PATIENT INFORMATION LEAFLET

ELISSAN 2 mg tablets

Loperamide hydrochloride

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

This medicine can be obtained without a prescription. However, for 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 any of the adverse effects you are experiencing to be severe, 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 for what it is used.
2. Before taking Elissan.
3. How to take Elissan.
4. Possible adverse effects.
5. Storage of Elissan.
6. Additional information.

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

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

Do not take Elissan

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

Elissan treatment for diarrhea 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 in 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 liquids to avoid dehydration, which manifests as: 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 medication for a use other than indicated (see section 1) and never take more than thecantity recommended (see section 3).Severe cases of heartgraves(characterized by symptomsincluding rapid or irregular heartbeats)have been reportedin patients who have taken an excessiveamount of loperamide,the active ingredient of Elissan.

Use of other medications

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

If you are taking any antibiotic or narcotic analgesic, consult your doctor or pharmacist before taking this medication, as it may interact with them.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Women who are breastfeeding should not use this medication 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 operating machinery

Although no effects are expected, if you experience fatigue, dizziness, or drowsiness, it is best not to drive, operate tools, or machinery.

Important information about some of the components of Elissan

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

Patients with an allergy to wheat starch (other than celiac disease) should not take this medication.

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

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

In adults and children over 12 years old, the initial dose is two tablets (4 mg) taken at one time. After that, take one tablet (2 mg) 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 Toxicological Information Service (Phone 91 562 04 20), indicating the medication and the amount ingested.

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

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

If you forgot to take Elissan

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

Like all medications, Elissan can produce adverse effects, although not all people will experience them.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The described adverse effects are:

• Rare (less than 1 in 100 but more than 1 in 1,000):Allergic reactions (skin rashes), constipation and/or abdominal distension.

• Unknown frequency(cannot be estimated from available data): Upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of acute pancreatitis.

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

If you observe these or any other adverse reaction not described above, consult your doctor or pharmacist.

Keep out of reach and sight of children.

Do not use Elissan after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition of Elissan

The active ingredient of this medication 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 Package

Elissan is presented in packages containing 10 and 20 tablets. The tablets are concave and white in color.

Holder of the Marketing Authorization and Responsible for Manufacturing

Laboratorios Serra Pamies S.A.

Ctra. de Castellvell, 24

43206 Reus (Tarragona)

This leaflet was approved in April 2024.

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