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LEKAP 50 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL

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Lekap 25 mg film-coated tablets
Lekap 50 mg film-coated tablets
Lekap 100 mg film-coated tablets
Sildenafil

Barcode

Artwork No.

Package leaflet: Information for the patient

You should not take Lekap if you do not have erectile dysfunction.
You should not take Lekap if you are a woman.
Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide
on a lower dose for you.
Children and adolescents
Lekap should not be given to individuals under the age of 18.

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.

Other medicines and Lekap
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

What is in this leaflet:
1.
What Lekap is and what it is used for
2.
What you need to know before you take Lekap
3.
How to take Lekap
4.
Possible side effects
5.
How to store Lekap
6.
Contents of the pack and other information

You should not take Lekap if you are taking medicines called nitrates, as the combination of
these medicines may lead to a dangerous fall in your blood pressure. Always tell your
doctor, pharmacist or nurse if you are taking any of these medicines that are often used for
the relief of angina pectoris (or “chest pain”).

1.

What Lekap is and what it is used for

Lekap contains the active substance sildenafil which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels
in your penis, allowing blood to flow into your penis when you get sexually excited. Lekap
will only help you to get an erection if you are sexually stimulated.
Lekap is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
2.

What you need to know before you take Lekap

Do not take Lekap
If you are allergic to sildenafil or any of the other ingredients of this medicine (listed
in section 6).
If you are taking medicines called nitrates, as the combination may lead to a
dangerous fall in your blood pressure. Tell your doctor if you are taking any of these
medicines which are often given for relief of angina pectoris (or “chest pain”). If
you are not certain, ask your doctor or pharmacist.
If you are using any of the medicines known as nitric oxide donors such as amyl
nitrite (“poppers”), as the combination may also lead to a dangerous fall in your
blood pressure.
If you have a severe heart or liver problem.
If you have recently had a stroke or a heart attack, or if you have low blood pressure.
If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
If you have ever had loss of vision due to non-arteritic anterior ischaemic optic
neuropathy (NAION).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lekap
If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia
(cancer of blood cells), multiple myeloma (cancer of bone marrow).
If you have a deformity of your penis or Peyronie's Disease.
If you have problems with your heart. Your doctor should carefully check whether
your heart can take the additional strain of having sex.
If you currently have a stomach ulcer, or bleeding problems (such as haemophilia).
If you experience sudden decrease or loss of vision, stop taking Lekap and contact
your doctor immediately.

Lekap may interfere with some medicines, especially those used to treat chest pain. In the
event of a medical emergency, you should tell your doctor, pharmacist or nurse that you
have taken Lekap and when you did. Do not take Lekap with other medicines unless your
doctor tells you that you can.

You should not take Lekap if you are using any of the medicines known as nitric oxide
donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous
fall in your blood pressure.
If you are taking medicines known as protease inhibitors, such as for the treatment of HIV,
your doctor may start you on the lowest dose (25 mg) of Lekap.
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or
prostate enlargement may experience dizziness or light-headedness, which may be caused
by low blood pressure upon sitting or standing up quickly. Certain patients have
experienced these symptoms when taking Lekap with alpha-blockers. This is most likely to
happen within 4 hours after taking Lekap. To reduce the chance that these symptoms might
happen, you should be on a regular daily dose of your alpha-blocker before you start Lekap.
Your doctor may start you on a lower dose (25 mg) of Lekap.
Lekap with food, drink and alcohol
Lekap can be taken with or without food. However, you may find that Lekap takes longer to
start working if you take it with a heavy meal.
Drinking alcohol can temporarily impair your ability to get an erection. To get the
maximum benefit from your medicine, you are advised not to drink excessive amounts of
alcohol before taking Lekap.
Pregnancy, breast–feeding and fertility
Lekap is not indicated for use by women.
Driving and using machines
Lekap can cause dizziness and can affect vision. You should be aware of how you react to
Lekap before you drive or use machinery.
Lekap contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, such as
lactose, contact your doctor before taking Lekap.
3.

How to take Lekap

Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg.
You should not take Lekap more than once a day.

You should not use Lekap with any other oral or local treatments for erectile dysfunction.

You should take Lekap about one hour before you plan to have sex. Swallow the tablet
whole with a glass of water.

You should not use Lekap with treatments for pulmonary arterial hypertension (PAH)
containing sildenafil or any other PDE5 inhibitors.

If you feel that the effect of Lekap is too strong or too weak, talk to your doctor or pharmacist.

Lekap will only help you to get an erection if you are sexually stimulated. The amount of
time Lekap takes to work varies from person to person, but it normally takes between half
an hour and one hour. You may find that Lekap takes longer to work if you take it with a
heavy meal.
If Lekap does not help you to get an erection or if your erection does not last long enough for
you to complete sexual intercourse you should tell your doctor.
If you take more Lekap than you should
You may experience an increase in side effects and their severity. Doses above 100 mg do
not increase the efficacy.
You should not take more tablets than your doctor tells you to.

vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the
white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the
inside of the nose, feeling irritable and sudden decrease or loss of hearing.
From post-marketing experience cases of unstable angina (a heart condition) and sudden
death have been reported rarely. Of note, most, but not all, of the men who experienced
these side effects had heart problems before taking this medicine. It is not possible to
determine whether these events were directly related to Lekap.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the safety of this medicine.

Contact your doctor if you take more tablets than you should.
5.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.
4.

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.

Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them.
The side effects reported in association with the use of Lekap are usually mild to moderate
and of a short duration.
If you experience any of the following serious side effects stop taking Lekap and seek
medical help immediately:

Do not use this medicine after the expiry date which is stated on the carton after EXP. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.
6.

Ÿ

An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people)
Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling
of the eyelids, face, lips or throat.

Ÿ

Chest pains - this occurs uncommonly
If this occurs during or after intercourse
Get in a semi-sitting position and try to relax.
Do not use nitrates to treat your chest pain.
-

Ÿ

Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in
1,000 people)
If you have an erection which lasts for more than 4 hours, you should contact a doctor
immediately.

Ÿ

Asudden decrease or loss of vision - this occurs rarely

Ÿ

Serious skin reactions - this occurs rarely
Symptoms may include severe peeling and swelling of the skin, blistering of the
mouth, genitals and around the eyes, fever.

Ÿ

How to store Lekap

Seizures or fits - this occurs rarely

Contents of the pack and other information

What Lekap contains
The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of
sildenafil (as the citrate salt).
The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate
(anhydrous), croscarmellose sodium, magnesium stearate.
Film-coat: hypromellose, titanium dioxide (E171), lactose monohydrate,
triacetin.
What Lekap looks like and contents of the pack
Lekap 25 mg film-coated tablets are white coloured, oval shaped, biconvex, film-coated
tablets plain on one side and debossed with 'B9' on the other side.
Lekap 50 mg film-coated tablets are white coloured, oval shaped, biconvex, film-coated
tablets plain on one side and debossed with 'C1' on the other side.
Lekap 100 mg film-coated tablets are white coloured, oval shaped, biconvex, film-coated
tablets plain on one side and debossed with '436' on the other side.
The tablets are provided in blister packs containing 1, 2, 4, 8 or 12 tablets in a carton.
Some pack sizes may not be marketed in your country.

Other side effects:
MarketingAuthorisation Holder and Manufacturer
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms
include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision,
blurred vision, visual disturbance, stuffy nose and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation,
bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light
sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low
blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the
ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose
(symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastrooesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain
in the arms or legs, nosebleed, feeling hot and feeling tired.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat,
temporary decreased blood flow to parts of the brain, feeling of tightening of the throat,
numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision,
abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your

MarketingAuthorisation Holder
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Manufacturer
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
This leaflet was last revised in July 2014.

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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.

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