LOPESTOP 2 mg HARD CAPSULES

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 administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, 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 leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days of treatment.

Contents of the Package Leaflet:

1. What is Lopestop and what is it 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 further information

1. What is Lopestop and what is it 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 it 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 any of the other components of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.
• If blood appears in the stool or high fever (above 38°C).
• If you have acute ulcerative colitis (inflammation of the intestine).
• If you suffer from severe diarrhea (pseudomembranous colitis) after taking antibiotics.
• If you have diarrhea due to an infection caused by organisms such as Salmonella, Shigellaor Campylobacter.

Do not take Lopestop if you are in any of the situations described above. If you are not sure, consult your doctor or pharmacist before taking Lopestop.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Lopestop.

• If there is no improvement within 48 hours, discontinue treatment and consult your doctor.
• You must discontinue treatment immediately if sudden constipation and/or abdominal distension or ileus (absence of intestinal movements) occurs.
• Patients with AIDS being treated with Lopestop should discontinue treatment when the first symptoms of abdominal distension appear.
• 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.
• Treatment of diarrhea with Lopestop is only symptomatic, diarrhea should be treated from its cause, when possible.
• Patients with liver problems should consult their doctor before taking this medicine.
• Medicines that prolong intestinal transit time may induce dilation of the large intestine (toxic megacolon).
• Do not take this medicine for a use other than indicated (see section 1).
• Never take more than the indicated 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, the active ingredient of Lopestop.

Children and Adolescents

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

Taking Lopestop with other medicinesInform your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• 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 (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 intense 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-induced diarrhea.

Lopestop may increase the effect of medicines with similar properties.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

The use of loperamide is not recommended in breastfeeding women as small amounts of this medicine may pass into breast milk.

Driving and Using Machines

If you experience drowsiness, dizziness, or somnolence during treatment with Lopestop, it is recommended not to use machinery or drive vehicles.

3. How to Take Lopestop

Follow exactly the administration instructions of this medicine contained in this leaflet or as 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 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:

Patient with liver disease

They should consult their doctor before taking this medicine.

Method of administration

This medicine is administered orally.

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

Do not exceed the recommended dose.

If you think the action of Lopestop is too strong or too weak, tell your doctor or pharmacist.

If you take more Lopestop than you should

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

Children react more severely to high amounts 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 medicine and the amount taken.

If you forget to take Lopestop

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

If you have any further questions on 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.

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

• Allergic reactions such as skin rash, swelling of the face, tongue, or throat that can cause difficulty swallowing or breathing (angioedema).
• Severe allergic reactions including anaphylactic shock.
• Severe abdominal pain.
• Blistering or significant skin peeling.
• Loss or decrease in level of consciousness.

Other side effects that may occur are:

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

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

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

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

Rare side effects (may affect up to 1 in 1,000 patients):

• Intestinal paralysis (absence of intestinal movements or paralytic ileus).
• Abdominal distension.
• Dilation of the large intestine (megacolon).
• Loss or decrease in level of consciousness.
• Stupor (general unconsciousness).
• Muscle hypertonia.
• Abnormal coordination.
• Blistering skin (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis).
• Decreased urine output (urinary retention).
• Fatigue.
• Pupil constriction (miosis).
• Itching (pruritus) or skin swelling (urticaria).

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 effects, 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is 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 the packaging of medicines you no longer need in the SIGRE collection point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Lopestop

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

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

Appearance of the Product and Contents of the Pack

Lopestop is presented in the form of hard gelatin capsules with a red cap and white body.

Each pack of Lopestop contains 10 or 20 hard capsules

Marketing Authorization Holder

Apotheke Laboratorios, S.L.

Paseo de la Castellana nº 40, 8ª

28046, Madrid (Madrid).

Spain

Phone: +34 91 669 03 45

Email: direcciontecnica@apothekelabs.com

Manufacturer

Laboratorio GENERFARMA, S.L.

C/ Isaac Peral 6 – Parque tecnológico

46980 Paterna – Valencia

Phone: +34 96 374 22 12

Fax: +34 96 395 19 82

Email: generfarma@generfarma.com

This leaflet was approved in: May 2022

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