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SILDENAFIL BLUEFISH 100 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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Bluefish Pharmaceuticals
Reason of change

Revised text received from RA (04.03.2014)

Sildenafil tablets

Product name
Strength

25/50/100 mg

Country

UK

Dimension

Artwork code
NA

Manufacturer

M/SIL/UK/P01

01

Pantone Shades
Hetero

Black

Leaflet

Artwork made to

100%

NA

Blister Layout No.:
NA
PDC

Reviewed
&
Approved by

Revision
History

No. of colours

200 x 325 mm

Component
Braille

Packs

03

Revision no.

QA

Remarks Font size: Heading 15, 12 pts.
Rest all 8 pts.

RA

Date: 04.03.2014
R1 - Initial mock-up artwork - 05.04.12 R2 - Revised text received from RA (28.02.2014) - 28.02.14

200 mm

United Kingdom

PACKAGE LEAFLET: INFORMATION FOR THE USER
Sildenafil 25 mg film-coated tablets
Sildenafil 50 mg film-coated tablets
Sildenafil 100 mg film-coated tablets
Sildenafil citrate
Other medicines and Sildenafil Tablet
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines

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, please 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 illnessare 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.

Sildenafil film-coated tablets 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 Sildenafil tablet and when you did. Do not take Sildenafil
with other medicines unless your doctor tells you that you can.
You should not take Sildenafil 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 or pharmacist or
nurse if you are taking any of these medicines that are often used for the
relief of angina pectoris (or “chest pain”).

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Sildenafil is and what it is used for
What you need to know before you take Sildenafil
How to take Sildenafil
Possible side effects
How to store Sildenafil
Contents of the pack and other information

1.

WHAT SILDENAFIL TABLET IS AND WHAT IT IS USED FOR

You should not take Sildenafil 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 Sildenafil tablet.

Sildenafil contains the active substance sildenafil which belongs to a
group of medicines called phosphodiesterase type 5 (PDE 5) 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. Sildenafil tablet
will only help you to get an erection if you are sexually stimulated.

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 Sildenafil with alpha-blockers. This is most
likely to happen within 4 hours after taking Sildenafil tablet. To reduce
the chance that these symptoms might happen, you should be on a
regular daily dose of your alpha-blocker before you start Sildenafil.
Your doctor may start you on a lower dose (25 mg) of Sildenafil tablet.

325 mm

Sildenafil 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
SILDENAFIL TABLET

KNOW BEFORE YOU TAKE

Sildenafil with food, drink and alcohol
Sildenafil tablet can be taken with or without food. However, you may
find that Sildenafil tablet takes longer to start working if you take it
with a heavy meal.

Do not take Sildenafil tablet









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 potentially dangerous fall in your blood pressure.
If you are allergic to sildenafil or any of the other ingredients of this
medicine (listed in section 6).
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

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 Sildenafil tablet.
Pregnancy, breast feeding and fertility
Sildenafil is not indicated for use by women.
Driving and using machines
Sildenafil may cause dizziness and can affect vision. You should be
aware of how you react to Sildenafil before you drive or use machinery.
Important information about some of the ingredients of Sildenafil
tablet If you have been told by your doctor that you have an intolerance
to some sugars, such as lactose, contact your doctor before taking
Sildenafil Tablet.
3.

HOW TO TAKE SILDENAFIL

Talk to your doctor, pharmacist or nurse before taking Sildenafil tablet
− 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 a bleeding problem (such
as haemophilia).
− If you experience sudden decrease or loss of vision, stop taking
Sildenafil tablet and contact your doctor immediately.

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 usual
starting dose is 50 mg.

You should not use Sildenafil with any other oral or local treatments for
erectile dysfunction.
You should not take Sildenafil if you do not have erectile dysfunction.
You should not take Sildenafil if you are a woman.

Sildenafil will only help you to get an erection if you are sexually
stimulated. The amount of time Sildenafil takes to work varies from
person to person, but it normally takes between half an hour and one
hour. You may find that Sildenafil takes longer to work if you take it
with a heavy meal.

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
Sildenafil should not be given to individuals under the age of 18.

You should not take Sildenafil more than once a day.
You should take Sildenafil tablet about one hour before you plan to have
sex. Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil is too strong or too weak, talk to
your doctor or pharmacist.

If Sildenafil 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.
The tablet can be divided into equal halves.

200 mm

If you take more Sildenafil than you should:
You may experience an increase in side effects and their severity. Doses
above 100 mg do not increase the efficacy.

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 Sildenafil.

You should not take more tablets than your doctor tells you to.

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 at:
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.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist, or nurse.
4.

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 Sildenafil are usually mild to moderate and of a short duration.

5.

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

If you experience any of the following serious side effects stop taking
Sildenafil and seek medical help immediately :

Do not use Sildenafil Bluefish after the expiry date which is stated on
the carton and blister after EXP. The expiry date refers to the last day of
the month.

An allergic reaction (this occurs rarely)
- Symptoms include sudden wheeziness, difficulty in breathing or
dizziness, swelling of the eyelids, face, lips or throat.

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.

If you have cChest 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

Prolonged and sometimes painful erections (frequency unknown)
If you have an erection which lasts for more than 4 hours, you should
contact a doctor immediately.

325 mm

A sudden decrease or loss of vision (frequency unknown)

HOW TO STORE SILDENAFIL

6.

CONTENTS OF THE PACK AND OTHER INFORMATION
What Sildenafil tablet contains
The active substance is sildenafil. Each film-coated tablet contains
25/50/100 mg of sildenafil (as citrate salt).

Serious skin reactions (frequency unknown)
Symptoms may include severe peeling and swelling of the skin,
blistering of the mouth, genitals and around the eyes, fever.

The other ingredients are:
• Tablet core : microcrystalline cellulose, calcium hydrogen
phosphate (anhydrous), croscarmellose sodium, magnesium stearate
• Tablet coating: lactose monohydrate, hypromellose, titanium
dioxide (E171), triacetin, indigo carmine aluminium lake (E132)

Seizures or fits (frequency unknown)

What Sildenafil tablet looks like and contents of the pack

Other side effects :.

Sildenafil 25 mg film-coated tablet
Blue coloured round, biconvex, film-coated tablets debossed with 124
on one side and J on the other side

Very common (may affect more than 1 in 10 people) :
- headache.
Common (may affect up to 1 in 10 people):
• facial flushing,
• indigestion,
• effects on vision (including colour tinge to vision, light sensitivity,
blurred vision or reduced sharpness of vision)
• stuffy nose,
• dizziness.
Uncommon (may affect up to 1 in 100 people)
• vomiting,
• skin rash,
• bleeding at the back of the eye,
• eye irritation,
• bloodshot eyes/red eyes,
• eye pain,
• double vision,
• abnormal sensation in the eye,
• watery eyes
• pounding or rapid heartbeat,
• muscle pain,
• feeling sleepy,
• reduced sense of touch,
• vertigo,
• ringing in the ears,
• nausea,
• dry mouth,
• penile bleeding
• pressure of blood in semen and/or urine
• chest pain,
• feeling tired.
Rare (may affect up to 1 in1000 people):
• high blood pressure,
• low blood pressure,
• fainting,
• stroke,
• heart attack
• irregular heartbeat
• nosebleed,
• sudden decrease or loss of hearing.
Not known (frequency cannot be estimated from the available data)
Additional side effects reported from post-marketing experience:
• pounding heartbeat Unstable angina (a heart condision),
• chest pain,
• sudden death
• temporary decreased blood flow to parts of the brain.

Sildenafil 50 mg film-coated tablet
Blue coloured round, scored biconvex, film-coated tablets debossed
with 125 on one side and J on the other side with the score line
Sildenafil 100 mg film-coated tablet
Blue coloured round, biconvex, scored film-coated tablets debossed
with 126 on one side and J on the other side with the score line
Sildenafil tablet is supplied in the following pack sizes:
Sildenafil 25 mg film-coated tablets
PVC/Aluminium foil blisters in cartons of 1, 2, 4, 8 or 12 tablets.
Sildenafil 50 mg film-coated tablets
PVC/Aluminium foil blisters in cartons of 1, 2, 4, 8 or 12 tablets.
Sildenafil 100 mg film-coated tablets
PVC/Aluminium foil blisters in cartons of 1, 2, 4, 8 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
Torsgatan 11, 111 23 Stockholm, Sweden
Medical information
For UK residents only: if you have any questions or would like more
information, call our Medical Information Department on 0808 178 9241
This medicinal product is authorised in the Member States of the
EEA under the following names:
Germany
Netherland
Poland
Portugal (RMS)
Spain
United Kingdom

Sildenafil Bluefish 25 mg/50 mg/100 mg
Filmtabletten
Sildenafil Bluefish 25 mg/50 mg/100 mg,
filmomhulde tabletten
Sildenafil Bluefish
Sildenafil Bluefish 25 mg/50 mg/100 mg
Comprimidos revestido por película
Sildenafilo Bluefish 25 mg/50 mg/100 mg
comprimidos recubiertos con película EFG
Sildenafil 25 mg/50 mg/100 mg film-coated tablets

This leaflet was last revised in 24.02.2014

PACKAGE LEAFLET: INFORMATION FOR THE USER
Sildenafil 25 mg film-coated tablets
Sildenafil 50 mg film-coated tablets
Sildenafil 100 mg film-coated tablets
Sildenafil citrate
Other medicines and Sildenafil Tablet
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines

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, please 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 illnessare 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.

Sildenafil film-coated tablets 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 Sildenafil tablet and when you did. Do not take Sildenafil
with other medicines unless your doctor tells you that you can.
You should not take Sildenafil 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 or pharmacist or
nurse if you are taking any of these medicines that are often used for the
relief of angina pectoris (or “chest pain”).

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Sildenafil is and what it is used for
What you need to know before you take Sildenafil
How to take Sildenafil
Possible side effects
How to store Sildenafil
Contents of the pack and other information

1.

WHAT SILDENAFIL TABLET IS AND WHAT IT IS USED FOR

You should not take Sildenafil 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 Sildenafil tablet.

Sildenafil contains the active substance sildenafil which belongs to a
group of medicines called phosphodiesterase type 5 (PDE 5) 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. Sildenafil tablet
will only help you to get an erection if you are sexually stimulated.

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 Sildenafil with alpha-blockers. This is most
likely to happen within 4 hours after taking Sildenafil tablet. To reduce
the chance that these symptoms might happen, you should be on a
regular daily dose of your alpha-blocker before you start Sildenafil.
Your doctor may start you on a lower dose (25 mg) of Sildenafil tablet.

Sildenafil 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
SILDENAFIL TABLET

KNOW BEFORE YOU TAKE

Sildenafil with food, drink and alcohol
Sildenafil tablet can be taken with or without food. However, you may
find that Sildenafil tablet takes longer to start working if you take it
with a heavy meal.

Do not take Sildenafil tablet









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 potentially dangerous fall in your blood pressure.
If you are allergic to sildenafil or any of the other ingredients of this
medicine (listed in section 6).
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 Sildenafil tablet
− 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 a bleeding problem (such
as haemophilia).
− If you experience sudden decrease or loss of vision, stop taking
Sildenafil tablet and contact your doctor immediately.
You should not use Sildenafil with any other oral or local treatments for
erectile dysfunction.
You should not take Sildenafil if you do not have erectile dysfunction.
You should not take Sildenafil 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
Sildenafil should not be given to individuals under the age of 18.

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 Sildenafil tablet.
Pregnancy, breast feeding and fertility
Sildenafil is not indicated for use by women.
Driving and using machines
Sildenafil may cause dizziness and can affect vision. You should be
aware of how you react to Sildenafil before you drive or use machinery.
Important information about some of the ingredients of Sildenafil
tablet If you have been told by your doctor that you have an intolerance
to some sugars, such as lactose, contact your doctor before taking
Sildenafil Tablet.
3.

HOW TO TAKE SILDENAFIL
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 usual
starting dose is 50 mg.
You should not take Sildenafil more than once a day.
You should take Sildenafil tablet about one hour before you plan to have
sex. Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil is too strong or too weak, talk to
your doctor or pharmacist.
Sildenafil will only help you to get an erection if you are sexually
stimulated. The amount of time Sildenafil takes to work varies from
person to person, but it normally takes between half an hour and one
hour. You may find that Sildenafil takes longer to work if you take it
with a heavy meal.
If Sildenafil 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.
The tablet can be divided into equal halves.

If you take more Sildenafil than you should:
You may experience an increase in side effects and their severity. Doses
above 100 mg do not increase the efficacy.

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 Sildenafil.

You should not take more tablets than your doctor tells you to.

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 at:
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.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist, or nurse.
4.

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 Sildenafil are usually mild to moderate and of a short duration.

5.

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

If you experience any of the following serious side effects stop taking
Sildenafil and seek medical help immediately :

Do not use Sildenafil Bluefish after the expiry date which is stated on
the carton and blister after EXP. The expiry date refers to the last day of
the month.

An allergic reaction (this occurs rarely)
- Symptoms include sudden wheeziness, difficulty in breathing or
dizziness, swelling of the eyelids, face, lips or throat.

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.

If you have cChest 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

Prolonged and sometimes painful erections (frequency unknown)
If you have an erection which lasts for more than 4 hours, you should
contact a doctor immediately.
A sudden decrease or loss of vision (frequency unknown)
Serious skin reactions (frequency unknown)
Symptoms may include severe peeling and swelling of the skin,
blistering of the mouth, genitals and around the eyes, fever.
Seizures or fits (frequency unknown)
Other side effects :.
Very common (may affect more than 1 in 10 people) :
- headache.
Common (may affect up to 1 in 10 people):
• facial flushing,
• indigestion,
• effects on vision (including colour tinge to vision, light sensitivity,
blurred vision or reduced sharpness of vision)
• stuffy nose,
• dizziness.
Uncommon (may affect up to 1 in 100 people)
• vomiting,
• skin rash,
• bleeding at the back of the eye,
• eye irritation,
• bloodshot eyes/red eyes,
• eye pain,
• double vision,
• abnormal sensation in the eye,
• watery eyes
• pounding or rapid heartbeat,
• muscle pain,
• feeling sleepy,
• reduced sense of touch,
• vertigo,
• ringing in the ears,
• nausea,
• dry mouth,
• penile bleeding
• pressure of blood in semen and/or urine
• chest pain,
• feeling tired.
Rare (may affect up to 1 in1000 people):
• high blood pressure,
• low blood pressure,
• fainting,
• stroke,
• heart attack
• irregular heartbeat
• nosebleed,
• sudden decrease or loss of hearing.
Not known (frequency cannot be estimated from the available data)
Additional side effects reported from post-marketing experience:
• pounding heartbeat Unstable angina (a heart condision),
• chest pain,
• sudden death
• temporary decreased blood flow to parts of the brain.

HOW TO STORE SILDENAFIL

6.

CONTENTS OF THE PACK AND OTHER INFORMATION
What Sildenafil tablet contains
The active substance is sildenafil. Each film-coated tablet contains
25/50/100 mg of sildenafil (as citrate salt).
The other ingredients are:
• Tablet core : microcrystalline cellulose, calcium hydrogen
phosphate (anhydrous), croscarmellose sodium, magnesium stearate
• Tablet coating: lactose monohydrate, hypromellose, titanium
dioxide (E171), triacetin, indigo carmine aluminium lake (E132)
What Sildenafil tablet looks like and contents of the pack
Sildenafil 25 mg film-coated tablet
Blue coloured round, biconvex, film-coated tablets debossed with 124
on one side and J on the other side
Sildenafil 50 mg film-coated tablet
Blue coloured round, scored biconvex, film-coated tablets debossed
with 125 on one side and J on the other side with the score line
Sildenafil 100 mg film-coated tablet
Blue coloured round, biconvex, scored film-coated tablets debossed
with 126 on one side and J on the other side with the score line
Sildenafil tablet is supplied in the following pack sizes:
Sildenafil 25 mg film-coated tablets
PVC/Aluminium foil blisters in cartons of 1, 2, 4, 8 or 12 tablets.
Sildenafil 50 mg film-coated tablets
PVC/Aluminium foil blisters in cartons of 1, 2, 4, 8 or 12 tablets.
Sildenafil 100 mg film-coated tablets
PVC/Aluminium foil blisters in cartons of 1, 2, 4, 8 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
Torsgatan 11, 111 23 Stockholm, Sweden
Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola, PLA 3000, Malta
Medical information
For UK residents only: if you have any questions or would like more
information, call our Medical Information Department on 0808 178 9241
This medicinal product is authorised in the Member States of the
EEA under the following names:
Germany
Sildenafil Bluefish 25 mg/50 mg/100 mg
Filmtabletten
Netherland
Sildenafil Bluefish 25 mg/50 mg/100 mg,
filmomhulde tabletten
Poland
Sildenafil Bluefish
Portugal (RMS) Sildenafil Bluefish 25 mg/50 mg/100 mg
Comprimidos revestido por película
Spain
Sildenafilo Bluefish 25 mg/50 mg/100 mg
comprimidos recubiertos con película EFG
United Kingdom Sildenafil 25 mg/50 mg/100 mg film-coated tablets
This leaflet was last revised in 11.06.2014

HO0030-0032/O/PIL/G1

Expand view ⇕

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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