188 – 08210 Barberá del Vallés, Barcelona. España.

Laboratorios ERN, S.A. Perú, 228 – 08020 Barcelona. España.

This product was approved in December 2011.

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