Package Insert: Information for the User

Loperamida Aurovitas 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 have any questions, consult your doctor or pharmacist.
• If you experience any adverse 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 symptoms worsen or do not improve after 2 days.

This medication contains loperamida, which helps to stop diarrhea by increasing the consistency of stools and decreasing the frequency of liquid stools.

This medication is indicated for the symptomatic treatment of acute nonspecific diarrhea (occasional) in adults and children 12 years of age and older.

Please note that this medication only alleviates diarrhea symptoms, it is essential to drink plenty of liquid to replace the water loss generated during the diarrheal process.

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

Do not take Loperamida Aurovitas:

• Do not use in children under 12 years old.

• If you are allergic to hydrochloride of loperamide or to any of the other components of this medication (listed in section 6).
• If you have acute diarrhea, characterized by the presence of blood in stools and high fever (above 38°C).
• If you have acute 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 an organism such as Salmonella, Shigella, and Campylobacter.
• Stop treatment immediately and consult your doctor if you experience constipation, abdominal distension (swelling) or ileus (absence of intestinal movements).

Warnings and precautions

Consult your doctor or pharmacist before taking Loperamida 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 medication, as it may cause central nervous system toxicity.
• If you have severe diarrhea, your body loses more fluids, sugars, and salts than normal, you will need to replenish them by drinking more than usual. Ask your pharmacist about preparations to replenish sugars and salts.
• If you develop intestinal obstruction, interrupt treatment and consult your doctor.
• The treatment with this medication is only symptomatic, so diarrhea should be treated from its cause.
• If you are taking a narcotic analgesic, consult your doctor or pharmacist before taking this medication, as it may interact with them.

Do not use this medication for any other indication (see section 1) and never take more than the recommended amount (see section 3). Severe cardiac arrhythmias (symptoms that include rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide.

If you do not see improvement in 48 hours or if you experience fever, constipation, or other symptoms, interrupt treatment and consult your doctor.

Patients with diarrhea should drink plenty of liquids to avoid dehydration, which manifests as 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 old.

Other medications and Loperamida Aurovitas

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

Particularly, inform them if you are taking any of the following medications:

• Ritonavir (used to treat HIV).
• Quinidine (used to treat abnormal heart rhythms or malaria).
• 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 blood 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 loperamide may worsen or prolong diarrhea caused by antibiotics, and increase loperamide levels in the blood.

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

Taking Loperamida Aurovitas with food and drinks

You can take this medication with food and drinks.

Pregnancy, breastfeeding, and fertility

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

Women who are breastfeeding should not use this medication as small amounts of it may pass into breast milk. Consult your doctor about the most suitable treatment.

Driving and operating machines

This medication may make you feel dizzy, tired, or drowsy. You may also lose consciousness, feel dizzy, or decrease your alertness. It is recommended not to use machinery or drive vehicles if you are affected.

Loperamida Aurovitas contains lactose

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 the 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 old

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 the body weight:

Take the capsules with a full glass of water.

Patients with liver disease:Should consult a doctor.

Advanced age and patients with renal disease

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

Use in children and adolescents

Children under 12 years old cannot take this medication.

If you take more Loperamida Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

The symptoms may include: rapid heart rate, irregular heartbeat, changes in your heartbeat (these symptoms may have potentially serious consequences or put your life at risk), 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 forgot to take Loperamida Aurovitas

Only take this medication as required, following the administration instructions carefully. If you forget to take a dose, take a dose after the next liquid stool. 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.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Severe side effects

Seek immediate medical assistance

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 of dizziness or decreased attention).
• Skin rash that may be severe and include blisters and skin peeling.

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 que you are going to be 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 urticaria.
• Pupil constriction.
• Difficulty urinating.
• Stomach inflammation, sensation of burning in the mouth, lips, or tongue.
• Tiredness.

Frequency not known (cannot be estimated from available data)

• Upper abdominal pain, upper abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of acute pancreatitis.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for 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.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofLoperamida Aurovitas

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

Content of the capsule:monohydrate lactose, cornstarch, talc, magnesium stearate.

Capsule coating:titanium dioxide (E171), gelatin.

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

Appearance of the product and content of the container

Hard gelatin capsules, with a cap and a body of white opaque color, size “4”, engraved with “2” on the cap and “L” on the body with black ink, and filled with a white or off-white powder.

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

Container sizes:10 and 20 hard capsules.

Only some container sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Last review date of this leaflet:March 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)