Bifiteral bag, 50x10 g

Instructions for use for Bifiteral bag, 50x10 g

Important notes (compulsory information):

Bifiteral powder Btl.. Active ingredient: lactulose. Applications: Constipation that can not be sufficiently resolved by a fiber-rich food; Relief of the intestinal emptying and softening of the chair in certain diseases, e.g. in painful care; Portocavale encephalopathy (brain damage in liver diseases).

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


Instructions for use:

Dear patient, dear patient!
Please read the following useful information because it contains important information about what you should consider when using this medicine. For questions, please contact your doctor or pharmacist.

Active ingredient: lactulose
composition
Active pharmaceutical ingredients:
10 g bifiteral® bag powder included 10 g lactulose (4-0-ß-D-Galactopyranosyl-D-fructose)

Other ingredients:
No.

Note:
Contains manufacturing fructose, galactose and lactose.

Dosage form and content
Original pack with 10 bags (N1)
Original pack with 20 bags (N2)
Original pack with 50 bags (N3)

Laxative; Liver and bowel therapy

Solvay Arzneimittel GmbH
Hans-Böckler-Allee 20
D - 30173 Hannover
Telephone: (0511) 857-2400
Fax. (0511) 857-3120
Manufacturer:
Solvay Pharmaceuticals B.V:
C.J. Van Houtenlaan 36
1380 Da Weesp
Netherlands

Application areas:
- Constipation that can not be sufficiently affected by fiber food and other general measures, as well as diseases requiring facilitated bowel movements.
- Prevention and treatment for postageocaral encephalopathy (i.e., Faults of brain function due to chronic liver diseases, especially in liver cirrhosis). Contraction

When should you do not take BiFiteral ® bag powder?
Complaints such as abdominal pain, vomiting and fever may be signs of a serious illness, e.g. intestinal closure (ileus) or inflammation in the gastrointestinal area.
For such complaints, you should not take BIFITERAL® bag powder and seek medical advice immediately.

Even with disturbances of the water and electrolyte household (Salvibles) If BiFiteral® bag powder should not be taken.
In the very rarely occurring incompatibilities of fructose (Fructose intolerance), galactose (galactosemia, glucose / galactose malabsorption syndrome) and lactose (lactase Insufficiency) If you do not take BIFITERAL® bag powder.

What should be considered in children?
Since in infants and toddlers, an inherited fructose incompatibility may have not yet been recognized, these BiFiteral® bag powder should only be consulted
received a doctor.

What do you need to consider in pregnancy and lactation?
Harmful effects of lactulose when ingested during pregnancy and lactation are not known. Lactulose can also be taken during pregnancy and lactation.

Precautions for the application and warnings
What precautions should be taken?
If you already suffer for a long time under constipation problems, so you should advise you from your doctor before starting a therapy with BiFiteral® bag powder from your doctor, because chronic disturbances or impairments of bowel movement can be signs of a serious disease!

Note for diabetics and patients with other explosive disorders of carbohydrates:
This medicinal product contains low amounts of digestible carbohydrates due to manufacturing, but only in relatively small amounts from the intestine into the body and therefore have almost no nutritional value. Nevertheless, note that BIFITERAL® bag powder in 1 bag (corresponding to 10 g of powder) max. 0.45 g of digestible carbohydrates e.g. Fructose (fructose), galactose, lactose
(Milk sugar) contains, which corresponds to max. 0.04 BE.

What do you need to consider in traffic as well as working with machinery and work without a secure stop?
BIFITERAL® BEYel powder has no adverse effect on the perception, judgment and the reaction assets.
Interactions with other means

Which other medicines affect the effect of BiFiteral® Bag powder or become even in their effect by Bifiteral ® Bag powder influenced?
BIFITERAL® bag powder can enhance potassium loss due to other simultaneously occupied drugs. These include certain urinary agents (diuretics) and adrenal tension hormones (corticosteroids) and the amphotericin used for fungi in potassium deficiency is the sensitivity to heart-for-seed glycosides (eg Digitoxin) increased. Substances which are released pH-dependent in the gut (such as 5-ASA) can be impaired by lactulose in their effect.

Dosage instructions, type and duration of the application
The following information apply, as far as your doctor Bifiteral® Bag powder did not prescribe otherwise. Please stick to the application rules, because Bifiteral® bag powder
Otherwise can not work properly! Also keep in mind that after taking the specified doses of Bifiteral® bag powder of a spacious, often different from patient to patient different
Time needed until the desired effect shows. Thus, the laxative effect of BiFiteral® bag powder can already after 2 - 10 Hours occur, but it can also 1 - 2 days
Until the first bowel movement, especially with insufficient dosage.

How much of BiFiteral® bag powder and how often should you take BIFITERAL® bag powder?
BIFITERAL® bag powder must be dosed differently depending on the field of application. The dosages specified here can only serve orientation and may need to be changed to achieve the desired effect.

1. For constipation:
Adults: 1-2 times a day 1/2 to 1 bag BiFiteral® bag powder (corresponding to 5 - 10 g lactulose )
Children: 1-2 times daily 1/4 to 1/2 bag Bifiteral® bag powder (corresponding to 3 - 6 g of lactulose)
Especially at the beginning of the treatment of constipation, larger doses BiFiteral® bag powder are often required. In general, this slightly higher start dose can be reduced after 3 to 4 days.

2. At Portokaval Encephalopathy, d. H. With impairment of brain function in the context of liver disease:
Adults: At the beginning of the treatment of postocorn enjoyphalopathy should
Adults 3 - 4 times a day 1/2 to 1 bag Bifiteral® bag powder (corresponding to 5 - 10 g of lactulose.
Then the dose should be slow and carefully to 3 - 4 times a day 2 to 3 bags bifiteral® bag powder (corresponding to 20 - 30 g) are increased. The goal should be the emptying of two to three soft chairs per day. There are no information for use in children.

This medicine contains in 1 bag (corresponding to 10 g of powder) Max.0.45 g digestible carbohydrates e.g. Fructose (fructose), Galactose, lactose (milk sugar), which corresponds
Max. 0.04 BE. (See also precautions for the application and warnings) How and when should you take BIFITERAL® bag powder? Please measure the dose of bifiteral® bag powder required for you. Subsequently, this amount BiFiteral® bag is powder with water or with warm beverages, eg. B. Coffee or
Tea, mixed or stuffed in yogurt, cereal or porridge and taken together with these foods.
The intake of lactulose can be done independently of meals. If a unique dose BiFiteral® bag powder is sufficient for the successful treatment of a constipation, then an ingestion in the morning after breakfast has become particularly
proven.

How long should you take BIFITERAL® bag powder?
The duration of treatment depends on the development of the respective clinical picture.

Overdose and other application errors
What to do if BiFiteral ® bag powder has been used in too large quantities (intended or accidental overdose)?
If BiFiteral® bag powder was taken in too large quantities, nausea, vomiting, diarrhea and losses of water and electrolytes (especially potassium and sodium) may occur, which may be compensated by a drug therapy
mustn. Inform your doctor if it has come to such complaints with overdose. This will then also decide on any treatment measures to be used.

What do you have to pay attention if you have taken powder's powder's powder's Bifiteral® bags or forgot a dose?
Even when taking the recommended dose Bifiteral® bag powder, it may take some time until the desired effect sets (see also "Dosing Instructions").
If you have taken too little, then the time can extend until the effect occurrence; The treatment success can then also be completely failed. If you have forgotten the intake of a dose BiFiteral® bag powder, please drive
With the therapy as recommended, without independently increasing the dose! In case of doubt please ask your doctor about advice!

What do you have to pay attention if you interrupt the treatment or end prematurely?
If you interrupt the treatment with BIFITERAL® bag powder or terminate the taking prematurely, so you need to expect that the desired effect does not adjust or the clinical picture deteriorates again. Please consult with
Your doctor if you want to end or interrupt the treatment.

Side effects
When assessing side effects, the following frequency information is usually used:
Very common: Often:
More than 1 out of 10 less than 1 of 10, but
Treated more than 1 of 100 treated
Occasionally: Rare:
less than 1 of 100, less than 1 of 1000,
But more than 1 of 1000 treated more than 1 of 10,000 Treated
Very rare:
Rarer than 1 of 10,000 treated, including individual cases

Which side effects can occur when taking BiFiteral® bag powder?
At the beginning of treatment with BIFITERAL® bag powder, slight bellyache and flatulence occur at medium dosage. Under high dosage, nausea, vomiting and diarrhea with disturbances in the electrolyte balance are also possible. In case of long-term intake of BiFiteral® powder powder in a dosage that leads to persistently thin chairs, must be calculated with the usual interference in the area of the water and electrolyte household (increased excretion of potassium, sodium and water) as well as their follow-ups. . Rare cases have been reported in the treatment of portocommalic epicphalopathy via a hyperrammia (increased sodium concentration in the serum). If you are watching side effects that are not listed in this leaflet, please tell your doctor or pharmacist.

Which countermeasures are to take with side effects?
The undesired drug reactions possible at the beginning of a treatment with BIFITERAL® bag powder, which can show in light abdominal pain and flatulence,
Mostly disappear from the alone in the further course of treatment.
If it comes under a - mostly high-dose - taking of BiFiteral® bag powder to diame and subsequent disturbances in the water and electrolyte balance, so these may need treated medical and a lack of water, potassium or
Sodium salts are compensated. Often then a reduction of the amount of BiFiteral® bag powder to be taken is required. If you notice these unwanted effects, please inform your attending physician. This will also decide whether a reduction or in rare
Cases a discontinuation of taking BiFiteral® bag powder is required.

Notes and information on the durability of the medicinal product
The expiration date of this pack is printed.
After this date, this pack may not be used! Shelf life after opening the container
Even after breaking the pack, BiFiteral® bag powder is stable for proper storage and storage for a maximum of 3 years up to the printed expiration date.

How is Bifiteral® bag powder to store?
BIFITERAL® bag powder must be stored at room temperature and must be kept well closed after breaking.
Note: Bifiteral® bag powder is to be kept so that it is not available for children.
> Stand: February 2003
Source: Manufacturer information