Prospecto: information for the user

LACTULOSA LAINCO 3.33 g/5 ml Oral Solution EFG

Lactulosa

Read this prospect carefully before starting to take this medication, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you and should not be given to others, even if they present the same symptoms of the disease, as it may harm them.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect.

1. WhatisLACTULOSA LAINCOand for what it is used

2. What you need to know before starting to takeLACTULOSA LAINCO

3. How to takeLACTULOSA LAINCO

4. Possible adverse effects

5. Conservation ofLACTULOSA LAINCO

6. Contents of the package and additional information

Lactulose belongs to a group of medications called oral osmotic laxatives, which act by increasing the size of the fecal bolus.

LACTULOSA LAINCO is used in the treatment of chronic constipation.

It is also used in cases where it is necessary to soften the stool to facilitate defecation (for example, hemorrhoids, fistulas, anal fissures, abscesses, ulcers, after surgical interventions of the rectum and anus).

And it is also used for the treatment and prevention of portosystemic hepatic encephalopathy.

Do not take LACTULOSA LAINCO if

-You are allergic to lactulose or any of the components of LACTULOSA LAINCO.

-You have galactose intolerance.

-You have intestinal obstruction.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take LACTULOSA LAINCO:

-If you have sugar in your blood (diabetes) and take high doses of LACTULOSA LAINCO.

-If high doses are used for a long period of time, as it may cause diarrhea with excessive loss of fluids (dehydration) and increased sodium levels. This is especially important for the elderly and children.

-Each 5 ml contains no more than 0.5 g of galactose, no more than 0.33 g of lactose, and very small amounts of fructose. Patients with hereditary intolerance to galactose (such as galactosemia) or fructose, with lactase deficiency of Lapp (observed in certain populations of Lapland) or malabsorption of glucose or galactose should not take this medication.

Consult your doctor, even if any of the previously mentioned circumstances have occurred at any time.

LACTULOSA LAINCO interaction with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

It is not advisable to use the following medications with LACTULOSA LAINCO:

-Mesalazine: may reduce its effect.

-Antacids: may alter the action of LACTULOSA LAINCO.

LACTULOSA LAINCO with food and drink

Food does not affect the effect of LACTULOSA LAINCO, so it can be taken before, during, or after meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

LACTULOSA LAINCO can be taken during pregnancy and during breastfeeding.

Driving and operating machinery

This medication does not affect the ability to drive or operate machinery.

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

LACTULOSA LAINCO is a medication administered orally.

The corresponding oral solution dose can be taken either diluted, mixing it with juices, infusions or water, or undiluted.

The recommended dose is:

-Adults

-Chronic constipation

The initial recommended dose is 30 ml (2 tablespoons), divided into two doses over 2-3 days.

The maintenance dose is 15-30 ml (1-2 tablespoons) per day, which will be administered in a single dose, preferably during breakfast.

-States in which soft stools are required

The recommended dose is 15 ml (1 tablespoon) once, twice or three times a day.

-Portosystemic hepatic encephalopathy

The initial dose will be 30 to 45 ml (2-3 tablespoons), three times a day.

The maintenance dose will be adjusted to achieve two or three bowel movements per day.

-Children and adolescents

-Chronic constipation and stool softening

Children under 1 year:The initial recommended dose is 5 ml (1 dessert spoon) per day, for 2 days. The maintenance dose is 5 ml (1 dessert spoon) per day.

Children between 1-6 years:The initial recommended dose is 10 ml (2 dessert spoons) per day, for 2 days. The maintenance dose is 5-10 ml (1-2 dessert spoons) per day.

In children under 6 years, LACTULOSA LAINCO should be administered undiluted.

Children and adolescents between 7-14 years:The initial recommended dose is 20 ml (4 dessert spoons) per day, for 2 days. The maintenance dose is 10-15 ml (2-3 dessert spoons) per day.

-Portosystemic hepatic encephalopathy

The doctor will adjust the dose based on the child's weight.

The effect of the medication may take 2 or 3 days to produce.

The doctor will establish the duration of treatment.

If you take more LACTULOSA LAINCO than you should

If you have taken more LACTULOSA LAINCO than you should, you may experience diarrhea that will disappear once you stop taking this medication. Treatment in these cases will be the administration of liquids and electrolytes.

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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take LACTULOSA LAINCO

If you forget to take a dose, take it as soon as you remember and continue with the normal treatment. Do not take a double dose to compensate for the missed doses.

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

Like all medications, LACTULOSA LAINCO can produce adverse effects, although not everyone will experience them.

During the first days of treatment, gas accumulation in the intestine may occur, causing abdominal discomfort and increased flatulence. These usually disappear within a few days.

Especially with high doses, abdominal pain and diarrhea may occur, with potential complications of fluid loss, decreased potassium levels, and increased sodium levels. Nausea and vomiting may also appear.

Infrequent adverse reactions (cannot be estimated from available data):allergic reactions, rash, pruritus, urticaria.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

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, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Store in the original packaging.

Do not freeze. Even under the recommended storage conditions, a darkening of the color may occur, which is characteristic of sugar solutions and does not affect the therapeutic action.

Do not throw the medications down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist where to dispose of the medications you no longer use.This will help protect the environment.

Composition of LACTULOSA LAINCO

The active ingredient is lactulosa. Each milliliter contains 0.67 g of lactulosa.

Appearance of the product and content of the container

This medication is presented in the form of an oral solution, yellowish in color. It is presented in plastic bottles of 200 ml or 800 ml and clinical packaging with 10 bottles of 800 ml.

Other presentations are: LACTULOSA LAINCO 10 g oral solution in EFG sachets. Packaging of 10 or 50 single-dose sachets of 15 ml and clinical packaging of 200 sachets of 15 ml.

It may not be marketed all the containers

Holder of the marketing authorization and responsible for manufacturing

LAINCO, S.A.

Avda. Bizet, 8-12, 08191-RUBÍ (Barcelona)

This leaflet was approved in July 2022

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