Lenaxolan

PACKAGE LEAFLET: INFORMATION FOR THE USER

LENAXOLAN 2 mg tablets
Equivalent medicine
Doxazosin mesilate
Please 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, please tell your doctor or pharmacist.

Contents of this leaflet:

1. What LENAXOLAN is and what it is used for
2. What you need to know before taking LENAXOLAN
3. How to take LENAXOLAN
4. Possible side effects
5. How to store LENAXOLAN
6. Contents of the pack and other information ***

1. WHAT LENAXOLAN IS AND WHAT IT IS USED FOR

Doxazosin belongs to a group of medicines known as vasodilators. These
medicines cause the blood vessels to widen, thereby lowering blood pressure. Doxazosin
also reduces tension in the muscle tissue of the prostate and urinary tract.
This medicine is indicated for the following conditions:

• treatment of high blood pressure;
• treatment of symptoms associated with an enlarged prostate.

***

2. WHAT YOU SHOULD KNOW BEFORE TAKING LENAXOLAN

Do not take LENAXOLAN

• If you are allergic (hypersensitive) to the active substance doxazosin, to other medicines
  of the same group (known as quinazolines, such as prazosin and terazosin) or to
  any of the excipients of this medicine (see also section 6)

• If you are breastfeeding

• If you have an enlarged prostate (benign prostatic hyperplasia) and suffer from low

  blood pressure

• If you have a history of a condition known as "orthostatic hypotension",
  which is a form of low blood pressure causing dizziness and mental confusion
  when rising from a sitting or lying position

• If you have an enlarged prostate with any of the following conditions: any type of
  urinary tract congestion or obstruction, chronic urinary tract infection, or bladder stones

• Do not use doxazosin as monotherapy if you suffer from overflow incontinence (you do not feel the urge to urinate), anuria (your body does not produce urine), or progressive kidney problems.
  ***
  Warnings and precautions
  Talk to your doctor or pharmacist before taking LENAXOLAN
  Reasons why LENAXOLAN may not be suitable for you:

• If you have liver disease

• If you are taking other medicines (see section 2 “Other medicines and LENAXOLAN”)

• If you suffer from heart disorders

If you are scheduled for cataract surgery (clouding of the lens), inform the specialist
before the operation that you are currently taking or have previously taken doxazosin.
This is because doxazosin may cause complications during surgery, which the specialist
can manage if informed in advance.
If any of these situations apply to you, inform your doctor before taking this medicine.
When starting treatment with LENAXOLAN, you may experience weakness or dizziness
caused by low blood pressure when rising from a sitting or lying position. If you feel
faint or dizzy, you should sit or lie down until you feel better, and avoid situations where
you might fall or injure yourself. Your doctor may decide to monitor your blood pressure
regularly at the beginning of treatment to reduce the likelihood of these effects.
Children and adolescents
LENAXOLAN is not recommended for children and adolescents.
Other medicines and LENAXOLAN
Some medicines may interact with doxazosin

• Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness due to low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers. To reduce the likelihood of such symptoms, you should already be on a stable dose of the alpha-blocker before starting treatment with erectile dysfunction medications.
• Doxazosin may lower your blood pressure even further if you are already taking other medicines for high blood pressure, such as terazosin and prazosin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
***
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
The safety of using doxazosin during pregnancy has not been established.
Do not take doxazosin if you are breastfeeding.
***
Driving and using machines
Be cautious if driving or operating machinery. Taking this medicine may affect your
ability to drive or operate machinery safely, especially at the beginning of treatment.
The medicine may cause weakness or dizziness. In such cases, do not drive or operate
machinery and contact your doctor immediately.
LENAXOLAN contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult your
doctor before taking this medicine.
***

3. HOW TO TAKE LENAXOLAN

Always take LENAXOLAN exactly as directed by your doctor. If
you have any doubts, consult your doctor or pharmacist.
Method of administration:
For oral use.
The tablets should be taken with water (approximately a full glass).
The tablet may be divided into equal doses.

Dose
The recommended dose is:
***
HIGH BLOOD PRESSURE
The initial dose is 1 mg per day (= 24 hours), taken as a single dose. After
a treatment period of 1 to 2 weeks, the dose is generally increased to
2 mg taken as a single daily dose (= 24 hours). This dose should be
maintained for a period of 1 to 2 weeks. If necessary, the dosage may
be further increased to 4, 8 or 16 mg per day, 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; this
means that any dizziness you may experience would be less problematic.
***
ENLARGED PROSTATE
The initial dose is 1 mg per day (= 24 hours), taken as a single daily dose from day 1 to day 8. From day 8 to day 14, a 2 mg tablet should be taken. If after a treatment period of 1 to 2 weeks the effect is insufficient, the dose may be increased to 4 mg per day. In some cases, the dose may be increased up to a maximum of 8 mg per day (= 24 hours).
***
The tablets must be taken as a single daily dose (= 24 hours) with plenty of water (± the content of a full glass).
If your doctor has prescribed a dosage of 1 mg per day of doxazosin,
split the 2 mg tablets in half and use one half.
***
If you take more LENAXOLAN than you should
If you take more than the prescribed dose, you must contact your doctor and/or pharmacist immediately. If you experience severe dizziness or feel faint, lie down immediately with your head in a lowered position.
***
If you forget to take LENAXOLAN
If you forget to take a tablet, skip the missed dose and take the next tablet at your usual time. For any doubts, consult your doctor or pharmacist. Do not take a double dose to make up for the forgotten tablet.
***
If you stop taking LENAXOLAN
If you suddenly stop treatment with doxazosin, the symptoms you had before starting treatment may return. Therefore, it is advisable to avoid abruptly stopping treatment. Your doctor will gradually reduce your dosage. For any doubts, ask your doctor or pharmacist for advice.
***
If you have any doubts about the use of doxazosin, consult your doctor or pharmacist.
***

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although
not everyone experiences them.
***
During treatment with doxazosin, the following adverse effects may occur:
Common: (occur in up to 1 in 10 patients)

• respiratory tract infections (nose, mouth, lungs), urinary tract infections
• drowsiness, dizziness, headache
• sensation of spinning environment (vertigo)
• awareness of heartbeat (palpitations), increased heart rate
• low blood pressure, dizziness or weakness caused by low blood pressure

occurring when standing up from a sitting or lying position

• bronchitis, cough, shortness of breath, runny nose due to inflammation

of the nasal lining (rhinitis)

• abdominal pain, indigestion, dry mouth, nausea
• itching
• back pain, muscle pain
• bladder inflammation, urinary incontinence (inability to control

urination)

• general weakness, chest pain, flu-like symptoms, swelling of the

feet, ankles or fingers.
Uncommon (up to 1 in 100 patients)

• allergic reactions
• gout, increased appetite, anorexia
• agitation, depression, anxiety, insomnia and nervousness
• stroke, reduced or altered sense of touch or sensation in hands and feet,

weakness, tremor

• ringing or noise in the ears
• chest pain, angina, heart attack
• nosebleeds
• constipation, flatulence, vomiting, inflammation of the stomach and

intestine (gastroenteritis), diarrhea

• increases in liver enzymes which may affect certain medical tests

• skin rash

• joint pain

• pain or discomfort when urinating, increased frequency of urination, blood

in urine

• inability to achieve erection
• general pain, facial swelling
• weight gain

Rare (up to 1 in 1,000 patients)

• muscle cramps, muscle weakness
• increased urine volume

Very rare (occur in up to 1 in 10,000 patients)

• changes in blood composition (lack of white blood cells associated with increased susceptibility to infections (leucopenia) and sudden bleeding or bruising (thrombocytopenia)
• dizziness caused by low blood pressure when standing up after sitting or lying down, tingling in hands and feet
• blurred vision
• decreased heart rate, irregular heartbeat
• hot flushes
• asthmatic wheezing
• biliary disorders, hepatitis (liver inflammation), jaundice
• urticaria, hair loss, red or purplish spots on the skin
• increased urine production, urinary disorders, need to urinate during the night
• breast enlargement in men, painful persistent erection
• fatigue, malaise

Not known: frequency cannot be estimated from available data

• Intraoperative Floppy Iris Syndrome (IFIS)
• Cloudy urine emission after ejaculation

If you experience any adverse effect, including those not listed in
this leaflet, consult your doctor or pharmacist.
***

5. HOW TO STORE LENAXOLAN

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30 °C.
***
Do not use this medicine after the expiry date stated on the carton after the text “exp.”. The expiry date refers to the last day of the month.
***
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
***

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What LENAXOLAN contains
The active substance is doxazosin mesilate.
One tablet of LENAXOLAN contains doxazosin mesilate equivalent to
doxazosin 2 mg.
***
The other components are microcrystalline cellulose (E460), anhydrous lactose,
sodium carboxymethylamide (type A), magnesium stearate (E572), sodium lauryl sulfate, and anhydrous colloidal silica.

Description of the appearance of LENAXOLAN and contents of the pack
LENAXOLAN 2 mg tablets: white, elongated tablets with a dividing score on one side and the imprint “D2” on the other.
The tablets are packaged in blisters.
LENAXOLAN is available in packs of 30 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LANOVA FARMACEUTICI S.r.l. – Via Conca D’Oro, 212 – 00141 Rome, Italy
Manufacturer
Teva Pharmaceutical Works Private Limited Company
13 Pallagi H-4042, Debrecen
Hungary
***
This patient information leaflet was last approved on
***

PACKAGE LEAFLET: INFORMATION FOR THE USER

LENAXOLAN 4 mg tablets
Equivalent medicine
Doxazosin mesilate
Please read this entire leaflet carefully before taking this medicine, as 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet

1. What LENAXOLAN is and what it is used for
2. What you need to know before taking LENAXOLAN
3. How to take LENAXOLAN
4. Possible side effects
5. How to store LENAXOLAN
6. Contents of the pack and other information

***

1. WHAT LENAXOLAN IS AND WHAT IT IS USED FOR

Doxazosin belongs to a group of medicines known as vasodilators. These
medicines cause the blood vessels to widen, thereby reducing blood pressure. Doxazosin
also reduces tension in the muscle tissue of the prostate and urinary tract.
This medicine is indicated for the following uses:

• treatment of high blood pressure;
• treatment of symptoms associated with enlarged prostate.

***

2. WHAT YOU NEED TO KNOW BEFORE TAKING LENAXOLAN

Do not take LENAXOLAN

• If you are allergic (hypersensitive) to the active substance doxazosin, to other medicines
  in the same group (known as quinazolines, such as prazosin and terazosin), or
  to any of the excipients of LENAXOLAN (see also section 6)

• If you are breastfeeding

• If you have an enlarged prostate (benign prostatic hyperplasia) and suffer from low blood pressure

• If you have a history of a condition known as "orthostatic hypotension",
  which is a form of low blood pressure causing dizziness and mental confusion
  when standing up from a sitting or lying position

• If you have an enlarged prostate with any of the following conditions: any type of
  urinary tract congestion or obstruction, a chronic urinary tract infection, or
  bladder stones

• You must not use doxazosin as monotherapy if you suffer from overflow incontinence (you do not feel the urge to urinate), anuria (your body does not produce urine), or progressive kidney problems.
  ***
  Warnings and precautions
  Talk to your doctor or pharmacist before taking LENAXOLAN
  Reasons why LENAXOLAN may not be suitable for you include:

• If you have liver disease

• If you are taking other medicines (see section 2 'Other medicines and LENAXOLAN')

• If you suffer from heart disorders

If you are scheduled for cataract surgery (clouding of the lens), inform the specialist
before the operation that you are currently taking or have previously taken doxazosin.
This is because doxazosin may cause complications during surgery, which the specialist
can manage if informed in advance.
If any of these situations apply to you, inform your doctor before taking this medicine.
When starting treatment with LENAXOLAN, you may experience weakness or
dizziness caused by low blood pressure when rising from a sitting or lying position.
If you feel faint or experience dizziness, you should sit or lie down until you feel better,
and avoid situations where you might fall or get injured. Your doctor may decide
to monitor your blood pressure regularly at the beginning of treatment to reduce
the likelihood of these effects occurring.
Children and adolescents
LENAXOLAN is not recommended for children and adolescents.
Other medicines and LENAXOLAN
Some medicines may interact with doxazosin:

• Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness due to low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers. To reduce the risk of such symptoms, you should already be on a stable dose of the alpha-blocker before starting treatment with medications for erectile dysfunction.
• Doxazosin may lower your blood pressure even further if you are already taking other medicines for high blood pressure, such as terazosin and prazosin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
***
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant,
or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of using doxazosin during pregnancy has not been established. Do not
take doxazosin if you are breastfeeding.
***
Driving and using machines
Exercise caution if driving or operating machinery. Taking this medicine may affect
your ability to drive or operate machinery safely, especially at the beginning of treatment.
It may cause weakness or dizziness. In such cases, do not drive or operate machinery,
and contact your doctor immediately.
LENAXOLAN contains lactose
If your doctor has informed you that you have an intolerance to certain sugars,
consult your doctor before taking this medicine.
***

3. HOW TO TAKE LENAXOLAN

Always take LENAXOLAN exactly as directed by your doctor. If
you have any doubts, consult your doctor or pharmacist.
Method of administration:
For oral use.
The tablets should be taken with water (approximately a full glass).
The tablet may be divided into equal doses.

Dose
The recommended dose is:
***
HIGH BLOOD PRESSURE
The initial dose is 1 mg per day (= 24 hours), taken as a single dose. After
a treatment period of 1 to 2 weeks, the dose is generally increased to
2 mg taken as a single daily dose (= 24 hours). This dose should be
maintained for a period of 1 to 2 weeks. If necessary, the dosage may
be further increased to 4, 8 or 16 mg per day, until the desired
reduction in blood pressure is achieved. The maximum daily dose is
16 mg.
The initial dose should preferably be taken before going to bed; this
means that any dizziness you may experience would be less problematic.
***
ENLARGED PROSTATE
The initial dose is 1 mg per day (= 24 hours), taken as a single daily dose from days 1 to 8. From days 8 to 14, a 2 mg tablet should be taken. If after a treatment period of 1 to 2 weeks the effect is insufficient, the dose may be increased to 4 mg per day. In some cases, the dose may be increased up to a maximum of 8 mg per day (= 24 hours).
***
The tablets must be taken once daily (= 24 hours) with plenty of water (± the volume of a full glass).
If your doctor has prescribed a dosage of 1 mg per day of doxazosin,
split the 2 mg tablets in half and use one half.
***
If you take more LENAXOLAN than you should
If you take more than the prescribed dose, you must contact your doctor and/or
pharmacist immediately. If you experience severe dizziness or feel you might faint, lie down immediately with your head in a lowered position.
***
If you forget to take LENAXOLAN
If you forget to take a tablet, skip the missed dose and take the next tablet at your usual time. For any doubts, consult your doctor or pharmacist. Do not take a double dose to make up for the forgotten tablet.
***
If you stop taking LENAXOLAN
If you suddenly stop treatment with doxazosin, the symptoms you had before starting treatment may return. Therefore, it is advisable to avoid sudden discontinuation of treatment. Your doctor will gradually reduce your dose. For any doubts, ask your doctor or pharmacist for advice.
***
If you have any questions about the use of doxazosin, consult your doctor or pharmacist.
***

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, LENAXOLAN may cause adverse effects, although
not everyone experiences them.
***
During treatment with doxazosin, the following adverse effects may occur:
Common: (occur in up to 1 in 10 patients)

• Respiratory tract infections (nose, mouth, lungs), urinary tract infections
• Drowsiness, dizziness, headache
• Sensation of the environment spinning (vertigo)
• Awareness of heartbeat (palpitations), increased heart rate
• Low blood pressure, dizziness or weakness due to low blood pressure occurring when standing up from a sitting or lying position
• Bronchitis, cough, shortness of breath, runny nose due to inflammation of the nasal lining (rhinitis)
• Abdominal pain, indigestion, dry mouth, nausea
• Itching
• Back pain, muscle pain
• Bladder inflammation, urinary incontinence (inability to control urination)
• General weakness, chest pain, flu-like symptoms, swelling of feet, ankles or fingers

Uncommon (occur in up to 1 in 100 patients)

• Allergic reactions
• Gout, increased appetite, anorexia
• Agitation, depression, anxiety, insomnia, restlessness
• Stroke, reduced or altered sense of touch or sensation in hands and feet, weakness, tremor
• Ringing or noise in the ears
• Chest pain, angina, heart attack
• Nosebleeds
• Constipation, flatulence, vomiting, inflammation of the stomach and intestine (gastroenteritis), diarrhoea
• Increased liver enzymes, which may affect certain medical tests
• Skin rash
• Joint pain
• Pain or discomfort when urinating, increased frequency of urination, blood in urine
• Inability to achieve erection
• General pain, facial swelling, weight gain

Rare (occur in up to 1 in 1,000 patients)

• Muscle cramps, muscle weakness
• Increased volume of urine

Very rare (occur in up to 1 in 10,000 patients)

• Changes in blood composition (lack of white blood cells associated with increased susceptibility to infections (leucopenia) and sudden bleeding or bruising (thrombocytopenia))
• Dizziness due to low blood pressure when standing up after sitting or lying down, tingling in hands and feet
• Blurred vision
• Decreased heart rate, irregular heartbeat
• Hot flushes
• Wheezing
• Biliary disorders, hepatitis (liver inflammation), jaundice
• Urticaria, hair loss, red or purplish spots on the skin
• Increased urine production, urinary disorders, need to urinate during the night
• Breast enlargement in men, painful prolonged erection
• Fatigue, malaise

Not known: frequency cannot be estimated from the available data

• Intraoperative Floppy Iris Syndrome (IFIS)
• Cloudy urine emission after ejaculation

If you experience any adverse effect, including those not listed in
this leaflet, consult your doctor or pharmacist.
***
If you experience any adverse effect, including those not listed
in this leaflet, consult your doctor or pharmacist.
***

5. HOW TO STORE LENAXOLAN

Keep LENAXOLAN out of the sight and reach of children.
Store below 30 °C.
***
Do not use LENAXOLAN after the expiry date stated on the carton after the text
“exp.”. The first two digits indicate the month; the following digits indicate the
year.
***
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will
help protect the environment.
***

6. PACKAGING CONTENTS AND OTHER INFORMATION

What LENAXOLAN contains
The active substance is doxazosin mesylate.
One tablet of LENAXOLAN contains doxazosin mesylate equivalent to
doxazosin 4 mg.
***
The other components are microcrystalline cellulose E460, anhydrous lactose,
sodium carboxymethyl starch (type A), magnesium stearate E572, sodium lauryl sulfate and
anhydrous colloidal silica.
***
Description of the appearance of LENAXOLAN and packaging contents
LENAXOLAN: white, elongated tablets with a dividing score line on one side
and the marking “D4” on the other.
***
The tablets are packaged in blisters.
LENAXOLAN is available in packs of 20 tablets.
***
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LANOVA FARMACEUTICI S.r.l. – Via Conca D’oro, 212 – 00141 Rome, Italy
Manufacturer
Teva Pharmaceutical Works Private Limited Company
13 Pallagi H-4042, Debrecen
Hungary
This summary of product characteristics was last approved on
***