LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES

2. What you need to know before taking Loperamide Aurovitas

Do not take Loperamide Aurovitas:

• It should not be used in children under 12 years of age.

• If you are allergic to loperamide hydrochloride or any of the other components of this medicine (listed in section 6).
• If you suffer from acute dysentery, characterized by the presence of blood in the stool and high fever (above 38°C).
• If you suffer from acute ulcerative colitis (inflammation of the intestine).
• If you suffer from severe diarrhea after taking antibiotics (pseudomembranous colitis).
• If you suffer from diarrhea due to an infection caused by organisms such as Salmonella, Shigella, and Campylobacter.
• Treatment should be discontinued immediately and a doctor consulted if constipation, abdominal distension (bloating), or ileus (absence of bowel movements) occurs.

Warnings and Precautions

Consult your doctor or pharmacist before taking Loperamide Aurovitas:

• If you have AIDS and your stomach is inflamed. Stop taking the capsules immediately and contact your doctor.
• If you have any liver disease, consult your doctor before taking this medicine, as it may cause toxicity in the central nervous system.
• If you have severe diarrhea, your body loses more fluids, sugars, and salts than usual; you will need to replace fluids by drinking more than usual. Ask your pharmacist about preparations to replace sugars and salts.
• If you develop intestinal obstruction, discontinue treatment and consult your doctor.
• Treatment with this medicine is only symptomatic; therefore, the diarrhea should be treated based on its cause.
• If you are taking any narcotic analgesic, consult your doctor or pharmacist before taking this medicine, as it may interact with them.

Do not use this medicine for any other indication (see section 1) and never take more than the recommended amount (see section 3). Serious cases of cardiac disorders (symptoms including rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide.

If you do not observe improvement within 48 hours or if fever, constipation, or other symptoms appear, discontinue treatment and consult your doctor.

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.

Children and Adolescents

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

Other Medicines and Loperamide Aurovitas

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

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

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

Consult your doctor before taking loperamide if you are being treated with any of the above-mentioned medicines.

Taking Loperamide Aurovitas with Food and Drinks

You can take this medicine with food and drinks.

Pregnancy, Breastfeeding, and Fertility

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.

Breastfeeding women should not use this medicine, as small amounts may pass into breast milk. Consult your doctor about the most suitable treatment.

Driving and Using Machines

This medicine may make you feel dizzy, tired, or drowsy. It may also cause loss of consciousness, dizziness, or decreased alertness. It is advised not to operate machinery or drive vehicles if you are affected.

Loperamide Aurovitas Contains Lactose

This medicine 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 Aurovitas

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in 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.

Children over 12 years

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

In children, the maximum daily dose should be related to body weight:

Take the capsules with a full glass of water.

Patient with Liver Disease:Should consult a doctor.

Advanced Age and Patients with Renal Disease

Follow the same instructions as for adults and children over 12 years.

Use in Children and Adolescents

Children under 12 years of age should not take this medicine.

If You Take More Loperamide Aurovitas Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken.

Symptoms may include: rapid heartbeat, irregular heartbeat, changes in heartbeat (these symptoms may have potentially serious or life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

Children react more intensely to large amounts of loperamide than adults. If a child takes too many capsules or shows any of the above symptoms, call a doctor immediately.

If You Forget to Take Loperamide Aurovitas

Only take this medicine as needed, carefully following the administration instructions. If you forget to take a dose, take a dose after the next liquid stool. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Serious Side Effects

Seek medical attention immediately

Rare: may affect up to 1 in 1,000 people

• Allergic reactions including wheezing, shortness of breath, swelling of the face and throat.
• Loss of consciousness or reduced level of consciousness (feeling dizzy or decreased attention).
• Severe skin rash that may include blisters and peeling skin.

Other Side Effects

If you experience any of the following side effects, discontinue treatment with this medicine and consult your doctor:

Common: may affect up to 1 in 10 people

• Headache, dizziness.
• Nausea (feeling sick), constipation, flatulence (gas).

Uncommon: may affect up to 1 in 100 people

• Fatigue, drowsiness.
• Stomach pain, vomiting, indigestion, and heartburn, dry mouth.

Rare: may affect up to 1 in 1,000 people

• Itching and hives.
• Pupil constriction.
• Difficulty urinating.
• Inflamed stomach, burning sensation in the mouth, lips, or tongue.
• Fatigue.

Frequency Not Known (cannot be estimated from the 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.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Loperamide Aurovitas

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Loperamide Aurovitas

• The active substance is loperamide hydrochloride. Each hard capsule contains 2 mg of loperamide hydrochloride.
• The other ingredients (excipients) are:

Capsule Content:lactose monohydrate, corn starch, talc, magnesium stearate.

Capsule Shell:titanium dioxide (E171), gelatin.

Black Ink:shellac, iron oxide black (E172).

Appearance of the Product and Package Contents

Hard gelatin capsules, with a white opaque cap and body, size "4", printed with "2" on the cap and "L" on the body with black ink, filled with a white or off-white powder.

Loperamide Aurovitas hard capsules are available in PVC/Aluminum blisters.

Package Sizes:10 and 20 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Date of the Last Revision of this Leaflet:March 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)