4 mg or 8 mg, the prolonged-release tablet is
doxazosin
1. What Alfadil is and what it is used for
Alfadil belongs to a group of medicines called alpha-blockers and is used to treat non-organ-related high blood pressure ( essential hypertension ). Alfadil lowers blood pressure by dilating the small blood vessels so that the blood passes more easily.
2. What you need to know before you use Alfadil
Do not take Alfadil
- 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 previously had a blockage in the gastrointestinal tract or a narrowing of the gastrointestinal tract.
- if you have or have previously had problems with dizziness or fainting when you get up from a lying or standing position due to low blood pressure ( orthostatic hypotension ).
- if you have benign prostatic hyperplasia along with a narrowing of the upper urinary tract, chronic urinary tract infection, or bladder stones
Warnings and cautions
Talk to your doctor or pharmacist before taking Alfadil.
The tablets should be swallowed whole. The tablets must not be chewed, divided, or crushed.
When using Alfadil, dizziness, weakness and, in rare cases, fainting may occur, especially at the beginning of treatment with Alfadil. 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 should be taken with caution. As with all medicines in this group, treatment with Alfadil should be monitored regularly, especially at the beginning of treatment.
If you have liver disease, Alfadil should be taken with caution due to a 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. This should be done as Alfadil may cause complications during the operation which can be avoided if your ophthalmologist is prepared.
Alfadil and certain medicines used to treat erectile dysfunction ( phosphodiesterase type 5 inhibitors, or PDE- 5 inhibitors, such as 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 if you are stable on your alpha-blocking treatment. You should also start your treatment with the lowest dose phosphodiesterase type 5 inhibitor one and you should take it at least 6 hours apart from taking Alfadil.
Persistent painful erection, may occur in very rare cases. If this happens you should contact a doctor immediately.
Children and young people
Alfadil is not recommended for use in children or adolescents below 18 years of age as safety and efficacy have not been established.
Other medicines and Alfadil
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:
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 with food, drink, and alcohol
Alfadil can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Alfadil should only be taken during pregnancy according to the doctor’s instructions and after careful risk-benefit assessment as there is a lack of relevant experience in the treatment of pregnant women.
Breast-feeding
Small amounts of doxazosin, the active substance in Alfadil, may be excreted in human milk. You should not take Alfadil while breast-feeding your baby unless your doctor tells you to.
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 contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
3. How to use Alfadil
Always take Alfadil exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Unless otherwise prescribed by your doctor, the usual dose at the start of treatment is 1 tablet of 4 mg daily. It can take up to 4 weeks before the optimal effect of Alfadil is achieved. If necessary, the dose can be increased after this period 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, the active substance is enclosed in a shell designed to control the release of one of the drugs 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 is too strong or too weak, talk to your doctor or pharmacist.
If you use more Alfadil than you should
A severe overdose of Alfadil 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
If you have taken a lower dose of Alfadil than you should, or if you have forgotten to take one 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
Do not stop taking Alfadil on your own as this may cause your blood pressure to rise.
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 users)
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, lack of appetite, gout, increased appetite, anxiety, depression, insomnia (difficulty sleeping), disturbances in brain blood flow, decreased sensitivity to touch ( hypoesthesia ), 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, abnormal, 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 trachea ( bronchospasm ), bile problems (cholestasis), hepatitis, jaundice, hair loss, slight bleeding in the skin (purpura), hives ( urticaria ), muscle cramps, muscle weakness, urinary disorders (micturition disorders), 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”).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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
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 carton and blister after “EXP”. 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 4 mg contains 4.85 mg doxazosin mesylate equivalent to 4.0 mg doxazosin. Each prolonged-release tablet Alfadil 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 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 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:
Germany: Cardular PP
This leaflet was last modified on 14/08/2019
The following information is intended for healthcare professionals only:
Characteristics
Alfadil lowers blood pressure as a result of a decrease in systemic vascular resistance by blocking alpha-1-adrenoreceptors. In patients with hypertension, blood pressure during treatment with Alfadil is equivalent in both supine and standing positions. With once-daily dosing, the effect lasts for 24 hours. In clinical trials, doxazosin gives rise to beneficial effects on blood lipids with a moderate increase in HDL / total cholesterol ratio. Alfadil can be used as the only drug to control blood pressure without the use of additional antihypertensive agents ( monotherapy). In patients who are not adequately controlled on monotherapy, Alfadil can be used in combination with another medicine such as a thiazide diuretic, a beta-blocker, a calcium channel blocker, or an ACE inhibitor.
Special care during administration
Abnormally short transport time through the gastrointestinal tract (eg after surgical resection ) could lead to incomplete absorption of the active substance. 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.