FIXAD 0.5 mg/0.4 mg Капсулы твердые

Содержание инструкции

1. FIXAD 0.5 mg/0.4 mg hard capsules
   1. What is FIXAD and what it is used for
   2. What you need to know before taking FIXAD
   3. How to take FIXAD
   4. Possible side effects
   5. How to store FIXAD
   6. Package Contents and Other Information

FIXAD 0.5 mg/0.4 mg hard capsules

dutasteride/tamsulosin hydrochloride
Generic medicine

Read this leaflet carefully before you start 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 FIXAD is and what it is used for
• 2. What you need to know before you take FIXAD
• 3. How to take FIXAD
• 4. Possible side effects
• 5. How to store FIXAD
• 6. Contents of the pack and other information

1. What is FIXAD and what it is used for

FIXADis used to treat male subjects with enlarged prostate
( benign prostatic hyperplasia) - a non-malignant increase in prostate volume, due to
excessive production of a hormone called dihydrotestosterone.
FIXAD is a combination of two different medicines called dutasteride and tamsulosin.
Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitorsand
tamsulosin belongs to a group of medicines called alpha blockers.
If the prostate increases in volume, this can lead to urinary problems, such as difficulty in
passing urine and the need to urinate frequently. This can also result in the
urine flow becoming slower and weaker. If left untreated, there is a risk that the urine flow
may become completely blocked ( acute urinary retention). This requires immediate medical
treatment. In some cases, surgery is necessary to remove or reduce the volume of the
prostate.
Dutasteride reduces the production of a hormone called dihydrotestosterone and this promotes
a decrease in prostate volume and relieves symptoms. This reduces the risk of acute urinary retention
and the need for surgery. Tamsulosin works by relaxing the muscles of the prostate
gland, making it easier to pass urine and quickly improving symptoms.

2. What you need to know before taking FIXAD

Do not take FIXAD

• if you are a woman(because this medicine is only indicated for men).
• if you are a child or adolescent under 18 years of age.
• if you are allergicto dutasteride,to other 5 alpha reductase inhibitors,to tamsulosin,to soy,to peanutsor to any of the other ingredients of this medicine (listed in section 6).
• if you have low blood pressurethat causes dizziness, a feeling of lightheadedness or fainting (orthostatic hypotension).
• if you have a severe liver disease.
• - If you think that any of the above applies to you, do not takethis medicine until you have consulted your doctor.

Warnings and precautions
Talk to your doctor before taking FIXAD

• In some clinical studies, more patients taking dutasteride and another medicine called an alpha blocker such as tamsulosin, developed heart failure compared to patients treated with dutasteride alone or an alpha blocker alone. Heart failure means that the heart does not pump blood as well as it should.
• Make sure your doctor is aware of any liver problems you have.If you have had any liver disease, further checks may be needed while you are taking FIXAD.
• Make sure your doctor is aware if you have severe kidney problems.Cataract surgery (cloudy lens).If you are about to have cataract surgery, your doctor may ask you to stop taking FIXAD for a period before the operation. Tell your ophthalmologist before the operation if you are taking FIXAD or tamsulosin (or if you have taken them in the past). The specialist will need to take appropriate precautions to help prevent complications during surgery.
• Women, children and adolescentsshould avoid contact with broken FIXAD capsules, because the active ingredient can be absorbed through the skin. If contact with the skin occurs, wash the affected area immediatelywith water and soap.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men treated with FIXAD. If your partner is or may be pregnant, she must avoid exposure to your semen as dutasteride can impair the normal development of a male child. Dutasteride has been shown to reduce sperm count, semen volume and sperm motility. This may decrease your fertility.
• FIXAD affects a blood test for PSA(prostate-specific antigen), which is used in some cases to detect prostate cancer. Your doctor must be aware of this effect and may continue to prescribe the test to find out if you have prostate cancer. If you are to have a PSA test, tell your doctor that you are taking FIXAD. Men taking FIXAD should have the PSA test done regularly.
• In a clinical study conducted on men at increased risk of prostate cancer, men taking dutasteride had more frequently a severe form of prostate cancercompared to men who were not taking dutasteride. The effect of dutasteride on this severe form of prostate cancer is unclear.
• FIXAD may cause breast enlargement and tenderness.If this becomes concerning, or if you notice breast lumpsor nipple discharge, you should talk to your doctor about these changes as they may be signs of a serious condition, such as breast cancer.
• - Ask your doctor or pharmacistif you have any questions about taking FIXAD.

Other medicines and FIXAD
Tell your doctor or pharmacist if you are taking, have recently taken or might take,
any other medicines.
Do not take FIXAD with these medicines:

• other alpha blockers(for enlarged prostate or high blood pressure).

FIXAD is not recommended with these medicines:

• ketoconazole(used to treat fungal infections).

Some medicines can interact with FIXAD and may increase the possibility of having undesirable effects. These medicines include:

• PDE5 inhibitors(used to help achieve or maintain an erection) such as vardenafil, sildenafil citrate and tadalafil
• verapamil or diltiazem(for high blood pressure)
• ritonavir or indinavir(for HIV)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)
• cimetidine(for stomach ulcers)
• warfarin(for blood clotting)
• erythromycin(an antibiotic used to treat infections)
• paroxetine(an antidepressant)
• terbinafine(used to treat fungal infections)
• diclofenac(used to treat pain and inflammation)
• - Tell your doctorif you are taking any of these medicines.

FIXAD with food
FIXAD should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding and fertility
FIXAD must not be taken by women.
Women who are pregnant (or may become pregnant) must not handle broken capsules.Dutasteride is absorbed through the skin and can interfere with the normal development of a male child. This is particularly risky in the first 16 weeks of pregnancy.

Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking FIXAD. If your partner is pregnant or may become pregnant, she must avoid contact with your semen.
FIXAD has been shown to reduce sperm count, semen volume and sperm motility. Therefore, male fertility may decrease.

• - Ask your doctorif a pregnant woman has come into contact with FIXAD.

Driving and using machines
FIXAD can cause dizziness in some people, therefore it may affect your ability to drive or operate machinery safely.

• - Do not drive or operate machineryif you feel this way.

FIXAD contains soy lecithin and propylene glycol
This medicine contains soy lecithin, which may contain soy oil. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially ‘sodium-free’.
This medicine contains 299 mg of propylene glycol per capsule.

3. How to take FIXAD

Always take FIXAD exactly as your doctor or pharmacist has told you. If you do not take it regularly, the control of your PSA levels may be affected. If you have any doubts, ask your doctor or pharmacist.

How much medicine to take
The recommended dose is one capsule to be taken once a day, 30 minutes after the same meal, every day.
How to take the medicine
Swallow the capsules whole with water.Do not chew or open the capsules. Contact with the contents of the capsules may irritate your mouth or throat.

If you take more FIXAD than you should
Contact your doctor or pharmacist for advice if you take more FIXAD capsules than you should.

If you forget to take FIXAD
Do not take a double dose to make up for a missed dose. Take the next dose as usual.

Do not stop taking FIXAD without your doctor's advice
Do not stop taking FIXAD without consulting your doctor first.
If you have any further questions about 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 everyone will experience them.
Allergic reaction
Signs of an allergic reaction may include:

• skin rash(which may be itchy)
• urticaria(similar to a nettle rash)
• swelling of the eyelids, face, lips, arms or legs.
• - Contact your doctor immediatelyif you experience any of these symptoms and stop taking FIXAD.

Dizziness, lightheadedness and fainting
FIXAD can cause dizziness, lightheadedness and, in rare cases, fainting. Be careful
when moving from a lying or sitting position to a standing position, especially if you
wake up at night, until you know how this medicine affects you. If you feel dizzy or
lightheaded at any time during treatment, sit or lie down until
these symptoms pass.
Severe skin reactions
Signs of severe skin reactions may include:

a widespread rash with blisters and peeling skin, especially around
the mouth, nose, eyes and genitals(Stevens-Johnson syndrome).

• - Contact your doctor immediatelyif you experience these symptoms and stop takingFIXAD.

Common side effects
These may affect up to 1 in 10 men treated with FIXAD:

• impotence (inability to achieve or maintain an erection)*
• decreased sexual desire ( libido)*
• difficulty ejaculating, such as a decrease in the amount of semen released during sexual intercourse*
• breast enlargement or tenderness ( gynecomastia)
• dizziness. * In a small number of people some of these effects may continue after you have stopped

taking FIXAD.

Uncommon side effects
These may affect up to 1 in 100:

• heart failure (the heart becomes less efficient at pumping blood around the body. You may have symptoms such as shortness of breath, extreme fatigue and swelling of the ankles and legs)
• low blood pressure when standing
• fast heartbeat ( palpitations)
• constipation, diarrhea, vomiting, feeling unwell (nausea)
• weakness or loss of strength
• headache
• itchy, blocked or runny nose ( rhinitis)
• skin rash, urticaria, itching
• hair loss (usually from the body) or hair growth.

Rare side effects
These may affect up to 1 in 1000:

• swelling of the eyelids, face, lips, arms or legs ( angioedema)
• fainting.

Very rare side effects
These may affect up to 1 in 10,000:

• painful, prolonged erection of the penis ( priapism)
• severe skin reactions ( Stevens-Johnson syndrome).

Other side effects
Other side effects have been reported in a small number of men but their exact frequency
is unknown (frequency cannot be estimated based on available data):

• abnormal or fast heartbeat ( arrhythmia or tachycardia or atrial fibrillation)
• shortness of breath ( dyspnea)
• depression
• pain and swelling of the testicles
• nosebleeds
• severe skin rash
• changes in vision ( blurred vision or impaired vision)
• dry mouth.

Reporting of side 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 to 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 FIXAD

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 package and bottle after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater 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 FIXAD contains
The active ingredients are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg of
dutasteride and 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin). The other
ingredients are:
Hard capsule coating:
Black iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)
Yellow iron oxide (E172)
Gelatin
Soft capsule content of dutasteride:
Propylene glycol monocaprylate, type II
Butylated hydroxytoluene (E321)
Soft capsule coating:
Gelatin
Glycerol
Titanium dioxide (E171)
Triglycerides (medium chain)
Lecithin (may contain soybean oil) (see paragraph 2)
Tamsulosin granules:
Acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (contains sodium lauryl sulfate,
polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Hydrated colloidal silica
Stearic acid
Black ink:
Shellac (E904)
Black iron oxide (E172)
Propylene glycol (E1520)
Concentrated ammonia solution (E527)
Potassium hydroxide (E525)
See paragraph 2 “FIXAD contains soybean lecithin and propylene glycol”.

Description of the appearance of FIXAD and package contents
This medicine is presented in the form of oblong hard capsules, approximately 21.4 mm x 7.4 mm, with a
brown body and an orange head with the inscription C001 printed in black ink.
Each hard capsule contains modified-release granules of tamsulosin hydrochloride and a soft gelatin
capsule of dutasteride.
The capsules are available in packs of 7, 30 and 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bruno Farmaceutici SpA
Via delle Ande 15
00144 Rome
Manufacturer:
Laboratorios LEÓN FARMA, SA
C/La Vallina, s/n, Polígono Industrial Navatejera
Villaquilambre-24008 (León)
SPAIN
Genericon Pharma Gesellschaft M.B.H,
Hafnerstrasse 211,
Graz 8054
Austria;

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
DK: Prostaduo
CZ: Duitam
HR: Duitam
IT: Fixad
PL: Duitam