Product Safety Information for Topical Finasteride & Minoxidil Solution

Read this patient information before you start using this medication 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.

1. What is Topical Finasteride & Minoxidil Serum and what is it used for?

This medicine combines two clinically proven hair loss treatments into one easy-to-use. The serum contains 0.3% Finasteride and 6% Minoxidil. Finasteride and Minoxidil work synergistically to treat common hereditary hair loss in men aged 18-65 (otherwise known as male pattern baldness, or androgenetic alopecia).

TOPICAL FINASTERIDE has been shown to lower the levels of DHT in the scalp, a major cause of male pattern hair loss. With continued use, Topical Finasteride can help to reverse the balding process and prevent further hair loss.

MINOXIDIL reactivates and revitalises shrunken hair follicles and increases their size. Minoxidil is thought to work by dilating the blood vessels around hair follicles and increasing nutrient supply to the follicles. With continued use, the hair follicles gain greater volume, which helps prevent further hair loss and promotes the growth of longer and thicker hairs.

This serum is used to treat male pattern hair loss in men aged 18-65 (a condition called androgenetic alopecia). Male pattern baldness is recognisable because of the areas which it affects, its gradual onset and its progressive nature.

This serum works best in men who have been losing hair at the top and front of the scalp, in a small area or over a short period of time. You are less likely to benefit if you have been balding for many years or have a large area of hair loss.

2. Is Topical Finasteride & Minoxidil Serum suitable for you?

Do not use this medicine if you:

  • are younger than 18 years or older than 65 years

  • are a woman (because this medicine is for men)

  • are allergic to Finasteride, Minoxidil or any of the other ingredients (listed in Section 7)

  • are already taking Finasteride, Dutasteride or any other 5-alpha reductase inhibitor for benign prostatic hyperplasia (BPH) or any other condition

  • have hair loss caused by drug treatment, or hair loss that is sudden and unexpected

  • have total baldness or complete loss of all body hair

  • have a shaved scalp

  • have any condition that affects your scalp, including psoriasis or sunburn

Talk to your doctor or pharmacist if you:

  • need to have a blood test called prostate–specific-antigen (PSA). Finasteride may alter the result of the test.

  • are using other medicines that are applied to the scalp which contain any of the following ingredients: Corticosteroids, Tretinoin, Dithranol, Petrolatum, Guanethidine. These medicines may cause the medicine to be absorbed quickly and increase the risk of side effects.

  • are taking medicines for high blood pressure that dilate (widen) the blood vessels, such as hydralazine. There is a potential risk that Minoxidil will increase their effect.

  • suffer from heart disease, including abnormal heart rhythms or rates, angina or chest pains and/or circulatory disorders

  • are unsure whether your scalp is normal and healthy

Warnings and Precautions

  • Finasteride should not be used by women. Women who are or may potentially be pregnant should not come into contact with this medicine. If Finasteride is absorbed through the skin or taken by mouth by women pregnant with a male foetus, the child may be born with malformed genital organs. When the patient’s sexual partner is or may become pregnant, the patient should discontinue treatment with this medicine.

  • mood alterations such as depressed mood have been reported in patients treated with oral Finasteride tablets. If you experience any of these symptoms from using the topical treatment, stop using the treatment and contact your doctor for further medical advice.

  • Finasteride may affect male fertility. Patients who are planning to father a child should consider stopping treatment.

3. How to use Topical Finasteride & Minoxidil Serum

Using the dropper, apply a total of 1ml of the solution across the areas of hair loss, once a day. The scalp should be dry or towel-dry before applying.

After applying, gently massage into your scalp. Then carefully blot any excess medication to keep it from running down your face and neck. Wash your hands afterwards.

Allow time for the solution to dry (approximately 5-10 minutes) before wearing a hat or lying on a pillow, to avoid the staining of clothing or linens. This medicine is for external use and should only be applied to the scalp. Some crystallisation of the solution may occur, so gently shake the bottle before use.

You can use hair sprays, mousses, conditioners, gels and waxes on your hair after applying the Topical Finasteride & Minoxidil Serum. For best results, the solution should be allowed to soak into the scalp before using any styling products.

If the product comes into contact with the eyes, broken skin or lining of the mouth, throat or nose, bathe the area with large amounts of cool water. If you use too much of the solution by mistake, or if it is accidentally swallowed, contact your doctor or pharmacist immediately.

4. How soon can I expect results using Topical Finasteride & Minoxidil Serum?

Since normal hair grows approximately 1.25 cm per month, hair regrowth with Topical Finasteride with Minoxidil also takes time. You may need to use this treatment for 4 months before you start seeing results. 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. The full effect of the treatment can be expected after 9-12 months. The best results will be achieved by using the medicine as instructed above.

When you first begin to use the Topical Finasteride & Minoxidil Serum, your hair loss may worsen temporarily for 2-4 weeks. This is likely a sign that you are shedding old hairs in order to regrow more new hairs. This hair shedding should be expected and is part of the process of how the Topical Finasteride & Minoxidil Serum regrows new hair. Remember, this increased hair loss is temporary, but if it continues after 4 weeks, it is advisable to see your doctor.

Once your hair has started to re-grow, you need to continue using this medicine daily for the growth to be maintained. If the treatment is stopped, you are likely to lose the hair you have gained within the next 9 to 12 months. 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 speak to your doctor about whether to contiunue using this treatment.

5. Possible side effects

Like all medicines, Topical Finasteride & Minoxidil Serum can cause side effects, although most people do not have any side effects while using it. The most common side effect is itching or irritation of the treated area of skin. If the skin irritation continues, stop using the medicine and see your doctor.

Stop using the medicine and seek medical advice immediately if you experience any of the following:

  • signs of allergic reaction, such as swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing

  • changes in breast tissue such as swelling, tenderness, or if there is any discharge from the nipple

  • chest pain or testicular 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 common side effects include:

  • 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. This should stop within a couple of weeks.

  • excessive hair growth on the face or body; itching; rash; dermatitis

  • headaches

Although uncommon, in clinical trials 3.8% of patients receiving a treatment of oral Finasteride tablets noticed some sort of sexual side effects, compared to 2.1% of patients who were taking the placebo. These side effects included less desire to have sex, difficulties with erectile function and decreases in the volume of semen released during sex. The side effects are usually temporary and disappear when the treatment is stopped. It is important to note that these side effects were observed in trials of oral Finasteride (tablet form) and that there is no conclusive evidence that the same symptoms are likely to occur with the use of topical Finasteride.

This is not an exhaustive list of possible side effects. Talk to your doctor or pharmacist if you get any other side effects or if you have any concerns.

6. How to store Topical Finasteride & Minoxidil Serum

  • 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 direct sunlight

  • when the bottle is empty, the bottle and applicators must be disposed of safely

7. What is in this medicine?

The serum contains 0.3% of the active ingredient Finasteride and 6% of the active ingredient Minoxidil.

The other ingredients are: aqua, lactic acid, polysorbate 80, lavandula officinalis water, parfum, phenoxyethanol, rosmarinus officinalis leaf oil, ethylhexylglycerin, oleic acid, BHT, juniperus communis fruit oil, PEG-40 hydrogenated castor oil, sodium benzoate, juniperus virginiana wood oil, amyris balsamifera bark oil, lavandula angustifolia herb oil, melaleuca alternifolia leaf oil, eucalyptus globulus leaf oil, acidity regulator.

This bottle contains 90 ml of solution (enough for 3 months of treatment) and 1 dropper applicator.

8. Who makes this medicine?

This medicine was manufactured and dispensed by London Specialist Pharmacy Limited, Yew Tree Avenue, Dagenham, RM10 7FN, United Kingdom.

9. Other important information

Do not use this medication for a condition for which it was not prescribed. Do not give this medication to other people, even if they have the same symptoms you have. It may harm them. 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.