Doxazosin Mylan Generics: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Doxazosina Mylan Generics 2 mg tablets, 4 mg tablets

Generic Medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Doxazosina Mylan Generics is and what it is used for
What you need to know before taking Doxazosina Mylan Generics
How to take Doxazosina Mylan Generics
Possible side effects
How to store Doxazosina Mylan Generics
Contents of the pack and other information

1. What Doxazosina Mylan Generics is and what it is used for

Doxazosina Mylan Generics belongs to a group of medicines known as vasodilators. These substances cause dilation of the blood vessels, thereby reducing blood pressure. Doxazosina Mylan Generics may also reduce the tension of the muscle tissues in the prostate and urinary tract.
It is used for:

high blood pressure;
treatment of symptoms of enlarged prostate.

2. What you need to know before taking Doxazosina Mylan Generics

Do not take Doxazosina Mylan Generics

if you are allergic to the active substance, to other medicines in the same group (known as quinazolines, such as prazosin and terazosin), or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from (or have previously suffered from) orthostatic hypotension, a condition in which a drop in blood pressure causes dizziness when standing up from a lying or sitting position;
if you have an enlarged prostate associated with difficulty in urinating, chronic inflammation of the urinary tract, or bladder stones;
if you are unable to retain urine or do not feel the urge to urinate (suffer from overflow incontinence), or if you are unable to produce urine (anuria), with or without kidney problems;
if you suffer from (or have previously suffered from) low blood pressure, which applies only if Doxazosina Mylan Generics has been prescribed to treat an enlarged prostate.

Warnings and precautions
Talk to your doctor or pharmacist before taking Doxazosina Mylan Generics

At the beginning of treatment or when the dose is increased. In these cases, the likelihood of a rapid drop in blood pressure is higher. You may experience this as dizziness and weakness, or more rarely fainting, when changing position. To reduce this risk, your doctor will carefully monitor your blood pressure at the start of treatment and when the dose is increased.

Before taking this medicine, consult your doctor:

If you are following a strict low-salt diet or are using diuretics;
If you are elderly;
If you have reduced kidney or liver function. In any of these cases, situations in which dizziness or fainting could lead to injury should be avoided at the beginning of treatment.
If you suffer from heart disease;
If you are taking doxazosin at the same time as medicines used to treat stomach problems such as cimetidine;
If your doctor has told you that you have an intolerance to certain sugars;
If you have nervous system disorders as a consequence of diabetes;
If you have been scheduled for cataract surgery (clouding of the lens), inform your ophthalmologist before the operation that you are currently being treated or have previously been treated with Doxazosina Mylan Generics. Doxazosina Mylan Generics may cause complications during surgery. However, these complications can be managed by the ophthalmologist if informed in advance.

Some patients taking alpha-blockers to treat high blood pressure or an enlarged prostate may experience dizziness or a lightheaded feeling, which may be caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) together with alpha-blockers. To prevent these symptoms, you must be stabilized on a regular daily dose of an alpha-blocker before starting treatment for erectile dysfunction.

Children and adolescents
Doxazosina Mylan Generics is not recommended for use in children or adolescents under 18 years of age, as safety and efficacy have not yet been established.

Other medicines and Doxazosina Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Note: The following comments may also apply to the use of medicines in the recent past or near future.
You may be more familiar with the medicines mentioned in this leaflet under a different name, often the brand name. This leaflet refers only to the active ingredient of the medicine, or to the group of medicines, but not to the brand name. Therefore, you should always carefully check the packaging or the package leaflet to see what the active substance is in the medicines you are using.
An interaction means that medicines or substances may affect each other in terms of their action or side effects when taken at the same time. Interactions may occur when Doxazosina Mylan Generics is used together with:

Other medicines used for high blood pressure, such as beta-blockers (e.g. atenolol);
Nitrates (medicines for heart problems) such as nitroglycerin and isosorbide mononitrate: these may increase the blood pressure-lowering effect;
Medicines that dilate blood vessels: these may increase the blood pressure-lowering effect;
Certain painkillers for rheumatism (known as non-steroidal anti-inflammatory drugs) such as naproxen, ibuprofen, or any other anti-inflammatory painkiller: these may reduce the blood pressure-lowering effect;
Medicines known as sympathomimetics (substances that have a stimulating effect on a particular part of the nervous system) such as dopamine, ephedrine, metaraminol, adrenaline, and phenylephrine: these may reduce the blood pressure-lowering effect;
Medicines that may also interfere with liver metabolism, e.g. cimetidine (a medicine for stomach disorders);
Certain medicines for erectile dysfunction such as sildenafil, tadalafil, and vardenafil: these may increase the blood pressure-lowering effect;
Medicines used to treat bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole;
Medicines used to treat HIV, such as indinavir, nelfinavir, ritonavir, saquinavir;
Nefazodone, a medicine used to treat depression. Doxazosina Mylan Generics may interfere with the interpretation of certain laboratory test results.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
There are insufficient data on use during pregnancy in humans to make any judgment about possible risks. Animal studies have not shown any harmful effects. Consult your doctor if you are pregnant or planning a pregnancy, as this medicine should only be used during pregnancy if a doctor decides that the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding
Small amounts of doxazosin may pass into breast milk. Do not breastfeed unless your doctor advises you to do so.

Driving and using machines
Doxazosina Mylan Generics may affect your ability to drive or use machinery, especially at the beginning of treatment. Doxazosina Mylan Generics may sometimes cause dizziness or fainting. In such cases, you should exercise caution during activities requiring attention, such as driving, operating machinery, or working at heights. If you are unsure whether Doxazosina Mylan Generics has negative effects on your ability to drive, discuss this with your doctor.

Doxazosina Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Doxazosina Mylan Generics contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Doxazosina Mylan Generics

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
HIGH BLOOD PRESSURE
The initial dose is 1 mg once daily (=24 hours). After 1 or 2 weeks, the dose is usually increased to 2 mg once daily (=24 hours). This dose should be maintained for 1 or 2 weeks. If necessary, the dose may be further increased to 4, 8 or 16 mg daily, until the desired reduction in blood pressure is achieved. The maximum daily dose is 16 mg.
The initial dose should preferably be taken at bedtime to minimize problems from possible dizziness.
ENLARGED PROSTATE
The initial dose is 1 mg once daily (=24 hours), taken from day 1 to day 8. From day 8 to day 14, take one 2 mg tablet daily. If after 1 or 2 weeks the effect is insufficient, the dose may be increased to 4 mg daily. In some cases, the dose may be increased up to a maximum of 8 mg daily (=24 hours).
The tablets must be taken every day (=24 hours) as a single daily dose. The tablets must be swallowed with plenty of water (approximately a full glass).
If your doctor has prescribed you a daily dose of 1 mg of Doxazosina Mylan Generics, you must split a 2 mg tablet in half and use one half.
If you take more Doxazosina Mylan Generics than you should
If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately. If you feel dizzy or think you might faint, lie down immediately with your head low.
If you forget to take Doxazosina Mylan Generics
If you have forgotten to take a tablet, skip the missed dose and take the next tablet at your usual time.
Ask your doctor or pharmacist if you are unsure.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Doxazosina Mylan Generics
If you stop taking Doxazosina Mylan Generics suddenly, the symptoms you had before starting treatment may return. Therefore, it is better not to stop taking this medicine abruptly. Your doctor will gradually reduce your dose. Always ask your doctor or pharmacist if you are unsure.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
The following side effects may occur when using Doxazosina Mylan
Generics:

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

Respiratory tract infection (nose, throat, lungs) and urinary tract infection
Headache, dizziness, drowsiness
Delayed ejaculation, lethargy
Visual disturbances
Palpitations, increased heart rate, swelling of different parts of the body
Low blood pressure, drop in blood pressure when changing position
Nasal congestion and runny nose
Cough, difficulty breathing
Abdominal pain, belching, nausea, heartburn (dyspepsia), dry mouth
Itching
Back pain
Loss of bladder control, bladder inflammation
Weakness
Flu-like symptoms
Swelling of the hands, ankles or feet.

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

Low potassium levels in the blood (hypokalaemia, which in severe cases may present as muscle cramps or muscle weakness and fatigue), thirst, joint swelling due to uric acid crystals
Increased appetite
Nightmares, memory loss, emotional instability, restlessness, depression, nervousness, difficulty falling asleep
Tremors, muscle stiffness, stroke, decreased touch or sensitivity, especially of the skin, weakness
Ringing in the ears
Excessive tearing, increased sensitivity to light
Constricting and painful sensation in the chest (angina pectoris), myocardial infarction
Diarrhoea, vomiting, constipation, inflammation of the stomach and intestine, presence of gas
Nosebleeds, sore throat
Abnormal liver function tests
Skin rash, sweating
Pain during urination, blood in the urine, frequent need to urinate
Inability to achieve or maintain an erection (impotence)
General or facial swelling, facial redness, fever, pallor
Weight gain
Taste disturbances.

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

Low blood sugar levels
Tingling or numbness of the hands or feet
Dizziness when changing position
Problems with blood vessels in the brain (cerebrovascular problems)
Passing much more urine than normal
Decreased body temperature in the elderly
Itchy eye discharge and gritty sensation in the eyelids (conjunctivitis)
Shortness of breath due to swelling of the larynx
Stomach pain
Increased urine production

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

Lack of white blood cells and decreased platelets associated with increased susceptibility to infections and unexpected bleeding or bruising
Slow heart rate, irregular heartbeat
Hot flushes
Shortness of breath due to cramping of the respiratory muscles (bronchospasm)
Blurred vision
Yellowing of the skin or eyes (jaundice), liver inflammation, bile problems
Hair loss, bruising under the skin (purpura), hives
Muscle cramps, muscle weakness
Increased urine production, problems during urination, need to urinate at night
Painful prolonged erection of the penis. Seek immediate medical attention.
Breast enlargement in men
Fatigue, general malaise.

Side effects with unknown frequency (frequency cannot be determined from the
available data):

Eye disorder called “Intraoperative Floppy Iris Syndrome (IFIS)”
Retrograde ejaculation

At the beginning of treatment, a drop in blood pressure (especially when changing position) may occur, which can lead to dizziness and lightheadedness; in rare cases, temporary loss of consciousness may occur, particularly at higher doses.
These effects may also occur when treatment is resumed after a short interruption.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Doxazosina Mylan Generics

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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Doxazosina Mylan Generics contains
The active substance is doxazosin mesylate.
One tablet of Doxazosina Mylan Generics 2 mg contains doxazosin mesylate
equivalent to 2 mg of doxazosin.
The other components are: microcrystalline cellulose, anhydrous lactose, sodium starch
glycolate (type A), magnesium stearate, sodium lauryl sulfate and anhydrous colloidal silica.
One tablet of Doxazosina Mylan Generics 4 mg contains doxazosin mesylate
equivalent to 4 mg of doxazosin.
The other components are: microcrystalline cellulose, anhydrous lactose, sodium starch
glycolate (type A), magnesium stearate, sodium lauryl sulfate and anhydrous colloidal silica.

Description of the appearance of Doxazosina Mylan Generics and package contents
2 mg: white, oblong tablet, with a break line on one side and the imprint “D2” on the other.
4 mg: white, oblong tablet, with a break line on one side and the imprint “D4” on the other.
The tablets are packaged in PVC/PVDC-aluminum blisters.
2 mg: packs containing 30 tablets.
4 mg: packs containing 20, 30 and 60 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124, Milan, Italy

Manufacturer
Teva Pharmaceutical Works Private Limited Company, 13 Pallagi, H-4042 Debrecen, Hungary