PROSTAMOL UNO 320mg x 60 tabl
PROSTAMOL UNO soft capsules 320 mg * 60
Leaflet: Patient information
Prostamol® uno 320 mg soft capsules
Prostamol® uno 320 mg soft capsules
Thick extract of the fruits of Serenoa repens
(Serenoae repentis fructus extractum spissum)
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.
- If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Prostamol® uno is and what it is used for
2. What you need to know before taking Prostamol® uno
3. How to take Prostamol® uno
4. Possible side effects
5. How to store Prostamol® uno
6. Contents of the package and additional information
1. What Prostamol® uno is and what it is used for
Prostamol® uno contains an extract from the fruits of Serenoa repens, which is a urological medicinal product of plant origin (prostate medicine).
Prostamol® uno is used in adult men for the treatment of urinary disturbances (difficulty emptying the bladder) due to benign enlargement of the prostate (of non-cancerous origin), stage I and II.
Classification of the stages of benign enlargement of the prostate (benign prostatic hyperplasia):
Stage Name Characteristics
I Inflammatory stage of the bladder
- Delayed initial urination
- Prolonged urination and intermittent stream
- Weak stream during urination
- Frequent urination, especially at night
- Complete emptying of the bladder after urination
II Stage of residual urine
- Urinary disturbances continue
- Bladder does not empty completely even after urination residual urine is retained. The patient has a feeling of incomplete emptying of the bladder.
In benign prostatic hyperplasia, the following symptoms can be observed:
• need to urinate more often, especially at night;
• weak or interrupted stream during urination;
• urinating in drops;
• feeling of incomplete emptying of the bladder;
• pain when urinating;
• disturbances in sexual life.
Most of these symptoms are caused by compression of the urethra by the enlarged prostate (the channel through which urine passes from the bladder).
Prostamol® uno prevents further enlargement of the prostate.
Prostamol® uno does not impair sexual function.
If you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before taking Prostamol® uno
Do not take Prostamol® uno
If you are allergic to Serenoa repens fruit extract 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 only relieves the symptoms associated with an enlarged prostate, without causing a change in its size. Therefore, please visit your doctor regularly.
You should see a doctor, especially if:
• You have a fever, spasm or blood in your urine;
• You experience pain when urinating;
• You constantly leak urine due to an overfilled bladder (urinary incontinence);
• You have a painful urge to urinate with a sudden inability to urinate (acute urinary retention).
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
Other medicines and Prostamol® uno
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Only a few cases of suspected interactions with warfarin (anticoagulant) have been described. Cases of increased INR values have been described.
Pregnancy, lactation and fertility
Prostamol® uno is not intended for women, therefore use during pregnancy and breastfeeding is not recommended. No data are available regarding fertility.
Driving and using machines
No studies have been conducted on the effects on the ability to drive and use machines.
3. How to take Prostamol® uno
Always take Prostamol® uno exactly as described in this leaflet or as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Dosage
The recommended dose is 1 soft capsule Prostamol® uno daily at the same time of the day. The capsule should be taken whole, with a sufficient amount of liquid, after a meal.
Use in children and adolescents
Prostamol® uno is not recommended for children and adolescents under 18 years of age.
Duration of application
The duration of treatment depends on the type, severity and course of the disease and is not limited in time. Please consult your doctor about this.
Benign prostatic hyperplasia is a long-term, chronic disease. That is why Prostamol® uno should be applied for a long time. Regular daily intake is very important for the success of the treatment. Improvement in symptoms can be expected after about six weeks. It may take about 3 months to achieve full effectiveness. Prostamol® uno can be used even for several years.
If you have taken more than the required dose of Prostamol® uno
So far, there are no known cases of overdose with Prostamol® uno.
If you forget to take Prostamol® uno
Do not take a double dose to make up for a missed capsule.
If you have stopped taking Prostamol® uno
If you stop taking Prostamol® uno, complaints may reappear.
If you have any further questions related to 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.
Rare side effects (may affect up to 1 in 1,000 people)
Uncommon (may affect up to 1 in 100 people):
• Nausea, vomiting, diarrhea, abdominal pain (especially when taken on an empty stomach)
Not known (frequency cannot be estimated from the available data):
• Allergic or hypersensitivity reactions may occur.
• A headache is possible.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
phone: +35 928903417
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Prostamol® uno
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date corresponds to the last day of the specified month.
This medicinal product does not require special storage conditions.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Prostamol® uno contains
- The active substance is: each soft capsule contains 320 mg of thick extract from the fruits of Serenoae repens (Serenoae repentis fructus extractum spisswn) (9-11:1). Extractant: ethanol (96%).
- The other ingredients are: succinated gelatin, glycerol, purified water, dyes titanium dioxide (E 171), iron oxide, yellow (E 172), iron oxide, black (E 172) and carmine varnish (E 120).
What Prostamol®uno looks like and what it contains
Oval soft gelatin capsule with an opaque, two-tone red-black shell containing a brown to yellowish-brown or greenish-brown (oily) liquid.
Original packages of 15, 30 or 60 soft capsules.
Not all types of packaging can be put on sale.
Marketing Authorization Holder and Manufacturer
BERLIN-CHEMIE AG (MENARINI GROUP)
Germany
Leaflet last revised date October 2017
Additional user information:
What is benign prostatic hyperplasia?
Benign prostatic hyperplasia (enlargement) is a natural aging process of the prostate. An enlarged prostate presses on the urethra and makes it difficult to empty the bladder. The first signs can appear in men aged 40-49 years and are markedly expressed in about 60% of men in their 60s.
