PROSTAMOL UNO CPS N30

ATC code: G04CX 

Active substances: Serenoae Repentis Fructus Extractum Spissum

Vendor, principal: Berlin-Chemie Ag. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

PROSTAMOL UNO 320MG N15

Package leaflet: Information for the user
Prostamol Uno 320mg soft capsules Thick extract of saw palmetto berries
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 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.
-   You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet
1.   What Prostamol Uno is and what it is used for
2.   What you need to know before you take Prostamol Uno
3.   How to take Prostamol Uno
4.   Possible side effects
5.   How to store Prostamol Uno
6.   Contents of the pack and other information
1. What Prostamol Uno is and what it is used for
Prostamol Uno contains substance thick extract of saw palmetto berries (Serenoae repentis extractum) which is urological medicine (for prostate).
Prostamol Uno is used in men to treat micturition disorders (difficulty in emptying the bladder) due to benign prostate enlargement (of non-carcinogenic origin), stage I and stage II.
Classification of the steps of a benign (non-carcinogenic) prostatic hyperplasia

Stages	Name	Features
I	Inflammatory stage of bladder	-delayed onset of urination -prolonged urination and interrupted jet -weak stream during urination -frequent urination (especially at night) -fully emptying the bladder after urination
II	Residual urine stage	-difficulties urinating -the bladder does not empty completely and residual urine is retained even after urinating. The patient has the feeling of incomplete emptying of the bladder.

Benign prostatic hyperplasia may have the following symptoms:
-   need for frequent urination, especially at night
-   weak and interrupted stream during urination
-   a feeling of incomplete emptying of the bladder
-   pain with urination
-   disturbed sexual function
Most of these symptoms are caused by compression of the urethra (the channel through which urine flows from the bladder) by the enlarged prostate.
Prostamol Uno prevents further enlargement of the prostate, thus reducing the pressure on bladder and improving urine stream.
Prostamol Uno does not inhibit sexual function.

2. What you need to know before you take Prostamol Uno

Do not take Prostamol Uno if you are allergic (hypersensitive) to:

If you are allergic to the berries of saw palmetto or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Prostamol Uno.
Prostamol Uno relieves symptoms associated with prostate enlargement, it does not entail a change in size. Thus, please visit your doctor regularly.
You must tell your doctor, if you
-   notice blood in the urine;
-   develop urinary incontinence (constant leakage of small amounts of urine, so-called overflow incontinence);
-   feel a sudden painful urge to urinate but are unable to empty your bladder (acute urinary retention);
-   feel the need to urinate but there is an obstruction (acute urinary retention).

Other medicines and Prostamol Uno

There are no known interactions with other medicines.

Driving and using machines

Prostamol Uno has no effect on the ability to drive or use machines.

3. How to take Prostamol Uno

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

Take 1 capsule of Prostamol Uno a day, each day at the same time of the day. Swallow the capsule whole with adequate volume of liquid and after meal.

Duration of administration

The duration of treatment shall be determined by your doctor and it depends on the course and severity of your disease.
The duration of treatment is not limited in time. Consult your doctor about the duration of treatment.
Treatment with Prostamol Uno is long-term and regular. Regula administration is necessary to achieve therapeutic effect. Improvement in symptoms can be expected in 6 weeks. It may take up to 3 months to achieve maximum therapeutic effect.
If your symptoms do not improve or get worse, you should contact your doctor.

If you take more Prostamol Uno than you should

There are no reports on overdose of Prostamol Uno.

If you forget to take Prostamol Uno

Do not take a double dose to make up for a forgotten dose.

If you stop taking Prostamol Uno

If you stop using Prostamol Uno, the symptoms may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Rare (may affect up to 1 in 1,000 people)
Gastrointestinal disorders: abdominal discomfort.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5.   How to store Prostamol Uno

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information What Prostamol Uno contains

Each soft capsule contains 320 mg of the extract of saw palmetto berries (9-11:1).
Other ingredients are:
Succinylated gelatine, glycerol (85%), colourings such as titanium oxide (E171), yellow iron oxide (E 172), black iron oxide (E172) and carmine (E120)

What Prostamol Uno looks like and contents of the pack

Oval soft capsules with bicolour (red/black) coating containing brown, brownish yellow or greenish brown (oily) liquid.
PVC/PVDC blister packs covered with aluminium foil.
Blister packs contain 15, 30 or 60 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Berlin-Chemie AG (MENARINI GROUP)
Glienicker Weg 125 12489 Berlin Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
OÜ Berlin-Chemie Menarini Eesti Paldiski mnt 27/29 Tallinn 10612 Estonia

This leaflet was last revised in March 2014.