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PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER


(Sabalis serrulatea extractum; 9,0-11,0:1)
320 mg, soft gelatin capsules

Please carefully read the entire leaflet, as it contains information that is important to the patient.
The drug is available without a prescription in order to treat some disorders without doctor’s assistance. However, PROSTAMOL UNO should be used with caution to achieve a good outcome of the treatment.
  • Please keep this leaflet to be able to read it again if needed.
  • If you need an advice or any additional information, please refer to your doctor or pharmacist.
  • If your symptoms aggravate or persist, please contact your doctor.
  • If any of the adverse reactions gets serious or if you experience any adverse reaction not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
  1. What PROSTAMOL UNO is and what it is used for
  2. Before you take PROSTAMOL UNO
  3. How to use PROSTAMOL UNO
  4. Possible adverse reactions
  5. How to store PROSTAMOL UNO
  6. Further information
1. WHAT PROSTAMOL UNO IS AND WHAT IT IS USED FOR

PROSTAMOL UNO is a medicine that relieves complaints related to prostate gland hypertrophy associated with urination, such as, e.g., poor stream of urine, urgent urination, pollakiuria, frequent urination at night.

PROSTAMOL UNO is used to treat disturbed urination accompanying the initial stage of benign prostate gland hypertrophy.

2. BEFORE YOU TAKE PROSTAMOL UNO

When not to use PROSTAMOL UNO:
  • in case of allergy (hypersensitivity) to the active ingredient of the medicine or to any of its excipients;
When to exercise particular caution while taking PROSTAMOL UNO:
PROSTAMOL UNO relieves complaints related to prostate gland hypertrophy without subsiding it, and hence, it dose not cure the disease.
You should regularly consult your doctor. In particular, medical advice is necessary in finding blood in urine and in retention of urine in the bladder.

Using PROSTAMOL UNO with other medicines
No interactions with other medicines are known.

Taking PROSTAMOL UNO with food and drinks
PROSTAMOL UNO should be taken after meals.

Pregnancy and breast-feeding
Not applicable. The medicine is used only in men.

Driving vehicles and operating machines
PROSTAMOL UNO does not affect ability to drive vehicles and operate machines.

3. HOW TO USE PROSTAMOL UNO

Always take PROSTAMOL UNO exactly as your doctor has told you. If you are not sure, please re-check with your doctor or pharmacist.

Mode of administration
Unless advised otherwise by your doctor, the usual dosage is 1 capsule per day. The capsules should be taken each day at the same time of the day, after a meal. The capsules should be swallowed whole with adequate volume of liquid. It is particularly important that PROSTAMOL UNO should be taken regularly to ensure efficacy of treatment.

Duration of therapy
Duration of therapy depends only on the nature, intensity and the course of your disease.
Duration of therapy shall be determined by your doctor, according to results of regular control tests.
Most commonly, improvement of patient's condition and relieve of symptoms is observed after about 4 weeks since the beginning of treatment.
If your symptoms do not subside or even aggravate, please contact your doctor.

If you have taken more PROSTAMOL UNO than you should
There are no reports on overdose and poisoning.

If you forget to take PROSTAMOL UNO
Do not take a double dose to make up for a forgotten one.

Discontinuation of PROSTAMOL UNO therapy
Do not interrupt your treatment without prior consulting your doctor.
If you have doubts on the use of the medicine, please ask you doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, PROSTAMOL UNO can cause adverse reactions, although not all patients experience them. If any of the adverse reactions gets serious or if you experience any adverse reaction not listed in this leaflet, please tell your doctor or pharmacist.

Gastric disorders may occur in rare cases.

5. HOW TO STORE PROSTAMOL UNO

Keep out of the sight and reach of children.

The shelf-life of the medicine is 3 years.

Do not use PROSTAMOL UNO after the expiration date shown on the packaging. The expiration date refers to the last day of the month indicated.

Do not discard any medicines into the sanitary sewage system or to household waste containers. Ask your pharmacist what to do with the drugs you do not need. Such procedure will help to protect environment.

Storage conditions
The medicine should be stored below 25οC.

6. FURTHER INFORMATION

What PROSTAMOL UNO contains
The active ingredient of PROSTAMOL UNO is the extract from saw palmetto berries.
Each capsule contains 320 mg of theextract from saw palmetto berries.
Other constituents of the medicine are: succinylated gelatin, glycerol, purified water, titanium dioxide (E 171), black iron oxide (E172), cochineal red (E214).

What PROSTAMOL UNO looks like and contents of the unit box?
Soft gelatin capsules.

PROSTAMOL UNO is available in packages containing 30 or 60 capsules.

Not all pack sizes must be marketed.

Further information may be obtained from the marketing authorization holder’s representative:
Berlin-Chemie / Menarini Polska Sp. z o.o.
ul. Cybernetyki 7
02-677 Warszawa
Ph: (22) 566 21 00
Fax: (22) 566 21 01


Before use, read the leaflet containing indications, contraindications, data and information concerning adverse effects and dosage, as well as information concerning the use of the medicinal product, or consult a doctor or a pharmacist, because each drug used inappropriately poses a risk for your life and health.
Before use, read the leaflet containing indications, contraindications, data and information concerning adverse effects and dosage, as well as information concerning the use of the medicinal product, or consult a doctor or a pharmacist, because each drug used inappropriately poses a risk for your life and health.
PROSTAMOL UNO: 1 capsule contains 320 mg of Sabalis serrulatae extractum; Indications: relieves complaints related to prostate gland hypertrophy associated with urination, such as, e.g., poor stream of urine, urgent urination, pollakiuria, frequent urination at night. Contrindications: allergy (hypersensitivity) to the active ingredient of the medicine or to any of its excipients; Marketing Authorisation Holder: Berlin Chemie AG, Germany Further information can be obtained at: Berlin-Chemie/Menarini Polska Sp. z o.o, ul. Cybernetyki 7b, 02-677 Warszawa, tel: (22) 566 21 00, fax: (22) 566 21 01
Created by QAH