Marumax

Package leaflet: Information for the user

Marumax, 0.5 mg + 0.4 mg, hard capsules
Dutasteridum + Tamsulosini hydrochloridum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Marumax is and what it is 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 Marumax is and what it is 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 excessive production of a hormone called dihydrotestosterone.
Marumax is a combination of two different medicines: dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-α-reductase inhibitors, and tamsulosin belongs to a group of medicines called α-adrenergic receptor antagonists.
An enlarged prostate gland may lead to urinary problems such as difficulty urinating and more frequent urination. There may also be reduced urine flow and a weak urine stream. If left untreated, complete blockage of urine flow (acute urinary retention) may occur. This situation 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 a hormone called dihydrotestosterone, which leads to a reduction in the size of the prostate gland and relief of symptoms. Thus, it reduces the likelihood 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 taking Marumax

When not to take Marumax

• in women (because this medicine is intended only for men);
• in children or adolescents under 18 years of age;
• if the patient is allergic to dutasteride, other 5-α-reductase inhibitors, 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, lightheadedness, or fainting (orthostatic hypotension);
• if the patient has severe liver disease.

→ If any of the above apply to the patient, the patient should not take this medicine until consulting a doctor.

Warnings and precautions
Before starting Marumax, discuss it with your doctor.

• In some clinical studies, heart failure occurred more frequently in patients taking dutasteride together with a medicine from the group called 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.
• Inform your doctor if you have liver disease. If you have any liver condition, additional tests may be needed during treatment with Marumax.
• Inform your doctor if you have kidney disease.
• Cataract surgery (cloudy lens). If you are scheduled for cataract surgery, your doctor may advise temporarily stopping Marumax before the procedure. Inform your ophthalmologist if you are taking (or have previously taken) Marumax or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescents must not touch damaged capsules of Marumax, because 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.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Marumax. If your partner is pregnant or may be pregnant, avoid exposing her to semen, as dutasteride may disrupt 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.
• Marumax affects the measurement of prostate-specific antigen (PSA), which is sometimes tested to detect prostate cancer. Despite this, your doctor may intentionally order this test to screen for prostate cancer. If you are having a PSA test, you should inform your doctor that you are taking Marumax. Men taking Marumax should have regular PSA tests.
• In a clinical trial involving patients at increased risk of prostate cancer, high-grade prostate cancer was diagnosed more frequently in patients taking dutasteride than in those not taking dutasteride. The effect of dutasteride on the risk of developing high-grade prostate cancer is not fully understood.
• Marumax may cause breast enlargement and tenderness. If these symptoms become bothersome, or if lumps in the breast or nipple discharge occur, contact your doctor, as these may be signs of a serious condition such as breast cancer.

Mood changes and depression
In patients taking another medicine from the same therapeutic group (a 5-alpha reductase inhibitor) orally, depressive mood, depression, and rarely suicidal thoughts have been reported. If any of these symptoms occur, seek immediate medical advice from your doctor.
→ If you have any questions about using Marumax, contact your doctor or pharmacist.

Marumax with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.

Do not take Marumax with the following medicines:

• other medicines from the group of α-adrenergic receptor antagonists (used to treat benign prostatic hyperplasia or high blood pressure).

The use of Marumax is not recommended with the following medicines:

• ketoconazole (used to treat fungal infections).

Some medicines taken together with Marumax may increase the risk of adverse effects. These include:

• PDE5 inhibitors (used to induce or maintain erection (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 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).

→ Inform your doctor if you are taking any of these medicines.

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

Pregnancy, breastfeeding and effects on fertility
Taking Marumax is contraindicated in women.
Pregnant women (or women who may become pregnant) must not touch damaged capsules. Dutasteride is absorbed through the skin and may disrupt the development of a male fetus. The risk is particularly high during the first 16 weeks of pregnancy.
→ If a pregnant woman has been exposed to Marumax, contact a doctor immediately.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Marumax. If the patient's partner is pregnant or may be pregnant, she must avoid exposure to semen.
It has been shown that dutasteride combined with tamsulosin reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.

Driving and operating machinery
Marumax may cause dizziness in some patients, which may negatively affect the ability to drive or operate machinery.
→ If such symptoms occur, do not drive or operate machinery.

Marumax contains:

• a colouring agent, Orange Yellow FCF (E 110). This medicine may cause allergic reactions.
• lecithin derived from soy. Do not use if you are known to be hypersensitive to peanuts or soy.
• less than 1 mmol of sodium (23 mg) per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Marumax

This medicine should always be taken exactly as directed by your doctor or pharmacist. Irregular
use of the medicine may affect PSA monitoring results. If in doubt, consult your doctor or pharmacist.
How much medicine to take
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.
Taking more Marumax than recommended
If you take more capsules than recommended, consult your doctor or pharmacist.
If you miss a dose of Marumax
Do not take a double dose to make up for a missed dose. Take the next capsule at the usual time.
Do not stop taking Marumax
Do not stop taking Marumax unless instructed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 any of these symptoms occur, you should contact your doctor immediately
and stop taking Marumax.
Dizziness, lightheadedness and fainting
Marumax may cause dizziness, lightheadedness, or, in rare cases, fainting. Until you are sure how the medicine affects you, take care when changing position from lying or sitting to standing, especially when getting up at night. If you experience dizziness or lightheadedness at any time during treatment, you should sit 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 genital area (Stevens-Johnson syndrome). → If any of these symptoms occur, you should contact your doctor immediately and stop taking Marumax.

Common side effects (may occur in at least 1 in 10 patients):

• impotence (inability to achieve or maintain an erection)*
• decreased sexual desire (libido)*
• problems with ejaculation, such as reduced amount of semen during ejaculation*
• enlargement or tenderness of the breasts (gynaecomastia)
• dizziness.

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

• heart failure (less efficient heart function. Possible symptoms include: shortness of breath, extreme tiredness, and swelling in the ankles and lower limbs)
• low blood pressure when standing
• rapid heartbeat (palpitations)
• constipation, diarrhoea, vomiting, nausea (feeling sick)
• weakness or loss of strength
• headache
• itching or stuffy nose, runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually body hair) or excessive hair growth.

Rare side effects (may occur in less than 1 in 1,000 patients)

• swelling of the eyelids, face, lips, hands or feet (angioedema)
• fainting.

Very rare side effects (may occur in less than 1 in 10,000 patients)

• prolonged, painful 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 men, but their exact frequency is unknown
(based on available data, frequency cannot be estimated):

• irregular or fast heartbeat (arrhythmia, tachycardia or atrial fibrillation)
• difficulty breathing (dyspnoea)
• depression
• pain and swelling of the testicles
• nosebleeds
• severe skin rash
• changes in vision (blurred vision or visual disturbances)
• dry mouth.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309. Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Marumax

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following the abbreviation
"EXP". The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. 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 components are:
• Hard capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide (E 171), iron oxide red (E 172), sunset yellow FCF (E 110), purified water.
• Soft capsules containing dutasteride: (contents) glycerol monooctanoate monocaprylocaprate (type I) and butylated hydroxytoluene (E 321); (soft capsule shell) gelatin, glycerol, titanium dioxide (E 171), iron oxide yellow (E 172), medium-chain triglycerides, soy lecithin, purified water.
• Pellets containing 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 an orange cap.
The medicine is available in packs containing 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
Poland

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 authorised in the European Economic Area countries 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