Skip to Content

PULMOPRESIL 20MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE / SILDENAFIL CITRATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

T00075-01 Malta Zejtun 190x380 PIL

Package leaflet: Information for the patient

Pulmopresil 20mg
Film-coated Tablets
sildenafil
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 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.

• if you currently have a stomach ulcer, a bleeding disorder (such
as haemophilia) or problems with nose bleeds.
• if you take medicines for erectile dysfunction.

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

Prolonged and sometimes painful erections have been reported
in men after taking sildenafil. If you have an erection, which lasts
continuously for more than 4 hours, stop taking Pulmopresil
and contact your doctor immediately (see also section 4).

When used to treat male erectile dysfunction (ED), the following
visual side effects have been reported with PDE5 inhibitors,
including sildenafil at an unknown frequency; partial, sudden,
temporary or permanent decrease or loss of vision in one or both
eyes.
If you experience sudden decrease or loss of vision, stop taking
Pulmopresil and contact your doctor immediately (see also
section 4).

Special considerations for patients with kidney or liver
problems

You should tell your doctor if you have kidney or liver problems, as
your dose may need to be adjusted.

Children

Pulmopresil should not be given to children below 1 year of age.

1 What Pulmopresil is and what it is used for
Pulmopresil contains the active substance sildenafil which
belongs to a group of medicines called phosphodiesterase type
5 (PDE5) inhibitors.
Pulmopresil brings down blood pressure in the lungs by widening
the blood vessels in the lungs.
Pulmopresil is used to treat adults, children and adolescents from
1 to 17 years old, with high blood pressure in the blood vessels in
the lungs (pulmonary arterial hypertension) and who are able to
swallow the tablets.

2 What you need to know before you take

Pulmopresil

Do not take Pulmopresil:

• if you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in section 6).
• if you are taking medicines containing nitrates, or nitric oxide
donors such as amyl nitrate (“poppers”). These medicines
are often given for relief of chest pain (or “angina pectoris”).
Pulmopresil can cause a serious increase in the effects of
these medicines. Tell your doctor if you are taking any of these
medicines. If you are not certain, ask your doctor or pharmacist.
• if you 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 sildenafil have been shown to increase the
hypotensive effects of this medicine. If you are taking riociguat or
are unsure tell your doctor.
• if you are taking a medicine to treat fungal infections such as
ketoconazole or itraconazole or medicines containing ritonavir
(for HIV).
• if you have ever had loss of vision because of a problem with
blood flow to the nerve in the eye called non-arteritic anterior
ischaemic optic neuropathy (NAION).
• if you have recently had a stroke, a heart attack or if you have
severe liver disease or very low blood pressure (< 90/50mmHg).

Warnings and precautions

Talk to your doctor before taking Pulmopresil
• if you have a disease due to a blocked or narrow vein in the lungs
rather than a blocked or narrow artery.
• if you have a severe heart problem.
• if you have a problem with the pumping chambers of your heart.
• if you have high blood pressure in the blood vessels in the lungs.
• if you have low blood pressure at rest.
• if you lose a large amount of body fluids (dehydration) which can
occur when you sweat a lot or do not drink enough liquids. This
can happen if you are sick with a fever, vomiting or diarrhoea.
• if you have a rare inherited eye disease (retinitis pigmentosa).
• if you have an abnormality of red blood cells (sickle cell anaemia),
cancer of blood cells (leukaemia), cancer of bone marrow
(multiple myeloma), or any disease or deformity of the penis.

Other medicines and Pulmopresil

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
•M
 edicines containing nitrates, or nitric oxide donors such as amyl
nitrate (“poppers”). These medicines are often given for relief of
angina pectoris or “chest pain” (see section 2. What you need to
know before you take Pulmopresil).
• Tell your doctor or pharmacist if you are already taking riociguat.
• Therapies for pulmonary hypertension (e.g. bosentan,
ambrisentan, iloprost).
•M
 edicines containing St. John’s Wort (herbal medicinal product),
rifampicin (used to treat bacterial infections), carbamazepine,
phenytoin and phenobarbital (used, among others, to treat
epilepsy).
•B
 lood thinning medicines (for example warfarin) although these
did not result in any side effect.
• Medicines containing erythromycin, clarithromycin, telithromycin
(these are antibiotics used to treat certain bacterial infections),
saquinavir (for HIV) or nefazodone (for mental depression), as
your dose may need to be adjusted.
•A
 lpha-blocker therapy (e.g. doxazosin) for the treatment of high
blood pressure or prostate problems, as the combination of the
two medicines may cause symptoms resulting in the lowering of
your blood pressure (e.g. dizziness, light headedness).

Pulmopresil with food and drink

You should not drink grapefruit juice while you are being treated
with Pulmopresil.

Pregnancy and breast-feeding

If you are pregnant or breast‑feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Pulmopresil should not be used during pregnancy unless strictly
necessary.
Pulmopresil should not be given to women of child bearing
potential unless using appropriate contraceptive methods.
Stop breast-feeding when you start Pulmopresil treatment.
Pulmopresil should not be given to women who are
breast‑feeding since it is not known if the medicine passes into the
breast milk.

Driving and using machines

Pulmopresil can cause dizziness and can affect vision. You should
be aware of how you react to the medicine before you drive or use
machines.

Pulmopresil contains lactose

If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.

Continued top of next column
BBBA0321

Continued over page

Sildenafil (Pulmopresil) 20mg 90 Tablets PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0321

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
06.12.16
07.12.16
S.Anson

Date sent:
06.12.16
Date received: 07.12.16

Dimensions:
190 x 380
Min Body Text Size: 9pts
Supplier:
Actavis Malta Zejtun

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

T00075-01 Malta Zejtun 190x380 PIL

3 How to take Pulmopresil
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 20mg three times a day, for adults
(taken 6 to 8 hours apart) taken with or without food.

Use in children and adolescents

For children and adolescents aged 1 year to 17 years old, the
recommended dose is either 10mg three times a day for children
and adolescents ≤ 20kg or 20mg (1 tablet) three times a day for
children and adolescents > 20kg, taken with or without food.
Higher doses should not be used in children. This medicine
should be used only in case of administration of 20mg three times
a day. Other pharmaceutical forms may be more appropriate for
administration to patients ≤ 20kg and other younger patients who
are not able to swallow tablets.

If you take more Pulmopresil than you should

You should not take more medicine than your doctor tells you to.
If you take more medicine than you have been told to take contact
your doctor immediately. Taking more Pulmopresil than you
should may increase the risk of known side effects.

If you forget to take Pulmopresil

• v iral infection in the stomach and intestines
•u
 rinary tract infection
• t ooth cavities.
The following serious adverse events were considered to be
treatment related and were reported uncommonly (may affect up
to 1 in 100 people):
• a llergic reaction (such as skin rash, swelling of the face, lips and
tongue, wheezing, difficulty breathing or swallowing)
• convulsion
• irregular heartbeat
•h
 earing impairment
• s hortness of breath
• inflammation of the digestive tract
•w
 heezing due to disrupted airflow.
Other side effects:
Very common (may affect more than 1 in 10 people):
• infection of the throat, headache
• vomiting
• fever
• diarrhoea
• flu
• nosebleed.
Common (may affect up to 1 in 10 people):
• increased erections
• nausea
•p
 neumonia and runny nose.

If you forget to take Pulmopresil, take a dose as soon as you
remember, then continue to take your medicine at the usual
times.
Do not take a double dose to make up for a forgotten dose.

Reporting of side effects

If you stop taking Pulmopresil

Suddenly stopping your treatment with Pulmopresil may lead to
your symptoms getting worse. Do not stop taking Pulmopresil
unless your doctor tells you to. Your doctor may tell you to reduce
the dose over a few days before stopping completely.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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.

5 How to store Pulmopresil

4 Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you experience any of the following side effects you should stop
taking Pulmopresil and contact a doctor immediately (see also
section 2):
• if you experience sudden decrease or loss of vision (frequency
not known)
• if you have an erection, which lasts continuously for more than
4 hours. Prolonged and sometimes painful erections have been
reported in men after taking sildenafil (frequency not known).
Adults
Very common (may affect more than 1 in 10 people):
• headache, facial flushing
• indigestion, diarrhoea
• pain in the arms or legs.

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 after EXP. The expiry date refers to the last day of that
month.
This medicinal product does not require any special storage
conditions
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 Pulmopresil contains

Common (may affect up to 1 in 10 people):
• flu-like symptoms, bronchitis, inflammation of the sinuses, runny
nose, nosebleed, cough, stuffy nose
• dry mouth
• reduced number of red blood cells (anaemia)
• fluid retention
• difficulty sleeping, anxiety, migraine, shaking, “pins and needles”
-like sensation, burning sensation, reduced sense of touch
• bleeding at the back of the eye, effects on vision, blurred vision
and light sensitivity, effects on colour vision, eye irritation,
bloodshot eyes/red eyes
• vertigo
• gastroenteritis, stomach inflammation, heartburn, piles,
abdominal distension
• infection under the skin, hair loss, redness of the skin, night
sweats
• muscle aches, back pain
• increased body temperature.
Uncommon (may affect up to 1 in 100 people):
• reduced sharpness of vision, double vision, abnormal sensation
in the eye
• penile bleeding, presence of blood in semen and/or urine
• breast enlargement in men.
Not known (frequency cannot be estimated from the available
data):
• skin rash
• sudden decrease or loss of hearing
• decreased blood pressure.
Children and adolescents
The following serious adverse events have been reported
commonly (may affect up to 1 in 10 people):
• pneumonia
• heart failure, right heart failure, heart related shock
• high blood pressure in the lungs, chest pain, fainting, respiratory
infection, bronchitis

• The active substance is sildenafil. Each tablet contains 20mg of
sildenafil (as the citrate).
• The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose,
povidone, croscarmellose sodium, magnesium stearate.
Film coat: hypromellose, titanium dioxide (E171), macrogol.

What Pulmopresil looks like and contents of the pack

Pulmopresil Film-coated Tablets are 6.5mm, white, round and
biconvex in shape. The tablets are marked with “SL20” on one side.
The tablets are provided in blister packs containing 90 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis Ltd.
BLB016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
This leaflet was last revised December 2016.

If you would like a
leaflet with larger text,
please contact
01271 385257.

Continued top of next column
BBBA0321

Actavis, Barnstaple, EX32 8NS, UK

Sildenafil (Pulmopresil) 20mg 90 Tablets PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0321

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
06.12.16
07.12.16
S.Anson

Date sent:
06.12.16
Date received: 07.12.16

Dimensions:
190 x 380
Min Body Text Size: 9pts
Supplier:
Actavis Malta Zejtun

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand Transcript

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.

Hide