HIPLAFIN 5 mg. 30 tablets

The active substance (the ingredient responsible for the action of the drug) is finasteride. One film-coated tablet contains 5 mg finasteride.

The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, maize starch, pregelatinised, lauroyl macrogolglycerides. sodium starch glycolate, magnesium stearate. Tablet coating contains hypromellose, macrogol, titanium dioxide (E171) and indigo carmine (E 132).
1. Indications
Hiplafin belongs to a group of medicines called inhibitors of 5-alpha-reductase. They work by reducing the size of the prostate gland in men.

Hiplafin be used for the treatment and control of benign (non-cancerous) prostate enlargement.

2. DOSAGE AND METHOD OF APPLICATION:
For oral use only.
The recommended dose is a tablet of 5 mg per day which may be administered without food. The tablet must be swallowed whole, not divided or crushed. Even if there is an improvement after only a short time, it is necessary to continue treatment for at least 6 months to assess objectively whether there has been a satisfactory therapeutic response.

Dosage in hepatic insufficiency

There are no data in patients with hepatic insufficiency.

Dosage in renal insufficiency

It is not necessary to make a dose adjustment in patients with varying degrees of renal failure, as it was not found that renal failure affects the elimination of finasteride. Finasteride has not been studied in patients on hemodialysis.

Dosage in elderly patients

There is no need to make changes in dosage, although studies show a small reduction in the elimination of finasteride in patients over the age of 70.
If you take more than the amount Hiplafin
Immediately contact a doctor, the nearest hospital casualty department or the Center for Toxicology and ask for advice.


If you forget to take Hiplafin
Do not take a double dose to make up for a missed tablet. Just take the next at the usual time.



3. WHEN NOT TO TAKE THE MEDICINE
Do not take Hiplafin:

if you are allergic (hypersensitive) to finasteride or any of the other ingredients of Hiplafin (see section 6);
if you are a woman or a child.

Take special care with Hiplafin

if you have reduced liver function
if you have difficulty emptying your bladder or severely reduced urinary flow, your doctor will need to examine you carefully before you start taking Hiplafin to exclude other obstructions in the urinary tract.

If your intimate partner is pregnant or may become pregnant should not expose your semen which could contain a tiny amount of the drug (see also the section on pregnancy and lactation).

If you need a blood test called "PSA", make sure your doctor or nurse that you are taking the drug because finasteride can affect test results.
Taking other medicines
Hiplafin tablets can normally be taken with other drugs. Please ask your doctor before taking other medicines simultaneously.

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

Pregnancy and lactation
Hiplafin is indicated only for men. If your intimate partner is or may be pregnant, avoid exposing her to your semen which could contain a small amount of the drug.

Women who are pregnant or may become pregnant should not handle broken or crushed tablets Hiplafin. If finasteride is absorbed through the skin or taken orally by pregnant with a male fetus, the child may be born with malformed genitals. The tablets are film coated, which prevents contact with finasteride, provided that the tablets are not broken or crushed.

Driving and using machines
There is no evidence that Hiplafin affect the ability to drive and use machines.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hiplafin can cause side effects, although not everybody gets them.

Common (occurring in more than 1 la 100): inability to get an erection, reduced sex drive, reduced ejaculatory volume.

Uncommon (occurring in less than 1 in 100 patients):
Sensitivity and / or breast enlargement, difficulty in ejaculation, rash.

Rare (less than 1 in 1000 patients):
Testicular pain, itching, hives (rash), allergic reactions such as swelling of the face and lips.

Very rare (less than 1 in 10,000 patients):
Excretion of fluid from the breast, sometimes having surgery to remove a lump from the breast.

Stop taking Hiplafin and contact your doctor immediately if you develop any of the following symptoms: swelling of the face or tongue, difficulty swallowing or urticaria and difficulty breathing.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. STORING HIPLAFIN
Keep out of reach of children.
Do not use Hiplafin after the expiry date stated on the label and carton.