Unisol

Package Leaflet: Information for the User

Unisol, 0.5 mg + 0.4 mg, hard capsules
dutasteride + tamsulosin hydrochloride

It is very important that you read the contents of this leaflet carefully before taking this medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Unisol and what is it used for

Unisol 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.
Unisol is a combination of two different medicines: dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-alpha-reductase inhibitors, and tamsulosin belongs to a group of medicines called alpha-adrenergic receptor antagonists.
Enlargement of the prostate gland can lead to problems with urination, such as difficulty urinating and frequent urination. It can also cause a decrease in urine flow and a weak urine stream. If left untreated, it can lead to complete blockage of urine flow ( acute urinary retention). This situation requires immediate treatment. In some cases, surgical intervention may be necessary to remove the prostate gland or reduce its size.
Dutasteride reduces the production of the hormone dihydrotestosterone, which leads to a decrease in the size of the prostate gland and relief of symptoms. By doing so, dutasteride reduces the risk of acute urinary retention and the need for surgical intervention. The action of tamsulosin is to relax the muscles in the prostate gland, making it easier to urinate and providing quick relief of symptoms.

2. Important information before taking Unisol

When not to take Unisol

if the patient is a woman(since this medicine is only intended for men),
if the patient is a child or adolescent under 18 years of age,
if the patient is allergic to dutasteride, other 5-alpha-reductase inhibitors,
tamsulosin, soy, peanutsor any of the other ingredients of this medicine (listed in section 6.),
if the patient has low blood pressure, causing dizziness or fainting ( orthostatic hypotension),
if the patient has severe liver disease.
If any of the above applies to you, do not take this medicineuntil you have consulted your doctor.

Warnings and precautions

Before taking Unisol, you should discuss it with your doctor.
In some clinical trials, an increased incidence of heart failure was observed in patients taking dutasteride in combination with an alpha-adrenergic receptor antagonist (such as tamsulosin), compared to patients taking dutasteride or an alpha-adrenergic receptor antagonist alone. Heart failure means that the heart is not pumping blood properly. You should inform your doctor if you have liver disease.If you have had liver disease, it may be necessary to perform additional tests while taking Unisol.

You should inform your doctor if you have kidney disease.

Cataract surgery (cloudy lens).If you are scheduled to have cataract surgery, your doctor may advise you to stop taking Unisol for a certain period before the surgery. You should inform your ophthalmologist if you are taking or have taken Unisol or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
Women, children, and adolescentsshould not handle damaged Unisol capsules, as the active substance may be absorbed through the skin. In case of skin contact, wash the affected area immediately with soap and water.
You should use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Unisol. If your partner is pregnant or may become pregnant, you should avoid exposing her to your semen, as dutasteride may interfere with the development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility.
Unisol affects the measurement of prostate-specific antigen (PSA), which is sometimes performed to diagnose prostate cancer. However, your doctor may still order this test.
If you have a PSA test, you should inform your doctor that you are taking Unisol. Men taking Unisol should have their PSA levels checked regularly.
In a clinical trial involving patients with an increased risk of prostate cancer, patients taking dutasteride were more likely to be diagnosed with high-grade prostate cancerthan those not taking dutasteride. The impact of dutasteride on high-grade prostate cancer is not clear.
Unisol may cause breast enlargement and tenderness. If these symptoms become troublesome or if you experience breast lumps or nipple discharge, you should consult your doctor, as these may be signs of a serious condition, such as breast cancer.
If you have any questions about taking Unisol, you should consult your doctor or pharmacist.

Unisol and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not take Unisol with the following medicines:
other alpha-adrenergic receptor antagonists(used to treat enlarged prostate or high blood pressure)
It is not recommended to take Unisol with the following medicines:
ketoconazole(used to treat fungal infections)
Some medicines may interact with Unisol and increase the risk of side effects. These include:
PDE5 inhibitors(used to induce or maintain an erection), such as vardenafil, sildenafil citrate, and tadalafil
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(an antidepressant)
cimetidine(used to treat stomach ulcers)
warfarin(used to treat blood clots)
erythromycin(an antibiotic used to treat infections)
paroxetine(an antidepressant)
terbinafine(used to treat fungal infections)
diclofenac(used to treat inflammatory conditions and pain)
You should inform your doctorif you are taking any of these medicines.

Unisol with food and drink

Unisol should be taken 30 minutes after the same meal every day.

Pregnancy, breastfeeding, and fertility

Unisol is contraindicated in women.

Pregnant women (or women who may become pregnant) should not handle damaged capsules.

Dutasteride is absorbed through the skin and may interfere with the development of a male fetus. There is a particular risk during the first 16 weeks of pregnancy.
You should use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Unisol. If your partner is pregnant or may become pregnant, you should avoid exposing her to your semen.
It has been shown that Unisol reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
If a pregnant woman has come into contact with Unisol, she should consult her doctor.

Driving and using machines

Unisol may cause dizziness in some patients, which may negatively affect the ability to drive or operate machinery.
If such symptoms occur, you should not drive or operate machinery.

Unisol contains lecithin derived from soy, propylene glycol, and sodium.

This medicine contains lecithin derived from soy. Do not take if you are hypersensitive to peanuts or soy.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.
This medicine contains 299 mg of propylene glycol in each capsule.

3. How to take Unisol

This medicine should always be taken exactly as advised by your doctor or pharmacist.Irregular intake of the medicine may affect the results of PSA tests. If you are unsure, consult your doctor or pharmacist.

How much to take

The recommended dose is one capsule taken once daily, 30 minutes after the same meal every day.

How to take it

The capsule should be swallowed whole with water.Do not chew or open the capsule. Contact with the contents of the capsule may cause mouth or throat pain.

Overdose

If you have taken more Unisol capsules than you should, consult your doctor or pharmacist.

Missed dose

Do not take a double dose to make up for a missed dose.
Take the next capsule at the usual time.

Stopping treatment

Do not stop taking Unisol without consulting your doctor.
If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions

Symptoms of an allergic reaction may include:
skin rash(which may be itchy)
hives
swelling of the eyelids, face, lips, hands, or feet.
If you experience any of these symptoms, contact your doctor immediately and stop taking Unisol.

Dizziness, fainting, and fainting spells

Unisol may cause dizziness, fainting, or fainting spells. Until you know how the medicine affects you, be careful when changing positions from lying down or sitting to standing, especially when getting up at night.
If you experience dizziness or fainting, sit or lie down and wait for the symptoms to pass.

Severe skin reactions

Symptoms of a severe skin reaction may include:
widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome)
If you experience any of these symptoms, contact your doctor immediately and stop taking Unisol.

Common side effects

These may occur in more than 1 in 10 men taking Unisol:
impotence ( inability to achieve or maintain an erection)
decreased libido ( sex drive)
difficulty with ejaculation, including reduced semen volume during ejaculation*
breast enlargement or tenderness ( gynaecomastia)
dizziness.
* In a small number of patients, these side effects may persist even after stopping Unisol.

Uncommon side effects

These may occur in more than 1 in 100 men taking Unisol:
heart failure (less efficient heart function, which may cause symptoms such as shortness of breath, extreme tiredness, and swelling in the ankles and legs)
low blood pressure when standing up (orthostatic hypotension)
rapid heartbeat ( palpitations)
constipation, diarrhea, vomiting, nausea
weakness or loss of strength
headache
flushing or nasal congestion ( rhinitis)
skin rash, hives, itching
hair loss (usually body hair) or excessive hair growth.

Rare side effects

These may occur in more than 1 in 1,000 men taking Unisol:
swelling of the eyelids, face, lips, hands, or feet ( angioedema)
fainting.

Very rare side effects

These may occur in more than 1 in 10,000 men taking Unisol:
prolonged and painful erection of the penis ( priapism)
severe skin reactions (Stevens-Johnson syndrome).

Other side effects

Other side effects have occurred in a small number of men, but their frequency is not known (the frequency cannot be estimated from the available data):
abnormal or rapid heart rhythm ( arrhythmia, tachycardia, or atrial fibrillation)
difficulty breathing ( dyspnoea)
depression
testicular pain and swelling
nosebleeds
severe skin rash
vision changes ( blurred vision or eye problems)
dry mouth.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system via the website [insert website]. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Unisol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Unisol 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 ingredients are:
Hard capsule shell:
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Yellow iron oxide (E 172)
Gelatin
Soft capsule contents:
Propylene glycol monocaprylate, type II
Butylhydroxytoluene (E 321)
Soft capsule shell:
Gelatin
Glycerol
Titanium dioxide (E 171)
Saturated fatty acid triglycerides (medium-chain)
Lecithin (may contain soybean oil)
Tamsulosin pellets:
Methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (contains sodium lauryl sulfate and polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Hydrated silica
Calcium stearate
Black ink
Shellac
Black iron oxide (E 172)
Propylene glycol
Concentrated ammonia solution
Potassium hydroxide

What Unisol looks like and contents of the pack

Unisol is a hard capsule, approximately 24.2 mm x 7.7 mm in size, with a beige-colored body and a reddish-brown cap, with a black ink print of "C001".
Inside each hard capsule, there are pellets with a modified release, containing tamsulosin hydrochloride, and one soft gelatin capsule containing dutasteride.
Unisol is available in packs of 7, 30, or 90 capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw

Manufacturer

Laboratorios LEÓN FARMA, SA
C/La Vallina, s/n, Polígono Industrial Navatejera
Villaquilambre-24008 (León)
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Unisol
Austria:
Unisol
Czech Republic:
Unisol
Germany:
Dutasterid/Tamsulosin Cipla 0.5 mg/0.4 mg Hartkapseln
Hungary:
Unisol
Lithuania:
Unisol
Poland:
Unisol
Slovakia:
Unisol
Estonia:
Unisol
Latvia:
Unisol
Portugal:
Unisol
Date of last revision of the leaflet:06.11.2021