Tamsulosin Kern Pharma 0.4 mg prolonged-release tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tamsulosina KERN PHARMA 0.4 mg prolonged-release tablets EFG
Tamsulosin hydrochloride
Read the entire leaflet carefully before you start taking this medicine.
- 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Tamsulosina Kern Pharma is and what it is used for
- Before you take Tamsulosina Kern Pharma
- How to take Tamsulosina Kern Pharma
- Possible side effects
- How to store Tamsulosina Kern Pharma
- Further information
1. What TAMSULOSINA KERN PHARMA is and what it is used for
The active substance is tamsulosin. It belongs to a group of medicines called selective α1A/D-adrenergic receptor antagonists. Tamsulosin works by relaxing the muscles in the prostate and the urinary tract. By relaxing these muscles, it allows urine to pass more easily through the urinary tract and facilitates urination. In addition, it reduces the sensation of urgency.
Tamsulosin is prescribed to men for the treatment of urinary symptoms associated with an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), dribbling, urgency, and the need to urinate frequently both during the night and during the day.
2. BEFORE TAKING TAMSULOSIN KERN PHARMA
Do not take Tamsulosin Kern Pharma
- if you are allergic (hypersensitive) to tamsulosin or to any of the other components of this medicine. Hypersensitivity may cause sudden swelling of soft tissues in the body (e.g. throat or tongue), difficulty breathing, and/or itching and rashes (angioedema).
- if you have previously experienced low blood pressure upon standing up from a sitting or lying position, causing dizziness, weakness, or fainting.
- if you have severe liver problems.
Take special care with Tamsulosin Kern Pharma
- if you feel weakness or dizziness, especially after standing up. Tamsulosin may cause a decrease in blood pressure. In such cases, you should sit or lie down until symptoms have disappeared.
- if you have severe kidney problems, inform your doctor.
- if you are scheduled for eye surgery due to lens opacity (cataract). During the procedure, a condition known as "intraoperative floppy iris syndrome" may occur (see section 4). Inform your ophthalmologist that you are currently taking or have previously taken tamsulosin hydrochloride, so that appropriate precautions regarding medication and surgical techniques can be taken.
Consult your doctor whether you should delay or temporarily discontinue taking this medicine prior to undergoing such surgery.
Regular medical check-ups are necessary to monitor the condition being treated.
You may notice tablet residue in your stools. The active ingredient of the tablet will have already been released, so there is no risk that the tablet will be less effective.
Taking other medicines
The effects of other medicines may be affected by taking tamsulosin. Likewise, these medicines may affect the effectiveness of tamsulosin. Tamsulosin may interact with:
- diclofenac, a painkiller and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening the duration of its effect.
- warfarin, an anticoagulant medicine. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening the duration of its effect.
- other alpha-adrenergic receptor blocking medicines. Combining tamsulosin with these medicines may cause a drop in blood pressure, which could lead to dizziness and weakness.
Please inform your doctor or pharmacist if you are currently using or have recently used any of the medicines listed above or any other medicines, including those obtained without a prescription.
Taking Tamsulosin Kern Pharma with food and drinks
Tamsulosin Kern Pharma can be taken with or without food.
Driving and using machines
There is no evidence that tamsulosin affects the ability to drive or operate tools or machinery. However, you should bear in mind that tamsulosin may cause dizziness and weakness. Do not drive or operate machinery if you experience any of these symptoms.
3. HOW TO TAKE TAMSULOSIN KERN PHARMA
Follow exactly the administration instructions for Tamsulosin Kern Pharma provided by your doctor. Consult your doctor or pharmacist if you have any doubts.
The usual dose is one tablet daily. You may take tamsulosin with or without food, preferably always at the same time each day.
The tablet must be swallowed whole and must not be broken or chewed, as this may affect the effectiveness of tamsulosin.
Tamsulosin is not indicated for use in children.
Tamsulosin is usually prescribed for long-term use. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin.
If you feel that the effect of tamsulosin is too strong or too weak, inform your doctor or pharmacist.
If you take more Tamsulosin Kern Pharma than you should
Taking too many tamsulosin tablets may cause a sudden drop in blood pressure. In this case, you may experience dizziness, weakness, vomiting, diarrhoea, and fainting. Lie down to minimize the effects of low blood pressure and contact your doctor immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Tamsulosin Kern Pharma
If you forget to take your tamsulosin as directed, take your daily tablet later the same day. If you forget to take it one day, simply take the next dose as prescribed. Do not take a double dose to make up for the missed dose.
If you stop taking Tamsulosin Kern Pharma
If treatment with tamsulosin is stopped prematurely, symptoms may return. Therefore, take tamsulosin for as long as your doctor instructs, even if your symptoms have already disappeared. Always consult your doctor before stopping this treatment.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Tamsulosina Kern Pharma may cause adverse effects, although not everyone experiences them.
Serious reactions to this medicine are very rare. Contact your doctor immediately if you experience a severe allergic reaction causing swelling of the face or throat (angioedema).
Frequent (may affect between 1 and 10 out of 100 treated patients):
Dizziness, especially when sitting down or standing up; ejaculation disorders, abnormal ejaculation. The latter means that semen does not exit through the urethra but remains in the bladder. This phenomenon is harmless.
Uncommon (may affect between 1 and 10 out of 1,000 treated patients):
Headache, palpitations (heartbeat faster than normal and noticeable), reduction in blood pressure, for example when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal drip or nasal blockage (rhinitis), diarrhoea, nausea and vomiting, constipation, weakness (asthenia), skin rash, itching and hives (urticaria).
Rare (may affect between 1 and 10 out of 10,000 treated patients):
Fainting, sudden localized swelling of soft body tissues (such as throat or tongue), breathing difficulty and/or itching and skin rash, often as an allergic reaction (angioedema).
Very rare (may affect fewer than 1 in 10,000 treated patients):
Priapism (undesired, prolonged and painful erection requiring immediate medical treatment); serious illness with blisters and burns on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
Frequency not known: Dry mouth.
If you are undergoing eye surgery due to lens opacity (cataract) and you are currently taking or have recently taken Tamsulosina Kern Pharma, your pupil may dilate poorly and the iris (the circular colored part of the eye) may become floppy during surgery.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
5. Storage of TAMSULOSIN KERN PHARMA
Keep out of the reach and sight of children.
Do not use Tamsulosin Kern Pharma after the expiry date 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 from light.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Tamsulosina Kern Pharma
- The active substance is tamsulosin hydrochloride. Each tablet contains 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
- The other components are: microcrystalline cellulose (E-460i), hypromellose (E-464), carbomer, anhydrous colloidal silica, iron oxide red (E-172), and magnesium stearate (E-470b).
Appearance of Tamsulosina Kern Pharma and contents of the container
Tamsulosina Kern Pharma tablets are round and white.
Tamsulosina Kern Pharma is presented in blister packs containing 30 tablets and clinical packages containing 100 tablets.
Marketing Authorization Holder and Manufacturer
Kern Pharma, S.L.
Polígono Ind. Colón II
Venus, 72
08228 Terrassa (Barcelona)
Manufacturer:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Manufacturer:
Synthon Hispania
Castelló 1
Polígono Las Salinas
08830 Sant Boi de Llobregat (Barcelona)
This leaflet was approved in May 2011
Date of revision of this leaflet: November 2013
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/