Patient Information Leaflet

Loperamide Hydrochloride 2 mg Tablets

Loperamide Hydrochloride

Read this leaflet carefully before you start taking this medicine. 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.

1. What is Loperamide Hydrochloride and what is it used for

2. What you need to know before taking Loperamide Hydrochloride

3. How to take Loperamide Hydrochloride

4. Possible side effects

5. Storage of Loperamide Hydrochloride

6. Contents of the pack and additional information

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

Salvacolina is used for the symptomatic treatment of acute unspecified diarrhea in adults and children over 12 years old.

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

Do not take Salvacolina

• If you are allergic to loperamide hydrochloride or any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years old.
• If there is blood in your stool or you have a high fever (above 38°C).
• If you have been diagnosed with acute ulcerative colitis (inflammation of the intestine).
• If you suffer from severe diarrhea (pseudomembranous colitis) after taking antibiotics.
• If you suffer from diarrhea caused by an infection caused by organisms such asSalmonella,ShigellaorCampylobacter.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Salvacolina.
• If you do not see improvement in 48 hours or fever, constipation or other symptoms such as abdominal swelling or paralytic ileus (absence of intestinal movements) interrupt treatment and consult your doctor.
• If you suffer from severe diarrhea your body loses more fluids, sugars and salts than normal, so you will need to replenish fluids by drinking more than usual. Dehydration manifests as dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness and drowsiness. It is very important to prevent dehydration in children and the elderly.
• Patients with AIDS should discontinue treatment when the first symptoms of abdominal swelling appear.
• If you have liver or kidney disease or blood disorders consult your doctor before taking this medication.
• Since the treatment of diarrhea with Salvacolina is only symptomatic, diarrhea should be treated from its cause, when possible.
• Do not take this medication for a use other than indicated (see section 1) and never take more than the recommended 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 Salvacolina.

Children and adolescents

Do not use in children under 12 years old without consulting a doctor.

Use of Salvacolina with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need 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 arrhythmias).
• Desmopressin (used to treat central diabetes insipidus and nocturnal urinary incontinence in children).
• Itraconazole or ketoconazole (used to treat fungal infections).
• Gemfibrozil (used to reduce cholesterol).
• St. John's Wort (used to improve mood and treat mild depressions).
• Valerian (used to treat mild states of nervousness and anxiety).
• Opioid analgesics (used to treat very intense pain) may increase the risk of severe constipation and central nervous system depression (e.g. drowsiness or decreased consciousness).
• Broad-spectrum antibiotics as it may worsen diarrhea caused by antibiotics.

Salvacolina may potentiate the action of similar drugs.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using 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.

Lactation

Women who are breastfeeding should not use this medication without consulting their doctor as small amounts of it may pass into breast milk.

Driving and operating machinery

You may experience fatigue, dizziness or drowsiness during treatment of diarrhea with Salvacolina, so it is recommended not to use machinery or drive vehicles.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults:

2 tablets (4 mg of loperamide hydrochloride) as the initial dose, followed by 1 tablet (2 mg of loperamide hydrochloride) after each diarrheal bowel movement. Do not take more than 8 tablets (16 mg of loperamide hydrochloride) per day.

Children over 12 years old::

1 tablet (2 mg of loperamide hydrochloride) as the initial dose, followed by 1 tablet (2 mg of loperamide hydrochloride) after each diarrheal bowel movement. In children, the maximum daily dose should be related to the child's body weight:

Patients with liver disease:

They should consult their doctor before taking this medication.

This medication is taken orally.

Take the Salvacolina tablets with a full glass of water.

If you take more Salvacolina than you should

If you have taken too much Salvacolina, contact a doctor or hospital as soon as possible to seek help. Symptoms may include: increased heart rate, irregular heartbeats, heart rhythm disturbances (these symptoms may have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Salvacolina

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

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

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

If you experience any of the following side effects, discontinue treatment and consult your doctor: hypersensitivity reactions (redness, itching, or swelling of the skin, difficulty swallowing or breathing), blisters or significant skin peeling, intestinal paralysis (absence of bowel movements or paralytic ileus), abdominal distension, severe abdominal pain, megacolon (dilation of the large intestine), and loss or decrease in level of consciousness.

Commonly(may affect up to 1 in 10 patients) may appear: constipation, nausea, gas (flatulence), headache (cephalalgia), and dizziness.

Occasionally(may affect up to 1 in 100 patients) may appear: vomiting, pain or unpleasant sensation in the upper-middle part of the stomach (dyspepsia), dry mouth, abdominal pain or discomfort, drowsiness, and skin discoloration (exanthema).

Rarely(may affect up to 1 in 1000 patients) may appear: intestinal paralysis (absence of bowel movements or paralytic ileus), abdominal distension, megacolon (dilation of the large intestine), loss or decrease in level of consciousness, stupor (general unconsciousness), excessive muscle tone (hypertonia), abnormal coordination, skin blisters (bullous eruptions, including Stevens-Johnson syndrome, multiform erythema, and toxic epidermal necrolysis), skin alteration that produces lesions and intense itching (urticaria), itching (pruritus), severe allergic reactions such as swelling of the lips, face, throat, or tongue that can cause difficulty swallowing or breathing (angioedema) including anaphylactic shock, decreased urine output (urinary retention), pupil constriction (miosis), and fatigue.

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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use http://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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at your pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Salvacolina

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

The other components are: mannitol (E-421), talc (E-553b), magnesium stearate (E-572), microcrystalline cellulose (E-460i), croscarmellose A, colloidal silica (E-551), yellow iron oxide (E-172).

Appearance of the product and content of the packaging

The tablets are yellowish in color, round, flat, with a diametral groove.

The groove serves to fraction and facilitate swallowing, but not to divide into equal doses.

Each package contains 12 or 20 tablets housed in a blister.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios SALVAT, S.A.

Gall, 30-36

08950 Esplugues de Llobregat (Barcelona) SPAIN

Date of the last review of this leaflet:March 2022

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