Lactulose Lainco 3.33 g/5 ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

LACTULOSE LAINCO 3.33 g/5 ml Oral solution EFG

Lactulose

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

What is in this leaflet

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 required to facilitate defecation (e.g. haemorrhoids, fistulas, anal fissures, abscesses, ulcers, after 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 to take 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 blood sugar (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 lactase deficiency (lactase deficiency observed in certain populations of Lapland), or glucose-galactose malabsorption should not take this medicine.

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

Interaction of LACTULOSA LAINCO with other medicines

Inform 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 taken during pregnancy and while breastfeeding.

Driving and using machines

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

3. How to take LACTULOSA LAINCO

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

LACTULOSA LAINCO is a medicine taken orally.

The corresponding dose of the oral solution can 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 tablespoonfuls), divided into two doses for 2-3 days.

The maintenance dose is 15–30 ml (1–2 tablespoonfuls) daily, administered as a single dose, preferably with breakfast.

• Conditions requiring soft stools

The recommended dose is 15 ml (1 tablespoonful) once, twice, or three times daily.

• Hepatic encephalopathy (portosystemic encephalopathy)

The initial dose is 30 to 45 ml (2–3 tablespoonfuls), three times daily.

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

- Children and adolescents

• Chronic constipation and stool softening

Children under 1 year: the recommended initial dose is 5 ml (1 dessertspoonful) daily for 2 days. The maintenance dose is 5 ml (1 dessertspoonful) daily.

Children aged 1–6 years: the recommended initial dose is 10 ml (2 dessertspoonfuls) daily for 2 days. The maintenance dose is 5–10 ml (1–2 dessertspoonfuls) daily.

In children under 6 years of age, it is recommended to administer LACTULOSA LAINCO undiluted.

Children and adolescents aged 7–14 years: the recommended initial dose is 20 ml (4 dessertspoonfuls) daily for 2 days. The maintenance dose is 10–15 ml (2–3 dessertspoonfuls) daily.

• Hepatic encephalopathy (portosystemic encephalopathy)

The doctor will adjust the dose according to the child's body weight.

The effect of the medicine 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, which will resolve once you stop taking 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 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 missed 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 produce adverse effects, although not everyone 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 unused medicines and their containers 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.

Appearance of the product and contents of the container

Yellowish oral solution.

It is presented in polyethylene bottles of 200 ml or 800 ml, fitted with polyethylene and polypropylene caps.

Available in single packs of 200 ml and 800 ml, and clinical pack containing 10 bottles of 800 ml.

Other presentations are: LACTULOSA LAINCO 10 g oral solution in sachets EFG. Packs of 10 or 50 single-dose sachets of 15 ml and clinical pack of 200 sachets of 15 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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/