Ranlosin

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Ranlosin, 0.4 mg, prolonged-release capsules

(tamsulosin hydrochloride)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 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, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS RANLOSIN AND WHAT IS IT USED FOR

The active substance of Ranlosin 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 pressure on the bladder.
Ranlosin is used to treat the symptoms of lower urinary tract disorders associated with an enlarged prostate gland (benign prostatic hyperplasia).
These symptoms include: difficulty urinating (weak stream), urinating in drops, pressure on the bladder, and increased frequency of urination both at night and during the day.

2. IMPORTANT INFORMATION BEFORE TAKING RANLOSIN

When not to take Ranlosin

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of the medicine (listed in section 6). Hypersensitivity may manifest as sudden swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and rash (angioedema).
• If you have severe liver impairment.
• If you have low blood pressure (when standing up from a sitting or lying position) that causes dizziness and fainting.

Warnings and precautions

Before starting to take Ranlosin, discuss it with your doctor or pharmacist.

• Regular medical check-ups are necessary to determine the progression of the disease being treated.
• Before starting treatment, inform your doctor about any other diseases you have.
• Rarely, as with other medicines in the same group, fainting may occur. If symptoms such as dizziness or weakness occur, sit or lie down until they pass.
• If you have severe kidney or liver disease, inform your doctor.
• If you are scheduled to undergo eye surgery for cataracts or glaucoma, inform your ophthalmologist that you are taking, have taken, or plan to take Ranlosin. Ranlosin may cause complications (intraoperative floppy iris syndrome, IFIS) during surgery. The specialist will then be able to take appropriate precautions regarding treatment and surgical technique. Ask your doctor if it is necessary to stop taking the medicine or temporarily discontinue it in connection with cataract or glaucoma surgery.

Children and adolescents

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

Ranlosin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
In particular, inform your doctor or pharmacist if you are taking:

• Diclofenac (an anti-inflammatory and analgesic) and/or warfarin (an anticoagulant).
• Medicines that may affect the level of tamsulosin in the blood, such as verapamil or diltiazem (blood pressure lowering), ritonavir and/or indinavir (used to treat HIV infection), ketoconazole, itraconazole, or erythromycin (used to treat fungal or bacterial infections).

Taking Ranlosin with other medicines in the same group (alpha-1 adrenergic receptor antagonists), such as doxazosin, indoramin, prazosin, or alfuzosin, may cause unintended lowering of blood pressure.
It is especially important to inform your doctor if you are taking medicines that may reduce the excretion of Ranlosin from the body (e.g., ketoconazole, erythromycin).
Other medicines can be taken with Ranlosin only with the doctor's consent.

Ranlosin with food, drink, and alcohol

Ranlosin should be taken after breakfast or after the first meal of the day.

Pregnancy, breastfeeding, and fertility

This does not apply, as Ranlosin is not intended for use in women.
In men, sexual function disorders have been observed after taking tamsulosin.

Driving and using machines

The effect of Ranlosin on the ability to drive and use machines has not been proven.
However, you should be aware of the possibility of dizziness. In this case, do not perform tasks that require attention.

Ranlosin contains orange yellow, azorubine, and cochineal red

Allergic reactions may occur due to the dyes present in this medicine: orange yellow (E110), azorubine (E122), and cochineal red (E124).

Ranlosin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. HOW TO TAKE RANLOSIN

This medicine should always be taken as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Usually, the recommended dose is one capsule per day, after breakfast or after the first meal of the day. The capsule should be taken while standing or sitting (not lying down), with a glass of water. The capsule should be taken whole, without chewing or crushing, as this would disrupt the slow release of the active substance.
Ranlosin is usually prescribed for long-term use. The effect on the bladder and urination is maintained during long-term use.

Taking a higher dose of Ranlosin than recommended

Taking too high a dose may lead to unwanted lowering of blood pressure and increased heart rate with a feeling of weakness. If you have taken too many Ranlosin capsules, contact your doctor immediately.

Missing a dose of Ranlosin

If you miss a capsule, you can take it later that day. If a day has passed, continue with the daily dose from the next day. Do not take a double dose to make up for the missed dose.

Stopping treatment with Ranlosin

If treatment is stopped earlier than recommended, the symptoms of the disease may return.
Therefore, you should take Ranlosin for the entire treatment period, as recommended by your doctor, even if the symptoms have disappeared. Stopping treatment should always be consulted with your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Severe side effects are rare or very rare. You should stop taking the medicine if you experience any of the following symptoms – you may need

medical attention:

• sudden local swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash, often in the form of an allergic reaction(angioedema) (may occur in less than 1 in 1,000 patients).
• priapism (painful, prolonged, involuntary erection of the penis), in which case immediate medical attention is required (may occur in less than 1 in 10,000 patients).
• severe skin and mucous membrane inflammation, which is an allergic reaction to medicines or other substances, called Stevens-Johnson syndrome (may occur in less than 1 in 10,000 patients).
• severe skin rashes (erythema multiforme, exfoliative dermatitis) (frequency cannot be estimated from available data).

The following side effects have also been reported:

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

• Dizziness, especially when sitting or standing up.
• Ejaculation disorders.
• Retropulsion: this means that semen does not flow through the urethra but flows back into the bladder. This phenomenon is not a threat.
• Absence of ejaculation.

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

• Headache.
• Palpitations (feeling of rapid heartbeat).
• Low blood pressure felt when changing position from lying to sitting or standing, sometimes associated with dizziness.
• Rhinitis or feeling of a blocked nose (inflammation of the nasal mucosa).
• Diarrhea, nausea, and vomiting.
• Constipation, feeling of weakness, rash, itching, and urticaria.

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

• Fainting.
• Weakness.

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

• Blurred vision, vision disturbances.
• Nosebleeds.
• Dry mouth.
• Irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).
• If you are scheduled to undergo eye surgery for cataracts or glaucoma and you are taking or have taken Ranlosin in the past, consider that your pupil may not dilate properly and the iris (the colored, round part of the eye) may become flaccid during the procedure.

During eye surgery for cataracts or glaucoma, if you are taking or have recently taken Ranlosin, the pupil may not dilate properly and the iris (the colored, round part of the eye) may become flaccid.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, 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 .
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 RANLOSIN

Keep the medicine out of the sight and reach of children.
No special precautions are required for storing the medicine.
Do not use Ranlosin after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ranlosin contains

The active substance of Ranlosin is tamsulosin hydrochloride. Ranlosin contains 400 micrograms of tamsulosin hydrochloride.
The other ingredients are:
Capsule content: microcrystalline cellulose (PH101), magnesium stearate, methacrylic acid and ethyl acrylate copolymer (1:1), sodium hydroxide, triacetin, titanium dioxide (E171), talc.
Capsule: gelatin, orange yellow (E110), cochineal red (E124), quinoline yellow (E104), titanium dioxide (E171), iron oxide yellow (E172), brilliant blue FCF (E133), azorubine (E122).
Ink: shellac, iron oxide black (E172), potassium hydroxide.

What Ranlosin looks like and contents of the pack

Ranlosin 0.4 mg prolonged-release capsules consist of a light brown cap and an orange body, size "2". They are printed with black edible ink "R" on the cap and "TSN400" on the body. They contain white to off-white granules.
The pack contains 14, 30, or 90 prolonged-release capsules.
Not all pack sizes may be marketed.

Marketing authorization holder:

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
tel.: (+48)(22) 785 27 60
fax: (+48)(22) 785 27 60 ext. 106

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands
Terapia, S.A.
124, Fabricii Street
400632 Cluj Napoca
Cluj county, Romania

Date of last revision of the leaflet:

• 22.09.2022