Sulatamin 0.4 Mg Prolonged-Release Capsules Hard
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tamsulosin hydrochloride
Read all of this leaflet carefully before you start 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Sulatamin is and what it is used for
2. What you need to know before you take Sulatamin
3. How to take Sulatamin
4. Possible side effects
5. How to store Sulatamin
6. Contents of the pack and other information
1. What Sulatamin is and what it is used for
The active ingredient in Sulatamin is tamsulosin. This is a selective alpha1A/1D-adrenoceptor antagonist. It reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to pass more readily through the urethra and facilitating urination.
Sulatamin is used to treat the symptoms of an enlarged prostate - a condition technically known as benign prostatic hyperplasia or BPH. If the gland becomes enlarged, it can squeeze the urethra, interfering with the flow of urine. This can cause difficulty in starting urination, a weak flow of urine, and the need to urinate urgently or more frequently. Sulatamin doesn't shrink the prostate. Instead, it relaxes the muscle around it, freeing the flow of urine and decreasing urinary symptoms.
2. What you need to know before you take Sulatamin Do not take Sulatamin
- If you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- If you feel dizzy when you stand up.
- If you have severe liver insufficiency.
Warnings and precautions
Before starting treatment you should tell your doctor if you are suffering from any other disease, particularly from kidney and liver disorders, heart and circulatory system diseases.
Rarely, fainting can occur during the use of Sulatamin, as with other medicinal products of this type. At the first signs of dizziness or weakness you should sit or lie down until they have disappeared.
Periodic medical examinations are necessary to monitor the development of the condition you are being treated for.
If you are undergoing eye surgery because of cloudiness of the lens (cataract), please inform your eye specialist that you are using or have previously used Sulatamin. This is because Sulatamin may cause complications during the surgery. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens.
Other medicines and Sulatamin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Certain medicines (e.g. medicines preventing blood clotting called anticoagulants, anti-inflammatory drugs such as diclofenac, some group of medicines to treat high blood pressure, anti-fungal medicines like ketoconazole) can influence the effects of tamsulosin. Therefore, you can only take medicines concomitantly with Sulatamin if your doctor allows it.
Pregnancy, breast-feeding and fertility
Sulatamin is intended for male patients only.
Ejaculation disorder may occur following treatment with tamsulosin and may consequently have an effect on fertility.
Driving and using machines
Sulatamin can adversely affect the ability to drive or operate machines. It should be taken into account that in some patients dizziness occur.
3. How to take Sulatamin
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If it is not prescribed otherwise by your doctor the usual dose is one capsule daily, to be taken after breakfast or the first meal of the day.
Do not crunch or chew the capsule, swallow it whole.
If you take more Sulatamin than you should
Contact your doctor or visit the emergency department of the nearest hospital as the consequences of accidental or deliberate overdose may require medical intervention.
If you forget to take Sulatamin
Take the forgotten capsule on the same day. However, on the next day do not take a double dose; just resume treatment at one capsule a day.
If you stop taking Sulatamin
You should not stop taking it without consulting your doctor before.
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. Do not be alarmed by this list of possible side effects, you may not have any of them. Most patients do not notice any side effects. However if you do and they bother you, talk to your doctor.
If you begin to feel light-headed or dizzy, sit or lie down until you feel better.
Common (may affect up to 1 in 10 people):
• ejaculation disorders called retrograde ejaculation (ejaculation into the bladder)
• dizziness, especially when you are getting up from a chair or bed
Uncommon (may affect up to 1 in 100 people):
• dropping of blood pressure especially when standing up
• feeling of rapid heartbeat
• headache
• constipation
• diarrhea
• nausea
• vomiting
• hives
• rash
• itching
• weakness
• obstructed or runny nose
Rare (may affect up to 1 in 1000 people):
• swelling of the lower layers of the skin, often around the mouth or of the mucosa of the mouth or throat which can appear very quickly
• fainting
Very rare (may affect up to 1 in 10 000 people):
• a severe inflammatory eruption of the skin and mucous membranes, which is an allergic reaction to drugs or other substances called Stevens-Johnson syndrome
• priapism (painful, persistent, involuntary erection of the penis), in which case immediate medical aid is needed
If you are undergoing eye surgery because of cloudiness of the lens (cataract) and are already taking or have previously taken tamsulosin hydrochloride, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure (see also section 2 “Warnings and precautions”).
In addition to the adverse events listed above irregular heart beat, abnormal heart rhythm (atrial fibrillation, arrhythmia), rapid heart beat (tachycardia) and shortness of breath (dyspnoea) have been reported in association with Sulatamin use. Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of Sulatamin in their causation cannot be reliably determined.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Sulatamin
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sulatamin contains
- The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
- The other ingredients are microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent (including polysorbate, sodium laurilsulfate), talc, triethyl citrate, calcium stearate in capsule filling and yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin in capsule shell.
What Sulatamin looks like and contents of the pack
White or off-white pellets are filled in the capsules which sizes are about 18 mm lengthwise and
6.3 mm in external diameter, the upper part is brown opaque, lower part is buff opaque.
30, 90 or 100 capsules are packed into clear or white opaque PVC/PVDC//Aluminium blisters.
The blisters are packed into folding box with a package leaflet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Vale Pharmaceuticals Ltd.
1B Gurtnafleur Business Park, Gurtnafleur, Co. Tipperary
Ireland
Manufacturer
Gedeon Richter Plc. Gyomroi ut 19-21. 1103 Budapest Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
Sweden: Tamsulosin Vale United Kingdom: Sulatamin
This leaflet was last revised in {08/2012}.
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