1 mg film-coated tablets
finasteride
1. What Finasteride Accord is and what it is used for
Finasteride Accord contains finasteride. Finasteride belongs to a group of medicines called 5-alpha-reductase inhibitors.
Your doctor has prescribed Finasteride Accord for you because you have male pattern baldness (so-called androgenic alopecia ). Finasteride Accord prevents further hair loss in men. Men with mild to moderate but not complete hair loss may benefit from using Finasteride Accord. Finasteride Accord blocks an important enzyme (Type II 5-alpha-reductase) that helps control hair follicle function.
Finasteride Accord lowers the level of DHT, which is an important contributing factor to male pattern hair loss, in the scalp. In this way, Finasteride Accord slows down the hair loss process and prevents further hair loss.
Finasteride contained in Finasteride Accord may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before taking Finasteride Accord
Do not take Finasteride Accord
- If you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
- If you are a child or teenager
- if you are a woman (see also under ‘Pregnancy and breastfeeding). Clinical studies have shown that Finasteride Accord does not affect the treatment of hair loss ( androgenic alopecia ) in women.
- If you have previously been treated with finasteride or another 5-alpha-reductase inhibitor for benign prostatic hyperplasia ( benign prostatic hypertrophy, BPH ) or any other disease.
Warnings and cautions
Talk to your doctor or pharmacist before taking Finasteride Accord.
Determination of serum prostate-specific antigen (PSA) levels should be performed before starting finasteride treatment and during treatment.
Finasteride may decrease male fertility. Men who are planning to have children should consider stopping treatment.
Mood swings and depression
Mood swings such as depression, and, less commonly, suicidal ideation have been reported with the use of Finasteride Accord. If you experience any of these symptoms, stop taking Finasteride Accord and contact your doctor as soon as possible for further medical advice.
Other medicines and Finasteride Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Finasteride Accord is not normally affected by other medicines.
There is no data available on the concomitant use of Finasteride Accord and topical(for external use) minoxidil for the treatment of male pattern hair loss. This combination is not recommended.
Taking Finasteride Accord with food and drink
Finasteride Accord can be taken with or without food.
Pregnancy, breastfeeding, and fertility
Finasteride Accord is for men only.
Women who are or may become pregnant should not handle Finasteride Accord, especially not crushed or divided tablets. If finasteride is used by a woman who is carrying a male fetus, the development of the fetal genitals may be inhibited as finasteride may be absorbed into the body. or through the skin.
If the patient’s sexual partner is or may become pregnant, the patient should either avoid exposing their partner to semen (eg by using a condom) or discontinue finasteride treatment.
Driving and using machines
There is no evidence to suggest that Finasteride Accord affects the ability to drive and use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist
Important information about some of the ingredients of Finasteride Accord
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Finasteride Accord
Use for children and adolescents
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one Finasteride Accord tablet a day (equivalent to 1 mg finasteride). The film-coated tablet can be taken either on an empty stomach or with food. The tablet should be swallowed whole and must not be split or crushed.
- Finasteride Accord does not have a faster or better effect if you take more than one tablet a day.
- Male hair loss progresses slowly. Generally, daily treatment is required for three to six months before it is noticed that the hair has become thicker or the hair loss has decreased.
- Your doctor will help you determine if Finasteride Accord is affecting your hair loss. It is important to use Finasteride Accord for as long as your doctor prescribes it.
Patients with hepatic impairment
There is no experience in treating patients with hepatic impairment with Finasteride Accord.
Patients with renal impairment
No dose adjustment is required for patients with renal impairment.
If you take more Finasteride Accord then you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Bring any leftover tablets and/or empty packaging for easy identification.
If you forget to take Finasteride Accord
If you forget to take a dose of Finasteride Accord, just continue with the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Finasteride Accord
You must continue to take Finasteride Accord for the best possible effect. If you stop the treatment, you will probably lose the hair you regained within 9 to 12 months.
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.
The side effects observed have usually been transient in those who continued the treatment or disappeared when the treatment was stopped.
Discontinue Finasteride Accord immediately and consult a physician if you experience any of the following:
- Symptoms of an allergic reaction: swelling of the lips, face, tongue, or throat, difficulty swallowing, lumps under the skin (hives), and difficulty breathing
- Depression (feeling of great sadness and worthlessness)
Contact a doctor as soon as possible if you notice changes in the breasts such as lumps, pain, enlarged breasts, or discharge from the nipple, as this may be a sign of a serious illness such as breast cancer.
Uncommon (affects up to 1 in 100 people):
- decreased sex drive
- erection difficulties
- ejaculation problems such as the decreased amount of semen during ejaculation during intercourse.
- Depression
Has been reported (occurs in an unknown number of users:
- allergic reactions, such as skin rash, itching, hives, and swelling of the lips and face
- breast enlargement or breast tenderness
- palpitation
- testicular pain
- increased heart rate
- persistent erection problems after treatment
- residual decreased desire for sex after completion of treatment
- persistent ejaculation problems after completion of treatment
- Infertility has been reported among men who have been taking finasteride for a long time and who at the same time had other risk factors that may affect fertility. Normalization or improvement in sperm quality has been reported after completion of finasteride treatment. No long-term studies have been performed on the effect of finasteride on male fertility.
- Changes in liver function, which can be tested with a blood test.
- Anxiety
5. How to store Finasteride Accord
- Keep this medicine out of the sight and reach of children.
- No special storage instructions.
- Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the blister after EXP. The expiration date refers to the last day of the specified month.
- 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 finasteride. One film-coated tablet contains 1 mg finasteride.
Other ingredients are:
Tablet cores: Lactose monohydrate; microcrystalline cellulose (E460); pregelatinized corn starch; sodium starch glycolate (type A); lauryl macrogolglycerides; magnesium stearate (E572).
Coating film: Hypromellose (E464), titanium dioxide (E171), macrogol 6000, iron oxide red (E172), iron oxide yellow (E172).
What the medicine looks like and the contents of the pack
Film-coated tablet.
Finasteride Accord is red-brown, round, biconvex film-coated tablets, labeled ‘F1’ on one side and unlabeled on the other.
Packed in aluminum / aluminum blisters containing 28, 30, 84 or 98 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
UK
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Laboratorios Normon SA,
Ronda de Valdecarrizo 6,
28760 Tres Cantos, Madrid,
Spain
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland