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NIKITID 5MG FILM COATED TABLETS
Active substance(s): FINASTERIDE / FINASTERIDE / FINASTERIDE
Nikitid 5 mg film – coated tablets
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
In this leaflet:
1. What Nikitid is and what it is used for
2. Before you take Nikitid
3. How to take Nikitid
4. Possible side effects
5. How to store Nikitid
6. Further information
1. WHAT Nikitid IS AND WHAT IT IS USED FOR
Nikitid belongs to a g roup of medicines called 5-alpha reductase inhibitors. It works by shrinking the enlarged
prostate gland in men.
Your doctor has prescribed Nikitid for you because you have a condition known as benign prostatic hyperplasia or
BPH. Your prostate gland, which is near your bladder, has become bigger and is making it more difficult for you to pass
Nikitid helps to shrink the enlarged prostate and relieves your symptoms. Nikitid will help reduce the risk of
you developing a sudden inability to pass urine (known as acute urinary retention) and the need for surgery.
2. BEFORE YOU TAKE Nikitid
Nikitid is for use in men only.
Do not take Nikitid
- if you are allergic (hypersensitive) to finasteride or any of the other ingredients of Finasteride.
- if you are a woman or a child (the condition for which Finasteride is prescribed occurs only in men. The tablets must
not be taken by women or by children).
Take special care with Nikitid
Nikitid can a ffect a blood test called PSA. If you have a PSA test done, tell your doctor that you are taking
BPH is not cancer and does not lead to cancer, but the two conditions can be present at the same time. Before starting
you on Nikitid, it is likely that your doctor will perform some simple tests to check whether you have prostate
cancer. Your doctor will evaluate your symptoms and their possible causes. Talk to your doctor if you have any
Before starting treatment with Nikitid, the t reating physician should exclude that the difficulty of you to pass urine
is due to trilobular growth pattern of the prostate.
The medicine contains sunset yellow. It may cause allergic reactions.
Taking other medicines
Nikitid does 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 Nikitid with food and drink
There are no data to suggest that Nikitid affects the ability to drive or use machines.
Pregnancy and breast-feeding
If the active ingredient in Nikitid is absorbed by a woman who is pregnant with a male baby, it may affect the
normal development of the baby’s sex organs. Therefore, women who are or may potentially be pregnant, should not
be exposed to Nikitid. They should not take Nikitid. In addition, they should not handle broken or crushed
tablets or be exposed to the drug through sexual contact with a man taking Nikitid. The refore, if your sexual
partner is or may potentially be pregnant, you must avoid exposing her to your semen which could contain a tiny
amount of the drug - for example, by using a condom during sexual activity. If a woman who is pregnant comes into
contact with the active ingredient in Nikitid, a doctor should be consu lted. Whole Nikitid tablets a re coated to
prevent contact with the active ingredient during normal handling.
Ask your doctor or pharmacist if you have any questions.
Driving and using machines
There are not data to suggest that Nikitid affects the ability to drive or use machines.
3. HOW TO TAKE Nikitid
Always take Nikitid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are
not sure. The usual dose is one tablet containing 5 mg finasteride to be taken by mouth once a day with or without
Your doctor may prescribe Nikitid along with another medicine called doxazosin to help you control your BPH.
If you take more Nikitid than you should
If you take too many tablets by mistake, contact your doctor immediately.
If you forget to take Nikitid
If you miss a dose, just carry on with the next one as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Nikitid
In order to treat your symptoms and control your BPH effectively, it is important that you continue to take Finasteride
for as long as your doctor prescribes, even if you do not feel an immediate benefit. Some patients show early improvement in symptoms, but you may need to take Finasteride for at least six months to see if it improves your symptoms.
Nikitid works best when taken long term.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nikitid can cause side e ffects, although not everybody gets them.
Side effects due to Nikitid m ay include:
Common (affects 1 to 10 users in 100):
changes with ejaculation (such as a decrease in the amount of semen released during sex which does not appear to
interfere with normal sexual function.), impotence (an inability to have an erection), less desire to have sex
Uncommon (affects 1 to 10 users in 1,000):
problems with ejaculation, breast swelling and/or tenderness, rash
Unknown (frequency cannot be estimated from the available data):
testicular pain, allergic reactions such as itching (pruritus), hives (urticaria) and swelling of the lips and face, palpitation
(a quicker and/or irregular heartbeat), increased hepatic enzymes
In some men, such side effects disappeared while the patient continued to take Finasteride. If symptoms persist, they
usually resolved on discontinuing Nikitid.
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
It will help if you make a note of what you experienced, when it started and how long it lasted.
5. HOW TO STORE Nikitid
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Nikitid after the expiry date which is stated on the carton. The expiry date r efers to the last day of that
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. FURTHER INFORMATION
What Nikitid contains
- The active substance is finasteride.
- The other ingredients are: microcrystalline cellulose, pregelatinized maize starch, sodium starch glycollate, iron oxide
yellow (E172), sodium docusate, magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), talc, propylene glycol, indigo carmine (E132), quinoline yellow FCF
(E104), sunset yellow FCF (E110).
What Nikitid looks like and contents of the pack
Nikitid is available as blue, round, biconvex, film – coated tablets scored on one side.
Nikitid is available in blister packs of 15 or 30 or 98 or 100 film – coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
6 Dervenakion str.
6 Dervenakion str.
189, Parnithos Ave.,
This leaflet was last revised in 12/2016.
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.