TWINPROS 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. Contents of the Package Leaflet
2. What is Twinpros and what is it used for
   1. Twinpros is used to treat men with an enlarged prostate gland
3. Important information before taking Twinpros
   1. When not to take Twinpros:
   2. Warnings and precautions
   3. PSA.
   4. Twinpros and other medicines
   5. Twinpros with food
   6. Pregnancy, breastfeeding, and fertility
   7. Pregnant women (or women who may become pregnant) must not handle damaged Twinpros capsules.
   8. Driving and using machines
   9. Twinpros contains soybean lecithin, propylene glycol, and sodium
4. How to take Twinpros
   1. How much to take
   2. The recommended dose is one capsule taken once daily, 30 minutes after the same meal each day.
   3. How to take the medicine
   4. Taking more than the recommended dose of Twinpros
   5. Missing a dose of Twinpros
   6. Stopping treatment with Twinpros
5. Possible side effects
   1. Like all medicines, Twinpros can cause side effects, although not everybody gets them.
   2. Allergic reactions
   3. Dizziness, lightheadedness, and fainting
   4. Severe skin reactions
   5. Common side effects
   6. Uncommon side effects
   7. Rare side effects
   8. Very rare side effects
   9. Other side effects
   10. Reporting side effects
6. How to store Twinpros
7. Contents of the pack and other information
   1. What Twinpros contains
   2. What Twinpros looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the User

Twinpros, 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What is Twinpros and what is it used for

Twinpros is used to treat men with an enlarged prostate gland

(benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate gland caused by an excess of a hormone called dihydrotestosterone.
Twinpros 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 gland can cause problems with urination, such as difficulty urinating and frequent urination. It can also cause a weak urine flow. 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 Twinpros

When not to take Twinpros:

• if you are a woman(as this medicine is only for men),
• if you are a child or adolescent under 18 years of age,
• if you are allergic to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, soy, or peanuts, or any of the other ingredients of this medicine (listed in section 6),
• if you have low blood pressurethat causes dizziness, lightheadedness, or fainting (orthostatic hypotension),
• if you have severe liver disease. If any of the above applies to you, do not takethis medicine until you have consulted your doctor.

Warnings and precautions

Before taking Twinpros, discuss it with your doctor.

• In some clinical studies, it was found that more patients taking dutasteride with an alpha-adrenergic receptor antagonist (such as tamsulosin) experienced heart failure than patients taking dutasteride or an alpha-adrenergic receptor antagonist alone. Heart failure means the heart is not pumping blood properly.
• Tell your doctor if you have liver disease. If you have had liver disease, you may need to have additional tests while taking Twinpros.
• Tell your doctor if you have severe kidney disease.
• Cataract surgery (cloudy lens). If you are scheduled to have cataract surgery, your doctor may recommend stopping Twinpros for a certain period before surgery. You should tell your ophthalmologist if you are taking or have taken Twinpros or tamsulosin in the past. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould not handle damaged Twinpros capsules, as the active substance may 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 found in the semen of men taking Twinpros. If your partner is pregnant or may become pregnant, you should avoid exposing her to your 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. This may lead to reduced fertility in men.
• Twinpros affects the measurement of prostate-specific antigen (PSA), which is sometimes performed to diagnose prostate cancer. However, your doctor may still recommend that you have this test. If you have had your PSA level measured, you should tell your doctor that you are taking Twinpros. Men taking Twinpros should have their PSA level checked regularly.

PSA.

• In a clinical study of men at high risk of prostate cancer, men taking dutasteride were more likely to be diagnosed with high-grade prostate cancerthan men who were not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is not clear.
• Twinpros may cause breast enlargement and tenderness. If these symptoms become troublesome or if you experience breast lumps or nipple discharge, you should contact your doctor, as these may be signs of a serious condition, such as breast cancer.

If you have any questions about taking Twinpros, you should contact your doctor or pharmacist.

Twinpros and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

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

It is not recommended to take Twinpros with the following medicines:

• ketokonazole(used to treat fungal infections)

Some medicines may interact with Twinpros 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)
• paroxetine(an antidepressant)
• terbinafine(used to treat fungal infections)
• diclofenac(used to treat inflammation and pain)

Tell your doctorif you are taking any of these medicines.

Twinpros with food

Twinpros should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Twinpros must not be taken by women.

Pregnant women (or women who may become pregnant) must not handle damaged Twinpros capsules.

Dutasteride is absorbed through the skin and may affect the development of a male fetus. There is a special risk during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Twinpros. If your partner is pregnant or may become pregnant, you should avoid exposing her to your semen.
It has been shown that Twinpros reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
If a pregnant woman has come into contact with Twinpros, she should contact her doctor.

Driving and using machines

Twinpros may cause dizziness in some patients, which may affect their ability to drive or operate machines.
If you experience such symptoms, do not drive or operate machines.

Twinpros contains soybean lecithin, propylene glycol, and sodium

This medicine contains soybean lecithin, which may contain soybean oil. Do not take if you are allergic to peanuts or soy.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially sodium-free.
This medicine contains 299 mg of propylene glycol in each capsule.

3. How to take Twinpros

This medicine should always be taken exactly as directed by your doctor or pharmacist. Irregular intake of the medicine may affect the results of PSA tests. If you are unsure, consult your doctor or pharmacist.

How much to take

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

How to take the medicine

Swallow the capsule whole with water. Do not chew or open the capsules. Contact with the contents of the capsules may cause mouth or throat pain.

Taking more than the recommended dose of Twinpros

If you have taken more than the recommended dose of Twinpros, consult your doctor or pharmacist.

Missing a dose of Twinpros

Do not take a double dose to make up for a missed dose. Take the next capsule at the usual time.

Stopping treatment with Twinpros

Do not stop taking Twinpros without consulting your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Twinpros can cause side effects, although not everybody gets them.

Allergic reactions

Signs of an allergic reaction may include:

• skin rash(which may be itchy)
• hives
• swelling of the eyelids, face, lips, hands, or feet. If you experience any of these symptoms, contact your doctor immediately and stop taking Twinpros.

Dizziness, lightheadedness, and fainting

Twinpros may cause dizziness, lightheadedness, or fainting. Until you know how the medicine affects you, be careful when changing positions from lying down or sitting to standing, especially when getting up at night. If you experience dizziness at any time during treatment, sit or lie down and wait for the symptoms to pass.

Severe skin reactions

Signs of severe skin reactions may include:

• widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome). If you experience any of these symptoms, contact your doctor immediately and stop taking Twinpros.

Common side effects

May affect up to 1 in 10 men taking Twinpros:

• impotence (inability to get or maintain an erection)*
• decreased libido (sex drive)*
• difficulty ejaculating, including reduced semen volume*
• breast enlargement or tenderness (gynaecomastia)
• dizziness*

Uncommon side effects

May affect up to 1 in 100 men taking Twinpros:

• heart failure (less efficient heart function). Possible symptoms include shortness of breath, extreme tiredness, and swelling in the ankles and feet.
• 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 side effects

May affect up to 1 in 1,000 men taking Twinpros:

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

Very rare side effects

May affect up to 1 in 10,000 men taking Twinpros:

• prolonged and 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 exact frequency is unknown (based on available data, the frequency cannot be estimated):

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Medicines Monitoring, 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, e-mail: [email protected]. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Twinpros

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack 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. 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 Twinpros contains

The active substances are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin). The other ingredients are:
Capsule shell:
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Yellow iron oxide (E 172)
Gelatin
Soft gelatin capsules containing dutasteride:
Propylene glycol monocaprylate, type II
Butylhydroxytoluene (E 321)
Capsule shell:
Gelatin
Glycerol
Titanium dioxide (E 171)
Saturated fatty acid triglycerides
Lecithin (may contain soybean oil) (see section 2)
Tamsulosin pellets:
Methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (contains sodium lauryl sulfate, polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Hydrated silica
Calcium stearate
Black ink:
Shellac
Black iron oxide (E 172)
Propylene glycol
Ammonium hydroxide
Potassium hydroxide
See section 2 “Twinpros contains soybean lecithin, propylene glycol, and sodium”.

What Twinpros looks like and contents of the pack

The medicine is in the form of hard gelatin capsules, 24.2 mm x 7.7 mm in size, with a brown body and a beige cap, printed with black ink with the code C001.
Each hard capsule contains pellets with modified release containing tamsulosin hydrochloride and one soft gelatin capsule containing dutasteride.
Twinpros is available in packs of 30 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Manufacturer:
Laboratorios León Farma, S.A.
C/La Vallina s/n, Polígono Industrial Navatejera
Villaquilambre-24193 (León)
Spain
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
SloveniaKRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500
Date of last revision of the package leaflet:01.01.2025