Flectone Xl 400 Microgram Prolonged-Release Tablets
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FLECTONE XL 400 microgram PROLONGED-RELEASE TABLETS Tamsulosin hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
Pharma code 305
1. What Flectone XL is and what it is used for
2. What you need to know before you take Flectone XL
3. How to take Flectone XL
4. Possible side effects
5. How to store Flectone XL
6. Contents of the pack and other information
WHAT FLECTONE XL IS AND WHAT IT IS USED FOR
The active ingredient of Flectone XL is tamsulosin. Tamsulosin is an alpha1-receptor blocker which reduces the tension in the muscles of the prostate and urethra (the tube that carries urine to the outside). As a result, the urethra, which runs through the prostate, is less contracted and urination is easier.
Flectone XL is intended for use in men to treat lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH), which is an enlargement of the prostate gland.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLECTONE XL
Do NOT take Flectone XL
• If you are allergic (hypersensitive) to tamsulosin or to any of the other ingredients listed in section 6. Contents of the pack and other information.
• If you have serious liver disease
• If you suffer from orthostatic hypotension (feeling dizzy because of low blood pressure when sitting or standing).
Warnings and precautions Talk to your doctor or pharmacist before taking tamsulosin
• If you have serious kidney disease
• In rare cases, Flectone XL may cause fainting when sitting down or standing up. If you feel dizzy or weak, lie or sit down until these symptoms disappear.
• Before you start taking Flectone XL, your doctor will examine you to make sure you do not have another illness likely to cause symptoms similar to those of a non-cancerous enlargement of the prostate. Your doctor will examine your prostate manually to look for possible abnormalities and will order tests for a chemical produced by the prostate (prostate-specific antigen, PSA) in your blood before you start treatment, and at regular intervals afterwards.
• In rare cases, a serious allergic reaction may occur with swelling of the face, lips, tongue and throat, which may make it hard to breathe, talk or swallow (angioedema).
If this happens, stop taking Flectone XL immediately and consult your doctor.
• If you are undergoing eye surgery because of cloudiness of the lens (cataract), please
inform your eye specialist that you have been or are taking Flectone XL. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used.
Consult your doctor if any of these warnings apply or would have applied to you in the past.
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 Flectone XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially if you are taking any of the following:
• Diclofenac (an anti-inflammatory medicine used to treat pain)
• Warfarin (used to prevent blood clotting)
• Ketoconazole (used to treat fungal infections).
No interactions have been reported, but using Flectone XL at the same time as other medicines belonging to the same class may lead to a drop in blood pressure.
Flectone XL with food and drink
You may take your Flectone XL independently of food.
Pregnancy and breast-feeding
Flectone XL is not indicated for use in women.
Driving and using machines
Flectone XL may cause dizziness. If you experience this symptom, do not drive or use any tools or machinery the handling of which requires concentration.
^ HOW TO TAKE FLECTONE XL
Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet per day, by mouth. No dose adjustment is required if you have impaired kidney function or mild to moderate liver disease (see also 'Do not take Flectone XL' in section 2 above).
Swallow the tablet whole with a glass of water, without crunching or chewing.
Do not forget to take your medicine. Your doctor will tell you how long you need to keep taking Flectone XL.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you take more Flectone XL than you should
If you take too much Flectone XL, contact your doctor or pharmacist or go to the nearest hospital casualty department immediately. Take along this leaflet and any remaining tablets with you. An overdose of Flectone XL may cause dizziness, fainting and headache.
If you forget to take Flectone XL
If you forget to take your daily tablet of Flectone XL, you may take it later on the same day. If you forget to take it at all one day, continue with your treatment the next day with the normal dose at the usual time. Do not take a double dose to make up for a forgotten one.
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If you stop taking Flectone XL
If you stop taking Flectone XL earlier than your doctor recommends, the initial symptoms may reappear. You must therefore keep taking Flectone XL for as long as your doctor tells you to, even if your symptoms have gone. Always talk to your doctor if you are considering stopping treatment.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Keep out of the sight and reach of children.
See your doctor or go to a hospital immediately if you experience any of the following rare side effects (you may be experiencing an allergic reaction):
• Rash, itching, inflamed or red skin (especially if your whole body is affected)
• Swelling of the face, lips, tongue or throat, which may cause difficulty swallowing or breathing (angioedema).
The following side effects have been observed with Tamsulosin:
Do not use Flectone XL after the expiry date which is stated on the carton and blister after EXP The expiry date refers to the last day of that month.
There are no special precautions for storage.
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 to protect the environment.
©CONTENTS OF THE PACK AND OTHER INFORMATION
Common side effects (may affect up to 1 in
10 people):
• Dizziness
• Ejaculation disorders
• Abnormal ejaculation (e.g. less, or no noticeable, semen ejaculated).
Uncommon side effects (may affect up to 1
in 100 people):
• Headache
• Pounding heart beat (palpitations)
• Orthostatic hypotension (feeling dizzy because of low blood pressure when sitting or standing)
• Runny or stuffy nose (rhinitis)
• Feeling or being sick (nausea or vomiting), diarrhoea, constipation
• Allergic reactions such as rash, itching and local inflammation
• Weakness.
Rare side effects (may affect up to 1 in 1,000 people):
• Fainting
• Nettle rash (hives) on the whole body with swelling of the hands, feet, lips, tongue, throat, airways (angioedema).
Very rare side effects (may affect up to 1 in 10,000 people):
• A severe skin rash which develops with flu-like symptoms (Stevens-Johnson syndrome)
• Priapism (persistent painful erection in the absence of sexual stimulation; this side effect requires immediate treatment).
Not known (frequency cannot be estimated from the available data):
• Blurred vision, problems with sight
• Nose bleeds
• Itchy, pink-red blotches on your limbs (Erythema multiforme)
• Redness and scaling of the skin (Dermatitis exfoliativa)
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia)
• Difficult breathing (dyspnoea)
• Dry mouth.
If you are undergoing eye surgery because of cloudiness of the lens (cataract) and have been or are taking Flectone XL, your pupil may not dilate right and your iris (the coloured part of the eye) may become floppy during the operation (see also 'Warnings and precautions' above).
What Flectone XL contains
• The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.40 mg tamsulosin hydrochloride equivalent to 0.367 mg tamsulosin.
• The other ingredients are cellulose microcrystalline, polyethylene oxide, silica colloidal anhydrous and magnesium stearate in the core and hypromellose 6cP, titanium dioxide (E171), macrogol 8000 and red and yellow iron oxide (E172) in the film-coating.
What Flectone XL looks like and contents of
the pack
• Prolonged-release tablet
• Yellow, biconvex, oval, film-coated tablet, debossed 'T04' on one side and plain on the other
• Available in pack sizes of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200 Tablets and 50 x 1 (hospital pack) prolonged-release tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised in 11/2013
PL 00289/1142
IMVil 76517;!
TEVA UK LIMITED 160 x 323