Product Safety Information for Finasteride & Minoxidil
FINASTERIDE is for use by MEN ONLY and should NOT be used by women or children.
Read this patient information before you start taking Finasteride & Minoxidil and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is Finasteride?
Finasteride is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia).
It is not known if Finasteride works for a receding hairline on either side of and above your forehead (temporal area).
Finasteride is not for use by women and children, and should not be handled by women and children.
Who should not take Finasteride?
Do not take Finasteride if you:
are pregnant or may become pregnant. Finasteride may harm your unborn baby.
Finasteride tablets are coated and will prevent contact with the medicine during handling, as long as the tablets are not broken or crushed. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed Finasteride tablets.
If a pregnant woman comes in contact with crushed or broken Finasteride tablets, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in Finasteride, a healthcare provider should be consulted. If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in Finasteride, the male baby may be born with sex organs that are not normal.
are allergic to any of the ingredients in Finasteride.
What should I tell my healthcare provider before taking Finasteride?
Before taking Finasteride, tell your healthcare provider if you:
have any other medical conditions, including problems with your prostate or liver.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Know the medications you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medication.
How should I take Finasteride?
Take Finasteride exactly as your healthcare provider tells you to take it.
You may take Finasteride with or without food.
If you forget to take Finasteride, do not take an extra tablet. Just take the next tablet as usual.
Finasteride will not work faster or better if you take it more than once a day.
What are the common side effects of this medication?
Common side effects include rash, breast tenderness or enlargement (reported in less than 1% of patients) which typically resolve after the medication is stopped, and sexual dysfunction (in clinical trials, 1.2%-1.4% of patients taking Finasteride experienced medication-related sexual dysfunction side effects including decreased libido, erectile dysfunction or a decrease in the volume of ejaculation vs. 1% of those taking placebo):
Decreased libido 1.8%
Erectile dysfunction 1.3%
Decreased volume of ejaculate 1.2%
Several studies have documented the majority of these side effects are reversible. However, 1.4% of the patients who experience side effects may continue to have symptoms following discontinuation of Finasteride. Of particular note there has been an association of the sexual dysfunction symptoms and the use of NSAIDS (Motrin, Advil, Aleve type medications.) For this reason Finasteride should be stopped for the period of time when you take NSAIDS.
Does Finasteride cause depression?
A literature review shows there may be evidence of increased depressive symptoms in individuals younger than age 45 while using Finasteride for hair loss. Patients with new or worsening depression should stop Finasteride use and follow up with their health care provider or a mental health therapist.
Does Finasteride cause prostate cancer or prostate enlargement (BPH)?
There have been reports of a slight increased risk (1.8% with 5mg Finasteride dosage versus 1.0% placebo) of high grade prostate cancer for men over age 55 years old. These reports are from men taking a higher dosage of Finasteride (5mg) than the dosage we prescribe for hair loss (1mg). There have been conflicting studies on the increased risk in the number of high grade prostate cancers; however, several recent studies have shown no increase in the number of deaths (with a recent study showing fewer deaths) in patients who use Finasteride at the 1mg dosage. Finasteride can be useful in the treatment of BPH and urinary retention because it can have an antiandrogenic effect (testosterone blocking) at a 5mg dosage. For hair loss, patients are given a 1mg dosage, which should not produce any antiandrogenic effect.
Does Finasteride change blood Prostate Specific Antigen (PSA) levels?
Finasteride can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done you should tell your healthcare provider that you are taking Finasteride because Finasteride decreases PSA.
The following have been reported as less common side effects with Finasteride use:
Allergic reactions including: rash, itching, hives and swelling of the lips, tongue, throat, and face
Testicular pain
Male infertility and/or poor quality of semen
In rare cases, male breast cancer
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Finasteride. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.
The following have been reported in general use with Finasteride:
breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
decrease in sex drive that continued after stopping the medication.
allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face.
problems with ejaculation that continued after stopping medication.
testicular pain.
difficulty in achieving an erection that continued after stopping the medication.
male infertility and/or poor quality of semen.
in rare cases, male breast cancer.
Depression: A literature review shows there may be evidence of increased depressive symptoms in users younger than age 45 while using finasteride for hair loss. Patients with new or worsening depression should stop finasteride use and follow up with their health care provider or a mental health therapist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Finasteride. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.
How should I store Finasteride?
Store Finasteride at room temperature between 15˚C to 30˚C (59˚F to 86˚F).
Keep Finasteride in a closed container and keep Finasteride tablets dry (protect from moisture).
Keep Finasteride and all medicines out of the reach of children.
General information about the safe and effective use of Finasteride.
Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use Finasteride for a condition for which it was not prescribed. Do not give Finasteride to other people, even if they have the same symptoms you have. It may harm them.
MINOXIDIL is used to treat common hereditary hair loss in men aged 18-65 (otherwise known as male pattern baldness, or androgenic alopecia). Minoxidil reactivates and revitalises shrunken hair follicles and increases their size. Minoxidil is thought to work by dilating the blood vessels around hair follicles so increasing the nutrient supply to the follicles. With continued use, the hair follicles gain greater volume, which helps prevent further hair loss and promotes the regrowth of longer and thicker hairs.
The Hims Minoxidil solution is a proprietary extra strength formula, which does not contain alcohol or propylene glycol. This is a compounded, unlicensed product. Minoxidil products that are available without a prescription contain these additives, which are known to cause itchy scalps, irritation and dandruff.
Trade names
Minoxidil is sold under many different trade names around the world, including Regaine® and Rogaine®.
How do I use this medicine?
Apply 1 ml of the solution directly onto the scalp twice daily (once in the morning and once at night), using the dropper provided.
Make sure that the scalp is dry before applying.
No need to wash your hair before use.
Allow a few minutes for the solution to dry before wearing a hat or lying on a pillow.
This medicine is for external use only and should only be applied directly to the scalp.
Do not use more than 2 ml of the solution in 24 hours. Each bottle should last one month, if used as directed.
Additional information is included with the product.
What if I miss an application?
No worries! If you miss one or two applications, just carry on as normal, as if you had not missed the application. Using more often will not improve results.
How soon can I expect to see results?
Since normal hair grows approximately 1.25 cm per month, hair regrowth with Minoxidil also takes time.
You may need to use Minoxidil twice a day for 2-4 months before you see results. The best results will be achieved by following the instructions.
New hairs may initially be fine and soft (similar to baby hairs) but should eventually become the same colour and thickness as the other hairs on your scalp.
When you first begin to use the medicine, your hair loss may increase temporarily for the first 2-4 weeks. This is likely a sign that you are getting rid of old hairs in order to regrow new, better quality hairs. Remember, this increased hair shedding is temporary!
Once your hair has started to regrow, you need to continue using this medicine twice a day for the growth to be maintained. If you stop the treatment, the new hair is likely to disappear after 3 to 4 months.
If you have no improvement in your hair growth after 6 months of use, you should consider speaking to your doctor about stopping the treatment.
Is this medicine suitable for me?
This medicine is suitable for most men aged 18-65. Women should not use extra strength minoxidil products. Do not use this medicine if you have an allergy to minoxidil.
What if the medicine gets in my eyes, mouth or nose?
If the medicine comes into contact with the eyes, mouth, nose, or any broken or sunburnt skin, bathe the area with large amounts of cool tap water.
Are there any possible side effects?
Minoxidil is generally safe but, like all medicines, it can cause side effects. The most common side effects are itching and skin irritation of the treated area of the scalp. If scalp irritation continues, you should stop using the medicine and discuss your symptoms with your doctor.
Stop using the medicine and seek medical advice immediately if you experience any of the following:
Swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing.
Chest pain.
Stop using the medicine and talk to your doctor or pharmacist if you experience any of the following:
Dizziness, feeling faint due to low blood pressure.
Palpitations and/or fast heart beat.
Swelling in the hands, feet or legs, or shortness of breath.
Sudden, unexplained weight gain.
Changes such as skin rash and redness where the product is applied.
Other side effects which may occur, include:
Excessive hair growth on the face or body.
Headache.
Temporary hair loss (or shedding) may occur during the first 2-4 weeks of use. This is likely to be a result of a change in the natural hair growth cycle and should stop within a couple of weeks.
This is not an exhaustive list of possible side effects. Talk to your doctor or pharmacist if you have any concerns.
How should I store the medicine?
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the bottle.
Store upright, below 25°C and protect from light.
When the bottle is empty, the bottle and applicators must be disposed of safely.
Other important information
As with any medicine, this medicine does not work for everyone. Some people may not experience improvements in hair growth. If you have no improvement in your hair growth after 6 months of use, you should consider speaking to your doctor about stopping the treatment.
Minoxidil is suspected to be toxic to cats and dogs. Please do not allow cats, dogs, or other pets to ingest this medication or to come into contact with the treatment site after the medication has been applied. If these occur, consult your pet's veterinarian.
This telemedicine consultation should not replace your regular visits to a GP or doctor. Please keep your GP or doctor informed of any medicines you are taking (including this treatment from Hims), as it could interact with other medicines you may be taking.