Landulosin

Leaflet included in the packaging: information for the user

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Landulosin and what is it used for

Landulosin is used to treat an enlarged prostate(benign prostatic hyperplasia)- a non-cancerous enlargement of the prostate 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 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 or reduce its size.
Dutasteride reduces the production of the hormone dihydrotestosterone, which causes the prostate to shrink and alleviates symptoms. By doing so, dutasteride reduces the risk of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscles in the prostate, making it easier for urine to flow and providing quick relief from symptoms.

2. Important information before taking Landulosin

When not to take Landulosin

• in women, this medicine is only intended for men)
• in children and adolescents under 18 years of age
• if you are allergic to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, soy, or peanuts, or any of the other ingredients of this medicine (listed in section 6).
• if you have orthostatic hypotension (a drop in blood pressure that may cause dizziness, lightheadedness, or fainting).
• in severe liver disease.If any of these situations apply to you, do not take this medicine without consulting your doctor first.

Warnings and precautions

You should discuss the use of Landulosin with your doctor before starting treatment.

• 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 Landulosin.
• 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 Landulosin for a certain period before the operation. You should inform your eye doctor if you are taking or have taken Landulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould not handle damaged Landulosin capsules, as the active substance may be absorbed through the skin. If contact with the skin occurs, the affected area should be washed immediately with soap and water.
• You should use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Landulosin. If your partner is pregnant or may become pregnant, you should avoid exposing her to your semen, as dutasteride may affect the development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility, which may lead to reduced fertility.
• Landulosin may affect 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 are having a PSA test, you should inform your doctor that you are taking Landulosin. PSA levels should be regularly monitored in patients taking Landulosin.
• In a clinical trial involving men with a high risk of prostate cancer, prostate cancer was diagnosed more frequently in men taking dutasteride than in men not taking dutasteride. The effect of dutasteride on the risk of developing prostate cancer is not clear.
• Landulosin may cause breast enlargement and tenderness.If this becomes 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 further questions about the use of Landulosin, you should consult your doctor or pharmacist.

Landulosin and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those available without a prescription.

• other alpha-adrenergic receptor antagonists(used to treat enlarged prostate 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, which may increase the risk of side effects. These medicines 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 pain and inflammation) You should inform your doctor if you are taking any of these medicines.

Landulosin with food

Landulosin should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Landulosin must not be taken by women.

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

Dutasteride is absorbed through the skin and may affect 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 Landulosin. If your partner is pregnant or may become pregnant, you should avoid exposing her to your semen.
It has been shown that the combination of dutasteride and tamsulosin reduces sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.
If a pregnant woman has come into contact with Landulosin, she should consult her doctor.

Driving and using machines

Landulosin may cause dizziness in some patients, which may affect their ability to drive or operate machinery.
If you experience such symptoms, you should not drive or operate machinery.

Landulosin contains soy lecithin, propylene glycol, and sodium

The medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, you should not take this medicinal product.
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means that it is essentially 'sodium-free'.
The medicine contains 229 mg of propylene glycol in each capsule.

3. How to take Landulosin

This medicine should always be taken exactly as advised by your doctor or pharmacist.

If you do not take the medicine regularly, it may affect the results of your PSA tests.
If you are unsure, you should ask your doctor or pharmacist.

How much to take

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

How to take the medicine

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

Taking more than the recommended dose of Landulosin

If you take more than the recommended dose of Landulosin, you should consult your doctor or pharmacist.

Missing a dose of Landulosin

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

Stopping treatment with Landulosin

You should not stop taking the medicine without consulting your doctor first.
If you have any further questions about the use of this medicine, you should ask 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
• swelling of the eyelids, face, lips, hands, or feet You should contact your doctor immediately and stop taking Landulosin if you experience any of these symptoms.

Dizziness, lightheadedness, and fainting

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

Severe skin reactions

Symptoms of severe skin reactions may include:

• widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome) You should contact your doctor immediately and stop taking Landulosin if you experience such symptoms.

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

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

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

• heart failure (the heart does not pump blood properly, which may cause shortness of breath, extreme tiredness, and swelling of the ankles and feet)
• low blood pressure when standing up
• rapid heartbeat (palpitations)
• constipation, diarrhea, vomiting, nausea
• weakness or loss of strength
• headache
• runny nose, stuffy nose, or sinusitis (inflammation of the nasal passages)
• skin rash, hives, or itching
• hair loss (usually affecting body hair) or excessive hair growth Rare side effects(may affect up to 1 in 1,000 people)
  • swelling of the eyelids, face, lips, arms, or legs (angioedema)
  • fainting

  Very rare side effects(may affect up to 1 in 10,000 people)

  • prolonged and painful erection (priapism)
  • severe skin reactions (Stevens-Johnson syndrome)

  Other side effects

  Other side effects have been reported in a small number of men, but the frequency of these side effects is not known (cannot be estimated from the available data)

  • abnormal or rapid heart rhythm (arrhythmia, tachycardia, or atrial fibrillation)
  • shortness of breath (dyspnea)
  • depression
  • testicular pain or swelling
  • nosebleeds
  • severe skin rash
  • vision problems (blurred vision or difficulty seeing)
  • dry mouth

  Reporting side effects

  If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the:

  Department of Drug Safety, 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
  Side effects can also be reported 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 Landulosin

  The medicine should be kept out of the sight and reach of children.
  Do not use this medicine after the expiry date stated on the carton and blister after EXP.
  The expiry date refers to the last day of the month.
  This medicine does not require any special storage conditions.
  Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the packaging and other information

  What Landulosin contains

  • The active substances of Landulosin 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:
  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
  Soy lecithin (see section 2)
  Tamsulosin pellets:
  Methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% (contains sodium lauryl sulfate and polysorbate 80)
  Microcrystalline cellulose
  Dibutyl sebacate
  Polysorbate 80
  Silica, colloidal, hydrated
  Calcium stearate
  Black ink:
  Shellac
  Black iron oxide (E 172)
  Propylene glycol
  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 a hard, gelatin capsule, approximately 24.2 mm x 7.7 mm in size, with a brown body and a beige cap, printed with black ink with the code C001.
  Each hard capsule contains tamsulosin pellets with modified release and one soft gelatin capsule of dutasteride.
  Landulosin is available in packs of 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, SA
  C/La Vallina, s/n, Polígono Industrial Navatejera
  Villaquilambre-24193 (León)
  Spain

  This medicine is authorized in the Member States of the European Economic Area 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, you should contact the local representative of the marketing authorization holder:

  G.L. PHARMA POLAND Sp. z o.o.
  ul. Sienna 75; 00-833 Warsaw, Poland
  Phone: 022/ 636 52 23; 636 53 02
  [email protected]

  Date of last revision of the leaflet: