Package Insert: Information for the Patient
Tamsulosin Kern Pharma 0.4 mg Modified Release Hard Capsules EFG
tamsulosin hydrochloride
Read this package insert carefully before you start taking this medicine, because it contains important information for you.
The active ingredient of this medication is tamsulosina. It is a selective antagonist of adrenergic receptors α1A/1D. It reduces the tension of the smooth muscles of the prostate and the urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.
This medication is used in men for the treatment of lower urinary tract discomfort associated with an enlarged prostate gland (benign prostatic hyperplasia). It is used to treat discomforts such as: difficulty urinating (weak urine stream), dripping, urgency, and the need to urinate frequently both at night and during the day.
Do not take Tamsulosina Kern Pharma:
Warnings and precautions
Consult your doctor or pharmacist before starting to take tamsulosina:
Children and adolescents
Do not administer this medication to children or adolescents under 18 years old because it does not work in this population.
Other medications and Tamsulosina Kern Pharma
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
The use of tamsulosina with other medications of the same group (alpha1 adrenergic receptor antagonists) may produce an undesirable drop in blood pressure.
It is especially important to inform your doctor if you are being treated at the same time with medications that can reduce the elimination of tamsulosina from the body (e.g., ketoconazole, erythromycin).
Taking Tamsulosina Kern Pharma with food and drinks
Tamsulosina should be taken after breakfast or the first meal of the day.
Pregnancy, breastfeeding, and fertility
This section is not relevant, as tamsulosina is intended only for male patients.
In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release from the body through the urethra, but rather goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.
Driving and using machines
There is no evidence that tamsulosina affects the ability to drive or use tools or machines. However, you should be aware that dizziness may occur, in which case you should not perform activities that require attention.
Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is 1 capsule per day and it should be taken after breakfast or after the first meal of the day. The capsule should be swallowed whole and not broken or chewed. Tamsulosina is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosina.
If you take more Tamsulosina Kern Pharma than you should
Taking too much tamsulosina may lead to an undesirable drop in blood pressure and an increase in heart rate, with a sensation of dizziness.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to take Tamsulosina Kern Pharma
If you have forgotten to take tamsulosina as recommended, you can take your daily dose of tamsulosina later in the same day. If you have missed a dose one day, you can simply continue taking your daily capsule as prescribed. Do not take a double dose to compensate for the missed doses.
If you interrupt the treatment with Tamsulosina Kern Pharma
When treatment with tamsulosina is discontinued prematurely, your original discomforts may return. Therefore, take tamsulosina for the entire time your doctor prescribes it, even if your discomforts have disappeared. Consult your doctor at all times if you decide to discontinue treatment.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking your medicine and seek medical help immediately if you experience any of the following allergic reactions:
Frequent (may affect up to 1 in 10 patients):
Less frequent (may affect up to 1 in 100 patients):
Rare (may affect up to 1 in 1,000 patients):
Very rare (may affect up to 1 in 10,000 patients):
Frequency unknown (cannot be estimated from available data)
If you are undergoing eye surgery due to a cataract opacity and are taking or have taken tamsulosin hydrochloride, the pupil may dilate slightly and the iris (the colored part of the eye) may become flaccid during the procedure (see section 2 "Warnings and precautions").
In addition to the side effects listed above,
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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
This medication does not require special conditions for conservation.
Do not use this medication after the expiration date that appears on the blister, bottle, and box after “CAD”. The expiration date is the last day of the month indicated.
Medications should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.
Tamsulosina Kern Pharma Composition
Each capsule contains 0.4 mg of tamsulosin hydrochloride.
Pellets: Copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30%*, microcrystalline cellulose, dibutyl sebacate, polysorbate 80 (E433).
Coating material:Copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30%*, dibutyl sebacate, polysorbate 80 (E433), hydrated colloidal silica.
Calcium stearate
Durable gelatin capsule:Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), indigo carmine (E132), gelatin.
*The dispersion contains 0.7% of sodium lauryl sulfate Ph.Eur / NF and 2.3% Polysorbate 80 Ph.Eur / NF in solid substance, as emulsifiers.
Product appearance and packaging content
The PVC/PVdC-aluminum blisters contain 10, 20, 30, 50, 90, or 100 capsules.
The pre-cut single-dose PVC/PVdC-aluminum blisters contain 10 x 1, 20 x 1, 30 x 1, 50 x 1, 90 x 1, or 100 x 1 capsules.
The HDPE bottles contain 30, 35, 50, 60, 90, 100, 112, or 200 capsules.
Only some packaging sizes may be commercially available.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder:
Kern Pharma, S.L.
Venus, 72 - Pol. Ind.Colón II
08228 Terrassa – Barcelona
Spain
Responsible manufacturer:
Avda. Miralcampo, No. 7
Pol. Ind. Miralcampo, 19200
Azuqueca de Henares, Guadalajara
Spain
This medicine is authorized in the member states of the European Economic Area with the following names:
Denmark - Tamsulosin "Liconsa", hard capsules with modified release
France - TAMSULOSINE LICONSA LP 0.4 mg, prolonged-release gelatin capsule
Romania - TAMSULOSIN LICONSA 0.4 mg caps
Spain – Tamsulosina Kern Pharma 0.4 mg hard capsules with modified release EFG
Portugal – Tansulosina Pharmakern 0.4 mg hard-release capsules
Ireland -Tamsulosin hydrochloride 0.4 mg modified release capsules, hard
Last review date of this leaflet: May 2024
The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/.
The average price of Tamsulosina kern pharma 0,4 mg capsulas duras de liberacion modificada efg in July, 2025 is around 10.96 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.