Twinpros

Patient Information Leaflet

Twinpros, 0.5 mg + 0.4 mg, hard capsules
dutasteride + tamsulosin hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

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

Leaflet Contents

1. What Twinpros is and what it is used for
2. What you need to know 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 Twinpros is and what it is 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 excessive production 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 may cause problems with urination, such as difficulty in passing urine and increased frequency of urination. There may also be a reduced urine flow and a weak urine stream. If left untreated, complete blockage of urine flow may occur (acute urinary retention). This situation requires immediate treatment. In some cases, surgery may be needed 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 gland and relief of symptoms. By this action, 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 helps urine to flow more easily and provides rapid symptom relief.

2. Important information before using Twinpros

When not to use Twinpros:

• 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 5-alpha-reductase inhibitor class, 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, lightheadedness, 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 Twinpros, discuss this with your doctor.

• In certain clinical studies, heart failure was observed in a higher number of patients taking dutasteride together with a medicine belonging to the class known as 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 is unable to 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 Twinpros.
• 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 advise stopping Twinpros for a certain period before the procedure. Inform the ophthalmologist before surgery if the patient is currently taking or has previously taken Twinpros or tamsulosin. The doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescents must not touch damaged Twinpros capsules, because 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.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Twinpros. 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.
• Twinpros affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes tested to diagnose prostate cancer. Despite this, your doctor may intentionally order this test. If the patient is having PSA levels measured, inform the doctor about taking Twinpros. Men taking Twinpros should have regular PSA testing.
• In a clinical study involving men at increased risk of prostate cancer, high-grade prostate cancer was diagnosed more frequently in men taking dutasteride than in men not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is not fully understood.
• Twinpros may cause breast enlargement and tenderness. If these symptoms become bothersome, or if lumps in the breast or nipple discharge occur, contact a doctor, as these may be signs of a serious condition such as breast cancer.

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

Twinpros and other medicines
Tell your doctor or pharmacist 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 Twinpros 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 Twinpros with the following medicines:

• ketoconazole (used to treat fungal infections)

Some medicines may interact with Twinpros and increase the likelihood of side effects. These include:

• PDE5 inhibitors (used to initiate 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 any of these medicines are being used.

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

Pregnancy, breastfeeding, and effects on fertility
Twinpros must not be taken by women.
Pregnant women (or women who may become pregnant) must not touch damaged capsules.
Dutasteride can be 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.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Twinpros. If the partner is pregnant or may be pregnant, exposure to semen should be avoided.
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 been exposed to Twinpros, contact a doctor immediately.

Driving and operating machinery
Twinpros may cause dizziness in some patients, which could impair the ability to drive or operate machinery.
If such symptoms occur, do not drive or operate machinery.

Twinpros contains soy lecithin, propylene glycol, and sodium
This medicine contains lecithin derived from soy, which may contain soy oil. Do not use if hypersensitivity to peanuts or soy has been diagnosed.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".
This medicine contains 299 mg of propylene glycol in each capsule.

3. How to use Twinpros

This medicine should always be taken exactly as recommended by your doctor or pharmacist. Irregular
use of the medicine may affect PSA level monitoring results. In case of 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 pain or throat pain.
Taking more Twinpros than recommended
If you take more capsules of Twinpros than recommended, consult your doctor or pharmacist.
If you forget to take Twinpros
Do not take a double dose to make up for a forgotten dose. Take the next capsule at the usual time.
Stopping treatment with Twinpros
Do not stop taking Twinpros 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 effects

Like all medicines, this medicine can cause adverse effects, 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, seek immediate medical advice and discontinue use of Twinpros.

Dizziness, dizziness sensation and fainting
Twinpros may cause dizziness, a feeling of dizziness or, in rare cases, fainting. Until you are certain how this medicine affects you, take care when changing body position from lying or sitting to sitting or standing, especially when getting up during the night. If dizziness occurs at any time during treatment, sit or lie down and wait for symptoms to subside.

Serious skin reactions
Symptoms of serious skin reactions 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, seek immediate medical advice and discontinue use of Twinpros.

Common adverse effects
May occur in no more than 1 in 10 men taking Twinpros:

• impotence (inability to achieve or maintain an erection)*
• decreased sexual drive (libido)*
• difficulty with ejaculation, including reduced volume of semen during ejaculation*
• enlargement or tenderness of the breast glands (gynaecomastia)
• dizziness * In a small number of individuals, the above adverse effects may persist even after stopping Twinpros.

Uncommon adverse effects
May occur in no more than 1 in 100 men taking Twinpros:

• heart failure (reduced heart function). Possible symptoms include shortness of breath, extreme fatigue, and swelling in the ankles and legs.
• low blood pressure when standing
• 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 effects
May occur in no more than 1 in 1,000 men taking Twinpros:

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

Very rare adverse effects
May occur in no more than 1 in 10,000 men taking Twinpros:

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

Other adverse effects
Other adverse effects 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 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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
e-mail: [email protected]
Adverse effects may also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Twinpros

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
the abbreviation "EXP". The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
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 packaging and other information

What Twinpros contains
The active substances in this medicine 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:

Hard capsule shell:
Iron oxide black (E 172)
Iron oxide red (E 172)
Titanium dioxide (E 171)
Iron oxide yellow (E 172)
Gelatin

Soft capsules containing dutasteride:
Propylene glycol monocaprylate, type II
Butylhydroxytoluene (E 321)

Soft capsule shell:
Gelatin
Glycerol
Titanium dioxide (E 171)
Medium-chain saturated triglycerides
Lecithin (may contain soybean oil) (see section 2)

Tamsulosin pellets:
Methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion (containing sodium lauryl sulfate, polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Colloidal anhydrous silica
Calcium stearate

Black printing ink:
Shellac
Iron oxide black (E 172)
Propylene glycol
Concentrated ammonium hydroxide
Potassium hydroxide

See section 2: "Twinpros contains soy lecithin, propylene glycol and sodium".

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturers:
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
Slovenia

For further information, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500