DUTASTERIDE 0.5 mg/0.4 mg Hard capsule

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1. Dutasteride and Tamsulosin Olpha 0.5 mg/0.4 mg hard capsules
   1. What is Dutasteride and Tamsulosin Olpha and what is it used for
   2. What you need to know before taking Dutasteride and Tamsulosin Olpha
   3. How to take Dutasteride and Tamsulosina Olpha
   4. Possible side effects
   5. How to store Dutasteride and Tamsulosina Olpha
   6. Package Contents and Other Information

Dutasteride and Tamsulosin Olpha 0.5 mg/0.4 mg hard capsules

Dutasteride/Tamsulosin hydrochloride
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Dutasteride and Tamsulosin Olpha and what is it used for

Dutasteride and Tamsulosin Olpha is used to treat male subjects 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 called 5-alpha reductase inhibitorsand tamsulosin belongs to a group of medicines called alpha blockers.
If the prostate increases in volume, it can lead to urinary problems such as difficulty in passing
urine and the need to urinate frequently. This can also result in the urine flow becoming
slower and weaker. If left untreated, there is a risk that the urine flow may be
completely blocked ( acute urinary retention). This requires immediate medical treatment.
In some cases, surgery may be necessary to remove or reduce the volume of the prostate.
Dutasteride reduces the production of a hormone called dihydrotestosterone and this promotes
a decrease in prostate volume and relieves symptoms. This will reduce the risk of acute urinary
retention and the need for surgery. Tamsulosin works by relaxing the muscles of the
prostate gland, making it easier to pass urine and quickly 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 only indicated for men)
• if you are a child or adolescent under 18 years of age
• if you are allergicto dutasteride,to other 5 alpha reductase inhibitors,to Tamsulosin,to soy,to peanutsor to 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 you think that any of the above applies to you, do not takethis 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 like Tamsulosin, experienced heart failure compared to patients treated with dutasteride alone or an alpha blocker alone. Heart failure means that the heart does not pump blood as well as it should.
• Make sure your doctor is aware of any liver problems you have.If you have had any liver disease, further checks may be needed while you are taking Dutasteride and Tamsulosin Olpha.
• Make sure your doctor is aware if you have severe kidney problems.
• Cataract surgery (cloudy lens).If you are about to have cataract surgery, your doctor may ask you to stop taking Dutasteride and Tamsulosin Olpha for a period before the operation. Tell your ophthalmologist if you are taking Dutasteride and Tamsulosin Olpha or Tamsulosin before the operation.
• (or have taken it previously). The specialist will need to take appropriate precautions to help prevent complications during the operation.
• Women, children and adolescents shouldnot handle broken capsules of Dutasteride and Tamsulosin Olpha, because the active ingredient is absorbed through the skin. If it comes into contact with the skin, wash the affected area immediatelywith water and soap.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men treated with Dutasteride and Tamsulosin Olpha. If your partner is or may be pregnant, she must avoid exposure to your semen as dutasteride can impair the normal development of a male child. Dutasteride has been shown to reduce sperm count, semen volume and sperm motility. This may decrease 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 needs to be aware of this effect and may continue to prescribe the test to detect prostate cancer. If you need to have a PSA test, tell your doctor that you are taking Dutasteride/Tamsulosin Olpha. Men who are taking Dutasteride and Tamsulosin Olpha should have the PSA test done regularly.
• In a clinical study conducted on men at increased risk of prostate cancer, men taking dutasteride had more frequently a severe form of prostate cancercompared to men who were not taking dutasteride. The effect of dutasteride on this severe form of prostate cancer is unclear.
• Dutasteride and Tamsulosin Olpha can cause enlargement and tenderness of the breasts.If this becomes worrying, or if you notice the presence of breast lumpsor 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 pharmacistif 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 these medicines:

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

Dutasteride and Tamsulosin Olpha is not recommended with these medicines:

• ketoconazole(used to treat fungal infections).

Some medicines can interact with Dutasteride and Tamsulosin Olpha and can increase the possibility of having unwanted effects. These medicines 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 ulcers)
• 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 doctorif 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 should not be taken by women.

Women who are pregnant (or may become pregnant) should not handle broken capsules.Dutasteride is absorbed through the skin and can interfere with the normal development of a male child. This is particularly risky in the first 16 weeks of pregnancy.

Ask your doctorif 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 who were taking dutasteride and tamsulosin. If your partner is pregnant or may become pregnant, she must avoid contact with your semen.
Dutasteride and tamsulosin has shown to reduce sperm count, semen volume and sperm movement. Therefore, male fertility may be reduced.

Driving and using machines
Dutasteride and Tamsulosin Olpha can cause dizziness in some people, therefore it may affect your ability to drive or operate machinery safely.

Do not drive or operate machineryif you feel this way.

Important information about some of the excipients of Dutasteride and Tamsulosin Olpha
Dutasteride and Tamsulosin Olpha contains the yellow sunset FCF (E110) dye which may cause allergic reactions.
Dutasteride and Tamsulosin Olpha contains soy lecithin. If you are allergic to peanuts or soy, 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 Tamsulosina Olpha

Take Dutasteride and Tamsulosina Olpha following the instructions of your doctor or pharmacist exactly. If you do not take it regularly, the control of your PSA levels may be affected. If you have any doubts, consult your doctor or pharmacist.

How much Dutasteride and Tamsulosina Olpha to take
The recommended dose is one capsule to be taken once a day, 30 minutes after the same meal, every day.
How to take Dutasteride and Tamsulosina Olpha
Swallow the capsules whole with water.Do not chew or open or break the capsules. Contact with the capsule contents may irritate the mouth or throat.

If you take more Dutasteride and Tamsulosina Olpha than you should
Contact your doctor or pharmacist for advice if you take more capsules of Dutasteride/Tamsulosina Olpha.

If you forget to take Dutasteride and Tamsulosina Olpha
Do not take a double dose to make up for a missed dose. Take the next dose as usual.

Do not stop Dutasteride and Tamsulosina Olpha without your doctor's advice
Do not stop taking Dutasteride and Tamsulosina Olpha without consulting your doctor first. If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Allergic reaction
Signs of an allergic reaction may include:

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

Dizziness, lightheadedness and fainting
Dutasteride and Tamsulosina Olpha can cause dizziness, lightheadedness and, in rare cases,
fainting. Be careful when moving from a lying or sitting position to a standing position, especially if you wake up at 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 these symptoms pass.
Severe skin reactions
Signs of severe skin reactions may include:

a widespread rash with blisters and peeling skin, especially
around the mouth, nose, eyes and genitals(Stevens-Johnson syndrome).
➔ Contact your doctor immediatelyif 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 get or maintain an erection) *
• decreased sexual desire ( libido)*
• difficulty ejaculating, such as a decrease in the amount of semen released during sexual intercourse *
• breast enlargement or tenderness ( gynecomastia)
• dizziness. * In a small number of people, some of these effects may continue after you stop taking 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. You may have symptoms such as shortness of breath, extreme fatigue and swelling of the ankles and legs)
• low blood pressure when standing up
• fast heartbeat ( palpitations)
• constipation, diarrhea, vomiting, feeling sick (nausea)
• weakness or loss of strength
• headache
• itchy, blocked or runny nose ( rhinitis)
• skin rash, hives, itching
• hair loss (usually from the body) or hair growth.

Rare side effects (may affect up to 1 in 1000 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)
• severe skin reactions ( Stevens-Johnson syndrome).

Other side effects
Other side effects have been reported in a small number of patients but their exact frequency
is not known (frequency cannot be estimated based on available data):

• abnormal or fast heartbeat ( arrhythmia or tachycardia or atrial fibrillation)
• shortness of breath ( dyspnea)
• depression
• pain and swelling of the testicles
• nosebleeds
• severe skin rash
• changes in vision ( blurred vision or impaired vision)
• dry mouth.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 Tamsulosina Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package/bottle/blister after
SCAD/EXP. The expiry date refers to the last day of that month.
HPDE bottles: use within 6 weeks after opening (30 capsule bottle) or within 18
weeks (90 capsule bottle).
Do not store Dutasteride and Tamsulosina Olpha at a temperature higher than 30°C.
Do not dispose of any medicine in 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 Tamsulosina Olpha Contains

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of Tamsulosina hydrochloride.
• The other ingredients (excipients) are:
• capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), sunset yellow FCF (E110).
• inside the capsule shell: glycerol monocaprylocaprate Type I, butylated hydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), 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 Tamsulosina Olpha and Package Contents
This medicine is presented in the form of oblong hard capsules approximately 24 mm in length, with a
brown body and an orange cap.
The capsules are available in packs of 7, 30 and 90 capsules in HDPE bottles or in 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
Manufacturer:
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 Member States of the European Economic Area under the
following denominations:
Malta: Dutasteride/Tamsulosin Olpha 0.5 mg/0.4 mg Hard Capsules
Czech Republic: Dutasteride/Tamsulosin Olpha 0.5mg/0.4mg Hard Capsule
Germany: Dutasterid/Tamsulosin Olpha 0.5 mg/0.4 mg Hard Capsules
Spain: Dutasterida/Tamsulosina Olpha 0.5 mg/0.4 mg Cápsulas duras EFG
France: Dutasteride/Tamsulosin Olpha 0.5mg/0.4mg, capsule
Poland: Dutasteride + Tamsulosin hydrochloride Olpha 0.5 mg + 0.4 mg hard capsules
Slovakia: Dutasteride/Tamsulosin Olpha 0.5 mg/0.4 mg hard capsules