Finasteride 1 mg Tablets / Capsules
Read all this document carefully before you start taking the medicine. If you have further questions, please ask your doctor or your pharmacist.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
- What Finasteride 1 mg Tablets/Capsules are and what they are used for
- Before you take Finasteride 1 mg Tablets/Capsules
- How to take Finasteride 1 mg Tablets/Capsules
- Possible side effects
- How to store Finasteride 1 mg Tablets/Capsules
- Further information
1. What Finasteride 1 mg Tablets/Capsules are and what they are used for
Finasteride 1 mg Tablets/Capsules contain finasteride. Finasteride belongs to the group of medicine called 5-alpha reductase inhibitors. Your doctor has prescribed Finasteride 1 mg Tablets/Capsules because you have male pattern hair loss (also known as androgenetic alopecia). Finasteride 1 mg Tablets/Capsules prevent further hair loss in men. Men with mild to moderate, but not complete hair loss, can benefit from using Finasteride 1 mg Tablets/Capsules. Finasteride 1 mg Tablets/Capsules block an important enzyme (Type II 5 a-reductase), which is involved in the regulation of the hair follicle. In the scalp, Finasteride 1 mg Tablets/Capsules specifically lower the levels of DHT, a major cause of male pattern hair loss. In this way, Finasteride 1 mg Tablets/Capsules help to reverse the balding process and prevent further hair loss.
2. Before you take Finasteride 1 mg Tablets/Capsules
Do not take Finasteride 1 mg Tablets/Capsules:
- If you are allergic (hypersensitive) to finasteride or any other ingredients of Finasteride 1 mg Tablets/ Capsules.
- If you are a child or adolescent.
- If you are a woman (see also ‘Pregnancy and breast-feeding’).
- If you are already taking finasteride or any other 5a-reductase inhibitor for benign prostatic hyperplasia (BHP) or any other condition.
Take special care with Finasteride 1 mg Tablets/ Capsules:
Finasteride may affect male fertility. Patients who are planning to father a child should consider stopping treatment. You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer.
Taking other medicines:
Finasteride 1 mg Tablets/Capsules do not usually interfere with other medicines. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Finasteride 1 mg Tablets/Capsules with food and drink:
Finasteride 1 mg Tablets/Capsules can be taken with or without food.
Pregnancy and breast-feeding:
Finasteride 1 mg Tablets/Capsules are only intended for men even though in special cases doctors can prescribe it for women. Women who are or may potentially be pregnant should not handle Finasteride 1 mg Tablets/Capsules especially if broken or crushed. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
There is no information to suggest that Finasteride 1 mg Tablets/Capsules affect the ability to drive and use machines.
Important Information about some if the ingredients of Finasteride 1 mg Tablets/Capsules:
This medicinal product may contain traces of lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Finasteride 1 mg Tablets/Capsules
The usual dose is one Finasteride 1 mg tablet/capsule daily (equivalent to 1 mg finasteride). The tablets/capsules can either be taken on an empty stomach or with a meal. The film-coated tablets should be swallowed whole and should not be divided or crushed.
Finasteride 1 mg Tablets/Capsules will not work faster or better if you take them more than once a day.
Male pattern hair loss is a condition that develops over a long period of time. In general, daily use for six months maybe necessary before you notice any increase in the hair density or reduction in hair loss.
Your doctor will help you assess if Finasteride 1 mg Tablets/Capsules are working. It is important to continue taking Finasteride 1 mg Tablets/Capsules for as long as your doctor prescribes them.
Patients with impaired liver function:
There is no information available on the use of Finasteride 1 mg Tablets/Capsules in patients with impaired liver function.
Patients with impaired kidney function:
No dosage adjustment is required in patients with impaired kidney function.
If you forget to take Finasteride 1 mg Tablets/ Capsules:
If you forget to take a dose of FINASTERIDE 1 MG Tablets/Capsules, just carry on with the next one as usual. Do not take a double dose to make up for the forgotten dose.
If you stop taking Finasteride 1 mg Tablets/ Capsules:
Continued use of Finasteride 1 mg Tablets/Capsules is recommended to obtain maximum benefit. If the treatment is stopped in between, you are likely to lose the hair you have gained within the next 9 to 12 months. If you have any further questions on the use if this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicine, Finasteride 1 mg Tablets/Capsules can cause side effects, although not everybody gets them. The side effects have usually been temporary with continued treatment or disappeared when treatment is stopped.
Uncommon (occur in less than 1 in 100 users):
- less desire to have sex
- difficulty having an erection
- problems with ejaculation such as a decrease in
- the amount of semen released during sex.
- allergic reactions such as rash, itching, lumps under your skin (hives) and swelling of your lips and face
- breast swelling or tenderness
- pain in the testicles
- fast heartbeat
- persistent difficulty having an erection after discontinuation of treatment
- infertility has been reported in men who took finasteride for a long time and had other risk factors that may affect fertility. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride. Long-term clinical studies about the effect of finasteride on fertility in men have not been conducted.
- Changes in the way your liver is working, which can be shown by a blood test.
Stop taking Finasteride 1 mg Tablets/Capsulesand talk to your doctor immediately if you have any of the following symptoms:
- swelling of your face, tongue or throat
- difficulty swallowing
- lumps under your skin (hives)
- breathing difficulties
- 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.
- 5. How to store Finasteride 1 mg Tablets/
- Keep out of the reach and sight of children.
- This medicinal product does not require any special storage conditions.
- Do not use Finasteride 1 mg Tablets/Capsules past the expiry date. The expiry date refers to the last date of the month.
- Medicines should not be disposed 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. Further information
What Finasteride 1 mg Tablets/Capsules contain:
The active substance is finasteride. One Tablet/ Capsule contains 1 mg of Finasteride.
Inactive ingredients: Tablet form:
Lactose monohydrate; cellulose, microcrystalline (E460); Starch, pregelatinised (maize); sodium starch glycolate (type-A); lauryl macrogolgycerides; magnesium stearate (E572). Hypromellose (E464), titanium dioxide (E171), macrogol 6000, iron oxide red (E172), iron oxide yellow (E172).
Inactive ingredients: Capsule form:
Hard gelatin, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, pregelatinised starch, docusate sodium, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide, talc, iron oxide yellow, and FD&C Blue #2 aluminum lake.
Tablets manufactured by:
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
Capsules produced by:
Claudia Ruiz-Capilla Gil D.N.I. 33.363.084 C, Rotonda De Suarez 3, 29011 Málaga, Spain