Findarts duo

Patient Information Leaflet

Findarts Duo, 0.5 mg + 0.4 mg, hard capsules
Dutasteridum + Tamsulosini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

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

Table of Contents

1. What Findarts Duo is and what it is 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 Findarts Duo is and what it is 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 combines two different medicines: dutasteride and tamsulosin. Dutasteride belongs to a group of medicines known as 5-alpha-reductase inhibitors, while tamsulosin belongs to a group of medicines known as alpha-adrenergic receptor antagonists.

An enlarged prostate can lead to urinary problems such as difficulty in urinating, increased frequency of urination, reduced urine flow, and a weak urine stream. In some cases, complete blockage of urine flow may occur (acute urinary retention). This condition requires immediate treatment. In certain cases, surgery may be needed to remove the prostate gland or reduce its size.

Dutasteride reduces the production of the hormone dihydrotestosterone, leading to a reduction in the size of the prostate gland 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 improves urine flow and provides rapid symptom relief.

2. Important information before using Findarts Duo

When not to use Findarts Duo

• if the patient is a woman, since 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 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, this medicine should not be taken until
consulted with a doctor.
Warnings and precautions
Before starting treatment with Findarts Duo, discuss this with your doctor.

• In some clinical studies, heart failure occurred more frequently in patients taking dutasteride together with a medicine belonging to a group called alpha-adrenergic receptor antagonists (such as tamsulosin) than in 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 Findarts Duo.
• 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 recommend temporarily discontinuing Findarts Duo before the procedure. The ophthalmologist must be informed before surgery if the patient is currently taking or has previously taken Findarts Duo or tamsulosin. The doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescents must not touch damaged capsules of Findarts Duo, 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 Findarts Duo. If the partner is pregnant or may be pregnant, exposure to semen should be avoided, as dutasteride may impair 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.
• Findarts Duo affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes performed to diagnose prostate cancer. Despite this, the doctor may deliberately order this test. If the patient is undergoing PSA testing, inform the doctor about taking Findarts Duo. Patients taking Findarts Duo should have regular PSA tests.
• In a clinical trial involving patients with an 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 clear.
• Findarts Duo may cause breast enlargement and tenderness. If these symptoms become bothersome or if lumps in the breast or nipple discharge appear, contact a doctor immediately, as these may be signs of a serious condition such as breast cancer.

Mood changes and depression
Low mood, depression, and, less frequently, suicidal thoughts have been reported in patients
taking orally another medicine from the same therapeutic group (5-alpha-reductase inhibitors). If
any of these symptoms occur, contact a doctor immediately for further medical advice.
➔ If you have any questions about using Findarts Duo, contact your doctor or pharmacist.
Findarts Duo and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be used by the patient.
Do not take Findarts Duo with the following medicines:

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

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

• ketoconazole (used to treat fungal infections).

Some medicines may interact with Findarts Duo 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 inflammation and pain).

➔ Inform your doctor if any of these medicines are being used.
Findarts Duo with food, drink, and alcohol
Findarts Duo should be taken 30 minutes after the same meal each day.
Pregnancy, breastfeeding, and effects on fertility
Taking Findarts Duo by women is contraindicated.
Pregnant women (or women who may be pregnant) must not touch damaged capsules.
Dutasteride is absorbed through the skin and may impair the development of a male fetus. The risk is particularly high during the first 16 weeks of pregnancy.
A condom should be used during sexual intercourse. Dutasteride has been detected in the semen of men taking Findarts Duo. If the partner is pregnant or may be pregnant, exposure to semen should be avoided.
It has been shown that Findarts Duo reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
➔ If a pregnant woman has been exposed to Findarts Duo, contact a doctor immediately.
Driving and operating machinery
In some patients, Findarts Duo may cause dizziness, which may negatively affect the ability to drive or operate machinery.
➔ If such symptoms occur, do not drive or operate machinery.
Findarts Duo contains the colouring agent quinoline yellow (E110)
Findarts Duo contains the colouring agent quinoline yellow (E110), which may cause allergic reactions.
Findarts Duo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, meaning the medicine is considered "sodium-free".

3. How to use Findarts Duo

This medicine should always be taken exactly as directed by your doctor or pharmacist. Irregular
use of the medicine may affect PSA level monitoring 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 mouth or throat pain.
Taking more Findarts Duo than recommended
If you take more capsules of Findarts Duo than recommended, consult your doctor or pharmacist.
If you forget to take Findarts Duo
Do not take a double dose to make up for a missed dose. Take the next capsule at your usual time.
Stopping Findarts Duo
Do not stop taking Findarts Duo 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 any medicine, 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, you must contact your doctor immediately and
stop taking Findarts Duo.

Dizziness, feeling faint and fainting
Findarts Duo 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 standing, especially when waking up at night. If you experience dizziness or feel faint at any time during treatment, sit or lie down and wait for the symptoms to subside.

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 genital organs (Stevens-Johnson syndrome).

➔ If any of these symptoms occur, you must contact your doctor immediately and
stop taking Findarts Duo.

Common: may occur in no more than 1 in 10 men taking Findarts Duo:

• Impotence (inability to achieve or maintain an erection);
• Decreased 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 men, these adverse reactions may persist even after stopping Findarts Duo.

Uncommon: may occur in no more than 1 in 100 men taking Findarts Duo:

• Heart failure (reduced heart function. Symptoms may include shortness of breath, extreme fatigue, and swelling in 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: may occur in no more than 1 in 1,000 men taking Findarts Duo:

• Swelling of the eyelids, face, lips, hands or feet (angioedema);
• Fainting.

Very rare: may occur in no more than 1 in 10,000 men taking Findarts Duo:

• Prolonged, painful erection (priapism);
• Serious skin reactions (Stevens-Johnson syndrome).

Other adverse reactions
Other adverse reactions have been reported 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 vision problems);
• Dry mouth.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 Findarts Duo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the bottle after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via the sewage system 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 package and other information

What Findarts Duo contains
The active substances in this medicine are dutasteride and tamsulosin hydrochloride.
Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
Other ingredients are:

• hard capsule:
  body: hypromellose, carrageenan, potassium chloride, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172);
  cap: hypromellose, carrageenan, potassium chloride, titanium dioxide (E 171), quinoline yellow (E 110), red iron oxide (E 172).

• soft capsule containing dutasteride:
  glyceryl monocaprylocaprate (Type I) and butylated hydroxytoluene (E 321).
  capsule shell: gelatin (160 Bloom), glycerol, titanium dioxide (E 171), yellow iron oxide (E 172).

• pellets containing tamsulosin hydrochloride:
  microcrystalline cellulose (Ph-101), talc, methacrylic acid-ethyl acrylate copolymer dispersion (1:1) 30% (containing 0.7% sodium lauryl sulfate and 2.3% polysorbate 80), triacetin, calcium stearate.

• printing ink (black):
  shellac (E 904), black iron oxide (E 172), potassium hydroxide.

What Findarts Duo looks like and contents of the pack
Hard capsule.
Size "00" hard capsules with an opaque orange cap printed with "DTT" in black ink and an opaque brown body printed with "0.5/0.4" in black ink. The capsule is approximately 23.5 mm in length.
Each capsule contains one opaque, yellow, soft, elongated gelatin capsule of dutasteride filled with a transparent, colourless or pale yellow sticky oil, and white or almost white granules of tamsulosin hydrochloride.

The medicinal product Findarts Duo is available in blister packs and HDPE bottles, both packed in cardboard cartons.

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

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

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 authorised in the European Economic Area under the following names:
Belgium: Dutasteride/Tamsulosine HCl AB 0.5 mg/0.4 mg, hard capsules
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
Spain: Dutasterida/Tamsulosina Aurovitas 0.5 mg/0.4 mg cápsulas duras EFG