4 mg prolonged-release tablet 
doxazosin

What Doxazosin Actavis is and what it is used for

Doxazosin Actavis belongs to a group of medicines called alpha-blockers. It is used to lower blood pressure in both women and men and to treat the symptoms caused by an enlarged prostate gland in men.

Doxazosin Actavis lowers high blood pressure ( hypertension ) by dilating blood vessels to facilitate blood flow. This helps to lower blood pressure.

In men with an enlarged prostate gland, Doxazosin Actavis is used to treat urinary symptoms such as a weak urine stream and the need to urinate frequently. These symptoms are common in men with an enlarged prostate gland. Doxazosin Actavis relaxes the muscles around the mouth of the bladder and the prostate gland to make it easier to urinate.

Doxazosin contained in Doxazosin Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Doxazosin Actavis

Do not take Doxazosin Actavis

  • if you are allergic to doxazosin, other so-called quinazolines (eg prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest itself in the form of a rash, itching, difficulty breathing, and swelling of the face, lips, throat, or tongue.
  • if you have benign prostatic hyperplasia and at the same time have bladder stones or have a narrowing or infection in the urinary tract
  • if you have benign prostatic hyperplasia and leakage from the bladder, problems producing urine, or increasing deterioration of kidney function
  • if you have any type of narrowing of the gastrointestinal tract
  • if you have previously had a drop in blood pressure when standing or sitting up too fast (orthostatic hypotension)
  • if you have abnormally low blood pressure (only relevant if you are being treated for an enlarged prostate gland)
  • if you are breast-feeding.

Warnings and cautions

Talk to your doctor or pharmacist before taking Doxazosin Actavis.

  • If you have had an operation.
  • At the beginning of the treatment, you may experience a drop in blood pressure when you get up from a lying or sitting position and feel weak or dizzy. In such cases, sit down or lie down until you feel better. Your doctor will monitor your blood pressure during the start of treatment.
  • If you have acute heart diseases such as swelling and/or fluid accumulation in the lungs ( pulmonary edema ) or heart failure.
  • Be careful if you have acute heart failure due to a blood clot or fluid accumulation around the heart.
  • If you have severe hepatic impairment.
  • If you are a man and use impotence drugs, which contain the substances sildenafil, tadalafil, or vardenafil, as concomitant use of these drugs and doxazosin may lead to low blood pressure. Your doctor will tell you how long you have to wait before taking doxazosin after using any of these medicines.
  • If you are going to undergo eye surgery due to cataracts (turbidity of the lens of the eye), you should inform your eye specialist before the operation if you are using or have used Doxazosin Actavis. This is because the use of Doxazosin Actavis can cause complications during the operation, which can be remedied if the ophthalmologist has been informed in advance.
  • If you have a urine or blood sample, remember to tell your doctor or nurse that you are being treated with Doxazosin Actavis.

Doxazosin Actavis is a prolonged-release tablet. The drug is enclosed by a shell designed to slowly release the drug. The empty shell disappears from the body through bowel movements and you can at times see something resembling a tablet in the stool. Do not worry because this is expected.

Children and young people

Doxazosin Actavis is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established.

Other medicines and Doxazosin Actavis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your treatment may be affected if Doxazosin Actavis is taken with certain other medicines.

You must tell your doctor if you are being treated with any of the following medicines:

  • Drugs for impotence in men (containing the substances sildenafil, tadalafil, and vardenafil) taken at the same time as doxazosin may cause low blood pressure.
  • Some patients treated with alpha-blockers for high blood pressure or prostate enlargement may experience dizziness or dizziness due to a drop in blood pressure when they sit down or stand up too quickly. Some patients have experienced these symptoms while using erectile dysfunction ( impotence ) while taking alpha-blockers. To reduce the risk of these symptoms occurring, you should have a regular daily dose of your alpha-blocker before you start using erectile dysfunction medication.
  • Other antihypertensive drugs – because the antihypertensive effect can be increased.
  • Anti-inflammatory drugs ( NSAIDs ) – as these may reduce the effect of DoxazosinActavis.
  • Cimetidine, a medicine used to treat stomach ulcers, if taken concomitantly with doxazosin increases the effect of doxazosin. Talk to your doctor about this.

Pregnancy, breastfeeding, and fertility

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.

Doxazosin Actavis must not be used during breast-feeding.

Driving and using machines

Be careful when driving or using machines. The tablets may affect your ability to drive or use machines safely, especially at the beginning of treatment. Do not drive or use machines if you feel affected by the treatment and contact a doctor as soon as possible.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Doxazosin Actavis contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, it is essentially ‘sodium-free’.

How to take Doxazosin Actavis

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The tablets should be swallowed whole with a glass of water. Do not chew, divide or crush the tablets.

The tablets can be taken with or without food.

Doxazosin Actavis can be used if you suffer from high blood pressure or prostate enlargement. Both conditions are treated simultaneously.

Adults, including the elderly:

• Treatment of high blood pressure in adult men and women

The recommended dose is 4 mg doxazosin (1 prolonged-release tablet ) once daily. If necessary, the dose can be increased to 8 mg doxazosin (2 prolonged-release tablets) once daily. It can take up to 4 weeks before maximum effect is reached.

• Treatment of symptoms of enlarged prostate in adult men

The recommended dose is 4 mg doxazosin (1 prolonged-release tablet ) once daily. If necessary, the dose can be increased to 8 mg doxazosin (2 prolonged-release tablets) once daily.

• Patients with hepatic impairment:

A lower dose may be necessary. Always follow a doctor’s prescription.

If you take more Doxazosin Actavis then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Symptoms of an overdose may include headache, dizziness, fainting, unconsciousness, difficulty breathing, low blood pressure, palpitations, rapid or irregular heartbeat, or nausea.

If you forget to take Doxazosin Actavis

If you miss a dose, take it as soon as you remember if it is not almost time for your next dose. Do not take a double dose to make up for a forgotten doseTake the next dose at the right time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you stop taking Doxazosin Actavis

Continue to take Doxazosin Actavis for the entire duration of your treatment as prescribed by your doctor. Do not stop taking Doxazosin Actavis or change your dose without consulting your doctor.

4. Possible side effects

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

Stop taking the medicine and contact a doctor immediately if you have an allergic reaction to the medicine. If you get a rash, swelling of the face, lips, tongue, or throat, difficulty breathing, or difficulty swallowing, stop taking DoxazosinActavis and contact a doctor immediately. You may need immediate medical attention or hospitalization.

Contact your doctor immediately if you have a heart attack. This is a very serious but less common side effect.

Contact your doctor immediately if you suffer from hepatitis (a liver disease with nausea, vomiting, loss of appetite, general malaise, fever, itching, the skin and whites of the eyes turn yellow and the urine becomes dark) or jaundice (the skin and whites of the eyes turn yellow) or tightness in the respiratory tract. This is a very serious but rare side effect.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

Respiratory tract infection Water accumulation in the legs
Dizziness and weakness and in rare cases fainting Urinary tract infection
Drowsiness Headache
Palpitations (more aware of the heartbeat) or faster heartbeat Balance effect if you get up quickly
Dizziness/tingling sensation especially if you get up quickly Low blood pressure
Cough Tracheal catarrh
Runny or stuffy nose, sneezing, pressure, or pain in the face Shortness of breath
Indigestion and heartburn Abdominal pain (abdominal pain and discomfort)
Nausea Dry mouth
Back pain Itching
Inflammation of the bladder ( cystitis ) Muscle pain
Chest pain Involuntary urine leakage
Feeling weak and weak Flu-like symptoms

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

Decreased appetite Pain in the middle of the chest (angina)
Increased appetite Nasal bleeding
Very severe depression Diarrhea
Stroke (inability to move one or more extremities on one side of the body, inability to understand or formulate speech, or unilateral vision loss) Stomach flu
Unconsciousness Rash
Involuntary shaking Pain when urinating
General fear Need to urinate more often
Difficulty sleeping Pain
The decreased feeling when touched Anxiety
Fainting Gout
Ringing or buzzing in the ears Joint pain
Constipation Blood in the urine
Gas formation Decreased sexual ability in men ( impotence )
Abnormal liver values ​​(measured in blood samples) Weight gain
Vomiting Tremors
Swelling of the face

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

Decreased white blood cell count(may lead to more infections (eg fever, severe chills, sore throat, or cold sores)) or platelets (may cause more bruising or bleeding) in the blood Persistent painful erection. Seek medical attention immediately.
Nervousness General malaise
Numbness Slower heartbeat
Dimsyn Excitement or restlessness ( agitation)
Airway constrictions, e.g. asthma (may cause difficulty breathing, wheezing, or coughing) Dizziness in connection with a change of position
Hair loss, baldness ( alopecia ) Tingling and tingling
Itchy rash Sudden redness
Muscle weakness Poor bile flow
Need to urinate frequently at night Red or purple discolorations on the skin (purple)
Muscle cramps Urination problem
More urine production than normal Breast augmentation in men
Fatigue Irregular heartbeat

Has been reported (occurs in an unknown number of users)

  • IFIS (a variant of small pupil syndrome) can be developed in connection with operations for cataract
  • Taste disorders
  • Delayed ejaculation, occurs when the semen is carried to the bladder instead of being normally ejaculated via the urethra.

5. How to store Doxazosin Actavis

No special storage instructions.

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

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiration date is the last day of the specified 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. Contents of the packaging and other information

Content declaration

  • The active substance is doxazosin (each tablet contains 4.85 mg doxazosin mesilate, equivalent to 4 mg doxazosin ).
  • The other ingredients are polyethylene oxide, microcrystalline cellulose, povidone K29-32, butylhydroxytoluene (E321), all-rac-α-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid ethyl acrylate copolymer, macrogol 1300-1600, macrogand 1300-1600.

What the medicine looks like and the contents of the pack

Doxazosin Actavis prolonged-release tablets are white, round, biconvex tablets marked “DL”.

The packages contain 10, 28, 30, 50, 90, 98 or 100 release tablet s

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Muhammad Nadeem

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