Loperamide Aurovitas 2 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Loperamida Aurovitas 2 mg hard capsules

Loperamide hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Follow exactly the instructions for taking this medicine as described in this leaflet or as advised by your doctor or pharmacist.
• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve within 2 days.

Contents of the leaflet

1. What Loperamida Aurovitas is and what it is used for
2. What you need to know before taking Loperamida Aurovitas
3. How to take Loperamida Aurovitas
4. Possible side effects
5. How to store Loperamida Aurovitas
6. Contents of the pack and other information

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

This medicine contains loperamide, which helps stop diarrhoea by increasing the consistency of stools and reducing the frequency of liquid bowel movements.

This medicine is indicated for the symptomatic treatment of acute nonspecific (occasional) diarrhoea in adults and children aged 12 years and older.

Please note that this medicine only relieves the symptoms of diarrhoea. It is important that you drink plenty of fluids to replace the loss of water caused during the diarrhoeal episode.

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

2. What you need to know before taking Loperamide Aurovitas

Do not take Loperamide Aurovitas:

• In children under 12 years of age.

• If you are allergic to loperamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

• If you have acute dysentery, characterized by blood in the stool and high fever (above 38°C).

• If you have acute ulcerative colitis (inflammation of the intestine).

• If you have severe diarrhoea following antibiotic treatment (pseudomembranous colitis).

• If your diarrhoea is due to an infection caused by organisms such as Salmonella, Shigella, and Campylobacter.

• Treatment should be stopped immediately and you should consult your doctor if constipation, abdominal distension (bloating), or ileus (lack of intestinal movements) occurs.

Warnings and precautions

Talk to your doctor or pharmacist before taking Loperamide Aurovitas:

• If you have AIDS and your stomach becomes inflamed. Stop taking the capsules immediately and contact your doctor.
• If you have any liver disease, consult your doctor before taking this medicine, as central nervous system toxicity may occur.
• If you have severe diarrhoea, your body loses more fluids, sugars, and salts than normal. You will need to replace fluids by drinking more than usual. Ask your pharmacist about rehydration preparations to replace sugars and salts.
• If intestinal obstruction develops, stop treatment and consult your doctor.
• Treatment with this medicine is only symptomatic, so diarrhoea should also be treated by addressing its underlying cause.
• If you are taking narcotic-type painkillers, 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 dose (see section 3). Serious cases of cardiac disturbances (symptoms including rapid or irregular heartbeat) have been reported in patients who have taken excessive amounts of loperamide.

If there is no improvement within 48 hours, or if fever, constipation, or other symptoms develop, stop treatment and consult your doctor.

Patients with diarrhoea should drink plenty of fluids to prevent dehydration, which may manifest as dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, or 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

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

In particular, inform your doctor 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 severe pain), as they may increase the risk of severe constipation and central nervous system depression (e.g. drowsiness or reduced consciousness).
• Broad-spectrum antibiotics, as loperamide may worsen or prolong antibiotic-associated diarrhoea and increase loperamide blood levels.

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

Taking Loperamide Aurovitas with food and drink

You may take this medicine with food and drink.

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

This medicine may cause dizziness, tiredness, or drowsiness. It may also cause loss of consciousness, dizziness, or reduced alertness. You are advised not to operate machinery or drive vehicles if affected.

Loperamide Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Loperamide Aurovitas

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults

2 capsules (4 mg) as the initial dose, followed by 1 capsule (2 mg) after each diarrheal stool.

The maximum daily dose for adults is 8 capsules (16 mg).

Children over 12 years of age

1 capsule (2 mg) as the 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.

Patients with liver disease: They should consult their doctor.

Elderly and patients with kidney disease

Follow the same instructions described for adults and children over 12 years of age.

Use in children and adolescents

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

If you take more Loperamida Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.

Symptoms may include: rapid heartbeat, irregular heartbeat, changes in heartbeat rhythm (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 Loperamida Aurovitas

This medicine should only be taken as needed, carefully following the administration instructions. If you forget to take a dose, take a dose after the next loose bowel movement. 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 adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Serious adverse effects

Seek immediate medical attention

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

• Allergic reactions including wheezing, difficulty breathing, swelling of the face and throat.
• Loss of consciousness or reduced level of consciousness (feeling faint or decreased alertness).
• Skin rash that may be severe and include blisters and peeling of the skin.

Other adverse effects

If you experience any of the following adverse effects, stop 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

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

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

• Itching and hives.
• Constriction of the pupils.
• Difficulty urinating.
• Swollen stomach, burning sensation in the mouth, lips or tongue.
• Tiredness.

Frequency not known (cannot be estimated from available data)

• Upper abdominal pain, abdominal pain radiating to the back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse 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 packaging 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 drains or household waste. Return any unused medicines and their containers to your pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loperamide Aurovitas

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

Capsule contents: lactose monohydrate, maize starch, talc, magnesium stearate.

Capsule shell: titanium dioxide (E171), gelatin.

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

Appearance of the product and contents of the container

Hard gelatin capsules with white opaque cap and body, size “4”, printed with “2” on the cap and “L” on the body in black ink, filled with white or almost white powder.

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

Pack sizes: 10 and 20 hard capsules.

Only certain 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 most recent revision of this leaflet: March 2023

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