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AVIDART - AVODART® 0,5 mg. soft capsules
Each capsule contains:
- Dutasteride ……………………………………………………………… 0,5 milligrams
- The solution inside the capsule shell contains: mono and diglycerides of caprylic/capric acid and butylated hydroxytoluene (E321).
- The capsule shell contains: gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), purified water and red printing ink (containing iron oxide red (E172) as the colourant).
WHAT IS AVIDART - AVODART
AVIDART - AVODART are oblong opaque, soft gelatin capsules printed with GX CE2 on one side in red ink and are available in packs of 30 capsules.
AVIDART - AVODART belongs to a group of medicines called 5-alpha reductase inhibitors.
AVIDART - AVODART is indicated in:
- The treatment of symptoms of benign prostatic hyperplasia (BPH).
- The reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.
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BEFORE TAKING AVIDART - AVODART
Do not take AVIDART - AVODART® 0,5 mg. soft capsules:
If you are allergic to dutasteride or any of the other ingredients in the soft capsules of dutasteride.
If you are a woman, adolescent or child.
If you have a serious liver disease.
Take special care with AVIDART - AVODART® 0,5 mg. soft capsules:
If you have an allergic reaction to this medication stop taking AVIDART - AVODART® and consult your doctor as soon as possible.
This medication should be administered with caution to patients with mild or moderate hepatic impairment.
Your semen may contain small amounts of the active ingredient in AVIDART - AVODART® which could affect the normal development of a male baby. Therefore, if your partner is or may be pregnant, you must avoid exposing her to your semen, for example by wearing a condom during sex.
The solution from the capsule may be absorbed through the skin, so it is important to thoroughly wash your hands with soap and water if you have handled any capsules which are punctured or leaking.
Driving and using machines
Based on how dutasteride works, treatment with AVIDART - AVODART® would not be expected to interfere with the ability to drive or operate machinery. If you have any questions consult your doctor.
Important information about some ingredients of AVIDART - AVODART® 0,5 mg. soft capsules
These capsules contain glycerol, which can in high doses cause headache, stomach upset and diarrhoea. They also contain butylated hydroxytoluene, which can cause irritation to the eyes, skin and mucous membranes.
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Taking or using other medications:
Inform your doctor or pharmacist if you are taking or have recently taken any other medication, even those bought without a prescription.
Certain medications may interact with AVIDART - AVODART®, in these cases it may be necessary to change the dosage or interrupt the treatment with some of these medications. It is particularly important that you inform your doctor if you are taking any of the following medications:
Ritonavir or indinavir (used in the treatment of AIDS).
Nefazodone (used to treat depression).
Itraconazole or ketoconazole (used to treat infections caused by a fungus).
HOW TO TAKE AVIDART - AVODART
Follow these instructions unless given other indications by your doctor.
Remember to take your medication.
Your doctor will indicate the duration of your treatment with AVIDART - AVODART®.
The usual dosage is one capsule (0,5 mg.) taken orally once a day, with or without food. The capsules should be swallowed whole, not chewed.
In order to treat your symptoms and control your BPH effectively, it is important that you continue to take AVIDART - AVODART® as long as your doctor prescribes it for you, even if you do not feel an immediate benefit. Some patients show early improvement in symptoms; however others may need to take AVIDART - AVODART® for three to six months before a response to the treatment can be achieved. You must continue to take your medicine as your symptoms improve. Do not stop taking your medicine, even if your symptoms improve, unless your doctor tells you to stop.
If you take more AVIDART - AVODART® 0,5 mg. soft capsules than you should
If you take more AVIDART - AVODART® 0,5 mg. soft capsules than you should, immediately consult your doctor or pharmacist or local poison centre (Servicio de Información Toxicológica), Telephone 91 562 04 20.
If you forget to take a dose of AVIDART - AVODART® 0,5 mg. soft capsules:
Do not take a double dose to make up for missed doses.
If you forget to take a dose, take the following dose as soon as possible and then carry on as usual.
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POSSIBLE SIDE EFFECTS
Like all medications, AVIDART - AVODART® may cause side effects.
If you experience any of the following symptoms:
o Tightness of the chest or difficulty breathing
o Swollen eyelids, face or lips
o Urticaria or lumpy skin rash.
It is possible that you may be suffering a severe allergic reaction and may require urgent medical assistance. Therefore you should stop taking this medication and should seek advice from your doctor immediately.
However this type of allergic reaction does not occur frequently.
You may also experience the following adverse reactions associated with the administration of AVIDART - AVODART® and similar medications:
o impotence (not able to achieve or maintain an erection)
o decrease in libido (decreased desire to have sex or a reduced sex drive)
o changes or problems with ejaculation
o breast swelling or tenderness.
If any of these symptoms occur you do not have to stop taking your medicine but you should seek advice from your doctor.
If you have any other symptoms not mentioned in this leaflet, tell your pharmacist or doctor.
STORAGE OF AVIDART - AVODART
As with all medicines, it is important to keep AVIDART - AVODART® out of the reach and sight of children.
Do not store above 30°C.
Expiry:
Do not use this medication after the expiry date printed on the carton.
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