MEZYM FORTE 10000 x 50 tabl
LEAFLET
Leaflet: patient information
Mezim â forte 10000 Ph. Eur. U. gastro-resistant tablets
Mezymâ forte 10000 Ph. Eur. U. gastro-resistant tablets
Pancreatine ( Pancreatine )
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 7-14 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What is Mezim ® forte 10000 Ph. Eur. U. and what it is used for
2. What you should know before taking Mezim ® forte 10000 Ph. Eur. U.
3. How to take Mezim ® forte 10000 Ph. Eur. U.
4. Possible side effects
5. How to store Mezim ® forte 10000 Ph. Eur. U.
6. Contents of the package and additional information
- 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 drug containing substances (enzymes) from pig pancreas (pancreatic powder, also called pancreatin) that aid 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 resulting from reduced or absent pancreatic function (exocrine pancreatic insufficiency).
- What you should know before taking Mezim ® forte 10000 Ph. Eur. U.
Do not take Mezim ® forte 10000 Ph. Eur. U. :
- if you are allergic to pancreatin, pork products, azorubin (E 122) or any of the other ingredients of this medicine (listed in point 6);
- if you suffer from acute inflammation of the pancreas or exacerbated chronic inflammation of the pancreas during the active phase of the disease. Sometimes, however, it is advisable to administer the drug in the recovery phase with a diet (light food) if the indigestion persists.
Warnings and precautions
Talk to your doctor or pharmacist before taking Mezim ® forte 10000 Ph.
Eur. U.:
- if you notice that you have symptoms similar to intestinal obstruction (e.g. abdominal pain, lack of bowel function, nausea, vomiting).
Intestinal obstruction is a known complication in patients with cystic fibrosis;
- in the event of unusual stomach or gastrointestinal discomfort or changes in complaints, as a precaution you should be examined by your doctor to exclude the possibility of intestinal damage. This mostly affects patients taking more than 10,000 units of lipase per kilogram of body weight per day.
- this medicine contains active enzymes which, when released in the oral cavity, e.g. when chewing the tablet, may cause damage to the oral mucosa (e.g. oral mucosal sores). That is why Mezim ® forte 10000 Ph tablets need attention. Eur. U. to accept wholes.
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 medicines containing pancreatin, which means that you may need to take extra folic acid.
The effect of oral drugs for lowering blood sugar (oral antidiabetic drugs) acarbose and miglitol can be reduced by simultaneous use of Mezim ® forte 10000 Ph. Eur. U.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
There is insufficient data on the use of Mezim ® forte 10000 Ph. Eur. U. in pregnant women. There are insufficient data from animal studies regarding pregnancy, development of the unborn child, birth and development of the child after birth. The possible risk to humans is not known. If you are pregnant or breastfeeding, you should not take Mezim ® forte 10000 Ph. Eur. U., unless your doctor determines that the intake is absolutely necessary.
Driving and using machines
Mezim ® forte 10000 Ph. Eur. U. has no or negligible influence on the ability to drive and use machines.
Mezim ® forte 10000 Ph. Eur. U. contains lactose and azorubin
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.
This medicinal product contains the coloring agent azorubin (E 122), which may cause allergic reactions.
- How to take Mezim ® forte 10000 Ph. Eur. U.
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.
Dosage
The recommended dose is:
2-4 tablets Mezim ® forte 10000 Ph. Eur. U. during meals (equivalent to 20,000-40,000 lipase units per meal).
The dosage of Mezim ® 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 should only be made under medical supervision and to improve symptoms (e.g. oily bulky 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 adequate fat absorption.
Use in children
The dosage for children should be determined by a doctor.
Method of application
Tablets Mezim ® forte 10000 Ph. Eur. U. should be swallowed whole with plenty of liquid (water or juice) with a meal. Please note that the tablets must be swallowed whole, since the effectiveness of Mezim ® forte 10000 Ph. is reduced when chewed. Eur. U. decreases, and the contained enzymes can, after release, damage the mucous membrane of the oral cavity. Then take a large amount of liquid (water or juice).
Duration of treatment
The duration of treatment is unlimited. The duration of use of Mezim ® forte 10000 Ph. Eur. U. corresponds to the duration of the disease and is determined by a doctor. Please talk to your doctor if you do not feel better or if you feel worse.
Please consult your doctor or pharmacist if you feel that the effect of Mezim ® forte 10000 Ph. Eur. U. is too strong or too weak.
If you have taken more than the required dose of Mezim ® forte 10000 Ph. Eur. U.
Afterwards, drink plenty of water and talk to your doctor or pharmacist.
Extremely high doses of pancreatin, especially in patients with cystic fibrosis, can lead to an increase in uric acid in the blood (hyperuricemia) and urine (hyperuricosuria).
If you forgot to take Mezim ® forte 10000 Ph. Eur. U.
Do not take a double dose to make up for a missed tablet and continue treatment as recommended.
If you have stopped taking Mezim ® forte 10000 Ph. Eur. U.
If you have stopped treatment with Mezim ® forte 10000 Ph. Eur. U. early or if you stop treatment, indigestion symptoms may reappear. Talk to your doctor.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
- Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects or signs to look out for and relevant measures to take
If you are affected by any of the listed side effects, do not take Mezim ® forte 10000 Ph. Eur. U. more and if possible consult a doctor immediately. He will assess further treatment.
Very rare side effects (may affect less than 1 in 10,000 patients)
- diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting;
- allergic reactions of an immediate type, for example skin rash, hives, sneezing, tearing, shortness of breath due to narrowing of the airways (bronchospasm), difficulty breathing;
- allergic reactions of the digestive system;
- narrowing of the small bowel/appendiceal region and descending colon has been described in cystic fibrosis patients with high-dose pancreatin. This narrowing can lead to intestinal obstruction (obstruction) (see section 2 “Warnings and precautions”).
Adverse reactions with an unknown frequency (cannot be determined from the available data)
- in patients with cystic fibrosis, especially when taking high doses of pancreatin, increased excretion of uric acid in the urine may be observed. Therefore, if you are a patient with cystic fibrosis, your doctor should monitor the excretion of uric acid in the urine to avoid the formation of urate stones.
- Azorubin (E 122) can cause allergic reactions.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
Tel.: +359 28903417
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
- 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 expiration date corresponds to the last day of the specified month.
Storage conditions
To be stored below 30 °C!
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
- Package contents and additional information
What does Mezim ® forte 10000 Ph contain. Eur. U.
The active substance is:
One gastro-resistant tablet contains 80 mg – 111,111 mg pancreatin (porcine pancreas powder), equivalent to not less than the following activity:
Lipase (Lipase) 10000 Ph. Eur. Units/pill
Amylase (Amylase) not less than 7500 Ph. Eur. Units/pill
Proteases not less than 375 Ph. Eur. Units/pill
Pancreas powder is produced from porcine pancreatic tissue.
The other ingredients are:
Core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate (Ph. Eur.) (vegetable).
Coating: hypromellose, copolymer of methacrylic acid - ethyl acrylate (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), azorubin (dyes E 122), titanium dioxide, sodium hydroxide.
What Mezim ® forte 10000 Ph looks like. Eur. U. and what the package contains
Mezim ® forte 10000 Ph. Eur. U. are pink, round, slightly rounded tablets with beveled edges with a gastro-resistant film coating. They are available in blisters in cardboard packs, together with a patient leaflet.
Original packs of 10, 20, 50 or 100 tablets.
Not all types of packaging can be put on sale.
Marketing Authorization Holder and Manufacturer
Berlin-Chemie AG (MENARINI GROUP)
Glienicker Weg 125
12489 Berlin
Germany
Date of last revision of leaflet
July, 2018
