EMPORTAL 10 g POWDER FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Emportal10 gpowder for oral solution

Lactitol monohydrate

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the Package Leaflet

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

1. What is Emportal and what is it used for

Emportal belongs to the group of medicines called osmotic laxatives.

Emportal is indicated in adults and children over 6 years:

• For the treatment of habitual constipation.
• In situations where it is necessary to facilitate the passage of stools, such as: anal, rectal, anal fissures, and hemorrhoids.

2. What you need to know before taking Emportal

Constipation should be treated, as a first measure, through a high-fiber diet, sufficient liquid intake, or physical exercise. If there is no improvement with these measures, your doctor may recommend the use of Emportal.

Especially in children, it should be taken into account that prolonged treatment with laxatives can hinder the normal functioning of the defecation reflex, so it is recommended to treat constipation with adequate hygiene and dietary measures.

The use of laxatives should be avoided during prolonged periods.

Do not take Emportal

• if you are allergic (hypersensitive) to lactitol;
• if you have intestinal obstruction or there is suspicion of organic lesions in the digestive tract;

• if there is unjustified abdominal pain or rectal bleeding;
• if you are following a galactose-free diet;
• in case of fecal stasis (prolonged retention), which should be treated previously by other means;
• if you have hereditary fructose or galactose intolerance, galactosemia, or glucose or galactose malabsorption;
• if you are breastfeeding a baby with hereditary autosomal recessive fructose intolerance;
• if you have a pre-existing electrolyte imbalance in serum.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Emportal.

• In elderly, debilitated, or dehydrated patients, or with hypokalemia (low potassium levels in blood), your doctor should regularly monitor the level of electrolytes in blood, especially in prolonged treatments;
• If you are to undergo any internal examination of the intestine, you should consult your doctor;

• In cases of ileostomy or colostomy (opening from the ileum or colon to the outside), the administration of Emportal is not recommended;
• In case of particularly resistant constipation, you should consult your doctor;
• In case of nausea, it is recommended to take Emportal during meals;
• Emportal does not affect blood glucose or insulin levels, so it is suitable for diabetic patients. Lactitol has a caloric value of 2.1 kcal/g.

Taking Emportal with other medicines

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

Certain medicines may interact with Emportal; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Thiazide diuretics (medicines used to increase urine elimination).
• Corticosteroids (anti-inflammatory and antiallergic medicines).
• Carbenoxolone (gastric mucosa protector and anti-inflammatory).
• Amphotericin B (medicine for the treatment of fungal infections).
• Mesalazine (intestinal anti-inflammatory medicine).

Pregnancy and breastfeeding

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

Emportal should not be used during the first trimester of pregnancy unless your doctor recommends otherwise.

Although it has not been studied whether lactitol passes into breast milk, the use of Emportal is considered safe for breastfeeding mothers.

Driving and using machines

Emportal does not have any effect on the ability to drive vehicles or use machinery.

3. How to take Emportal

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

Treatment with Emportal should be adapted individually to achieve a daily bowel movement.

Emportal is administered orally in a single daily dose, in the morning or at night, preferably mixed with food or drink, and taking 1-2 glasses of liquid during the meal. The patient should choose to take the medicine in the morning or at night, according to their response, since the laxative effect occurs mostly a few hours after taking it.

The first laxative response may not appear until the second or third day of treatment.

Use in children: The initial daily dose is 0.25 g/kg body weight per day in a single dose; a general guideline can be the following:

• from 6 to 12 years: 5 to 10 g of powder/day (½-1 sachet)
• from 12 to 16 years: 10 to 20 g of powder/day (1-2 sachets)

The intake of Emportal by children should be supervised by an adult.

Adults (including elderly patients): Emportal is administered orally, although in hospitalized patients it can also be administered through a nasogastric tube or retention enema via a rectal balloon catheter, according to the doctor's instructions.

The initial daily dose should be 2 sachets (20 g of lactitol) in a single dose. After a few days, a daily dose of 1 sachet (10 g) may be sufficient for many patients.

In case the initial dose is not effective, a maximum dose of 3 sachets (30 g/day) may be administered.

If you take more Emportal than you should

If you have taken more Emportal than you should, consult your doctor or pharmacist immediately.

The sign of overdose with Emportal is diarrhea, which may disappear by reducing the dose. If diarrhea persists, consult your doctor.

In case of accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service. Phone 91 562 04 20.

If you forget to take Emportal

Take the next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Emportal can cause side effects, although not everybody gets them.

At the start of treatment, abdominal discomfort and flatulence may occur; sometimes stomach pain or spasms may appear. These effects tend to decrease or disappear after a few days of regular intake of Emportal.

Due to individual differences, some patients may experience diarrhea at the recommended doses. This problem is resolved by reducing the dose.

Rare side effects (affects 1 to 10 patients in every 10,000)

• abdominal pain
• abdominal discomfort
• diarrhea
• flatulence
• vomiting

Very rare side effects (affects less than 1 patient in every 10,000)

• nausea
• abnormal gastrointestinal noises
• anal itching

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Emportal

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

This medicine does not require special storage conditions.

The prepared solution should be kept preferably between 2°C and 8°C (in the refrigerator) and should be consumed within a maximum of 2 days.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, consult your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Emportal

The active substance is lactitol monohydrate. One sachet contains 10 grams of lactitol monohydrate.

Emportal does not contain any excipients.

Appearance of the product and pack contents

Emportal 10 g powder for oral solution is a powder for oral solution, white, crystalline, with a slightly sweet taste, presented in paper/aluminum/polyethylene sachets, of 10 g, in boxes of 20 and 50 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3ª planta, módulo A-Edificio Australia

08840 Viladecans, Barcelona (España)

Manufacturer

Lamp S. Prospero SpA

Via della Pace, 25/A

San Prospero (Módena)

Italy

or

A.C.R.A.F. S.p.A (Aziende Chimiche Riunite Angelini Francesco)

Via Vecchia Del Pinocchio, 22

60131 Ancona (AN)

Italy

Date of the last revision of this leaflet: November 2015.

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