LACTULOSE LAINCO 3.33 g/5 ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

LACTULOSA LAINCO 3.33 g/5 ml Oral Solution EFG

Lactulosa

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as your illness, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

Contents of the Package Leaflet

1. What LACTULOSA LAINCO is and what it is used for
2. What you need to know before taking LACTULOSA LAINCO
3. How to take LACTULOSA LAINCO
4. Possible side effects
5. Storage of LACTULOSA LAINCO
6. Contents of the packaging and additional information

1. What LACTULOSA LAINCO is and what it is used for

Lactulosa belongs to a group of medications called oral osmotic laxatives, which work 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 (e.g., hemorrhoids, fistulas, anal fissures, abscesses, ulcers, after surgical interventions in the rectum and anus).

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

2. What you need to know before taking LACTULOSA LAINCO

Do not take LACTULOSA LAINCO if

• You are allergic to lactulosa 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 blood sugar (diabetes) and take high doses of LACTULOSA LAINCO.
• If high doses are used for a long period, as diarrhea may occur 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 galactose intolerance (such as galactosemia) or fructose intolerance, with Lapp lactase deficiency (deficiency observed in certain Lapland populations) or glucose or galactose malabsorption should not take this medication.

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Interaction of LACTULOSA LAINCO with other medications

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

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

• Mesalazine: may decrease 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

LACTULOSA LAINCO can be taken during pregnancy and breastfeeding.

Driving and using machines

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

3. How to take LACTULOSA LAINCO

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

LACTULOSA LAINCO is a medication that is administered orally.

The corresponding dose of the oral solution can be taken diluted, mixed 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 where soft stools are necessary

The recommended dose is 15 ml (1 tablespoon) one, two, 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, it is recommended to administer LACTULOSA LAINCO 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 occur.

The doctor will determine 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 when you stop taking this medication. The treatment in these cases will be the administration of fluids and electrolytes.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the packaging and the package leaflet of the medication 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 make up for forgotten doses.

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

4. Possible side effects

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

During the first days of treatment, gas may accumulate in the intestine, which can cause abdominal discomfort and increased flatulence. They usually disappear after 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.

Adverse reactions with unknown frequency (cannot be estimated from available data): allergic reactions, rash, pruritus, urticaria.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

5. Storage of LACTULOSA LAINCO

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 in 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 away medications through the sewers or in the trash. Deposit the packaging and medications that you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist where to throw away medications that you no longer use. This way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of LACTULOSA LAINCO

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

Appearance of the product and contents of the packaging

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 a clinical package with 10 bottles of 800 ml.

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

Not all packages may be marketed

Marketing authorization holder and manufacturer

LAINCO, S.A.

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

This package leaflet was approved in July 2022

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/