FINDARTS 0.5 mg + 0.4 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
2. What is Findarts Duo and what is it used for
3. Important information before taking Findarts Duo
   1. When not to take Findarts Duo
   2. Warnings and precautions
   3. Patients taking Findarts Duo should have their PSA level checked regularly.
   4. Findarts Duo and other medicines
   5. Findarts Duo with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Pregnant women (or women who may be pregnant) should not handle damaged capsules.
   8. Driving and using machines
   9. Findarts Duo contains tartrazine (E 102)
   10. Findarts Duo contains sodium
4. How to take Findarts Duo
   1. How much to take
   2. The recommended dose is one capsule taken once a day, 30 minutes after the same meal every day.
   3. How to take it
   4. What to do if too much Findarts Duo is taken
   5. What to do if a dose of Findarts Duo is missed
   6. What to do if the patient stops taking Findarts Duo
5. Possible side effects
   1. Allergic reactions
   2. Dizziness, lightheadedness, and fainting
   3. Severe skin reactions
   4. Other side effects
   5. Reporting side effects
6. How to store Findarts Duo
7. Contents of the pack and other information
   1. What Findarts Duo contains
   2. What Findarts Duo looks like and contents of the pack
   3. Pack sizes:
   4. Marketing authorization holder
   5. Marketing authorization holder:
   6. Manufacturer/Importer:
   7. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Findarts Duo, 0.5 mg + 0.4 mg, hard capsules
Dutasteride + Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Findarts Duo and what is it used for

Findarts Duo is used in men with an enlarged prostate gland(benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
Findarts Duo 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.
Enlargement of the prostate gland can lead to problems with urination, such as difficulty urinating and frequent urination. It can also cause a decrease in urine flow and a weak urine stream. If left untreated, it can lead to complete blockage of urine flow (acute urinary retention). This situation requires immediate treatment. In some cases, surgery may be necessary to remove the prostate gland or reduce its size.
Dutasteride reduces the production of the hormone dihydrotestosterone, which causes the prostate gland to shrink and alleviates symptoms. By doing so, dutasteride reduces the risk of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscles in the prostate gland, making it easier to urinate and providing quick relief from symptoms.

2. Important information before taking Findarts Duo

When not to take Findarts Duo

• if the patient is a woman, as this medicine is only intended for men,
• if the patient is a child or adolescent under 18 years of age,
• if the patient is allergic to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, 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 applies to the patient, they should not take this medicineuntil they have consulted their doctor.

Warnings and precautions

Before taking Findarts Duo, the patient should discuss it with their doctor.

• In some clinical studies, an increased risk of heart failure was observed in patients taking dutasteride with an alpha-adrenergic receptor antagonist (such as tamsulosin) compared to those taking dutasteride or an alpha-adrenergic receptor antagonist alone. Heart failure means the heart does not pump blood properly.
• The patient should inform their doctor if they have liver disease. If the patient has had liver disease, additional tests may be necessary while taking Findarts Duo.
• The patient should inform their doctor if they have kidney disease.
• Cataract surgery (cloudy lens). If the patient is scheduled to have cataract surgery, their doctor may recommend stopping Findarts Duo for a certain period before the surgery. The patient should inform their ophthalmologist if they are taking or have taken Findarts Duo or tamsulosin. The doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould not handle damaged Findarts Duo capsules, as the active substance may be absorbed through the skin. In case of skin contact, the affected area should be washed immediately with soap and water.
• A condom should be used during sexual intercourse. Dutasteride has been found in the semen of men taking Findarts Duo. If the partner is pregnant or may become pregnant, they should avoid exposure to semen, as dutasteride may affect the development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.
• Findarts Duo affects the measurement of prostate-specific antigen (PSA), which is sometimes performed to diagnose prostate cancer. However, the doctor may still order this test. If the patient's PSA level is being measured, they should inform their doctor that they are taking Findarts Duo.

Patients taking Findarts Duo should have their PSA level checked regularly.

• In a clinical study involving patients with an increased risk of prostate cancer, patients taking dutasteride were more likely to be diagnosed with high-grade prostate cancerthan those not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is unclear.
• Findarts Duo may cause breast enlargement and tenderness. If these symptoms become troublesome or if the patient experiences breast lumps or nipple discharge, they should consult their doctor, as these may be signs of a serious condition, such as breast cancer.

➔ If the patient has any questions about taking Findarts Duo, they should consult their doctor or pharmacist.

Findarts Duo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Findarts Duo should not be taken with the following medicines:

• other alpha-adrenergic receptor antagonists(used to treat enlarged prostate or high blood pressure).

It is not recommended to take Findarts Duo with the following medicines:

• ketokonazole(used to treat fungal infections).

Some medicines may interact with Findarts Duo and increase the risk of side effects. These include:

• PDE5 inhibitors[used to induce or maintain an 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 ketokonazole(used to treat fungal infections);
• nefazodone(an antidepressant);
• cimetidine(used to treat stomach ulcers);
• 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).

➔ The patient should inform their doctorif they are taking any of these medicines.

Findarts Duo with food, drink, and alcohol

Findarts Duo should be taken 30 minutes after the same meal every day.

Pregnancy, breastfeeding, and fertility

Findarts Duo is contraindicated in women.

Pregnant women (or women who may be pregnant) should not handle damaged capsules.

Dutasteride is absorbed through the skin and may affect the development of a male fetus. There is a particular risk during the first 16 weeks of pregnancy.
A condom should be used during sexual intercourse. Dutasteride has been found in the semen of men taking Findarts Duo. If the partner is pregnant or may become pregnant, they should avoid exposure to semen.
It has been shown that Findarts Duo reduces sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.
➔ If a pregnant woman has come into contact with Findarts Duo, she should consult her doctor.

Driving and using machines

Findarts Duo may cause dizziness in some patients, which may affect their ability to drive or operate machinery.
➔ If such symptoms occur, the patient should not drive or operate machinery.

Findarts Duo contains tartrazine (E 102)

Findarts Duo contains a colorant – tartrazine (E 102), which may cause allergic reactions.

Findarts Duo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, which means it is essentially "sodium-free".

3. How to take Findarts Duo

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. Irregular intake of the medicine may affect the results of PSA tests. In case of doubts, the patient should consult their doctor or pharmacist.

How much to take

The recommended dose is one capsule taken once a day, 30 minutes after the same meal every day.

How to take it

The capsule should be swallowed whole with water. The capsule should not be chewed or opened. Contact with the contents of the capsule may cause mouth or throat pain.

What to do if too much Findarts Duo is taken

In case of overdose, the patient should consult their doctor or pharmacist.

What to do if a dose of Findarts Duo is missed

The patient should not take a double dose to make up for a missed dose. They should take the next capsule at the usual time.

What to do if the patient stops taking Findarts Duo

The patient should not stop taking Findarts Duo without consulting their doctor.
If the patient has any further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Findarts Duo can cause side effects, although not everybody gets 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, the patient should contact their doctor immediately and stop taking Findarts Duo.

Dizziness, lightheadedness, and fainting

Findarts Duo may cause dizziness, lightheadedness, or fainting. Until the patient knows how the medicine affects them, they should be careful when changing positions from lying down or sitting to standing, especially when getting up at night. If dizziness or lightheadedness occurs, the patient should sit or lie down and wait for the symptoms to pass.

Severe skin reactions

Symptoms of a severe skin reaction may include:

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

➔ If any of these symptoms occur, the patient should contact their doctor immediately and stop taking Findarts Duo.

Common:may affect up to 1 in 10 men taking Findarts Duo:

• impotence (inability to achieve or maintain an erection);
• reduced sex drive (libido);
• difficulty with ejaculation, including reduced semen volume during ejaculation;
• breast enlargement or tenderness (gynecomastia);
• dizziness. In a small number of men, these side effects may persist even after stopping Findarts Duo.

Uncommon:may affect up to 1 in 100 men taking Findarts Duo:

• heart failure (less efficient heart function, which may cause symptoms such as shortness of breath, extreme tiredness, and swelling in the ankles and legs);
• low blood pressure when standing up;
• rapid heartbeat (palpitations);
• constipation, diarrhea, vomiting, nausea;
• weakness or loss of strength;
• headache;
• itching or blocked nose, runny nose (rhinitis);
• skin rash, hives, itching;
• hair loss (usually body hair) or excessive hair growth.

Rare:may affect up to 1 in 1,000 men taking Findarts Duo:

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

Very rare:may affect up to 1 in 10,000 men taking Findarts Duo:

• prolonged, painful erection of the penis (priapism);
• severe skin reactions (Stevens-Johnson syndrome).

Other side effects

Other side effects have occurred in a small number of men, but their frequency is unknown (based on available data, the frequency cannot be estimated):

• abnormal or rapid heart rhythm (arrhythmia, tachycardia, or atrial fibrillation);
• difficulty breathing (dyspnea);
• depression;
• testicular pain and swelling;
• nosebleeds;
• severe skin rash;
• vision changes (blurred vision or vision problems);
• dry mouth.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system at [insert website URL].
Side effects can also be reported to the marketing authorization holder.

5. How to store Findarts Duo

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Findarts Duo 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 ingredients are:

• hard capsule:body: hypromellose, carrageenan, potassium chloride, titanium dioxide (E 171), iron oxide black (E 172), iron oxide red (E 172). cap: hypromellose, carrageenan, potassium chloride, titanium dioxide (E 171), tartrazine (E 102), iron oxide red (E 172).

soft capsule with dutasteride:
Glycerol monocaprylocaprate (Type I) and butylhydroxytoluene (E 321).
capsule shell: gelatin (160 Bloom), glycerol, titanium dioxide (E 171), iron oxide yellow (E 172).
pellets with tamsulosin hydrochloride:
Microcrystalline cellulose (Ph-101), talc, dispersion of methacrylic acid-ethyl acrylate copolymer (1:1) 30% (contains 0.7% sodium lauryl sulfate and 2.3% polysorbate 80), triacetin, calcium stearate.
black ink for printing:
Shellac (E 904), iron oxide black (E 172), potassium hydroxide.

What Findarts Duo looks like and contents of the pack

Hard capsule.
The hard capsules are size "00", with an orange, opaque cap with "DTT" printed in black ink and a brown, opaque body with "0.5/0.4" printed in black ink. The size is approximately 23.5 mm.
Each capsule contains one matte, yellow, opaque, elongated, soft gelatin capsule of dutasteride, containing a clear, colorless or pale yellow viscous oil, and white or almost white pellets of tamsulosin hydrochloride.
Findarts Duo is available in blisters and HDPE bottles, packaged in cartons.

Pack sizes:

Blisters: 7, 30, 50, and 90 hard capsules.
HDPE bottles: 30, 90, and 500 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Generiques
26 avenue Tony Garnier
69007 Lyon
France

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

Belgium:
Dutasteride/Tamsulosine HCl AB 0.5 mg/0.4 mg, hard capsules
Czech Republic:
Dutasterid/Tamsulosin Aurovitas
France:
Dutastéride/Tamsulosine Arrow 0.5 mg/0.4 mg, gélule
Germany:
Dutasterid/Tamsulosin PUREN 0.5 mg/0.4 mg Hartkapseln
Netherlands:
Dutasteride/Tamsulosine HCl Aurobindo 0.5/0.4 mg, harde capsules
Poland:
Findarts Duo
Portugal:
Dutasterida + Tansulosina Aurovitas
Romania:
Dutasteridă/Tamsulosin Aurobindo 0.5 mg/0.4 mg capsule
Spain:
Dutasterida/Tamsulosina Aurovitas 0.5 mg/0.4 mg cápsulas duras EFG

Date of last revision of the package leaflet: