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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 vasodilators.
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

• during breastfeeding,
• in patients under 18 years of age,
andlow blood pressure,

Warnings and precautions

Before starting to take Adadox, discuss it with your doctor or pharmacist.
Tell your doctor before starting to take the medicine if you:

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

If the patient is undergoing eye surgery for cataracts (clouding of the lens), they should tell the ophthalmologist before the surgery about the use of Adadox now or 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 diseases 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 a case, 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 with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or recently, and about the medicines you plan to take.

• In some patients taking alpha-blockers for the treatment of high blood pressure or enlarged prostate, dizziness or fainting may occur, which may be due to low blood pressure when standing up quickly or getting up. In some patients, these symptoms occur while taking medicines for erectile dysfunction with alpha-blockers. To reduce the likelihood of these symptoms, the regular daily dose of alpha-blockers should be taken before starting to take medicines for erectile dysfunction.
• Adadox may further lower blood pressure if you are 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, discuss it with your doctor or pharmacist.
The safety of using doxazosin in pregnant women has not been established. If you are pregnant or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not breastfeed while taking Adadox.

Driving and using machines

Be careful when driving or operating machinery. The tablets may affect your ability to drive or operate machinery safely, especially when you start taking them for the first time. They may cause drowsiness or dizziness. If you experience such symptoms, do not drive or operate machinery and contact your doctor immediately.

Adadox contains lactose

If you have been diagnosed with intolerance to some sugars, contact your 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• The recommended dose of Adadox is one tablet taken once a day.
• If you are taking Adadox for the first time, the normal dose is 1 mg per day. Your 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 you are being treated for prostate enlargement or to a maximum of 16 mg if you are being treated for high blood pressure.
• Adadox can be taken in the morning or evening.
• It is best to take the tablets at the same time every day with a glass of water.
• Take the tablets as directed by your doctor.
• It is important to continue taking the tablets. They help control your blood pressure.
• Do not change the dose or stop taking the tablets without consulting your doctor first.
• Do not delay your doctor's visit until you run out of medicine.

Using Adadox in children

The safety of using doxazosin in children has not been established.

Taking a higher dose of Adadox than recommended

Taking too many tablets at once may cause you to feel unwell.
Taking several tablets may be dangerous. Tell your doctor or go to the nearest hospital immediately.

Missing a dose of Adadox

If you forget to take a tablet, skip that dose and take the next tablet at the usual time. Do 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.
Stop taking Adadox and contact the emergency department of the nearest hospital immediately if you 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 this medicine

Contact your doctor immediately if you experience any of the following side effects:

• Shortness of breath, difficulty breathing (common: may affect up to 1 in 10 people)
• Increased or decreased heart rate (common: may affect up to 1 in 10 people)
• Feeling of an irregular heartbeat (palpitations) (common: may affect up to 1 in 10 people)
• Chest pain (angina pectoris) (uncommon: may affect up to 1 in 100 people)
• Irregular heartbeat (very rare: may affect up to 1 in 10,000 people)
• Yellowing of the skin or eyes (jaundice) (very rare: may affect up to 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. Seek medical attention immediately (very rare: may affect up to 1 in 10,000 people)

Common (may affect up to 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 infection of the nasal mucosa (rhinitis)
• Abdominal pain, feeling unwell
• Urinary tract infection, 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 affect up to 1 in 100 people):

• 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
• Facial swelling, general swelling, chills, fever, pallor
• Insomnia, restlessness, anxiety, depression or nervousness, emotional instability, apathy
• Decreased or changed sensation of touch in 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 affect up to 1 in 1,000 people):

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

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

• 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 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 volume of urine
• 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 careful when taking Adadox"
• Small amount or absence of semen during ejaculation during orgasm, cloudy urine after orgasm (retrograde ejaculation)

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Adadox

Keep the medicine out of the 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.
No special precautions for storage of the medicinal product.
Medicines should 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. 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 signs '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 signs '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:
Package sizes: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets
HDPE containers with PP closure:
Package 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