ELISSAN 2 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ELISSAN 2 mg tablets

Loperamide hydrochloride

Read all of this leaflet carefully because it contains important information for you.

This medicine can be obtained without a prescription. Nevertheless, to get the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 2 days, you should consult a doctor.
• If you consider that any of the adverse effects you are suffering from is serious, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

This leaflet explains:

1. What Elissan is and what it is used for.
2. Before taking Elissan.
3. How to take Elissan.
4. Possible side effects.
5. Storage of Elissan.
6. Additional information.

1. What Elissan is and what it is used for

Loperamide is an antidiarrheal that reduces intestinal movements and secretions, resulting in a decrease in liquid stools.

This medicine is indicated for the symptomatic treatment of acute diarrhea (occasional).

2. Before taking Elissan

Do not take Elissan

If you are allergic (hypersensitive) to loperamide or any of the other components of Elissan.

Treatment of diarrhea with Elissan is only symptomatic and should not be used in cases of:

• Presence of blood in the stool and high fever (above 38°C).
• Patients diagnosed with acute ulcerative colitis or pseudomembranous colitis associated with broad-spectrum antibiotic treatment.

Be especially careful with Elissan

• If you do not observe clinical improvement within 48 hours or if fever, constipation, or other symptoms appear, discontinue treatment and consult your doctor.
• Patients with liver problems should consult their doctor or pharmacist before starting treatment with Elissan.
• Patients with diarrhea should drink plenty of fluids to avoid dehydration, which is manifested by: dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and drowsiness. This is especially important in children and the elderly.
• Do not take this medicine for a use other than that indicated (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (whose symptoms include rapid or irregular heartbeats) have been reported in patients who have taken an excessive amount of loperamide, the active ingredient in Elissan.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

If you are taking any antibiotic or narcotic analgesic, 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.

Breastfeeding women should not use this medicine without consulting their doctor.

Use in children

Do not use in children under 12 years old without consulting a doctor.

Use in the elderly

Consult a doctor.

Driving and using machines

Although no effects are expected, if drowsiness, dizziness, or somnolence occur, it is preferable not to drive, handle tools, or machines.

Important information about some of the components of Elissan

This medicine contains wheat starch, which is equivalent to 547 ppm of gluten, which should be taken into account by celiac patients.

Patient with wheat starch allergy (different from celiac disease) should not take this medicine.

3. How to take Elissan

Follow these instructions unless your doctor has given you different instructions.

If you think the action of Elissan is too strong or too weak, inform your doctor or pharmacist.

In adults and children over 12 years old, the initial dose is 2 tablets (4 mg) in a single dose. Subsequently, 1 tablet (2 mg) will be taken after each diarrheal stool.

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 center or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you have taken too much Elissan, contact a doctor or hospital as soon as possible for help. Symptoms may include: increased heart rate, irregular heartbeats, cardiac arrhythmias (these symptoms can have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, somnolence, difficulty urinating, or weak breathing.

Children react more severely to high amounts of Elissan than adults. If a child takes an excessive amount or presents any of the above symptoms, call a doctor immediately.

If you forget to take Elissan

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

4. Possible side effects

Like all medicines, Elissan can cause side effects, although not everyone gets them.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

The side 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, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which can be symptoms of pancreatitis (acute pancreatitis).

Also, discomfort that is normally difficult to distinguish from symptoms associated with diarrhea, such as: abdominal pain and/or distension, nausea, and vomiting, fatigue, somnolence, or dizziness, and dry mouth.

If you observe 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 expiration date stated on the packaging. The expiration 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. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Elissan

The active ingredient of this medicine is loperamide hydrochloride, 2 mg.

The other ingredients (excipients) are: wheat starch, microcrystalline cellulose, magnesium stearate, and talc.

Appearance of the product and packaging content

Elissan is presented in packaging containing 10 and 20 tablets. The tablets are white, 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 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/