Lopestop 2 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lopestop 2 mg hard capsules

Loperamide hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for use of this medicine as contained in this leaflet or those provided by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 2 days of treatment.

Package leaflet contents:

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

1. What Lopestop is and what it is used for

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

Lopestop is a medicine indicated for the symptomatic treatment of acute nonspecific diarrhea in adults and adolescents over 12 years of age.

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

2. What you need to know before taking Lopestop

Do not take Lopestop:

• If you are allergic to loperamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• 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 acute ulcerative colitis (inflammation of the intestine).
• If you have severe diarrhea (pseudomembranous colitis) following antibiotic treatment.
• If your diarrhea is due to an infection caused by organisms such as Salmonella, Shigella, or Campylobacter.

Do not take Lopestop if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before taking Lopestop.

Warnings and precautions:

Consult your doctor or pharmacist before starting treatment with Lopestop.

• If there is no improvement within 48 hours, stop the treatment and consult your doctor.
• You must stop treatment immediately if sudden constipation and/or abdominal distension (swelling) or ileus (absence of intestinal movements) occurs.
• Patients with AIDS who are treated with Lopestop must discontinue treatment at the first signs of abdominal swelling or distension (toxic megacolon).
• Patients with diarrhea should drink plenty of fluids to prevent dehydration, which may manifest as dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and lightheadedness. This is especially important in children and the elderly.
• Treatment of diarrhea with Lopestop is only symptomatic; diarrhea should be treated based on its underlying cause whenever possible.
• Patients with liver problems should consult their doctor before taking this medicine.
• Medications that prolong intestinal transit time may induce dilation of the large intestine (toxic megacolon).
• Do not take this medicine for any use other than that specified (see section 1).
• 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 substance in Lopestop.

Children and adolescents

This medicine must not be administered to children under 12 years of age without medical prescription and supervision.

Taking Lopestop 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 or pharmacist if you are taking any of the following medicines:

• Ritonavir, saquinavir (used to treat HIV).
• Oral desmopressin (used to treat central diabetes insipidus and nocturnal enuresis in children).
• Itraconazole (used to treat fungal infections).
• Ketoconazole (used to treat Cushing's syndrome).
• 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 Lopestop may increase the risk of severe constipation and central nervous system depression (e.g., drowsiness or decreased consciousness).
• Broad-spectrum antibiotics, as Lopestop may worsen or prolong antibiotic-associated diarrhea.

Lopestop may enhance the effect of medicines with similar properties.

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.

Pregnancy

The safety of using this medicine during pregnancy has not been established; therefore, pregnant women should not take this medicine unless prescribed by a doctor.

Breastfeeding

Loperamide is not recommended for women who are breastfeeding, as small amounts of this medicine may pass into breast milk.

Driving and use of machinery

If fatigue, dizziness, or drowsiness occur during treatment for diarrhea with Lopestop, it is advisable to avoid operating machinery or driving vehicles.

3. How to take Lopestop

Follow exactly the administration instructions for this medicine 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 an initial dose, followed by 1 capsule (2 mg) after each diarrheal stool. Do not take more than 8 capsules (16 mg) per day.

Adolescents over 12 years of age

1 capsule (2 mg) as an initial dose, followed by 1 capsule (2 mg) after each diarrheal stool. In children, the maximum daily dose should be related to body weight:

Patients with liver disease

They should consult their doctor before taking this medication.

Method of administration

This medicine is administered orally.

The capsules should be taken with a full glass of water.

Do not exceed the recommended dose.

If you feel that the effect of Lopestop is too strong or too weak, inform your doctor or pharmacist.

If you take more Lopestop than you should

If you have taken too much Lopestop, contact a doctor or hospital as soon as possible for assistance. Symptoms may include: increased heart rate, irregular heartbeat, disturbances in cardiac rhythm (these symptoms may have potentially serious and life-threatening consequences), muscle rigidity, uncoordinated movements, drowsiness, difficulty urinating, weak breathing, pupil constriction (miosis), dry mouth, abdominal discomfort, nausea, vomiting, and constipation.

Children react more severely to high doses of Lopestop than adults. If a child takes an excessive amount or shows any of the above symptoms, call a doctor immediately.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Lopestop

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.

If you experience any of the following adverse effects, stop treatment and consult your doctor immediately:

• Allergic reactions such as skin rash, swelling of the face, tongue or throat, which may cause difficulty swallowing or breathing (angioedema).
• Severe allergic reactions including anaphylactic shock.
• Severe abdominal pain.
• Blisters or extensive peeling of the skin.
• Loss of or decreased level of consciousness.

Other adverse effects that may occur are:

Frequent adverse reactions (may affect up to 1 in 10 patients):

• Headache (cephalalgia).
• Dizziness.
• Constipation.
• Nausea.
• Gas (flatulence).

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Vomiting.
• Pain or discomfort in the upper middle part of the stomach (dyspepsia).
• Dry mouth.
• Abdominal pain or discomfort.
• Skin rash (exanthema).
• Drowsiness.

Rarely (may affect up to 1 in 1,000 patients):

• Intestinal paralysis (lack of intestinal movements or paralytic ileus).
• Abdominal swelling (distension).
• Dilation of the large intestine (megacolon).
• Loss of or decreased level of consciousness.
• Stupor (generalized unconsciousness).
• Exaggerated muscle tone (hypertonia).
• Abnormal coordination.
• Skin blisters (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis).
• Decreased urine output (urinary retention).
• Fatigue.
• Contraction of the pupils (miosis).
• Itching (pruritus) and/or swelling of the skin (urticaria).

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 can 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 Lopestop

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

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 or household waste. Dispose of unused medicine containers at the SIGRE collection point at your usual pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Lopestop

The active substance in Lopestop is: loperamide hydrochloride. Each capsule contains 2 mg of loperamide hydrochloride.

The other components (excipients) are: microcrystalline cellulose, talc (E-553b) and magnesium stearate (E-572). The components of the capsule shell are: gelatin, titanium dioxide (E-171) and red iron oxide (E-172).

Appearance of the product and contents of the pack

Lopestop is available as hard gelatin capsules with a red cap and a white body.

Each Lopestop pack contains 10 or 20 hard capsules.

Marketing Authorization Holder

Apotheke Laboratorios, S.L.

Paseo de la Castellana nº 40, 8th floor

28046, Madrid (Madrid)

Spain

Telephone: +34 91 669 03 45

Email: [email protected]

Manufacturer

Laboratorio GENERFARMA, S.L.

C/ Isaac Peral 6 – Parque tecnológico

46980 Paterna – Valencia

Telephone: +34 96 374 22 12

Fax: +34 96 395 19 82

Email: [email protected]

This leaflet was last approved in: May 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es