Prostamol UNO x 30 capsules

PROSTAMOL UNO 320 mg. x 30 capsules PROSTAMOL UNO BERLIN CHIME 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 includes any possible side effects not listed in this leaflet. See section 4. If you do not feel better or your condition worsens, you should seek medical advice. What this leaflet contains 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 is Prostamol® uno and what is it used for? Prostamol® uno contains an extract of the fruits of Serenoa repens, which is a urological medicinal product of plant origin (prostate medicine). Prostamol® uno is used in adult men to treat urination disorders (difficulty emptying the bladder) due to benign prostatic hyperplasia (of non-cancerous origin), stage I and II.
Classification of stages of benign prostate enlargement (benign prostatic hyperplasia):
Stage Name CharacteristicsI Inflammatory stage of the bladder Delayed onset of urinationProlonged urination and interrupted streamWeak stream during urinationFrequent urination (especially at night)Complete emptying of the bladder after urinationII Residual urine stage Urinary disturbances continueThe bladder is not completely emptied, even after urination, residual urine is retained. The patient has a feeling of incomplete emptying of the bladderThe following symptoms may be observed in benign prostatic hyperplasia:
need to urinate more frequently, especially at night; weak or interrupted stream during urination; dribbling; feeling of incomplete bladder emptying; pain when urinating; sexual dysfunction. Most of these symptoms are caused by the enlarged prostate pressing on the urethra (the tube 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 you take Prostamol® uno Do not take Prostamol® uno If you are allergic to saw palmetto 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 prostate enlargement, without causing a change in its size. Therefore, please visit your doctor regularly.
You should see a doctor, especially if:
You have a fever, cramps 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 (an 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 lactation is not recommended. There are no data regarding fertility.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
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.
DosageThe recommended dose is 1 soft capsule Prostamol® once daily at the same time of day. The capsule should be taken whole, with sufficient 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 applicationThe 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. This is why Prostamol® uno should be used for a long time. Regular daily intake is very important for the success of the treatment. An improvement in symptoms can be expected after about six weeks. It may take about 3 months to achieve full effectiveness. Prostamol® uno can even be used for several years.
If you take more Prostamol® uno than you should: 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 the missed capsule.
If you stop taking Prostamol® unoIf you stop taking Prostamol® uno, the symptoms may reappear.
If you have any further questions on 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. Headache may occur. Reporting of side effects If you get any side effects, tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Executive Agency for Medicines, Damyan Gruev Str., No. 81303 Sofia.
By reporting side effects, you can help provide 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 expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information What Prostamol® uno contains The active substance is: each soft capsule contains 320 mg of thick extract of the fruits of Serenoa repens (Serenoae repentis fmctus extractum spissum) (9-11:1). Extractant: ethanol (96%). The other ingredients are: succinic gelatin, glycerol, purified water, dyes titanium dioxide (E 171), iron oxide, yellow (E 172), iron oxide, black (E 172) and carmine lake (E 120). What Prostamol® uno looks like and what the pack contains Oval soft gelatin capsule with an opaque, two-tone red-black shell with 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 released for sale.
Marketing Authorisation Holder and Manufacturer BERLIN-CHEMIE AG (MENARINI GROUP) Germany
Date of last revision of the leaflet October, 2019
Additional information for the user:
What is benign prostatic hyperplasia? Benign prostatic hyperplasia (enlargement) is a natural aging process of the prostate. The enlarged prostate presses on the urethra and makes it difficult to empty the bladder. The first signs can appear in men aged 40-49 and are most pronounced in about 60% of men aged 60.