Flomaxtra XL
tamsulosin hydrochloride
Read all of this leaflet carefully before you start taking this medicine. 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 your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Flomaxtra XL is and what it is used for
- 2. Before you use Flomaxtra XL
- 3. How to use Flomaxtra XL
- 4. Possible side effects
- 5. How to store Flomaxtra XL
- 6. Further information
What Flomaxtra Xl Is And What It Is Used For
What is Flomaxtra XL
The active ingredient in Flomaxtra XL is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination.
In the prostate gland, bladder and urethra there are specialised cells containing alpha1A-receptors that cause the muscles in the urethra to tighten. Flomaxtra XL is an alpha1A-adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water.
What Flomaxtra XL is used for
Flomaxtra XL is used to treat the symptoms associated with benign prostatic hyperplasia (BPH) which is enlargement of the prostate gland.
These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.
Before You Use Flomaxtra Xl
Do not use Flomaxtra XL if you
- are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Flomaxtra XL (see list in section 6 `Further information´)
- have a severe liver condition
- have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking Flomaxtra XL, particularly if you are also taking other alpha1- blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared.
Take special care with Flomaxtra XL (and speak to your doctor)
- If you have kidney problems
- 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 tamsulosin hydrochloride. 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.
Taking other medicines
Make sure you tell your doctor about all other medicines you are taking particularly those that lower blood pressure as there maybe a theoretical risk of an enhanced effect whilst taking Flomaxtra XL.
Please inform your doctor that you are on Flomaxtra XL before any operation or dental procedure as there is a potential that your medicine may interfere with the effects of the anaesthetic.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Driving and using machines
You should not drive or operate machinery if you feel faint, dizzy, drowsy or have blurred vision until the symptoms have passed.
How To Take Flomaxtra Xl
Dosage
For adults and the elderly, the dose is one tablet each day. It can be taken with or without food. Swallow the tablet whole. Do not crunch or chew.
Your doctor may want to examine you from time to time whilst you are taking this medicine.
If you take more Flomaxtra XL than you should
If you have taken too many tablets, contact your doctor immediately or go to the nearest hospital casualty department taking any remaining medication and this patient information leaflet with you.
If you forget to take Flomaxtra XL
You may take your tablet later the same day if you have forgotten to take it earlier. If you have missed a day, just continue to take your daily tablet from the next day. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Flomaxtra XL Side Effects
Like all medicines, Flomaxtra XL may cause side effects, although not everybody gets them.
There have been rare reports of:
- Swelling of the face, throat or tongue with breathing problems linked to allergy
There have been very rare reports of:
- Persistent painful erection usually unrelated to sexual activity.
Consult your doctor immediately if any of the above occur.
The following side effects have been reported:
Common (affects less than 1 in 10 people)
- dizziness
Uncommon (affects less than 1 in 100 people)
- abnormal ejaculation (i.e. less, or no noticeable, semen ejaculated)
- weakness
- headache
- runny or blocked nose
- dizziness as you sit or stand up
- palpitations (rapid or irregular heart beat)
- gastro-intestinal symptoms such as nausea and vomiting (feeling or being sick), diarrhoea or constipation
- hypersensitivity reactions such as rash, itching, redness, local swelling and breathing problems
Rare (affects less than 1 in 1000 people)
- fainting
As with other medicines of this type, drowsiness, blurred vision, dry mouth or swelling of the hands and feet can occur.
Tell your doctor or pharmacist if any of the above symptoms become troublesome or last longer than a few days, or if you notice any side effects not listed in this leaflet.
How To Store Flomaxtra Xl
Keep your tablets below 30°C in the pack in which they were supplied.
Keep out of the reach and sight of children.
Do not use Flomaxtra XL after the expiry date printed on the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Flomaxtra XL contains
Flomaxtra XL contains the active ingredient, tamsulosin hydrochloride. Each modified release tablet contains 400 micrograms tamsulosin hydrochloride which is equivalent to 367 micrograms of tamsulosin.
The other ingredients are macrogol, magnesium stearate, butylhydroxytoluene, hypromellose and yellow iron oxide E172.
What Flomaxtra XL looks like and contents of the pack
Flomaxtra XL tablets are round, yellow tablets with `04´ imprinted on them.
The tablets are supplied in blister packs of 30.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Flomaxtra XL is held by
Flomaxtra XL is manufactured by
at their site at
This leaflet was last approved in December 2009.
© Astellas Pharma Ltd.
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