Elissan 2 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELISSAN 2 mg tablets
Loperamide hydrochloride
Read the entire leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen or persist beyond 2 days, you must consult a doctor.
- If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
This leaflet explains:
- What Elissan is and what it is used for.
- Before you take Elissan.
- How to take Elissan.
- Possible side effects.
- How to store Elissan.
- Further information.
1. What Elissan is and what it is used for
Loperamide is an antidiarrheal that reduces intestinal motility and secretions, resulting in a decrease in liquid stools.
This medicinal product is indicated for the symptomatic treatment of acute (occasional) diarrhea.
2. Before taking Elissan
Do not take Elissan
If you are allergic (hypersensitive) to loperamide or to any of the other components of Elissan.
The treatment of diarrhoea with Elissan is only symptomatic and should not be used in the following cases:
- Presence of blood in the stools and high fever (above 38°C).
- Patients diagnosed with acute ulcerative colitis or pseudomembranous colitis associated with treatment with broad-spectrum antibiotics.
Take special care with Elissan
- If you do not observe clinical improvement within 48 hours, or if fever, constipation or other symptoms occur, stop treatment and consult your doctor.
- Patients with liver problems should consult their doctor or pharmacist before starting treatment with Elissan.
- Patients with diarrhoea should drink plenty of fluids to avoid dehydration, which may manifest as dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, or lightheadedness. This is especially important in children and elderly people.
- Do not use this medicine for a purpose other than that indicated (see section 1) and never take more than the recommended dose (see section 3). Serious heart problems (symptoms of which include rapid or irregular heartbeat) have been reported in patients who have taken excessive amounts of loperamide, the active substance in Elissan.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
If you are taking any antibiotic or any narcotic-type painkiller, you should consult your doctor or pharmacist before taking this medicine, as it may interact with them.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
Women who are breastfeeding should not use this medicine without consulting their doctor.
IMPORTANT FOR WOMEN If you are pregnant or think you might be pregnant, consult your doctor before taking this medication. Taking medications during pregnancy can be harmful to the embryo or fetus, and must be supervised by your doctor. |
Use in children
Do not use in children under 12 years of age without consulting a doctor.
Use in elderly
Consult a doctor.
Driving and operating machinery
Although effects in this regard are not expected, if fatigue, dizziness, or drowsiness occur, it is preferable not to drive or operate tools or machinery.
Important information about some of the components of Elissan
This medicine contains wheat starch, equivalent to 547 ppm of gluten, which must be taken into account by celiac patients.
Patients with allergy to wheat starch (other than celiac disease) must not take this medicine.
3. How to take Elissan
Follow these instructions unless your doctor has given you different ones.
If you feel that the effect of Elissan is too strong or too weak, tell your doctor or pharmacist.
In adults and children over 12 years of age, the initial dose is two tablets (4 mg) taken at once. Afterwards, take one tablet (2 mg) after each episode of diarrhoea.
Do not take more than 8 tablets (16 mg) per day.
Take the tablet with a sufficient amount of water (a glass of water).
If you take more Elissan than you should
In case of overdose or accidental ingestion, go immediately to a medical centre or call the Toxicology Information Service (Telephone 91 562 04 20), stating the medication and the amount ingested.
If you have taken too much Elissan, contact a doctor or hospital as soon as possible for assistance. Symptoms may include: increased heart rate, irregular heartbeat, disturbances in heart rhythm (these symptoms may have potentially serious and life-threatening consequences), muscle rigidity, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.
Children react more severely to high doses of Elissan than adults. If a child takes an excessive amount or shows any of the symptoms listed above, contact a doctor immediately.
If you forget to take Elissan
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, Elissan can cause adverse effects, although not everyone experiences them.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.
The adverse effects described are:
-
Uncommon (less than 1 in 100 but more than 1 in 1,000): Hypersensitivity reactions (skin rashes), constipation and/or abdominal distension.
-
Frequency not known (cannot be estimated from available data): Upper abdominal pain, abdominal pain radiating to the back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).
Also, discomforts that are usually difficult to distinguish from symptoms associated with diarrhoea, such as: abdominal pain and/or abdominal distension, nausea and vomiting, fatigue, drowsiness or dizziness, and dry mouth.
If you experience any of these or any other adverse reactions not described above, consult your doctor or pharmacist.
5. Storage of Elissan
Keep out of the reach and sight of children.
Do not use Elissan after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Additional Information
Composition of Elissan
The active substance in this medicine is loperamide hydrochloride, 2 mg.
The other components (excipients) are: wheat starch, microcrystalline cellulose, magnesium stearate and talc.
Appearance of the product and contents of the pack
Elissan is available in packs containing 10 and 20 tablets. The tablets are white and concave.
Marketing Authorization Holder and Manufacturer
LABORATORIOS SERRA PAMIES S.A.
Ctra. de Castellvell, 24
43206 REUS (Tarragona)
This leaflet was approved in April 2024.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/