Package Leaflet: Information for the User

Lopestop 2 mg Hard Capsules

Loperamide Hydrochloride

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

Follow exactly the instructions for taking the medicine contained in this leaflet or those given 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 2 days of treatment.

Contents of the package leaflet:

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

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

Lopestop is a medication indicated for the symptomatic treatment of acute non-specific diarrhea in adults and adolescents over 12 years old.

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

Do not take Lopestop:

• If you are allergic to hydrochloride of loperamide or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years old.
• If blood appears in the stool or high fever (above 38°C) occurs.
• If you have acute ulcerative colitis (inflammation of the intestine).
• If you have severe diarrhea (pseudomembranous colitis) after taking antibiotics.
• If you have diarrhea caused by an infection caused by organisms such as Salmonella, Shigella, or Campylobacter.

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Lopestop.

• If no improvement is observed in 48 hours, interrupt the treatment and consult your doctor.
• You must immediately discontinue treatment if sudden constipation and/or abdominal distension or ileus (absence of intestinal movements) occurs.
• Patients with AIDS who are treated with Lopestop must discontinue treatment when the first symptoms of abdominal distension or distension (megacolon) appear.
• Patients with diarrhea should drink plenty of liquids to avoid dehydration, which manifests as: dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and drowsiness. This is especially important in children and the elderly.
• The treatment of diarrhea with Lopestop is only symptomatic, the diarrhea should be treated from its cause, when possible.
• Patients with liver problems should consult their doctor before taking this medication.
• Medications that prolong intestinal transit time may induce toxic megacolon.
• Do not take this medication for use other than indicated (see section 1).
• Never take more than the indicated amount (see section 3). Severe 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 medication should not be administered to children under 12 years old without a prescription and medical supervision.

Lopestop with other medications
Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

- 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 states).

- Valerian (used to treat mild anxiety).

- Opioid analgesics (used to treat very 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 diarrhea caused by antibiotics.

Lopestop may increase the effect of medications with similar properties.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

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

Breastfeeding

Loperamide should not be used by women who are breastfeeding as small amounts of this medication may pass into breast milk.

Driving and operating machinery

If drowsiness, dizziness, or somnolence appears during treatment of diarrhea with Lopestop, it is best not to use machinery or drive vehicles.

Follow exactly the administration instructions of this medication contained in this leaflet or those 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 initial dose, followed by 1 capsule (2 mg) after each diarrheal stool. Do not take more than 8 capsules (16 mg) per day.

Older adolescents (over 12 years)

1 capsule (2 mg) as 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.

Administration form

This medication is administered orally.

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

Do not exceed the recommended dose.

If you estimate that Lopestop's action 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 to seek help. Symptoms may include: increased heart rate, irregular heartbeats, arrhythmias (these symptoms may 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 presents 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 Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Lopestop

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

Other side effects that may appear are:

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

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

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

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

In rare cases (may affect up to 1 in 1,000 patients):

• Intestinal paralysis (absence of intestinal movements or paralytic ileus).
• Abdominal distension.
• Colon dilation (megacolon).
• Loss or decrease in level of consciousness.
• Stupor (general unconsciousness).
• Exaggerated muscle tone (hypertonia).
• Abnormal coordination.
• Blisters on the skin (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis).
• Decreased urine output (urinary retention).
• Fatigue.
• Pupil constriction (miosis).
• Itching or/and skin swelling (urticaria).

Unknown frequency (cannot be estimated from available data)

Upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of acute pancreatitis.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Unused medications should not be disposed of through drains or in the trash. Dispose of the packaging of unused medications at your local pharmacy's SIGRE point or ask your pharmacist for guidance on how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lopestop

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

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

Appearance of the product and contents of the packaging

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

Each package of Lopestop contains 10 or 20 hard capsules.

Holder of the marketing authorization

Apotheke Laboratorios, S.L.

Paseo de la Castellana nº 40, 8ª

28046, Madrid (Madrid).

Spain

Phone: +34 91 669 03 45

Email: [email protected]

Responsible for manufacturing

Laboratorio GENERFARMA, S.L.

C/ Isaac Peral 6 – Technological Park

46980 Paterna – Valencia

Phone: +34 96 374 22 12

Fax: +34 96 395 19 82

Email: [email protected]

This leaflet has been approved in: May 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es