BENUR 2 mg Tabletki
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Treść ulotki
BENUR 2 mg tablets, 4 mg tablets
Doxazosina
Read this leaflet carefully before taking this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Benur is and what it is used for
- 2. What you need to know before you take Benur
- 3. How to take Benur
- 4. Possible side effects
- 5. How to store Benur
- 6. Contents of the pack and other information
1. What is Benur and what is it used for
Benur contains the active substance doxazosin, which belongs to a group of medicines called
prostatic urologicals. It is used for the treatment of symptoms caused by enlargement of the prostate, a
gland of the male genital apparatus.
In patients who present with enlargement of the prostate gland, Benur is used to treat
poor and/or frequent urine flow. Benur works by relaxing the muscle around the outlet
of the bladder and the prostate gland in order to facilitate the passage of urine.
2. What you need to know before taking Benur
Do not take Benur
- If you are allergic to doxazosin, to other types of quinazolines (such as prazosin or terazosin) or to any of the other components of this medicine (listed in section 6).
- If you have suffered from a condition known as "orthostatic hypotension", a form of low blood pressure that causes dizziness or a feeling of faintness when getting up from a sitting or lying position.
- If you have an enlarged prostate gland (benign prostatic hyperplasia) together with: any type of congestion or blockage of the urinary tract, a persistent urinary tract infection or have bladder stones.
- If you suffer from excessively low blood pressure (hypotension).
- If you have a particular form of urinary incontinence in which involuntary loss of urine occurs as a result of an overly full bladder, or if you do not produce an adequate amount of urine, with or without a progressive loss of kidney function.
Warnings and precautions
Talk to your doctor or pharmacist before taking Benur.
When you start taking Benur you may experience a feeling of weakness, dizziness and, rarely, fainting
caused by a drop in blood pressure when getting up from a sitting or lying position. If
you experience a feeling of weakness, dizziness or fainting, you should sit or lie down until you
feel better and avoid situations where you could fall or get injured. Your doctor may decide to
measure your blood pressure regularly at the beginning of treatment to reduce the possibility that
these side effects occur.
If you are about to undergo eye surgery for cataracts (clouding of the lens),
tell your ophthalmologist before the operation that you are using or have previously used Benur.
Benur can cause complications during surgery that can be managed if the
specialist is warned in advance.
Tell your doctor or pharmacist before taking Benur if any of the following conditions apply to you,
because in these cases Benur must be used with caution:
- If you suffer from a heart condition.
- If you suffer from or have suffered from a liver disease.
- If you are taking medicines for the treatment of erectile dysfunction (impotence), called phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil and vardenafil), as both medicines have the effect of lowering blood pressure by dilating blood vessels. The simultaneous use of Benur and these other medicines could cause an excessive drop in blood pressure (see Other medicines and Benur). To reduce the likelihood of symptoms occurring, you should start Benur therapy first by regularly taking a daily dose. Then, once Benur therapy is stabilized, you can start taking medicines for erectile dysfunction.
Persistent painful erections of the penis –can occur very rarely. If this happens, contact
your doctor immediately.
Before starting therapy with Benur, your doctor may perform tests to rule out other diseases
such as prostate cancer, which could cause the same symptoms as benign prostatic hyperplasia.
Children and adolescents
Benur is not recommended for use in children and adolescents under 18 years of age as the safety and
efficacy of the treatment have not been established.
Other medicines and Benur
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Tell your doctor or pharmacist before use if you are taking any of the following medicines,
as they may affect the effect of Benur:
- Medicines called phosphodiesterase type 5 inhibitors for the treatment of erectile dysfunction, such as sildenafil, tadalafil and vardenafil (see Warnings and precautions).
- Medicines that lower blood pressure.
- Medicines for the treatment of bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
- Medicines used to treat HIV, such as indinavir, nelfinavir, ritonavir, saquinavir.
- Nefazodone, a medicine used to treat depression.
Pregnancy and breastfeeding
The use of Benur is not indicated in women.
Driving and using machines
Be careful if you drive or operate machinery. These tablets may impair your ability
to drive or operate machinery safely, especially at the beginning of treatment. They may
cause you to feel weak or dizzy. If you experience these symptoms, do not drive or operate machinery
and contact your doctor immediately.
Benur contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.
Benur contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
3. How to take Benur
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
The initial dose of Benur is 1 mg administered as a single dose every day.
After one or two weeks, your doctor may increase the dose to 2 mg per day, based on the results of your tests on bladder and urethra function (small duct of the last part of the urinary tract that
carries urine from the bladder to the outside) or based on your symptoms caused by prostate enlargement.
If necessary, after a further period of one or two weeks, your doctor may decide to increase the dose again to 4mg per day. The doctor, after a further period of one or two weeks and if
necessary, may further increase the dose to 8 mg per day. However, 8 mg per day is the maximum recommended dose.
Benur can be taken indifferently in the morning or evening.
If you take more Benur than you should
Taking too many tablets together can make you feel unwell, as blood pressure drops
excessively. If this happens, lie down. Taking many tablets can
be dangerous. If you take more Benur than you should, inform your doctor immediately or go to the emergency room of the nearest
hospital.
If you forget to take Benur
If you forget to take Benur, skip the dose completely. Do not take a double dose to make up for the
forgotten dose.
If you forget to take the tablets for a few days, however, restarting Benur should be done starting again from
the lowest dose of 1 mg.
4. Possible Undesirable Effects
Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
If you experience any of these symptoms, STOP treatment with Benur and immediately call
an ambulance:
- chest pain, chest discomfort (angina, myocardial infarction);
- feeling of difficulty breathing (dyspnea), accompanied by discomfort and tightness in the chest (bronchospasm);
- sudden headache, feeling of fainting, weakness in the arms, legs, or problems with speech, which could be symptoms of a stroke;
- swelling of the face and allergic reactions.
Immediatelyinform your doctor if you experience any of the following symptoms after taking Benur:
- fast, slow, or irregular heartbeat;
- perception of your own heartbeat (palpitations);
- yellowing of the skin or eyes (jaundice);
- low number of white blood cells or platelets in the blood. These situations can respectively lead to a greater predisposition to contracting infections or increased bruising or a tendency to bleed.
The following adverse events have also been reported in patients treated with Benur.
Common undesirable effects(may affect up to 1 in 10 people):
- feeling of dizziness or spinning around (vertigo), headache;
- low blood pressure or a drop in pressure when moving from a sitting or lying position to a standing position;
- swelling of feet, ankles, or toes;
- bronchitis, cough, respiratory tract infection (nose, throat, lungs);
- stuffy nose, sneezing and/or runny nose due to inflammation of the nasal mucosa (rhinitis);
- abdominal pain, nausea;
- urinary tract infection, urinary incontinence (inability to control and retain urine), bladder inflammation (cystitis);
- drowsiness, general weakness;
- feeling of fullness and discomfort in the stomach, dry mouth;
- itching;
- chest pain, back pain, muscle pain;
- flu-like symptoms.
Uncommon undesirable effects(may affect up to 1 in 100 people):
- constipation, flatulence, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhea and vomiting;
- pain or discomfort when urinating, needing to urinate more often than usual, blood in the urine;
- swelling and inflammation of the joints (gout), joint pain, generalized pain;
- swelling of the face;
- insomnia, agitation, anxiety, depression, or nervousness;
- temporary loss of consciousness;
- reduced or altered sensitivity to touch in hands and feet;
- increased or decreased appetite, weight gain;
- nosebleeds;
- skin rash;
- ringing or buzzing in the ears, tremor;
- inability/incapacity to achieve or maintain an erection of the penis;
- increased liver enzymes, which can alter some medical tests.
Rare undesirable effects(may affect up to 1 in 1,000 people):
- increased number of times you need to urinate;
- muscle cramps, muscle weakness.
Very rare undesirable effects(may affect up to 1 in 10,000 people):
- hepatitis (inflammation of the liver) or biliary disorder (cholestasis);
- urticaria, hair loss, red or purple patches on the skin due to bleeding under the skin or mucous membranes (purpura);
- feeling of tingling or numbness in hands and feet;
- fatigue, general feeling of unwellness;
- blurred vision;
- hot flashes;
- urinary disorders, needing to urinate at night, increased urine volume;
- enlargement of the breasts in men;
- painful persistent erection of the penis. Seek immediate medical attention;
- sudden dizziness accompanied by loss of balance.
Other undesirable effects(frequency cannot be defined based on available data):
- retrograde ejaculation (semen is ejaculated not externally but into the bladder), which can cause cloudy urine after orgasm;
- problems with the eyes may occur during surgery for cataracts (clouding of the lens). See section "Warnings and precautions".
Reporting of undesirable effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Benur
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Expiry”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Benur contains
The active ingredient is doxazosin.
Each 2 mg tablet contains 2.43 mg of doxazosin mesylate equivalent to 2 mg of doxazosin.
Each 4 mg tablet contains 4.85 mg of doxazosin mesylate equivalent to 4 mg of doxazosin.
The other ingredients are: microcrystalline cellulose, lactose, sodium glycolate starch, magnesium stearate,
sodiumlauryl sulfate.
Description of the appearance of Benur and package contents
PVC-PVDC/Aluminum blister with titanium dioxide opacification.
Package containing 30 divisible 2 mg tablets in blisters.
Package containing 20 divisible 4 mg tablets in blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan
Manufacturer
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35,
89257 Illertissen
Germany
Pfizer Manufacturing Deutschland GmbH
Freiburg Site Mooswaldallee 1
79090 Freiburg
Germany
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- Postać farmaceutycznaTablet, 2 MG
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- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki BENURPostać farmaceutyczna: Extended-release tablet, 10 MGSubstancja czynna: alfuzosinProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga receptyPostać farmaceutyczna: Extended-release tablet, 10 MGSubstancja czynna: alfuzosinProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Extended-release tablet, 10 MGSubstancja czynna: alfuzosinProducent: SANDOZ S.P.A.Wymaga recepty
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BENUR jest produkowany przez VIATRIS PHARMA S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie BENUR jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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