Leaflet: information for the user

Emportal10 gpowder for oral solution

Lactitol monohydrate

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

Follow exactly the administration instructions contained in this leaflet or those given 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 any 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 you get worse or do not improve after 3 days.

1. What is Emportal and what it is used for

2. What you need to know before starting to take Emportal

3. How to take Emportal

4. Possible side effects

5. Storage of Emportal

6. Contents of the pack and additional information

Emportal belongs to a group of medications known as osmotic laxatives.

Emportal is indicated in adults and children over 6 years old:

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

Constipation should be treated, as a first measure, with a diet rich in fiber, sufficient liquid intake, or physical exercise. If no improvement is seen 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 impede the normal functioning of the defecation reflex, so it is recommended to treat constipation with appropriate hygiene and dietary measures.

Prolonged use of laxatives should be avoided.

Do not take Emportal

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

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

Warnings and precautions

Consult your doctor or pharmacist beforesstarting to take Emportal.

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

• in cases of ileostomy or colostomy (opening from the ileum or colon to the exterior) Emportal administration is not recommended;
• in case of particularly resistant constipation, consult your doctor;
• in the 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.

Emportal use with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

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

Pregnancy and lactation

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

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

Although the passage of lactitol to breast milk has not been studied, the use of Emportal is considered safe for lactating mothers.

Driving and operating machinery

Emportal has no effect on the ability to drive vehicles or operate machinery.

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

The Emportal treatment should be adapted individually in order to achieve a daily bowel movement.

Emportal is administered orally in a single daily dose, either in the morning or at night, preferably mixed with food or drink and taking 1-2 glasses of liquid during meals. The patient should choose between taking the medication in the morning or at night, according to their response, since the laxative effect occurs mainly 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 of body weight per day in a single dose; a general regimen can be as follows:

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

The administration of Emportal to children should be supervised by an adult.

Adults (including elderly patients): Emportal is administered orally, although in hospitalized patients it can also be administered via nasogastric tube or rectal balloon catheter enema, as indicated by the doctor.

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

If the initial dose is not effective, a maximum dose of 3 scoops (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 Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Emportal

Take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Emportal may produce adverse effects, although not all people will experience them.

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

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

Rare Adverse Effects (affects 1 to 10 patients per 10,000)

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

Very Rare Adverse Effects (affects less than 1 patient per 10,000)

• nausea
• abnormal gastrointestinal sounds
• anal itching

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

The prepared solution should be stored preferably between2°Cand8°C(in the refrigerator) and should be consumed within a maximum of 2 days.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Emportal

The active ingredient is lactitol monohydrate. A packet contains 10 grams of lactitol monohydrate.

Emportal does not contain any excipients.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Responsible for manufacturing

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

Last review date of this leaflet: November 2015.

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