Mucofalk 300g granules for the preparation of suspension for oral administration


Application Questions

How to take Mucofalk correctly in relation to food intake: before, after, during?

Mucofalk can be taken at any convenient time, except when it is taken to lower cholesterol, lose weight and reduce insulin resistance (for type 2 diabetes and impaired glucose tolerance) - in this case it is taken 15-30 minutes before meals.
It is important to space the intake of Mucofalk and other medications/dietary supplements by at least 40 minutes. - otherwise, psyllium may adsorb some of the drugs taken.

Will taking 150-200 ml of liquid complicate the condition of patients with kidney, heart and vascular diseases?

Even with minimal fluid requirements, it is necessary to consume at least 1.5 liters of fluid, as indicated in the instructions for use of the drug Mucofalk. Fluid deficiency (less than 1.5 liters per day) can cause constipation, thrombosis, kidney stones, etc.

When using Mucofalk, it is not necessary to exceed the physiological norm of fluid intake per day (2.0-2.5 liters of total fluid per day). When it comes to treating constipation, it is recommended that you take more fluids than usual as part of the general approach to treating constipation.

In any case, Mucofalk binds all the ingested liquid in the form of a gel - it does not enter the patient’s bloodstream.

Consequently, Mucofalk can be freely used in patients with cardiovascular diseases and other diseases when there are restrictions on fluid intake.

Is it possible to dissolve Mukofalk not only in water?

Mucofalk can be dissolved not only in water, but also in other liquids (kefir, milk, drinking yogurt, mineral water, juices, etc.).

Will there be a deficiency of fat-soluble vitamins and microelements when taking Mucofalk?

Psyllium has been used in world practice for a long time. Although it has pronounced properties of a natural enterosorbent, over the years of clinical experience there have been no cases of deficiency of vitamins and microelements during treatment with psyllium.

According to a meta-analysis of 8 studies on the use of psyllium for long periods (4-6 months or more), Mucofalk does not reliably affect the level of absorption of both vitamins and microelements (the concentrations of vitamins and microelements in the blood and urine were assessed).

One study examined the effect of psyllium on calcium absorption in 15 postmenopausal women in a randomized crossover study, the results of which showed that psyllium did not affect blood calcium levels.

Mukofalk

When taking the drug, you should drink at least 1.5 liters of liquid per day.

The use of psyllium husks as a dietary supplement for hypercholesterolemia requires medical supervision.

In the absence of doctor's prescriptions

Mucofalk should not be taken by patients with coprostasis and symptoms such as abdominal pain, nausea and vomiting. These symptoms may be signs of a potential or existing intestinal obstruction.

Patients taking Mucofalk to treat chronic constipation should stop treatment with Mucofalk and contact their doctor if they experience abdominal pain or have irregular bowel movements.

While taking Mucofalk, ensure plenty of fluid intake, for example 150 ml of water (1 glass of water) for each sachet/measuring spoon (equivalent to 5 g) of Mucofalk.

Ingestion of dry granules may cause difficulty swallowing and choking.

In the absence of an adequate amount of fluid, taking bulking drugs can lead to obstruction of the airways and esophagus, accompanied by suffocation and intestinal obstruction. Symptoms of these events may include chest pain, vomiting, or difficulty swallowing or breathing.

Treatment of debilitated and/or elderly patients requires medical supervision.

When gastrointestinal disease is present, the most important aspect of treatment is to ensure fluid and salt (electrolyte) replacement.

The drug Mucofalk contains sucrose. Patients with hereditary fructose intolerance, glucose-galactose malabsorption or congenital sucrase-isomaltase deficiency should avoid sucrose consumption.

A single dose of Mucofalk (5 g) contains 0.5 g of sucrose and 3.07 kcal (12.86 kJ), which is equivalent to 0.064 XE.

A single dose of Mucofalk (5 g) contains 3.9 mmol (90 mg) sodium. This should be taken into account by those on a sodium controlled (low sodium/sodium chloride) diet.

Influence on the ability to drive vehicles and machinery.

The use of the drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

MUCOFALC ORANGE

Compound:

Active ingredient: Ispaghula husk (plantain seed husk Plantago ovata Forssk.)

1 package (5 g of granules) contains Ispaghula husk (plantain seed husk Plantago ovata Forssk.) - 3.25 g;

Excipients: sucrose, dextrin, citric acid, sodium alginate, sodium, sodium chloride, sodium saccharin, orange flavor.

Dosage form. Granules.

Basic physicochemical properties: beige granules with brown particles of the epidermis and adjacent destroyed layers, taken from dried mature seeds of the plantain Plantago ovata Forssk.

Pharmacological group. Laxatives. Drugs that increase the volume of intestinal contents. Preparations from the seeds of plantain ovoid (flea).

ATX code A06A C01.

Lipid-modifying agents. Code ATX S10A X.

Pharmacological properties.

Pharmacodynamics.

The active ingredient is psyllium husk, consisting of the epidermis and adjacent degraded layers taken from the dried mature seeds of Plantago ovata Forssk. (Plantago ispaghula Roxb.). Psyllium seed husks are especially rich in nutritional fiber and mucilage; the mucilage content is much higher than that of other Plantago species.

The active substance of the drug absorbs an amount of water approximately 40 times its own weight. It consists of 85% water-soluble fiber and is partially enzymatic (in vitro 72% initial residue) and acts by hydrating stool.

Intestinal motility and transit rate can be modified by seed husks, which cause mechanical expansion of the intestinal wall. This occurs due to an increase in intestinal volume and a decrease in the viscosity of the luminescent content due to water absorption.

If taken with a large amount of liquid, the seed husk increases the volume of intestinal contents through the high bulking properties of the husk and the resulting irritating distension that causes bowel movements. In turn, the edematous mass of mucous forms forms a lubricating layer, facilitating the transit of intestinal contents.

Start of action. Psyllium husk certainly acts as a laxative for 12-24 hours after a single administration. Sometimes the maximum effect is achieved only after 2-3 days.

With mild to moderate hypercholesterolemia, there is a decrease in LDL (low-density lipoprotein) cholesterol by approximately 7%. There is no data on the effect of psyllium husk on the incidence of cardiovascular complications and overall mortality.

Clinical characteristics.

Indications.

  • Chronic constipation;
  • diseases in which it is desirable to have a soft, facilitated bowel movement, such as anal fissures, hemorrhoids, as well as the condition after surgery in the rectal area;
  • irritable bowel syndrome;
  • used as maintenance therapy in addition to diet for hypercholesterolemia.

Contraindications.

  • Known hypersensitivity reaction to Ispaghula (Plantago, Psyllium), as well as hypersensitivity to the components of the drug;
  • any sudden change in bowel habits that lasts more than two weeks;
  • taking a laxative without defecation;
  • rectal bleeding of unknown etiology;
  • difficulty swallowing or other throat or swallowing problems;
  • stenosis of the esophagus, cardiac opening of the esophagus or other parts of the gastrointestinal tract;
  • risk of developing or existing intestinal obstruction (ileus) or megacolon; intestinal paralysis.

Special security measures.

Mucofalk Orange must be used with a sufficient amount of liquid (minimum 150 ml) per 1 sachet (5 g). Taking this medicine without enough liquid may cause difficulty swallowing or cause choking. Mucofalk Orange should not be taken lying down or immediately before bed.

Interaction with other drugs and other types of interactions.

Between taking the drug Mucofalk Orange and other medications, you need to take a break of approximately 30-60 minutes, since the absorption in the intestines of other drugs that the patient takes simultaneously, such as minerals (for example, calcium, iron, zinc), vitamins (vitamin B12), lithium, cardiac glycosides, coumarins and carbamazepine, may be slowed down.

Excipients and drugs that inhibit natural intestinal motility (eg, loperamide, tincture of opium) should not be used at the same time as this drug, as intestinal obstruction may develop.

Patients with diabetes mellitus may require adjustment of antidiabetic treatment when using Mucofalk Orange simultaneously. The effect of thyroid hormones may be weakened, even if they are used simultaneously.

Features of application.

The use of psyllium husk for maintenance therapy to the diet for hypercholesterolemia requires medical supervision.

When using the drug Mucofalk Orange, it is necessary to ensure that a sufficient amount of liquid is taken, at least 150 ml of water per 1 sachet.

If insufficient fluids are taken, bulking agents can cause obstruction of the throat and esophagus with choking and intestinal obstruction. Symptoms may include chest pain, vomiting, or difficulty swallowing or breathing.

Swallowing granules dry may cause difficulty swallowing and choking.

For diarrhea, the most important aspect of treatment is restoring electrolyte balance.

Mucofalk Orange should not be taken by patients with bowel problems and symptoms such as abdominal pain, nausea and vomiting. These symptoms may be signs of existing or possible intestinal obstruction.

Patients taking Mucofalk Orange for the treatment of chronic constipation should stop treatment with the drug and consult a doctor if pain in the abdominal cavity or irregular consistency of stool occurs.

Debilitated and elderly patients should be monitored during treatment.

Mucofalk Orange contains sucrose; therefore, the drug should not be used in patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome or congenital sucrase-isomaltase deficiency.

One dose of Mucofalk Orange (5 g) contains 0.5 g of sucrose (sugar) and 3.07 kcal (12.86 kJ), which is equivalent to 0.064 exchangeable hydrocarbon units.

One dose of Mucofalk Orange (5 g) contains 3.9 mmol (90 mg) sodium. This should be taken into account in patients who adhere to a low-sodium/low-salt diet.

Use during pregnancy or breastfeeding.

There are no contraindications for the use of Mucofalk Orange during pregnancy or breastfeeding.

There are only limited data (less than 300 pregnancies) on the use of the drug during pregnancy. Animal studies are insufficient to draw conclusions about reproductive toxicity.

The use of the drug during pregnancy and lactation is possible if necessary or if there is no effect from changing the diet. It is necessary to carry out a bowel cleansing procedure before using other laxatives.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

There was no effect on the ability to drive vehicles or operate machinery.

Method of administration and dose.

Unless otherwise prescribed, you must adhere to the following recommendations for use, otherwise Mucofalk Orange will not have a therapeutic effect!

For chronic constipation and diseases in which easier bowel movements are desirable, adults and children over 12 years of age take 1 sachet (5 g) of Mucofalk Orange 2-3 times a day orally after stirring in a sufficient amount of liquid (at least 150 ml one sachet ).

If the drug is intended as an adjuvant for diarrhea or irritable bowel syndrome, or hypercholesterolemia, use 1 sachet (5 g), dissolved in a sufficient amount of liquid (at least 150 ml per sachet), 2-6 times a day.

If the patient has prolonged constipation and irregular bowel movements that last more than 3 days, or diarrhea that lasts more than 2 days and is accompanied by blood or fever, you should consult a doctor.

Recommendations for use:

  1. Never take this medication dry as it may cause difficulty swallowing.
  2. Pour the granules from the bag into an empty glass.
  3. Slowly fill the glass with cold water (at least 150 ml).
  4. Stir with a spoon and, making sure that there are no lumps left, drink immediately. Do not take while lying down or just before bedtime!
  5. Then drink another glass of water.

The effect of using the drug Mucofalk Orange is usually observed 12-24 hours after administration.

Take Mucofalk Orange during the day at least half an hour before or after taking other medications.

When used for maintenance therapy for moderately elevated cholesterol levels, it is recommended to take Mucofalk Orange with food.

If the patient forgets to take the drug, it is necessary to continue treatment in accordance with the dosage recommendations, but do not increase the dose.

Before interrupting or stopping treatment, it is advisable to consult a doctor.

Children.

Mucofalk Orange should not be used in children under 12 years of age due to insufficient experience in using the drug in patients of this age group.

Overdose.

If the patient has taken a larger dose of the drug than recommended, side effects may occur such as abdominal pain, flatulence, or an increased feeling of fullness in the intestines. First of all, you need to drink enough liquid. If necessary, the doctor should prescribe symptomatic therapy.

Adverse reactions.

Flatulence and a feeling of fullness in the intestines are possible, but they usually disappear with further treatment.

Abdominal bloating and problems with bowel movements are possible, and there is also a risk of intestinal or esophageal obstruction, especially if you do not take enough fluids.

Psyllium husk contains allergens that may cause a hypersensitivity reaction through oral administration or skin contact. Symptoms of allergic reactions may include rhinitis, conjunctivitis, bronchospasm and sometimes anaphylactic shock. Skin reactions such as rash and itching have also been reported.

The frequency of these side effects is unknown.

Best before date . 5 years.

Do not use after the expiration date stated on the packaging.

Storage conditions.

Keep out of the reach of children.

Package.

5 g granules per bag. 20 bags in a cardboard box.

Vacation category. Over the counter.

Manufacturer.

Dr. Falk Pharma GmbH, Germany/Dr. Falk Pharma GmbH, Germany.

The location of the manufacturer and its address of place of business.

Leinenweberstrasse 5, 79108 Freiburg, Germany/Leinenweberstrasse 5, 79108 Freiburg, Germany.

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