0.4 mg hard capsule with modified release
tamsulosin hydrochloride
What Tamicten is and what it is used for
Tamsulosin is an alpha 1A -adrenoreceptor blocker. It causes the muscles in the prostate and urethra to relax.
Tamsulosin is used to treat problems with urination caused by an enlarged prostate ( benign prostatic hyperplasia ). As the muscles relax, urine can pass more easily, which facilitates urination.
Tamsulosin hydrochloride contained in Tamicten may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Tamicten
Do not use Tamicten:
- if you are allergic to tamsulosin or 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 previously experienced dizziness, a feeling of fainting, or have fainted due to temporarily low blood pressure when you stood up
- if you have severe liver problems
Warnings and precautions
Talk to your doctor or pharmacist before taking Tamicten
- if you get dizzy, or feel faint especially when you stand up. Tamsulosin can lower blood pressure and cause these symptoms. Sit or lie down until the symptoms are gone.
- if you have severe kidney problems. The normal dose of tamsulosin may not have the intended effect if your kidneys are not working normally.
- if you are going to undergo eye surgery due to a cloudy lens ( cataract ). This can cause a condition called IFIS (Intraoperative Floppy Iris Syndrome, a variant of small pupil syndrome) (see section 4, Possible side effects ). Tell the ophthalmologist that you are using or have previously used tamsulosin hydrochloride before surgery. The specialist can then take this into account when choosing the surgical technique and medication. Ask the doctor if you should postpone or temporarily stop taking this medicine in connection with surgery for the cloudy lens ( cataract ) or increased pressure in the eye ( glaucoma ).
Before you start using tamsulosin, the doctor should examine you to make sure that your symptoms are due to a benign enlargement of the prostate.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age. It doesn’t work for them.
Other medicines and Tamicten
Other medicines may be affected by tamsulosin. They, in turn, can affect how well tamsulosin works. Tamsulosin may affect or be affected by:
- diclofenac, a drug for pain and inflammation. The medicine can speed up the removal of tamsulosin from your body, thereby shortening the time tamsulosin works.
- warfarin, a blood-thinning drug. The medicine can speed up the removal of tamsulosin from your body, thereby shortening the time tamsulosin works.
- other alpha 1 -adrenoreceptor blockers. The combination can lower blood pressure and cause dizziness and fainting.
- ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol ). The medicine can enhance the effect of tamsulosin.
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Damien with food and drink
You should take tamsulosin with a glass of water after breakfast or after the first meal of the day.
Pregnancy, breastfeeding, and fertility
amict should not be used by women.
In men, abnormal ejaculation (ejaculatory disorder) has been reported. This means that the seminal fluid does not leave the body via the urethra but instead enters the bladder ( retrograde ejaculation) or that the ejaculatory volume is small or completely absent (absence of ejaculation). This phenomenon is harmless.
Driving ability and use of machinery
There is no information on the effect of Tamicten on the ability to drive or use machines. You should be aware that tamsulosin can cause dizziness and fainting. Only drive or operate machinery if you are well.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tamicten contains excipients
Damien contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost “sodium-free”.
How to use Tamicten
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The usual dose is one capsule daily after breakfast or after the first meal of the day.
The capsule should be taken in a standing or sitting position (not lying down) and swallowed whole with a glass of water. The capsule must not be chewed or crushed as this may affect how well tamsulosin works.
If you have mild or moderate kidney or liver disease, you can take a normal dose of tamsulosin.
If you have taken too much Tamicten
If you have ingested too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Your blood pressure may drop suddenly if you take more Tamicten than you should. You may experience dizziness, weakness and fainting, vomiting, and diarrhea. Lie down to minimize the effect of low blood pressure and then consult a doctor. The doctor may be able to give you medication to help restore your blood pressure and fluid balance and monitor your body functions. If necessary, the doctor may perform gastric lavage and give laxatives to remove tamsulosin that has not yet been absorbed into the blood.
If you forget to take Tamicten
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you stop using Tamicten
If treatment with Tamicten is stopped too early, your symptoms may return. Therefore, continue to take Tamicten as long as your doctor has prescribed it, even if your symptoms have disappeared. Always consult your doctor before you stop taking Tamicten.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are rare. Contact a doctor immediately if you have a severe allergic reaction that causes swelling of the face or throat ( angioedema ). You should then not resume treatment with tamsulosin (see section 2, Do not use Tamicten).
Common side effects ( may affect up to 1 in 10 users)
- dizziness, especially when sitting up or standing up
- abnormal ejaculation (ejaculation disorder). This means that the seminal fluid does not leave the body via the urethra but instead enters the bladder ( retrograde ejaculation) or that the ejaculatory volume is small or completely absent (absence of ejaculation). This phenomenon is harmless.
Uncommon side effects ( may affect up to 1 in 100 users)
- headache
- palpitation
- drop in blood pressure when you stand up, which can cause dizziness, fainting, or fainting ( orthostatic hypotension )
- swelling and irritation of the nose (runny nose)
- constipation
- diarrhea
- nausea
- vomiting
- rash
- hives
- feeling of weakness
- itching
Rare side effects ( may affect up to 1 in 1,000 users)
- fainting
Very rare side effects ( in fewer than 1 in 10,000 users)
- painful erection (priapism)
- serious illness with widespread skin rash with blistering of the skin, mouth, eyes, and genitals ( Stevens-Johnson syndrome )
Has been reported (occurring in an unknown number of users)
- blurred vision
- impaired vision
- nosebleed
- dry mouth
- severe skin rashes (erythema multiforme, exfoliative dermatitis )
- abnormal, irregular heart rhythm ( atrial fibrillation, heart rhythm disorder, high heart rate)
- difficulty breathing ( dyspnea )
In connection with surgery for a cloudy lens (cataract) or increased pressure in the eye ( glaucoma ), a condition called IFIS may occur: the pupil dilates poorly and the iris (the colored circular part of the eye) may become limp during surgery (see section 2, Warnings and Precautions).
How to store Tamicten
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton, blister, or can after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is tamsulosin hydrochloride 0.4 mg.
Other ingredients are:
Capsule contents: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent, polysorbate 80, sodium lauryl sulfate, triethyl citrate, and talc.
Capsule shell: gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172).
Appearance and package sizes of the medicine
Orange/olive modified release capsule (19.3 x 6.4 mm). The capsule contains white to yellowish-white pellets.
Tamicten is available in blisters and in cans containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified -release capsules .
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Evans Pharma Oy
Technology 14
02150 Espoo
Finland
Manufacturer
Synthon Hispania SL
C/Castelló, n 1
Terminal. Las Salinas
08830 Sant Boi de Llobregat
Spain