Flomax Mr 367mcg Capsules
Patient Information Leaflet
Flomax MR
tamsulosin hydrochloride
Read all of this leaflet carefully before you start taking this medicine. It contains important information for you.
- Keep this leaflet. Y ou 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 Flomax MR is and what it is used for
2. Before you use Flomax MR
3. How to use Flomax MR
4. Possible side effects
5. How to store Flomax MR
6. Further information
1. What Flomax MR is and what it is used for What is Flomax MR
The active ingredient in Flomax MR 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. Flomax MR is an alphaJA-adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water.
What Flomax MR is used for
Flomax MR 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. Before you use Flomax MR Do not use Flomax MR if you
• are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Flomax MR (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 Flomax MR, particularly if you are also taking other alphas 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 Flomax MR (and speak to your doctor)
• 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).
Children
Do not give this medicine to children or adolescents under 18 years because it does not work in this population.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Flomax MR can affect the way that some other medicines work and some other medicines can affect the way that Flomax MR 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 or alfuzosin
• Erythromycin, an antibiotic used to treat infections
Please inform your doctor that you are on Flomax MR 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
Flomax MR 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.
3. How to take Flomax MR Dosage
For adults and the elderly, the dose is one capsule per day to be taken after breakfast or the first meal of each day. Swallow the capsule 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 Flomax MR than you should
If you have taken too many capsules, 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 Flomax MR
You may take your capsule later the same day if you have forgotten to take it earlier. If you have missed a day, just continue to take your daily capsule 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.
4. Possible side effects
Like all medicines, Flomax MR 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).
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 multiform, dermatitis exfoliative)
• abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea).
• 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.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Flomax MR
Store in the original package.
Keep out of the reach and sight of children.
Do not use Flomax MR 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.
6. Further information What Flomax MR contains
Flomax MR contains the active ingredient, tamsulosin hydrochloride. Each modified release capsule contains 400 micrograms tamsulosin hydrochloride which is equivalent to 367 micrograms of tamsulosin.
The other ingredients are microcrystalline cellulose (E460), methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80 (E433), sodium laurilsulfate, triacetin (E1518), calcium stearate (E470a), talc (E553b) in the capsule content,. Hard gelatin, indigotine (E132), titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172) in the capsule shell. Shellac (E904), purified water, N butanol, isopropyl alcohol, propyl glycol and black iron oxide (E172) in the printing ink.
What Flomax MR looks like and contents of the pack
Flomax MR capsules are orange/olive-green coloured capsules imprinted with ‘0.4’ and logo and ‘701’.
The capsules are packed in aluminium blisters that are supplied in a cardboard box. The packs contain 10, 20, 30, 50 60, 90, 100 or 200 capsules. Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Flomax MR is held by Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK.
Flomax MR is manufactured by Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands.
This leaflet was last revised in March 2014.
4