Prostazyn film-coated tablet

with natural active substances

Why do we recommend this preparation?


Prostazyn contains natural active substances:

  • Saw palmetto fruit extract – reduces symptoms caused by the enlarged prostate and inhibits its further growth
  • Nettle root and goldenrod extracts – ease concomitant symptoms of benign prostatic hyperplasia owing to their anti-inflammatory and pain relieving effects.

In what cases is the preparation recommended?


It is recommended for benign prostatic hyperplasia, as well as the concomitant complaints and symptoms listed below:

  • frequent or urging need to urinate night and day,
  • difficulty, intermittency or pain experienced during urination,
  • dripping after urination,
  • feeling of incomplete voiding of the urinary bladder.

Pack size:
60 film-coated tablets


Dosing:
2x1 film-coated tablet per day. Take the preparation in the morning and the evening after meals with little liquid.

Quantities of active substances per film-coated tablet:
Name of active substance Active substance content
Saw palmetto fruit dry extract (8-11:1) 100 mg
Nettle root dry extract (12-16:1) 35 mg
Goldenrod dry extract (5-7:1) 29,1 mg

 

Prostazyn film-coated tablet

Saw palmetto fruit extract, nettle root and goldenrod herbal extract

 

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. You may need to read it again.

-        Ask your pharmacist if you need more information or advice.

-        If any of the side effects get severe talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

-        You must talk to a doctor if you do not feel better of if you feel worse.

 

In this leaflet:

  1. What Prostazyn film-coated tablet is and what it is used for
  2. What you need to know before you take Prostazyn film-coated tablet

3.       How to take Prostazyn film-coated tablets

4.       Possible side effects

5        How to store Prostazyn film-coated tablets

6.       Contents of the pack and further information

 

 

1.       WHAT PROSTAZYN FILM-COATED TABLET IS AND WHAT IT IS USED FOR

 

Prostazyn film-coated tablet is a medicine of herbal origin recommended for the symptoms of the early stages of benign enlargement of the prostate gland, as well as concomitant complaints listed below:

- frequent or sudden urge to urinate both day and night,

- experiencing difficulties, pain or stopping and starting while urinating,

- dribbling at the end of urinating,

- sense of incomplete emptying of the bladder.

 

 

2.       WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROSTAZYN FILM-COATED TABLETS

 

Do not take Prostazyn film-coated tablets if

  • you are allergic (hypersensitive) to any of the active substances or other ingredients of the medicine (listed in point 6),
  • you have renal insufficiency,
  • you have elevated calcium levels in your blood,
  • you are below 18 years of age.

 

Warnings and precautions

If you have chronic kidney disease talk to your doctor or pharmacist before starting to take Prostasyn.

 

Prostazyn alleviates the unpleasant symptoms of prostate gland enlargement without influencing the enlargement itself. Therefore, see your doctor on a regular basis. Talk to your doctor in those cases in particular when you experience blood in the urine or suddenly developed stopping of urine.

 

Children and adolescents

Do not take this medicine below 18 years of age.

 

Taking other medicines and Prostazyn film-coated tablet

Tell your doctor or pharmacist if you are taking, have recently taken any other medicines including non-prescription preparations.

Owing to its calcium content, Prostazyn may interact with particular medicines. At least 3 hours should pass between taking antacids, as well as medicines containing fluoroquinolones, tetracycline, phenytoin, penicillamine, biphosphonates, and Prostazyn.

Take special care with vitamin D, owing to the likelihood of excessive calcium intake when co-administered with Prostazyn.

 

Pregnancy, breast-feeding and fertility

Do not use this product. It is for use in men only.

 

Driving and using machines

Prostazyn has to known affect on the ability to drive or use machines.

 

Prostazym film-coated tablet contains calcium hydrogen phosphate, which equals 243 mg calcium.

 

 

3.       HOW TO TAKE PROSTAZYN FILM-COATED TABLETS

 

Always take Prostazyn film-coated tablet as the doctor has told you. Check with your doctor or pharmacist if you are not sure.

 

Its usual dose:

Adults:

Its usual dose is 3x1 film-coated tablet per day in the morning, at noon and in the evening after a meal taken with little liquid.

 

The duration of the treatment is not limited, it needs to be in accordance with the nature, severity and course of the disease. Its regular daily administration is very important for a successful treatment. You must talk to a doctor if your symptoms do not ease or get worse.

 

Children and adolescents

It can be used in adults above 18 years of age only.

 

The score line is only there to help you break the tablet if you have difficulty swallowing it whole and not to divide the tablet into equal doses.

 

If you take more Prostazyn film-coated tablets than you should

Symptoms emerging owing to overdose are not known.                 

 

If you forget to take Prostazyn film-coated tablets

Do not take a double dose the next time because you cannot make up for the missed quantity this way. Continue as described in this leaflet.

 

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

 

 

4.       POSSIBLE SIDE EFFECTS

 

Like all medicines, Prostazyn film-coated tablets can cause side effects, although not everybody gets them.

 

Hypersensitivity reactions (rashes, hives, itching), mild digestive complaints (feeling sick, heartburn, diarrhoea, constipation) may occur when using the product. Their frequency is unknown.

 

If you experience any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

 

 

5.       HOW TO STORE PROSTAZYN FILM-COATED TABLETS

 

Store at or below 25 °C.

Keep the container tightly closed to protect the tablets from moisture.

 

Keep this medicine out of the sight and reach of children.

 

Do not take Prostazyn film-coated tablets after the expiry date printed on the packaging (Felhasználható: mm/yyyy). The expiry date refers to the last day of that month.

 

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 

 

6.       CONTENTS OF THE PACK AND FURTHER INFORMATION

 

What Prostazyn film-coated tablets contain

Active substances: 100 mg saw palmetto fruit (Serenoa repens, Bartram Small, fructus) dry extract (8-11:1) (which equals 800-1100 mg saw palmetto fruit) extraction solvent 90 m/m% ethanol,

35 mg nettle root (Urtica dioica L., radix) dry extract (12-16:1) (with min. 30 ppm scopoletin content), (which equals 420 - 560 mg nettle root) extraction solvent 70 v/v% ethanol,

29.1 mg goldenrod herbal (Solidago virgaurea L. herba) dry extract (5-7:1) (which equals 145.5 - 203.7 mg goldenrod) extraction solvent 60 v/v% ethanol.

 

Other ingredients:

Tablet core: calcium hydrogen phosphate (which equals 243 mg calcium), microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica, maltodextrin. 

Tablet coating (Opadry OY-B-28920 white): poly(vinyl alcohol), talc, soy lecithin (E322), xanthan gum (E415), titanium dioxide (E 171).

 

What Prostazyn film-coated tablets look like and the contents of the pack

White, oblong film-coated tablet scored on both sides.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole and not to divide the tablet into equal doses.

 

 

30, 60, 90 film-coated tablets in white HDPE container, sealed with a heat-adhesive foil to ensure integrity, and closed a white polypropylene screw cap in a box.

 

Not all pack sizes may be marketed.

 

Marketing authorisation holder

Béres Gyógyszergyár Zrt.

1037 Budapest, Mikoviny u. 2-4.

Tel: +36-1-430-5500

Fax: +36-1-250-7251

E-mail: [email protected]

 

Manufacturer

Béres Gyógyszergyár Zrt.

5005 Szolnok, Nagysándor József út 39.

 

 

OGYI-T-22106/01                  30 film-coated tablets

OGYI-T-22106/02                  60 film-coated tablets

OGYI-T-22106/03                  90 film-coated tablets

 

 

This leaflet was last revised in: April, 2012.

Registration category:Over-the-counter medicinal preparation

FOR RISKS AND SIDE EFFECTS, PLEASE READ THE PATIENT INFORMATION LEAFLET OR CONSULT YOUR DOCTOR, PHARMACIST!

GOOD TO KNOW – Useful information prior to administration

Gluten-free - Suitability for people with coeliac disease

Lactose-free - Suitability for lactose intolerant people

Suitability for people with diabetes

Suitability for vegetarians

Suitability for pregnant women and nursing mothers

Suitability for people with high blood pressure



© Copyright 2012 Béres Pharmaceuticals Ltd.

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