ABECLIN 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Abeclin 2 mg Tablets EFG

Loperamide Hydrochloride

Read this package 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 package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the Package Leaflet

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

1. What is Abeclin 2 mg and what is it used for

It is an antidiarrheal medication that reduces intestinal movements and secretions, resulting in a decrease in liquid stools.

It is indicated for the symptomatic treatment of acute nonspecific diarrhea (occasional) in adults and children over 12 years old.

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

2. What you need to know before taking Abeclin 2 mg

Do not takeAbeclin 2 mgif:

• Children under 12 years old.
• If you are allergic (hypersensitive) to loperamide hydrochloride or any of the other components of this medicine (listed in section 6).
• If you have a high fever (above 38°C) or blood in your stool.
• If you suffer from ulcerative colitis (inflammation of the intestine).
• If you have severe diarrhea after taking antibiotics.
• If you have diarrhea caused by an infection caused by organisms such as Salmonella, Shigella, and Campylobacter.
• Treatment should be suspended immediately and a doctor consulted if constipation, abdominal distension (bloating), or ileus (absence of intestinal movements) occurs.

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 usual, and you will need to replenish fluids by drinking more than usual. Ask your pharmacist about preparations to replenish sugars and salts.
• Treatment with this medicine is only symptomatic, so the diarrhea should be treated based on its cause.
• If you have AIDS and your stomach swells, 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 any narcotic analgesic, consult your doctor or pharmacist before taking this medicine, as it may interact with them.

Do not take this medicine for a use other than indicated (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (whose symptoms include rapid or irregular heartbeats) have been reported in patients who have taken an excessive amount of loperamide.

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

Patients 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 old.

TakingAbeclin 2 mgwith Other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use another medicine.

• It is considered especially important if you are taking medicines that contain:
• Ritonavir, saquinavir (used to treat HIV).
• Quinidine (used to treat abnormal heart rhythms).
• 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 cholesterol).
• St. John's Wort (used to improve mood).
• Valerian (used to treat mild anxiety).
• Opioid analgesics (used to treat 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 this medicine may worsen or prolong antibiotic-induced diarrhea and increase loperamide levels in the blood.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 no experience with its use in pregnant women.

Do not take this medicine if you are breastfeeding. Small amounts of the medicine may pass into breast milk.

Driving and Using Machines

You can drive and use tools and machines unless you feel drowsy, dizzy, or sleepy. Do not drive or use machines in those situations.

Abeclin 2 mgcontains Lactose

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

3. How to Take Abeclin 2 mg

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of 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 dose for adults is 8 tablets (16 mg) per day.

Children over 12 years old:

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:

Take the tablets with a full glass of water.

Patient 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 old.

Use in Children and Adolescents

Children under 12 years old should not take this medicine. It is contraindicated.

If you take moreAbeclin 2 mgthan you should

Taking too many tablets can 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, Telephone 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to takeAbeclin 2 mg

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very Rare Adverse Reactions(may affect up to 1 in 10,000 people):

• Swelling of the face, lips, tongue, or throat that can cause difficulty swallowing or breathing (angioedema)
• Allergic reactions (including anaphylactic shock)
• Fatigue
• Decreased urine output
• Loss or decrease of consciousness
• Abnormal coordination
• Increased muscle tension (hypertonia)
• Stupor
• Pupil constriction (miosis)
• Loss of intestinal mobility (ileus, including paralytic ileus)
• Itching or hives
• Drowsiness
• Abnormal dilation of the colon (megacolon)
• Bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme)

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 pancreatitis (acute pancreatitis).

Reporting of Side Effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.notificaram.es. By reporting side 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 special storage conditions.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE Point of your pharmacy. In case of doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofAbeclin 2 mg

The active ingredient is: loperamide hydrochloride (2 mg per tablet).

The other ingredients (excipients) are: anhydrous lactose, cornstarch, polysorbate 80, talc (E-553 B), colloidal silica (E-551), and magnesium stearate (E-572).

Appearance of the Product and Package Contents

The tablets are white, round, biconvex, and engraved with "C" on one face and "11" on the other.

Each package contains 10 or 20 tablets housed in blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

UXA FARMA S.A.

Avda. San Francisco Javier 24

41018 Sevilla

Spain

info@uxafarma.com

Manufacturer:

Netpharmalab Consulting Services S.L.

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

Date of the Last Revision of this Package Leaflet:September 2022

Updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es