Package Insert: Information for the User

Loperan 2 mg Hard Capsules

Loperamide Hydrochloride

Read this entire package insert carefully before you start taking this medicine because it contains important information for you.

• Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.
• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

-You should consult a doctor if your condition worsens or does not improve after 2 days.

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

Loperan is indicated for the symptomatic treatment of acute non-specific diarrhea in adults and children over 12 years old.

Do not take Loperan

• If you are allergic to loperamide hydrochloride or any of the other ingredients of this medication (listed in section 6).
• If you have constipation or abdominal swelling.
• If you have severe liver problems (severe hepatic insufficiency).
• Do not administer to children under 2 years old.
• If you have blood in your stool or 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 caused by an infection caused by organisms such asSalmonella,ShigellaorCampylobacter.

Warnings and precautions

• Do not take this medication for a use other than the indicated (see section 1) and never take more than the recommended amount (see section 3). Severe 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 of Loperan.
• If you do not see improvement in 48 hours or if you have a fever, interrupt the treatment and consult your doctor.
• If you have liver problems, consult your doctor before taking Loperan.
• Patients with AIDS who are treated with Loperan for diarrhea should discontinue treatment when the first symptoms of abdominal swelling or distension (megacolon) appear.
• Patients with diarrhea should drink plenty of liquids to avoid dehydration, which manifests as: dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, drowsiness. This is especially important in children and the elderly.
• Treatment of diarrhea with loperamide is only symptomatic, so the diarrhea should be treated from its cause.
• Stop treatment immediately if you experience constipation, abdominal distension (swelling) or ileus (absence of intestinal movements).

Children and adolescents

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

Loperan with other medications

Inform your doctor or pharmacist if you are using, have used recently 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 states).
• Valerian (used to treat mild anxiety).
• Opioid analgesics (used to treat very 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 diarrhea caused by antibiotics.

Loperan may potentiate the action of medications with similar properties.

Pregnancy, breastfeeding and fertility

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

Pregnancy

The safety of loperamide use during pregnancy has not been established, so it is recommended 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 the medication may pass into breast milk.

Fertility

No data is available on the possible effects of Loperan on human fertility.

Driving and operating machinery

You may experience drowsiness, dizziness or somnolence during treatment of diarrhea with Loperan. In case of these effects, it is recommended not to use machines or drive vehicles.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 duration of treatment will be 2 days.

Use in children and adolescents

The recommended dose in children over 12 years old 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 duration of treatment will be 2 days.

Patients with liver disease

They should consult their doctor before taking this medication.

Administration form:

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 as soon as possible to seek help, a pharmacist, or the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

The 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 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, administer activated charcoal as soon as possible, followed by gastric lavage if vomiting has not occurred. Naloxone may be used as an antidote.

If you forgot to take Loperan

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common: occurs in at least 1 in 10 patients.

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

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

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

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

Frequency not known: cannot be estimated from available data.

The described side effects are:

Skin and subcutaneous tissue disorders:

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

Frequency not known: sudden appearance of blisters on the skin (bullous reactions) that are very severe, 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:

Diverse discomforts have been described that are usually difficult to distinguish from symptoms associated with diarrhea syndrome.

Very rare: dry mouth, abdominal pain, intestinal paralysis (no bowel movements), abdominal distension, dilation of the large intestine (seeWarnings 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 may be symptoms of acute pancreatitis.

Renal and urinary disorders:

Frequency not known: urinary retention.

Psychiatric disorders:

Very rare: drowsiness.

Nervous system disorders:

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

If any of the following side effects appear, discontinue treatment and seek medical attention immediately:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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

Medications should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Loperan

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

Appearance of the product and content of the packaging

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

Loperan is presented in packaging containing 10 and 20 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer

LABORATORIOS ALCALA FARMA S.L.U.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Last review date of this leaflet: March 2022.

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/