Nortase, 200 Capsules

active ingredients

• 54 FIP-E. Aspergillus oryzae protease at least
• 700 FIP E. Aspergillus oryzae amylase at least
• 7000 FIP-E. rizolipase

ingredients

• magnesium stearate
• hypromellose
• Iron(III) oxide, red
• lactose-1 water
• titanium dioxide

Indication :

• Substance group:

  • NORTASE ^® is an acid-stable digestive enzyme preparation of plant origin. The active ingredients are:

    • Rizolipase (lipase from Rhizopus oryzae)

    • Protease from Aspergillus oryzae

    • Amylase from Aspergillus oryzae

• Application areas:

  • NORTASE ^® is used:

    • to replace digestive enzymes in maldigestion (indigestion) as a result of impaired pancreatic function.

Dosage :

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The recommended dose is:

  • The dosage of NORTASE ^® is determined by the doctor depending on the severity of the disease. As a guide, a daily dose of 30,000 - 100,000 FIP units of lipase, 200 - 6,000 units of amylase and 100 - 300 units of protease can be recommended. For the fat-splitting enzyme lipase, this corresponds to approx. 5 - 15 capsules per day, which should be taken at meals (1 - 3 capsules per meal).

  • Treatment with NORTASE ^® is aimed at achieving or maintaining a normal body weight and normalizing the frequency and consistency of bowel movements.

  • In patients with cystic fibrosis, the dose should not exceed the enzyme dose necessary for adequate fat absorption, taking into account the quantity and composition of meals.

  • Make sure you drink plenty of fluids.

• Duration of use:

  • The duration of use is determined by the attending physician depending on the need for treatment of the disease. There is no fundamental restriction on the duration of treatment.

• If you take more NORTASE ^{® than you should:}

  • Overdoses and symptoms of poisoning are not known.

• If you forget to take NORTASE ^®

  • Do not take twice the amount the next time you take it, but continue taking it as described in the dosage instructions.

• If you stop taking NORTASE ^®

  • In this case, the symptoms may recur.

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

way :

• NORTASE ^® capsules are swallowed whole with sufficient liquid (water, juice or lukewarm tea) during a meal or a snack.

Side effects :

• Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is based on the following categories:

  • Very common: may affect more than 1 in 10 people

  • Common: may affect up to 1 in 10 people

  • Uncommon: may affect up to 1 in 100 people

  • Rare: may affect up to 1 in 1,000 people

  • Very rare: may affect up to 1 in 10,000 people

  • Not known: frequency cannot be estimated from the available data

• The following side effects have been observed with NORTASE ^® :

  • Rare: Unspecific side effects such as diarrhea, nausea, constipation, upper abdominal pain and allergic respiratory and skin reactions after occupational sensitization to mold enzymes. If you notice breathing difficulties or skin reactions after taking NORTASE ^® , please consult your doctor immediately and do not take any more NORTASE ^® capsules in the meantime.

  • Please tell your doctor or pharmacist if any of the listed side effects gets serious.

• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Interactions :

• Taking NORTASE ^® together with other medicines

  • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

  • The absorption of folic acid into the blood can be reduced by taking finished medicinal products containing digestive enzymes, so that an additional folic acid supply may be necessary.

  • The effect of the blood-sugar-lowering drugs acarbose and miglitol can be reduced by taking digestive enzymes at the same time.

Contraindications :

• NORTASE ^® must not be taken:

  • if you suffer from acute pancreatitis (inflammation of the pancreas).

  • in the acute episode of chronic pancreatitis

  • if you are allergic to mold (mold allergy) or any of the other ingredients of this medicine.

Pregnancy and lactation :

• There are no objections to taking NORTASE ^® during pregnancy or breastfeeding.

Patient Notes :

• Warnings and Precautions

  • Please talk to your doctor or pharmacist before taking NORTASE ^® .

  • In patients with cystic fibrosis, a congenital metabolic disorder, the formation of narrowing of the ileum/cecum and the ascending sections of the large intestine has been described in individual cases after the administration of high doses of digestive enzymes. In the presence of symptoms similar to intestinal obstruction, the possibility of intestinal constriction should therefore also be considered.

  • NORTASE ^® capsules contain active enzymes which, when released in the oral cavity, e.g. B. by chewing, there can lead to mucosal damage (ulceration of the oral mucosa). It is therefore important to ensure that the capsules are swallowed whole.

• Ability to drive and use machines

  • There are no special precautions required.

What speaks against an application?

Always:
- Hypersensitivity to the ingredients

Under certain circumstances - talk to your doctor or pharmacist about this:
- Inflammation of the pancreas, in the acute state

What about pregnancy and breastfeeding?
- Pregnancy: According to current knowledge, the medicine has no harmful effects on the development of your child or the birth.
- Breast-feeding: According to current knowledge, there are no indications that the drug should not be used during breast-feeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

What adverse effects may occur?

- Gastrointestinal complaints, such as:
  - Nausea
  - Diarrhea
  - Constipation
  - Stomach pain
- Allergic reactions of the skin and respiratory tract

. If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Storage

The medicinal product may be used for a maximum of 6 months after opening/preparation!
The medicinal product must be stored at room temperature after opening/preparation!

What should you consider?
- Be careful if you are allergic to mold!
- Beware of intolerance to lactose. If you have to follow a diabetic diet, you should consider the sugar content.
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

How do the ingredients of the drug work?

The drug contains various digestive enzymes obtained from certain mushrooms. These digestive enzymes are very similar to the naturally occurring digestive enzymes in the human gastrointestinal tract and mix with the chyme in the stomach and intestines after ingestion. There they help to break down food by breaking down fats, proteins and carbohydrates into smaller units. This supports the digestion of the food.

What is included in medicines?

Manufacturer: REPHA GmbH Biological medicinal products