Adadox

Package leaflet: Information for the patient

Adadox, 2 mg, tablets
Adadox, 4 mg, tablets
doxazosinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms appear identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Adadox is and what it is 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 Adadox is and what it is used for

Doxazosin belongs to a group of medicines known as vasodilators.
These substances cause dilation of blood vessels, thereby lowering blood pressure.
Doxazosin may also reduce the tone of the smooth muscle tissue in the prostate gland and urinary tract.
Doxazosin is used in the treatment of:

• arterial hypertension;
• symptoms of benign prostatic hyperplasia.

2. Important information before taking Adadox

When not to take Adadox

• if the patient is allergic to doxazosin, other quinazolines (for example prazosin and terazosin), or any of the other ingredients of this medicine (listed in section 6). This may manifest as itching, skin redness or difficulty breathing.
• during breastfeeding,
• in patients under 18 years of age,
• if the patient has an enlarged prostate gland (benign prostatic hyperplasia) and low blood pressure,
• if the patient has orthostatic hypotension, i.e. a form of low blood pressure causing dizziness or lightheadedness upon standing up from a sitting or lying position,
• if the patient has an enlarged prostate gland with one of the following conditions: congestion or obstruction of the urinary tract, persistent urinary tract infection, or bladder stones,
• if the patient has overflow incontinence (without the sensation of needing to pass urine) or anuria (the body does not produce urine), with or without kidney-related disorders.

Warnings and precautions
Before starting to take Adadox, discuss this with your doctor or pharmacist.
Inform your doctor before starting treatment if the patient:

• is pregnant or planning to become pregnant,
• has liver disease,
• is taking other medicines,
• has heart conditions.

If the patient is undergoing cataract surgery (clouding of the lens), inform the ophthalmologist before the procedure about current or previous use of Adadox. This is because Adadox may cause complications during surgery, which can be prevented if the ophthalmologist is informed in advance.
Before starting Adadox, the doctor may order tests to rule out conditions such as prostate cancer, which may cause symptoms similar to benign prostatic hyperplasia (enlarged prostate gland).
Prolonged painful erections may occur very rarely. In such a case, contact a doctor immediately.
After starting 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 might fall or injure themselves. The doctor may regularly monitor blood pressure at the beginning of treatment to reduce the likelihood of these effects.

Adadox and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.

• In some patients taking alpha-blocker medicines for the treatment of high blood pressure or enlarged prostate gland, dizziness or lightheadedness may occur due to low blood pressure when standing up quickly. In some patients, these symptoms may occur when taking medications for erectile dysfunction together with alpha-blockers. To reduce the likelihood of such symptoms, the regular daily dose of alpha-blockers should be established before starting erectile dysfunction medication.
• 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
Refer to section 3.
Pregnancy, breastfeeding and fertility
Before starting any medicine, discuss this with your doctor or pharmacist.
The safety of using doxazosin in pregnant women has not been established. If the patient is pregnant or planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Breastfeeding must not be undertaken while taking Adadox.
Driving and using machines
Exercise caution when driving or operating machinery. The tablets may affect the ability to drive or operate machinery safely, especially when first starting treatment. They may cause drowsiness or dizziness. If such symptoms occur, do not drive or operate machinery and contact your doctor immediately.
Adadox contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Adadox contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Adadox

This medicine should always be taken exactly as directed by your doctor. If you are unsure,
you should consult your doctor or pharmacist.

• The recommended dose of Adadox is one tablet taken once daily.
• If the patient is taking Adadox for the first time, the usual starting 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, the dose may be increased up to a maximum of 8 mg per day if the patient is being treated for benign prostatic hyperplasia, or up to a maximum of 16 mg per day if the patient is being treated for hypertension.
• Adadox may be taken in the morning or in the evening.
• It is best to take the tablets at the same time each day, with water.
• You must take the tablets exactly as prescribed by your doctor.
• It is important to continue taking the tablets regularly, as they help control your blood pressure.
• Do not change the dose or stop taking the tablets without first consulting your doctor.
• Do not delay your doctor's appointment until the medicine runs out.

Use of Adadox in children
The safety of doxazosin in children has not been established.

Taking more Adadox than recommended
Taking too many tablets at once may cause the patient to feel unwell. Taking several tablets may be dangerous. You should immediately inform your doctor or go to the nearest hospital emergency department.

If you miss a dose of Adadox
If the patient forgets to take a tablet, the missed dose should be skipped and the next tablet should be taken at the usual time. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking Adadox immediately and contact the emergency department of the nearest hospital if any of the following adverse effects occur:

• Heart attack
• Weakness in arms, legs, or problems with speech, which may be signs of stroke
• Swelling of the face, tongue or throat, which may be due to an allergic reaction to this medicine

Seek immediate medical advice if any of the following adverse effects occur:

• Shortness of breath, difficulty breathing (common: may occur in 1 out of 10 people)
• Increased or decreased heart rate (common: may occur in 1 out of 10 people)
• Feeling of irregular heartbeat (palpitations) (common: may occur in 1 out of 10 people)
• Chest pain (angina) (uncommon: may occur in no more than 1 out of 100 people)
• Irregular heartbeat (very rare: may occur in no more than 1 out of 10,000 people)
• Yellowing of the skin or eyes (jaundice) (very rare: may occur in no more than 1 out of 10,000 people)
• Low number of white blood cells or platelets, which may lead to bruising or easy bleeding (very rare: may affect up to 1 in 10,000 people)
• Persistent painful penile erection. Urgent medical advice should be sought (very rare: may affect up to 1 in 10,000 people)

Common (may occur in 1 out of 10 people):

• Dizziness, sensation of spinning or rotation of surroundings (dizziness), headache
• Low blood pressure
• Swelling of feet, ankles or fingers
• Bronchitis, cough, respiratory tract infections (nose, throat, lungs)
• Nasal congestion, sneezing and/or runny nose due to infection of the nasal mucous membrane (rhinitis)
• Abdominal pain, malaise
• Urinary tract infection, urinary incontinence (loss of bladder control), cystitis
• Drowsiness, general fatigue
• Indigestion, heartburn, dry mouth
• Itching
• Back pain, muscle pain
• Influenza-like symptoms
• Accommodation disorders

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

• Constipation, diarrhoea, gastroenteritis which may cause diarrhoea and vomiting
• Pain or discomfort when passing urine, increased frequency of urination, presence of blood in urine
• Joint inflammation, joint pain, generalised pain, thirst
• Facial swelling, generalised swelling, chills, fever, pallor
• Insomnia, restlessness, anxiety, depression or nervousness, emotional lability, apathy
• Reduced or altered sensation to touch in hands and feet
• Increased or decreased appetite, weight gain, decreased blood potassium levels
• Nosebleeds, sore throat
• Skin rash
• Ringing or buzzing in the ears, tremor
• Inability to achieve erection
• Increased liver enzyme levels, which may affect certain medical tests
• Stroke
• Watery eyes, photophobia

Rare (occur in less than 1 out of 1,000 patients):

• Decreased frequency of urination
• Muscle cramps, muscle weakness, muscle stiffness
• Low blood sugar levels
• Cerebrovascular disorders
• Laryngeal oedema
• Lowered body temperature in elderly patients

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

• Weakness, dizziness upon standing from a sitting or lying position
• Hepatitis or disorders of bile production
• Urticaria, hair loss, red or purple spots on the skin, purpura
• Tingling or numbness in hands and feet, nightmares, memory loss, taste disturbances
• Fatigue, general malaise
• Wheezing
• Blurred vision
• Hot flushes
• Urination disorders, need to urinate at night, increased volume of urine passed
• Discomfort or enlargement of breasts in men

Unknown (frequency cannot be determined from available data):

• During cataract removal surgery (clouding of the eye lens), eye disorders may occur. See section "When to take special care with Adadox"
• Small amount or absence of semen during ejaculation at orgasm, cloudy urine after orgasm (retrograde ejaculation)

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Adadox

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, bottle, and carton after:
EXP. The expiry date refers to the last day of the stated month.
No special precautions regarding storage of the medicinal product are required.
Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Adadox contains

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

What Adadox looks like and contents of the pack
2 mg tablets:
White to off-white, uncoated, capsule-shaped tablets, with the engraved marks 'D O' on one side separated by a division line and the number '2' on the other side. The tablet can be divided into equal doses.
4 mg tablets:
White to off-white, uncoated, diamond-shaped tablets, with the engraved marks 'D O' on one side separated by a division line and the number '4' on the other side. The tablet can be divided into equal doses.
Packs of PVC/PVDC/Aluminium blisters:
Pack sizes: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets
HDPE containers with PP closure
Pack sizes: 100 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised 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 comprimidos EFG
Germany Doxazosin Aurobindo 1mg/ 2mg/ 4mg/ 8mg Tabletten
Poland Adadox 2mg/ 4 mg
Doxazosin Aurobindo 1 mg
Italy Doxazosin 2mg/ 4mg compresse
04.2024