Dutasteride tamsulosin accord

Package leaflet: Information for the user

Dutasteride + Tamsulosin Accord, 0.5 mg + 0.4 mg, hard capsules
Dutasteridum + Tamsulosini hydrochloridum
Please read the entire leaflet carefully before starting to take this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Dutasteride + Tamsulosin Accord 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. Dutasteride + Tamsulosin Accord is 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 urinating and increased frequency of urination. There may also be reduced urine flow and a weak urine stream. If left untreated, complete blockage of urine flow (acute urinary retention) may occur. This condition requires immediate treatment. In some cases, surgery may be necessary to remove the prostate gland or reduce its size.

Dutasteride reduces the production of a hormone called dihydrotestosterone, which leads to a reduction in the size of the prostate and relief of symptoms. By this mechanism, 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 facilitates urine flow and provides rapid symptom relief.

2. Important information before taking Dutasteride + Tamsulosin Accord

When not to take Dutasteride + Tamsulosin Accord

• if the patient is a woman (because 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 drugs 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 or fainting ( orthostatic hypotension ),
• if the patient has severe liver disease.

If any of the above applies to the patient, do not take this medicine until consulting a doctor.

Warnings and precautions
Before starting to take Dutasteride + Tamsulosin Accord, discuss this with your doctor.

• In some clinical studies, heart failure was observed in a higher number of patients taking dutasteride together with a medicine belonging to a class called 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 does not pump blood properly.

• Inform your doctor if the patient has liver disease. If the patient has liver disease, additional tests may be required during treatment with Dutasteride + Tamsulosin Accord.

• Inform your doctor if the patient has severe kidney disease.

• Cataract surgery (cloudy lens). If the patient is scheduled for surgical removal of a cataract, the doctor may recommend temporarily stopping treatment with Dutasteride + Tamsulosin Accord before the procedure. Before surgery, inform the ophthalmologist if the patient is currently taking or has previously taken Dutasteride + Tamsulosin Accord or tamsulosin. The doctor will take appropriate precautions to prevent complications during surgery.

• Women, children and adolescents must not touch damaged capsules of Dutasteride + Tamsulosin Accord, because the active substance can be absorbed through the skin. In case of skin contact, the affected area should be washed immediately with soap and water.

• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutasteride + Tamsulosin Accord. If the partner is pregnant or may be pregnant, avoid exposing her to contact with 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 Accord affects the measurement of prostate-specific antigen (PSA), which is sometimes tested to diagnose prostate cancer. Despite this, your doctor may intentionally order this test. If the patient undergoes PSA testing, inform the doctor about taking Dutasteride + Tamsulosin Accord. Patients taking Dutasteride + Tamsulosin Accord 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 the development of high-grade prostate cancer is not fully understood.

• Dutasteride + Tamsulosin Accord may cause breast enlargement and breast pain. If these symptoms become bothersome or if lumps in the breast or nipple discharge appear, consult a doctor, as these may be signs of a serious condition such as breast cancer.

• If you have any questions about using Dutasteride + Tamsulosin Accord, contact your doctor or pharmacist.

Dutasteride + Tamsulosin Accord and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Dutasteride + Tamsulosin Accord with the following medicines:

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

The use of Dutasteride + Tamsulosin Accord is not recommended with the following medicines:

• ketoconazole (used to treat fungal infections).

Some medicines may interact with Dutasteride + Tamsulosin Accord and increase the risk 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 any of these medicines are being used.

Dutasteride + Tamsulosin Accord with food and drink
Dutasteride + Tamsulosin Accord should be taken 30 minutes after the same meal each day.
Pregnancy, breastfeeding and effects on fertility
Taking Dutasteride + Tamsulosin Accord 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 Dutasteride + Tamsulosin Accord, contact a doctor immediately.

Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutasteride + Tamsulosin Accord. If the partner is pregnant or may be pregnant, avoid exposing her to contact with semen.
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 operating machinery
In some patients, Dutasteride + Tamsulosin Accord may cause dizziness, which could negatively affect the ability to drive safely or operate machinery.

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

Dutasteride + Tamsulosin Accord contains:
Dutasteride + Tamsulosin Accord contains a colouring agent – Orange Yellow FCF (E110), which may cause allergic reactions.
Dutasteride + Tamsulosin Accord contains lecithin derived from soy. Do not use if hypersensitivity to peanuts or soy has been diagnosed.
Dutasteride + Tamsulosin Accord contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered “sodium-free”.

3. How to take Dutasteride + Tamsulosin Accord

This medicine should always be taken 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 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. Do not chew or open the capsule.
Contact with the capsule contents may cause pain in the mouth or throat.
If you take more Dutasteride + Tamsulosin Accord than recommended
If you take more capsules than recommended, consult your doctor or pharmacist.
If you forget to take Dutasteride + Tamsulosin Accord
Do not take a double dose to make up for a forgotten dose. Take the next capsule at the usual time.
Stopping Dutasteride + Tamsulosin Accord
Do not stop taking Dutasteride + Tamsulosin Accord without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Dutasteride + Tamsulosin Accord can cause adverse effects,
although not everybody gets them.

Allergic reaction
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, you must contact your doctor immediately and stop taking Dutasteride + Tamsulosin Accord.

Dizziness, feeling faint and fainting
Dutasteride + Tamsulosin Accord may cause dizziness, feeling faint or, in rare cases, fainting. Until you are sure how the medicine affects you, take care when changing position from lying or sitting to sitting or standing, especially when getting up during the night. If you experience dizziness or feel faint at any time during treatment, you should sit or lie down and wait until the symptoms pass.

Serious skin reactions
Symptoms of a serious skin reaction may include:

• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).

If any of these symptoms occur, you must contact your doctor immediately and stop taking Dutasteride + Tamsulosin Accord.

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

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• problems with ejaculation, including reduced amount of semen during ejaculation*
• enlargement or tenderness of the breasts (gynaecomastia)
• dizziness.

*In a small number of patients, some of these symptoms may persist after stopping Dutasteride + Tamsulosin Accord.

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

• heart failure (the heart's ability to pump blood becomes less efficient; symptoms may include shortness of breath, extreme tiredness, and swelling of the ankles and legs)
• low blood pressure when standing (orthostatic hypotension)
• 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 effects (may affect up to 1 in 1,000 people)

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

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

• prolonged, painful erection of the penis (priapism)
• serious skin reaction (Stevens-Johnson syndrome).

Other adverse effects
Other adverse effects 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 fast 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 effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Dutasteride + Tamsulosin Accord

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 bottle after EXP. The expiry date refers to the last day of the stated month.
HDPE bottles: bottles containing 30 capsules should not be used for longer than 6 weeks, and bottles containing 90 capsules for longer than 18 weeks after first opening.
Do not store Dutasteride + Tamsulosin Accord above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dutasteride + Tamsulosin Accord 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 are:
  • hard capsule shell: hypromellose, carrageenan (E 407), potassium chloride, titanium dioxide (E 171), iron oxide red (E 172), Orange Yellow FCF (E 110);
  • inside the hard capsule: glyceryl monocaprylocaprate (type I), butylhydroxytoluene (E 321), gelatin, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), medium-chain triglycerides, soy lecithin, microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion, magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E 171).

What Dutasteride + Tamsulosin Accord looks like and contents of the pack
Dutasteride + Tamsulosin Accord is a hard, elongated capsule (approximately 24 mm in length) with a brown body and an orange cap.
The medicine is available in packs containing 7, 28, 30 or 90 capsules in HDPE bottles or aluminium/aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

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

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50, 95-200 Pabianice
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names: