Dutasteride + tamsulosin hydrochloride olpha

Package leaflet: Information for the patient

Dutasteride + Tamsulosin hydrochloride Olpha, 0.5 mg + 0.4 mg, hard capsules
Dutasteridum + Tamsulosini hydrochloridum
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

1. What Dutasteride + Tamsulosin hydrochloride Olpha is and what it is used for
2. What you need to know before taking Dutasteride + Tamsulosin hydrochloride Olpha
3. How to take Dutasteride + Tamsulosin hydrochloride Olpha
4. Possible side effects
5. How to store Dutasteride + Tamsulosin hydrochloride Olpha
6. Contents of the pack and other information

1. What Dutasteride + Tamsulosin hydrochloride Olpha is and what it is used for

Dutasteride + Tamsulosin hydrochloride Olpha is used in men with an enlarged prostate
(benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate gland caused by
excessive production of a hormone called dihydrotestosterone.
Dutasteride + Tamsulosin hydrochloride Olpha capsules contain a combination of two different
medicines: dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called
5-alpha-reductase inhibitors, and tamsulosin belongs to a group of medicines called alpha-adrenergic receptor antagonists.
An enlarged prostate can lead to problems with urination, such as difficulty passing urine, more
frequent urination, a slow urine flow, or a weak stream. If left untreated, it may result in a complete
blockage of urine flow (acute urinary retention). This situation requires immediate treatment. In
some cases, surgery may be needed to remove or reduce the size of the prostate.
Dutasteride reduces the production of the hormone dihydrotestosterone, which causes the
prostate to shrink and symptoms to improve. By this action, dutasteride reduces the risk of acute
urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles in the prostate
and bladder neck, which improves urine flow and provides rapid symptom relief.

2. What you need to know before taking Dutasteride + Tamsulosin hydrochloride Olpha

Do not take Dutasteride + Tamsulosin hydrochloride Olpha:

• in women, as this medicine is intended only for men,
• in children or individuals under 18 years of age,
• if you are allergic to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6),
• if you have low blood pressure causing dizziness or fainting (orthostatic hypotension),
• if you have severe liver disease.
  → If any of the above apply to you, do not take this medicine until you have consulted your doctor.

Warnings and precautions
Before starting Dutasteride + Tamsulosin hydrochloride Olpha, discuss the following with your doctor:

• In some clinical studies, heart failure was observed in a higher number of patients taking dutasteride in combination with a medicine from the class of alpha-adrenergic receptor antagonists (such as tamsulosin) compared to patients taking dutasteride alone or an alpha-adrenergic receptor antagonist alone. Heart failure means the heart is unable to pump blood properly.

• Inform your doctor if you have liver disease. If you have liver disease, additional monitoring may be required during treatment with Dutasteride + Tamsulosin hydrochloride Olpha.

• Inform your doctor if you have kidney disease.

• Cataract surgery (cloudy lens). If you are scheduled for cataract surgery, your doctor may advise you to stop taking Dutasteride + Tamsulosin hydrochloride Olpha for a period before the procedure. Inform your ophthalmologist if you are currently taking or have previously taken Dutasteride + Tamsulosin hydrochloride Olpha or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.

• Women, children, and adolescents must not handle damaged capsules of Dutasteride + Tamsulosin hydrochloride Olpha, as the active substance can be absorbed through the skin. If skin contact occurs, wash the affected area immediately with soap and water.

• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutasteride + Tamsulosin hydrochloride Olpha. If your partner is pregnant or could be pregnant, avoid exposing her to semen, 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.

• Dutasteride + Tamsulosin hydrochloride Olpha affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes used to screen for prostate cancer. Despite this, your doctor may still recommend this test. If you are having PSA levels measured, inform your doctor that you are taking Dutasteride + Tamsulosin hydrochloride Olpha. Patients taking Dutasteride + Tamsulosin hydrochloride Olpha should have regular PSA tests.

• 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.

• Dutasteride + Tamsulosin hydrochloride Olpha may cause breast enlargement and breast tenderness. If these symptoms become bothersome, or if you notice lumps in the breast or nipple discharge, contact your doctor, as these may be signs of a serious condition such as breast cancer.

Mood changes and depression
Depressed mood, depression, and, rarely, suicidal thoughts have been reported in patients taking another oral medicine from the same therapeutic class (5-alpha-reductase inhibitor). If any of these symptoms occur, contact your doctor immediately for further medical advice.
→ If you have any questions about using Dutasteride + Tamsulosin hydrochloride Olpha, contact your doctor or pharmacist.

Dutasteride + Tamsulosin hydrochloride Olpha and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Dutasteride + Tamsulosin hydrochloride Olpha with the following medicines:

• other alpha-adrenergic receptor antagonists (used to treat benign prostatic hyperplasia or high blood pressure).

Concomitant use of Dutasteride + Tamsulosin hydrochloride Olpha with the following medicines is not recommended:

• ketoconazole (used to treat fungal infections).

Some medicines may interact with Dutasteride + Tamsulosin hydrochloride Olpha and increase the risk of side effects. These include:

• PDE5 inhibitors (used to induce or maintain 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 inflammation and pain).
  → Inform your doctor if you are taking any of these medicines.

Dutasteride + Tamsulosin hydrochloride Olpha with food and drink
Take Dutasteride + Tamsulosin hydrochloride Olpha 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility
Taking Dutasteride + Tamsulosin hydrochloride Olpha is contraindicated in women.
Pregnant women (or women who may become pregnant) must not handle damaged capsules.
Dutasteride can be 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 Dutasteride + Tamsulosin hydrochloride Olpha, contact a doctor immediately.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutasteride + Tamsulosin hydrochloride Olpha. If your partner is pregnant or could be pregnant, avoid exposing her to semen.
Dutasteride + Tamsulosin hydrochloride Olpha has been shown to reduce sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.

Driving and operating machinery
Dutasteride + Tamsulosin hydrochloride Olpha may cause dizziness in some patients, which may impair the ability to drive or operate machinery.
→ If you experience such symptoms, do not drive or operate machinery.

Dutasteride + Tamsulosin hydrochloride Olpha contains
Dutasteride + Tamsulosin hydrochloride Olpha contains a colouring agent – Orange Yellow FCF (E 110), which may cause allergic reactions.
Dutasteride + Tamsulosin hydrochloride Olpha contains lecithin derived from soy. Do not use if you are hypersensitive to peanuts or soy.
Dutasteride + Tamsulosin hydrochloride Olpha contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is considered "sodium-free".

3. How to use Dutasteride + Tamsulosin hydrochloride Olpha

This medicine should always be used as directed by a doctor or pharmacist. Irregular
use of the medicine may affect PSA test results. If in doubt, consult a doctor or pharmacist.
How much medicine to take
The recommended dose is one capsule taken once daily, 30 minutes after the same meal each day.
How to take the medicine
The capsule should be swallowed whole with water. Capsules must not be chewed or opened.
Contact with the capsule contents may cause oral cavity pain or throat pain.
Taking more than the recommended dose of Dutasteride + Tamsulosin hydrochloride Olpha
If more capsules than recommended have been taken, consult a doctor or pharmacist.
Missed dose of Dutasteride + Tamsulosin hydrochloride Olpha
Do not take a double dose to make up for a missed dose. Take the next capsule at the usual time.
Do not stop using Dutasteride + Tamsulosin hydrochloride Olpha without consulting a doctor.
Do not discontinue use of Dutasteride + Tamsulosin hydrochloride Olpha unless advised by a doctor.
If you have any further questions regarding the use of this medicine, consult a 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, contact a doctor immediately and discontinue use of Dutasteride + Tamsulosin hydrochloride Olpha.

Dizziness, lightheadedness and fainting
Dutasteride + Tamsulosin hydrochloride Olpha may cause dizziness or, in rare cases, fainting. Until it is clear how the medicine affects the individual patient, caution should be taken when changing position from lying or sitting to standing, especially when waking up at night. If dizziness occurs at any time during treatment, sit or lie down and wait for symptoms to subside.
Serious skin reactions
Symptoms of a serious skin reaction may include:

• widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome). → If any of these symptoms occur, contact a doctor immediately and discontinue use of Dutasteride + Tamsulosin hydrochloride Olpha.

Common adverse reactions (may occur in 1 out of 10 people):

• impotence (inability to achieve or maintain an erection)*
• decreased sexual desire (libido)*
• difficulty with ejaculation, including reduced volume of semen during ejaculation*
• enlargement or tenderness of the breasts (gynaecomastia)
• dizziness. * In a small number of individuals, the aforementioned adverse reactions may persist even after discontinuation of Dutasteride + Tamsulosin hydrochloride Olpha.

Uncommon adverse reactions (may occur in 1 out of 100 people):

• heart failure (reduced heart function. Symptoms may include shortness of breath, extreme fatigue, and swelling in the ankles and lower limbs)
• low blood pressure when standing (orthostatic hypotension)
• rapid heartbeat ( palpitations )
• constipation, diarrhoea, vomiting, nausea
• weakness or loss of strength
• headache
• itching or nasal congestion, runny nose ( rhinitis )
• skin rash, hives, itching
• hair loss (usually body hair) or excessive hair growth.

Rare adverse reactions (may occur in 1 out of 1,000 people):

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

Very rare adverse reactions (may occur in 1 out of 10,000 people):

• prolonged, painful erection ( priapism )
• serious skin reactions ( Stevens-Johnson syndrome ).

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

• irregular or rapid heartbeat ( 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 a doctor, pharmacist or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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, website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Dutasteride + Tamsulosin hydrochloride Olpha

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
bottle, or blister pack following "EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging following the abbreviation "Lot".
For HDPE bottles: the 30-capsule pack should not be used for more than 6 weeks after
first opening the bottle, and the 90-capsule pack should not be used for more than 18 weeks after
first opening the bottle.
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. Such measures help protect
the environment.

6. Contents of the Pack and Other Information

What Dutasteride + Tamsulosin hydrochloride Olpha 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 ingredients are:
  • Capsule shell: hypromellose, carrageenan (E 407), potassium chloride, titanium dioxide (E 171), iron oxide red (E 172), orange-yellow FCF (E 110);
  • Capsule contents: glyceryl monooctanoate-caprylocaproyl glyceride (type I), butylated hydroxytoluene (E 321), gelatin, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), medium-chain triglycerides, soy lecithin (E 322), microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate (1:1), dispersion 30%, copolymer of methacrylic acid and ethyl acrylate (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E 171).

What Dutasteride + Tamsulosin hydrochloride Olpha Looks Like and Contents of the Pack
This medicine is in the form of elongated hard capsules approximately 24 mm in length, with a brown body and an orange cap.
Available pack sizes are 30 and 90 capsules in HDPE bottles or 7, 30 and 90 capsules in aluminium/aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]

Manufacturers
SAG MANUFACTURING, S.L.U.
Crta. N-I, km 36
28750 San Agustín de Guadalix, Madrid
Spain

Galenicum Health, S.L.U.
Carrer De Sant Gabriel 50
08950 Esplugues de Llobregat, Barcelona
Spain

CYNDEA PHARMA, S.L.
Polígono Industrial Emiliano Revilla Sanz. Avenida de Ágreda, 31
42110 Olvega
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Malta: Dutasteride/Tamsulosin Olpha 0.5 mg/0.4 mg Hard Capsules
Czech Republic: Dutasteride/Tamsulosin Olpha 0,5 mg/0,4 mg Tvrdá tobolka
Germany: Dutasterid/Tamsulosin Olpha 0,5 mg/0,4 mg Hartkapseln
Spain: Dutasterida/Tamsulosina Olpha 0,5 mg/0,4 mg Cápsulas duras EFG
France: Dutasteride/Tamsulosine Olpha 0.5 mg/0.4 mg, gélule
Poland: Dutasteride + Tamsulosin hydrochloride Olpha
Italy: Dutasteride e Tamsulosina Olpha 0,5 mg/0,4 mg capsule rigide
Slovakia: Dutasteride/Tamsulosin Olpha 0,5 mg/0,4 mg tvrdé kapsuly