Lactulose Lainco 10 g oral solution in sachets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

LACTULOSE LAINCO 10 g Oral solution in sachets EFG

Lactulose

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet.

Leaflet contents

1. What LACTULOSE LAINCO is and what it is used for
2. What you need to know before taking LACTULOSE LAINCO
3. How to take LACTULOSE LAINCO
4. Possible side effects
5. How to store LACTULOSE LAINCO
6. Contents of the pack and other information

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

Lactulose belongs to a group of medicines called oral osmotic laxatives, which work by increasing the size of the stool.

LACTULOSE LAINCO is used in the treatment of chronic constipation.

It is also used in cases where softening of the stools is necessary to facilitate defecation (e.g., hemorrhoids, fistulas, anal fissures, abscesses, ulcers, following rectal and anal surgery).

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

2. What you need to know before starting LACTULOSA LAINCO

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 the blood (diabetes) and are taking high doses of LACTULOSA LAINCO.
• If high doses are used for a long period of time, as diarrhea may occur, leading to excessive fluid loss (dehydration) and increased sodium levels. This is especially important for elderly patients and children.
• Each 5 ml contains no more than 0.5 g of galactose, no more than 0.33 g of lactose, and trace amounts of fructose. Patients with hereditary galactose intolerance (such as galactosemia) or fructose intolerance, Lapp-type lactase deficiency (a deficiency observed in certain populations in Lapland), or glucose-galactose malabsorption should not take this medicine.

Consult your doctor, even if any of the above circumstances have occurred previously.

Interaction of LACTULOSA LAINCO with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines should not be used 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 action of LACTULOSA LAINCO, so it can be taken before, during, or after meals.

Pregnancy, breastfeeding, and fertility

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

LACTULOSA LAINCO may be used during pregnancy and while breastfeeding.

Driving and using machines

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

3. How to take LACTULOSA LAINCO

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

LACTULOSA LAINCO is a medicine administered orally.

The appropriate dose of the oral solution may be taken either diluted, mixed with juices, infusions, or water, or undiluted.

The recommended dose is:

- Adults

• Chronic constipation

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

The maintenance dose is 15-30 ml (1-2 sachets) per day, administered as a single dose, preferably during breakfast.

• Conditions requiring soft stools

The recommended dose is 15 ml (1 sachet) one, two, or three times a day.

• Portal-systemic hepatic encephalopathy

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

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

- Children and adolescents

For more accurate dosing, it is recommended to use LACTULOSA LAINCO 3.33 g/5 ml oral solution EFG.

The effect of the medicine may take 2 or 3 days to occur.

Your 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, which will resolve upon discontinuation of the medicine. Treatment in such cases consists of administering fluids and electrolytes.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and 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 your normal treatment schedule. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, LACTULOSE LAINCO may cause adverse effects, although not everybody will experience them.

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

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

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

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

5. Storage of LACTULOSE LAINCO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to 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, darkening of the colour may occur, which is characteristic of sugar-containing solutions and does not affect the therapeutic action.

Do not dispose of medicines via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist where to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Composition of LACTULOSA LAINCO

The active substance is lactulose. Each millilitre contains 0.67 g of lactulose.

Nature and contents of the container

This medicine is presented as a yellowish oral solution. It is available in single-dose sachets of 15 ml in packs of 10 or 50 sachets and hospital pack containing 200 sachets of 15 ml.

Other presentations are: LACTULOSA LAINCO 3.33 g/5 ml oral solution EFG. Plastic bottles of 200 or 800 ml and hospital pack with 10 bottles of 800 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LAINCO, S.A.

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

This leaflet was approved in July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/