DUTTAM 0,5 MG/0,4 MG Kapsułki twarde

Treść ulotki

1. DUTTAM 0.5 mg/0.4 mg hard capsules
   1. What is Duttam and what it is used for
   2. What you need to know before taking Duttam
   3. How to take Duttam
   4. Possible side effects
   5. How to store Duttam
   6. Package contents and other information

DUTTAM 0.5 mg/0.4 mg hard capsules

Dutasteride and 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 their symptoms are the same as yours, as it could 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 Duttam is and what it is used for
• 2. What you need to know before you take Duttam
• 3. How to take Duttam
• 4. Possible side effects
• 5. How to store Duttam
• 6. Contents of the pack and other information

1. What is Duttam and what it is used for

Duttam is used to treat male subjects with enlarged prostate
( benign prostatic hyperplasia) - a non-cancerous growth of the prostate, caused by an
excessive production of a hormone called dihydrotestosterone.
Duttam 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, it 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 be
completely blocked ( acute urinary retention). This requires immediate medical treatment.
In some cases, surgery may be necessary to remove or reduce the volume of the prostate.
Dutasteride reduces the production of a hormone called dihydrotestosterone and this helps to decrease
prostatic volume and relieve symptoms. This will reduce 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 its symptoms.

2. What you need to know before taking Duttam

Do not take Duttam

• 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 allergic to 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, 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 Duttam.

• 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 necessary while you are taking Duttam.
• 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 Duttam for a period before the operation. Tell your ophthalmologist if you are taking Duttam or tamsulosin (or have taken them previously) before the operation. The specialist will need to take appropriate precautions to help prevent complications during surgery.
• Women, children and adolescentsshould not handle broken or opened Duttam capsules, because the active ingredient is 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 Duttam. If your partner is or may be pregnant, she must avoid exposure to your semen as dutasteride may 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.
• Duttam affects a blood test forPSA (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 detect prostate cancer. If you need to have a PSA test, tell your doctor that you are taking Duttam . Men taking Duttam should have the PSA testregularly.
• 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.
• Duttam can cause breast enlargement and tenderness.If this becomes problematic, or if you notice the presence of 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 Duttam.

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

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

Duttam is not recommended with these medicines:

• ketoconazole(used to treat fungal infections)

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

• PDE5 inhibitors(used to help achieve or maintain an erection) such as vardenafil, sildenafil citrate and tadalafil
• verapamilor 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.

Duttam with food and drink
Duttam should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding and fertility
Duttam should not be taken by women.
Women who are pregnant (or may become pregnant) should not handle broken or opened 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.

• Askyour doctor if a pregnant woman has come into contact with Duttam.

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

Driving and using machines
Duttam can cause dizziness in some people and may therefore affect your ability to drive or
use machines safely.

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

Duttam contains
Duttam contains the yellow sunset dye (E110) which may cause allergic reactions.
Duttam contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.
Duttam contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Duttam

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

How much 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 Duttam
Swallow the capsules whole with water.Do not chew or open the capsules. Contact with the capsule contents may irritate the mouth or throat.

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

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

Do not stop taking Duttamwithout your doctor's advice
Do not stop taking Duttam without consulting your doctor first.
If you have any further questions on 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 everybody gets them.
Allergic reaction
Signs of allergic reactions may include:

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

Dizziness,mild confusion and fainting
Duttam can cause dizziness, mild confusion and, in rare cases, fainting. Be careful
when moving from a lying or sitting position to a sitting or standing position, especially if you
wake up at night until you know how this medicine affects you. If you feel dizzy or a

mild confusionat 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, especiallyaround the mouth, nose, eyes and genitals(Stevens-Johnson syndrome).
• Contact your doctor immediatelyif you experience these symptoms and stop taking Duttam.

Common side effects(may affect up to 1 in 10 people)

• 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 stop taking Duttam.

Uncommon side effects(may affect up to 1 in 100 people)

• 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 up
• fast heartbeat ( palpitations)
• constipation, diarrhea, vomiting, feeling sick (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(may affect up to 1 in 1,000 people)

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

Very rare side effects(may affect up to 1 in 10,000 people)

• 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 patients 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
• nosebleed
• severe skin rash
• changes in vision ( blurred vision or impaired vision)
• dry mouth

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at 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 Duttam

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 box or blister after
Exp. The expiry date refers to the last day of that month.
Do not store Duttam at a temperature above 30 °C.
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 Duttam contains

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
• The other ingredients (excipients) are:
• Hard capsule coating: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), sunset yellow FCF (E110).
• Inside the hard capsule: caprylic/capric acid monoglycerides and butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin (which may contain soybean oil) (E322), microcrystalline cellulose, 30% dispersion of the methacrylic acid-ethyl acrylate copolymer 1:1, methacrylic acid-ethyl acrylate copolymer 1:1, magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Description of the appearance of Duttam and package contents
This medicine is presented in the form of oblong hard capsules, approximately 24 mm in length with a
brown body and an orange cap.
They are available in packs of 30 and 90 capsules placed in aluminum/aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Pharmacare Srl
Via Marghera, 29

• 20149 - Milan – Italy

Manufacturer:
SAG MANUFACTURING S.L.U.
Crta. N-I, Km 36

• 28750 - San Agustin de Guadalix Madrid (Spain)

GALENICUM HEALTH, S.L.
Avda. Cornellà 144, 7º-1ª, Edificio Lekla

• 08950 - Esplugues de Llobregat - Barcelona (Spain)

This medicinal product is authorized in the Member States of the European Economic Area under the
following denominations:
Italy: DUTTAM