Package leaflet: Information for the patient

CARDURA 2 mg tablets, 4 mg tablets

Doxazosin
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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cardura is and what it is used for

Cardura contains the active substance doxazosin, which belongs to a group of medicines called alpha-blockers. It is used to treat high blood pressure (essential hypertension).
Cardura works by relaxing the blood vessels, allowing blood to flow more easily through them.
This helps to lower blood pressure.

2. What you should know before taking Cardura

Do not take Cardura

If you are allergic to doxazosin, to other types of quinazolines (such as prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6).
If you have an enlarged prostate gland (benign prostatic hyperplasia) together with difficulty in urinating, chronic urinary tract infection, or bladder stones.
If you have suffered from a condition known as "orthostatic hypotension", a form of low blood pressure causing dizziness or a feeling of lightheadedness upon standing up from a sitting or lying position.
If you have a particular type of urinary incontinence characterized by involuntary urine leakage due to an overfilled bladder, or if you are unable to produce an adequate amount of urine, with or without progressive loss of kidney function.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cardura.
When you start taking Cardura, you may experience weakness, dizziness, and rarely fainting, caused by a drop in blood pressure upon standing up from a sitting or lying position. If you feel weak, dizzy, or faint, sit or lie down until you feel better and avoid situations where you could 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 side effects.
If you are scheduled for eye surgery for cataracts (clouding of the lens), inform your ophthalmologist before the operation that you are currently taking or have previously taken Cardura. Cardura may cause complications during surgery, which can be managed if the specialist is informed in advance.
Inform your doctor or pharmacist before taking Cardura if any of the following apply to you, as Cardura should be used with caution in these cases:

If you have a heart condition.
If you have or have had a liver disease.
If you are taking medicines for erectile dysfunction (impotence), called phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil, and vardenafil), as both medicines lower blood pressure by dilating blood vessels. Taking Cardura together with these medicines may cause excessive lowering of blood pressure (see Other medicines and Cardura). To reduce the likelihood of symptoms occurring, you should first start treatment with Cardura and take it regularly at a daily dose. Then, once your treatment with Cardura is stabilized, you may begin taking medicines for erectile dysfunction.

Prolonged painful erections of the penis – may occur very rarely. If this happens, contact a doctor immediately.
Children and adolescents
Cardura is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of treatment have not been established.
Other medicines and Cardura
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor or pharmacist before using Cardura if you are taking any of the following medicines, as they may affect the action of Cardura:

Medicines called phosphodiesterase type 5 inhibitors used for erectile dysfunction, such as sildenafil, tadalafil, and vardenafil (see Warnings and precautions).
Medicines that lower blood pressure.
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.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of using Cardura during pregnancy has not been established. Therefore, your doctor will prescribe Cardura only if the potential benefits outweigh the risks.
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
Be cautious if driving or operating machinery. This medicine may impair your ability to drive or operate machinery safely, especially at the beginning of treatment. It may cause weakness or dizziness. If you experience these symptoms, do not drive or operate machinery and contact your doctor immediately.
Cardura contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Cardura contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Cardura

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The initial dose of Cardura is 1 mg taken as a single daily dose.
After one or two weeks, your doctor may increase your dose to 2 mg per day. If necessary, after a further period of one or two weeks, your doctor may decide to increase the dose again to 4 mg per day. After another period of one or two weeks, and if needed, your doctor may further increase the dose to 8 mg per day, until the blood pressure is lowered to the desired level. In some cases, the dose may be increased up to a maximum of 16 mg per day.
The usual dose is 2 – 4 mg per day. The maximum recommended dose is 16 mg per day. If necessary, your doctor will instruct you to take other medicines together with Cardura to achieve the desired effect.
Cardura may be taken either in the morning or in the evening.
If you take more Cardura than you should
Taking too many tablets at the same time may make you feel unwell, as your blood pressure may drop too low. If this happens, lie down flat. Taking many tablets may be dangerous. If you take more Cardura than you should, contact your doctor immediately or go to the nearest hospital emergency department.
If you forget to take Cardura
If you forget to take Cardura, simply skip the missed dose. Do not take a double dose to make up for the forgotten dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you experience any of the following symptoms, STOP taking Cardura and call an ambulance
immediately:

chest pain (angina, myocardial infarction);
difficulty breathing (dyspnoea), accompanied by discomfort and tightness in the chest (bronchospasm);
sudden headache, feeling of fainting, weakness in arms or legs, or difficulty speaking, which could be signs of a stroke;
swelling of the face and allergic reactions.

Inform your doctor immediately if, after taking Cardura, you experience any of the following symptoms:

fast, slow or irregular heartbeat;
awareness of your own heartbeat (palpitations);
yellowing of the skin or eyes (jaundice);
low number of white blood cells or platelets in the blood. These conditions may lead to an increased susceptibility to infections or increased bruising and bleeding tendency, respectively.

The following adverse events have also been reported in patients treated with Cardura.

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

dizziness, headache;
low blood pressure or drop in blood pressure when moving from a sitting or lying position to standing;
swelling of feet, ankles or fingers;
bronchitis, cough, respiratory tract infections (nose, throat, lungs);
nasal congestion, sneezing and/or runny nose due to inflammation of the nasal mucosa (rhinitis);
abdominal pain, nausea;
urinary tract infections, urinary incontinence (inability to control or retain urine), inflammation of the bladder (cystitis);
drowsiness, generalised weakness;
stomach fullness and discomfort, dry mouth;
itching;
chest pain, back pain, muscle pain;
influenza-like symptoms.

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

constipation, flatulence, inflammation of the stomach and intestine (gastroenteritis), which may cause diarrhoea and vomiting;
pain or discomfort when urinating, need to urinate more frequently than usual, blood in the urine;
swelling and inflammation of the joints (gout), joint pain, generalised pain;
facial swelling;
insomnia, restlessness, anxiety, depression or nervousness;
temporary loss of consciousness;
reduced or altered sensitivity to touch in hands and feet;
increased or decreased appetite, weight gain;
nosebleeds;
skin rash;
ringing or buzzing in the ears (tinnitus), tremor;
inability/inability to achieve or maintain penile erection;
increased liver enzymes, which may affect certain medical tests.

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

increased frequency of needing to urinate;
muscle cramps, muscle weakness.

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

hepatitis (liver inflammation) or bile-related disorder (cholestasis);
urticaria, hair loss, red or purple spots on the skin due to bleeding under the skin or mucous membranes (purpura);
tingling or numbness in hands and feet;
fatigue, general feeling of malaise;
blurred vision;
hot flushes;
urinary disturbances, need to urinate at night, increased urine volume;
breast enlargement in men;
prolonged painful erection of the penis. Seek immediate medical attention;
sudden dizziness accompanied by loss of balance.

Other adverse effects (frequency cannot be determined from available data)

retrograde ejaculation (semen is ejaculated not externally but into the bladder), which may cause cloudy urine after orgasm;
eye problems may occur during cataract surgery (clouding of the lens). See section "Warnings and precautions".

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Cardura

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Expiry". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Cardura contains
The active substance is doxazosin.
Each 2 mg tablet contains 2.43 mg of doxazosin mesilate equivalent to 2 mg of doxazosin.
Each 4 mg tablet contains 4.85 mg of doxazosin mesilate equivalent to 4 mg of doxazosin.
The other components are: microcrystalline cellulose, lactose, sodium glycolate starch, magnesium stearate,
sodium lauryl sulfate.
Description of the appearance of Cardura and contents of the pack
PVC-PVDC/Aluminum blisters with titanium dioxide.
Carton pack containing 30 divisible tablets of 2 mg in blisters.
Carton pack containing 20 divisible tablets of 4 mg in blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan
Italy
Manufacturer
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35,
89257 Illertissen
Germany
Pfizer Manufacturing Deutschland GmbH
Freiburg site, Mooswaldallee 1
79090 Freiburg
Germany