Tamsucon 0,4 mg. 30 capsules

1. What Tamsucon is and what it is used for
The active ingredient in Tamsucon is tameulosin hydrochloride. It works by relaxing the muscles in the prostate and urethra (the tube that carries urine out of the body) and allowing urine to pass more easily through the urethra, helping you pass urine.

There are special cells in the prostate gland, bladder and urethra that contain alpha-adrenoceptors that cause the muscles in the urethra to tighten. Tamsucon is an alpha-adrenoceptor blocker that weakens the action of these special cells and relaxes the muscles, making it easier to pass urine.

Tamsucon is used in men to treat lower urinary tract complaints associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms include difficulty urinating, frequent trips to the toilet to urinate, a feeling that the bladder is not completely empty and getting up several times during the night to urinate.

2. What you need to know before you take Tamsucon
Do not take Tamsucon:
If you are allergic (hypersensitive) to tameulozin or any of the other ingredients of Tamsucon (listed in section 6).
If you have liver damage.
If you have fainted or felt dizzy when sitting up or standing up suddenly. Dizziness can sometimes occur when taking Tamsucon, especially if you are also taking other alpha1-blockers. If you feel faint or dizzy, sit down or lie down immediately until the symptoms go away.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsucon.

Take special care with Tamsucon (and talk to your doctor)
If you have kidney problems.
If you are having or are going to have eye surgery due to clouding of the lens (cataract) or increased pressure in the eye (glaucoma).
Please inform your eye specialist that you have used, are using or plan to use tamsulosin. Your eye specialist can take appropriate precautions regarding the medicines used and the surgical technique. Talk to your doctor about whether you should postpone or temporarily stop taking this medicine before undergoing eye surgery due to clouding of the lens (cataract) or increased pressure in the eye (glaucoma).

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age because it is not effective in this age group.

Other medicines and Tamsukon
Taking Tamsukon together with other medicines of the same class (alpha-adrenoceptor antagonists) may cause an unwanted decrease in blood pressure.
It is especially important to inform your doctor if you are being treated with medicines that can reduce the removal of Tamsukon from the body (e.g. ketoconazole, erythromycin).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tamsukon with food and drink
Tamsukon should be taken after breakfast or the first meal of the day.

Pregnancy, breast-feeding and fertility
Tamsukon is not indicated for use in women.

Abnormal ejaculation (ejaculation disorder) has been reported in men. This means that semen does not leave the body through the urethra but instead goes into the bladder (retrograde ejaculation) or the volume of the ejaculate is reduced or absent (failed ejaculation). This phenomenon is harmless.

Driving and using machines
There is no evidence that Tamsukon affects the ability to drive or use machines and equipment. However, you should be aware that dizziness may occur, in such cases you should not undertake activities that require attention.

3. How to take Tamsucon
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is 1 capsule a day, which should be taken after breakfast or the first meal of the day. The capsule should be swallowed whole and not chewed or crushed. Tamsucon is usually prescribed for long periods of time. The effects on the bladder and urination persist during long-term treatment with Tamsucon.

If you take more Tamsucon than you should
Taking too much Tamsucon may lead to an unwanted drop in blood pressure and an increase in heart rate, with feelings of fainting. Contact your doctor immediately if you have taken too much Tamsucon.

If you forget to take Tamsucon
You can take your daily dose of Tamsucon later in the day if you have forgotten to take it as directed. If you miss a day. Simply continue taking your daily capsule as prescribed. Never take a double dose to make up for a forgotten capsule.

If you stop taking Tamsucon
When treatment with Tamsucon is stopped prematurely, your original symptoms may return. Therefore, take Tamsucon for as long as your doctor has prescribed, even if your symptoms have disappeared. Always consult your doctor.
Talk to your doctor if you are considering stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)
Dizziness, especially when sitting or standing up.
Abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body through the urethra but instead goes into the bladder (retrograde ejaculation) or the volume of the ejaculate is reduced or absent (failed ejaculation). This is harmless.
Uncommon (may affect up to 1 in 100 people)
Feeling of palpitations causing headache (the heart beats faster than normal and this is felt).
Low blood pressure, e.g. when standing up quickly, sometimes associated with dizziness.
Runny or stuffy nose (rhinitis).
Diarrhea.
Nausea and vomiting.
Constipation.
Weakness (asthenia).
Rashes, itching and urticaria (hives).
Rare (may affect up to 1 in 1,000 people)
Weakness and sudden local swelling of the soft tissues of the body (e.g. throat or tongue), difficulty breathing and/or itching and rash, often as an allergic reaction (angioedema).
Very rare (may affect up to 1 in 10,000 people)
Priapism (painful prolonged unwanted erection requiring immediate medical treatment).
Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).
Not known (frequency cannot be estimated from the available data)
Blurred or impaired vision.
Nosebleed.
Dry mouth.
Serious skin rashes (erythema multiforme, exfoliative dermatitis)
Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia).
Difficulty breathing (dyspnoea).
If you are having eye surgery due to clouding of the lens (cataract) or increased pressure in the eye (glaucoma) and are taking or have taken Tamsucon before, the pupil may dilate and the iris (the coloured part of the eye) may relax during the procedure.

If any of these side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, tell your doctor or pharmacist.

5. How to store Tamsucon
Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be thrown away via wastewater or household waste.

Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.

6. Contents of the pack and other information
What Tamsulosin contains
The active substance is tamsulosin hydrochloride.
The other ingredients are: polysorbate 80, methacrylic acid and ethyl acrylate copolymer, triacetin, sodium lauryl sulfate, microcrystalline cellulose and calcium stearate.

The capsule contents contain FD&C Blue 2 (E 132), black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin, purified water, sodium lauryl sulfate; ink shellac (E904), anhydrous alcohol, isopropyl alcohol, butyl alcohol, concentrated ammonia solution, propylene glycol, black iron oxide (E 172), potassium hydroxide and purified water.
What Tamsucon looks like and contents of the pack
Tamsucon capsules are green/orange, size "2", hard gelatin capsules containing free-flowing white to off-white spheroids with "CE 23" on the cap and "0.4" on the body, printed in black ink.

The capsules are packed in PVC/PE/PVdC - Aluminum blisters of 10 or 14 capsules. Two blisters of 14 capsules or 3 blisters of 10 capsules are placed in a cardboard box with a leaflet.

Not all pack sizes may be marketed.

 

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