Mucofalk o

Package leaflet: Information for the user

MUCOFALK O, granules for oral suspension
Plantaginis ovatae seminis tegumentum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

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

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

Mucofalk O contains plantago seed husks and is a herbal medicinal product used:

• for the treatment of habitual constipation;
• in conditions where easier bowel evacuation with soft stools is desirable, e.g. painful defecation after surgery on the anus or rectum, anal fissures, or haemorrhoidal disease;
• in patients in whom increased daily intake of dietary fibre is desirable, e.g. as supportive treatment in constipation-predominant irritable bowel syndrome, or as a dietary supplement in patients with hypercholesterolaemia.

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

2. Important information before using Mucofalk O

When not to use Mucofalk O:

• if the patient is allergic to the active substance, i.e. Plantago ovata seed husks, 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 unexplained rectal bleeding;
• if the patient has not had a bowel movement after taking laxatives;
• if the patient has gastrointestinal strictures, including diseases of the oesophagus and cardia of the stomach, intestinal obstruction (ileus) or risk of its occurrence, intestinal paralysis, or colonic dilation (megacolon);
• if the patient suffers from swallowing difficulties or other disorders affecting the throat and larynx.

Warnings and precautions
Before starting treatment with Mucofalk O, consult your doctor or pharmacist.
Mucofalk O should not be used in patients suffering from faecal impaction, abdominal pain, nausea, or vomiting. These symptoms may indicate potential or existing intestinal obstruction.
If abdominal pain or irregular bowel movements occur, patients taking Mucofalk O should stop using the medicine and consult a doctor.
Mucofalk O should be taken with plenty of fluid—at least 150 ml (1 glass of water, fruit juice, or similar liquid) per 1 sachet (5 g of medicine). Swallowing granules without adequate fluid intake may lead to swallowing difficulties and choking.
If Mucofalk O is taken with insufficient fluid, the medicine may swell in the throat and cause obstruction of the throat or oesophagus, potentially leading to choking or intestinal obstruction.
Immediately consult a doctor if chest pain, vomiting, difficulty swallowing, or breathing problems occur after taking Mucofalk O.
Patients in poor general health and elderly patients require medical supervision when taking Mucofalk O.
The use of Mucofalk O as a dietary supplement in patients with hypercholesterolaemia requires medical supervision.

Children
Mucofalk O should not be given to children under 12 years of age due to insufficient data in this age group.

Mucofalk O and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to take.
Delayed intestinal absorption of other concurrently administered medicines may occur, such as:

• mineral compounds
• vitamins (vitamin B)
• cardiac drugs (cardiac glycosides)
• anticoagulants (coumarin derivatives)
• antiepileptic drugs (carbamazepine) and antidepressants (lithium).
  Therefore, an interval of 30 to 60 minutes should be maintained between taking Mucofalk O and other medicines.

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

• Drugs that inhibit intestinal peristalsis (e.g. loperamide, opioids), as intestinal obstruction (ileus) may occur.
• Thyroid hormones, as dose adjustment may be necessary.
  Patients with diabetes require medical supervision when taking Mucofalk O, as dosage adjustments of antidiabetic medicines may be needed.

Taking Mucofalk O with food and drink
There are no special recommendations regarding taking Mucofalk O with meals.
However, if Mucofalk O is used as a dietary supplement in patients with hypercholesterolaemia, it is advisable to take the medicine during meals.
The medicine should always be taken with plenty of fluid—at least 150 ml of water, fruit juice, or similar liquid.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Mucofalk O may be used during pregnancy and breastfeeding only if necessary or if dietary modification is insufficient. Medicines that facilitate stool formation, such as Mucofalk O, should be used first; if ineffective, other laxatives should be considered.

Driving and operating machinery
Mucofalk O has no influence on the ability to drive or operate machinery.

Mucofalk O contains sodium and sucrose.

• Sodium: The maximum recommended daily doses of this medicinal product, depending on 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 sodium intake in the diet for adults. Patients, especially those monitoring dietary sodium intake, who take 4 sachets or more daily over a prolonged period should consult their doctor or pharmacist.
• Sucrose (sugar): If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Note for diabetic patients: A single dose (1 sachet) of Mucofalk O contains 0.5 g of sucrose; energy value: 3.07 kcal (12.86 kJ), equivalent to 0.064 carbohydrate exchange units (so-called "bread units").
Note for patients with coeliac disease: Mucofalk O does not contain gluten.
Note for patients with lactose intolerance: Mucofalk O does not contain lactose.

3. How to use Mucofalk O

This medicine should always be used as described in this patient leaflet or as directed by a doctor. If in doubt, consult a doctor or pharmacist.
Use in children
Mucofalk O should not be given to children under 12 years of age due to insufficient data in this age group.
Dosage
Adolescents over 12 years of age, adults and elderly patients

• For treatment of habitual constipation and conditions where easier evacuation of the intestines with soft stools is desired, e.g. painful defecation after anal or rectal surgery, anal fissures, haemorrhoidal disease: One sachet of Mucofalk O (5 g of granules) mixed with a large amount of liquid, at least 150 ml (1 g of granules to be taken with at least 30 ml of liquid), 2 to 3 times daily.
• For patients in whom increased daily intake of dietary fibre is desired, e.g. as supportive treatment in constipation predominant in irritable bowel syndrome or as an adjunct to diet in patients with hypercholesterolaemia: One sachet of Mucofalk O (5 g of granules) mixed with a large amount of liquid, at least 150 ml (1 g of granules to be taken with at least 30 ml of liquid), 2 to 6 times daily.

If Mucofalk O is used as a dietary supplement in patients with hypercholesterolaemia, it is recommended to take the medicine during meals.
Instructions for use :

1. Never consume the medicine in dry form, as it may block the throat, airways or oesophagus and lead to choking. 2 . Empty the contents of one sachet of Mucofalk O into a glass.

3 . Slowly fill the glass with water, fruit juice, milk or another similar liquid (at least 150 ml).

4. Stir with a spoon to ensure no lumps form, and drink immediately.
5. Follow with an additional glass of liquid. 6 . Do not consume while lying down or immediately before going to sleep.

The effect of Mucofalk O is usually observed 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 effect of Mucofalk O seems too strong or too weak, consult a doctor or pharmacist.
If a patient suffers from long-lasting constipation and irregular bowel movements lasting longer than 3 days, diarrhoea lasting longer than 2 days, or if diarrhoea is accompanied by blood or fever, medical advice should be sought. Also refer to the instructions in section "Warnings and precautions" point 2.
Use of a higher than recommended dose of Mucofalk O
If too much Mucofalk O is taken, symptoms such as abdominal pain, bloating (flatulence), and a feeling of fullness may worsen. Intestinal obstruction may occur. Drink a large amount of fluid immediately and then contact a doctor, who will determine whether further treatment is necessary.
Missed dose of Mucofalk O
If a dose of Mucofalk O is missed, continue treatment as recommended. Do not take a double dose to make up for the missed dose. If in doubt, consult a doctor.
Stopping Mucofalk O
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Abdominal bloating and a feeling of fullness may occur during treatment with Mucofalk O; however, these effects usually subside during continued treatment.

Abdominal distension and intestinal obstruction may occur, as well as a risk of faecal impaction or oesophageal obstruction, especially if Mucofalk O is taken with insufficient fluid intake. Frequency is not known.

The seed husks of Plantago ovata contain allergens which, when the medicine is taken orally or comes into contact with the skin, may cause hypersensitivity reactions. Symptoms of hypersensitivity may include: rhinitis, conjunctivitis, bronchospasm, and in some cases, anaphylactic shock (a sudden, generalized allergic reaction which may lead to a life-threatening condition).

Skin reactions such as rash and itching have also been reported. Frequency of these adverse effects is not known.

If the first signs of an allergic reaction occur, treatment with Mucofalk O should be discontinued and the use of this medicine should be avoided in the future.

If any adverse effects not listed above occur, consult a doctor or pharmacist.

Reporting of adverse effects

If any undesirable effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Mucofalk O

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the sachet and carton. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Mucofalk O contains
The active substance is Plantago ovata seed husk (Plantaginis ovatae seminis tegumentum).
One sachet (5 g of granules) contains 3.25 g of Plantago ovata seed husk.
The other ingredients are: sucrose, citric acid, dextrin, sodium alginate, sodium citrate, sodium chloride, sodium saccharin, orange flavour [Evogran No. 301768].

What Mucofalk O looks like and contents of the pack
Mucofalk O is beige granules with brown particles, with an orange flavour.
The packaging consists of a sachet made of PE/Al/PE laminated coated paper.
Pack sizes available: 20 sachets in a cardboard box.

Marketing Authorisation Holder and Manufacturer:
Dr. Falk Pharma GmbH
Leinenweberstrasse 5
79108 Freiburg
Germany

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Ewopharma AG Sp. z o.o., Leszno 14, 01-192 Warsaw, tel. 22 620 11 71