Dutasteride and tamsulosin Olpha: detailed information

Patient Information Leaflet

Dutasteride and Tamsulosin Olpha 0.5 mg/0.4 mg hard capsules

Dutasteride/Tamsulosin hydrochloride
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
1. What Dutasteride and Tamsulosin Olpha is and what it is used for
2. What you need to know before taking Dutasteride and Tamsulosin Olpha
3. How to take Dutasteride and Tamsulosin Olpha
4. Possible side effects
5. How to store Dutasteride and Tamsulosin Olpha
6. Contents of the pack and other information

1. What Dutasteride and Tamsulosin Olpha is and what it is used for

Dutasteride and Tamsulosin Olpha is used to treat men with
enlarged prostate ( benign prostatic hyperplasia ) – a non-cancerous growth of the prostate
caused by excessive production of a hormone called dihydrotestosterone.
Dutasteride and Tamsulosin Olpha is a combination of two different medicines called dutasteride
and tamsulosin. Dutasteride belongs to a group of medicines known as 5-alpha reductase inhibitors,
and tamsulosin belongs to a group of medicines called alpha-blockers.
When the prostate enlarges, it can cause urinary problems such as difficulty in passing urine and the
need to urinate frequently. This may also result in a weaker and slower urine flow. If left untreated,
there is a risk that urine flow may become completely blocked ( acute urinary retention ). This requires
immediate medical treatment. In some cases, surgery may be needed to remove or reduce the size
of the prostate. Dutasteride reduces the production of a hormone called dihydrotestosterone, thereby
helping to shrink the size of the prostate and relieve symptoms. This reduces the risk of acute urinary
retention and the need for surgical intervention. Tamsulosin works by relaxing the muscle of the
prostate gland, making it easier for urine to pass and rapidly improving symptoms.

2. What you need to know before taking Dutasteride and Tamsulosin Olpha

Do not take Dutasteride and Tamsulosin Olpha

if you are a woman (because this medicine is intended 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, peanuts, or any of the other ingredients of this medicine (listed in section 6)
if you have low blood pressure causing dizziness, mental lightheadedness, or fainting ( orthostatic hypotension )
if you have severe liver disease

If you think any of the above apply to you, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor before taking Dutasteride and Tamsulosin Olpha

In some clinical studies, more patients taking dutasteride and another medicine called an alpha-blocker such as tamsulosin developed heart failure compared to patients treated only with dutasteride or only with an alpha-blocker. Heart failure means the heart does not pump blood as well as it should.
Make sure your doctor knows about any liver problems you have. If you have had any liver disease, you may need additional monitoring while taking Dutasteride and Tamsulosin Olpha.
Make sure your doctor knows if you have severe kidney problems.
Cataract surgery (cloudy lens). If you are scheduled to undergo cataract removal surgery, your doctor may ask you to stop taking Dutasteride and Tamsulosin Olpha for a period before the surgery. Inform your ophthalmologist before surgery if you are taking Dutasteride and Tamsulosin Olpha or tamsulosin.
(or have previously taken them). The specialist will need to take appropriate precautions to help prevent complications during surgery.
Women, children, and adolescents must not handle damaged capsules of Dutasteride and Tamsulosin Olpha, because the active ingredient can be absorbed through the skin. In case of skin contact, wash the affected area immediately with soap and water.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men being treated with Dutasteride and Tamsulosin Olpha. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce your fertility.
Dutasteride and Tamsulosin Olpha affects a blood test for PSA ( prostate-specific antigen ), which is used in some cases to detect prostate cancer. Your doctor should be aware of this effect and may continue to prescribe the test to screen for prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking Dutasteride/Tamsulosin Olpha. Men taking Dutasteride and Tamsulosin Olpha must have the PSA test regularly.
In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride had a higher incidence of high-grade prostate cancer compared to men not taking dutasteride. The effect of dutasteride on this high-grade form of prostate cancer is not clear.
Dutasteride and Tamsulosin Olpha may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, you should talk to your doctor about these changes, as they may be signs of a serious condition such as breast cancer.
Ask your doctor or pharmacist if you have any questions about taking Dutasteride and Tamsulosin Olpha.

Other medicines and Dutasteride and Tamsulosin Olpha

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Dutasteride and Tamsulosin Olpha with the following medicines:

other alpha-blockers (for enlarged prostate or high blood pressure)

Dutasteride and Tamsulosin Olpha is not recommended with the following medicines:

ketoconazole (used to treat fungal infections)

Some medicines may interact with Dutasteride and Tamsulosin Olpha and may increase the risk of side effects. These include:

PDE5 inhibitors (used to help achieve or maintain an erection), such as vardenafil, sildenafil citrate, and tadalafil
verapamil or diltiazem (for high blood pressure)
ritonavir or indinavir (for HIV)
itraconazole or ketoconazole (for fungal infections)
nefazodone (an antidepressant)
cimetidine (for stomach ulcer)
warfarin (for blood clotting)
erythromycin (an antibiotic used to treat infections)
paroxetine (an antidepressant)
terbinafine (used to treat fungal infections)
diclofenac (used to treat pain and inflammation)

Tell your doctor if you are taking any of these medicines.

Dutasteride and Tamsulosin Olpha with food and drink

Dutasteride/Tamsulosin Olpha should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding and fertility

Dutasteride and Tamsulosin Olpha must not be taken by women.

Pregnant women (or women who may become pregnant) must not handle damaged capsules. Dutasteride is absorbed through the skin and may interfere with the normal development of a male fetus. This is particularly risky during the first 16 weeks of pregnancy.

Ask your doctor if a pregnant woman has come into contact with Dutasteride and Tamsulosin Olpha.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride and tamsulosin. If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen.

Dutasteride and tamsulosin have been shown to reduce sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.

Driving and using machines

Dutasteride and Tamsulosin Olpha may cause dizziness in some people and therefore may affect your ability to drive or operate machinery safely.

Do not drive or operate machinery if you feel dizzy.

Important information about some excipients in Dutasteride and Tamsulosin Olpha

Dutasteride and Tamsulosin Olpha contains the colour sunset yellow FCF (E110), which may cause allergic reactions.

Dutasteride and Tamsulosin Olpha contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

Dutasteride and Tamsulosin Olpha contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.

3. How to take Dutasteride and Tamsulosin Olpha

Take Dutasteride and Tamsulosin Olpha exactly as your doctor or pharmacist has told you.
If you do not take it regularly, monitoring of PSA levels may be affected. If you have any doubts, consult your doctor or pharmacist.
How much Dutasteride and Tamsulosin Olpha to take
The recommended dose is one capsule taken once daily, 30 minutes after the same meal, every day.
How to take Dutasteride and Tamsulosin Olpha
Swallow the capsules whole with water. Do not chew, open, or break the capsules. Contact with the contents of the capsules may irritate the mouth or throat.
If you take more Dutasteride and Tamsulosin Olpha than you should
Contact your doctor or pharmacist for advice if you take more capsules than Dutasteride/Tamsulosin Olpha than prescribed.
If you forget to take Dutasteride and Tamsulosin Olpha
Do not take a double dose to make up for a forgotten dose. Take the next dose as scheduled.
Do not stop Dutasteride and Tamsulosin Olpha without consulting your doctor
Do not stop taking Dutasteride and Tamsulosin Olpha without first consulting your doctor.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reaction
Signs of allergic reactions may include:

rash (which may be itchy)
hives
swelling of the eyelids, face, lips, arms or legs. ➔ Contact your doctor immediately if you experience any of these symptoms and stop taking Dutasteride and Tamsulosina Olpha.

Dizziness, lightheadedness and fainting
Dutasteride and Tamsulosina Olpha may cause dizziness, lightheadedness and, in rare cases, fainting. Be careful when moving from a lying or sitting position to a standing position, especially when getting up during the night, until you know how this medicine affects you. If you feel dizzy or lightheaded at any time during treatment, sit or lie down until the symptoms pass.

Serious skin reactions
Signs of serious skin reactions may include:
a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
➔ Contact your doctor immediately if you experience these symptoms and stop taking Dutasteride and Tamsulosina Olpha.

Common side effects (may affect up to 1 in 10 people):

impotence (inability to achieve or maintain an erection) *
decreased sexual desire ( libido )*
ejaculation disorders, such as reduced amount of semen released during sexual intercourse *
enlarged or tender breasts ( gynaecomastia )
dizziness. * In a small number of people, some of these side effects may continue after stopping Dutasteride and Tamsulosina Olpha.

Uncommon side effects (may affect up to 1 in 100 people):

heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include breathlessness, extreme tiredness and swelling of the ankles and legs)
low blood pressure upon standing
rapid heartbeat ( palpitations )
constipation, diarrhoea, vomiting, feeling unwell (nausea)
weakness or loss of strength
headache
itchy, blocked or runny nose ( rhinitis )
rash, hives, itching
hair loss (usually from the body) or excessive hair growth.

Rare side effects (may affect up to 1 in 1,000 people):

swelling of the eyelids, face, lips, arms or legs ( angioedema )
fainting.

Very rare side effects (may affect up to 1 in 10,000 people):

prolonged painful erection of the penis ( priapism )
serious skin reactions ( Stevens-Johnson syndrome ).

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

irregular or rapid heartbeat ( arrhythmia, tachycardia or atrial fibrillation )
shortness of breath ( dyspnoea )
depression
pain and swelling of the testicles
nosebleeds
severe rash
changes in vision ( blurred vision or impaired vision )
dry mouth.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutasteride and Tamsulosin Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/bottle/blister after EXP/EXP. The expiry date refers to the last day of that month.
HPDE bottles: after opening, use within 6 weeks (bottle of 30 capsules) or within 18 weeks (bottle of 90 capsules).
Do not store Dutasteride and Tamsulosin Olpha above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dutasteride and Tamsulosine Olpha 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 components (excipients) are:
- capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), sunset yellow FCF (E110).
- capsule contents: glyceryl monocaprylocaprate Type I, butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer 1:1 (30% dispersion), methacrylic acid-ethyl acrylate copolymer 1:1, magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Description of the appearance of Dutasteride and Tamsulosine Olpha and pack sizes

This medicine is an oblong hard capsule approximately 24 mm in length, with a brown body and an orange cap.

Capsules are available in packs of 7, 30 and 90 capsules in HDPE bottles or aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturers:
SAG MANUFACTURING, S.L.U.
Ctra. N-I, km 36
28750 San Agustín de Guadalix
Madrid
Spain

CYNDEA PHARMA, S.L.
Polígono Industrial Emiliano Revilla Sanz. Avenida de Ágreda, 31,
Olvega, 42110 Soria
Spain

Galenicum Health, S.L.U.
Carrer De Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Malta: Dutasteride/Tamsulosin Olpha 0.5 mg/0.4 mg Hard Capsules
Czech Republic: Dutasteride/Tamsulosin Olpha 0.5 mg/0.4 mg Tvrdá tobolka
Germany: Dutasterid/Tamsulosin Olpha 0.5 mg/0.4 mg Hartkapseln
Spain: Dutasterida/Tamsulosina Olpha 0.5 mg/0.4 mg Cápsulas duras EFG
France: Dutasteride/Tamsulosin Olpha 0.5 mg/0.4 mg, gélule
Poland: Dutasteride + Tamsulosin hydrochloride Olpha 0.5 mg + 0.4 mg kapsułki twarde
Slovakia: Dutasteride/Tamsulosin Olpha 0.5 mg/0.4 mg tvrdé kapsuly