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LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES

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About the medicine

How to use LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Loperamide Aurovitas 2 mg Hard Capsules

Loperamide Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.
  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
  • You should consult a doctor if your symptoms worsen or do not improve after 2 days.

Contents of the Package Leaflet

  1. What is Loperamide Aurovitas and what is it used for
  2. What you need to know before taking Loperamide Aurovitas
  3. How to take Loperamide Aurovitas
  4. Possible side effects
  5. Storage of Loperamide Aurovitas
  6. Package Contents and Additional Information

1. What is Loperamide Aurovitas and what is it used for

This medicine contains loperamide, which helps stop diarrhea by increasing the consistency of the stool and reducing the frequency of liquid stools.

This medicine is indicated for the symptomatic treatment of acute non-specific diarrhea (occasional) in adults and children from 12 years of age.

Consider that this medicine only alleviates the symptoms of diarrhea; it is essential to drink plenty of fluids to replace the lost water during the diarrhea process.

You should consult a doctor if your symptoms worsen or do not improve after 2 days.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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:

Child's Weight

Maximum Number of Capsules per Day

From 27 kg

Maximum 4 capsules

From 34 kg

Maximum 5 capsules

From 40 kg

Maximum 6 capsules

From 47 kg

Maximum 7 capsules

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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)

Online doctors for LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

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Endocrinology – Diabetes, thyroid, metabolism:
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Gastroenterology – Digestive health:
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General internal medicine and preventive care:
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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

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Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
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  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
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During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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Sviatoslav Chekhun

Oncology 13 years exp.

Dr. Sviatoslav Chekhun is a medical oncologist with international clinical and research experience, specializing in modern medical oncology and a personalized approach to cancer treatment.

Currently (since 2025), he works as a Medical Oncologist at Institut Català d’Oncologia (Girona, Spain). Previously, he completed his residency in Medical Oncology and was involved in clinical research at Hospital Universitari Germans Trias i Pujol.

Dr. Chekhun has a strong academic and scientific background. He served as a lecturer in Internal Medicine at O.O. Bohomolets National Medical University and conducted research in experimental oncology at the R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology.

Earlier in his career, he worked as a medical oncologist at the Kyiv City Clinical Oncological Center and contributed to regulatory evaluation of medicinal products at the State Expert Center of the Ministry of Health of Ukraine.

When to consult Dr. Chekhun:

  •  for diagnosis or clarification of a cancer diagnosis
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Consultation format

Dr. Chekhun provides online consultations, where you can receive:

  •  expert second opinion 
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Important:
Prescription and monitoring of medications must be carried out by your treating physician in an in-person (offline) setting. An online consultation does not replace a face-to-face visit but helps you make more informed decisions about your treatment.

Dr. Sviatoslav Chekhun combines clinical practice, research, and international experience, enabling him to provide patients with modern, evidence-based approaches in oncology.

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Frequently Asked Questions

Is a prescription required for LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES?
LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES?
The active ingredient in LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES is loperamide. This information helps identify medicines with the same composition but different brand names.
Who manufactures LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES?
LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES is manufactured by Aurovitas Spain, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to LOPERAMIDE AUROVITAS 2 mg HARD CAPSULES?
Other medicines with the same active substance (loperamide) include ABECLIN 2 mg TABLETS, DIARFIN 2 mg HARD CAPSULES, DIARFIN FLAS 2 mg ORAL LYOPHILIZED. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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