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What is Mezim Forte 10000 Ph. Eur. U. and what it is used for
What is Mezim Forte 10000 Ph. Eur. U.?
Mezim forte 10000 Ph. Eur. U. is a medicine that contains substances (enzymes) from porcine pancreas (pancreatic powder, also called pancreatin) that promote digestion.
What is Mezim Forte 10000 Ph used for? Eur. U.?
Mezim forte 10000 Ph. Eur. U. is used to replace digestive enzymes in indigestion due to reduced or absent pancreatic function (exocrine pancreatic insufficiency).
2. What you need to know before you take Mezim® Forte 10000 Ph. Eur. U.
Do not take Mezim Forte 10000 Ph. Eur. U .:
- if you are allergic to pancreatin, porcine products, azorubine (E 122) or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from acute pancreas inflammation or severe chronic inflammation of the pancreas during the active phase of the disease. Sometimes, however, it is advisable to use the drug in the diet with a diet (light meal) if the digestive tract continues.
Warnings and precautions
Talk to your doctor or pharmacist before taking Mezim forte 10000
- if you notice you have complaints like bowel obstruction (eg abdominal pain, lack of intestinal function, nausea, vomiting).
Intestinal obstruction is a known complication in patients with fibrotic fibrosis;
- this medicine contains active enzymes that, when released into the oral cavity, chewing the tablet may result in damage to the mucous membrane of the mouth (eg, oral mucous membrane wounds). Therefore, the Mezim® forte 10000 Ph tablets is necessary. Eur. U. to adopt goals.
Other medicines and Mezim Forte 10000 Ph. Eur. U.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The absorption of folic acid (the passage of folic acid into the blood) can be reduced by taking medicinal products containing pancreatin, which means that additional folic acid may be needed.
The effect of oral glucose lowering drugs (oral antidiabetic medicines) acarbose and miglitol may be reduced by the simultaneous administration of Mezim forte 10000 Ph. Eur. U.
Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
There is insufficient data on the use of Mezim Forte 10000 Ph. Eur. U. in pregnant women. There are only insufficient data from animal studies on pregnancy, development of the unborn child, childbirth and development after childbirth. The potential risk to humans is unknown. If you are pregnant or breast-feeding, you should not take Mezim Forte 10000 Ph. Eur. U., unless your doctor thinks that taking is absolutely necessary.
Driving and using machines
Mezim forte 10000 Ph. Eur. U. does not have or has an insignificant effect on the ability to drive or use machines.
Mezim forte 10000 Ph. Eur. U contains lactose and azorubine
This medicine contains lactose and azorubine.
This medicinal product contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
This medicinal product contains azorubine (E 122) which may cause allergic reactions.
3. How to take Mezim Forte 10000
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
2-4 tablets Mezim forte 10000 meal (equivalent to 20,000-40,000 lipase units per meal).
The dosage of Mesim forte 10000 Ph. Eur. U. is determined by the severity of the existing digestive disorder. The required dose may be even higher. Larger dose increases can only be performed under medical supervision and are intended to improve symptoms (eg fatty stools, abdominal pain).
A daily enzyme dose of 15,000-20,000 units of lipase per kilogram of body weight should not be exceeded. Especially in patients with cystic fibrosis, the dose of enzymes should not be higher than that required for sufficient fat absorption.
Use in children and adolescents
Dosage in children should be determined by a physician.
Mezim forte 10000 Ph. Eur. U. should be swallowed whole with plenty of liquid (water or juice) during meals. Note that the tablets should be swallowed whole, as the effectiveness of Mezim forte 10000 Ph. Eur. U. decreases, and the enzymes contained may, after release, damage the lining of the oral cavity. Then take a large amount of liquid (water or juice).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Important side effects or signs that you need to be aware of and appropriate measures you should take
If you are affected by any of the side effects listed above, do not take Mesim Forte 10000 Ph. Eur. U. more and if possible immediately consult a doctor. He will consider further treatment.
Very rare side effects (may affect less than 1 in 10,000 patients)
- diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting;
- immediate-type allergic reactions such as skin rash, urticaria, sneezing, tearing, shortness of breath due to narrowing of the airways (bronchospasm), difficulty in breathing; allergic reactions of the digestive system;
- narrowing of the small intestine / appendix area and descending colon is described in patients with cystic fibrosis when high doses of pancreatin are administered. This narrowing may result in intestinal obstruction (see "Warnings and Precautions" section).
- if you have an abnormal stomach or gastrointestinal discomfort or a change in your complaints, your doctor will have to look after you to prevent the possibility of damage to your bowel. This particularly affects patients taking daily more than 10,000 units of lipase per kilogram of body weight.
Adverse reactions of unknown frequency (can not be estimated from the available data)
- In patients with cystic fibrosis, especially with high doses of pancreatin, an increased urinary excretion of uric acid may occur. Therefore, if you are a cystic fibrosis patient, your doctor should monitor the urinary excretion of uric acid to avoid urate stones.
- Azorubine can cause allergic reactions.
As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How to store Mezim forte 10000 Ph. Eur. U.
Keep out of the reach of children!
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 30 ° C.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Mezim Forte 10000 Ph contains. Eur. U.
The active substance is:
A gastro-resistant tablet contains 80 mg - 111,111 mg of pancreatic powder (porcine pancreas powder) equivalent to at least the following activity
Lipase 10000 Ph. Eur. Units / Tablet
Amylase not less than 7500 Ph. Eur. Units / Tablet
Proteases not less than 375 Ph. Eur. Units / Tablet
The pancreatic powder is made from porcine pancreatic tissue.
The other ingredients are:
Core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate (Ph.Eur.) (Vegetable).
Wrap: hypromellose, methacrylic acid-ethyl acrylate copolymer (1: 1 dispersion) 30%, triethyl citrate, talc, simethicone emulsion consisting of simethicone, methylcellulose, sorbic acid (Ph. Eur), water; macrogol 6000, carmellose sodium, polysorbate 80 (vegetable), azorubine (colorants E 122), titanium dioxide, sodium hydroxide.
What does Mezim forte 10000 Ph look like? Eur. U. and what the package contains
Mezim forte 10000 Ph. Eur. U. are pink, round, slightly rounded tablets with bevelled edges with gastro-resistant film coating. Available in blister packs in cartons, together with a leaflet for the patient.
Original packs of 10, 20, 50 or 100 tablets.
Not all pack sizes may be marketed.
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