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PHLOGENZYM mono gastro-resistant tablets

MUCOS Pharma GmbH & Co. KG

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PHLOGENZYM mono gastro-resistant tablets

Dosage form:Tablets, gastro-resistant

Phlogenzym ® mono, gastro-resistant tablets.

Active ingredient: bromelain.

Areas of application: acute swelling after operations and injuries, particularly of the nose and sinuses. Contains lactose.

For risks and side effects, read the package insert and ask your doctor or pharmacist!

Status: 08/09

Mucos Pharma GmbH & Co. KG, Miraustr. 17, 13509 Berlin

Phlogenzym mono, 100 tablets

For swelling after operations

Tooth extraction or root canal treatment?
Around 12.5 million teeth are removed in Germany every year. It is one of the most common operations in dentistry. Wisdom tooth extraction, tooth pulling and root canal treatment are also everyday procedures today.

Even though these dental operations are now routine, the consequences for patients are more than unpleasant. The painful "swollen cheek" almost always occurs after a visit to the dentist - which significantly impairs everyday life.

This is where Phlogenzym mono can help with its decongestant and therefore pain-relieving effect.

Faster decongestion – naturally
Phlogenzym mono helps to reduce swelling after dental surgery more quickly. The active ingredient bromelain is a highly active, purely plant-based enzyme from pineapple. Its special effect reduces fluid retention in injured tissue. The pressure in the wound decreases – and with it the pain.

At a glance:
Reduces swelling and therefore pain
Natural and well tolerated
Suitable for adults and adolescents aged 12 and over Can be kept in the medicine cabinet

Areas of use
Unless otherwise prescribed by the therapist:
Adults and adolescents aged 12 and over 1 x 1 tablet daily, maximum 2 x 1 tablet daily. Take unchewed with plenty of liquid, at least 30 minutes before or at least 90 minutes after a meal.

What speaks against use?

Always:
Hypersensitivity to the ingredients
In certain circumstances – speak to your doctor or pharmacist about this:
Blood clotting disorder

Which age group should be considered?
Children under 12 years: The medicine should not generally be used in this age group.

What about pregnancy and breast-feeding?
Pregnancy: Contact your doctor. Various considerations play a role in whether and how the medicine can be used during pregnancy. Breastfeeding: Contact your doctor or pharmacist. He or she will examine your particular situation and advise you accordingly as to whether and how you can continue breastfeeding.
If the medicine has been prescribed for you despite a contraindication, speak to your doctor or pharmacist. The therapeutic benefit may be greater than the risk of using it in the event of a contraindication.
Important information on PHLOGENZYM mono gastro-resistant tablets
Information on allergies (concerning active ingredients and excipients), complications with food and beverages, and other warnings.

What should you bear in mind?
Be careful if you are allergic to pineapple, kiwi, melon and papaya!
Be careful if you are intolerant to lactose. If you have to follow a diabetic diet, you should take the sugar content into account. There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already taking before treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or that you have used some time ago.

For the treatment of acute swelling after operations and injuries

Active ingredients

  • Pineapple stem bromelain 120-136 mg

Excipients

  • Maltodextrin
  • Triethyl citrate
  • Methacrylic acid-methyl methacrylate copolymer (1:1)
  • Silicon dioxide, highly dispersed
  • Corn starch, pregelatinized
  • Cellulose, microcrystalline
  • Magnesium stearate (vegetable)
  • Water, purified
  • Vanillin
  • Sodium dodecyl sulfate
  • Lactose-1-water
  • Macrogol 6000
  • talc
Indication :
  • The medicine is a herbal medicine and contains the active ingredient bromelain.
  • It is used in adults and adolescents aged 12 years and over for acute swelling after operations and injuries, especially of the nose and sinuses.
Dosage :
  • Always take this medicine exactly as directed. If you are not sure, ask your doctor or pharmacist.
  • The recommended dose is:
    • Unless otherwise prescribed by your doctor, the usual dose for adults and adolescents aged 12 years and over is:
      • 1 tablet, maximum 2 times 1 tablet per day.
  • Use in children and adolescents
    • Since the safety and efficacy in children under 12 years of age have not yet been adequately studied, use in children under 12 years of age is not recommended.
  • Use in elderly patients and patients with impaired organ function
    • Elderly patients
      • No dosage adjustment is necessary for elderly patients.
    • Impaired renal / liver function
      • No dosage adjustment is necessary in patients with mild or moderate impairment of renal/hepatic function. For patients with severe renal/hepatic impairment, see "Patient information".

 

  • Duration of application:
    • Do not take this medicine for longer than 8-10 days without medical or dental advice.
    • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

 

  • If you take more than you should
    • When high doses are used, the side effects described under "Side effects" may be more pronounced. In this case, the medicine should be stopped immediately and your doctor should be informed.

 

  • If you forget to take it
    • Do not take a double dose to make up for a forgotten dose, but continue your dosing schedule as usual.

 

  • If you stop taking it
    • A short-term interruption of medication intake is not a problem. If treatment is stopped prematurely, the symptoms may reappear.

 

  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Manner :
  • Take the tablets whole with plenty of liquid at least 30 minutes before a meal or 90 minutes after a meal.
Side effects :
  • Like all medicines, this medicine can cause side effects, although not everybody gets them.
    • Common: up to 1 in 10 people treated
      • Allergic reactions (e.g. itching, redness, swelling in the face and throat), diarrhea, abdominal pain, nausea, vomiting.
    • Uncommon: up to 1 in 100 people treated
      • Changes in stool texture, color and smell
    • In case of significant allergic reactions (for example noticeable swelling of the face or throat (e.g. Quincke's edema)), the preparation should be discontinued immediately and a doctor should be informed.
  • If you notice any side effects, please contact your doctor or pharmacist. This also applies to side effects not listed.
Interactions :
  • Taking with other medicines
    • Tell your doctor or pharmacist if you are taking or using, have recently taken or might take or use any other medicines, including medicines obtained without a prescription.
    • The medicine may increase the absorption of other medicines taken at the same time.
    • The blood and urine levels of antibiotics (agents used to kill germs [bacteria], such as tetracyclines) may be increased when taken at the same time.
    • Concomitant use with medicines that inhibit blood clotting (anticoagulants, platelet aggregation inhibitors) may increase the inhibition of blood clotting.
  • Taking with food and drink
    • The medicine should not be taken with food as this may cause digestive problems and intolerances; please take the preparation according to the recommendation under the category "Dosage".
Contraindications :
  • The medicine must not be taken
    • if you are hypersensitive (allergic) to the active ingredient bromelain (enzyme from pineapple) or any of the other ingredients of this medicine. If you have a known hypersensitivity to pineapple fruit, you must not take the preparation either.
    • if you suffer from blood clotting disorders (e.g. haemophilia, severe liver damage, dialysis patients).
    • during simultaneous treatment with medicines that inhibit blood clotting (anticoagulants, platelet aggregation inhibitors).
  • If any of these conditions apply to you, please consult your doctor before taking the medication.
Pregnancy and breastfeeding :
  • 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.
  • The safety and tolerability during pregnancy and breastfeeding have not been studied. Taking the drug during pregnancy or breastfeeding is therefore not recommended. Use in women of childbearing age who are not using contraception should be considered due to the possibility of early pregnancy.
  • In animals, no impairment of reproductive capacity was observed due to ingestion.
Patient information :
  • Warnings and precautions
    • Please talk to your doctor or pharmacist before taking this medicine.
    • Patients with blood clotting disorders (e.g. haemophilia, dialysis patients, severe liver damage) or patients undergoing treatment with drugs that inhibit blood clotting (anticoagulants, platelet aggregation inhibitors) should only take the medication under medical supervision.
    • Special caution is required
      • if an existing swelling increases,
      • with (increasing) pain
      • with (increasing) restriction of movement
      • if there is bloody or purulent discharge from the wound area
      • in case of local overheating/redness
      • especially with fever.
    • In these cases, you should immediately consult a doctor who will decide on the necessary measures.
    • Taking the medication does not replace medical measures for treating injuries or wounds.
    • As a precaution, this medicine should be discontinued before surgery as it may affect the blood's ability to clot.
    • Gastrointestinal complaints can often be avoided by strictly following the recommendations for use: take the tablets whole with plenty of liquid at least 30 minutes before a meal or 90 minutes after a meal.
    • Children and young people
      • Due to insufficient studies, use in children under 12 years of age is not recommended.

 

  • Ability to drive and use machines
    • No special precautions are necessary, as no limitations on your ability to react are to be expected after taking the medication.