Salvacolina 2 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Salvacolina 2 mg tablets
Loperamide hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Always 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve within 2 days.
Leaflet contents
- What Salvacolina is and what it is used for
- What you need to know before taking Salvacolina
- How to take Salvacolina
- Possible adverse effects
- Storage of Salvacolina
- Contents of the pack and other information
1. What Salvacolina is and what it is used for
Salvacolina is an antidiarrheal that reduces intestinal movements and secretions, thereby decreasing liquid stools.
Salvacolina 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
Do not take Salvacolina
- 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 diarrhoea (pseudomembranous colitis) after having taken antibiotics.
- If your diarrhoea is 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.
- If no improvement is observed 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 have severe diarrhoea, your body loses more fluids, sugars, and salts than normal, so you will need to replenish fluids by drinking more than usual. Dehydration is characterized by 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 diarrhoea with Salvacolina is only symptomatic, the diarrhoea should be treated by addressing its underlying cause whenever possible.
- Do not take this medicine for any use other than that specified (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.
Use of Salvacolina 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 HIV).
- Quinidine (used to treat cardiac 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 lower 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 reduced consciousness).
- Broad-spectrum antibiotics, as they may worsen antibiotic-associated diarrhoea.
Salvacolina may enhance the effect of similar medicinal products.
Pregnancy and breastfeeding
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 use of machines
Fatigue, dizziness, or drowsiness may occur during treatment of diarrhoea with Salvacolina; therefore, it is advisable not to operate machinery or drive vehicles.
3. How to take Salvacolina
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Adults:
2 tablets (4 mg of loperamide hydrochloride) as the initial dose, followed by 1 tablet (2 mg of loperamide hydrochloride) after each diarrhoeal stool. Do not take more than 8 tablets (16 mg of loperamide hydrochloride) per day.
Children over 12 years:
1 tablet (2 mg of loperamide hydrochloride) as the initial dose, followed by 1 tablet (2 mg of loperamide hydrochloride) after each diarrhoeal stool. 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.
Take 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 as soon as possible for assistance. Symptoms may include: increased heart rate, irregular heartbeats, 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (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 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 immediately and consult your doctor: hypersensitivity reactions (skin redness, itching or swelling, difficulty swallowing or breathing), blisters or extensive peeling of the skin, intestinal paralysis (absence of intestinal movements or paralytic ileus), abdominal swelling (distension), severe abdominal pain, dilation of the large intestine (megacolon), and loss or reduction in level of consciousness.
The following are frequently observed (may affect up to 1 in 10 patients): constipation, nausea, gas (flatulence), headache (cephalalgia), and dizziness.
The following are uncommon (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): intestinal paralysis (absence of intestinal movements or paralytic ileus), abdominal swelling (distension), dilation of the large intestine (megacolon), loss or reduction in level of consciousness, stupor (generalized unconsciousness), excessive increase in muscle tone (hypertonia), abnormal coordination, skin blisters (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis), skin disorders causing lesions and intense itching (urticaria), itching (pruritus), severe allergic reactions such as swelling of the lips, face, throat or tongue which may cause difficulty swallowing or breathing (angioedema), including anaphylactic shock, decreased urine output (urinary retention), pupil constriction (miosis), and tiredness (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 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 Medicines: http://www.notificaram.es.
By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Salvacolina
The active substance is: loperamide hydrochloride 2 mg per tablet.
The other components 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).
Nature of the product and contents of the container
The tablets are yellowish, round, flat, with a diametral score line.
The score line is intended to facilitate breaking the tablet for ease of swallowing, but not to divide it into equal doses.
Each pack contains 12 or 20 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
Up-to-date and detailed 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