Package Insert: Information for thePatient

Salvacolina 0.2 mg/ml Oral Solution

Loperamide Hydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert.See section 4.
• You should consult a doctor if your condition worsens or does not improve after 2 days.

1. What is Salvacolina and what is it used for

2. What you need to know before starting to take Salvacolina

3. How to take Salvacolina

4. Possible adverse effects

5. Storage of Salvacolina

6. Contents of the package 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.s.

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 presence of blood in stool or if you have 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 no improvement is observed in 48 hours or if fever, constipation, or other symptoms such as abdominal distension or paralytic ileus (absence of intestinal movements) appear, 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 the 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 distension 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, the diarrhea should be treated from its cause, when possible.
• Do not take this medication for a use other than the 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 heart rhythm disorders).
• 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 they may worsen diarrhea caused by antibiotics.

Salvacolina may potentiate the action of similar drugs.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be 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 operate machinery or drive vehicles.

Salvacolina contains polyoxylglycerides ricinus oil, glycerol, red ponceau (E-124) colorant, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and sodium.

This medication may cause stomach discomfort and diarrhea because it contains polyoxylglycerides ricinus oil.

This medication may cause allergic reactions because it contains red ponceau (E-124) colorant. It may provoke asthma especially in patients allergic to acetylsalicylic acid.

This medication may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

Patients with low-sodium diets should note that this medication contains 5 mg (0.24 mmol) of sodium per ml.

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

20 ml of oral solution (4 mg of loperamide hydrochloride) as the initial dose, followed by 10 ml of oral solution (2 mg of loperamide hydrochloride) after each diarrheal stool up to a maximum of 80 ml of oral solution per day (16 mg of loperamide hydrochloride).

Children over 12 years old

10 ml of oral solution (2 mg of loperamide hydrochloride) as the initial dose, followed by 10 ml of oral solution (2 mg of loperamide hydrochloride) 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.

This medication is taken orally

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, stop 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, 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, 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 in the lips, face, throat, or tongue that may 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 leaflet. 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Composition of Salvacolina

The active principle is: loperamide hydrochloride 0.2 mg/ml.

The other components are: Sodium saccharin (E954ii), Sodium cyclamate (E952ii), Polyoxylated ricin oil, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Propylene glycol (E1520), Glycerol (E422), Citric acid (E330), Sodium hydroxide (E524), Disodium edetate, Strawberry flavor, Red 4R (E-124) and Purified water.

Appearance of the product and contents of the packaging

Clear oral solution of red color.

Each bottle contains 100 ml of oral solution.

20 bottles of 100 ml of oral solution.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Salvat, S.A.

C/ Gall 30-36

08950-Esplugues de Llobregat (Barcelona)

SPAIN

Last review date of this leaflet:March 2022