SALVACOLINA 0.2 mg/ml ORAL SOLUTION

2. What you need to know before taking Salvacolina

Do not take Salvacolina

• 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 there is blood in your stool or if 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 have diarrhea caused by an infection with organisms such as Salmonella, Shigellaor Campylobacter.

Warnings and precautions

• Consult your doctor or pharmacist before taking Salvacolina.
• If you do not see improvement within 48 hours or if fever, constipation, or other symptoms such as abdominal swelling or paralytic ileus (absence of intestinal movements) appear, discontinue treatment and consult your doctor.
• If you have severe diarrhea, your body loses more fluids, sugars, and salts than usual, so you will need to replenish fluids by drinking more than usual. Dehydration is characterized by 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 medicine.
• Since the treatment of diarrhea with Salvacolina is only symptomatic, diarrhea should be treated based on its cause, when possible.
• Do not take this medicine for a use other than that indicated (see section 1) and never take more than the recommended 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 in Salvacolina.

Children and adolescents

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

Using Salvacolina with other medicines

Tell 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 heart rhythm disorders).
• Desmopressin (used to treat central diabetes insipidus and nocturnal enuresis 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 depression).
• Valerian (used to treat mild nervousness and anxiety).
• Opioid analgesics (used to treat severe pain) as they 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 antibiotic-associated diarrhea.

Salvacolina may enhance the action of similar drugs.

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 using 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

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

Driving and using machines

Fatigue, dizziness, or drowsiness may occur during treatment with Salvacolina, so it is advised not to operate machinery or drive vehicles.

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

This medicine may cause stomach upset and diarrhea because it contains castor oil polyoxyethylated.

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

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

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

3. How to take Salvacolina

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

20 ml of oral solution (4 mg of loperamide hydrochloride) as an 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 of age

10 ml of oral solution (2 mg of loperamide hydrochloride) as an 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:

Patient with liver disease

They should consult their doctor before taking this medicine.

This medicine 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 for help. 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, or weak breathing.

Children react more severely to high amounts of Salvacolina 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Salvacolina

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

If you have any other questions about 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, discontinue treatment and consult your doctor: hypersensitivity reactions (redness, itching, or swelling of the skin, difficulty swallowing or breathing), blisters or significant skin peeling, paralytic ileus (absence of intestinal movements or paralytic ileus), abdominal swelling (distension), severe abdominal pain, dilatation of the large intestine (megacolon), and loss or decrease in level of consciousness.

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

Uncommonly (may affect up to 1 in 100 patients) the following 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 1,000 patients) the following may appear: paralytic ileus (absence of intestinal movements or paralytic ileus), abdominal swelling (distension), dilatation of the large intestine (megacolon), loss or decrease in level of consciousness, stupor (general unconsciousness), increased muscle tone (hypertonia), abnormal coordination, blisters on the skin (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, 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 may cause difficulty swallowing or breathing (angioedema) including anaphylactic shock, decreased urine output (urinary retention), pupil constriction (miosis), and fatigue (fatigue).

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 they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use http://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Salvacolina

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Salvacolina

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

The other ingredients are: sodium saccharin (E954ii), sodium cyclamate (E952ii), castor oil polyoxyethylated, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), glycerol (E422), citric acid (E330), sodium hydroxide (E524), disodium edetate, strawberry flavor, red ponceau (4R) (E-124), and purified water.

Appearance of the product and package contents

Transparent red oral solution.

Each bottle contains 100 ml of oral solution.

20 bottles of 100 ml of oral solution.

Marketing authorization holder and manufacturer

LABORATORIOS SALVAT, S.A.

C/ Gall 30-36

08950-Esplugues de Llobregat (Barcelona)

SPAIN

Date of last revision of this leaflet:March 2022