4 mg prolonged-release tablet is 
doxazosin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Doxazosin Sandoz is and what it is used for 
2. What you need to know before taking Doxazosin Sandoz 
3. How to use Doxazosin Sandoz 
4. Possible side effects 
5. How to store Doxazosin Sandoz 
6. Package contents and other information

1. What Doxazosin Sandoz is and what it is used for

Doxazosin Sandoz belongs to a group of medicines called alpha-blockers.

It is used to treat:

  • High blood pressure
  • Symptoms are caused by the enlarged prostate gland in men.

In patients taking this medicine for the treatment of high blood pressure ( hypertension ), the medicine works by relaxing the blood vessels so that the blood can pass through them more easily. This helps to lower blood pressure.

In patients with an enlarged prostate gland, this medicine is used to treat poor and/or frequent urination. This is common in patients with an enlarged prostate gland ( benign prostatic hyperplasia ). This drug works by making the muscle around the exit of the bladder and the prostate gland relax so that the urine can pass more easily.

Doxazosin contained in Doxazosin Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Doxazosin Sandoz

Do not use Doxazosin Sandoz

  • if you are allergic to doxazosin, related quinazolines e.g. prazosin and terazosin, or any of the other ingredients of this medicine (listed in section 6).
  • if you have had any narrowing of the gastrointestinal tract
  • if you have an enlarged prostate gland together with obstruction of the urinary outflow in the upper urinary tract, chronic urinary tract infections, or urinary stones
  • if you have difficulty controlling your bladder (excess incontinence), can not urinate, or have kidney failure
  • if you are receiving treatment due to an enlarged prostate and have low blood pressure
  • if you have ascended or have ever had low blood pressure which led to dizziness, dizziness, or fainting.

Warnings and cautions

Talk to your doctor before using Doxazosin Sandoz:

  • if you have any liver disease
  • if you have any heart disease, especially heart failure or pulmonary edema(accumulation of fluid in the lungs)
  • if you are undergoing surgery for cataract, ie cataracts
  • if you are pregnant or trying to become pregnant
  • if you are also taking medicines for erection problems ( PDE -5 inhibitors, such as sildenafil, tadalafil, or vardenafil) (see section Other medicines and DoxazosinSandoz).

Dizziness, weakness, and in rare cases fainting may occur, especially when you first start taking this medicine. Therefore, you should be careful at the beginning of treatment and avoid situations that could lead to injury if these symptoms occur. If you feel dizzy or faint, you should lie down and the symptoms will disappear quickly.

Prolonged and sometimes painful erections can occur in very rare cases. Contact a doctor immediately if this should happen.

Before you start using Doxazosin Sandoz to treat an enlarged prostate gland, your doctor may perform some tests to rule out other conditions, such as prostate cancer, which may cause the same symptoms as an enlarged prostate gland ( benign prostatic hyperplasia ).

Other medicines and Doxazosin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is especially important to mention the following before you start taking this medicine:

  • medicines to treat erectile dysfunction (eg sildenafil, tadalafil, and vardenafil) together with Doxazosin Sandoz may cause low blood pressure. Some patients may experience dizziness or dizziness due to low blood pressure when sitting or standing up quickly. To reduce the risk of these symptoms, you should take a regular dose of Doxazosin Sandoz every day before starting to use erectile dysfunction medication. Your doctor may prescribe you to start with the lowest dose of one of your erectile dysfunction medicines, and it is recommended that you take this medicine at least 6 hours after taking Doxazosin Sandoz.
  • medicines for high blood pressure
  • drugs for the treatment of bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, and voriconazole
  • drugs for the treatment of HIV – infection, such as indinavir, nelfinavir, ritonavir, and saquinavir
  • nefazodone, an antidepressant.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be preg,nant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  • You should not take this medicine if you are pregnant without first talking to your doctor. The safety of this medicine during pregnancy has not been established well enough.
  • Small amounts of doxazosin, the active substance in this medicine, may be excreted in human milk. You should not take this medicine if you are breast-feeding unless your doctor tells you to.

Driving and using machines

Be careful when driving or using machines. These tablets may affect your ability to drive and use machines safely, especially at the beginning of your treatment. They can make you feel weak or dizzy. If you are affected by the tablets, do not drive or use machines and contact your doctor immediately.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Doxazosin Sandoz contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

3. How to use Doxazosin Sandoz

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Adults (including the elderly)

The recommended dose of Doxazosin Sandoz is 4 mg once a day as a single dose.

Your doctor may increase the dose to one to 8 mg once a day. This is the maximum dose of Doxazosin Sandoz.

Doxazosin Sandoz is a prolonged-release tablet. The drug is enclosed in a shell that is not absorbed by the body but is specially designed to slowly release the drug. When the tablet is swallowed, doxazosin is slowly released into the body from the tablet, until the tablet is empty. 

Because the empty tablet disappears from the body through bowel movements, you can sometimes see something in the stool that looks like a tablet. This is expected so you do not have to worry.

Method of administration:

  • Do not chew, divide or crush the tablets.
  • Swallow the tablets whole along with water.
  • You can take these tablets with or without food.

Patients with liver disease

If you have liver problems, your doctor will monitor you closely during the treatment. Doxazosin Sandoz is not recommended for patients with severe liver problems (see section Warnings and precautions).

Use for children and adolescents

This medicine is not recommended for patients under 18 years of age.

If you take more Doxazosin Sandoz then you should

Too many tablets at once can make you feel bad. Taking several tablets can be dangerous.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Doxazosin Sandoz

If you forget to take a tablet, skip that dose altogether. Continue to take your tablets as usual. Do not take a double dose to make up for a forgotten dose .

If you stop using Doxazosin Sandoz

It is important to keep taking your tablets. Do not change the dose or stop taking the tablets without first checking with your doctor.

Do not wait to consult a doctor until your tablets have run out.

If you have any further questions on the use of this product, ask your doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Some side effects can be serious:

If any of the following occur, stop taking the medicine and contact your doctor or emergency department immediately at the nearest hospital:

  • Allergic reactions such as wheezing, shortness of breath, extreme dizziness or collapse, swelling of the face or throat, or severe skin rash with red spots or blisters.
  • Chest pain, increasing or irregular heartbeat, heart attack or stroke .
  • Yellowing of the skin or whites of the eyes, itching , loss of appetite and dark urine, which are caused by liver problems.
  • Unusual bruising or bleeding, caused by decreased platelet count .
  • Persistent painful erection .

These side effects are uncommon (may affect up to 1 in 100 people) or very rare (may affect up to 1 in 1,000 people).

Other side effects:

Common (may affect up to 1 in 10 people):

  • infection you in the respiratory and urinary tract
  • dizziness, headache, drowsiness
  • palpitation
  • low blood pressure
  • drop in blood pressure on ascent which may lead to dizziness, dizziness or fainting
  • carousel feeling
  • itching
  • shortness of breath, nasal congestion or runny nose
  • bronchitis ( bronchitis ), cough
  • abdominal pain, indigestion, dry mouth , nausea
  • back pain, muscle aches
  • painful and dense urination, inability to control bladder (urinary incontinence)
  • weakness, chest pain, flu-like symptoms, swollen hands, ankles or feet.

Less common (may affect up to 1 in 100): 

  • loss of appetite, increased appetite
  • gout (pain and swelling in the joints)
  • anxiety, depression, sleep problems
  • decreased skin sensitivity, fainting, tremors
  • earrings or ear noise
  • nosebleeds
  • constipation, diarrhea, flatulence, vomiting, inflammation of the gastrointestinal tract ( gastroenteritis )
  • abnormal blood counts for liver function
  • rash
  • painful joints
  • blood in the urine, difficult or painful to urinate, need to urinate abnormally often
  • inability to get an erection
  • pain, swelling of the face (facial edema)
  • weight gain.

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

  • stop in the gastrointestinal tract.

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

  • low white blood cell count
  • elation, nervousness
  • tingling or sensory disturbances in the hands and feet
  • dimsyn
  • slow pulse
  • hot herds
  • difficulty breathing or wheezing
  • hair loss, purple spots on the skin, itchy rash
  • muscle cramps, muscle weakness
  • difficulty urinating, urination, more frequent need to urinate, need to urinate at night
  • breast augmentation in men
  • fatigue, general malaise.

Has been reported (occurs in an unknown number of users):

  • ejaculation backwards in the bladder and not towards the urethra ( retrogradeejaculation, “dry orgasm”) 
  • a certain complication that may occur during cataract surgery (IFIS syndrome, see also section “Warnings and Precautions”).

5. How to store Doxazosin Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and outer carton after EXP. or EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is doxazosin .One tablet contains 4 mg doxazosin (as mesilate).
  • The other ingredients are macrogol 200; macrogol 900; butylhydroxytoluene (E321); cellulose, microcrystalline; povidone K30; all-rac-α-tocopherol (E307); silica, colloidal , anhydrous; sodium lauryl fumarate; methacrylic acid-ethyl acrylate copolymer (1: 1), dispersion 30%; silica, colloidal , hydrated; macrogol (1300-1600); titanium dioxide (E171)

What the medicine looks like and the contents of the pack

Doxazosin Sandoz are white, round, biconvex tablets engraved with “DL”.

The tablets are packaged in blister cards (PVC / PVDC / ALU) which are enclosed in a carton.

Pack sizes:

14, 28, 30, 56, 98 or 100 tablets or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Synoptis Industrial Sp. z oo, ul. Rabowicka 15, 62-020 Swarzędz, Poland

Muhammad Nadeem

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