Ranlosin Xr

Leaflet attached to the packaging: Patient Information

Ranlosin XR, 0.4 mg, prolonged-release tablets

Tamsulosin hydrochloride
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Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Ranlosin XR and what is it used for

The active substance of Ranlosin XR is tamsulosin. Tamsulosin is a selective alpha-1 adrenergic receptor antagonist. It reduces the tension of the smooth muscles of the prostate gland (prostate) and the urethra, facilitating the flow of urine through the urethra and urination. Additionally, tamsulosin reduces the feeling of urgency to urinate. Ranlosin XR is used to treat the symptoms of lower urinary tract disorders associated with prostate enlargement (benign prostatic hyperplasia). These symptoms include: difficulty urinating (weak stream), urinating in drops, sudden urge to urinate, and increased frequency of urination both at night and during the day.

2. Important information before using Ranlosin XR

When not to use Ranlosin XR

• If the patient is allergic (hypersensitive) to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden local swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and rash (angioedema).
• If the patient has severe liver impairment.
• If the patient experiences blood pressure drops (causing dizziness and fainting) when standing up from a sitting or lying position.

Warnings and precautions

Before starting to use Ranlosin XR, the patient should discuss it with their doctor or pharmacist.

• Regular medical check-ups are necessary to determine the degree of development of the disease being treated.
• Rarely, as with other medicines in the same group, fainting may occur. If symptoms such as dizziness or weakness occur, the patient should sit or lie down until the symptoms pass.
• If the patient has severe kidney disease, they should inform their doctor.
• If the patient is scheduled to undergo eye surgery for cataracts, they should inform their ophthalmologist that they are taking, have taken, or plan to take Ranlosin XR. The doctor will then be able to take appropriate precautions regarding treatment and surgical technique. The patient should ask their doctor if it is necessary to stop taking the medicine or temporarily discontinue it in connection with the cataract surgery.

Children and adolescents

Ranlosin XR should not be used in children and adolescents under 18 years of age, as it is not effective in this population.

Ranlosin XR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Taking Ranlosin XR with other medicines in the same group (alpha-1 adrenergic receptor antagonists) may result in unintended lowering of blood pressure. It is especially important to inform the doctor if the patient is taking medicines that may reduce the elimination of Ranlosin XR from the body (e.g., ketoconazole, erythromycin).

Ranlosin XR with food, drink, and alcohol

Ranlosin XR can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

Pregnancy and breastfeeding: Not applicable, as Ranlosin XR is not intended for use in women. Fertility: There have been reports of ejaculation disorders in men. This means that semen does not flow through the urethra but instead flows back into the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or does not occur. These symptoms are not harmful to the patient.

Driving and using machines

The effect of Ranlosin XR on the ability to drive and use machines has not been proven. However, the patient should be aware of the possibility of dizziness. In such cases, the patient should not perform tasks that require concentration and attention.

3. How to use Ranlosin XR

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose for adults and the elderly is one tablet per day. The medicine can be taken independently of meals. The tablet should be taken whole, without being chewed or crushed. Ranlosin XR is a tablet designed to release the active substance gradually and evenly after swallowing. The remains of the tablet may appear in the stool. There is no reason to suspect that the tablet is ineffective, as the active substance has already been released from the tablet. Ranlosin XR is usually prescribed for long-term use. The effect on the bladder and urination persists during long-term use of Ranlosin XR.

Using a higher dose of Ranlosin XR than recommended

Taking too high a dose may lead to unintended, sudden lowering of blood pressure and increased heart rate with a feeling of weakness. If the patient has taken too many Ranlosin XR tablets, they should contact their doctor immediately.

Missing a dose of Ranlosin XR

If a tablet is missed, the patient can take it later on the same day. If more than a day has passed since missing the tablet, the patient should continue with the daily dose from the next day. The patient should not take a double dose to make up for the missed dose.

Stopping the use of Ranlosin XR

If the treatment is stopped earlier than recommended, the symptoms of the disease may recur. Therefore, the patient should use Ranlosin XR for as long as their doctor has prescribed, even if the symptoms have disappeared. Stopping the treatment should always be consulted with the doctor. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ranlosin XR can cause side effects, although not everybody gets them.

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

• Dizziness, especially when sitting or standing up.
• Ejaculation disorders. Ejaculation disorders mean that semen does not flow through the urethra but instead flows back into the bladder (retrograde ejaculation) or the volume of ejaculate is reduced or does not occur. This phenomenon is not harmful.

Uncommon (may affect up to 1 in 100 people):

• Headache, palpitations (feeling of rapid heartbeat), low blood pressure felt, for example, when changing position from lying to sitting or standing, and sometimes associated with dizziness, nasal congestion, diarrhea, nausea and vomiting, constipation, feeling of weakness (asthenia), rash, itching, and hives.

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

• Fainting and sudden, local swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and rash (angioedema), often as a result of an allergic reaction.

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

• Priapism (unwanted, painful, and prolonged erection, which requires immediate treatment).
• Rash, inflammation, and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome).

Frequency not known (frequency cannot be estimated from the available data):

• Blurred vision.
• Visual disturbances.
• Nosebleeds.
• Severe skin reactions (erythema multiforme, exfoliative dermatitis),
• Abnormal, irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).
• If the patient is scheduled to undergo eye surgery for cataracts or increased eye pressure (glaucoma) and is taking or has taken Ranlosin XR, it should be considered that the patient's pupil may not dilate properly, and the iris may become flaccid during the procedure.
• Dryness in the mouth.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, PL-02-222 Warszawa, Tel.: +48 22 49 21 301, Faks: +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, more information can be gathered on the safety of the medicine.

5. How to store Ranlosin XR

The medicine should be stored out of sight and reach of children. Do not use Ranlosin XR after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Ranlosin XR contains

The active substance of Ranlosin XR is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride. The other ingredients are: tablet core: macrogol 7,000,000; microcrystalline cellulose type 200, colloidal silica anhydrous, magnesium stearate coating: hypromellose HPMC 2910, titanium dioxide (E 171), macrogol 8000, yellow iron oxide (E 172)

What Ranlosin XR looks like and contents of the pack

Ranlosin XR 0.4 mg prolonged-release tablets are yellow, film-coated, round (9 mm in diameter), biconvex, with a score line on one side. The packaging contains 30, 90, or 120 prolonged-release tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o. ul. Ostrzykowizna 14A 05-170 Zakroczym tel.: (+48)(22) 785 27 60 faks: (+48)(22) 785 27 60 wew. 106

Manufacturer:

Adamed Pharma S.A. ul. Marszałka Józefa Piłsudskiego 5 95-200 Pabianice

Date of last revision of the leaflet: