Loperan 2 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Loperan 2 mg hard capsules
Loperamide hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Follow the instructions for use of this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
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You should consult a doctor if you worsen or do not improve after 2 days.
Contents of the leaflet
- What Loperan is and what it is used for
- What you need to know before taking Loperan
- How to take Loperan
- Possible side effects
- How to store Loperan
- Contents of the pack and other information
1. What Loperan is and what it is used for
Loperan is an antidiarrheal that reduces intestinal movements and secretions, resulting in a decrease in liquid stools.
Loperan is indicated for the symptomatic treatment of acute nonspecific diarrhea in adults and children over 12 years of age.
2. What you need to know before taking Loperan
Do not take Loperan
- If you are allergic to loperamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- If you have constipation or abdominal bloating.
- If you have severe liver problems (severe hepatic insufficiency).
- Do not administer to children under 2 years of age.
- If you notice blood in your stools or have a high fever (above 38°C).
- If you have ulcerative colitis (inflammation of the intestine).
- If you have severe diarrhea after taking antibiotics (pseudomembranous colitis).
- If your diarrhea is due to an infection caused by organisms such as Salmonella, Shigella, or Campylobacter.
Warnings and precautions
- Do not take this medicine for any use other than that indicated (see section 1), and never take more than the recommended dose (see section 3). Serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported in patients who have taken an excessive amount of loperamide, the active ingredient in Loperan.
- If you do not notice improvement within 48 hours or if you develop a fever, stop treatment and consult your doctor.
- If you have liver problems, you should consult your doctor before taking Loperan.
Patients with AIDS who are being treated with Loperan for diarrhea should discontinue treatment at the first signs of abdominal bloating or distension (megacolon).- Patients with diarrhea should drink plenty of fluids to prevent dehydration, which manifests as: dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, or lightheadedness. This is especially important in children and elderly people.
- Treatment should be stopped promptly if constipation, abdominal distension (bloating), or ileus (lack of intestinal movement) occurs.
- Treatment of diarrhea with loperamide is only symptomatic; therefore, the underlying cause of the diarrhea should be addressed.
Children and adolescents
Do not administer this medicine to children under 12 years of age without medical prescription and supervision.
Taking Loperan with other medicines
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, saquinavir (used to treat HIV).
- Quinidine (used to treat abnormal heart rhythms).
- 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 cholesterol).
- St. John’s wort (used to improve mood).
- Valerian (used to treat mild anxiety).
- Opioid analgesics (used to treat severe pain), as this may increase the risk of severe constipation and central nervous system depression (e.g., drowsiness or reduced consciousness).
- Broad-spectrum antibiotics, as Loperan may worsen or prolong antibiotic-induced diarrhea.
Loperan may enhance the effects of drugs with similar properties.
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.
Pregnancy
The safety of loperamide use during pregnancy has not been established; therefore, it is advised not to use this medicine without first consulting your doctor.
Breastfeeding
Women who are breastfeeding should not use this medicine without first consulting their doctor, as small amounts may pass into breast milk.
Fertility
There are no data available on the possible effects of Loperan on human fertility.
Driving and use of machines
Fatigue, dizziness, or drowsiness may occur during treatment of diarrhea with Loperan. If any of these effects occur, it is advisable not to operate machinery or drive vehicles.
3. How to take Loperan
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Dosage
Adults
The recommended dose for adults is:
- Initial dose: 2 capsules (4 mg), followed by 1 capsule (2 mg) after each diarrheal stool.
- The maximum dose should not exceed 8 capsules (16 mg/day).
The maximum duration of treatment is 2 days.
Use in children and adolescents
The recommended dose for children over 12 years of age is:
- Initial dose: 1 capsule (2 mg), followed by 1 capsule (2 mg) after each diarrheal stool. 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 |
The maximum duration of treatment is 2 days.
Patients with liver disease
They should consult their doctor before taking this medicine.
Method of administration:
This medicine is administered orally.
Swallow the capsules with an adequate amount of water.
If you take more Loperan than you should
If you have taken too much Loperan, contact a doctor or hospital immediately for assistance, speak to a pharmacist, or contact the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.
Symptoms may include: increased heart rate, irregular heartbeat, disturbances in cardiac rhythm (these symptoms may have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.
Children react more severely to high doses of Loperan than adults. If a child takes an excessive amount or shows any of the above symptoms, call a doctor immediately.
In case of accidental ingestion, activated charcoal should be administered as soon as possible, followed by gastric lavage if vomiting has not occurred. Naloxone may be used as an antidote.
If you forget to take Loperan
Do not take a double dose to make up for missed 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 cause adverse effects, although not everybody gets them.
Very common: at least 1 in 10 patients.
Common: at least 1 in 100 but less than 1 in 10 patients.
Uncommon: at least 1 in 1,000 but less than 1 in 100 patients.
Rare: at least 1 in 10,000 but less than 1 in 1,000 patients.
Very rare: less than 1 in 10,000 patients.
Frequency not known: cannot be estimated from the available data.
The adverse effects reported are:
Disorders of the skin and subcutaneous tissue:
Very rare: redness of the skin, itching and/or swelling of the skin (rash, urticaria and pruritus).
Frequency not known: sudden appearance of blisters on the skin (bullous reactions), which may be very serious, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Immune system disorders:
Frequency not known: severe allergic reactions (including anaphylactic shock), such as swelling of the lips, face or tongue, and breathing difficulties.
Gastrointestinal disorders:
Various gastrointestinal disturbances have been reported, which are usually difficult to differentiate from symptoms associated with diarrhoeal syndrome.
Very rare: dry mouth, abdominal pain, intestinal paralysis (lack of bowel movements), abdominal distension, dilation of the large intestine (see Warnings and precautions), nausea, vomiting, flatulence and dyspepsia (pain or discomfort in the upper middle part of the stomach).
Frequency not known: 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).
Renal and urinary disorders:
Frequency not known: urinary retention.
Psychiatric disorders:
Very rare: somnolence.
Nervous system disorders:
Very rare: loss of consciousness, decreased level of consciousness, dizziness and fatigue.
If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:
- Allergic reactions such as skin rash, swelling of the face or breathing difficulties.
- Severe abdominal pain.
- Blisters or extensive peeling of the skin.
- Loss or decrease in level of consciousness.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Conservation of Loperan
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.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Loperan
- The active substance is loperamide hydrochloride. Each capsule contains 2 mg of loperamide hydrochloride.
- The other components are: microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, titanium dioxide (E-171), gelatin, indigo carmine (E-132), and quinoline yellow (E-104).
Appearance of the product and contents of the pack
Loperan capsules are hard gelatin capsules, white and green in colour.
Loperan is available in packs containing 10 and 20 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHIESI ESPAÑA, S.A.
Plaça d’Europa, 41-43, Planta 10
08908 L’Hospitalet de Llobregat
Barcelona (Spain)
Manufacturer
LABORATORIOS ALCALA FARMA S.L.U.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)
Date of the most recent revision of this leaflet: March 2022.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/