Package leaflet: Information for the user

Unisol, 0.5 mg + 0.4 mg, hard capsules
dutasteride + tamsulosin hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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.

Contents of the leaflet

What Unisol is and what it is used for
What you need to know before taking Unisol
How to take Unisol
Possible side effects
How to store Unisol
Contents of the package and other information

1. What Unisol is and what it is 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 contains a combination of two different medicines: dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-alpha-reductase inhibitors, while tamsulosin belongs to a group of medicines called alpha-adrenergic receptor antagonists.
Enlargement of the prostate gland may lead to urinary problems such as difficulty in urinating, more frequent urination, reduced urine flow, and weak urinary stream. If left untreated, complete blockage of urine flow (acute urinary retention) may occur. This condition requires immediate treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate gland.
Dutasteride reduces the production of the hormone called dihydrotestosterone, which leads to a reduction in the size of the prostate gland and relief of symptoms. By this action, dutasteride reduces the risk of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscles in the prostate gland, which facilitates urine flow and provides rapid symptom relief.

2. Important information before using Unisol

When not to use Unisol
if the patient is a woman (since this medicine is intended only for men),
if the patient is a child or person under 18 years of age,
if the patient is allergic to dutasteride, other medicines in the 5-alpha-reductase inhibitor class,
tamsulosin, soy, peanuts, or 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 apply to the patient, this medicine should not be taken
until consulting a doctor.

Warnings and precautions
Before starting treatment with Unisol, discuss this with your doctor.
In certain clinical studies, heart failure occurred more frequently in patients taking dutasteride together with a medicine belonging to the class known as alpha-adrenergic receptor antagonists (such as tamsulosin) than in patients taking dutasteride alone or an alpha-adrenergic receptor antagonist alone. Heart failure means the heart does not pump blood properly.
You should inform your doctor if you have liver disease. If you have liver disease, additional tests may be required during treatment with Unisol.
You should inform your doctor if you have kidney disease.
Cataract surgery. If you are scheduled for cataract surgery, your doctor may recommend temporarily stopping Unisol before the procedure. You must inform your ophthalmologist before surgery if you are currently taking or have previously taken Unisol or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
Women, children and adolescents must not touch damaged Unisol capsules, because the active substance may be absorbed through the skin. In case of skin contact, the contaminated area should be washed immediately with soap and water.
You should use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Unisol. If your partner is pregnant or may become pregnant, you should avoid exposing her to semen, because dutasteride may impair the development of a male fetus. Dutasteride has been shown to reduce sperm count, semen volume and sperm motility. This may lead to reduced fertility.
Unisol affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes tested to diagnose prostate cancer. Despite this, your doctor may still decide to perform this test. If you are being tested for PSA levels, you must inform your doctor that you are taking Unisol. Men taking Unisol should have regular PSA level checks.
In a clinical trial involving patients at increased risk of prostate cancer, more cases of high-grade prostate cancer were diagnosed in patients taking dutasteride than in those not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is not fully understood.
Unisol may cause breast enlargement and tenderness. If these symptoms become bothersome or if lumps in the breast or nipple discharge appear, you should contact your doctor, as these may be signs of a serious condition such as breast cancer.
If you have any questions about using Unisol, you should contact 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.
Do not take Unisol with the following medicines:
other alpha-adrenergic receptor antagonists (used to treat benign prostatic hyperplasia or high blood pressure)
Concomitant use of Unisol is not recommended 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 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 peptic ulcer disease)
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 inflammation and pain)
You should inform your doctor if you are taking any of these medicines.

Unisol with food and drink
Unisol should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding and effects on fertility
Unisol must not be used by women.
Women who are pregnant (or may be pregnant) must not touch damaged capsules.
Dutasteride is absorbed through the skin and may impair the development of a male fetus. The risk is particularly high during the first 16 weeks of pregnancy.
You should use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Unisol. If your partner is pregnant or may become pregnant, you should avoid exposing her to 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 been exposed to Unisol, you should contact a doctor immediately.

Driving and operating machinery
Unisol may cause dizziness in some patients, which could impair the ability to drive or operate machinery.
If such symptoms occur, do not drive or operate machinery.

Unisol contains lecithin derived from soy, propylene glycol and sodium.
This medicine contains lecithin derived from soy. Do not use if you have known hypersensitivity to peanuts or soy.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".
This medicine contains 299 mg of propylene glycol in each capsule.

3. How to use Unisol

This medicine should always be used exactly as recommended by your doctor or pharmacist. Irregular
use of the medicine may affect PSA level monitoring results. If in doubt, consult your doctor or pharmacist.
How much medicine to use
The recommended dose is one capsule taken once daily, 30 minutes after the same meal each day.
How to take the medicine
The capsule should be swallowed whole with water. Do not chew or open the capsule.
Contact with the capsule contents may cause pain in the mouth or throat pain.
Taking more Unisol than recommended
If you take more capsules than recommended, consult your doctor or pharmacist.
Missing a dose of Unisol
Do not take a double dose to make up for a missed dose.
Take the next capsule at your usual time.
Stopping use of Unisol
Do not stop using Unisol unless your doctor advises you to do so.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences 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 any of these symptoms occur, you should immediately contact a doctor and discontinue use of the medicine Unisol.

Dizziness, feeling of dizziness and fainting
Unisol may cause dizziness, a feeling of dizziness or, in rare cases, fainting. Until you are certain how the medicine affects you, you should exercise caution when changing body position from lying or sitting to sitting or standing, particularly when getting up at night.
If dizziness or a feeling of dizziness occurs at any time during treatment, you should sit down or lie down and wait for the symptoms to subside.

Serious skin reactions
Symptoms of a serious skin reaction may include:
widespread rash with blisters and peeling skin, particularly around the mouth,
nose, eyes and genitals (Stevens-Johnson syndrome)
If any of these symptoms occur, you should immediately contact a doctor and discontinue use of the medicine Unisol.

Common adverse reactions
May occur in more than 1 in 10 men using Unisol:
impotence (inability to achieve or maintain an erection)*
decreased sexual drive (libido)*
difficulty with ejaculation, including reduced volume of semen during ejaculation*
enlargement or tenderness of the breast glands (gynaecomastia)
dizziness.
* In a small number of patients, the aforementioned adverse reactions may persist even after discontinuation of Unisol.

Uncommon adverse reactions
May occur in less than 1 in 100 men using Unisol:
heart failure (less efficient heart function. Possible symptoms include shortness of breath, extreme fatigue, and swelling around the ankles and legs)
low blood pressure in the standing position
rapid heartbeat (palpitations)
constipation, diarrhoea, vomiting, nausea
weakness or loss of strength
headache
itching or stuffy nose, runny nose (inflammation of the nasal mucosa)
skin rash, hives, itching
hair loss (usually body hair) or excessive hair growth.

Rare adverse reactions
May occur in less than 1 in 1000 men using Unisol:
swelling of the eyelids, face, lips, hands or feet (angioedema)
fainting.

Very rare adverse reactions
May occur in less than 1 in 10,000 men using Unisol:
prolonged, painful erection of the penis (priapism)
serious skin reactions (Stevens-Johnson syndrome).

Other adverse reactions
Other adverse reactions 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)
difficulty breathing (shortness of breath)
depression
pain and swelling of the testicles
nosebleeds
severe skin rash
changes in vision (blurred vision or vision problems)
dry mouth.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the 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 cardboard box and on the bottle after: EXP. The expiry date refers to the last day of the stated month. The batch number is shown on the packaging after "Lot".
There are no special requirements for the storage of this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Unisol contains
The active substances in Unisol 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:
Iron oxide black (E 172)
Iron oxide red (E 172)
Titanium dioxide (E 171)
Iron oxide yellow (E 172)
Gelatin
Soft capsule contents with dutasteride:
Propylene glycol monocaprylate, type II
Butylhydroxytoluene (E 321)
Soft capsule shell:
Gelatin
Glycerol
Titanium dioxide (E171)
Saturated medium-chain triglycerides
Lecithin (may contain soybean oil)
Pellets containing tamsulosin:
Methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion (containing sodium lauryl sulfate and polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Colloidal anhydrous silica
Calcium stearate
Black ink
Shellac
Iron oxide black (E172)
Propylene glycol
Concentrated ammonium hydroxide
Potassium hydroxide

What Unisol looks like and contents of the pack
Unisol is in the form of elongated hard capsules, approximately 24.2 mm x 7.7 mm in size, with a beige body and an orange cap, printed in black ink with the code C001.
Inside each hard capsule there are modified-release pellets containing tamsulosin hydrochloride and one gelatin soft capsule containing dutasteride.
Unisol is available in packs containing 7, 30 or 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
Poland

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

This medicinal product is authorised in the following European Economic Area countries 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