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VARDENAFIL ALEMBIC 20 MG FILM-COATED TABLETS

Active substance(s): VARDENAFIL / VARDENAFIL

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Package Leaflet: Information for the user
Vardenafil Alembic 5 mg film-coated tablets
Vardenafil Alembic 10 mg film-coated tablets
Vardenafil Alembic 20 mg film-coated tablets
vardenafil
Read all of this leaflet carefully before you start using 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 or pharmacist.
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 or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Vardenafil Alembic is and what it is used for
2.
What you need to know before you take Vardenafil Alembic
3.
How to take Vardenafil Alembic
4.
Possible side effects
5.
How to store Vardenafil Alembic
6.
Contents of the pack and other information
1.

What Vardenafil Alembic is and what it is used for

Vardenafil Alembic contains vardenafil, a member of a class of medicines called
phosphodiesterase type 5 inhibitors. They are used for the treatment of erectile dysfunction in
adult men, a condition which implies difficulties in getting or keeping an erection.
At least one in ten men has trouble getting or keeping an erection at some time. There may be
physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle
and blood vessel changes not enough blood stays in the penis to make it hard and keep it
hard.
Vardenafil Alembic will only work when you are sexually stimulated. It reduces the action of
the natural chemical in your body which makes erections go away. Vardenafil Alembic
allows an erection to last long enough for you to satisfactorily complete sexual activity.
2.

What you need to know before you take Vardenafil Alembic

Do not take Vardenafil Alembic if you:
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are allergic to vardenafil or any of the other ingredients of this medicine (listed in
section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips
and shortness of breath.
are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric
oxide donors, such as amyl nitrite. Taking these medicines with Vardenafil Alembic
could seriously affect your blood pressure.

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-

are taking ritonavir or indinavir, medicines used to treat human immunodeficiency
virus (HIV) infections.
are over 75 years of age and are taking ketaconazole or itraconazole, anti- fungal
medicines.
have a severe heart or liver problem.
are having kidney dialysis.
have recently had a stroke or heart attack.
have or have had low blood pressure.
family has a history of degenerative eye diseases (such as retinitis pigmentosa).
have ever had a condition involving loss of vision due to damage to the optic nerve
from insufficient blood supply known as non-arteritic ischemic optic neuropathy
(NAION).
are taking riociguat. This drug is used to treat pulmonary arterial hypertension
(i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary
hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5
inhibitors, such as Vardenafil Alembic have been shown to increase the hypotensive
effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vardenafil Alembic.
Take special care with Vardenafil Alembic if you
have heart trouble. It may be risky for you to have sex.
suffer from irregular heart beat (cardiac arrythmia) or inherited heart diseases
affecting your electrocardiogram.
have a physical condition affecting the shape of the penis. This includes conditions
called angulation, Peyronie’s disease and cavernosal fibrosis.
have an illness that can cause erections which won’t go away (priapism). These
include sickle cell disease, multiple myeloma and leukaemia.
have stomach ulcers (also called gastric or peptic ulcers).
have a bleeding disorder (such as haemophilia).
are using any other treatments for erection difficulties, including Vardenafil Alembic
orodispersible tablets (see section: Other medicines and Vardenafil Alembic).
experience sudden decrease or loss of vision, stop taking Vardenafil Alembic and
contact your doctor immediately.
Children and adolescents
Vardenafil Alembic is not intended for use by children and adolescents under the age of 18.
Other medicines and Vardenafil Alembic
Please tell your doctor or pharmacist if you are using, have recently used or might use any
other medicines, including medicines obtained without a prescription.
Some medicines may cause problems, especially these:
nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking
these medicines with Vardenafil Alembic could seriously affect your blood pressure.
Talk to a doctor without taking Vardenafil Alembic.
medicine for the treatment of arrythmias, such as quinidine, procainamide,
amiodarone or sotalol

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ritonavir or indinavir, medicines for HIV. Talk to a doctor without taking Vardenafil
Alembic.
ketoconazole or itraconazole, anti-fungal medicines
erythromycin or clarithromycin, macrolide antibiotics
alpha-blockers, a type of medicine used to treat high blood pressure and enlargement
of the prostate (as benign prostatic hyperplasia)
Riociguat.

Do not use Vardenafil Alembic film-coated tablets combined with any other treatment for
erectile dysfunction, including Vardenafil orodispersible tablets.
Vardenafil Alembic with food and drink
you can take Vardenafil Alembic with or without food – but preferably not after a
heavy or high-fat meal as this may delay the effect.
don’t drink grapefruit juice when you use Vardenafil Alembic. It can interfere with
the usual effect of the medicine.
alcoholic drink can make erection difficulties worse.
Pregnancy and breast-feeding
Vardenafil Alembic is not for use by women.
Driving and using machines
Vardenafil Alembic might make some people feel dizzy or affect their vision. If you feel
dizzy, or if your vision is affected after taking Vardenafil Alembic don’t drive or operate any
tools or machines.
Vardenafil Alembic film-coated tablets contains tartrazine aluminium lake (E102) and sunset
yellow FCF aluminium lake (E110), which may cause allergic reactions.
3.

How to take Vardenafil Alembic

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure. The recommended dose is 10 mg.
Take a Vardenafil Alembic tablet about 25 to 60 minutes before sexual activity. With sexual
stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours
after taking Vardenafil Alembic.
Swallow one tablet with a glass of water.
Do not take Vardenafil Alembic more than once a day.
Tell your doctor if you think Vardenafil Alembic is too strong or too weak.
If you take more Vardenafil Alembic than you should
Men who take too much Vardenafil Alembic may experience more side effects or may get
severe back pain. If you take more Vardenafil Alembic than you should, tell your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the effects are mild or moderate.
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has
been experienced by patients. Stop taking Vardenafil Alembic and contact your doctor
immediately. Sudden decrease or loss of hearing has been reported.
The chance of having a side effect is described by the following categories:
Very common (may affect more than 1 in 10 people)
- headache
Common (may affect up to 1 in 10 people)
- dizziness
- flushing
- blocked or runny nose
- indigestion
Uncommon (may affect up to 1 in 100 people)
- swelling of skin and mucous tissue including swollen face, lips or throat
- sleep disorder
- numbness and impaired perception of touch
- sleepiness
- effects on vision; redness of the eye, effects on colour vision, eye pain and discomfort,
light sensitivity
- ringing in the ears; vertigo
- fast heart beat or pounding heart
- breathlessness
- stuffy nose
- acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling sick (nausea), dry
mouth
- raised levels of liver enzymes in your blood
- rash, reddened skin
- back or muscle pain; increase in blood of a muscle enzyme (creatine phosphokinase),
muscle stiffness
- prolonged erections
- malaise
Rare (may affect up to 1 in 1,000 people)
- inflammation of the eyes (conjunctivitis)
- allergic reaction
- anxiety
- fainting
- amnesia
- seizure
- increase pressure in the eye (glaucoma), lacrimation increased
- effects on the heart (such as heart attack, altered heart beat or angina)
- high or low blood pressure

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nose bleed
effect on results of blood tests to check liver function
sensitivity of the skin to sun light
painful erections
chest pain

Very rare or not known (may affect less than 1 in 10,000 people or frequency cannot be
estimated from the available data)
- blood in the urine (Haematuria)
- penile bleeding (Penile Haemorrhage)
- presence of blood in the semen (Haematospermia)
Reporting of side effects
If you get any side effects, talk to your doctor or 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.
5.

How to store Vardenafil Alembic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
“EXP”. The expiry date refers to the last day of that month.
5mg, 10mg and 20mg (Aluminium-aluminium blister):
This medicine does not require any special storage conditions.
5mg and 10mg (Aluminium-PVC and aluminium-PVC/PVdC blister)
This medicine does not require any special storage conditions.
20mg (Aluminium-PVC and aluminium-PVC/PVdC blister)
Do not store above 30°C.
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 to protect the
environment.
6.

Contents of the pack and other information

What Vardenafil Alembic contains
The active substance is vardenafil.
Each tablet contains 5 mg, 10 mg or 20 mg of vardenafil (as hydrochloride trihydrate).
The other ingredients of the tablets are:
Tablet core: Cellulose, microcrystalline, hydroxypropylcellulose, crospovidone Type
B, silica, colloidal anhydrous, magnesium stearate
Film-coat: Opadry beige 03F570025

Composition of Opadry beige 03F570025: Hypromellose (E464), titanium dioxide (E171),
macrogol (E1521), iron oxide yellow (E172), tartrazine aluminium lake (E102), sunset
yellow FCF aluminium lake (E110), iron oxide red (E172)
What Vardenafil Alembic looks like and contents of the pack
Vardenafil Alembic 5 mg is a light orange to orange, film-coated round tablets debossed with
‘L’ on one side and ‘05’ on the other side.
Vardenafil Alembic 10 mg is a light orange to orange, film-coated round tablets debossed
with ‘480’ on one side and plain on the other side.
Vardenafil Alembic 20 mg is a light orange to orange, film-coated round tablets debossed
with ‘481’ on one side and plain on the other side.
Vardenafil Alembic 5 mg, 10 mg and 20 mg is available in blister packs of 2, 4, 8, 12 and 20
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Alembic Pharmaceuticals Europe Ltd
Palazzo Pietro Stiges
103 Strait Street
Valletta VLT 1436
Malta
Manufacturer
Pharmadox Healthcare Ltd
KW20A Corradino Industrial Estate
Paola PLA 3000
Malta
This leaflet was last revised in 02/2017

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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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