Flomaxtra Xl 400 Micrograms
PACKAGE LEAFLET: INFORMATION FOR THE USER
Flomaxtra® XL 400 micrograms film-coated prolonged release Tablets (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, pharmacist or nurse.
• This medicine has been prescribed for you. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Flomaxtra XL 400 micrograms film-coated prolonged release Tablets but will be referred to as Flomaxtra XL throughout the remainder of the leaflet.
What is in this leaflet:
1. What Flomaxtra XL is and what it is used for
2. What you need to know before you use Flomaxtra XL
3. How to use Flomaxtra XL
4. Possible side effects
5. How to store Flomaxtra XL
6. Contents of the pack and other information
1. What Flomaxtra XL is and what it is used
What is Flomaxtra XL
Flomaxtra XL contains the active substance 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 alpha-iA-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.
2. What you need to know before you use Flomaxtra XL
Do not use Flomaxtra XL if you
• are allergic to tamsulosin or any of the other ingredients of Flomaxtra XL
(listed in section 6)
• 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 alpha-i-blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared.
Warnings and precautions
Talk to your doctor before using Flomaxtra
XL
• If you have kidney problems
• If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma)
Please inform your eye specialist that you have previously used, are using or are planning to use 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 (cataract) or increased pressure in the eye (glaucoma).
(leaflet continued overleaf)
(leaflet continued)
Children and adolescents
Do not give this medicine to children or adolescents under 18 years because it does not work in this population.
Other medicines and Flomaxtra XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Flomaxtra XL can affect the way that some other medicines work and some other medicines can affect the way that Flomaxtra XL works.
In particular tell your doctor or pharmacist if you are taking:
• Medicines to lower your blood pressure such as verapamil and diltiazem.
• Medicines to treat HIV such as ritonavir or indinavir.
• Medicines to treat a fungal infection such as ketaconazole or itraconazole
• Other alpha blockers such as doxazosin, indoramin, prazosin oralfuzosin
• Erythromycin, an antibiotic used to treat infections
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.
Pregnancy, breast-feeding and fertility
Flomaxtra XL is not indicated for use in women.
In men, abnormal ejaculation has been reported (ejaculation disorder).This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.
Driving and using machines
There is no information available on whether Flomaxtra XL affects the ability to drive or to operate machinery or equipment. However, it is known that Flomaxtra XL may cause drowsiness, blurred vision, dizziness and fainting. If you suffer from these do not drive or operate machinery.
3. How to take Flomaxtra XL
Always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Check with your doctor, pharmacist or nurse if you are not sure. The recommended dose for adults and the elderly 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 or nurse.
4. Possible side effects
Like all medicines, Flomaxtra XL may cause side effects, although not everybody gets them.
Stop taking this medicine and consult your doctor immediately if any of the following occur - you may need medical treatment.
Rare (affects less than 1 in 1000 people)
• Swelling of the face, throat or tongue with breathing problems linked to allergy.
Very rare (affects less than 1 in 10,000 people)
• Persistent painful erection usually unrelated to sexual activity.
• Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea).
5. How to store Flomaxtra XL
Keep out of the sight and reach 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.
If the tablets show any signs of discolouration or deterioration consult your pharmacist for advice.
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.
6. Contents of the pack and other information
What Flomaxtra XL contains
Each film-coated tablet contains 400 micrograms tamsulosin hydrochloride equivalent to 367 micrograms of tamsulosin in a prolonged release formulation.
The other ingredients are macrogol 8000, macrogol 7000000, magnesium stearate E470B, butylhydroxytoluene (E321), colloidal anhydrous silica (E551), hypromellose (E464) 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 one side and plain on the reverse.
The tablets are supplied in blister packs of 30.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock house, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
Manufactured by Astellas Pharma Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, The Netherlands or Astellas Pharma Europe B.V., Sylviusweg 62 2333 BE Leiden Holland.
POM
The following side effects have also been reported:
Common (affects less than 1 in 10 people)
• dizziness
• abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.
Uncommon (affects less than 1 in 100 people)
• 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
Not known (frequency cannot be estimated from the available data):
• blurred vision
• impaired vision
• nose bleeds (epistaxis)
• serious skin rashes (erythema multiforme, dermatitis exfoliative)
• dry mouth
As with other medicines of this type, drowsiness, blurred vision, or swelling of the hands and feet can occur.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
Flomaxtra XL 400 micrograms film-coated prolonged release Tablets PL 20774/1110
Leaflet prepared date: 27th October 2015 Flomaxtra is a registered trademark of Yamanouchi Europe B.V. PP6/1110/V2