4 mg prolonged-release tablet
Doxazosin
1. What Doxazosin Stada is and what it is used for
Your doctor may have prescribed Doxazosin Stada for high blood pressure, which may increase the risk of heart disease and stroke if left untreated. The active substance in the tablet, doxazosin, belongs to a group of medicines called alpha-1 antagonists. These drugs work by dilating the blood vessels, making it easier for the heart to pump blood through them. This helps to lower blood pressure and reduce the risk of heart disease.
Your doctor may also have prescribed Doxazosin Stada to treat the symptoms of benign prostatic hyperplasia. This condition means that the prostate, which is located just below the bladder in men, is enlarged. This makes it more difficult to empty the bladder. Doxazosin Stada works by relaxing muscles around the bladder outlet and the prostate gland, making it easier to empty the bladder.
Doxazosin contained in Doxazosin Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Doxazosin Stada
Do not use Doxazosin Stada
- if you are allergic to doxazosin, quinolones (eg prazosin, terazosin) which are the chemical family of medicines to which doxazosin belongs, or any of the other ingredients of this medicine (listed in section 6)
- if you have low blood pressure ( hypotension ) or if you have a drop in blood pressure when you get up that has caused dizziness, fainting, or fainting ( orthostatic hypotension )
- if you have benign prostate enlargement and at the same time a narrowing of the upper urinary tract, chronic urinary tract infection, or stones in the bladder
- if you have or have had any kind of narrowing of the gastrointestinal tract
- if you have overflow incontinence (loss of bladder control), anuria (no urinary excretion), or progressive deterioration of kidney function
- if you are breast-feeding.
Warnings and cautions
Talk to your doctor or pharmacist before taking Doxazosin Stada.
- if you have any liver disease
- if you have had an acute heart disease such as heart failure
- if you are under 18 years of age
- if you are taking Doxazosin Stada and so-called phosphodiesterase -5 inhibitors (eg sildenafil, tadalafil, or vardenafil), both of which have an antihypertensive effect (see section 2 “Other medicines and Doxazosin Stada”)
- dizziness, weakness, and in rare cases fainting may occur, especially at the beginning of treatment. You should therefore be especially careful at the beginning of treatment and avoid situations that could lead to injury should these symptoms occur.
Your doctor will tell you what to do if you experience postural hypotensive symptoms (a decrease in blood pressure and symptoms when you change your posture, for example from lying or sitting to a standing position).
You should not worry if you sometimes discover a tablet-like part of your stool. Doxazosin Stada has a tablet casing that is not absorbed in the gastrointestinal tract, this is designed to control the release from the tablet over a delayed time.
If you are going to have eye surgery due to cataracts (turbidity of the lens of the eye), you must inform your eye specialist before the operation that you are using or have used Doxazosin Stada. This is because the use of Doxazosin Stada can cause complications during the surgery which can be managed if your specialist is informed.
Children and young people
Doxazosin Stada is not recommended for use in children or adolescents below 18 years of age as safety and efficacy have not yet been established.
If you are not sure, talk to your doctor or pharmacist.
Other medicines and Doxazosin Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor in particular if you are taking any of the following medicines:
- Other medicines for high blood pressure
Some patients who use alpha-receptor blockers such as Doxazosin Stada for the treatment of high blood pressure or prostate enlargement can experience dizziness or fainting, which can be caused by low blood pressure when you quickly sit or stand up. Some patients have experienced these symptoms after using impotence ( erectile dysfunction ) medicines with alpha-receptor blockers. To reduce the risk of these symptoms, you should use alpha-receptor blockers regularly with a fixed daily dose before you start using impotence medicines.
Doxazosin Stada with food and drink
Doxazosin Stada can be taken with or without food.
Pregnancy and breastfeeding
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Do not use Doxazosin Stada without talking to your doctor first if you are pregnant or trying to become pregnant. Experience with the use of doxazosin during pregnancy is limited.
Do not use Doxazosin Stada if you are breast-feeding.
Driving and using machines
Doxazosin Stada may cause drowsiness. Take special care when taking your first dose, if your dose is increased or if you start taking the medicine again after a break. Do not drive or use machines if you feel dizzy or faint.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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 Stada contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. next to “sodium-free”.
3. How to use Doxazosin Stada
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The dosage one for Doxazosin Stada is the same for treating high blood pressure as for treating the symptoms of benign prostatic hyperplasia. The usual dose is one tablet (4 mg) daily. Your doctor may increase the dose to a maximum recommended dose, 2 tablets daily.
Doxazosin Stada is specially designed to release active ingredients evenly throughout the day. The tablet can be taken at any time of the day with or without food. Choose the time of drug intake that is right for you and take the tablets at that time each day. The tablets should be swallowed whole with a large amount of liquid and should not be chewed, divided, or crushed.
If you use more Doxazosin 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.
The most likely symptoms of an overdose if you have taken too many tablets are that you feel faint or dizzy which is due to a drop in blood pressure. You should then lie down on your back with your feet high.
If you forget to use Doxazosin Stada
If you miss a dose, do not worry about taking the next day’s dose when it’s time. Do not take a double dose to make up for a forgotten tablet.
If you stop using Doxazosin Stada
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- infection in the respiratory
- dizziness, headache, drowsiness
- clumsiness / balance disorders
- palpitation er (a feeling of irregular and/or strong heartbeat), increased heart rate
- low blood pressure and low blood pressure in connection with getting up from a sitting or lying position ( postural hypotension )
- inflammation of the lungs’ airways, cough, shortness of breath, nasal congestion, and/or runny nose
- abdominal pain, digestive problems, dry mouth, nausea
- itching
- back pain, muscle aches
- urinary tract infection, inflammation of the bladder ( cystitis ), urinary incontinence
- general weakness, chest pain, flu-like symptoms, swelling.
Uncommon (may affect up to 1 in 100 people):
- allergic reactions to the drug
- loss of appetite, gout, increased appetite
- anxiety, emotional instability, sleep disorders ( insomnia )
- stroke, decreased sensation, fainting, tremors, tinnitus (ringing or noise in the ears)
- chest pain, myocardial infarction (heart attack), nosebleeds
- constipation, diarrhea, bloating, vomiting, inflammation of the gastrointestinal tract
- abnormal liver function tests
- rash
- joint pain
- pain or difficulty urinating, red blood cells in the urine (hematuria), increased frequency of urination
- impotence
- pain
- weight gain
- swelling of the face.
Very rare (may affect up to 1 in 10,000 people):
- decreased platelet count
- decreased number of red and white blood cells
- dizziness with the rapid change of posture from lying or sitting to standing
- restlessness, anxiety
- stinging and crawling feeling
- dimsyn
- slow heartbeat, irregular heartbeat
- redness (swelling)
- bronchial spasm
- blocked the flow of bile (cholestasis), liver inflammation ( hepatitis ), yellowing of the skin
- alopecia (hair loss), purpura (a rash caused by bleeding under the skin), hives
- muscle cramps, muscle weakness
- disturbances in urination, several urination times at night, increased urine output
- temporary enlargement of the breasts ( gynecomastia )
- persistent painful erection of the penis. Seek medical attention immediately
- fatigue, malaise.
Has been reported (occurs in an unknown number of users):
- a complication affecting the iris muscle can occur during cataract surgery (“Intraoperative Floppy Iris Syndrome”)
- taste changes
- restrained ejaculation
Rare cases of fainting spells associated with postural hypotension (drops in blood pressure due to getting up from a sitting or lying position) have been observed.
5. How to store Doxazosin Stada
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 carton after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
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 (mesilate). One prolonged-release tablet contains 4.85 mg doxazosin mesilate equivalent to 4 mg doxazosin.
Other ingredients are:
Core:
Macrogol, microcrystalline cellulose, Povidone K 29-32, butylhydroxytoluene (E321), α-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate
coating:
Methacrylic acid-ethyl acrylate copolymer (1: 1) dispersion 30 percent, colloidal anhydrous silica macrogol 1300-1600, and titanium dioxide (E171)
What the medicine looks like and the contents of the pack
The tablets are white, round, and biconvex embossed with “DL” on one side.
The drug is available in PVC / PVDC / aluminum blisters in pack sizes 5, 10,14,
20, 28, 30, 40, 50, 56, 60, 80, 84, 90, 98, 100, 150, 196, 200, 250, 300, 400, 500, and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, 611 18 Bad Vilbel; Germany
Manufacturer
Centrafarm Services BV, Nieuwe Donk 9, 4897 AC Etten-Leur, The Netherlands
STADA Production Ireland Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland
STADApharm GmbH, Stadastr. 2-18, 61118 Bad Vilbel, Germany
PharmaCoDane ApS, Marielundvej 46 A, 2730 Herlev, Denmark
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark