Salvacoline Flas 2 mg 12 Oral...

Salvacoline Flas 2 mg 12 Oral Dispersible Tablets

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Salvacoline Flas is used for the symptomatic treatment of acute non-specific diarrhoea in adults and children over 12 years of age. A doctor should be consulted if it gets worse or does not improve after 2 days.

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Description

Salvacoline Flas 2 mg 12 Oral Dispersible Tablets

What is Salvacoline Flas?

Salvacoline Flas is an anti-diarrhoeal medicine whose active ingredient is Loperamide. It reduces peristalsis and intestinal secretions, leading to a reduction in liquid stools.

What is Salvacoline Flas for?

Salvacolina Flas orodispersible tablets are indicated for the symptomatic treatment of acute non-specific diarrhoea in adults and children over 12 years of age.

Consult a doctor if it gets worse or does not improve after 2 days.

How to take Salvacoline Flas

Follow the instructions on the package leaflet, or as directed by your doctor or pharmacist. If you are in any doubt, ask your doctor or pharmacist again.

Dosage

The recommended dose in adults is: 2 orodispersible tablets, i.e. the equivalent of 4 mg loperamide hydrochloride, as an initial dose, followed by 1 orodispersible tablet (2 mg loperamide hydrochloride) after each diarrhoeal stool.

Do not take more than 8 orodispersible tablets per day, i.e. 16 mg loperamide hydrochloride per day.

The dose in children over 12 years of age is: 1 orodispersible tablet (2 mg loperamide hydrochloride) as an initial dose, followed by 1 orodispersible tablet (2 mg loperamide hydrochloride) after each diarrhoeal stool.

In children the maximum daily dose should be related to body weight:

Child weight from 27 kg| Maximum 4 tablets.

Child weight from 34 Kg| Maximum 5 tablets.

Child weight from 40 Kg| Maximum 6 tablets.

Child weight from 47 Kg| Maximum 7 tablets.

Patients with liver disease, consult your doctor before taking this medicine.

Form of administration

It is administered orally. Place the tablet on the tongue, where it will dissolve quickly and swallow it with saliva.

Before you start taking Salvacoline Flas

See the enclosed leaflet for possible contraindications, interactions, side effects, warnings and precautions.

Do not take Salvacoline if you are allergic to loperamide or any of the other ingredients.

Do not administer to children under 2 years of age.

If blood is present 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 bowel.

If you have severe diarrhoea (pseudomembranous colitis) after taking antibiotics.

If you have diarrhoea from an infection caused by organisms such as Salmonella, Shigella or Campylobacter.

Children and adolescents

Do not use in children under 12 years of age without consulting a doctor.

Use of Salvacoline with other medicines

Tell your doctor or pharmacist if you are taking, or are going to take, any other medicines. If you are taking:

Ritonavir, saquinavir (used to treat HIV).

Quinidine, to treat heart rhythm).

Desmopressin, to treat central diabetes insipidus and nocturnal urinary incontinence in children.

Itraconazole or ketoconazole, to treat fungal infections).

Gemfibrozil , to lower cholesterol.

St. John's wort, to improve mood.

Valerian , to treat mild nervousness and anxiety.

Opioid analgesics, to treat very severe pain, as it can increase the risk of severe constipation and central nervous system depression.

Broad-spectrum antibiotics, as it may worsen diarrhoea caused by antibiotics.

Salvacoline may potentiate the action of similar drugs.

There is extensive information in the package leaflet on incompatible medicines, those for which your doctor has to adjust the dose, or those for which he may advise you to stop treatment. 

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnant women should not take this medicine unless prescribed by a doctor.

They should not use this medicine without consulting their doctor as small amounts of this medicine may pass into breast milk.

Driving and using machines

Tiredness, drowsiness or dizziness may occur during treatment of diarrhoea with Salvacoline, so you are advised not to use machinery or drive.

Salvacoline Flas contains aspartame

Aspartame is a source of phenylalanine and may be harmful to people with phenylketonuria.

Composition of Salvacoline Flas

Active substance: Loperamide hydrochloride 2 mg per orodispersible tablet.

Other ingredients: Mannitol (E-421), magnesium stearate (E-572), microcrystalline cellulose (E-460 I), croscarmellose sodium, aspartame (E-951), aniseed flavouring, apple flavouring.

Appearance of the product and contents of the package

The orodispersible tablets are round and almost white in colour. Each pack of Salvacoline Flas contains 12 orodispersible tablets in blister packs.

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