Abeclin 2 mg tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Abeclin 2 mg tablets EFG
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 use provided in this leaflet or those indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.
- You must consult a doctor if your condition worsens or if you do not improve after 2 days.
Contents of the leaflet
- What Abeclin 2 mg is and what it is used for
- What you need to know before taking Abeclin 2 mg
- How to take Abeclin 2 mg
- Possible side effects
- How to store Abeclin 2 mg
- Contents of the pack and other information
1. What Abeclin 2 mg is and what it is used for
It is an antidiarrheal medicine that reduces intestinal movements and secretions, resulting in a decrease in liquid stools.
It is indicated for the symptomatic treatment of acute nonspecific (occasional) diarrhoea in adults and children aged 12 years and above.
You should consult a doctor if your condition worsens or does not improve after 2 days.
2. What you need to know before taking Abeclin 2 mg
Do not take Abeclin 2 mg:
- In children under 12 years of age.
- If you are allergic (hypersensitive) to loperamide hydrochloride or to any of the other components of this medicine (listed in section 6).
- If you have high fever (above 38°C) or blood in your stools.
- If you have ulcerative colitis (inflammation of the intestine).
- If you have severe diarrhea following antibiotic use.
- If your diarrhea is due to an infection caused by organisms such as Salmonella, Shigella, and Campylobacter.
- Treatment must be stopped immediately and a doctor consulted if constipation, abdominal distension (bloating), or ileus (absence of intestinal movements) occur.
Warnings and precautions
- Consult your doctor or pharmacist before starting to take this medicine.
- If you have severe diarrhea, 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 restore sugars and salts.
- Treatment with this medicine is only symptomatic; therefore, the underlying cause of the diarrhea should also be treated.
- If you have AIDS and your stomach becomes swollen, stop taking this medicine immediately and consult your doctor.
- If you have liver disease, consult your doctor before taking this medicine, as it may cause toxicity in the central nervous system.
- If you are taking narcotic-type painkillers, consult your doctor or pharmacist before taking this medicine, as it may interact with them.
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 (symptoms include 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 appear, stop treatment and consult your doctor.
Patients with diarrhea should drink plenty of fluids to prevent dehydration, which may manifest as dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, or lightheadedness. This is especially important in children and elderly people.
Children and adolescents: Do not use in children and adolescents under 12 years of age.
Taking Abeclin 2 mg with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
- It is considered especially important if you are taking medicines containing:
- 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 this medicine may worsen or prolong antibiotic-associated diarrhea and increase blood levels of loperamide.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnant women should not take this medicine unless prescribed by a doctor, as there is limited experience with its use during pregnancy.
Do not take this medicine while breastfeeding. Small amounts of the medicine may pass into breast milk.
Driving and using machines
You may drive and operate tools or machinery unless you experience tiredness, dizziness, or drowsiness. Do not drive or operate machinery if these symptoms occur.
Abeclin 2 mg contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Abeclin 2 mg
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 again.
The recommended dose is:
Adults:
2 tablets (4 mg) as an initial dose, followed by 1 tablet (2 mg) after each diarrheal stool. The maximum daily dose for adults is 8 tablets (16 mg).
Children over 12 years:
1 tablet (2 mg) as an initial dose, followed by 1 tablet (2 mg) after each diarrheal stool. In children, the maximum daily dose should be related to body weight:
Child's weight | Maximum number of tablets per day |
From 27 kg | Maximum 4 tablets |
From 34 kg | Maximum 5 tablets |
From 40 kg | Maximum 6 tablets |
From 47 kg | Maximum 7 tablets |
Take the tablets with a full glass of water.
Patients with liver disease:
They should consult their doctor before taking this medicine.
Elderly patients and patients with renal disease:
Follow the same instructions described for adults and children over 12 years of age.
Use in children and adolescents
This medicine must not be given to children under 12 years of age. It is contraindicated.
If you take more Abeclin 2 mg than you should
Taking too many tablets may cause abnormal coordination, stupor, pupil constriction, increased muscle tension, difficulty breathing (children are more sensitive to these effects than adults), and reduced urine output.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to take Abeclin 2 mg
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 can cause adverse effects, although not everyone experiences them.
Very rare adverse reactions (may affect up to 1 in 10,000 people):
- Swelling of the face, lips, tongue, or throat which may cause difficulty swallowing or breathing (angioedema)
- Allergic reactions (including anaphylactic shock)
- Fatigue
- Decreased amount of urine
- Loss or reduction of consciousness
- Abnormal coordination
- Increased muscle tension (hypertonia)
- Stupor
- Constriction of the pupil (miosis)
- Loss of intestinal motility (ileus, including paralytic ileus)
- Itching or urticaria
- Somnolence
- Abnormal dilation of the colon (megacolon)
- Bullous rash (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme)
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 it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Abeclin 2 mg
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Abeclin 2 mg
The active substance is: loperamide hydrochloride (2 mg per tablet).
The other components (excipients) are: anhydrous lactose, corn starch, polysorbate 80, talc (E-553 B), colloidal silica (E-551), and magnesium stearate (E-572).
Appearance of the product and contents of the pack
The tablets are white, round, biconvex, and marked with “C” on one side and “11” on the other.
Each pack contains 10 or 20 tablets in a blister.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
UXA FARMA S.A.
Avda. San Francisco Javier 24
41018 Seville
Spain
Manufacturer:
Netpharmalab Consulting Services S.L.
Carretera de Fuencarral 22
28108 Alcobendas, Madrid
Spain
Date of the most recent review of this leaflet: September 2022
Up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es