Carefinast
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAREFINAST
1 mg film-coated tablets
Finasteride
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, inform your doctor or pharmacist, including any possible side effect not listed in this leaflet. See section 4.
Contents of this leaflet:
- What CAREFINAST is and what it is used for
- What you need to know before taking CAREFINAST
- How to take CAREFINAST
- Possible side effects
- How to store CAREFINAST
- Contents of the pack and other information
1. What CAREFINAST is and what it is used for
CAREFINAST is intended for use in men only and must not be taken by women or children.
CAREFINAST contains an active substance called finasteride. CAREFINAST is indicated for the treatment of early stages of hair loss (also known as androgenetic alopecia) in men aged between 18 and 41 years. If, after reading this leaflet, you have any questions about the mechanism of male hair loss, please consult your doctor.
Male hair loss is a common condition believed to be caused by a combination of genetic factors and a specific hormone called dihydrotestosterone (DHT). DHT contributes to the shortening of the hair growth phase and to hair thinning.
In the scalp, CAREFINAST specifically reduces levels of DHT by inhibiting an enzyme (type II 5-alpha reductase) that converts testosterone into DHT. Only men with mild to moderate hair loss, but not complete baldness or bi-temporal recession, may expect benefit from the use of CAREFINAST. In most men treated with CAREFINAST for 5 years, progression of hair loss has been slowed, and at least half of these men experienced improvement in hair growth.
2. What you need to know before taking CAREFINAST
Do not use CAREFINAST:
- if you are allergic to finasteride or to any of the excipients of this medicine (listed in section 6)
- if you are a child or adolescent (< 18 years of age)
- if you are a woman (see also “Pregnancy and breastfeeding”). Clinical studies have shown that CAREFINAST 1 mg tablets are not effective in treating hair loss (androgenetic alopecia) in women.
CAREFINAST must not be taken by men who are already being treated with other medicines containing finasteride or other 5α-reductase inhibitors for benign prostatic hyperplasia or other conditions.
Warnings and precautions:
Pregnant women or women of childbearing age must not handle crushed or split CAREFINAST tablets. Finasteride may be absorbed through the skin and could interfere with the development of the external genitalia of a male embryo. If a pregnant woman comes into contact with finasteride (the active substance), she must inform her doctor immediately.
If you notice any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, you must report them to your doctor immediately, as these may be signs of a serious condition such as breast cancer.
Finasteride may affect male fertility. Male patients who are planning to father a child should consider discontinuing treatment.
CAREFINAST may affect a blood test called PSA. If you are due to have blood tests to check your prostate gland, inform your doctor that you are taking finasteride.
Serum prostate-specific antigen (PSA) levels should be measured before starting finasteride therapy and during treatment.
The effects of hepatic impairment on finasteride metabolism have not been studied.
Other medicines and CAREFINAST
CAREFINAST 1 mg tablets do not interfere with other medications.
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those not requiring a prescription.
There are no available data on the use of finasteride 1 mg tablets in combination with topical minoxidil (applied to the skin) for hair loss in men.
CAREFINAST with food and drink
CAREFINAST 1 mg tablets can be taken during or independent of meals.
Pregnancy and breastfeeding
CAREFINAST must not be used in women.
Pregnant women or women of childbearing age must not handle CAREFINAST 1 mg tablets, especially if the tablets are crushed or broken. If finasteride is absorbed through the skin or ingested by a pregnant woman carrying a male fetus, the baby may be born with genital abnormalities.
The tablets have a coating that prevents contact with finasteride unless the tablets have been split or crushed.
When the patient’s partner is or may potentially be pregnant, it is recommended to minimize the partner’s exposure to seminal fluid (e.g. by using condoms) or to discontinue treatment with finasteride.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There are no data suggesting that CAREFINAST affects the ability to drive or operate machinery.
Important information about some excipients of CAREFINAST
This medicine contains lactose. If you know you are intolerant to certain sugars, inform your doctor before taking this medicine.
3. How to take CAREFINAST
Always take CAREFINAST exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Taking the tablets: The tablets should be swallowed whole with a glass of water. They must not be split or divided. The tablets may be taken during meals or on an empty stomach.
Unless otherwise prescribed by your doctor, the recommended dose for all patients is one tablet daily.
Follow your doctor's instructions. Do not change the dose or stop taking the medicine without first consulting your doctor.
Taking CAREFINAST more than once a day will not make it work faster or better. To achieve increased hair thickness or reduce hair loss, the medicine must be taken daily for a period of 3 to 6 months or longer. Together with your doctor, you can assess whether treatment with CAREFINAST has provided the expected benefits. No changes to your usual hair care routine are necessary during treatment with CAREFINAST.
If you feel that the effects of CAREFINAST are too weak or too strong, consult your doctor or pharmacist.
If you take more CAREFINAST than you should
If you have accidentally taken too many tablets, inform your doctor immediately.
If you forget to take CAREFINAST
Do not take a double dose to make up for the forgotten tablet. Continue treatment at the usual dose and time.
If you stop taking CAREFINAST
To maintain the benefits of treatment, continuous use of this medicine is recommended. If you stop treatment with CAREFINAST, the increased hair thickness achieved during treatment will likely be lost within 9 to 12 months.
If you have any questions about the use of CAREFINAST, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The potential side effects of CAREFINAST are generally mild in severity and transient.
Side effects are usually transient if treatment is continued, or disappear if treatment is discontinued.
Uncommon (may affect less than 1 in 100 patients):
- Decreased libido
- Difficulty in achieving an erection
- Ejaculation problems, such as reduced amount of semen
Frequency not known:
- Allergic reactions such as rash, itching, subcutaneous welts (urticaria), and swelling of the lips and face
- Swelling or enlargement of the breasts
- Testicular pain
- Depressed mood
- Tachycardia
- Persistent difficulty in achieving an erection after discontinuation of treatment
- Infertility, reported in men who have taken finasteride for a long time and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been reported after discontinuation of treatment. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
- Increased liver enzymes
- Breast cancer in men (see also section 2 “Take special care with Carefinast”)
Persistent sexual dysfunction (decreased libido, erectile dysfunction, and ejaculation disorders) after discontinuation of treatment with Carefinast
Stop taking CAREFINAST and contact your doctor immediately if you notice any of the following side effects:
- Swelling of the face, tongue or throat
- Difficulty swallowing
- Subcutaneous welts (urticaria)
- Breathing difficulties
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.
5. How to store CAREFINAST
Keep this medicine out of the sight and reach of children.
Do not use CAREFINAST after the expiry date stated on the carton and on the bottle after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Other information
What CAREFINAST contains
The active substance is finasteride.
Each tablet contains 1 mg of finasteride.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized starch,
lauroyl macrogol glycerides, sodium starch glycolate (type A), magnesium stearate
Film coating: hypromellose, titanium dioxide (E 171), yellow and red iron oxide (E172), macrogol 6000.
Description of the appearance of CAREFINAST and packaging contents
CAREFINAST 1 mg are red-brown, spherical, biconvex, film-coated tablets, marked on one side with the code "F1".
CAREFINAST 1 mg film-coated tablets are available in packs containing 28, 56, 84, or 98 tablets.
Blister packs (Aluminum/PVC; Aluminum/Aluminum)
Pack:
28, 56, 84, 98 tablets
HDPE container with LDPE screw cap
Pack:
28, 56, 84, 98 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder
Difa Cooper S.p.A.
Via Milano, 160
21042 Caronno Pertusella (VA)
Italy
Manufacturers
Pharbil Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany
Actavis hf.
Reykjavíkurvegi 78
IS-222 Hafnarfjördur
Iceland
This medicinal product is authorized in the European Member States under the following names:
Germany: Finasterid IFC 1 mg Filmtabletten
Spain: ALOCARE 1 mg comprimidos recubiertos con película