Sebrane 0.4 mg prolonged-release hard capsules EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Sebrane 0.4 mg prolonged-release hard capsules EFG
Tamsulosin hydrochloride
Read all of this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms, as it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, including any side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- What Sebrane is and what it is used for
- What you need to know before taking Sebrane
- How to take Sebrane
- Possible side effects
- How to store Sebrane
- Contents of the pack and other information
1. What Sebrane is and what it is used for
The active substance in Sebrane is tamsulosin hydrochloride. It is a selective antagonist of alpha1A/1D adrenergic receptors. It reduces the tone of smooth muscles in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it decreases the sensation of urgency.
Sebrane is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These are symptoms such as: difficulty urinating (weak urine stream), dribbling, urgency, and frequent need to urinate both during the day and at night.
2. What you need to know before taking Sebrane
Do not take Sebrane:
- If you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of soft tissues in the body (for example, throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).
- If you have severe liver impairment.
- If you experience fainting upon changing posture (standing up or sitting up) due to low blood pressure.
Warnings and precautions
Consult your doctor before starting to take Sebrane.
- Periodic medical examinations are necessary to monitor the progression of the condition being treated.
- Fainting may rarely occur during treatment with tamsulosin, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms resolve.
- If you have severe kidney problems, consult your doctor.
- If you are scheduled for or undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), please inform your ophthalmologist if you are currently taking or have previously taken Sebrane. This is because Sebrane may cause complications during surgery. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should delay or temporarily discontinue taking this medicine if you are undergoing eye surgery due to lens opacity (cataract) or increased eye pressure (glaucoma).
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as there is no specific indication for the use of Sebrane in this age group and its efficacy has not been established in this population.
Other medicines and Sebrane
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines (e.g., blood clot preventers such as warfarin, known as anticoagulants, and anti-inflammatory drugs such as diclofenac) may affect the effects of tamsulosin. Therefore, you may only take this medicine with other medicines if your doctor permits it.
Pregnancy, breastfeeding and fertility
Sebrane is not indicated for use in women.
In men, cases of abnormal ejaculation (ejaculation disorders) have been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the volume of ejaculated semen is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.
Driving and use of machines
Sebrane may have a negative effect on the ability to use machines. It should be noted that dizziness may occur in some patients.
Sebrane contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release hard capsule, i.e., essentially "sodium-free".
3. How to take Sebrane
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.
If your doctor has not prescribed a different regimen, the recommended dose is one capsule per day, to be taken after breakfast or after the first meal of the day.
The capsule must be swallowed whole without breaking or chewing.
If you take more Sebrane than you should
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested, as consequences may require medical intervention.
Taking too much Sebrane may lead to an undesirable drop in blood pressure and an increased heart rate, accompanied by a feeling of fainting.
If you forget to take Sebrane
Take the missed capsule on the same day. If this is not possible, do not take a double dose the next day to make up for the missed doses; simply resume taking one capsule per day.
If you stop taking Sebrane
Do not stop taking it without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Do not be alarmed by this list of possible adverse effects — you may not experience any of them. Most patients do not notice any adverse effects. However, if you do notice any and they bother you, please inform your doctor.
If you start feeling dizzy or lightheaded, sit or lie down until you feel better.
Common (may affect up to 1 in 10 people):
- Dizziness, especially when getting up from a chair or bed
- Ejaculation disorder
- Retrograde ejaculation (ejaculation into the bladder)
- Inhibited ejaculation
Uncommon (may affect up to 1 in 100 people):
- Headache
- Tachycardia (faster than normal heartbeat)
- Sudden drop in blood pressure, especially upon standing
- Nasal congestion or continuous mucus production
- Constipation
- Diarrhea
- Nausea
- Vomiting
- Rash
- Urticaria (hives)
- Itching
- Weakness
Rare (may affect up to 1 in 1,000 people):
- Fainting
- Swelling of the deep layers of the skin, often around the mouth or involving the mucosa of the mouth or throat, which may occur very rapidly
Very rare (may affect up to 1 in 10,000 people):
- Priapism (a painful, persistent, involuntary penile erection), in which case you must seek immediate medical attention.
- A severe inflammatory skin and mucosal rash, an allergic reaction to drugs or other substances known as Stevens-Johnson syndrome.
Frequency not known (cannot be estimated from available data):
- Nosebleeds
- Blurred vision, visual impairment
- Dry mouth
- Severe skin rashes (erythema multiforme, exfoliative dermatitis)
If you are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), and you are currently taking or have previously taken tamsulosin, your pupil may dilate poorly during surgery and the iris (the circular colored part of the eye) may become floppy (see also section 2 “Warnings and precautions”).
In addition to the adverse events listed above, the following have been reported with the use of Sebrane:
- Very rapid and uncoordinated contractions of the heart,
- Irregular heartbeat,
- Abnormally fast heart rate, and
- Difficulty breathing.
As these events have been reported spontaneously from post-marketing experience worldwide, their frequency and the causal role of tamsulosin cannot be reliably determined.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sebrane
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Sebrane
The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
The other components are:
- capsule contents:
microcrystalline cellulose (E-460), methacrylic acid-ethyl acrylate copolymer 1:1 (containing: polysorbate and sodium lauryl sulfate), talc, triethyl citrate, calcium stearate
- capsule shell:
yellow iron oxide (E-172), black iron oxide (E-172), red iron oxide (E-172), titanium dioxide (E-171), gelatin
Appearance of the product and contents of the pack
The capsules are opaque, with one part beige and the other brown. Each capsule contains white or pale white granules.
30, 90 or 100 capsules are packed in PVC/PVDC/aluminum blisters and presented in a cardboard box.
Only some pack sizes may be commercially available.
Marketing Authorization Holder:
Biowise Pharmaceuticals, S.L.
C/Teixidors, 22. Polígono Can Rubiol
07141 Marratxí, Spain
Manufacturer:
Gedeon Richter Plc.
1103 Budapest, Gyömroi út 19-21
Hungary
or
TOLL MANUFACTURING SERVICES, S.L.
C/ Aragoneses, 2
28108 Alcobendas, (Madrid)
This medicinal product is authorized in the European Economic Area member states under the following names:
Spain - Sebrane 0.4 mg prolonged-release hard capsules EFG
Hungary - Tamsulosin-Richter 0.4 mg retard kemény kapszula
Date of the most recent review of this leaflet: November 2022
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es