Other medicines and Benph

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription or the following:

•    medicines to lower blood pressure

(e.g. diltiazem), ACE inhibitors (e.g. ramipril) or other alpha-blockers (e.g. doxazosin, alfuzosin)

•    diuretics (water tablets) e.g. furosemide

•    medicine to thin the blood e.g. warfarin

•    medicine for erectile dysfunction (impotence) (e.g. sildenafil, tadalafil, vardenafil)

•    anti-inflammatory painkillers e.g. ibuprofen, diclofenac.

Some patients who take alpha-blocker therapy for the treatment of prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start medicines for erectile dysfunction.

Benph with alcohol

Alcohol can increase the effects of this medicine causing dizziness or fainting. Do not drink alcohol while taking this medicine if you are affected.

Pregnancy and breast-feeding

Benph is used to treat a condition found only in men. It should not be prescribed to women.

Driving and using machines

Benph may make you feel dizzy, light headed and drowsy. These side effects are more likely at the start of treatment, or in the case of missed doses and where treatment has been stopped and then restated again. You may also suffer from blurred vision or other eyesight changes. Do not drive, operate machinery or perform any hazardous tasks for 12 hours when you first start taking your medicine, or when your doctor increases the dose you are taking. After this time, make sure you are not suffering any of these side effects before carrying out these tasks.

Benph contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Benph 5 mg and 10 mg tablets contain sunset yellow (E110)

Sunset yellow (E110), may cause allergic reactions.

3. How to take Benph

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    Swallow the tablets whole with a full glass of water

•    Take with or without food

•    Do not chew, break or crush the tablets.

Adults and the elderly (over 65 years of age) only:

The recommended starting dose is 1 mg of Benph. Take the very first dose at bedtime as Benph may make you feel dizzy or faint when taken for the first time.

Your doctor may adjust your dose depending on how you respond to the tablets. If your doctor increases your dose, he or she may double your dose at intervals of one week or every two weeks. The usual maintenance dose is 5 to 10 mg once daily. The maximum daily dose is 10 mg of Benph.

Use in children and adolescents (under 18 years):

There is no relevant use in children and adolescents under 18 years.

If you take more Benph than you should

If you take more Benph than you should your blood pressure may suddenly drop and you may feel dizzy or even faint. If you begin to feel dizzy, lie down until you feel better.

If the symptoms do not disappear, contact your doctor or nearest hospital casualty department immediately. Take any remaining tablets and the container with you.

If you forget to take Benph

If you forget to take Benph, do not take a double dose to make up for a forgotten dose as this may cause a sudden drop in blood pressure, especially if you take blood pressure lowering medicines, just carry on as before.

If for any reason, you have stopped taking Benph for several days, do not continue your treatment using the same dose. Contact your doctor as you may need to start taking your medicine at a lower strength than you have been used to taking.

If you stop taking Benph

Do not suddenly stop taking your medicine as this may cause serious changes in your blood pressure. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following, stop taking Benph and tell you doctor immediately or go to the nearest hospital emergency department:

Very rare (may affect up to 1 in 10,000 people):

•    itchy skin or a rash, difficulty breathing, feeling wheezy, or swelling of the face, mouth or throat,

•    fast and uneven heartbeat, which may make you feel tired, dizzy and short of breath (atrial fibrillation)

Tell your doctor if you suffer from a painful, prolonged erection which continues even after sex or masturbation. This is a rare side effect in men but can lead to permanent impotence (failure to get and maintain an erection) if not treated.

Benph can make you feel dizzy or faint which is more likely after your first dose. You may also notice your heart beating faster before you feel faint. Your first dose is best taken at bedtime to help avoid these side effects.

Other possible side effects:

Common (may affect up to 1 in 10 people):

•    feeling dizzy, light-headed or weak

•    sleepiness

•    feeling nervous

•    constipation, diarrhoea, feeling or being sick

•    swelling of the ankles or hands

•    itchy skin or skin rash

•    uneven or rapid heart beat

•    breathlessness

•    headache

•    impotence

•    chest pain

•    tingling or numbness in the hands and feet

•    fainting on standing

•    blurred vision or decreased vision (lazy eye)

•    pain in the extremities (hands and feet)

•    back pain

•    feeling weak

•    nose bleeds, sinusitis or blocked nose

Uncommon (may affect up to 1 in 100 people):

•    depression

•    weight gain

•    loss of sexual desire

•    fainting

Rare (may affect up to 1 in 1,000 people):

•    bladder (urinary tract) infection or loss of control of passing water (incontinence), mostly in women who have been through the menopause

Very rare (may affect up to 1 in 10,000 people):

•    unusual bruising or bleeding of the skin

Not known (frequency cannot be estimated from the available data): anxiety, difficulty sleeping, abnormal vision, infection causing redness and swelling of the thin layer covering the front of the eye (conjunctivitis), ringing in the ears, spinning sensation, irregular heart beat, bronchitis, flu symptoms, sore throat, cold symptoms, cough, dry mouth, indigestion, wind, swelling of the face, sweating, stomach, neck and shoulder pain, gout, painful joints or muscles, changes in urinary frequency, fever, dilation of the blood vessels which may cause redness of the skin.

If you are undergoing eye surgery because of cataract and you are taking or have taken this medicine in the past, there may be complications during the surgery (please see "Warnings and precautions").

The use of this medicine may affect the results of some blood tests. Always tell your doctor that you are taking this medicine.

Reporting of side effects

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 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 Benph

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

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 protect the environment.

6.    Contents of the pack and other information

What Benph contains

•    The active substance is terazosin hydrochloride dihydrate (equivalent to 1 mg, 2 mg, 5 mg and 10 mg of terazosin).

•    The other ingredients are talc, magnesium stearate, povidone, pregelatinised starch, lactose monohydrate (see section 2. "Important information about some of the ingredients of Benph"). In addition, the 2mg tablet contains quinoline yellow (E104). The

5 mg and 10 mg tablets contain sunset yellow (E110) (see section 2 "Benph 5 mg and 10 mg tablets contain sunset yellow [E110]").

What Benph looks like and contents of the pack

The 1mg tablets are white, round, flat bevel-edged tablets imprinted 'E' and '451' on one side.

The 2 mg tablets are yellow, round, flat bevel-edged tablets imprinted 'E' and '452' on one side.

The 5 mg tablets are light orange, round, flat bevel-edged tablets imprinted 'E' and '453' on one side.

The 10 mg tablets are orange, round, flat bevel-edged tablets imprinted 'E' and '454' on one side.

They are available in PVC/PVDC/ aluminium blister packs of:

1    mg: 7, 10, 14, 20, 28, 50 and 100 tablets *

2    mg: 7, 10, 14, 20, 28, 50, 84, 98 and 100 tablets * 5 mg: 14, 20, 28, 30, 50, 84, 98 and 100 tablets * 10 mg: 28, 50, 84, 98 and 100 tablets *

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

Gerard Laboratories,

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

EGIS Pharmaceuticals PLC, H-1165 Budapest Bokenyfoldi ut. 118-120., Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

Italy:    Terazosina Mylan Generics

2 mg, 5 mg compresse Portugal:    Terazosina Mylan 1 mg,

2 mg, 5mg comprimidos United Kingdom: Benph 1 mg, 2 mg, 5 mg, 10 mg Tablets

This leaflet was last revised in: August 2015

2/2