TAMFREX XL 400 microgram capsules

• 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. See section 4

1. What TAMFREX XL is and what it is used for
2. What you need to know before you take TAMFREX XL
3. How to take TAMFREX XL
4. Possible side effects
5. How to store TAMFREX XL
6. Contents of the pack and other information

• if you are allergic to tamsulosin hydrochloride or any of the other ingredients of TAMFREX XL (listed in section 6).
• if you suffer have a severe liver condition
• if you have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking TAMFREX 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.

Talk to your doctor or pharmacist before taking TAMFREX 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 TAMFREX XL.

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).

Do not give this medicine to children or adolescents under 18 years because it does not work in this population.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because TAMFREX XL can affect the way that some other medicines work and some other medicines can affect the way that TAMFREX 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 or alfuzosin
• Erythromycin, an antibiotic used to treat infections

Please inform your doctor that you are on TAMFREX XL before any operation or dental procedure as there is a potential that your medicine may interfere with the effects of the anaesthetic.

TAMFREX 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.

There is no information available on whether TAMFREX XL affects the ability to drive or to operate machinery. However, it is known that TAMFREX XL may cause drowsiness, blurred vision, dizziness and fainting. If you suffer from these do not drive or operate machinery.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

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.

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.

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).

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)
• dry mouth

As with other medicines of this type, drowsiness, blurred vision or swelling of the hands and feet can occur.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is tamsulosin hydrochloride.

Each prolonged-release capsule hard contains 0.4 mg of tamsulosin hydrochloride.

• The other ingredients are
  Capsule content: Cellulose microcrystalline, talc, methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triacetin and calcium stearate.
  Capsule shell: Indigo carmine (E 132), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), sodium lauryl sulfate, gelatin.
  Printing Ink: Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

Prolonged-release capsules, hard

Olive green opaque/Orange opaque size ‘1EL’ hard gelatin capsules imprinted with ‘D’ on cap and ‘53’ on body with black edible ink. The capsules are filled with white to off-white beadlets.

TAMFREX XL 400 microgram capsules are available in:

PVC/PE/PVDC blister pack: 1, 2, 4, 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 200 hard, capsules.

White opaque round HDPE bottle with white opaque polypropylene closure: 10 and 250 hard, capsules.

Not all pack sizes may be marketed.

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