Tamsulosin Stada 0.4 mg modified-release hard capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Tamsulosina Stada 0.4 mg modified-release hard capsules EFG
Tamsulosin hydrochloride
Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to anyone else, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet, see section 4.
Leaflet contents
- What Tamsulosina Stada is and what it is used for
- What you need to know before taking Tamsulosina Stada
- How to take Tamsulosina Stada
- Possible side effects
- How to store Tamsulosina Stada
- Contents of the pack and other information
1. What Tamsulosin Stada is and what it is used for
Tamsulosin is an α1A-adrenergic receptor blocker. It relaxes the muscle tissue of the prostate and urinary tract.
Tamsulosin is prescribed to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). Relaxation of the muscle tissue facilitates the passage of urine, making urination easier.
2. What you need to know before taking Tamsulosina Stada
Do NOT take Tamsulosina Stada:
- If you are allergic to tamsulosin or to any of the other ingredients of this medicine listed in section 6 [symptoms may include swelling of the face and throat (angioedema)].
- If you have a history of low blood pressure upon standing, causing dizziness, lightheadedness, or fainting.
- If you have severe liver impairment.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsulosina Stada:
- If you experience dizziness or lightheadedness, especially when standing up. Tamsulosin may lower your blood pressure, causing these symptoms. You should lie down or sit until the symptoms resolve.
- If you have severe kidney impairment. The standard dose of tamsulosin may not have the expected effect when your kidneys are not functioning properly.
- If you develop swelling of the face or throat. These symptoms indicate angioedema (see section 2, Do NOT take Tamsulosina Stada). Stop taking tamsulosin immediately and contact your doctor. You must not take tamsulosin again.
- If you are scheduled for cataract surgery (loss of vision, especially of the blue color) or glaucoma surgery (increased eye pressure), and you are currently taking or have recently taken tamsulosin, an intraoperative condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur during surgery. IFIS may lead to surgical complications. It is recommended that you discontinue treatment 1–2 weeks before surgery. Please consult your doctor and surgeon in advance to discuss this issue.
Children
Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.
Other medicines and Tamsulosina Stada
Other medicines may be affected by tamsulosin, and they may in turn affect the action of tamsulosin. Tamsulosin may interact with:
- Diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening the time during which tamsulosin is effective.
- Warfarin, a medicine used to prevent blood clots. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening the time during which tamsulosin is effective.
- Medicines to lower your blood pressure, such as verapamil or diltiazem.
- Medicines for the treatment of HIV, such as ritonavir or indinavir.
- Medicines for the treatment of fungal infections, such as ketoconazole or itraconazole.
- Other α1A-adrenergic receptor blockers, such as doxazosin, indoramin, prazosin, or alfuzosin. The combination may lower your blood pressure, causing dizziness or lightheadedness.
- Erythromycin, an antibiotic used to treat infections.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Tamsulosina Stada with food and drink
Take tamsulosin with a glass of water after breakfast or after the first meal of the day.
Pregnancy, breastfeeding, and fertility
Tamsulosin is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.
Driving and using machines
There is no information on the effects of tamsulosin on the ability to drive and use machinery. You should bear in mind that tamsulosin may cause dizziness and lightheadedness. Only drive or operate machinery if you feel well.
Tamsulosina Stada contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per capsule; hence, it is essentially “sodium-free”.
3. How to take Tamsulosin Stada
Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.
The recommended dose is one capsule daily, taken after breakfast or after the first meal of the day.
The capsule should be swallowed whole with a glass of water while sitting or standing (you should not lie down). It is important not to break or crush the capsules, as this may affect the way tamsulosin works.
If you take more Tamsulosin Stada than you should
Your blood pressure may drop suddenly if you take more tamsulosin than you should. You may experience dizziness, lightheadedness, and fainting. Lie down to minimize the effects of low blood pressure and contact your doctor immediately. Your doctor will provide medications to restore your blood pressure and monitor your bodily functions. If necessary, your doctor will empty your stomach and administer a laxative to remove any tamsulosin that has not yet been absorbed.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Tamsulosin Stada
Do not take a double dose to make up for missed doses. Take the next dose at your usual time. If you have any questions about how to use 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.
Frequent (may affect up to 1 in 10 people):
Dizziness, abnormal ejaculation (ejaculation disorders). This means that semen does not leave the body through the urethra, but instead goes into the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (inability to ejaculate). This phenomenon is harmless.
Uncommon (may affect up to 1 in 100 people):
Headache, faster than normal heartbeat (tachycardia), palpitations, drop in blood pressure upon standing, causing dizziness, lightheadedness or fainting (orthostatic hypotension); nasal swelling and irritation (rhinitis), constipation, diarrhoea, nausea, vomiting, rash, itching, urticaria, feeling of weakness (asthenia).
Rare (may affect up to 1 in 1,000 people):
Fainting (syncope), severe allergic reaction causing swelling of the face and throat (angioedema): contact your doctor immediately, you must not take tamsulosin again (see section 2, DO NOT take Tamsulosina Stada).
Very rare (may affect up to 1 in 10,000 people):
Painful erection (priapism), serious illness with blisters on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
Not known (frequency cannot be estimated from available data):
Severe skin rashes (erythema multiforme, exfoliative dermatitis), nosebleeds (epistaxis), blurred vision or vision problems. During cataract or glaucoma surgery, a condition involving a small pupil, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with tamsulosin therapy in post-marketing surveillance (see also section 2, Warnings and precautions), dry mouth.
Additional adverse effects (post-marketing experience):
In addition to the adverse effects described above, abnormal heart rhythm (atrial fibrillation), irregular heartbeats (arrhythmia), and shorter breathing than usual (dyspnoea) have been reported in association with the use of tamsulosin.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tamsulosin Stada
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect it from moisture.
Keep the container tightly closed to protect it from moisture.
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 Tamsulosina Stada
- The active substance is tamsulosin hydrochloride, 0.4 mg.
- The other components are:
Capsule: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate and talc.
Capsule shell: gelatin, indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Appearance of the product and contents of the pack
Modified-release hard capsules, orange/olive green in colour. The capsules contain white or almost white pellets.
They are presented in blisters containing 10, 14, 15, 20, 28, 30, 48, 50, 56, 60, 90, 98, 100 or 200 modified-release capsules or in bottles containing 60 or 250 modified-release capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18,
61118 Bad Vilbel
Germany
or
Synthon Hispania S.L.
Castelló, 1
Polígono las Salinas
08830 Sant Boi de Llobregat (Barcelona)
Spain
or
Eurogenerics N.V.
Heizel Esplanade, Heysel b22,
B-1020 Brussels
Belgium
or
LAMP SAN PROSPERO S.p.A.,
Via della Pace, 25/A
41030 San Prospero – Modena
Italy
Date of the most recent review of this leaflet: January 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/