Salvacolina 0.2 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Salvacolina 0.2 mg/ml oral solution
Loperamide hydrochloride
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for taking this medicine as described in this leaflet or as advised 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 effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 2 days.
Contents of the leaflet
- What Salvacolina is and what it is used for
- What you need to know before taking Salvacolina
- How to take Salvacolina
- Possible adverse effects
- How to store 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, resulting in a decrease in 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 have severe diarrhea (pseudomembranous colitis) following antibiotic use.
- 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 Salvacolina.
- If there is no 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 have 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 elderly patients.
- 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 is only symptomatic, the underlying cause of the diarrhea should be treated whenever possible.
- Do not take this medicine for uses other than those indicated (see section 1), and never exceed 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 ingredient 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 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 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 decreased consciousness).
- Broad-spectrum antibiotics, as they may worsen antibiotic-associated diarrhea.
Salvacolina may enhance the effects of similar drugs.
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 diarrhea with Salvacolina; therefore, it is advisable not to operate machinery or drive vehicles.
Salvacolina contains polyethylene glycol castor oil, glycerol, Ponceau red dye (E-124), methylparaben, propylparaben, and sodium.
This medicine may cause stomach discomfort and diarrhea because it contains polyethylene glycol castor oil.
This medicine may cause allergic reactions because it contains Ponceau red dye (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
It may cause allergic reactions (possibly delayed) because it contains methylparaben and propylparaben.
Patients on low-sodium diets should be aware that this medicine contains 5 mg (0.24 mmol) of sodium per ml.
3. How to take Salvacolina
Follow exactly the instructions for use of the medicine provided in this leaflet or those 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 the initial dose, followed by 10 ml of oral solution (2 mg of loperamide hydrochloride) after each diarrheal bowel movement, up to a maximum of 80 ml of oral solution daily (16 mg of loperamide hydrochloride).
Children over 12 years
10 ml of oral solution (2 mg of loperamide hydrochloride) as the initial dose, followed by 10 ml of oral solution (2 mg of loperamide hydrochloride) after each diarrheal bowel movement. 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 40 ml |
From 34 kg | Maximum 50 ml |
From 40 kg | Maximum 60 ml |
From 47 kg | Maximum 70 ml |
Patients 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 immediately 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 above symptoms, call a doctor immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number (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 may produce adverse effects, although not everyone experiences 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 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 uncommonly (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 1000 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 disorders 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 tiredness (fatigue).
Frequency not known (cannot be estimated from available data): upper abdominal pain, abdominal pain radiating to the back, tenderness when 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
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 containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and other information
Composition of Salvacolina
The active substance is: loperamide hydrochloride 0.2 mg/mL.
The other components are: sodium saccharin (E954ii), sodium cyclamate (E952ii), polyoxyl 40 hydrogenated castor oil, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), propylene glycol (E1520), glycerol (E422), citric acid (E330), sodium hydroxide (E524), disodium edetate, strawberry flavour, Ponceau 4R (E124), and purified water.
Appearance of the product and contents of the container
Red, clear oral solution.
Each bottle contains 100 mL of oral solution.
20 bottles of 100 mL oral solution.
Marketing Authorization Holder and Manufacturer
LABORATORIOS SALVAT, S.A.
C/ Gall 30-36
08950 - Esplugues de Llobregat (Barcelona)
SPAIN
Date of the most recent revision of this leaflet: March 2022