Dutamsol

Package leaflet: information for the patient

Dutamsol, 0.5 mg + 0.4 mg, hard capsules
Dutasteride + Tamsulosin hydrochloride
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Dutamsol is and what it is used for
2. Important information before taking Dutamsol
3. How to take Dutamsol
4. Possible side effects
5. How to store Dutamsol
6. Contents of the pack and other information

1. What Dutamsol is and what it is used for

Dutamsol is used in men with an enlarged prostate gland (benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate caused by excessive production of a hormone called dihydrotestosterone. Dutamsol is a combination of two different medicines: 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-adrenergic receptor antagonists.
An enlarged prostate can lead to problems with urination, such as difficulty in passing urine and increased frequency of urination. There may also be a reduced flow of urine and a weak urine stream. If left untreated, complete blockage of urine flow may occur (acute urinary retention). This situation requires immediate treatment. In some cases, surgery may be needed to remove part of the prostate or reduce its size.
Dutasteride reduces the production of the hormone called dihydrotestosterone, which leads to a reduction in the size of the prostate and relief of symptoms. By this action, dutasteride reduces the risk of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscles in the prostate gland, which helps urine flow and provides rapid relief of symptoms.

2. Important information before using Dutamsol

When not to use Dutamsol:

• if the patient is a woman (as this medicine is intended only for men).
• if the patient is a child or person under 18 years of age.
• if the patient is allergic to dutasteride, other medicines in the class of 5-alpha reductase inhibitors, tamsulosin, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has low blood pressure causing dizziness, lightheadedness, or fainting (orthostatic hypotension).
• if the patient has severe liver disease.
• If any of the above apply to the patient, this medicine must not be taken until consultation with a doctor.

Warnings and precautions:
Before starting treatment with Dutamsol, discuss this with your doctor or pharmacist.

• In some clinical studies, heart failure was observed in a higher number of patients receiving dutasteride together with a medicine belonging to the class known as alpha-adrenergic receptor antagonists (such as tamsulosin), compared to patients receiving dutasteride alone or the alpha-adrenergic receptor antagonist alone. Heart failure means that the heart does not pump blood as well as it should.
• Inform your doctor if the patient has liver disease. If the patient has liver disease, additional tests may be required during treatment with Dutamsol.

Inform your doctor if the patient has kidney disease.

• Cataract surgery (cloudy lens). If the patient is scheduled for surgical removal of cataracts, the doctor may advise temporarily discontinuing Dutamsol before the procedure. Before surgery, inform the ophthalmologist if the patient is taking (or has previously taken) Dutamsol or tamsulosin. The doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescents must not touch damaged capsules of Dutamsol, as the active substance may be absorbed through the skin. In case of skin contact, the contaminated area should be washed immediately with soap and water.
• A condom should be used during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutamsol. If the partner is pregnant or may be pregnant, exposure to semen should be avoided, as dutasteride may disrupt the development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility.
• Dutamsol affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes performed to diagnose prostate cancer. Despite this, the doctor may intentionally order this test. If the patient is undergoing PSA testing, inform the doctor about taking Dutamsol. Patients taking Dutamsol should have their PSA levels monitored regularly.
• In a clinical trial involving patients at increased risk of prostate cancer, high-grade prostate cancer was diagnosed more frequently in patients taking dutasteride than in those not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is not fully understood.
• Dutamsol may cause breast enlargement and tenderness. If these symptoms become bothersome or if lumps in the breast or nipple discharge occur, contact the doctor, as these may be symptoms of a serious condition such as breast cancer.

If you have any questions about using Dutamsol, contact your doctor or pharmacist.

Dutamsol and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

Do not take Dutamsol with the following medicines:

• other medicines in the class of alpha-adrenergic receptor antagonists (used to treat benign prostatic hyperplasia or high blood pressure)

Concomitant use of Dutamsol with the following medicines is not recommended:

• ketoconazole (used to treat fungal infections)

Some medicines may interact with Dutamsol and increase the likelihood of adverse effects. These include:

• PDE5 inhibitors [used to induce or maintain erection (erection)], such as vardenafil, sildenafil citrate, and tadalafil
• verapamil or diltiazem (used to treat high blood pressure)
• ritonavir or indinavir (used to treat HIV infection)
• itraconazole or ketoconazole (used to treat fungal infections)
• nefazodone (an antidepressant)
• cimetidine (used to treat peptic ulcer disease)
• warfarin (used to treat blood clots)
• erythromycin (an antibiotic used to treat infections)
• paroxetine (an antidepressant)
• terbinafine (used to treat fungal infections)
• diclofenac (used to treat inflammatory conditions and pain)

Inform your doctor if you are taking any of these medicines.

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

Pregnancy, breastfeeding, and effects on fertility
Use of Dutamsol by women is contraindicated.
Pregnant women (or women who may become pregnant) must not touch damaged capsules.
Dutasteride is absorbed through the skin and may disrupt the development of a male fetus. The risk is particularly high during the first 16 weeks of pregnancy.

• If a pregnant woman has been exposed to Dutamsol, contact a doctor immediately.

A condom should be used during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutamsol. If the partner is pregnant or may be pregnant, exposure to semen should be avoided.

It has been shown that the combination of dutasteride and tamsulosin reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.

Driving and using machines
In some patients, Dutamsol may cause dizziness, which could impair the ability to drive or operate machinery.

• If such symptoms occur, do not drive or operate machinery.

Dutamsol contains a colouring agent – Sunset Yellow FCF (E 110), which may cause allergic reactions.
Dutamsol contains lecithin derived from soy. Do not use if hypersensitivity to peanuts or soy has been diagnosed.
Dutamsol contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".

3. How to use Dutamsol

This medicine should always be used exactly as directed by your doctor or pharmacist.
Irregular use of this medicine may affect PSA test results. If in doubt, consult your doctor or pharmacist.

How much Dutamsol should be taken
The recommended dose is one capsule taken once daily, 30 minutes after the same meal each day.

How to take Dutamsol
The capsule should be swallowed whole with water. Do not chew or open the capsule.
Contact with the capsule contents may cause oral pain or throat irritation.

Taking more Dutamsol than recommended
If you have taken more capsules than recommended, consult your doctor or pharmacist immediately.

If you forget to take Dutamsol
Do not take a double dose to make up for the missed dose.
Take the next capsule at your usual time.

Stopping Dutamsol
Do not stop taking Dutamsol unless advised by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Allergic reactions
Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• hives
• swelling of the eyelids, face, lips, hands or feet.
• If any of these symptoms occur, seek immediate medical advice and discontinue use of Dutamsol.

Dizziness, lightheadedness and fainting
Dutamsol may cause dizziness, lightheadedness, or in rare cases fainting. Until you are certain how the medicine affects you, take care when changing position from lying or sitting to sitting or standing, especially when getting up at night. If dizziness or lightheadedness occurs at any time during treatment, sit or lie down and wait for symptoms to subside.

Severe skin reactions
Symptoms of a severe skin reaction may include:

• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome)
• If any of these symptoms occur, seek immediate medical advice and discontinue use of Dutamsol.

Common adverse reactions (may occur in no more than 1 in 10 men taking Dutamsol):

• impotence (inability to achieve or maintain an erection)
• reduced sexual desire (libido)
• problems with ejaculation, including reduced volume of semen during ejaculation
• enlargement or tenderness of the breasts (gynaecomastia)
• dizziness.
  In a small number of individuals, these adverse reactions may persist even after stopping Dutamsol.

Uncommon adverse reactions (may occur in no more than 1 in 100 men taking Dutamsol):

• heart failure (the heart's ability to pump blood becomes less efficient; symptoms may include shortness of breath, extreme fatigue, and swelling of the ankles and legs)
• low blood pressure upon standing
• rapid heartbeat (palpitations)
• constipation, diarrhoea, vomiting, nausea
• weakness or loss of strength
• headache
• itching or stuffy nose, runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually body hair) or excessive hair growth.

Rare adverse reactions (may occur in no more than 1 in 1,000 men taking Dutamsol):

• swelling of the eyelids, face, lips, hands or feet (angioedema)
• fainting.

Very rare adverse reactions (may occur in no more than 1 in 10,000 men taking Dutamsol):

• prolonged, painful erection (priapism)
• severe skin reaction (Stevens-Johnson syndrome).

Other adverse reactions
Other adverse reactions have been observed in a small number of men, but their exact frequency is unknown (based on available data, frequency cannot be estimated):

• irregular or rapid heart rhythm (arrhythmia, tachycardia or atrial fibrillation)
• difficulty breathing (dyspnoea)
• depression
• pain and swelling of the testicles
• nosebleeds
• severe skin rash
• changes in vision (blurred vision or visual disturbances)
• dry mouth.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dutamsol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or
bottle, or blister pack after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Dutamsol contains
The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains
0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
Other components are:

• hard capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide (E 171), iron oxide red (E 172), Orange Yellow FCF (E 110).
• inside the hard capsule: glyceryl monocaprylocaprate (type I) and butylated hydroxytoluene (E 321), gelatin, glycerol, yellow iron oxide (E 172), medium-chain saturated fatty acid triglycerides, soy lecithin, microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, magnesium stearate, triacetin, talc, titanium dioxide (E 171), sodium hydroxide.

What Dutamsol looks like and contents of the pack
This medicinal product is in the form of elongated hard capsules with a brown body and an orange cap.
The medicine is available in packs containing 7, 30 or 90 capsules, placed in HDPE bottles or Aluminium/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Solinea Sp. z o.o. Sp. K.
Elizówka 65
21-003 Ciecierzyn
Tel. 81-4634882
Fax 81-4634886
e-mail: [email protected]

Manufacturer
SAG MANUFACTURING S.L.U.
Crta. N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain

Galenicum Health., S.L.
Avda. Cornellá 144, Edificio LEKLA,
Esplugues de Llobregat,
08950, Barcelona, Spain