LOPERAMIDE OPKO 2 mg HARD CAPSULES

2. What you need to know before taking Loperamide OPKO 2 mg Capsules

Do not take Loperamide OPKO 2 mg Capsules:

• Children under 12 years of age
• If you are allergic to loperamide or any of the other components of this medicine (listed in section 6)
• If you have a high fever (over 38 °C) and blood in the stool (acute dysentery)
• If you suffer from ulcerative colitis (inflammation of the intestine)
• If you suffer from intense diarrhea after taking antibiotics
• If you suffer from diarrhea caused by an infection caused by a microorganism such as Salmonella, Shigella, or Campylobacter.

Treatment should be stopped quickly and a doctor consulted if constipation, abdominal distension (flatulence), or ileus (absence of defecations) occurs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Loperamide OPKO 2 mg Hard Capsules

• If you have intense diarrhea, your body loses more fluids, sugars, and salts than usual. You will need to drink more than usual to replenish fluids. Ask your pharmacist about preparations to replenish sugars and salts
• If you have AIDS and your stomach swells, stop taking this medicine immediately and consult your doctor
• If you have any liver disease, consult your doctor before taking this medicine, as it could produce toxicity in the central nervous system.
• If you have had diarrhea for more than 48 hours, stop taking this medicine and consult your doctor.

Treatment with this medicine is only symptomatic, so the diarrhea should be treated from its cause.

Do not take this medicine for a use other than indicated (see section 1) and never take more than the recommended amount (see section 3). Serious cardiac 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 Loperamide OPKO 2 mg Hard Capsules.

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.

Children and adolescents

Do not use in children and adolescents under 12 years of age.

Other medicines and Loperamide OPKO 2 mg Hard Capsules

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important if you are taking medicines that contain

• 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)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women, especially in the first trimester, should not take this medicine unless prescribed by a doctor.

Do not take Loperamide OPKO 2 mg Hard Capsules if you are breastfeeding. Small amounts of the medicine may pass into breast milk.

Driving and using machines

You can drive and use tools and machines, unless you feel tired, dizzy, or drowsy. Do not drive or use machines in these situations.

Loperamide OPKO 2 mg Hard Capsules contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Loperamide OPKO 2 mg Capsules

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is

Adults

• 2 capsules (4 mg) as an initial dose, followed by 1 capsule (2 mg) after each diarrheal stool.
• The maximum dose for adults is 8 capsules (16 mg) per day

A one-hour break should be made after the initial dose.

Children over 12 years of age

• 1 capsule (2 mg) as an initial dose, followed by 1 capsule (2 mg) after each diarrheal stool

The maximum dose in children between 12 and 18 years of age is 4 capsules (8 mg).

A one-hour break should be made after the initial dose.

Treatment should not exceed 48 hours.

Loperamide OPKO 2 mg Hard Capsules should not be used in children under 12 years of age.

Take the capsules with a glass of water.

Patient with liver disease should consult their doctor.

Elderly population

No dose adjustment is necessary in elderly patients.

Kidney problems

No dose adjustment is necessary in patients with renal insufficiency.

Liver problems

If you have liver insufficiency, consult your doctor or pharmacist before taking this medicine.

If you take more Loperamide OPKO 2 mg Capsules than you should

Symptoms

In case of overdose (including relative overdose caused by liver dysfunction), central nervous system depression (stupor, altered coordination, drowsiness, miosis, muscle hypertonia, and respiratory depression), urinary retention, and ileus may occur. Children may be more sensitive to the effects on the central nervous system.

Cardiac events, such as prolonged QT interval and QRS complex, torsades de pointes, other serious ventricular arrhythmias, cardiac arrest, and syncope have been observed in patients who ingested an overdose of loperamide (see section 4.4). Fatal cases have also been reported. Overdose may unmask a pre-existing Brugada syndrome.

Treatment

In cases of overdose, ECG monitoring of the QT interval prolongation should be initiated.

If symptoms of central nervous system overdose occur, naloxone may be administered as an antidote. Since the duration of action of loperamide is longer than that of naloxone (1 to 3 hours), repeated treatment with naloxone may be indicated. Therefore, the patient should be closely monitored for at least 48 hours to detect possible central nervous system depressions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, Phone 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Loperamide OPKO 2 mg Capsules

You should only take this medicine when you need it, following the instructions above about the doses.

If you forget to take a dose, take it after the next loose stool.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek medical attention immediately if you experience any of the following serious side effects:

Serious adverse reactions

Rare:

• Immune system: hypersensitivity, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction.
• Nervous system: loss of consciousness, stupor, altered consciousness, hypertonia, altered coordination.
• Eyes: miosis
• Gastrointestinal tract: acute pancreatitis
• Skin and subcutaneous tissue: bullous eruptions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme), angioedema, urticaria, pruritus
• Kidney and urinary tract: urinary retention

Frequent:

• Nervous system: headache, dizziness
• Gastrointestinal tract: constipation, nausea, flatulence

Uncommon:

• Nervous system: drowsiness
• Gastrointestinal tract: abdominal pain, abdominal discomfort, dry mouth, upper abdominal pain, vomiting, dyspepsia (including paralytic ileus), megacolon (including toxic megacolon), abdominal distension
• Skin and subcutaneous tissue: rash

Rare:

• Symptoms and reactions at the administration site: fatigue

In children and adolescents, the following side effects may also occur:

The side effects observed in children and adolescents in clinical studies were generally similar to those observed in adults and children over 12 years of age.

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Loperamide OPKO 2 mg Capsules

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the outer packaging after (EXP). The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Loperamide OPKO 2 mg Capsules

• The active substance is loperamide hydrochloride. Each capsule contains 2 mg of loperamide hydrochloride.
• The other ingredients are lactose monohydrate

The capsule is made of:

Titanium dioxide (E171)

Black iron oxide (E172)

Red iron oxide (E172)

Yellow iron oxide (E172)

Brilliant blue FCF (E133)

Gelatin.

Appearance of the product and pack contents

The loperamide hydrochloride capsule is a hard gelatin capsule of size «4» 14.0 mm to 14.8 mm filled with white to off-white powder with a grey and green cap. Blister packs of aluminum and PVC with 20 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

OPKO Health Spain, S.L.U.

Pl. 13-15, 08908

L’Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94,

Alcalá de Henares,

28802 Madrid,

Spain

Date of last revision of this leaflet: January 2023.

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