Duttam

Patient Information Leaflet

DUTTAM 0.5 mg/0.4 mg Hard Capsules

Dutasteride and tamsulosin hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before 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 they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Duttam is and what it is used for

Duttam is used to treat men with an enlarged prostate
( benign prostatic hyperplasia ) – a non-cancerous enlargement of the prostate caused by
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 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 in passing urine and the need to urinate frequently. This may also result in a weaker and slower urine flow. 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 may be needed to remove or reduce the size of the prostate.
Dutasteride reduces the production of a hormone called dihydrotestosterone, 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 of the prostate gland, making it easier to pass urine and rapidly improving urinary symptoms.

2. What you need to know before taking Duttam

Do not take Duttam

• 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, to soy, to 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 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 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 Duttam.
• Make sure your doctor knows if you have severe kidney problems.
• Cataract surgery (cloudy lens). If you are scheduled to undergo cataract removal surgery, your doctor may ask you to stop taking Duttam for a period before the procedure. Inform your ophthalmologist before surgery if you are currently taking Duttam 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 not handle damaged Duttam capsules, as the active ingredient 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 Duttam. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair 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.
• Duttam 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 this test to screen for prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking Duttam. Men taking Duttam should 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 form of aggressive prostate cancer is not fully understood.
• Duttam may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, speak to your doctor about these changes, as they may be signs of a serious condition such as breast cancer.
• Ask your doctor or pharmacist for advice if 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 medicines.
Do not take Duttam with the following medicines:

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

Duttam is not recommended with the following medicines:

• ketoconazole (used to treat fungal infections)

Some medicines may interact with Duttam 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.

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

Pregnancy, breastfeeding, and fertility
Duttam must not be taken by women.
Pregnant women (or women who may become 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 dangerous during the first 16 weeks of pregnancy.

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

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

Driving and using machines
Duttam 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.

Duttam contains
Duttam contains the yellow dye sunset yellow (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 instructed by your doctor or pharmacist. 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 to take
The recommended dose is one capsule taken once daily, 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 contents of the capsules 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 prescribed.
If you forget to take Duttam
Do not take a double dose to make up for the missed dose. Take the next dose as scheduled.
Do not stop Duttam without medical advice
Do not stop taking Duttam without first consulting your doctor.
If you have any 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 everybody gets them.

Allergic reaction
Signs of allergic reactions may include:

• rash (which may be itchy)
• hives
• swelling of the eyelids, face, lips, arms or legs

Contact your doctor immediately if you experience any of these symptoms and stop taking Duttam.

Dizziness, mild mental confusion and fainting
Duttam may cause dizziness, mild mental confusion and, in rare cases, fainting. Be careful when moving from a lying or sitting position to standing, especially if you wake up at night, until you know how this medicine affects you. If you feel dizzy or mildly confused at any time during treatment, sit or lie down until the symptoms pass.

Severe skin reactions
Signs of severe skin reactions may include:

• a 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 Duttam.

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

• impotence (inability to achieve or maintain an erection) *
• decreased sexual desire (libido)*
• ejaculation disorders, such as reduced volume 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 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. 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)
• skin rash, hives, itching
• loss of body hair or increased 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)

• prolonged, painful 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 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 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 stated on the carton or blister after Exp.. The expiry date refers to the last day of that month.
Do not store Duttam above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Duttam contains

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

Description of the appearance of Duttam and contents of the pack
This medicinal product is presented as an oblong hard capsule, approximately 24 mm in length, with a brown body and an orange cap.
Available in packs of 30 and 90 capsules contained 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
Manufacturers:
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 European Economic Area countries under the following names:
Italy: DUTTAM