Marumax

Package Leaflet: Information for the User

Marumax, 0.5 mg + 0.4 mg, hard capsules
Dutasteride + Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• -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 only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Marumax and what is it used for

Marumax is used in men with an enlarged prostate gland(benign prostatic hyperplasia) - a non-cancerous enlargement of the prostate gland caused by an excess of a hormone called dihydrotestosterone.
Marumax is a combination of two different medicines called 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.
An enlarged prostate gland can cause problems with urination, such as difficulty urinating and frequent urination. It can also cause a decrease in the flow of urine 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 causes the prostate gland to shrink and alleviates symptoms. It also reduces the likelihood of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscles in the prostate gland, making it easier to urinate and quickly relieving symptoms.

2. Important information before taking Marumax

When not to take Marumax

• -in women(since this medicine is only intended for men);
• -in children or adolescents under 18 years of age;
• -if the patient is allergic to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, soy, or peanutsor any of the other ingredients of this medicine (listed in section 6);
• -if the patient has low blood pressurecausing dizziness, lightheadedness, or fainting (orthostatic hypotension);
• -if the patient has severe liver disease.

If any of the above statements apply to the patient, the patient should not take this medicineuntil they have consulted a doctor.

Warnings and precautions

Before taking Marumax, the patient should discuss it with their 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.
• -The patient should inform their doctor if they have liver disease.If the patient has had liver disease, additional tests may be necessary while taking Marumax.
• -The patient should inform their doctor if they have kidney disease.
• -Cataract surgery (cloudy lens).If the patient is scheduled to have cataract surgery, the doctor may recommend stopping Marumax for a certain period before the surgery. The patient should inform their ophthalmologist if they are taking or have taken Marumax or tamsulosin. The doctor will take appropriate precautions to prevent complications during surgery.
• -Women, children, and adolescentsshould not handle damaged Marumax capsules, as the active substance may be absorbed through the skin. In case of skin contact, the affected area should be washed immediately with soap and water.
• -A condom should be used during sexual intercourse.Dutasteride has been found in the semen of men taking Marumax. If the patient's partner is pregnant or may become pregnant, they should avoid exposure to the patient's semen, as dutasteride may affect the development of a male fetus. It has been shown that dutasteride with tamsulosin can reduce sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.
• -Marumax affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes performed to detect prostate cancer. However, the doctor may still order this test to detect prostate cancer. If the patient is having a PSA test, they should inform their doctor that they are taking Marumax. Men taking Marumax 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 cancer than patients not taking dutasteride. The effect of dutasteride on the risk of developing high-grade prostate cancer is unclear.
• -Marumax may cause breast enlargement and tenderness.If these symptoms become troublesome or if the patient experiences breast lumps or nipple discharge, they should contact their doctor, as these may be signs of a serious condition, such as breast cancer.

In case of questions about taking Marumax, the patient should contact their doctor or pharmacist.

Marumax and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• -other alpha-adrenergic receptor antagonists(used to treat benign prostatic hyperplasia or high blood pressure).

The patient should not take Marumax with the following medicines:

• -ketokonazole(used to treat fungal infections).

Some medicines taken with Marumax may 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(used to treat depression)
• 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).

The patient should tell their doctorif they are taking any of these medicines.

Marumax with food and drink

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

Pregnancy, breastfeeding, and fertility

Marumax is contraindicated in women.
Pregnant women (or women who may become pregnant) should not handle damaged Marumax capsules.Dutasteride is absorbed through the skin and may affect the development of a male fetus. There is a special risk during the first 16 weeks of pregnancy.
If a pregnant woman has come into contact with Marumax, she should contact her doctor.
A condom should be used during sexual intercourse.Dutasteride has been found in the semen of men taking Marumax. If the patient's partner is pregnant or may become pregnant, she should avoid exposure to the patient's semen.
It has been shown that dutasteride with tamsulosin can reduce sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.

Driving and using machines

Marumax may cause dizziness in some patients, which may affect their ability to drive or operate machinery.
If these symptoms occur, the patient should not drive or operate machinery.

What Marumax contains

• Marumax contains the dye orange yellow FCF (E 110), which may cause allergic reactions.
• Marumax contains soy lecithin. Do not take if you are allergic to peanuts or soy.
• Marumax contains less than 1 mmol of sodium (23 mg) per capsule, which means it is essentially sodium-free.

3. How to take Marumax

This medicine should always be taken exactly as directed by the doctor or pharmacist. Irregular intake of the medicine may affect the results of PSA tests. If in doubt, the patient should consult their doctor or pharmacist.

How much to take

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

How to take it

The capsule should be swallowed whole, with water.The capsule should not be chewed or opened. Contact with the contents of the capsule may cause mouth or throat pain.

Overdose

If the patient has taken more Marumax capsules than recommended, they should consult their doctor or pharmacist.

Missed dose

The patient should not take a double dose to make up for a missed dose. They should take the next capsule at the usual time.

Do not stop taking Marumax

The patient should not stop taking Marumax unless their doctor recommends it.
If the patient has any further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Marumax 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(red rash on the skin)
• -swelling of the eyelids, face, lips, hands, or feet.

If the patient experiences any of these symptoms, they should contact their doctor immediately and stop taking Marumax.

Dizziness, lightheadedness, and fainting

Marumax may cause dizziness, lightheadedness, or fainting. Until the patient knows how the medicine affects them, they should be careful when changing positions from lying down or sitting to standing, especially when getting up at night. If the patient experiences dizziness or lightheadedness at any time during treatment, they should 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 on the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome). If the patient experiences any of these symptoms, they should contact their doctor immediately and stop taking Marumax.

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

• -impotence (inability to achieve or maintain an erection)*
• -decreased libido (sex drive)*
• -difficulty with ejaculation, such as decreased semen volume during ejaculation*
• -breast tenderness or enlargement (gynecomastia)
• -dizziness.

*In a small number of people, these side effects may persist even after stopping Marumax.
Uncommon side effects(may affect up to 1 in 100 people):

• -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
• -rapid heartbeat (palpitations)
• -constipation, diarrhea, vomiting, nausea (feeling sick)
• -weakness or loss of strength
• -headache
• -itching or blocked nose, runny nose (rhinitis)
• -skin rash, hives, itching
• -hair loss (usually body hair) or excessive hair growth.

Rare side effects(may affect up to 1 in 1,000 people)

• -swelling of the eyelids, face, lips, hands, or feet (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 occurred in a small number of men, but their exact frequency is unknown (based on available data, the frequency cannot be estimated):

• -abnormal or rapid heart rhythm (arrhythmia, tachycardia, or atrial fibrillation)
• -difficulty breathing (dyspnea)
• -depression
• -testicular pain and swelling
• -nosebleeds
• -severe skin rash
• -changes in vision (blurred vision or vision disturbances)
• -dry mouth.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.

5. How to store Marumax

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Marumax 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.
• Other ingredients are:
• capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide (E 171), iron oxide red (E 172), orange yellow FCF (E 110), purified water.
• soft capsules with dutasteride: (contents of the soft capsule) glycerol monocaprylocaprate (type I) and butylhydroxytoluene (E 321); (soft capsule shell) gelatin, glycerol, titanium dioxide (E 171), iron oxide yellow (E 172), medium-chain triglycerides, soy lecithin, purified water.
• pellets with tamsulosin hydrochloride: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, methacrylic acid - ethyl acrylate copolymer (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E 171).

What Marumax looks like and contents of the pack

Oval, hard capsules, approximately 24 mm in length, with a brown body and orange cap.
Marumax is available in packs of 30 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw

Manufacturer

SAG MANUFACTURING S.L.U.
Crta. N-I, Km 36
San Agustin de Guadalix
28750 Madrid
Spain
Galenicum Health S.L.U.
Calle Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona
Spain

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

Czech Republic
Marumax
Spain
Dutasterida/Tamsulosin Aristo
Germany
Dutalosin
Poland
Marumax
Portugal
Dutasterida/Tansulosina Aristo
United Kingdom
Dutasteride/Tamsulosin hydrochloride 0.5 mg/ 0.4 mg hard capsules
Date of last revision of the leaflet:April 2023