Dutasteride olpha

Dutasteride Olpha, 0.5 mg, soft capsules
Dutasteridum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

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

Table of contents:

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

1. What Dutasteride Olpha is and what it is used for
Dutasteride Olpha 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.
The active substance in this medicine is dutasteride, which belongs to a group of medicines known as 5-alpha reductase inhibitors.
An enlarged prostate gland may lead to problems with urination, such as difficulty 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 or reduce the size of the prostate gland. Dutasteride reduces the production of dihydrotestosterone, which leads to a reduction in the size of the prostate gland and relief of symptoms. Thus, it reduces the likelihood of acute urinary retention and the need for surgical intervention.
Dutasteride Olpha may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate gland).

2. Important information before taking Dutasteride Olpha

When not to take Dutasteride Olpha

• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.

If any of the above apply to you, do not take this medicine without first consulting your doctor.
This medicine is intended for men only. It must not be used in women, children or adolescents.

Warnings and precautions
Before taking Dutasteride Olpha, consult your doctor.

• Inform your doctor if you have liver disease. If you have liver disease, additional tests may be required during treatment with Dutasteride Olpha.
• Women, children and adolescents must not touch damaged capsules of Dutasteride Olpha, 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.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutasteride Olpha. If your partner is pregnant or may be pregnant, avoid exposing her to semen, as dutasteride may impair the development of a male fetus. It has been shown that dutasteride may reduce sperm count, semen volume and sperm motility. This may lead to reduced fertility.
• Dutasteride Olpha affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes used to detect prostate cancer. Despite this, your doctor may deliberately order this test to screen for prostate cancer. If you are having PSA tests, you must inform your doctor that you are taking Dutasteride Olpha. Patients taking Dutasteride Olpha should have regular PSA monitoring.
• 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 the medicine. The effect of dutasteride on the risk of developing high-grade prostate cancer is not fully understood.
• Dutasteride may cause breast enlargement and breast tenderness. If these symptoms become bothersome or if lumps in the breast or nipple discharge occur, consult your doctor, as these may be signs of a serious condition such as breast cancer.

If you have any questions about the use of Dutasteride Olpha, consult your doctor or pharmacist.

Dutasteride Olpha and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken or plan to take.
Some medicines taken together with Dutasteride Olpha may increase the risk of adverse effects. These include:

• 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 (used to treat depression)
• alpha-blocker medicines (used to treat enlarged prostate or high blood pressure).

Inform your doctor if you are taking any of these medicines. A dose adjustment of Dutasteride Olpha may be necessary.

Dutasteride Olpha with food and drink
This medicine may be taken with or without food.

Pregnancy, breastfeeding and effects on fertility
Women who are pregnant (or who may become pregnant) must not handle 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.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutasteride Olpha. If your partner is pregnant or may be pregnant, avoid exposing her to semen.
It has been shown that dutasteride reduces sperm count, semen volume and sperm motility. This may lead to reduced fertility in men.
If a pregnant woman has been exposed to dutasteride, consult a doctor immediately.

Driving and operating machinery
It is unlikely that Dutasteride Olpha will affect your ability to drive or operate machinery.

Dutasteride Olpha contains soy lecithin
This medicine contains soy lecithin derived from soy, which may contain soy oil. Do not use if you are known to be hypersensitive to peanuts or soy.

3. How to take Dutasteride Olpha
Always take Dutasteride Olpha exactly as prescribed by your doctor or pharmacist.
Irregular use of the medicine may affect PSA monitoring. If in doubt, consult your doctor or pharmacist.

How much medicine to take

• The recommended dose of Dutasteride Olpha is one capsule (0.5 mg) taken once daily. 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 irritation.
• Treatment with Dutasteride Olpha is long-term. Some patients may experience symptom relief early in treatment. However, others may require treatment with Dutasteride Olpha for 6 months or longer to see improvement. Continue taking Dutasteride Olpha for as long as your doctor recommends.

Taking more Dutasteride Olpha than prescribed
If you take more than the recommended dose of Dutasteride Olpha, consult your doctor or pharmacist immediately.

If you miss a dose of Dutasteride Olpha
Do not take a double dose to make up for a missed capsule. Take the next capsule at your usual time.

Do not stop taking Dutasteride Olpha without consulting your doctor
Do not discontinue treatment with Dutasteride Olpha unless instructed by your doctor. Improvement may require continued treatment for 6 months or longer.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Allergic reaction
Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• urticaria
• swelling of the eyelids, face, lips, hands and feet.

If any of these symptoms occur, contact your doctor immediately and discontinue use of Dutasteride Olpha.
Common adverse reactions
may occur in no more than 1 in 10 men taking Dutasteride Olpha:

• inability to achieve or maintain an erection (impotence); this effect may persist after discontinuation of Dutasteride Olpha;
• decreased sexual desire (libido); this effect may persist after discontinuation of Dutasteride Olpha;
• ejaculation disorders, including reduced volume of semen during ejaculation; this effect may persist after discontinuation of Dutasteride Olpha;
• enlargement or tenderness of the breasts (gynaecomastia);
• dizziness when used concomitantly with tamsulosin.

Uncommon adverse reactions
may occur in no more than 1 in 100 men taking Dutasteride Olpha:

• heart failure (reduced cardiac performance – symptoms may include shortness of breath, extreme fatigue, and swelling in the ankles and lower limbs);
• hair loss (usually body hair) or hair growth.

Adverse reactions with unknown frequency
Frequency cannot be estimated from the available data:

• depression,
• testicular pain and swelling.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dutasteride Olpha
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the stated month.
Do not store Dutasteride Olpha above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dutasteride Olpha contains
The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
The other ingredients are:

• inside the capsule: glycerol monooctanoate-caprylate (type I) and butylhydroxytoluene (E 321);
• capsule shell: gelatine (E 441), glycerol (E 422), titanium dioxide (E 171), yellow iron oxide (E 172), medium-chain triglycerides, lecithin (may contain soybean oil) (E 322) and purified water.

What Dutasteride Olpha looks like and contents of the pack
Dutasteride Olpha is a soft capsule of size 6; it is an elongated, opaque, yellow gelatin soft capsule filled with an oily, yellowish liquid. The medicine is available in packs containing 30, 60 or 90 capsules. Not all pack sizes may be marketed.
Dimensions of the soft capsules: 19 ± 0.8 mm x 6.9 ± 0.4 mm.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
e-mail: [email protected]
Manufacturer
Cyndea Pharma S.L
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
Olvega, 42110 Soria
Spain
Galenicum Health S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
SAG Manufacturing, S.L.U.
Crta. N-I, Km 36, San Agustin de Guadalix
Madrid, 28750
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
Malta: Dutasteride Olpha 0.5 mg soft capsules
Germany, Poland, Czech Republic, Slovakia, Italy: Dutasteride Olpha
France: DUTASTERIDE OLPHA 0.5 mg capsule molle
Spain: Dutasteride Olpha 0.5 mg cápsulas blandas EFG