Slocinx Xl 4mg Prolonged-Release Tablets
Package Leaflet: Information for the patient
SLOCINX XL 4MG PROLONGED RELEASE TABLETS
(DOXAZOSIN)
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 side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet
1. What Slocinx XL is and what it is used for
2. What you need to know before you take Slocinx XL
3. How to take Slocinx XL
4. Possible side effects
5. How to store Slocinx XL
6. Contents of the pack and other information
1. WHAT SLOCINX XL IS AND WHAT IT IS USED FOR
The name of this product is Slocinx XL 4mg Tablets (referred to as Slocinx XL throughout this leaflet).
It contains a medicine called doxazosin. This belongs to a group of medicines called alpha-blockers.
It can be used to treat:
• High blood pressure (hypertension). It works by relaxing the blood vessels so that the blood passes through them more easily. This helps to lower your blood pressure.
• The symptoms caused by the enlargement of the prostate gland in men. Common symptoms are poor or frequent passing of water (urine). Slocinx XL works by relaxing the muscle around the urethra (the thin tube that carries urine from the bladder out of the body). This allows your water (urine) to pass more easily.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SLOCINX XL
Do not take Slocinx XL and tell your doctor if:
• You have ever suffered an allergic reaction to doxazosin or any of the other ingredients of this medicine (listed in section 6)
Signs of an allergic reaction include itching, reddening of the skin or difficulty breathing.
• You know that you are sensitive to medicines like doxazosin - such as prazosin and terazosin.
• You are breast feeding.
• You have a benign prostatic enlargement and any kind of congestion or blockage in your urinary tract (which includes your kidneys, bladder and urethra), an infection of the urinary tract or have had bladder stones forming in your urine.
• You have kidney problems, you do not feel the urge to urinate (overflow incontinence) or your body is not making any urine (anuria).
• You have or have ever had constipation or any kind of blockage in your gut (digestive tract).
• You have low blood pressure (hypotension) or if you have ever had orthostatic hypotension (a fall in blood pressure on standing up which causes dizziness, light headedness or fainting).
Do not take if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Slocinx XL.
Warnings and precautions
Talk to your doctor or pharmacist before taking Slocinx XL if:
• You have heart disease
• You have liver disease
• You take drugs for erectile dysfunction (impotence) (e.g. sildenafil, tadalafil, vardenafil). This is because some patients may experience dizziness or light-headedness, which may be caused by low blood pressure (see section “Other medicines and Slocinx XL”)
• You have something called ‘diabetic autonomic neuropathy’. This is a disease related to diabetes which affects your nervous system
If you are going to have an anaesthetic (for an operation, or dental treatment), tell your doctor or dentist you are taking Slocinx XL.
If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Slocinx XL. This is because Slocinx XL may cause complications during the surgery which can be managed if your specialist is prepared in advance.
At initiation of treatment with this medicine you may experience dizziness, weakness and in rare occasions fainting. You should therefore be careful and avoid situations that could lead to injury if these symptoms occur.
Children and adolescents
Slocinx XL is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established.
Other medicines and Slocinx XL
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, including herbal medicines. This is because Slocinx XL can affect the way some other medicines work. Also some medicines can affect the way Slocinx XL works.
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or 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 drugs 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 drugs for erectile dysfunction.
Tell your doctor if you are taking any of the following:
• Painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) - such as ibuprofen.
• Other medicines which lower blood pressure.
• Medicines containing oestrogen - such as the contraceptive pill or hormone replacement therapy (HRT).
• Medicines containing dopamine, metaraminol, methoxamine, adrenaline (epinephrine). Also, medicines for coughs and colds (as they may contain ephedrine, phenylephrine).
Slocinx XL with food and drink
Slocinx XL can be taken with or after food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Taking Slocinx XL is not recommended if you are pregnant or might become pregnant. Do not take this medicine if you are breast-feeding. Driving and using machines
Slocinx XL may affect your ability to drive or use any machinery, especially when you first start to take your tablets. If affected, do not drive or use machines.
3. HOW TO TAKE SLOCINX 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.
Slocinx XL is a modified release tablet. The active compound is surrounded by a non-absorbable shell that has been specially designed to slowly release the medicine. Once swallowed, doxazosin is slowly released into the body from the tablet, until the tablet shell is empty. The empty tablet shell is excreted, you may occasionally observe in the stools something that looks like a tablet. This is to be expected and you should not be concerned.
Taking this medicine
• Swallow your tablets whole.
• Do not chew or crush them as this can affect the way your medicine works.
• Your tablets can be taken at any time of day, during or after meals. Choose a time that is convenient and take your tablet at this time each day.
How much Slocinx XL to take
• The usual dose is one tablet each day.
• Your doctor may increase your dose to two tablets (8mg) each day.
• Do not take more than 8mg of Slocinx XL in one day.
• Do not change the dose unless you have spoken to your doctor.
Use in children and adolescents
Slocinx XL is not recommended for use in children and adolescents below 18 years as safety and efficacy have not yet been established.
If you take more Slocinx XL than you should
Tell your doctor or go to the nearest hospital casualty department straight away. Remember to take any remaining tablets and the pack with you. Taking too many tablets at once can make you feel unwell. qqqqq
If you forget to take Slocinx XL
Do not worry. Leave the dose out completely and then go on as before. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Slocinx XL
Keep taking your tablets until your doctor tells you to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Slocinx XL and see a doctor or go to a hospital straightaway:
• If you get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria) This may mean you are having an allergic reaction to Slocinx XL tablets.
• If you get symptoms such as: yellowing of your skin or whites of your eyes, tiredness and fever. This may be due to inflammation of the liver or changes in the way your liver is working.
While these are serious side effects that require urgent medical attention, they are rare.
Tell your doctor as soon as possible:
• If you feel nervous, shaky or sweaty. These may be signs of low blood sugar levels (hypoglycaemia)
• If you have chest pain (angina), a fast, slow or uneven heart beat. These could be signs of a heart attack
• If you are getting more infections or feeling more tired than normal. This may be caused by changes in your blood.
• If you have a painful erection of the penis, unrelated to sexual activity, that will not go away (priapism)
• If you feel weak or numb on one side of your body, have problems speaking or understanding what is said. These could be signs of a stroke.
Other side effects include:
Common (may affect up to 1 in 10 people)
• lack of interest or emotion (apathy)
• headache, sleepiness
• problems with focussing your eyes
• very fast and uneven heartbeat (palpitations), chest pain
• water retention
• feeling dizziness or “spinning” (vertigo)
• shortness of breath, runny nose (rhinitis), cough, bronchitis
• indigestion, stomach ache, dry mouth, feeling sick (nausea)
• weakness or lack of strength (asthenia)
• low blood pressure (hypotension), feeling faint or dizzy when standing up from sitting or lying position (orthostatic hypotension). This happens especially at the beginning of your treatment or if you restart your treatment after a break. If these symptoms last for a long time or become a problem, talk to your doctor or pharmacist
• muscle pain, back pain
• loss of control of your bladder (urinary incontinence), inflammation or infection of the bladder (cystitis) and urinary tract infections
• itching of the skin
• flu like symptoms
Uncommon (may affect up to 1 in 100 people)
• low levels of potassium in the blood, gout, feeling more thirsty than usual
• nightmares, forgetfulness (amnesia), feeling emotionally unstable
• shaking (tremor)
• watery eyes, being more sensitive to light than usual
• ringing in the ears (tinnitus)
• reduced blood supply to the limbs
• fainting (syncope)
• nose bleeds, tightening of the chest, sore throat
• loss of appetite or increased appetite, weight gain
• muscle pain, swelling of the joints and pain (arthralgia), muscle weakness
• difficulty or pain when passing water (urinating), needing to pass urine more often than usual, blood in urine
• flushing, high temperature (fever), shivers
• constipation, wind (flatulence), stomach pain, diarrhoea, vomiting
• low mood (depression), anxiety, sleeplessness
• rash
• difficulty in getting or keeping an erection, or in ejaculating (impotence)
• abnormal results of blood tests which show changes in the way your liver is working Rare (may affect up to 1 in 1,000 people)
• swelling of the voice box (inside the throat) - this can affect your voice
• low body temperature (especially in the elderly)
Very rare (may affect up to 1 in 10,000 people)
• a blood or urine test may show changes to the way your kidneys are working
• tiredness, a general feeling of being unwell
• an increased desire or need to pass water (urinate), disorder on passing urine, needing to pass urine at night
• hair loss
• muscle cramps, muscle weakness
• feeling restless (agitation), nervousness
• pins and needles (paraesthesia)
• blurred vision
• red or purple patches on the skin
• decreased number of platelets, which can be showed as painless, round and pinpoint purple spots on the skin, sometimes grouped to bigger patches, bleeding gums, nosebleeds or bruising with minor trauma
• difficulty in breathing of wheezing
• discomfort or enlargement of the breasts in men
Not known (frequency cannot be estimated from the available data)
• delayed ejaculation
• changes in the way things taste
• complications during eye surgery (Intraoperative floppy iris syndrome, see “Take special care with”)
Reporting of side effectsIf 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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children
Do not use after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions
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
What Slocinx XL 4mg Tablets contain:
• The active substance is doxazosin mesilate. Each tablet contains the active ingredient doxazosin mesilate equivalent to 4 mg of doxazosin
• The other ingredients are: blends of polyethylene oxide preparations containing butylhydroxytoluene (E321), microcrystalline cellulose, povidone, a- tocopherol, colloidal anhydrous silica and sodium stearyl fumarate. The tablet coating contains methacrylic acid copolymer, colloidal anhydrous silica, macrogol and titanium dioxide (E171).
What Slocinx XL 4mg Tablets look like and contents of the pack
Your medicine is in the form of a round biconvex white prolonged release tablet marked “DL” on one side. Slocinx XL 4mg Tablets are available in blister packs of 28 tablets. Tablets are available in blister packs of 28, 30 and 100 tablets.
Not all pack size may be marketed.
Marketing Authorisation Holder and Manufacturer:
The Marketing Authorisation Holder is:
Winthrop Pharmaceuticals UK Ltd, 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK Or
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK The Manufacturer is:
Winthrop Pharmaceuticals UK Ltd, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
Or
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK This leaflet was last revised in March 2015
© 2015 Zentiva
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