Salvacolina Flas 2 mg orodispersible tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Salvacolina Flas 2 mg orodispersible tablets
Loperamide hydrochloride
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided 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 side effects not listed in this leaflet. See section 4.
- You must consult a doctor if your condition worsens or if you do not improve within 2 days.
Leaflet Contents
- What Salvacolina Flas is and what it is used for
- What you need to know before taking Salvacolina Flas
- How to take Salvacolina Flas
- Possible side effects
- How to store Salvacolina Flas
- Contents of the pack and other 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 of age.
You should consult a doctor if your condition 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 to any of the other ingredients of this medicine (listed in section 6).
- Do not administer to children under 2 years of age.
- If there is blood in the 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 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 notice improvement within 48 hours, or if fever, constipation, or other symptoms such as abdominal distension or paralytic ileus (absence of intestinal movements) occur, stop 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, reduced urine output, wrinkled skin, dizziness, and lightheadedness. Preventing dehydration is especially important in children and the elderly.
- Patients with AIDS should discontinue treatment at the first signs of abdominal distension.
- If you have liver or kidney disease, or blood disorders, consult your doctor before taking this medicine.
- Since treatment of diarrhea with Salvacolina Flas is only symptomatic, diarrhea should be treated by addressing its underlying cause whenever possible.
- Do not take this medicine for uses other than those indicated (see section 1) and never take more than the recommended dose (see section 3). Serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported in patients who have taken excessive amounts of loperamide, the active substance in Salvacolina.
Children and adolescents
Do not use in children under 12 years of age without consulting a doctor or pharmacist.
Taking Salvacolina Flas with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 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 Flas may enhance the effect of similar drugs.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The safety of this medicine during pregnancy has not been established; therefore, 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 may pass into breast milk.
Driving and using machines
Fatigue, dizziness, or drowsiness may occur during treatment of diarrhea with Salvacolina Flas; therefore, it is advisable not to operate dangerous machinery or drive vehicles.
Salvacolina Flas contains aspartame
This medicine may be harmful to people with phenylketonuria, as it contains aspartame, a source of phenylalanine.
3. How to take Salvacolina Flas
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Adults:
2 orodispersible tablets (4 mg of loperamide hydrochloride) as the initial dose, followed by 1 orodispersible tablet (2 mg of loperamide hydrochloride) after each episode of diarrhoea. Do not take more than 8 orodispersible tablets (16 mg of loperamide hydrochloride) per day.
Children over 12 years:
1 orodispersible tablet (2 mg of loperamide hydrochloride) after each episode of diarrhoea. In children, the maximum daily dose should be related to body weight:
Child's weight | Maximum number of tablets per day |
From 27 kg | Maximum 4 tablets |
From 34 kg | Maximum 5 tablets |
From 40 kg | Maximum 6 tablets |
From 47 kg | Maximum 7 tablets |
Patients 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 assistance. Symptoms may include: increased heart rate, irregular heartbeat, disturbances in cardiac rhythm (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 doses of Salvacolina than adults. If a child takes an excessive amount or shows any of the symptoms listed above, call a doctor immediately.
In case of overdose or accidental ingestion, go immediately to a medical center or contact the Toxicology Information Service at telephone number 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 a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you experience any of the following adverse effects, stop treatment and contact your doctor immediately: hypersensitivity reactions (skin redness, itching or swelling, difficulty swallowing or breathing), blisters or severe skin peeling, intestinal paralysis (absence of intestinal movements or paralytic ileus), abdominal swelling (distension), severe abdominal pain, dilation of the large intestine (megacolon), and loss or decreased level of consciousness.
The following effects may occur frequently (may affect up to 1 in 10 patients): constipation, nausea, gas (flatulence), headache (cephalalgia), and dizziness.
The following effects may occur infrequently (may affect up to 1 in 100 patients): vomiting, pain or discomfort in the upper middle part of the stomach (dyspepsia), dry mouth, abdominal pain or discomfort, somnolence, and skin rash (exanthema).
Rarely (may affect up to 1 in 1,000 patients), the following may occur: intestinal paralysis (absence of intestinal movements or paralytic ileus), abdominal swelling (distension), dilation of the large intestine (megacolon), loss or decreased level of consciousness, stupor (general unconsciousness), excessive increase in muscle tone (hypertonia), abnormal coordination, blisters on the skin (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis), skin disorder causing 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, reduced urine output (urinary retention), pupil constriction (miosis), and fatigue.
Frequency not known (cannot be estimated from the available data): upper abdominal pain, abdominal pain radiating to the back, tenderness upon touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es.
By reporting adverse 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 below 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Salvacolina Flas
The active substance is: loperamide hydrochloride 2 mg per orodispersible tablet.
The other components are: mannitol (E-421), magnesium stearate (E-572), microcrystalline cellulose (E-460 I), sodium croscarmellose, aspartame (E-951), anise flavour, apple flavour.
Appearance of the product and contents of the pack
The orodispersible tablets are round, white or almost white.
Each pack of Salvacolina Flas contains 6 or 12 orodispersible tablets in a blister.
Marketing Authorization Holder and Manufacturer
Laboratorios SALVAT, S.A.
Gall, 30-36
08950 Esplugues de Llobregat (Barcelona), Spain
Date of the most recent review of this leaflet: March 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /