Anasso

Package leaflet: Information for the user

ANASSO 0.5 mg/0.4 mg hard capsules

dutasteride/tamsulosin hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start 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 you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ANASSO is and what it is used for

ANASSO is used to treat men with enlarged prostate
(benign prostatic hyperplasia) – a non-malignant enlargement of the prostate gland caused by
excessive production of a hormone called dihydrotestosterone.
ANASSO 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 known as alpha blockers.
When the prostate gland enlarges, it may cause urinary problems such as difficulty in passing urine and the need to urinate frequently. This may also result in the urine flow becoming slower and weaker. 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 reduce 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 tissue of the prostate gland, making it easier for urine to pass and rapidly improving symptoms.

2. What you need to know before taking ANASSO

Do not take ANASSO

• 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, to other 5-alpha reductase inhibitors, to tamsulosin, to soy, to peanuts, or to any of the other ingredients of this medicine (listed in section 6).
• if you have low blood pressure causing dizziness, 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 ANASSO

• In some clinical studies, more patients taking dutasteride and another medicine called an alpha blocker such as tamsulosin experienced 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, additional monitoring may be needed while you are taking ANASSO.
• Make sure your doctor knows if you have severe kidney problems.

Cataract surgery (cloudy lens). If you are scheduled for cataract removal surgery, your doctor may ask you to stop taking ANASSO for a period before the operation. Inform your ophthalmologist before surgery if you are taking ANASSO or tamsulosin (or have taken them previously). The specialist will need to take appropriate precautions to help prevent complications during surgery.

• Women, children, and adolescents must avoid contact with damaged ANASSO capsules, as 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 ANASSO. 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.
• ANASSO affects a blood test for PSA ( prostate-specific antigen ), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still recommend the test to check for prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking ANASSO. Men taking ANASSO should have regular PSA tests.
• In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride developed a more frequent occurrence 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 fully understood.
• ANASSO may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, you should speak to your doctor about these changes, as they may be signs of a serious condition, such as breast cancer.

Mood changes and depression
In patients treated with another medicine of the same therapeutic class (oral 5-alpha reductase inhibitors), depressive mood, depression, and, less frequently, suicidal thoughts have been reported. If any of these symptoms occur, contact your doctor as soon as possible for further advice.
➔ Ask your doctor or pharmacist if you have any questions about taking ANASSO.
Other medicines and ANASSO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take ANASSO with these medicines:

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

ANASSO is not recommended with these medicines:

• ketoconazole (used to treat fungal infections).

Some medicines may interact with ANASSO and 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 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)

➔ Inform your doctor if you are taking any of these medicines.
ANASSO with food
ANASSO should be taken 30 minutes after the same meal each day.
Pregnancy, breastfeeding, and fertility
ANASSO must not be taken by women.
Pregnant women (or those who may become pregnant) must not handle damaged capsules. Dutasteride can be 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.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking ANASSO. If your partner is pregnant or could become pregnant, you must avoid exposing her to your semen.
ANASSO has been shown to reduce sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.
➔ Consult your doctor if a pregnant woman has been exposed to ANASSO.
Driving and using machines
ANASSO may cause dizziness in some people and may therefore affect your ability to drive or operate machinery safely.
➔ Do not drive or operate machinery if you feel dizzy.
ANASSO contains soy lecithin and propylene glycol
This medicine contains soy lecithin, which may contain soy oil. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., it is essentially ‘sodium-free’.
This medicine contains 299 mg of propylene glycol per capsule.

3. How to take ANASSO

Take ANASSO exactly as your doctor or pharmacist has told you. If you do not
take it regularly, PSA level monitoring may be affected. If you are unsure, consult your
doctor or pharmacist.
How much ANASSO to take
The recommended dose is one capsule taken once daily, 30 minutes after the same meal, every day.
How to take ANASSO
Swallow the capsules whole with water. Do not chew or open the capsules. Contact with the contents
of the capsules may irritate the mouth or throat.
If you take more ANASSO than you should
Contact your doctor or pharmacist for advice if you take more ANASSO capsules than prescribed.
If you forget to take ANASSO
Do not take a double dose to make up for the missed dose. Take the next dose as usual.
Do not stop taking ANASSO without medical advice
Do not stop taking ANASSO 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 everybody gets them.

Allergic reaction
Signs of allergic reactions may include:

• rash (which may be itchy)
• hives (similar to a rash caused by nettles)
• swelling of the eyelids, face, lips, arms or legs.

➔ Contact your doctor immediately if you experience any of these symptoms and stop taking ANASSO.

Dizziness, lightheadedness and fainting
ANASSO may 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 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 these symptoms pass.

Serious skin reactions
Signs of serious skin reactions may include:
widespread rash with blistering 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 ANASSO.

Common side effects
These may affect up to 1 in 10 men treated with ANASSO:

• impotence (inability to achieve or maintain an erection)*
• decreased sexual desire ( libido )*
• ejaculation disorders, such as reduced 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 stopping ANASSO.

Uncommon side effects
These may affect up to 1 in 100 men:

• 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
• loss of body hair or excessive hair growth.

Rare side effects
These may affect up to 1 in 1,000 men:

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

Very rare side effects
These may affect up to 1 in 10,000 men:

• 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 men, 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 skin 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 ANASSO

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 carton and bottle after
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ANASSO contains
The active substances 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
components are:
Capsule shell:
Black iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)
Yellow iron oxide (E172)
Gelatin
Contents of the soft capsule containing dutasteride:
Propylene glycol monocaprylate, type II
Butylated hydroxytoluene (E321)
Soft capsule shell:
Gelatin
Glycerol
Titanium dioxide (E171)
Medium-chain triglycerides
Lecithin (may contain soybean oil) (see section 2)
Tamsulosin granules:
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (containing sodium lauryl sulfate,
polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Hydrated colloidal silica
Calcium stearate
Black ink:
Shellac (E904)
Black iron oxide (E172)
Propylene glycol
Concentrated ammonia solution (E527)
Potassium hydroxide (E525)
See section 2 “ANASSO contains soy lecithin and propylene glycol”.

Description of the appearance of ANASSO and package contents
This medicinal product is presented as an oblong hard capsule, approximately 24.2 mm x 7.7 mm, with a brown body and a beige cap, printed with the code C001 in black ink.
Each hard capsule contains modified-release granules of tamsulosin hydrochloride and a soft gelatin capsule containing dutasteride.
Capsules are available in packs of 7, 30 and 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy

Manufacturer:
Laboratorios LEON FARMA SA
C/La Vallina, s/n, Poligono Industrial Navatejera
Villaquilambre-24193 (Leon) - Spain

This medicinal product is authorized in the European Economic Area Member States under the
following names:
Italy: Anasso
Germany: Tamsublock duo
Ireland: Dutasteride/Tamsulosin hydrochloride Pinewood 0.5 mg/0.4 mg hard capsules
Norway: Dutasteride/Tamsulosin Orion