Tilactamed Chewable Tablets, 100 pcs

Instructions for use for Tilactamed Chewable Tablets, 100 pcs

Important notes (compulsory information):

Tilactamed 2000 FCC units / chewable tablet. Active substance: Tilactase from Aspergillus Oryzae. Areas of application: For symptomatic treatment of lactose intolerance (lactose intolerance), which occurs after milk recording or consumption of other dairy products or lactose-containing food.

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


LEAFLET: INFORMATION FOR THE USER

Tilactamed 2000 FCC units / chewable tablet
Active substance: Tilactase from Aspergillus Oryzae

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

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If no improvement occurs or worsen your symptoms, you definitely have to visit a doctor.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.

What is in this leaflet

1. What is Tilactamed and what is it used for?
2. What should you consider before taking?
3. How to take Tilactamed?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Tilactamed?
6. Content of the pack and more information

1. What is Tilactamed and what is it used for?

What is Tilactamed?
Tilactamed is an enzyme preparation that is effective in the stomach.

What is it used for?
Tilactamed is used to symptomatic treatment of lactose intolerance (lactose intolerance) occurring after milk holder or consumption of other dairy products or lactose-containing food.

2. What should you consider before taking?

2.1 Do not take
You may not take Tilactamed,

• if you allergic against Aspergillus (a mold style) or one of the other ingredients of this medicine referred to in section 6. In patients with an allergy against this mold, the intake of Tilactamed Allerg
• if your pancreas is acute or chronically inflamed (Pancreatitis).

Children under 3 years are not intended to take Tilactamed, since there is accidental risk due to accidental ingestion.

2.2 Warnings and precautions
When is special caution required when taking?
Special caution is required if your lactose intolerance was created by a gastrointestinal disease, e.g. B. by a chronic inflammatory bowel disease or a native Sprüe (celiac disease). In these cases, you should ask your doctor before taking Tilactamed. If you react hypersensitive to milk, this may be a lactose intolerance (lactose intolerance), or even an incompatibility with the milk protein (Milk Iwitch Allergy or Pseudoallergy). Tilactamed only affects the milk sugar incompatibility, but it is ineffective in milk protein incompatibility. For persistent complaints, despite sufficient dosage of tilactamed, therefore, a cause of complaints must be thought of a milk protein intolerance. Please discuss in this case the further procedure with your doctor.

What should be considered in children?
An application of tilactamed in children should only be followed by secure diagnosis of milk sugar incompatibility. Especially the presence of milk protein allergy or
-Pseudoallergy should be connected with TI before taking dairy productslactamed to be excluded.

What do you need in pregnancy and lactation?
There are no sufficient investigations for the use of tilactamed in pregnancy and lactation. You should take TILACTAMED in pregnancy and lactation only after consulting your doctor. Ask your doctor or pharmacist for advice before taking all medicines.

What should be considered in older people?
There are no special precautions required.

Impact on the ability to drive and use machines:
There are no special precautions required.

2.3 Interactions
Drugs can influence each other, so that their effect is then stronger or weaker than usual. Please inform your doctor or pharmacist if you take other medicines, recently occupied other medicines or intend to take other medicines.

What should be noted if you take other medicines at the same time?
Simultaneous administration of iron or zinc-containing preparations can attenuate the effect of tilactamed.

2.4 Notes on other ingredients
This medicine contains sugar (sucrose) and grape sugar (Glucose). Please take Tilactamed only after consulting with your doctor if you are familiar with any intolerance to certain sugars.

3. How to take Tilactamed?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. Note: Tilactamed is not a substitute for a milk sugar-reduced diet. In the milk sugar incompatibility, in which gastrointestinal complaints are triggered by eating milk and dairy products, a dietary therapy should be in the foreground. Accordingly, the most priority measure should be in a nutritional change.

Note for diabetics:
1 chewing tablet contains 278.8 mg carbohydrates, corresponding to 0.02 Be.

How and how often should you take Tilactamed?
Unless otherwise prescribed by the doctor, the usual dose for adults and children from 3 years: 1 to a maximum of 5 chewable tablets per meal. Tilactamed tablets are chewed directly to meals that contain milk or dairy products. The in 1 Chewable contained enzyme activity is sufficient for the recovery of about 10 g of milk sugar or 200 ml of whole milk. With higher milk sugar or milk content of the meal, the dose must be increased accordingly. The intake of more than 5 chewable tablets per meal should not be exceeded, as higher dosages there are no sufficient clinical experiences. Please talk to your doctor or pharmacist if you have the impression that the effect of tilactamed is too strong or too weak.

Lighth sugar (lactose) content of common food in grams per 100 g:
Cow Milk (1.5 - 3.7%) 4.8 - 5.0; Yogurt 3.7 - 5.6; Quarry (10 - 40%) 2.0 - 3.8; Gouda cheese up to 2.2.

How long do you take Tilactamed?
Tilactamed only relieves the complaints of a lactose intolerance. Since the cause is not resolved by taking, a limitation of the application time is not provided.

If you take a larger amount of Tilactamed than you should, this has no negative consequences for you. Passional symptoms are unknown.

If you forget to take Tilactamed, with a meal that contains milk or dairy products, the complaints of your lactose intolerance will temporarily occur. Subsequent intake of Tilactamed can not eliminate these complaints. Tilactamed can only be effective if you take the chewable tablets together with the food.

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

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other. The assessment of side effects is based on the following frequency information:

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Possible side effects:
Very rarely has been reported by allergic reactions in patients sensitive to the mold of aspergillus.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. 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 security of this medicine.

5. How to keep Tilactamed?

Storage conditions:

• Store drug out of reach of children.
• Do not store more than 25 ° C.
• Store in the original packaging to protect the content from moisture.

Durability:
You must not use the medicinal product after the specified expiration date. This date is on the pushback pack and the folding box after printed. The expiration date refers to the last day of the month.

Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What Tilactamed contains:
The active ingredient is Tilactase. 1 chewing tablet contains 14.8 - 15.8 mg Tilactase from Aspergillus Oryzae; Activity: 2000 FCC units (Food Chemical Codex). The other ingredients are: Carmelosis Calcium, Cellulose Powder, D-Glucose, Hochdiserses Silica Dioxide, Caramel Toffee Aroma, Magnesium Stearate (Ph.eur.) Plant, microcrystalline cellulose, povidone 25, sucrose.

How to look tilactamed and content of the pack:
The chewable tablets are packed in throughput strips, which are inserted in folding boxes. Tilactamed is packed with 25, 50, 100, 200, 300, 400 and 1000 chewing tablets available. Not all pack sizes may be placed on the market.

Pharmaceutic entrepreneur:
Strathmann GmbH & Co. KG
Mailbox 610425
22424 Hamburg
Tel: 040/55 90 5-0
Fax: 040/55 90 5-100
E-Mail: [email protected]

Manufacturer:
Biokirch GmbH
At the damps 11
21220 Seevetal

This information information was last revised in April 2014.

Source: Information of the leaflet
Status: 05/2016