4 mg, 8 mg prolonged-release tablet is

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

– Save this leaflet, 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 Alfadil BPH is and what it is used for 
2. What you need to know before you use Alfadil BPH 
3. How to use Alfadil BPH 
4. Possible side effects 
5. How to store Alfadil BPH 
6. Contents of the packaging and other information 

1. What Alfadil BPH is and what it is used for

Alfadil BPH belongs to a group of medicines called alpha-blocking agents. It is used to treat the symptoms of benign prostatic hyperplasia. Alfadil BPH improves urine flow by reducing muscle tension in the prostate and bladder orifice.

2. What you need to know before you use Alfadil BPH

Do not use Alfadil BPH

  • if you are allergic to doxazosin, other quinazolines (eg prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6).
  • if you have low blood pressure or if you have previously had problems with fainting or felt dizzy when you got up from a lying or sitting to standing position due to low blood pressure ( orthostatic hypotension ).
  • if you have previously had a blockage in the gastrointestinal tract or a narrowing of the gastrointestinal tract.
  • if you have benign prostate enlargement along with a narrowing of the upper urinary tract, chronic urinary tract infection, or bladder stones.
  • if you are a patient with either overactive bladder or lack of urinary incontinence ( anuria ), with or without progressive deterioration of renal function.

Warnings and cautions

Talk to your doctor or pharmacist before taking Alfadil BPH.

The tablets should be swallowed whole. The tablets must not be chewed, divided, or crushed.

When using Alfadil BPH, dizziness and weakness and in rare cases, fainting may occur, especially at the beginning of treatment with Alfadil BPH. You should, especially at the beginning of the treatment, avoid situations where you can injure yourself when you feel dizzy and weak. As with all medicines in this group, your blood pressure should be checked regularly at the beginning of treatment. If you experience dizziness or fainting, lie down and the symptoms should disappear quickly.

If you have severe heart problems and especially heart failure or pulmonary edema (water in the lungs), Alfadil BPH should be taken with caution. As with all medicines in this group, treatment with Alfadil BPH should be monitored regularly, especially at the beginning of treatment.

If you have liver disease, Alfadil BPH should be taken with caution due to lack of data. The use of this drug in patients with severe liver disease is not recommended.

If you are going to have eye surgery due to cataracts (turbidity of the lens) inform your ophthalmologist before surgery that you are using or have previously used Alfadil BPH. This should be done as Alfadil BPH may cause complications during the operation which can be avoided if your ophthalmologist is prepared beforehand.

Alfadil BPH and certain medicines used to treat erectile dysfunction ( phosphodiesterase type 5 inhibitors, or PDE- 5 inhibitors, eg sildenafil, tadalafil, and vardenafil) both have antihypertensive effects. When both drugs are taken together, therefore, a drop in blood pressure with dizziness and fainting, as a result, can occur, e.g. when switching from landscape to portrait. To reduce this risk, phosphodiesterase type 5 inhibitors should only be taken with Alfadil BPH if you are stable on your alpha-blocking treatment. You should also start your treatment with the lowest dose phosphodiesterase type 5 inhibitor on and you should take it at least 6 hours apart from taking Alfadil BPH.

Persistent painful erection may occur in very rare cases. If this happens you should contact a doctor immediately.

Before starting treatment with Alfadil BPH, your doctor may perform tests to rule out other conditions such as prostate cancer, which may cause the same symptoms as benign prostate enlargement.

Children and young people

Alfadil BPH is not recommended for use in children or adolescents below 18 years of age as safety and efficacy have not been established. Benign prostatic hyperplasia is not relevant in children.

Other medicines and Alfadil BPH

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Ask your doctor or pharmacist for advice before taking any of these medicines as they may affect the effect of Alfadil BPH:

  • Drugs called PDE – 5 inhibitors for the treatment of erectile dysfunction, e.g. sildenafil, tadalafil, vardenafil) (see section “Warnings and precautions”).
  • Drugs that lower your blood pressure
  • Drugs that treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole
  • Drugs used to treat HIV e.g. indinavir, nelfinavir, ritonavir, saquinavir

Nefazodone, a medicine used to treat depression.

Alfadil BPH with food, drink, and alcohol

Alfadil BPH can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Not relevant (prescribed for men only).

Driving and using machines

The ability to use machines and drive a car may be impaired, especially at the beginning of treatment.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Alfadil BPH contains sodium

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

3. How to use Alfadil BPH

Always use Alfadil BPH exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Unless otherwise prescribed by your doctor, the usual dose at the start of treatment is 1 tablet of 4 mg daily. If necessary, the dose can be increased to 2 tablets of 4 mg daily or 1 tablet of 8 mg daily, depending on how you as a patient respond to the treatment.

The maximum recommended dose is 8 mg daily (2 tablets of 4 mg daily or 1 tablet of 8 mg daily).

Use in the elderly

The usual dose for adults is recommended for the elderly.

Use in patients with kidney disease

The normal doses for adults can be used in patients with kidney disease.

Use in patients with liver disease

Due to the lack of data, the use of this medicine is not recommended for patients with severe liver disease (see section “Warnings and precautions”).

Do not chew, divide, or crush the tablets. The tablets should be swallowed whole with enough liquid (a glass of water is preferable).

In Alfadil BPH, the active substance is enclosed in a shell designed to control the release of one of the medicinal products over a long period of time and which is not affected by digestion. This means that the shell is excreted in the feces. Do not worry if you occasionally see something resembling a tablet in your stool.

Your doctor will determine the length of treatment. A specific time limit is not defined.

If you have the impression that the effect of Alfadil BPH is too strong or too weak, talk to your doctor or pharmacist.

If you use more Alfadil BPH than you should  

A severe overdose of Alfadil BPH may lead to a marked and persistent drop in blood pressure. Symptoms of overdose may include dizziness, rapid heartbeat, and hot flashes.

Tell your doctor immediately if you suspect you have overdosed. Lie down with your legs raised. If additional measures are required, these should be taken by a physician.

If you forget to use Alfadil BPH

If you have taken a lower dose of Alfadil BPH than you should, or if you forget to take a dose, skip it and take the next one as usual. Do not take a double dose to make up for a forgotten dose.

If you stop using Alfadil BPH

Do not stop taking Alfadil BPH on your own as this may cause the symptoms of benign prostate enlargement to intensify or recur.

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.

Common (may affect up to 1 in 10 people)

Respiratory tract infections, urinary tract infections, dizziness, headache, drowsiness, dizziness, palpitations ( palpitation s), rapid heartbeat ( tachycardia ), low blood pressure, low blood pressure that occurs when standing up from a lying to a standing position, bronchitis ( bronchitis ), cough, dyspnea ( dyspnea), rhinitis (nasal congestion or rhinitis), stomachache, indigestion ( dyspepsia ), dry mouth, nausea, pruritus, back pain, muscle pain, bladder infection ( cystitis ), involuntary urination (urinary incontinence), weakness, chest pain,flu-like symptoms, accumulation of fluid in the arms and legs (swelling).

Uncommon (may affect up to 1 patient in 100 people)

Allergic reactions, loss of appetite, gout, increased appetite, anxiety, depression, insomnia (difficulty sleeping), disturbances in brain blood flow, decreased sensitivity to touch ( hyperesthesia ), short-term fainting ( syncope ), tremors ( tremor ), tinnitus( tinnitus ) ), angina ( angina pectoris ), heart attack, nosebleeds, constipation, diarrhea, flatulence, vomiting, gastroenteritis, rash, joint pain, difficulty emptying the bladder, blood in the urine, increased need to urinate, impotence, pain, swelling of face, abnormal liver values, 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 levels of white blood cells ( leukopenia ), low levels of platelets ( thrombocytopenia ), anxiety, nervousness, dizziness when changing position from lying to standing, and crawling ( paresthesia ), blurred vision, slow heart rhythm, irregular heart rhythm, redness of the skin with hot flashes, cramps the airways ( bronchospasm ), the release of toxins (cholestasis), inflammation of the liver, jaundice, loss of hair, spotting in the skin (purpura), hives ( urticaria ), muscle cramps, muscle weakness, disorders of urination (micturition), increased need to urinate at night, increased urination, enlargement of the mammary gland in men ( gynecomastia), fatigue, malaise.

Persistent painful erection. Seek medical attention immediately.

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

Dry ejaculation in men (reverse ejaculation), complications of eye surgery (see section “Warnings and precautions”).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Alfadil BPH

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 carton after “EXP. that. ” or “EXP”. The expiration date is the last day of the specified month.

Storage instructions

Store in the original package in order to protect the contents from moisture. Do not store above 30 ° C.

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 mesylate. Each prolonged-release tablet Alfadil BPH 4 mg contains 4.85 mg doxazosin mesylate equivalent to 4.0 mg doxazosin. Each prolonged-release tablet Alfadil BPH 8 mg contains 9.70 mg doxazosin mesylate equivalent to 8.0 mg doxazosin.
  • The other ingredients are macrogol, hypromellose, red iron oxide (E172), magnesium stearate ( Ph . Eur.), Sodium chloride, cellulose acetate, titanium dioxide (E171), shellac, black iron oxide (E172).

What the medicine looks like and the contents of the pack

Alfadil BPH prolonged-release tablets are round biconvex, white film-coated tablets. The 4 mg tablets have “CXL 4” printed on one side and the 8 mg tablets have “CXL 8” printed on one side. The active substance is excreted slowly through a small hole in one side of the prolonged-release tablet.

Alfadil BPH is available as

  • PVC / PVdC blisters with aluminum foil in pack sizes of 7, 10, 14, 20, 28, 30, 56, 98 and 100 tablets; 50 tablets (single or blister pack of 5 or 10 tablets); 140 tablets (hospital pack).
  • Blisters with aluminum foil / aluminum foil in pack sizes of 7, 10, 14, 20, 28, 30, 50, 98 and 100 tablets; 50 tablets (single or blister pack of 5 or 10 tablets); 300 tablets (hospital packaging).
  • White, opaque, cans of HDPE (high-density polyethylene) with childproof closure and desiccant, containing 30 and 100 tablets.

Not all packaging may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08 – 550 520 00

Email: eumedinfo@pfizer.com

Manufacturer

R-Pharm Germany GmbH

Heinrich-Mack-Str. 35, 89257 Illertissen

Germany

Pfizer Manufacturing Deutschland GmbH

Company Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

This medicinal product is authorized under the European Economic Area under the names:

France Germany Zoxan LPAlfadil BPHCardular PP Uro

This leaflet was last amended on 28/01/2019

The following information is intended for healthcare professionals only:

Characteristics

In patients with symptomatic benign prostatic hyperplasia, urodynamics and symptoms improve with the use of Alfadil BPH. This effect is due to a selective blockade of the alpha-1 receptor in the muscles of the prostate and bladder neck. In patients with hypertension, Alfadil BPH lowers blood pressure by blocking alpha-1 receptors.

Dose -response studies have not been conducted with Alfadil BPH, therefore, has an increased efficacy with increased dose (up to 8 mg) not yet been demonstrated.

Alfadil BPH can be used in patients with benign prostatic hyperplasia, who have either normal or high blood pressure. Changes in blood pressure in patients with normal blood pressure and benign prostatic hyperplasia are generally minimal. Patients with hypertension and benign prostatic hyperplasia treated with both clinical conditions effectively with Alfadil BPH in monotherapy. As with other drugs of this type, it is recommended to monitor patients initially during treatment.

Special care during administration

Abnormally short transport time through the gastrointestinal tract (eg after surgical resection ) could lead to incomplete absorption. Given the long half-life of doxazosin, the clinical significance of this is unclear.

Overdose

Should overdose lead to hypotension, the patient should be placed immediately in the supine position with the head low. Other supportive measures are taken if necessary. Because doxazosin is highly protein-bound, dialysis is not indicated.

Muhammad Nadeem

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