SALVACOLINA FLAS 2 mg ORALLY DISINTEGRATING TABLETS

Introduction

Leaflet: Information for the User

Salvacolina Flas 2 mg Oral Disintegrating Tablets

Loperamide Hydrochloride

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as indicated 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 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 it worsens or does not improve after 2 days.

Contents of the Leaflet

1. What Salvacolina Flas is and what it is used for
2. What you need to know before taking Salvacolina Flas
3. How to take Salvacolina Flas
4. Possible side effects
5. Storage of Salvacolina Flas
6. Package contents and additional information

1. What Salvacolina Flas is and what it is used for

Salvacolina Flas is an antidiarrheal that reduces intestinal movements and secretions, resulting in a decrease in liquid stools.

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

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

2. What you need to know before taking Salvacolina Flas

Do not take Salvacolina Flas

• 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 old.
• 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 due to an infection caused by organisms such as Salmonella, Shigella, or Campylobacter.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Salvacolina Flas.

• If you do not observe improvement within 48 hours or if fever, constipation, or other symptoms such as abdominal bloating 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 bloating 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 Flas is only symptomatic, diarrhea should be treated based on its cause, when possible.
• Do not take this medicine for a use other 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 of Salvacolina.

Children and adolescents

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

Using Salvacolina Flas 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 AIDS).
• 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 Flas may enhance the action of similar drugs.

Pregnancy, breastfeeding, and fertility

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

Breastfeeding

Breastfeeding women 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 Flas, so it is advised not to use hazardous machinery or drive vehicles.

Salvacolina Flas contains aspartame

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Salvacolina Flas

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

Adults:

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

Children over 12 years old:

1 oral disintegrating 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 medicine.

This medicine is taken orally.

Place the tablet on the tongue, where it will dissolve rapidly, and swallow it with saliva.

If you take more Salvacolina Flas 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, go to a medical center or consult the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Salvacolina Flas

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

If you have any other doubts 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 everyone 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, intestinal paralysis (absence of intestinal movements or paralytic ileus), abdominal bloating, severe abdominal pain, dilation of the large intestine (megacolon), and loss or decrease of consciousness level.

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

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

Rarely (may affect up to 1 in 1000 patients) the following may appear: intestinal paralysis (absence of intestinal movements or paralytic ileus), abdominal bloating, dilation of the large intestine (megacolon), loss or decrease of consciousness level, stupor (general unconsciousness), excessive muscle tension (hypertonia), abnormal coordination, blisters on the skin (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 may 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 leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) http://www.notificaram.es.

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

5. Storage of Salvacolina Flas

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

Store at a temperature not exceeding 30°C.

Do not use this medicine after the expiration date stated on the packaging 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 medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Salvacolina Flas

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

The other ingredients are: mannitol (E-421), magnesium stearate (E-572), microcrystalline cellulose (E-460 I), sodium croscarmellose, aspartame (E-951), anise flavor, apple flavor.

Appearance of the product and package contents

The oral disintegrating tablets are round and white or almost white.

Each package of Salvacolina Flas contains 6 or 12 oral disintegrating tablets presented 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 leaflet: March 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es