Mezym Forte 3500
80 film-coated tablets
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using 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 have told you.
Keep this leaflet. You may need to read it later.
If you need more information or advice, ask your pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better after 7 to 14 days or if you feel worse, you should consult your doctor.
In this leaflet you can find out:
What is Mezym Forte 3500 and what is it used for
What you need to know before using Mezym Forte 3500.
How to Use Mezym Forte 3500
Possible side effects
How to Store Mezym Forte 3500
Contents of the pack and other information
1. What Mezym Forte 3500 is and what it is used for
What is the Mezym Forte 3500 ?
Mezym Forte3500 is a medicine that contains digestive substances (enzymes) from the pig's pancreas (a powder of the pancreas, also called pancreatin).
What is Mezym Forte 3500 used for?
Mezym 3500 U is used to treat digestive enzymes in the pancreas when digestion is inadequate, such as:
chronic pancreatitis or cystic fibrosis, and nutrient dysfunction;
flatulence (flatulence and gastro-cardiac syndrome), especially after gastrointestinal surgery;
accelerated transit of food through the intestine (due to nervousness, bowel disease);
liver and gall bladder problems;
indigestion with loss of appetite, belching, retching and diarrhea (dyspepsia);
at the same time the use of poorly digestible vegetable, fatty and unusual foods;
Mezym Forte 3500 is also suitable for the removal of gases from the intestine prior to diagnostic examinations (X-rays, ultrasound) if there is flatulence due to the above-mentioned digestive disorders.
2. What you need to know before using Mezym Forte 3500.
Do not use Mezym Forte 3500 V if:
if you are allergic to pancreas powder, azorubine glaze (E 122) or any of the other ingredients of this medicine (listed in section 6).
if you have inflammation of the pancreas or acute exacerbations of chronic inflammation of the pancreas. However, in some cases, the use of the product is useful during the remission phase of the disease during diet regimen (light food) if the symptoms of indigestion persist.
Warnings and precautions
Ask your doctor or pharmacist for advice before using Mezym 3500 V:
- if you notice symptoms similar to a bowel obstruction (such as abdominal pain, stopping bowel movements, nausea, vomiting).
Intestinal obstruction is a known complication in patients with cystic fibrosis;
This medicine contains active enzymes which, when released in the mouth, such as chewing, can damage the oral mucosa (wounds may form). So try to swallow Mezym 3500 U tablets whole.
Other medicines and Mezym Forte 3500
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
The use of pancreatic powder may reduce the absorption of folic acid from vitamin preparations in the blood and additional folic acid may be needed.
Mezym Forte 3500 may reduce the effect of co-administered glucose lowering medicines (oral antidiabetics), the active substances of which are acarbose or miglitol.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are no adequate data from the use of Mezym forte 3500 in pregnant women. Only limited data are available from experimental animal studies on effects on pregnancy, stillbirth, parturition and postnatal development. The potential risk for humans is unknown. If you are pregnant or breast-feeding, you should not take Mezym Forte 3500 unless your doctor considers it absolutely necessary.
Driving and using machines
Mezym Forte 3500 has no or negligible influence on the ability to drive and use machines.
Mezym Forte 3500 contains azorubine
This medicinal product contains azorubine glaze (E 122) as a coloring agent which may cause allergic reactions.
3. How to use Mezym Forte 3500
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
Recommended dose:
1-2 Mezym Forte 3500 tablets per meal (equivalent to 3500-7000 units of lipase per meal).
The dose of Mezym Forte 3500 is individualized according to the severity of the indigestion.
Depending on the type of meal and the known or established severity of the indigestion, the required dose may also be significantly higher, so that another 2 to 4 film-coated tablets may be taken with food. The daily dose of enzymes should not exceed 15,000-20,000 units of lipase / kg body weight.
Children and adolescents:
The dose to be given to your child will be determined by your doctor.
Method of administration:
The film-coated tablets should be swallowed whole with plenty of liquid. Try to swallow the tablets whole as chewing reduces the effect of Mezym Forte 3500 and the enzymes may release the oral mucosa after release. Drink plenty of liquid (water or juice) on the tablets.
Duration of treatment
Your doctor will decide on the need for continued use. If you do not feel better or feel worse, consult your doctor.
Children and adolescents
The length of treatment in children is also decided by the doctor.
If you take more Mezym Forte 3500 than you should
The amount of Mezym Forte 3500 U used may significantly exceed the recommended dose. No adverse effects are expected.
If you forget to take Mezym Forte 3500
Do not take a double dose to make up for a forgotten tablet, but continue treatment as directed.
If you stop taking Mezym Forte 3500
If you stop treatment with Mezym Forte 3500 prematurely or completely, your symptoms may return. Contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare: Affecting less than 1 in 10,000 people
Cystic fibrosis patients have occasionally reported narrowing of the lower intestine following the administration of high doses of pancreatic powder (active substance Mezym Forte 3500 ).
Gastrointestinal hypersensitivity reactions such as diarrhea, stomach discomfort and nausea have been reported following the use of pancreas powder.
Immediate-type hypersensitivity reactions (eg skin rash, sneezing, tearing, shortness of breath due to bronchoconstriction) have been reported following the use of pancreas powder.
Frequency not known: cannot be estimated from the available data
Patients with cystic fibrosis may have increased uric acid excretion, especially after high doses of pancreatin. If you have cystic fibrosis, your doctor will check the uric acid excretion to prevent the formation of uric acid stones.
Azorubine glaze (E 122) may cause allergic reactions.
5. How to store Mezym Forte 3500.
Keep this medicine out of sight and reach of children.
Storage conditions
Do not store above 25 ° C.
6. Contents of the pack and other information
What Mezym Forte 3500 contains
The active substance is porcine pancreas powder.
One film-coated tablet contains porcine pancreatic powder with at least:
- lipase activity: 3500 EFV,
- amylase activity: 4200 EFV,
- protease activity: 250 EFV.
Excipients
Core:
microcrystalline cellulose, starch sodium glycolate (type A), colloidal anhydrous silica, magnesium stearate.
Coating::
Polyacrylate 30% dispersion, hypromellose, talc, simethicone emulsion, macrogol 6000, azorubine glaze (E 122), titanium dioxide (E 171).
What Mezym Forte 3500 looks like and contents of the pack
Mezym Forte 3500 tablets are pink, flat, cylindrical, film-coated tablets with almost flat faces and bevelled edges.
The film-coated tablets are contained in blisters. The blisters are made of clear, dense PVC film and rigid aluminum foil or OPA / Al / PVC film and rigid aluminum foil or PVC / PE / PVDC film and rigid aluminum foil.