Fixad

Package leaflet: Information for the user

FIXAD 0.5 mg/0.4 mg hard capsules

dutasteride/tamsulosin hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including 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 taking 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 FIXAD is and what it is used for

FIXAD is used to treat men with an enlarged prostate
(benign prostatic hyperplasia) – a non-malignant enlargement of the prostate gland caused by
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 known as 5-alpha reductase inhibitors, and
tamsulosin belongs to a group of medicines known as alpha-blockers.
When the prostate enlarges, it can cause urinary problems such as difficulty passing urine and the need to urinate frequently. This may also result in a weaker and less forceful urine stream. If left untreated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be necessary to remove or reduce the size of the prostate.
Dutasteride reduces the production of a hormone called dihydrotestosterone, thereby helping to reduce prostate size and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscle tissue of the prostate gland, making it easier for urine to pass and rapidly improving symptoms.

2. What you need to know before taking FIXAD

Do not take FIXAD

• if you are a woman (because this medicine is intended only for men).
• if you are a child or adolescent under 18 years of age.
• if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to tamsulosin, soy, peanuts, or to any of the other ingredients of this medicine (listed in section 6).
• if you have low blood pressure causing dizziness, lightheadedness, or fainting ( orthostatic hypotension ).
• if you have severe liver disease.
• • If you think any of the above apply to you, do not take this 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 only with dutasteride or only with an alpha blocker. Heart failure means that the heart does not pump blood as well as it should.
• Make sure your doctor knows about any liver problems you have. If you have had any liver disease, you may need additional monitoring while taking FIXAD.
• Make sure your doctor knows if you have severe kidney problems. Cataract surgery (cloudy lens). If you are scheduled for cataract removal surgery, your doctor may ask you to stop taking FIXAD for a period before the operation. Inform your ophthalmologist before surgery if you are taking FIXAD or tamsulosin (or have taken them previously). The specialist will need to take appropriate precautions to help prevent complications during surgery.
• Women, children, and adolescents must avoid contact with damaged FIXAD capsules, as the active substance can be absorbed through the skin. In case of skin contact, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men being treated with FIXAD. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce your fertility.
• FIXAD affects a blood test for PSA ( prostate-specific antigen ), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may continue to order the test to check for prostate cancer. If you are to have a PSA test, inform your doctor that you are taking FIXAD. Men taking FIXAD must have the PSA test regularly.
• In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride had a higher incidence of high-grade prostate cancer compared to men not taking dutasteride. The effect of dutasteride on this high-grade form of prostate cancer is not clear.
• FIXAD may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, you should discuss these changes with your doctor, as they may be signs of a serious condition, such as breast cancer.
• • Ask your doctor or pharmacist if you have any questions about taking FIXAD.

Other medicines and FIXAD
Inform 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 may interact with FIXAD and increase the risk of side effects. These 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)
• • Inform your doctor if you are taking any of these medicines.

FIXAD and food
FIXAD should be taken 30 minutes after the same meal every day.
Pregnancy, breastfeeding, and fertility
FIXAD must not be taken by women.
Pregnant women (or women who could be pregnant) must not handle damaged capsules. Dutasteride can be absorbed through the skin and may interfere with the normal development of a male fetus. This is particularly risky during 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 could be pregnant, you must avoid exposing her to your semen.
FIXAD has been shown to reduce sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.

• • Consult your doctor if a pregnant woman has been exposed to FIXAD.

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

• • Do not drive or operate machinery if you feel dizzy.

FIXAD contains soy lecithin and propylene glycol
This medicine contains soy lecithin, which may contain soybean 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

Take FIXAD exactly as your doctor or pharmacist has told you to. If you do not
take it regularly, monitoring of PSA levels may be affected. If you have any doubts, consult your
doctor or pharmacist.
How much medicine to take
The recommended dose is one capsule taken once daily, 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 the mouth or throat.
If you take more FIXAD than you should
Contact your doctor or pharmacist for advice if you have taken more FIXAD capsules than prescribed.
If you forget to take FIXAD
Do not take a double dose to make up for the missed dose. Take the next dose as usual.
Do not stop FIXAD without medical advice
Do not stop taking FIXAD without first consulting your doctor.
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 gets them.

Allergic reaction
Signs of allergic reactions may include:

• rash (which may be itchy)
• hives (similar to a rash caused by nettles)
• swelling of the eyelids, face, lips, arms or legs.
• • Contact your doctor immediately if you experience any of these symptoms and stop taking FIXAD.

Dizziness, lightheadedness and fainting
FIXAD may cause dizziness, lightheadedness and, in rare cases, fainting. Be cautious 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:
widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).

• • Contact your doctor immediately if you experience these symptoms and stop taking FIXAD.

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 )*
• ejaculation disorders, such as reduced amount of semen released during sexual intercourse*
• breast enlargement or tenderness ( gynecomastia )
• dizziness. * In a small number of people, some of these side effects may continue after stopping treatment with FIXAD.

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

• heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include shortness of breath, extreme tiredness and swelling of the ankles and legs)
• low blood pressure upon standing
• fast heartbeat ( palpitations )
• constipation, diarrhoea, vomiting, feeling unwell (nausea)
• weakness or loss of strength
• headache
• itchy, blocked or runny nose ( rhinitis )
• rash, hives, itching
• loss of body hair or excessive hair growth.

Rare side effects
These may affect up to 1 in 1,000 men:

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

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

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

Other side effects
Other side effects have occurred in a small number of men, but their exact frequency is unknown (frequency cannot be estimated from the available data):

• irregular or fast heartbeat ( arrhythmia, tachycardia or atrial fibrillation )
• shortness of breath ( dyspnoea )
• 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and vial 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FIXAD contains
The active substances 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
components are:
Capsule shell of the hard capsule:
Iron oxide black (E172)
Iron oxide red (E172)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Gelatin
Contents of the soft dutasteride capsule:
Propylene glycol monocaprylate, type II
Butylated hydroxytoluene (E321)
Shell of the soft capsule:
Gelatin
Glycerol
Titanium dioxide (E171)
Medium-chain triglycerides
Lecithin (may contain soybean oil) (see section 2)
Tamsulosin granules:
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (containing sodium lauryl sulfate,
polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Hydrated colloidal silica
Calcium stearate
Black ink:
Shellac (E904)
Iron oxide black (E172)
Propylene glycol (E1520)
Concentrated ammonia solution (E527)
Potassium hydroxide (E525)
See section 2 “FIXAD contains soybean lecithin and propylene glycol”.
Description of the appearance of FIXAD and contents of the pack
This medicinal product is presented as an oblong hard capsule, approximately 21.4 mm x 7.4 mm, with a brown body and an orange cap printed with the code C001 in black ink.
Each hard capsule contains modified-release granules of tamsulosin hydrochloride and a soft gelatin capsule containing 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
Italy
Manufacturer:
Laboratorios LEÓN FARMA, S.A.
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 European Economic Area countries under the following
names:
DK: Prostaduo
CZ: Duitam
HR: Duitam
IT: Fixad
PL: Duitam