Emportal 10 g powder for oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Emportal 10 g powder for oral solution
Lactitol monohydrate
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 3 days.
Contents of the leaflet
- What Emportal is and what it is used for
- What you need to know before taking Emportal
- How to take Emportal
- Possible adverse effects
- Storage of Emportal
- Contents of the pack and other information
1. What Emportal is and what it is used for
Emportal belongs to a group of medicines called osmotic laxatives.
Emportal is indicated in adults and children over 6 years of age:
- In the treatment of habitual constipation.
- In those situations where facilitation of bowel movements is required, such as: anal or rectal surgery, anal fissures, and haemorrhoids.
2. What you need to know before starting to take Emportal
Constipation should first be treated with a high-fiber diet, adequate fluid intake, and physical exercise. If these measures do not improve the condition, your doctor may recommend the use of Emportal.
Particularly in children, it should be noted that prolonged treatment with laxatives may interfere with the normal defecation reflex; therefore, constipation should preferably be managed with appropriate dietary and hygienic 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 suspected organic lesions in the gastrointestinal tract;
- if you have unexplained abdominal pain or rectal bleeding;
- if you are on a galactose-free diet;
- in cases of fecal impaction (prolonged retention), which must be treated previously by other means;
- if you suffer from hereditary fructose or galactose intolerance, galactosemia, or glucose-galactose malabsorption;
- if you are breastfeeding an infant with autosomal recessive hereditary fructosuria;
- if you have a pre-existing serum electrolyte imbalance.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Emportal.
- In elderly, debilitated patients, or those with dehydration or hypokalemia (low blood potassium levels), your doctor should regularly monitor blood electrolyte levels, especially during prolonged treatment;
- if you are scheduled to undergo any internal intestinal examination, consult your doctor;
- in cases of ileostomy or colostomy (an opening from the ileum or colon to the outside), administration of Emportal is not recommended;
- if you have particularly resistant constipation, consult your doctor;
- if nausea occurs, it is advisable to take Emportal with meals;
- Emportal does not affect blood glucose or insulin levels and is therefore suitable for diabetic patients. Lactitol has a caloric value of 2.1 kcal/g.
Taking Emportal with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Emportal; in such cases, it may be necessary to adjust the dose or discontinue 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 (a gastric mucosal protectant and anti-inflammatory).
- Amphotericin B (a medicine used to treat fungal infections).
- Mesalazine (an intestinal anti-inflammatory medicine).
Pregnancy and breastfeeding
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.
Emportal should not be used during the first trimester of pregnancy unless your doctor advises otherwise.
Although passage of lactitol into breast milk has not been studied, the use of Emportal is considered safe for breastfeeding mothers.
Driving and use of machines
Emportal has no effect on the ability to drive or operate machinery.
3. How to take Emportal
Follow exactly the administration instructions for Emportal given by your doctor. If in doubt, consult your doctor or pharmacist again.
Treatment with Emportal should be individually adjusted in order to achieve one daily bowel movement.
Emportal is administered orally as a single daily dose, in the morning or at night, preferably mixed with food or drink and taken with 1–2 glasses of liquid during the meal. The patient should choose to take the medicine either in the morning or at night, depending on their response, as the laxative effect occurs mostly several hours after administration.
The first laxative response may not occur until the second or third day of treatment.
Use in children: The initial daily dose is 0.25 g/kg body weight per day, taken as a single dose; a general guideline may be as follows:
- 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)
Administration of Emportal to children must be supervised by an adult.
Adults (including elderly patients): Emportal is administered orally; however, in hospitalized patients, it may also be administered via nasogastric tube or as a retention enema via rectal balloon catheter, according to the physician's instructions.
The initial daily dose should be 2 sachets (20 g of lactitol) as a single dose. After a few days, a daily dose of 1 sachet (10 g) may be sufficient for many patients.
If the initial dose is not effective, the dose may be increased up to a maximum of 3 sachets (30 g/day).
If you take more Emportal than you should
If you have taken more Emportal than you should, contact your doctor or pharmacist immediately.
The sign of overdose with Emportal is diarrhea, which may resolve by reducing the dose. If diarrhea persists, consult your doctor.
In case of accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Emportal may cause adverse effects, although not everyone will experience them.
At the beginning 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 adverse effects (affects 1 to 10 patients in 10,000)
- abdominal pain
- abdominal discomfort
- diarrhea
- flatulence
- vomiting
Very rare adverse effects (affects less than 1 patient in 10,000)
- nausea
- abnormal gastrointestinal sounds
- anal pruritus
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 any special storage conditions.
The prepared solution should preferably be stored between 2°C and 8°C (in the refrigerator) and must be used within a maximum of 2 days.
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.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Emportal
The active substance is lactitol monohydrate. One sachet contains 10 grams of lactitol monohydrate.
Emportal contains no excipients.
Appearance of the medicinal product and contents of the pack
Emportal 10 g oral powder for oral solution is a white, crystalline powder with a slightly sweet taste, intended for oral solution. It is supplied in 10 g sachets made of paper/aluminum/polyethylene, packed in boxes of 20 and 50 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ANGELINI PHARMA ESPAÑA, S.L.
c/ Antonio Machado, 78-80
3rd floor, module A-Edificio Australia
08840 Viladecans, Barcelona (Spain)
Manufacturer
Lamp S. Prospero SpA
Via della Pace, 25/A
San Prospero (Modena)
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 most recent revision of this leaflet: November 2015.
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/