Ranlosin xr

Package leaflet: Information for the patient

Ranlosin XR, 0.4 mg, prolonged-release tablets
Tamsulosini hydrochloridum

Please read this leaflet carefully before taking this medicine, because
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 pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Ranlosin XR is and what it is used for
The active substance in Ranlosin XR is tamsulosin. Tamsulosin is a selective α-adrenergic receptor antagonist. It reduces the tone of smooth muscles in the prostate gland and urethra, facilitating urine flow through the urethra and urination. Additionally, tamsulosin reduces the sensation of urinary urgency.
Ranlosin XR is used in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (enlarged prostate).
These symptoms include: difficulty in urination (weak stream), dribbling of urine, sudden urgency to urinate, and increased frequency of urination both during the night and during the day.

2. Important information before taking Ranlosin XR

When not to take Ranlosin XR

• If you are 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 in breathing and/or itching and rash (angioedema).
• If you have severe hepatic impairment.
• If you experience drops in blood pressure (causing dizziness and fainting) upon standing up from a sitting or lying position.

Warnings and precautions
Before starting treatment with Ranlosin XR, discuss this with your doctor or pharmacist.

• Regular medical check-ups are necessary to monitor the progression of the condition being treated.
• Rarely, as with other medicines in this class, fainting may occur. If symptoms such as dizziness or weakness occur, sit or lie down until symptoms subside.
• If you have severe kidney disease, inform your doctor.
• If you are scheduled for eye surgery due to cataract (lens opacity), inform your ophthalmologist that you are currently taking, have previously taken, or plan to take Ranlosin XR. The specialist will then be able to take appropriate precautions regarding treatment and surgical technique. Ask your doctor whether you need to stop or temporarily interrupt taking Ranlosin XR prior to 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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Concomitant use of Ranlosin XR with other medicines from the same class (α-adrenergic receptor antagonists) may result in unintended lowering of blood pressure.
It is particularly important to inform your doctor if you are 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 regardless of meals.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
Not applicable, as Ranlosin XR is not intended for use in women.

Fertility
Cases of ejaculation disorders in men have been reported. This means that semen does not exit through the urethra but instead flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or ejaculation 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 operate machinery has not been established. However, bear in mind the possibility of dizziness occurring. In such a case, do not perform activities requiring concentration and attention.

3. How to take Ranlosin XR
Always take this medicine exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
The recommended dose for adults and elderly patients is one tablet per day. The medicine may be taken regardless of meals.
The tablet should be swallowed whole and must not be chewed or crushed.
Ranlosin XR is a tablet designed to release the active substance gradually and evenly after swallowing. Tablet remnants may appear in the stool. There is no reason to suspect that the tablet was ineffective, as the active substance has already been released from the tablet earlier.
Ranlosin XR is usually prescribed for long-term use. The effect on the urinary bladder and urination persists during prolonged treatment with Ranlosin XR.

Taking more Ranlosin XR than recommended
Taking an excessive dose may lead to unwanted, sudden lowering of blood pressure, increased heart rate, and a feeling of weakness. If you have taken too many Ranlosin XR tablets, contact your doctor immediately.

If you forget to take Ranlosin XR
If you miss a dose, you may take it later the same day. If more than 24 hours have passed since the missed dose, continue with the next day's daily dose. Do not take a double dose to make up for the missed dose.

Stopping Ranlosin XR
If treatment is stopped earlier than recommended, symptoms may recur. Therefore, continue taking Ranlosin XR for as long as your doctor has advised, even if symptoms have improved. Always consult your doctor before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.

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

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

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

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

Rare (may affect up to 1 in 1,000 patients):

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

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

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

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

• Blurred vision.
• Visual disturbance.
• Nosebleeds.
• Severe skin reactions (erythema multiforme, exfoliative dermatitis).
• Irregular, abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea).
• If a patient is scheduled for eye surgery due to cataract or elevated intraocular pressure (glaucoma), and the patient is currently taking or has previously taken Ranlosin XR, it should be considered that the patient's pupil may not dilate properly and the iris (the coloured, circular part of the eye) may become floppy during the procedure.
• Dryness of the mouth.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can 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 181 C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ranlosin XR

Keep this medicine out of sight and reach of children.
Do not use Ranlosin XR after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ranlosin XR contains
The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride.
The other ingredients are:
Tablet core: polyethylene glycol 7 000 000; microcrystalline cellulose type 200, colloidal anhydrous silica, magnesium stearate
Coating: hypromellose HPMC 2910, titanium dioxide (E 171), polyethylene glycol 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, coated, round (9 mm in diameter), biconvex, with an engraving "04" on one side.
The pack contains 30, 90 or 120 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
LEK-AM Sp. z o.o. Pharmaceutical Company
ul. Ostrzykowizna 14A
05-170 Zakroczym
tel.: (+48)(22) 785 27 60
fax: (+48)(22) 785 27 60 ext. 106

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