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CARDURAN® NEO 4-8mg. modified release tablets, Doxazosin
The active ingredient is Doxazosin. Each tablet contains 4-8mg of Doxazosin as mesylate. The other components are: The tablet core: polyethylene oxide, sodium chloride, hydroxypropyl methylcellulose, red ferric oxide (E 172), magnesium stearate. The tablet coating: cellulose acetate, polyethylene glycol (Macrogol 3350), hydroxypropyl methylcellulose, titanium dioxide (E 171), modified pharmaceutical glaze and black iron oxide (E 172).
WHAT IS DOXAZOSIN
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) is an agent with vasodilator action developed by Pfizer for the treatment of arterial hypertension and benign prostatic hyperplasia.
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) is indicated in the treatment of high blood pressure (arterial hypertension) and in the treatment of urinary outflow obstruction and irritative symptoms associated with benign prostatic hyperplasia (BPH).
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) may be used in BPH patients who are either hypertensive or normotensive. CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) can be used as a mono-agent in the treatment of patients with both pathologies.
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BEFORE TAKING DOXAZOSIN
Treatment with CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) requires periodic medical control.
Do not take CARDURAN NEO, DOXAZOSIN if:
o You are hypersensitive (allergic) to any of the components of CARDURAN NEO, DOXAZOSIN or to other quinazolines (for example, terazosin or prazosin).
o You have a history of gastro-intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract.
o You suffer severe hepatic insufficiency. Since there is no clinical experience in patients with severe hepatic insufficiency, the use of this medication by these patients is not recommended.
Take special care with CARDURAN NEO, DOXAZOSIN:
o If you suffer liver impairment
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) should be used with caution and under close medical surveillance in patients with evidence of impaired hepatic function (mild-moderate).
o If you suffer benign prostatic hyperplasia and are hypotensive
Although it is not expected with this modified release pharmaceutical form, it should be administered with caution to hypotensive patients that suffer benign prostatic hyperplasia.
o In children. No experience is available on usage of CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) in children.
o As with other antihypertensive medications (for example, alpha-blockers), the administration of CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) may cause postural hypotension evidenced by dizziness, weakness or rarely loss of consciousness (syncope). When instituting therapy with any effective alpha-blocker, the patient should be advised how to avoid symptoms resulting from postural hypotension and what measures to take should they develop.
No special care is needed when using CARDURAN NEO, DOXAZOSIN:
o In the elderly. At the same dose, CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) is equally well tolerated in young and elderly patients, therefore in both cases the usual dosage is recommended.
o In patients with impaired renal function since the usual dose can be administered.
Taking CARDURAN NEO, DOXAZOSIN with food and drink
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) can be taken with or without food.
Pregnancy
The safety of CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) during pregnancy has not yet been established.
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) should only be taken while pregnant if, in the opinion of the doctor, there is no safer alternative medication and only when the potential benefit outweighs the potential risk to the mother or foetus.
Consult your doctor or pharmacist before taking any medication.
Lactation
The safety of CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) during lactation has not yet been established.
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) should only be taken during lactation if, in the opinion of the doctor, there is no safer alternative medication and only when the potential benefit outweighs the potential risk to the mother or foetus.
Consult your doctor or pharmacist before taking any medication.
Effects on ability to drive and use machines
The ability to carry out activities such as driving a vehicle or using machinery may be impaired, especially when initiating therapy with CARDURAN NEO, DOXAZOSIN (modified release Doxazosin).
Taking other medications
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) has been concomitantly administered with other antihypertensive agents, other medications like non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycaemic drugs, uricosuric agents, anticoagulants, digoxin, warfarin, phenytoin and indomethacin without causing adverse drug interactions. Doxazosin potentiates the blood pressure-lowering effect of other antihypertensive agents.
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HOW TO TAKE DOXAZOSIN
Your doctor will decide what dose of CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) is most appropriate for you.
Do not take more tablets than recommended by your doctor. The dose of CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) should be adjusted by your doctor according to your individual response. Strictly follow the instructions given by your doctor with regard to dosage and method of administration.
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) 4-8mg. tablets are taken by mouth.
The initial dose is one tablet (4-8mg. CARDURAN NEO, DOXAZOSIN) once per day.
The optimal effect is obtained after 4 weeks. If necessary, after this period, dosage can be increased to one daily dose of 8 mg. according to the patient response.
The maximum recommended dose is 8 mg. taken once daily.
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) may be administered either in the morning or in the evening.
All dosage adjustments and controls should always be done under medical supervision.
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) may be administered with other medications also used for the treatment of arterial hypertension and BPH prescribed by your doctor.
Instructions for the correct administration of the product
CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) should be swallowed whole. Patients should not chew, divide or crush the tablets.
The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water).
In CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) the medication is contained within a non-absorbable shell that has been specially designed to slowly release the medicine. When this process is completed the empty tablet is eliminated from the body in the faeces.
Take CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) once a day, every day and at about the same time each day.
Taking the tablets at the same time each day will have the best effect. It will also help you to remember when to take your tablets. CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) may be administered with or without meals
Follow these instructions unless given other indications by your doctor.
Always remember to take your medication.
The duration of the treatment with CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) will be determined by your doctor. Do not suspend treatment before, as it may harm your health.
If you consider the effect of CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) to be too strong or too weak, consult your doctor or pharmacist.
Do not take more tablets than recommended by your doctor.
If you take more CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) than you should:
If you take more CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) than you should, consult your doctor or pharmacist immediately.
Overdosage with CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) may lead to hypotension; in this case the patient should be immediately placed in a supine, head down position.
In the case of an overdose or accidental ingestion, immediately consult your local poison centre (Servicio de Información Toxicológica). Telephone 91 562 04 20.
If you forget to take CARDURAN NEO, DOXAZOSIN (modified release Doxazosin):
Do not take a double dose to make up for the forgotten doses.
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POSSIBLE SIDE EFFECTS
Like all medicines, CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) can have side effects. The side effects of Doxazosin vary in intensity from patient to patient and should be taken into account especially at the beginning of the treatment or when changing medications, these effects are usually mild.
The most common adverse effects reported in post-marketing experience have been:
Nervous System Disorders: dry mouth and abnormal persistent erection of the penis (priapism).
General Disorders: allergic reactions, hot flushes, pain, weight gain, tiredness and general malaise.
Cardiovascular Disorders: dizziness, hypotension, syncope and postural dizziness. More specifically in hypertensive patients, there have been reports of a slow heart rate (bradycardia), rapid beating of the heart (tachycardia), palpitations, chest pain, angina pectoris, myocardial infarction, cerebrovascular accidents and variation in the rhythm of the heartbeat (cardiac arrhythmias).
Central and Peripheral Nervous System Disorders: decreased sensitivity (hypoaesthesia), tingling sensation (paraesthesia) and tremor.
Endocrine System Disorders: enlargement of the breasts in men (gynaecomastia).
Gastrointestinal Disorders: constipation, diarrhoea, indigestion (dyspepsia), flatulence and vomiting.
Haematological Disorders: a reduction in the number of white blood cells (leucopoenia), a purple colouring on the skin (purpura) and low number of platelets in the blood (thrombocytopenia).
Hepatobiliary Disorders: abnormal liver function tests, slowing or cessation of the flow of bile (cholestasis), inflammation of the liver (hepatitis) and yellowing of the skin (jaundice).
Musculoskeletal Disorders: pain in a joint (arthralgia), cramps and muscle weakness.
Psychiatric Disorders: agitation, loss of appetite (anorexia), anxiety, depression, impotence, insomnia and nervousness.
Respiratory Disorders: coughing, difficulty in breathing (dyspnoea), aggravated bronchospasm and nosebleed (epistaxis).
Skin and Appendages Disorders: hair loss (alopecia), itching (pruritus), redness of the skin (rubor), hives (urticaria).
Sensory Organ disorders: blurred vision, ringing in the ears (tinnitus).
Urinary System Disorders: difficulty in passing urine (dysuria), presence of blood in the urine (haematuria), passing urine during the night (nocturia), involuntary emission of urine (urinary incontinence) and the passing of a large quantity of urine (polyuria)
In addition, the most common reactions associated with Doxazosin therapy during clinical trials were fatigue (asthenia), back pain, flu-like symptoms, swelling of the hands, feet or ankles (oedema), headache (cephalalgia), vertigo, dry mouth and sleeplessness (somnolence), abdominal pain, muscle pain (myalgia), bronchitis, respiratory tract infections, inflammation of the mucous membrane in the nose (rhinitis), inflammation of the urinary bladder (cystitis) and urinary infection.
When CARDURAN NEO, DOXAZOSIN was administered to elderly patients no increase in the incidence or change in the type of medicine related side effects was observed compared to younger patients.
In such cases, consult your doctor or pharmacist immediately.
If you notice any other side effect not mentioned in this leaflet please inform your doctor or pharmacist.
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STORAGE OF DOXAZOSIN
Store CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) out of the reach and sight of children.
Protect from moisture and humidity.
Do not store above 30°C.
Store in the original package.
Expiry: Do not use CARDURAN NEO, DOXAZOSIN (modified release Doxazosin) after the expiry date stated on the carton
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