DUTASTERIDE 0.5 mg/0.4 mg Hard capsule

Содержание инструкции

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

Dutasteride and Tamsulosin Aristo 0.5 mg/0.4 mg hard capsules

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 Aristo is and what it is used for
• 2. What you need to know before you take Dutasteride and Tamsulosin Aristo
• 3. How to take Dutasteride and Tamsulosin Aristo
• 4. Possible side effects
• 5. How to store Dutasteride and Tamsulosin Aristo
• 6. Contents of the pack and other information

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

Dutasteride and Tamsulosin Aristo 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 Aristo 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 helps to decrease the
prostatic volume and relieve 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 its symptoms.

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

Do not take Dutasteride and Tamsulosin Aristo

• 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 allergic to 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 Aristo:

• 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 Aristo.
• 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 Aristo for a period before the operation. Tell your ophthalmologist if you are taking Dutasteride and Tamsulosin Aristo or tamsulosin (or have taken them previously) before the operation. The specialist will need to take appropriate precautions to help prevent complications during the operation.
• Women, children and adolescentsshould not handle broken Dutasteride and Tamsulosin Aristo capsules, because the active ingredient is absorbed through the skin. If contact with the skin occurs, 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 Aristo. If your partner is or could become pregnant, she must avoid exposure to your semen as dutasteride may 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 Aristo affects a blood test for PSA(prostate-specific antigen), which is used in some cases to detect prostate cancer. Your doctor must 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 and Tamsulosin Aristo. Men who are taking Dutasteride andTamsulosin Aristo should have the PSA test regularly.
• In a clinical study conducted on men at increased risk of prostate cancer, men taking dutasteride had more frequentlya 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 Aristo may cause enlargement and tenderness of thebreast.If this becomes problematic, or if you notice 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 Aristo.

Other medicines and Dutasteride and Tamsulosin Aristo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Dutasteride and Tamsulosin Aristo with the following medicines:

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

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

• ketoconazole(used to treat fungal infections).

Some medicines can interact with Dutasteride and Tamsulosin Aristo 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 Aristo with food and drink
Dutasteride and Tamsulosin Aristo should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding and fertility
Dutasteride and Tamsulosin Aristo must 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.

• Askyour doctorif a pregnant woman has come into contact with Dutasteride and Tamsulosin Aristo.

Use a condom during sexual intercourse.Dutasteride has been found in the semen of
men who were taking dutasteride/tamsulosin. If your partner is pregnant or may become pregnant, she must
avoid contact with your semen.
Dutasteride/Tamsulosin has been shown to reduce sperm count, semen volume and
sperm motility. Therefore male fertility may be reduced.

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

• Do not drive or operate machineryif you feel this way.

Dutasteride and Tamsulosin Aristo contains
Dutasteride and Tamsulosin Aristo contains the yellow sunset FCF (E110) dye which may cause
allergic reactions.
Dutasteride and Tamsulosin Aristo contains soy lecithin. If you are allergic to peanuts or soy, do not
use this medicine.
Dutasteride and Tamsulosin Aristo contains less than 1 mmol (23 mg) of sodium per capsule, which is
essentially “sodium-free”.

3. How to take Dutasteride and Tamsulosin Aristo

Always take this medicine exactly as your doctor or pharmacist has told you.If you do not take it regularly, the control of your PSA levels may be affected. If you have any doubts, ask your doctor or pharmacist.

How much Dutasteride and Tamsulosin Aristo 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 Tamsulosin Aristo
Swallow the capsules whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.

If you take more Dutasteride and Tamsulosin Aristo than you should
Contact your doctor or pharmacist for advice if you take more capsules of Dutasteride and Tamsulosin Aristo.

If you forget to takeDutasteride and Tamsulosin Aristo
Do not take a double dose to make up for a missed dose. Take the next dose as usual.

Do not stop Dutasteride and Tamsulosin Aristo without consulting your doctor
Do not stop taking Dutasteride and Tamsulosin Aristo without first consulting your doctor.
If you have further questions 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 will experience them.
Allergic reaction
Signs of allergic reactions 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 Aristo.

Dizziness, mild confusion and fainting
Dutasteride and Tamsulosina Aristo may cause dizziness, mild confusion 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 experience mild confusionat 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, especiallyaround the mouth, nose, eyes and genitals(Stevens-Johnson syndrome).
• Contact your doctor immediatelyif you experience these symptoms and stop taking Dutasteride and Tamsulosina Aristo.

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

• impotence ( inability toachieve 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 persist after stopping Dutasteride and Tamsulosina Aristo.

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 shortness of breath, extreme fatigue and swelling of the ankles and legs)
• low blood pressure when standing
• fast heartbeat ( palpitations)
• constipation, diarrhea, vomiting, feeling unwell (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 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)

• painful prolonged 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://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 Aristo

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 or blister after
“EXP”. The expiry date refers to the last day of that month.
Do not store Dutasteride Tamsulosina Aristo at a temperature above 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 the medicine containsDutasteride and Tamsulosin Aristo

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
• The other ingredients (excipients) are:
• hard capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), sunset yellow FCF (E110).
• inside the hard capsule caprylic/capric acid monoglycerides and butylated hydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin (which may contain soybean oil) (E322), cellulose

microcrystalline, 30% dispersion of methacrylic acid-ethyl acrylate copolymer 1:1,
methacrylic acid-ethyl acrylate copolymer 1:1, magnesium stearate, sodium hydroxide,
triacetin, talc, titanium dioxide (E171).

Description of the appearance of Dutasteride and Tamsulosin Aristo 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.
It is available in packs of 9, 30 and 90 capsules in aluminum/aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer
SAG Manufacturing S.L.U.
Crta. N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain
Galenicum Health, S.L.
Avda. Cornellà 144, 7º-1ª, Edificio Lekla
08950 Esplugues de Llobregat, Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany Dutalosin
Italy Dutasteride and Tamsulosin Aristo
Malta Dutasteride/Tamsulosin Aristo
Poland Marumax 0.5 mg/0.4 mg hard capsules
Portugal Dutasterida/Tansulosina Aristo
Czech Republic Dutasteride/Tamsulosin Aristo
Spain Dutasterida/Tamsulosin Aristo 0.5 mg/0.4 mg hard capsule
United Kingdom Dutasteride/Tamsulosin hydrochloride 0.5 mg/0.4 mg hard capsules