Adadox

Package Leaflet: Information for the Patient

Adadox, 2 mg, tablets

Adadox, 4 mg, tablets

Doxazosin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Adadox and what is it used for

Doxazosin belongs to a group of medicines called alpha-blockers.
These substances cause the blood vessels to dilate, which lowers blood pressure.
Doxazosin may also reduce the tension of the prostate and urinary tract muscles.
Doxazosin is used to treat:

• high blood pressure;
• symptoms of an enlarged prostate.

2. Important information before taking Adadox

When not to take Adadox

• if the patient is allergic to doxazosin, other types of quinazolines (e.g. prazosin and terazosin) or any of the other ingredients of this medicine (listed in section 6). This may manifest as itching, redness of the skin or difficulty breathing.
• during breastfeeding,
• in patients under 18 years of age,
• if the patient has an enlarged prostate (benign prostatic hyperplasia) andlow blood pressure,
• if it is known that the patient has orthostatic hypotension, i.e. a form of low blood pressure that causes dizziness or fainting when standing up from a sitting or lying position,
• if the patient has an enlarged prostate with one of the following conditions: congestion or obstruction of the urinary tract, persistent urinary tract infection or bladder stones,
• if the patient has urinary incontinence due to overflow (no feeling of needing to urinate) or anuria (the body does not produce urine) with or without kidney problems.

Warnings and precautions

Before starting to take Adadox, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor before starting to take the medicine if they:

• are pregnant or planning to become pregnant
• suffer from liver disease
• are taking other medicines
• suffer from heart disease

If the patient is undergoing eye surgery for cataracts (clouding of the lens), they should tell the ophthalmologist before the surgery that they are taking or have taken Adadox in the past. This is because Adadox may cause complications during surgery that can be prevented if the ophthalmologist is informed in advance.
Before starting to take Adadox, the doctor may order tests to rule out conditions such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia (enlarged prostate).
Persistent painful erections may occur very rarely. In such cases, the patient should contact their doctor immediately.
After starting to take Adadox, fainting or dizziness caused by low blood pressure may occur when standing up from a sitting or lying position. If the patient feels weak or dizzy, they should sit or lie down until they feel better and avoid situations where they may fall or injure themselves. The doctor may regularly check the patient's blood pressure at the beginning of treatment to reduce the likelihood of these effects.

Adadox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or plan to take.

• In some patients taking alpha-blockers for the treatment of high blood pressure or enlarged prostate, dizziness or fainting may occur due to low blood pressure when standing up quickly or getting up. In some patients, these symptoms may occur when taking medicines for erectile dysfunction with alpha-blockers. To reduce the likelihood of these symptoms, the patient should take their regular daily dose of alpha-blockers before starting to take medicines for erectile dysfunction.
• Adadox may further lower blood pressure if the patient is already taking other medicines for high blood pressure.
• Medicines used to treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used to treat HIV infection, e.g. indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Adadox with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

Before taking any medicine, the patient should discuss it with their doctor or pharmacist.
The safety of doxazosin in pregnant women has not been established. If the patient is pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The patient should not breastfeed while taking Adadox.

Driving and using machines

The patient should be cautious when driving or operating machinery. The tablets may affect the ability to drive or operate machinery safely, especially when the patient first starts taking them. They may cause drowsiness or dizziness. If the patient experiences such symptoms, they should not drive or operate machinery and should contact their doctor immediately.

Adadox contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Adadox contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Adadox

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

• The recommended dose of Adadox is one tablet taken once a day.
• If the patient is taking Adadox for the first time, the normal dose is 1 mg per day. The doctor may increase this dose after a few weeks to the usual dose of 2 mg or 4 mg per day. In some cases, it may be increased to a maximum of 8 mg per day if the patient is being treated for enlarged prostate or to a maximum of 16 mg if the patient is being treated for high blood pressure.
• Adadox can be taken in the morning or evening.
• The patient should take the tablets at the same time every day, with a glass of water.
• The patient should take the tablets as directed by their doctor.
• It is essential to continue taking the tablets. They help control blood pressure.
• The patient should not change the dose or stop taking the tablets without consulting their doctor first.
• The patient should not delay their doctor's visit until the medicine runs out.

Using Adadox in children

The safety of doxazosin in children has not been established.

Taking a higher dose of Adadox than recommended

Taking too many tablets at once may cause the patient to feel unwell.
Taking several tablets may be dangerous. The patient should immediately tell their doctor or go to the nearest hospital.

Missing a dose of Adadox

If the patient forgets to take a tablet, they should skip that dose and take the next tablet at the usual time. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Adadox can cause side effects, although not everybody gets them.
The patient should stop taking Adadox and contact the emergency department of the nearest hospital immediately if they experience any of the following side effects:

• Heart attack
• Weakness of the arms, legs, or problems with speech, which may be symptoms of a stroke
• Swelling of the face, tongue, or throat, which may be a sign of an allergic reaction to the medicine

The patient should contact their doctor immediately if they experience any of the following side effects:

• Shortness of breath, difficulty breathing (common: may occur in 1 in 10 people)
• Increased or decreased heart rate (common: may occur in 1 in 10 people)
• Feeling of irregular heartbeat (palpitations) (common: may occur in 1 in 10 people)
• Chest pain (angina pectoris) (uncommon: may occur in no more than 1 in 100 people)
• Irregular heartbeat (very rare: may occur in no more than 1 in 10,000 people)
• Yellowing of the skin or eyes (jaundice) (very rare: may occur in no more than 1 in 10,000 people)
• Low white blood cell or platelet count, which may cause bruising or bleeding easily (very rare: may affect up to 1 in 10,000 people)
• Persistent painful erection. The patient should seek medical attention immediately (very rare: may affect up to 1 in 10,000 people)

Common (may occur in 1 in 10 people):

• Dizziness, feeling of spinning or rotation of the environment (dizziness), headache
• Low blood pressure
• Swelling of the feet, ankles, or toes
• Bronchitis, cough, respiratory tract infections (nose, throat, lungs)
• Stuffy nose, sneezing, and (or) runny nose caused by an infection of the nasal mucosa (rhinitis)
• Abdominal pain, feeling unwell
• Urinary tract infection, urinary incontinence (loss of control over urination), cystitis
• Drowsiness, general weakness
• Nausea, heartburn, dry mouth
• Itching
• Back pain, muscle pain
• Flu-like symptoms
• Accommodation disorders

Uncommon (may occur in 1 to 10 patients in 1,000):

• Constipation, diarrhea, gastroenteritis, which may cause diarrhea and vomiting
• Pain or discomfort when urinating, increased frequency of urination, presence of blood in the urine
• Arthritis, joint pain, general pain, thirst
• Swelling of the face, general swelling, chills, fever, pallor
• Insomnia, restlessness, anxiety, depression, or nervousness, emotional instability, apathy
• Decreased or changed sensation of touch in the hands and feet
• Increased or decreased appetite, weight gain, decreased potassium levels in the blood
• Nosebleeds, pharyngitis
• Rash
• Ringing or buzzing in the ears, tremors
• Impotence
• Increased liver enzymes, which may affect some medical tests
• Stroke
• Lacrimation, photophobia

Rare (may occur in less than 1 in 1,000 patients)

• Decreased frequency of urination
• Muscle spasms, muscle weakness, muscle stiffness
• Low blood sugar
• Cerebrovascular disorders
• Laryngeal edema
• Decreased body temperature in elderly patients

Very rare (may occur in less than 1 in 10,000 patients):

• Weakness, dizziness caused by standing up from a sitting or lying position
• Hepatitis or bile disorders
• Hives, hair loss, red or purple spots on the skin, purpura
• Numbness or tingling of the hands and feet, nightmares, memory loss, taste disorders
• Fatigue, general feeling of being unwell
• Wheezing
• Blurred vision
• Hot flashes
• Urination disorders, need to urinate at night, increased urine output
• Discomfort or enlargement of the breasts in men

Unknown (frequency cannot be estimated from the available data):

• During cataract surgery (clouding of the lens), eye disorders may occur. See section "When to be cautious when taking Adadox"
• Small amount or absence of semen during ejaculation at the time of orgasm, cloudy urine after orgasm (retrograde ejaculation)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Adadox

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the blister, bottle, and carton after:
EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Adadox contains

• The active substance of Adadox is doxazosin. Each 2 mg tablet contains 2 mg of doxazosin in the form of doxazosin mesylate. Each 4 mg tablet contains 4 mg of doxazosin in the form of doxazosin mesylate.
• The other ingredients are: microcrystalline cellulose, lactose, sodium carboxymethylcellulose (Type A), magnesium stearate.

What Adadox looks like and contents of the pack

2 mg tablets:
The tablet is white to off-white, capsule-shaped, with the marks 'D O' engraved on one side, separated by a dividing line, and the number '2' on the other. The tablet can be divided into equal doses.
4 mg tablets:
The tablet is white to off-white, rhomboid-shaped, with the marks 'D O' engraved on one side, separated by a dividing line, and the number '4' on the other. The tablet can be divided into equal doses.
PVC/PVDC/Aluminum blisters:
Pack sizes: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, and 140 tablets
HDPE containers with PP closures:
Pack sizes: 100 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. +48 22 732 77 00

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Importer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Doxazosin Aurobindo 1mg/ 2mg/ 4mg tablets
Czech Republic
Doxazosin Aurovitas
Spain
DOXAZOSINA AUROBINDO 2mg/ 4mg tablets EFG
Germany
Doxazosin Aurobindo 1mg/ 2mg/ 4mg/ 8mg tablets
Poland
Adadox 2mg/ 4 mg
Doxazosin Aurobindo 1 mg
Italy
Doxazosin 2mg/ 4mg tablets

Date of last revision of the leaflet:

• 04.2024