Mucofalk

MUCOFALK Orange Gran. for the preparation of a suspension for oral use

Important notes (mandatory information)

Mucofalk Orange Granules. Active ingredient: Indian psyllium 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), haemorrhoids, painful bowel movements after surgical interventions in the rectal area, diarrhoea of various causes for supportive treatment and in conditions in which an increase in daily fibre intake is desired, such as in support of irritable bowel syndrome when constipation is the main issue.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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

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

What is in this package leaflet

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

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

Mucofalk Orange contains Indian psyllium husks (ground) as the active ingredient, a vegetable swelling agent for regulating bowel movements. Mucofalk Orange 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), haemorrhoids, painful bowel movements after surgical interventions in the rectal area, diarrhoea of various causes for supportive treatment and in conditions in which an increase in daily fibre intake is desired, such as in support of irritable bowel syndrome when constipation is the main issue.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MUCOFALK ORANGE?

Mucofalk Orange must not be taken if you:

• are allergic to psyllium (Plantago, Psyllium) or any of the other ingredients listed in section 6 of this medicine,
• experience 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 oesophageal problems,
• notice blood in your stools without the cause being clear,
• have a pathological narrowing in the gastrointestinal tract,
• have a disease of the oesophagus 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 Orange, especially if you suffer from constipation with unclear abdominal complaints, abdominal pain, nausea and vomiting. These symptoms may indicate impending or existing intestinal obstruction. In this case, you must not take Mucofalk Orange. Take each individual dose of Mucofalk Orange with a glass of water (at least 150 ml), fruit juice or similar liquids. If you take Mucofalk Orange without sufficient liquid, the medicine may swell in the throat and block it or the oesophagus. This can lead to a choking fit or intestinal obstruction. Contact a doctor immediately if you experience chest pain, vomiting, difficulty swallowing or breathing after taking Mucofalk Orange. If constipation persists and bowel movements are irregular for more than 3 days or if diarrhoea lasts for more than 2 days or is accompanied by blood or fever, please contact your doctor. In the case of diarrhoeal diseases, attention must be paid to replacing fluids and salts (electrolytes) as the most important treatment measure. If you are taking Mucofalk Orange to treat chronic constipation and you experience abdominal pain or irregular bowel movements, you should stop taking Mucofalk Orange and consult a doctor. The treatment of weakened or elderly patients should be appropriately monitored.

Taking Mucofalk Orange 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 approx. 1/2 to 1 hour between taking Mucofalk Orange and other medicines.

The following medicines should only be taken under medical supervision if you are taking Mucofalk Orange 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 Orange. 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 Orange under medical supervision, as it may be necessary to adjust your antidiabetic treatment.

Taking Mucofalk Orange 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 breast-feeding

Use during pregnancy and breast-feeding 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 Orange has no influence on the ability to drive and use machines.

Mucofalk Orange contains sodium and sucrose

Sodium: A single dose of Mucofalk Orange (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 Orange (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 coeliac disease: Mucofalk Orange is gluten-free. Note for patients with lactose intolerance: Mucofalk Orange is lactose-free.

3. HOW TO TAKE MUCOFALK ORANGE?

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

Use in children

As there is insufficient experience, you should not use Mucofalk Orange 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, haemorrhoids): Adults and adolescents aged 12 and over take the contents of one sachet of Mucofalk Orange 2 to 3 times a day after stirring into plenty of liquid (at least 150 ml).
• for supportive treatment of diarrhoea and irritable bowel syndrome: Adults and adolescents aged 12 and over take the contents of one sachet of Mucofalk Orange 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 oesophagus.
• Pour the contents of one sachet of Mucofalk Orange 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 prepared liquid immediately.
• Drink another glass of liquid afterwards.
• Do not take the medicine lying down or immediately before going to bed!

The effect of Mucofalk Orange usually sets in 12 to 24 hours after taking it. Take Mucofalk Orange 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 information on 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 Orange is too strong or too weak. Please contact your doctor or pharmacist if your constipation has not cleared up within 3 days or your diarrhoea has not cleared up within 2 days. Please also observe the further information in the section "Warnings and precautions".

If you have taken more Mucofalk Orange 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. They will decide whether countermeasures are necessary.

If you forget to take Mucofalk Orange

If you forget to take a dose, please continue with the 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 Orange

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

If you have any further questions on the use of this 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 oesophagus. Indian psyllium 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 generalised allergic reaction that can lead to a life-threatening shock reaction). The frequency of the side effects mentioned is not known. Mucofalk Orange must not be taken again at the first signs of a hypersensitivity reaction.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package leaflet. 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 on the safety of this medicine.

5. HOW SHOULD MUCOFALK ORANGE 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 sachets and the folding box. The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mucofalk Orange contains

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

What Mucofalk Orange looks like and contents of the pack

Mucofalk Orange is a beige coloured granules with brown particles and smells of oranges. Mucofalk Orange is available in cans with 150 and 300 g granules.

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 leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Indian psyllium 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), haemorrhoids, painful bowel movements after surgical interventions in the rectal area, diarrhoea of various causes for supportive treatment and in conditions in which an increase in daily fibre intake is desired, such as in support of irritable bowel syndrome when constipation is the main issue.