Landulosin

Package leaflet: Information for the user

Landulosin, 0.5 mg + 0.4 mg, hard capsules
Dutasteridum + Tamsulosini hydrochloridum
Please read all of 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, 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Landulosin is and what it is used for

Landulosin is used in the treatment of enlarged prostate gland (benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
Landulosin is a combination of two other 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 may lead to problems with urination, such as difficulty passing urine 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 the prostate gland or reduce its size.
Dutasteride reduces the production of a hormone called dihydrotestosterone, which causes the prostate gland to shrink and symptoms to improve. 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 helps urine flow and quickly relieves symptoms.

2. What you need to know before taking Landulosin

Do not take Landulosin

• if you are a woman (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, other 5-alpha-reductase inhibitors, tamsulosin, soy, peanuts, or 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 any of these situations apply to you, do not take this medicine without first consulting your doctor.

Warnings and precautions
Before starting Landulosin, discuss this with your doctor.

• In some clinical studies, heart failure was observed more frequently in patients taking dutasteride together with a medicine belonging to the group of 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 is unable to pump blood properly.
• Tell your doctor if you have liver disease. If you have liver disease, additional tests may be required during treatment with Landulosin.
• Tell your doctor if you have kidney disease.
• Cataract surgery (clouded lens). If you are scheduled for cataract surgery, your doctor may recommend temporarily stopping Landulosin before the operation. You must inform your ophthalmologist before surgery if you are taking or have previously taken Landulosin or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescents must not touch damaged capsules of Landulosin because the active substance may be absorbed through the skin. If contact with the skin occurs, the contaminated area must 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 Landulosin. If your partner is pregnant or could become pregnant, you should avoid exposing her to contact with 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.
• Landulosin affects the measurement of prostate-specific antigen (PSA) levels, which is sometimes performed to diagnose prostate cancer. Despite this, your doctor may still decide to perform this test. If you are having your PSA levels measured, you must inform your doctor that you are taking Landulosin. Patients taking Landulosin should have their PSA levels monitored regularly.
• In a clinical trial involving men at increased risk of prostate cancer, more cases of high-grade prostate cancer were diagnosed in men taking dutasteride than in men not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is not fully understood.
• Landulosin may cause breast enlargement and tenderness. If this becomes bothersome or if you notice lumps in the breast or nipple discharge, you should contact your doctor, as these may be signs of a serious condition such as breast cancer.

 If you have any further questions about the use of Landulosin, you should contact your doctor or pharmacist.

Landulosin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including medicines available without a prescription.

Do not take Landulosin with the following medicines:

• other medicines from the group of alpha-adrenergic receptor antagonists (used to treat prostate enlargement or high blood pressure)

It is not recommended to take Landulosin with the following medicines:

• ketoconazole (used to treat fungal infections)

Some medicines may interact with Landulosin, increasing the risk of side effects. These include:

• PDE5 inhibitors [used to induce or maintain erection (erectile dysfunction)] 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 pain and inflammation)

 You should inform your doctor if you are taking any of the medicines listed above.

Landulosin and food
Take Landulosin 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and effects on fertility
Landulosin must not be used by 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.
You should use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Landulosin. If your partner is pregnant or could become pregnant, you should avoid exposing her to contact with semen.
It has been shown that the combination of dutasteride and tamsulosin reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
 You should contact your doctor if a pregnant woman has been exposed to Landulosin.

Driving and operating machinery
Landulosin may cause dizziness in some patients, which may negatively affect the ability to drive or operate machinery safely.
 If you experience such symptoms, do not drive or operate machinery.

Landulosin contains soy lecithin, propylene glycol, and sodium
This medicine contains soy lecithin, which may contain soy oil. If you are allergic to peanuts or soy, do not take this medicinal product.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. it is considered "sodium-free".
This medicine contains 229 mg of propylene glycol in each capsule.

3. How to take Landulosin

This medicine should always be taken exactly as recommended by your doctor or pharmacist.
If the medicine is not taken regularly, it may affect PSA concentration monitoring results.
In case of 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, crush, or open the capsule.
Contact with the capsule's contents may cause pain in the mouth or throat.

Taking more Landulosin than recommended
If you take more Landulosin than recommended, contact your doctor or pharmacist immediately.

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

Stopping treatment with Landulosin
Do not stop taking Landulosin without consulting your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects,
although not everyone experiences them.

Allergic reactions
Symptoms of an allergic reaction may include:

• Skin rash (which may be itchy)
• Hives (urticaria)
• Swelling of the eyelids, face, lips, hands or feet
   If any of these symptoms occur, contact a doctor immediately and discontinue use of Landulosin.

Dizziness, dizziness sensation and fainting
Landulosin may cause dizziness, a sensation of dizziness, and in rare cases fainting. Until you are certain how the medicine affects you, caution should be exercised when changing positions from sitting or lying to standing, especially when getting up at night. If dizziness or a sensation of dizziness occurs during treatment, sit or lie down immediately and wait until symptoms subside.

Severe skin reactions
Symptoms of severe skin reactions may include:

• Widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome)
   Contact a doctor immediately and discontinue use of Landulosin if such symptoms occur.

Common adverse effects (may occur in more than 1 in 10 patients)

• Impotence (inability to achieve or maintain an erection)*
• Decreased sexual desire (libido)*
• Ejaculation disorders, such as reduced volume of semen released during intercourse*
• Breast enlargement or tenderness (gynaecomastia)
• Dizziness

*In a small number of individuals, some of these adverse effects may persist even after discontinuation of Landulosin.

Uncommon adverse effects (may occur in more than 1 in 100 patients)

• Heart failure (heart pumps blood less effectively; patients may experience shortness of breath, extreme fatigue, and swelling of the ankles and legs)
• Low blood pressure upon standing (orthostatic hypotension)
• Fast heartbeat (palpitations)
• Constipation, diarrhoea, vomiting, nausea
• Weakness or loss of strength
• Headache
• Itchy nose, nasal congestion, runny nose (rhinitis)
• Skin rash, hives, itching
• Hair loss (usually affecting body hair) or excessive hair growth

Rare adverse effects (may occur in more than 1 in 1,000 patients)

• Swelling of the eyelids, face, lips, arms or legs (angioedema)
• Fainting

Very rare adverse effects (may occur in more than 1 in 10,000 patients)

• Prolonged, painful erection (priapism)
• Serious skin reactions (Stevens-Johnson syndrome)

Other adverse effects
Other adverse effects have been reported in a small number of men, but the exact frequency is unknown (cannot be estimated from available data):

• Irregular or rapid heartbeat (arrhythmia, tachycardia or atrial fibrillation)
• Shallow breathing (shortness of breath)
• Depression
• Pain and swelling of the testicles
• Nosebleeds
• Severe skin rash
• Vision disturbances (blurred vision or visual problems)
• Dry mouth

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Landulosin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP.
The expiry date refers to the last day of the indicated month.
This medicine does not require any special storage conditions.
Medicines must 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. Package contents and other information

What Landulosin contains

• The active substances are dutasteride and tamsulosin hydrochloride. Each 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

Contents of the soft capsule containing dutasteride:
Propylene glycol monocaprylate, type II
Butylated hydroxytoluene (E 321)

Soft capsule shell:
Gelatin
Glycerol
Titanium dioxide (E 171)
Medium-chain saturated triglycerides
Soy lecithin (see section 2)

Tamsulosin pellets:
Methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% (containing sodium lauryl sulfate and
polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Hydrated colloidal silica
Magnesium stearate

Black printing ink:
Shellac
Iron oxide black (E 172)
Propylene glycol
Concentrated ammonium hydroxide
Potassium hydroxide

See section 2: "Landulosin contains soy lecithin, propylene glycol and sodium."

What Landulosin looks like and contents of the pack

Landulosin is an elongated, gelatin hard capsule measuring approximately 24.2 mm x 7.7 mm, with a brown body and a beige cap, printed with black ink with the code C001.
Each hard capsule contains modified-release tamsulosin pellets and one gelatin soft capsule containing dutasteride.
The medicine is available in packs containing 30 capsules.

Marketing Authorization Holder
G.L. Pharma GmbH
Schlossplatz 1,
8502 Lannach,
Austria

Manufacturer
G.L. Pharma GmbH
Schlossplatz 1,
8502 Lannach,
Austria

Laboratorios LEÓN FARMA, S.A.
C/La Vallina, s/n, Polígono Industrial Navatejera
Villaquilambre-24193 (León)
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Aglandut
Denmark: Dutasterid/Tamsulosinhydrochlorid G.L. Pharma
Lithuania: Dutamsin
Poland: Landulosin
Slovakia: Aglandin
Hungary: Aglandin

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:
G.L. PHARMA POLAND Sp. z o.o.
Sienna 75 Street; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]