Mucofalk O

Package Leaflet: Information for the User

MUCOFALK O, Granules for Oral Suspension

Plantaginis ovataeseminis tegumentum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by the doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in the package leaflet, the doctor or pharmacist should be informed.
• If there is no improvement after 3 days or the patient feels worse, the doctor should be contacted.

Table of Contents of the Package Leaflet:

• 1. What is Mucofalk O and what is it used for
• 2. Important information before using Mucofalk O
• 3. How to use Mucofalk O
• 4. Possible side effects
• 5. How to store Mucofalk O
• 6. Contents of the pack and other information

1. What is Mucofalk O and what is it used for

Mucofalk O contains psyllium seed husk and is a herbal medicinal product used:

• for the treatment of habitual constipation;
• in conditions where it is desirable to facilitate bowel movements with soft stool, e.g., painful defecation after anal or rectal surgery, with anal fissures, or hemorrhoids;
• in patients where it is desirable to take an increased daily intake of dietary fiber, e.g., as a supportive treatment for constipation, which is a dominant symptom in irritable bowel syndrome, or as a dietary supplement in patients with hypercholesterolemia.

Mucofalk O is used in adults and adolescents over 12 years of age.

2. Important information before using Mucofalk O

When not to use Mucofalk O:

• if the patient is allergic to the active substance, i.e., psyllium seed husk, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced sudden changes in bowel habits lasting more than two weeks;
• if the patient has experienced unexplained rectal bleeding;
• if the patient has not had a bowel movement after taking laxatives;
• if the patient has narrowing of the gastrointestinal tract, including esophageal and gastric cardia diseases, intestinal obstruction (ileus), or risk of its occurrence, intestinal paralysis, or colon enlargement (megacolon).
• if the patient has difficulty swallowing or other throat and larynx disorders.

Warnings and precautions

Before starting to use Mucofalk O, the doctor or pharmacist should be consulted.
Mucofalk O should not be used in patients suffering from fecal impaction, abdominal pain, nausea, or vomiting. These symptoms may be a sign of potential or actual intestinal obstruction.
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If abdominal pain or irregular bowel movements occur, patients using Mucofalk O should stop using the medicine and consult a doctor.
Mucofalk O should be taken with a large amount of fluid, at least 150 ml (1 glass of water, fruit juice, or other similar liquid) per 1 sachet (5 g of medicine). Swallowing granules without drinking may lead to difficulty swallowing and choking.
If Mucofalk O is taken with insufficient fluid, the medicine may swell in the throat and lead to throat and esophageal obstruction, which can cause choking or intestinal obstruction.
A doctor should be consulted immediately if chest pain, vomiting, difficulty swallowing, or breathing difficulties occur after taking Mucofalk O.
Patients in poor general condition and the elderly require medical supervision while taking Mucofalk O.
Using Mucofalk O as a dietary supplement in patients with hypercholesterolemia requires medical supervision.

Children

Mucofalk O should not be given to children under 12 years of age due to the lack of sufficient data in this age group.

Mucofalk O and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
There may be a delay in the intestinal absorption of other medicines taken simultaneously, such as:

• mineral compounds
• vitamins (vitamin B)
• cardiac glycosides
• anticoagulants (coumarin derivatives)
• antiepileptic and antidepressant medicines (lithium). For this reason, a gap of 30 to 60 minutes should be maintained between taking Mucofalk O and other medicines.

The following medicines can be taken simultaneously with Mucofalk O only under medical supervision:

• Medicines that inhibit intestinal peristalsis (e.g., loperamide, opioids), as intestinal obstruction (ileus) may occur.
• Thyroid hormones, as the dose of hormones may need to be adjusted.
• In patients with diabetes, using Mucofalk O requires medical supervision, as the dosage of antidiabetic medicines may need to be adjusted.

Using Mucofalk O with food and drink

There are no special recommendations for taking Mucofalk O with meals.
If Mucofalk O is used as a dietary supplement in patients with hypercholesterolemia, it is recommended to take the medicine during meals.
However, the medicine should always be taken with a large amount of fluid - at least 150 ml of water, fruit juice, or other similar liquid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
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Mucofalk O can be used during pregnancy and breastfeeding only if necessary or if a change in diet is insufficient. Medicines that facilitate the formation of stool mass, such as Mucofalk O, should be used first, and if they are not effective, other laxatives should be used.

Driving and using machines

Mucofalk O does not affect the ability to drive or use machines.

Mucofalk O contains sodium and sucrose.

• Sodium: The maximum recommended daily doses of this medicinal product, depending on the indication and dosage, 3 sachets or 6 sachets, contain 270 mg or 540 mg of sodium (a component of table salt), respectively. This corresponds to 13.5% or 27% of the maximum recommended daily intake of sodium in the diet for adults. If 4 sachets or more are taken per day for a long time, patients, especially those controlling sodium intake, should consult a doctor or pharmacist.
• Sucrose (sugar): If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.

Warning for diabetics: a single dose (1 sachet) of Mucofalk O contains 0.5 g of sucrose; energy value: 3.07 kcal (12.86 kJ), which corresponds to 0.064 bread units (so-called carbohydrate exchange).
Warning for celiac patients:Mucofalk O does not contain gluten.
Warning for patients with lactose intolerance:Mucofalk O does not contain lactose.

3. How to use Mucofalk O

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.

Use in children

Mucofalk O should not be given to children under 12 years of age due to the lack of sufficient data in this age group.

Dosage

Adolescents over 12 years of age, adults, and the elderly

• Treatment of habitual constipation and conditions where it is desirable to facilitate bowel movements with soft stool, e.g., painful defecation after anal or rectal surgery, with anal fissures, or hemorrhoids: One sachet of Mucofalk O (5 g of granules) 2 to 3 times a day, mixed with a large amount of fluid, at least 150 ml (1 glass of water, fruit juice, or other similar liquid).
• Patients where it is desirable to take an increased daily intake of dietary fiber, e.g., as a supportive treatment for constipation, which is a dominant symptom in irritable bowel syndrome, or as a dietary supplement in patients with hypercholesterolemia. One sachet of Mucofalk O (5 g of granules) 2 to 6 times a day, mixed with a large amount of fluid, at least 150 ml (1 glass of water, fruit juice, or other similar liquid).

If Mucofalk O is used as a dietary supplement in patients with hypercholesterolemia, it is recommended to take the medicine during meals.
How to take the medicine:

• 1. Nevertake the medicine in a dry state, as it may block the throat, airways, or esophagus and cause choking. 2. The contents of one sachet of Mucofalk O should be poured into a glass.

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3. The glass should be slowly filled with water, fruit juice, milk, or other similar liquid (at least 150 ml).

• 4.The mixture should be stirred with a spoon to ensure that no lumps form and then drunk immediately.
• 5.An additional glass of liquid should be drunk. 6. The medicine should not be taken while lying down or immediately before bedtime.

The effect of Mucofalk O is usually observed within 12 to 24 hours after administration.
Mucofalk O should be taken during the day, at least 30 to 60 minutes before or after taking other medicines.

Duration of treatment

If the patient feels that the effect of Mucofalk O is too strong or too weak, the doctor or pharmacist should be consulted.
If the patient suffers from prolonged constipation and irregular bowel movements lasting more than 3 days, diarrhea lasting more than 2 days, or accompanied by blood or fever, the doctor should be contacted. The instructions in the "Warnings and precautions" section should also be followed.

Using more than the recommended dose of Mucofalk O

In case of taking too much Mucofalk O, symptoms such as abdominal pain, bloating (gas), and feeling of fullness may worsen. Intestinal obstruction may occur. A large amount of fluid should be drunk immediately, and then a doctor should be consulted to determine if further treatment is necessary.

Missing a dose of Mucofalk O

If a dose of Mucofalk O is missed, treatment should be continued as prescribed. A double dose should not be taken to make up for the missed dose. In case of doubt, the doctor should be consulted.

Stopping the use of Mucofalk O

In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Mucofalk O can cause side effects, although not everybody gets them.
Bloating and feeling of fullness may occur during the use of Mucofalk O, but these effects usually disappear during continued treatment.
Abdominal bloating and intestinal obstruction may occur, as well as the risk of fecal impaction or the risk of esophageal obstruction, especially if Mucofalk O is taken with insufficient fluid. The frequency of these side effects is not known.
Psyllium seed husk contains allergens that can cause allergic reactions when taken orally or in contact with the skin. Symptoms of an allergic reaction may include: rhinitis, conjunctivitis, bronchospasm, and in some cases, anaphylactic shock (a sudden, generalized allergic reaction that can be life-threatening).
Skin reactions, such as rash and itching, have also been reported. The frequency of these side effects is not known.
If the first signs of an allergic reaction occur, the use of Mucofalk O should be stopped and the medicine should not be used in the future.
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If other side effects occur that are not listed above, the doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including those not listed in the package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Mucofalk O

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the sachet and carton. The expiration date refers to the last day of the specified month.
There are no special storage temperature recommendations for the medicine.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Mucofalk O contains

The active substance of Mucofalk O is psyllium seed husk (Plantaginis ovataeseminis tegumentum).
One sachet (5 g of granules) contains 3.25 g of psyllium seed husk.
The excipients are: sucrose, citric acid, dextrin, sodium alginate, sodium citrate, sodium chloride, sodium saccharin, and orange flavor [Evogran No. 301768].

What Mucofalk O looks like and contents of the pack

Mucofalk O is a beige-colored granule with brown particles, with an orange flavor.
The pack consists of a paper bag coated with PE/Al/PE foil.
Available packs: 20 sachets in a carton.

Marketing authorization holder and manufacturer:

Dr. Falk Pharma GmbH
Leinenweberstrasse 5
79108 Freiburg
Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Ewopharma AG Sp. z o.o., ul. Leszno 14, 01-192 Warsaw, tel. 22 620 11 71

Date of last revision of the package leaflet: 11/2021

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