Tamsugen 0.4 mg, modified release capsules, hard
Poland
Table of Contents
Package leaflet: Information for the patient
Tamsugen 0.4 mg, modified-release hard capsules
Tamsulosini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
- 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 give it to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet:
- What Tamsugen is and what it is used for
- What you need to know before taking Tamsugen
- How to take Tamsugen
- Possible side effects
- How to store Tamsugen
- Contents of the pack and other information
1. What Tamsugen is and what it is used for
Tamsugen contains tamsulosin hydrochloride as the active substance, which belongs to a group of medicines called alpha-adrenergic receptor antagonists (alpha-blockers), used to reduce the tension of smooth muscles in the prostate gland and urethra. This improves urine flow through the urethra and consequently facilitates urination.
Tamsugen is used in men to treat symptoms associated with enlargement of the prostate gland known as benign prostatic hyperplasia (BPH).
2. What you need to know before taking Tamsugen
Do not take Tamsugen if:
- You are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). Allergy to tamsulosin may manifest as sudden swelling of hands or feet, difficulty breathing and/or itching and rash (angioedema).
- You have previously experienced dizziness or fainting due to low blood pressure (e.g., when standing up or sitting down suddenly).
- You have severe liver impairment.
Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Tamsugen if:
- You have severe kidney disease.
- You are undergoing or are scheduled for surgery related to cataract or increased intraocular pressure (glaucoma).
An intraoperative floppy iris syndrome (IFIS) may occur (see section 4 – Possible side effects). Inform your ophthalmologist that you have previously taken, are currently taking, or plan to take tamsulosin. The doctor will then be able to take appropriate precautions regarding treatment and surgical techniques.
Ask your doctor whether you should delay starting treatment or temporarily discontinue Tamsugen prior to planned cataract surgery or surgical treatment of glaucoma.
During treatment
Inform your doctor or pharmacist:
- If you experience dizziness or fainting while taking tamsulosin. If such symptoms of orthostatic hypotension occur, sit or lie down until symptoms subside.
- If you develop sudden swelling of hands or feet, swelling of lips, tongue or throat, difficulty breathing and/or itching and rash due to an allergic reaction (angioedema).
Before taking Tamsugen, your doctor should perform an examination of the prostate and urinary system. Subsequent examinations should be carried out at regular intervals.
Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age, as it is ineffective in this age group.
Other medicines and Tamsugen
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
- Tamsulosin may lower blood pressure when used concomitantly with other alpha-adrenergic receptor antagonists, such as doxazosin, prazosin, and indoramin.
- Diclofenac (an anti-inflammatory painkiller) and warfarin (used to thin the blood) may affect the elimination of tamsulosin from the body.
- Medicines that lower blood pressure, such as verapamil and diltiazem.
- Immunosuppressive medicines, such as cyclosporine.
- Antibiotics used to treat infections, such as erythromycin, clarithromycin.
- Medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole, voriconazole.
- Medicines used to treat HIV infection, such as ritonavir, saquinavir.
The above statements may also apply to medicines taken previously or those to be taken in the future.
Pregnancy and breastfeeding
Tamsulosin is not indicated for use in women.
Tamsulosin may cause ejaculation disorders, including retrograde ejaculation (ejaculation into the bladder) or inability to ejaculate.
Driving and using machines
No studies on the effect of tamsulosin on the ability to drive or use machines have been conducted. Nevertheless, patients should be aware that dizziness may occur.
3. How to take Tamsugen
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is one capsule after breakfast or after the first meal of the day.
Swallow the capsule whole.
Do not chew or crush the capsules, as this may affect the modified release of the active substance.
Taking more Tamsugen than you should
If you take more than the recommended dose, contact your doctor or pharmacist immediately.
Symptoms of low blood pressure may occur, such as dizziness, feeling faint, fainting, blurred vision, irregular heartbeat, confusion, or weakness. If any of these symptoms occur, sit or lie down.
If you forget to take Tamsugen
If you forget to take the medicine after the first meal of the day, you may take it later that same day after a meal. If you forget to take the medicine for the entire day, skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Serious adverse reactions:
If any of the following symptoms occur, stop taking the medicine immediately
and contact your doctor or go to the nearest hospital emergency department without delay:
Rare (may occur in up to 1 in 1,000 patients):
Sudden swelling of the face, lips, tongue or throat, difficulty breathing and/or wheezing, rash (angioedema)
Very rare (may occur in up to 1 in 10,000 patients):
Widespread rash with numerous blisters, skin peeling, and bleeding around the lips, eyes, mouth, nose, and genital organs (Stevens-Johnson syndrome)
Frequency unknown (frequency cannot be estimated from available data):
Irregular or very rapid heartbeat (atrial fibrillation)
Other possible adverse reactions:
Common (may occur in up to 1 in 10 patients):
- Dizziness
- Ejaculation disorders, including inability to ejaculate or retrograde ejaculation (ejaculation of semen into the bladder)
Uncommon (may occur in up to 1 in 100 patients):
- Headache
- Palpitations (awareness of irregular heartbeat)
- Dizziness, especially when changing position suddenly from lying down to sitting or standing (orthostatic hypotension)
- Runny or stuffy nose (rhinitis)
- Constipation
- Diarrhoea
- Nausea
- Vomiting
- Rash
- Itching
- Feeling of weakness
Rare (may occur in up to 1 in 1,000 patients):
- Fainting
Very rare (may occur in up to 1 in 10,000 patients):
- Painful, prolonged, and unwanted erection (priapism)
Frequency unknown (frequency cannot be estimated from available data):
Generalised skin inflammation with red spots having a pale centre (erythema multiforme)
Heart rhythm disturbances (arrhythmia)
Rapid heartbeat (tachycardia)
Shortness of breath (dyspnoea)
Blurred or reduced vision (visual disturbances)
Nosebleeds
Skin rash with peeling (exfoliative dermatitis)
Dry mouth
In some cases, complications related to cataract or glaucoma surgery have been observed. During eye surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur: the pupil may dilate poorly and the iris may become floppy during surgery. For more information, see section 2 "Warnings and precautions".
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store Tamsugen 0,4mg, modified-release hard capsules
Keep this medicine out of sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the specified month.
Medicines must 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 Tamsugen contains
The active substance is tamsulosin hydrochloride.
One modified-release capsule contains 0.4 mg of tamsulosin hydrochloride.
The other ingredients are: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.
Capsule shell composition: gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).
What Tamsugen looks like and contents of the pack
Tamsugen capsules have an orange body and an olive cap. The capsules contain white or almost white pellets.
Capsules are available in blisters containing 30 or 60 modified-release hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate, Dublin 13
Ireland
Manufacturer
McDermott Laboratories t/a Gerard Laboratories
Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Synthon Hispania S.L.
Castelló, 1
Polígono las Salinas
08830 Sant Boi de Llobregat
Spain
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1
Hungary
For more detailed information about this medicine and its trade names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 546 64 00