SALVACOLINA 2 mg TABLETS

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 medication (listed in section 6).
• Do not administer to children under 2 years of age.
• If there is blood in the 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 have diarrhea caused by infection with organisms such as Salmonella, Shigella, or Campylobacter.

Warnings and Precautions

• Consult your doctor or pharmacist before starting to take Salvacolina.
• If you do not see improvement within 48 hours or if fever, constipation, or other symptoms such as abdominal bloating or paralytic ileus (absence of intestinal movements) occur, 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 bloating 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 different use than 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 Medications

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

In particular, 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 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 intense 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 potentiate 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 medication.

Pregnancy

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

Breastfeeding

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 Using Machines

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

3. How to Take Salvacolina

Follow the administration instructions for the medication contained in this package leaflet or as 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 an initial dose, followed by 1 tablet (2 mg of loperamide hydrochloride) after each diarrheal stool. Do not take more than 8 tablets (16 mg of loperamide hydrochloride) per day.

Children over 12 years of age:

1 tablet (2 mg of loperamide hydrochloride) as an initial dose, followed by 1 tablet (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 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 immediately for assistance. 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 presents 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 medication 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 medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can 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, paralytic ileus (absence of intestinal movements), abdominal bloating, severe abdominal pain, dilation 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 occur: constipation, nausea, gas (flatulence), headache, and dizziness.

Uncommonly (may affect up to 1 in 100 patients) the following may occur: vomiting, discomfort 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) the following may occur: paralytic ileus, abdominal bloating, dilation of the large intestine, loss or decrease in level of consciousness, stupor (generalized unconsciousness), increased muscle tone (hypertonia), abnormal coordination, skin blisters (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis), skin disorder 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.

Frequency not known (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 pancreatitis (acute pancreatitis).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.notificaram.es.

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

5. Storage of Salvacolina

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 stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Salvacolina Composition

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

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

Product Appearance and Package Contents

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

The score line is for breaking and facilitating swallowing, but not for dividing into equal doses.

Each package contains 12 or 20 tablets in blisters.

Marketing Authorization Holder and Manufacturer

Laboratorios SALVAT, S.A.

Gall, 30-36

08950 Esplugues de Llobregat (Barcelona) SPAIN

Date of the Last Revision of this Package Leaflet:March 2022

Updated and detailed information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.