Sildenafil Zentiva 20mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SILDENAFIL CITRATE

Available from:

Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic

ATC code:

G04BE03

INN (International Name):

SILDENAFIL CITRATE 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SILDENAFIL CITRATE 20 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2017-04-18

Patient Information leaflet

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL ZENTIVA 20 MG 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.
WHAT IS IN THIS LEAFLET
1. What Sildenafil Zentiva is and what it is used for
2. What you need to know before you take Sildenafil Zentiva
3. How to take Sildenafil Zentiva
4. Possible side effects
5. How to store Sildenafil Zentiva
6. Contents of the pack and other information
1.
WHAT SILDENAFIL ZENTIVA IS AND WHAT IT IS USED FOR
Sildenafil
Zentiva
contains
the
active
substance
sildenafil
which
belongs
to
a
group
of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Sildenafil Zentiva brings down blood pressure in the lungs by widening
the blood vessels in the
lungs.
Sildenafil Zentiva is used to treat adults and children and
adolescents from 1 to 17 years old
with high blood pressure in the blood vessels in the lungs (pulmonary
arterial hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SILDENAFIL ZENTIVA
DO NOT TAKE SILDENAFIL ZENTIVA IF YOU
−
are allergic to sildenafil or any of the other ingredients of this
medicine (listed in section
6).
−
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”).
PAGE 2 OF 7
Sildenafil Zentiva 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.
−
are

Summary of Product characteristics

PAGE 1 OF 22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sildenafil Zentiva 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg sildenafil (as citrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, round, lens-shape, film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Treatment of adult patients with pulmonary arterial hypertension
classified as WHO functional
class II and III, to improve exercise capacity. Efficacy has been
shown in primary pulmonary
hypertension and pulmonary hypertension associated with connective
tissue disease.
Paediatric population
Treatment
of
paediatric
patients
aged
1
year
to
17
years
old
with
pulmonary
arterial
hypertension.
Efficacy
in
terms
of
improvement
of
exercise
capacity
or
pulmonary
haemodynamics
has
been
shown
in
primary
pulmonary
hypertension
and
pulmonary
hypertension associated with congenital heart disease (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experienced in the treatment
of pulmonary arterial hypertension. In case of clinical deterioration
in spite of Sildenafil Zentiva
treatment, alternative therapies should be considered.
PAGE 2 OF 22
Posology
_Adults _
The recommended dose is 20 mg three times a day (TID). Physicians
should advise patients
who forget to take Sildenafil Zentiva to take a dose as soon as
possible and then continue with
the normal dose. Patients should not take a double dose to compensate
for the missed dose.
_Paediatric population (1 year to 17 years) _
For paediatric patients aged 1 year to 17 years old, the recommended
dose in patients ≤ 20 kg
is 10 mg three times a day and for patients > 20 kg is 20 mg three
times a day. Higher than
recommended doses should not be used in paediatric patients with PAH
(see also sections 4.4
and 5.1). The 20 mg tablet should not be used in cases where 10 mg TI