Mucofalk

MUCOFALK Apple Granules for the preparation of suspension for oral administration in sachets

Important notes (mandatory information)

Mucofalk Apple Granules. Active ingredient: Indian flea seed husks, ground. Areas of application: long-term (chronic) constipation (obstipation), conditions in which easier bowel movements with soft stools are desired, e.g. in the case of tears in the mucous membrane of the anus (anal fissures), hemorrhoids, painful bowel movements after surgical interventions in the rectal area, diarrhea of various causes for supportive treatment and in conditions in which an increase in daily fiber intake is desired, such as support for irritable bowel syndrome when constipation is the main issue.

For risks and side effects, read the package insert and consult your doctor or pharmacist.


PACKAGE INSERT: INFORMATION FOR THE USER

Mucofalk Apple Granules, for use in adults and adolescents aged 12 and over
Active ingredient: Indian flea seed husks, ground (Plantago ovata seed husks)

Read the entire package insert carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package insert or exactly as directed by your doctor or pharmacist.

• Keep the package insert. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package insert (see section 4).
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

What is in this package insert

1. WHAT IS MUCOFALK APPLE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MUCOFALK APPLE?
3. HOW SHOULD YOU TAKE MUCOFALK APPLE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MUCOFALK APPLE BE STORED?
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

1. WHAT IS MUCOFALK APPLE AND WHAT IS IT USED FOR?

Mucofalk Apple contains Indian flea seed husks (ground) as the active ingredient, a plant-based swelling agent for regulating bowel movements. Mucofalk Apple is used for: long-term (chronic) constipation (obstipation), conditions in which easier bowel movements with soft stools are desired, e.g. in the case of tears in the mucous membrane of the anus (anal fissures), hemorrhoids, painful bowel movements after surgical interventions in the rectal area, diarrhea of various causes for supportive treatment and in conditions in which an increase in daily fiber intake is desired, such as support for irritable bowel syndrome when constipation is the main issue.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MUCOFALK APPLE?

Mucofalk Apple must not be taken if you:

• are allergic to flea seeds (Plantago, Psyllium) or any of the other ingredients listed in section 6 of this medicine,
• notice a sudden change in your bowel habits that lasts for more than 2 weeks,
• have not had a bowel movement after taking a laxative,
• have difficulty swallowing or other throat and esophageal problems,
• notice blood in your stool without the cause being clear,
• have a pathological narrowing in the gastrointestinal tract,
• have a disease of the esophagus or the entrance to the stomach,
• suffer from impending or existing intestinal obstruction (ileus), intestinal paralysis or pathological enlargement of the colon (megacolon syndrome).

Warnings and precautions

Talk to your doctor or pharmacist before taking Mucofalk Apple, especially if you suffer from constipation with unclear abdominal discomfort, abdominal pain, nausea and vomiting. These symptoms may indicate impending or existing intestinal obstruction. In this case, you must not take Mucofalk Apple. Take each individual dose of Mucofalk Apple with a glass of water (at least 150 ml), fruit juice or similar liquids. If you take Mucofalk Apple without sufficient liquid, the medicine may swell in the throat and block it or the esophagus. This can lead to a choking attack or intestinal obstruction. Contact a doctor immediately if you experience chest pain, vomiting, difficulty swallowing or breathing after taking Mucofalk Apple. If constipation persists and bowel movements are irregular for more than 3 days or if diarrhea lasts for more than 2 days or is accompanied by blood or fever, please contact your doctor. In the case of diarrheal diseases, attention must be paid to replacing fluids and salts (electrolytes) as the most important treatment measure. If you are taking Mucofalk Apple to treat chronic constipation and you experience abdominal pain or irregular bowel movements, you should stop taking Mucofalk Apple and see a doctor. The treatment of weakened or elderly patients should be appropriately monitored.

Taking Mucofalk Apple with other medicines

Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Please note that this information may also apply to medicines that you have used recently.

If you are taking the following medicines at the same time, their absorption into the blood may be delayed:

• Minerals
• Vitamins (vitamin B12)
• Medicines for heart failure (cardiac glycosides)
• Medicines that inhibit blood clotting (coumarin derivatives)
• Medicines for epilepsy (carbamazepine) or depression (lithium)

You should always allow a time interval of about 1/2 to 1 hour between taking Mucofalk Apple and other medicines.

The following medicines should only be taken under medical supervision if you are taking Mucofalk Apple at the same time:

• Medicines that inhibit natural bowel movements (e.g. loperamide, opiates), as intestinal obstruction may occur.
• Thyroid hormones, as a weakening of the effect of thyroid hormones can also occur if they are not taken at the same time as Mucofalk Apple. Please talk to your doctor, as the dose of thyroid hormones may need to be adjusted.

If you are diabetic, you should only take Mucofalk Apple under medical supervision, as an adjustment of the antidiabetic treatment may be necessary.

Taking Mucofalk Apple with food and drink

No special precautions are necessary. However, always take this medicine with a sufficient amount of liquid - at least 150 ml of water, fruit juice or similar liquids.

Pregnancy and breastfeeding

Use during pregnancy and breastfeeding can be considered if necessary and a change in diet is not successful. Laxative swelling agents should be used before other laxatives are used.

Driving and operating machinery

Mucofalk Apple has no influence on the ability to drive and operate machinery.

Mucofalk Apple contains sodium and sucrose

Sodium: A single dose of Mucofalk Apple (5 g) contains 3.9 mmol (90 mg) of sodium. If you need to follow a low-salt diet, you should take this into account. Sucrose (sugar): Please only take this medicine after consulting your doctor if you know that you suffer from an intolerance to certain sugars. Note for patients with diabetes: A single dose of Mucofalk Apple (5 g) contains 0.5 g of sucrose (sugar) as well as 3.07 kcal (12.86 kJ) and corresponds to 0.064 bread units. Note for patients with celiac disease: Mucofalk Apple is gluten-free. Note for patients with lactose intolerance: Mucofalk Apple is lactose-free.

3. HOW SHOULD YOU TAKE MUCOFALK APPLE?

Always take this medicine exactly as described in this package insert or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Use in children

Since there is insufficient experience, you should not use Mucofalk Apple in children under 12 years of age.

The recommended dose is:

• for the treatment of chronic constipation and in conditions in which easier bowel movements with soft stools are desired (e.g. tears in the mucous membrane of the anus, hemorrhoids): Adults and adolescents aged 12 and over take the contents of one portion bag of Mucofalk Apple 2 to 3 times a day after stirring into plenty of liquid (at least 150 ml).
• for supportive treatment of diarrhea and irritable bowel syndrome: Adults and adolescents aged 12 and over take the contents of one portion bag of Mucofalk Apple 2 to 6 times a day after stirring into plenty of liquid (at least 150 ml).

Method of administration:

• Never take the medicine dry, as this can block the throat, airways or esophagus.
• Pour the contents of one bag of Mucofalk Apple into a glass.
• Slowly fill the glass with water, fruit juice or similar liquids (at least 150 ml).
• Stir quickly with a spoon. Make sure that no lumps form and drink the liquid you have prepared immediately.
• Drink another glass of liquid.
• Do not take the medicine lying down or immediately before going to bed!

The effect of Mucofalk Apple usually sets in 12 to 24 hours after taking it. Take Mucofalk Apple during the day at least 1/2 to 1 hour before or after taking other medicines. Please also observe the warnings and precautions for use and the instructions for taking with other medicines in section 2.

Duration of use

Please talk to your doctor or pharmacist if you have the impression that the effect of Mucofalk Apple is too strong or too weak. Please contact your doctor or pharmacist if your constipation has not cleared up within 3 days or your diarrhea has not cleared up within 2 days. Please also observe the other information in the section "Warnings and precautions".

If you have taken more Mucofalk Apple than you should

Even if you have taken several portions at the same time, overdose symptoms are generally not to be expected. However, if the dosage is too high, symptoms such as abdominal pain, flatulence and a feeling of fullness may be intensified. Intestinal obstruction may possibly occur. First drink plenty of fluids and contact a doctor. He will decide whether countermeasures are necessary.

If you forget to take Mucofalk Apple

If you forget to take a dose, please continue treatment as recommended in the dosage instructions without increasing the dose. If in doubt, please ask your doctor or pharmacist for advice.

If you stop taking Mucofalk Apple

If you interrupt or stop treatment prematurely, you must expect that Mucofalk Apple will not work as desired or that your symptoms will worsen again. If you are taking Mucofalk Apple on the advice of a doctor, please consult your doctor before stopping treatment.

If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can have side effects, although not everybody gets them. Flatulence and a feeling of fullness may occur, but these generally subside as treatment continues. Especially if there is insufficient fluid intake, flatulence and hard stools may occur, and there is a risk of intestinal obstruction and blockage of the esophagus. Indian flea seed husks contain substances that can lead to hypersensitivity reactions after oral ingestion of the medicine or through skin contact with the medicine. The symptoms of hypersensitivity reactions can include a runny nose, red eyes, difficulty breathing, skin reactions, itching and, in some cases, anaphylactic shock (a sudden generalized allergic reaction that can lead to a life-threatening shock reaction). The frequency of the side effects mentioned is not known. At the first signs of a hypersensitivity reaction, Mucofalk Apple must not be taken again.

Reporting of side effects

If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the safety of this medicine.

5. HOW SHOULD MUCOFALK APPLE BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the bags and the folding box. The expiry date refers to the last day of the month indicated. This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Mucofalk Apple contains

The active ingredient is: Indian flea seed husks, ground. 5 g granules (= 1 bag) contain: 3.25 g Indian flea seed husks, ground. The other ingredients are: Sucrose (saccharose), citric acid, dextrin (from corn or potatoes), sodium alginate, sodium citrate (Ph.Eur.), apple flavor, sodium chloride, saccharin sodium (For more information on sodium and sucrose, see the end of section 2)

What Mucofalk Apple looks like and contents of the pack

Mucofalk Apple is a beige-colored granule with brown particles and smells like apples. Mucofalk Apple is available in packs of 20 and 100 portion bags of 5 g granules each.

Pharmaceutical entrepreneur and manufacturer

Dr. Falk Pharma GmbH
Leinenweberstr. 5
79108 Freiburg
Germany

Tel.: 0761/1514-0
Fax: 0761/1514-321
E-mail: zentrale@drfalkpharma.de
www.drfalkpharma.de

This package insert was last revised in May 2014.

Source: Information from the package insert
Status: 10/2016
Active ingredient: Indian flea seed husks, ground. Areas of application: long-term (chronic) constipation (obstipation), conditions in which easier bowel movements with soft stools are desired, e.g. in the case of tears in the mucous membrane of the anus (anal fissures), hemorrhoids, painful bowel movements after surgical interventions in the rectal area, diarrhea of various causes for supportive treatment and in conditions in which an increase in daily fiber intake is desired, such as support for irritable bowel syndrome when constipation is the main issue.