LOPERAN 2 mg HARD CAPSULES

2. What you need to know before taking Loperan

Do not take Loperan

• If you are allergic to loperamide hydrochloride or any of the other components of this medication (listed in section 6).
• If you have constipation or abdominal bloating.
• If you have severe liver problems (severe hepatic insufficiency).
• Do not administer to children under 2 years of age.
• If blood appears in stools or you have a high fever (above 38°C).
• If you have ulcerative colitis (inflammation of the intestine)
• If you have severe diarrhea after taking antibiotics (pseudomembranous colitis).
• If you have diarrhea due to an infection caused by organisms such as Salmonella, Shigella, or Campylobacter.

Warnings and precautions

• Do not take this medication for a use other than 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 Loperan.
• If you do not observe improvement within 48 hours or if a fever appears, discontinue treatment and consult your doctor.
• If you have liver problems, you should consult your doctor before taking Loperan.
• Patients with AIDS who are being treated with Loperan for diarrhea should discontinue treatment when the first symptoms of abdominal bloating or distension (megacolon) appear.
• Patient 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.
• Treatment should be suspended rapidly if constipation, abdominal distension (bloating), or ileus (absence of intestinal movements) occurs.
• Treatment of diarrhea with loperamide is only symptomatic, so the diarrhea should be treated based on its cause.

Children and adolescents

Do not administer this medication to children under 12 years of age without medical prescription and supervision.

Taking Loperan with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

In particular, inform them if you are taking any of the following medications:

• Ritonavir, saquinavir (used to treat HIV).
• Quinidine (used to treat abnormal heart rhythms).
• Desmopressin oral (used to treat central diabetes insipidus and nocturnal urinary incontinence in children).
• Itraconazole or ketoconazole (used to treat fungal infections).
• Gemfibrozil (used to lower cholesterol).
• St. John's Wort (used to improve mood).
• Valerian (used to treat mild anxiety).
• Opioid analgesics (used to treat intense pain) as it may increase the risk of severe constipation and central nervous system depression (e.g., drowsiness or decreased consciousness).
• Broad-spectrum antibiotics, as Loperan may worsen or prolong antibiotic-induced diarrhea.

It may potentiate the action of drugs with similar properties.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The safety of using loperamide during pregnancy has not been established, so it is advised not to use this medication without consulting your doctor first.

Breastfeeding

Women who are breastfeeding should not use this medication without consulting their doctor first, as small amounts of it may pass into breast milk.

Fertility

There is no data available on the possible effects of Loperan on fertility.

Driving and using machines

Drowsiness, dizziness, or somnolence may occur during treatment with Loperan. If these effects appear, it is advised not to use machines or drive vehicles.

3. How to take Loperan

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

Adults

The recommended dose in adults is:

• The initial dose is 2 capsules (4 mg), followed by 1 capsule (2 mg) after each diarrheal stool.
• Do not exceed 8 capsules (16 mg/day).

The maximum treatment duration will be 2 days.

Use in children and adolescents

The recommended dose in children over 12 years of age is:

• The initial dose is 1 capsule (2 mg), followed by 1 capsule (2 mg) after each diarrheal stool. The maximum daily dose should be related to body weight:

The maximum treatment duration will be 2 days.

Patient with liver disease

They should consult their doctor before taking this medication.

Method of administration:

This medication is administered orally.

Swallow the capsules with a sufficient amount of water.

If you take more Loperan than you should

If you have taken too much Loperan, contact a doctor or hospital for help as soon as possible, or a pharmacist or the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

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 Loperan than adults. If a child takes an excessive amount or presents any of the above symptoms, call a doctor immediately.

In case of accidental ingestion, activated charcoal should be administered as soon as possible, followed by gastric lavage if vomiting has not occurred. Naloxone can be used as an antidote.

If you forget to take Loperan

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Very common: at least 1 in 10 patients.

Common: at least 1 in 100 but less than 1 in 10 patients.

Uncommon: at least 1 in 1,000 but less than 1 in 100 patients.

Rare: at least 1 in 10,000 but less than 1 in 1,000 patients.

Very rare: at least 1 in 10,000 patients.

Frequency not known: cannot be estimated from available data.

The side effects described are:

Skin and subcutaneous tissue disorders:

Very rare: skin redness, itching, and/or skin swelling (exanthema, urticaria, and pruritus).

Frequency not known: sudden appearance of blisters on the skin (severe bullous reactions) such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Immune system disorders:

Frequency not known: severe allergic reactions (including anaphylactic shock), such as swelling of the lips, face, or tongue, and difficulty breathing.

Gastrointestinal disorders:

Various discomforts have been described that are normally difficult to distinguish from the symptoms associated with the diarrheal syndrome.

Very rare: dry mouth, abdominal pain, intestinal paralysis (no intestinal movements), abdominal distension, dilation of the large intestine (see Warnings and precautions), nausea, vomiting, flatulence, and dyspepsia (pain or unpleasant sensation in the upper-middle part of the stomach).

Frequency not known: upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which can be symptoms of pancreatitis (acute pancreatitis).

Renal and urinary disorders:

Frequency not known: urinary retention.

Psychiatric disorders:

Very rare: somnolence.

Nervous system disorders:

Very rare: loss of consciousness, decreased level of consciousness, dizziness, and fatigue.

If any of the following side effects occur, discontinue treatment and consult your doctor immediately:

• Allergic reactions such as skin rash, facial swelling, or difficulty breathing.
• Severe abdominal pain.
• Blistering or significant skin peeling.
• Loss or decrease in level of consciousness.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Loperan

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Loperan composition

• The active ingredient is loperamide hydrochloride. Each capsule contains 2 mg of loperamide hydrochloride.
• The other ingredients are: microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, titanium dioxide (E-171), gelatin, carmine indigo (E-132), and quinoline (E-104).

Appearance of the product and package contents

Loperan capsules are hard gelatin capsules, colored: white and green.

Loperan is available in packages containing 10 and 20 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

CHIESI ESPAÑA, S.A.

Plaça d’Europa, 41-43, Planta 10

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer

LABORATORIOS ALCALA FARMA S.L.U.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the last revision of this leaflet: March 2022.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/