Salofalk (mesalazine) coated enteric tablets 250 mg. №100

Description

Salofalk (mesalazine) coated enteric tablets 250 mg. №100

Composition

active ingredient: mesalazine;

1 tablet contains 250 mg of mesalazine (5-aminosalicylic acid);

excipients: anhydrous sodium carbonate, glycine, povidone (K25), microcrystalline cellulose, anhydrous colloidal silicon dioxide, calcium stearate, hypromelose, methacrylate copolymer (type A), talc, titanium dioxide (E 171), iron hydroxide yellow (E 172) , macrogol 6000, acrylate copolymer.

1 tablet contains 500 mg of mesalazine (5-aminosalicylic acid);

excipients: anhydrous sodium carbonate, glycine, povidone (K25), microcrystalline cellulose, anhydrous colloidal silicon dioxide, calcium stearate, sodium croscarmellose, hypromelose, methacrylate copolymer (type A), talc, titanium dioxide (E 171), iron hydroxide yellow ( E 172), macrogol 6000, acrylate copolymer.

Dosage form

Coated tablets, enteric.

Basic physical and chemical properties:

• 250 mg: oily yellow to ocher, smooth, round tablets with an unpolished surface;
• 500 mg: Oil-yellow to ocher, non-glossy tablets, oblong in shape, with a smooth surface without noticeable cracks.

Pharmacological group

The gastrointestinal tract and metabolism. Antidiarrheals, intestinal anti-inflammatory/antimicrobials. Intestinal anti-inflammatory drugs. Aminosalicylic acid and the like. Mesalazine.
ATX code A07EC02.

Pharmacological properties

It belongs to the category of agents acting on the foci of inflammation. Shows itself as an antioxidant.
Available in various application forms.
The drug begins to act from an hour and a half after administration or administration (depending on the form of application).
The forms of oral administration of the medication are protected by the membrane from the destructive effect, and therefore they fall as intended in the place of action – the small and large intestines.
Salofalk is not affected by factors such as pH, other medications and food intake.
The withdrawal of the drug is carried out by the kidneys.

Indications

Treatment and prevention of gastrointestinal diseases:

• Ulcerative colitis: treatment of exacerbations and prevention of relapses.
• Crohn’s disease: treatment of exacerbations.

Contraindications

Do not use the drug in children under 2 years of age.
Allergic reactions and high sensitivity to the active substance of the drug or auxiliary components, compounds from the salicylate group.
Salofalk is unacceptable to use in the presence of severe functional disorders of the liver and kidneys, peptic ulcer of the stomach and / or duodenum.
Patients who suffer from hemorrhagic diathesis and diseases of the blood and circulatory system should also refrain from taking the drug.

Application during pregnancy and lactation

If you follow strict indications and under the supervision of a doctor, the drug can be used up to 12 weeks of pregnancy.
It is forbidden to take Salofalk one month before the expected birth, provided that the disease does not require constant intake of the drug.
Information about taking the drug during breastfeeding is not enough, therefore it is recommended to refrain from treatment with Salofalk while breastfeeding.
If you are planning a pregnancy, you should stop taking the medication or keep the dose to a minimum.

Method of administration and dosage

Salofalk tablets 250 mg.

Adults and elderly patients

For the treatment of chronic inflammatory bowel diseases (Crohn’s disease, ulcerative colitis), both Salofalk 250 mg tablets and Salofalk 500 mg tablets can be used.

If necessary, a dosage exceeding 1.5 g of mesalazine per day is recommended to use Salofalk 500 mg tablets.

Depending on the clinical need in each particular case, the following daily doses are recommended for the treatment of adults:

Children under 6

Salofalk tablets should not be used in children under 6 years of age. There are limited data on the use of the drug in children from 6 to 18 years.

Children from 6 years old

In acute attacks, depending on the severity of the disease, a dose of 30-50 mg of mesalazine / kg of body weight / day is prescribed, which is divided into 3 doses. The maximum dose is 75 mg mesalazine/kg body weight/day. The total daily dosage should not exceed the maximum adult dose.

For the prevention of relapses (nonspecific ulcerative colitis), the drug is prescribed individually, starting with a dose of 15-30 mg mesalazine / kg body weight / day, which is divided into 2-3 doses. The total daily dosage should not exceed the maximum adult dose.

Children weighing up to 40 kg are recommended to take half the adult dose, children weighing more than 40 kg – the usual adult dose.

For the treatment of children from 6 years of age, the following daily doses are recommended:

Salofalk tablets 500 mg.

If the recommended dose exceeds 1.5 g of mesalazine per day, salofalk 500 mg tablets are usually used.

Adults and elderly patients

Depending on the clinical need in each particular case, the following daily doses are recommended:

Children under 6

Salofalk tablets should not be used in children under 6 years of age. There are limited data on the use of the drug in children from 6 to 18 years.

Children from 6 years old

In acute attacks, depending on the severity of the disease, a dose of 30-50 mg of mesalazine / kg of body weight / day is prescribed, which is divided into 3 doses. The maximum dose is 75 mg mesalazine/kg body weight/day. The total daily dosage should not exceed the maximum adult dose.

For the prevention of relapses (nonspecific ulcerative colitis), the drug is prescribed individually, starting with a dose of 15-30 mg mesalazine / kg body weight / day, which is divided into 2-3 doses. The total daily dosage should not exceed the maximum adult dose.

Children weighing up to 40 kg are recommended to take half the adult dose, children weighing more than 40 kg – the usual adult dose.

Depending on the clinical needs and body weight (up to 40 kg) of the child, a decision should be made which type of tablets should be used: Salofalk tablets 250 mg. or Salofalk tablets 500 mg.

General recommendations for use

Salofalk tablets should be taken in the morning, afternoon and evening 1 hour before meals. Tablets should be swallowed whole, without chewing, with a sufficient amount of liquid.

Both in acute conditions with inflammation and in long-term use, Salofalk tablets should be taken regularly and continuously to achieve the desired therapeutic effect.

The duration of use is determined by the doctor.

To maintain remission in ulcerative colitis, the dose can be reduced to 1.5 g mesalazine per day (adults and children weighing more than 40 kg) to 0.75 mg mesalazine per day (children / adolescents).

Children

Salofalk tablets should not be used in children under 6 years of age. There are limited data on the use of the drug in children from 6 to 18 years.

Overdose

Usually, there is no overdose at a controlled dose. Overdose symptoms appear the same as the side effects.

Side effects

Salofalk is well tolerated, but sometimes (extremely rarely) patients notice pain in the joints and muscles.
Individual reactions of some people can manifest themselves in the form of allergic reactions: urticaria, spasms in the bronchi, itching, myo- and pericarditis, and fever.
In some cases, problems arise with the circulatory system, the organs of the digestive tract – abdominal pain, nausea, vomiting, inflammation in the pancreas, hepatitis and others.
Dizziness and headaches are extremely rare.
Mesalazine and drugs similar in structure to it can cause systemic lupus erythematosus syndrome.