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TOVEDESO 7MG PROLONGED-RELEASE TABLETS

Active substance(s): DESFESOTERODINE SUCCINATE / DESFESOTERODINE SUCCINATE

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TOVEDESO 3.5 mg AND 7 mg
PROLONGED-RELEASE
TABLETS
desfesoterodine succinate
Package leaflet:
Information for the user

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

1 What Tovedeso is and what
it is used for

Tovedeso contains an active
substance called desfesoterodine
succinate, and is a so-called
antimuscarinic treatment which
reduces the activity of an overactive
bladder and it is used in adults to
treat the symptoms.





as changes in your blood
pressure or disorders in the
bowel or sexual function
if you have a gastrointestinal
disease that affects the passage
and/or digestion of food
if you have heartburn or belching
if you have an infection of the
urinary tract, your doctor may
need to prescribe some
antibiotics.

Heart problems: Talk to your doctor
if you suffer from any of the
following conditions:
• you have an ECG (heart tracing)
abnormality known as QT
prolongation or you are taking
any medicine known to cause
this
• you have a slow heart rate
(bradycardia)
• you suffer from heart disease
such as myocardial ischaemia
(reduced blood flow to the heart
muscle), irregular heartbeat or
heart failure
• you have hypokalemia, which is
a manifestation of abnormally
low levels of potassium in your
blood.
Children and adolescents
Do not give this medicine to
children and adolescents below
18 years of age because it is yet to
be established whether it would
work for them and whether it would
be safe.
Other medicines and Tovedeso
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
Your doctor will tell you whether
you can take Tovedeso with other
medicines.

Please inform your doctor if you are
taking medicines according to the
following list. Taking them at the
same time as desfesoterodine may
make side effects such as dry
mouth, constipation, difficulty in
completely emptying your bladder
or drowsiness more serious or
occur more often.
• medicines containing the active
substance amantadine (used to
treat Parkinson’s disease)
What
you
need
to
know

certain medicines used to
2
before you take Tovedeso
enhance gastrointestinal motility
or to relieve stomach cramps or
Do not take Tovedeso if:
spasm and to prevent travel
• you are allergic to
sickness like medicines
desfesoterodine, fesoterodine or
containing metoclopramide
to any of the other ingredients of • certain medicines used to treat
Tovedeso (listed in section 6) (see
psychiatric diseases, like
section 2, “Tovedeso contains
anti-depressives and
lactose”)
neuroleptics.
• you are not able to completely
empty your bladder (urinary
Please also inform your doctor if
retention)
you are taking any of the following
• your stomach empties slowly
medicines:
(gastric retention)
• medicines containing any of the
• you have an eye disease called
following active substances may
narrow angle glaucoma (high
increase the break-down of
pressure in the eye), which is not
desfesoterodine and thus
under control
decrease its effect: St. John’s
• you have excessive weakness of
Wort (herbal medicinal product),
the muscles (myasthenia gravis)
rifampicin (used to treat bacterial
• you have ulceration and
infections), carbamazepine,
inflammation of the colon
phenytoin and phenobarbital
(severe ulcerative colitis)
(used, among others, to treat
• you have an abnormally large or
epilepsy)
distended colon (toxic
• medicines containing any of the
megacolon)
following active substances may
• you have severe liver problems
increase the blood levels of
• you have kidney problems or
desfesoterodine: itraconazole or
moderate to severe liver
ketoconazole (used to treat
problems and are taking
fungal infections), ritonavir,
medicines containing any of the
atazanavir, indinavir, saquinavir
following active substances:
or nelfinavir (antiviral medicine
itraconazole or ketoconazole
for treating HIV), clarithromycin
(used to treat fungal infections),
or telithromycin (used to treat
ritonavir, atazanavir, indinavir,
bacterial infections), nefazodone
saquinavir or nelfinavir (antiviral
(used to treat depression),
medicine for treating HIV),
fluoxetine or paroxetine (used to
clarithromycin or telithromycin
treat depression or anxiety),
(used to treat bacterial infections)
bupropion (used for smoking
and nefazodone (used to treat
cessation or to treat depression),
depression) (see “Other
quinidine (used to treat
medicines and Tovedeso”).
arrhythmias) and cinacalcet
(used to treat
Warnings and precautions
hyperparathyroidism)
Desfesoterodine may not always be • medicines containing the active
suitable for you. Talk to your doctor
substance methadone (used in
before taking Tovedeso, if any of the
the treatment of severe pain and
following apply to you:
abuse problems).
• if you have difficulties in
completely emptying your
Pregnancy and breast-feeding
bladder (for example due to
Pregnancy
prostate enlargement)
Do not take Tovedeso if you are
• if you ever experience decreased pregnant, as the effects of
bowel movements or suffer from desfesoterodine on pregnancy and
severe constipation
the unborn baby are not known. Tell
• if you are being treated for an
your doctor if you are pregnant or
eye disease called narrow angle planning to become pregnant.
glaucoma
Breast-feeding
• if you have serious kidney or
liver problems, your doctor may It is not known whether
desfesoterodine is excreted into
need to adjust your dose
human milk; therefore, do not
• if you have a disease called
breast-feed during treatment with
autonomic neuropathy which
you notice from symptoms such Tovedeso.
Tovedeso treats the symptoms of an
overactive bladder such as:
• not being able to control when
you empty your bladder (called
urgency incontinence)
• suddenly needing to empty your
bladder (called urgency)
• having to empty your bladder
more often than usual (called
increased urinary frequency).

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.

Driving and using machines

Tovedeso can cause blurred vision, •
dizziness and sleepiness. If you

experience any of these effects, do

not drive or use any tools or

machines.

Tovedeso contains lactose
Tovedeso contains lactose. If you
have been told by your doctor that
you have an intolerance to some
sugars, contact your doctor before
taking this medicine.

3 How to take Tovedeso
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.

delay in passing urine (urinary
hesitation)
extreme tiredness (fatigue)
increased heart beat
(tachycardia)
palpitations
liver problems
cough
nasal dryness
throat pain
stomach acid reflux
blurred vision.

Rare: may affect up to 1 in 1,000
people
• urticaria
• confusion.
Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. 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.

The recommended starting dose of
Tovedeso is one 3.5 mg tablet a day.
Based on how you respond to the
medicine, your doctor may
5 How to store Tovedeso
prescribe you a higher dose; one
7 mg tablet a day.
Keep this medicine out of the sight
and reach of children.
You should swallow your tablet
whole with a glass of water. Do not
chew the tablet. Tovedeso can be
taken with or without food.
To help you remember to take your
medicine, you may find it easier to
take it at the same time every day.
If you take more Tovedeso than you
should
If you have taken more tablets than
you have been told to take, or if
someone else accidentally takes
your tablets, contact your doctor or
hospital for advice immediately.
Show them your pack of tablets.

Do not use this medicine after the
expiry date which is stated on the
carton and the blister after “EXP”.
The expiry date refers to the last
day of that month.
This medicine 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 protect
the environment.

If you forget to take Tovedeso
6 Contents of the pack and
other information
If you forget to take a tablet, take
your tablet as soon as you
What Tovedeso contains
remember, but do not take more
than one tablet in one day. Do not
• The active substance is
take a double dose to make up for a
desfesterodine succinate.
forgotten tablet.
Each Tovedeso 3.5 mg
If you stop Tovedeso
Prolonged-release Tablets contains
Do not stop taking Tovedeso without 3.5 mg desfesoterodine succinate,
talking to your doctor, as your
equivalent to 2.6 mg of
symptoms of overactive bladder
desfesoterodine.
may come back again or become
Each Tovedeso 7 mg
worse once you stop taking this
Prolonged-release Tablets contains
medicine.
7 mg desfesoterodine succinate,
If you have any further questions on equivalent to 5.2 mg of
the use of this medicine, ask your
desfesoterodine.
doctor or pharmacist.
• The other ingredients are:
microcrystalline cellulose,
4 Possible side effects
povidone, hypromellose 2208,
Microcelac 100, magnesium
Like all medicines, this medicine can
stearate, hypromellose 2910,
cause side effects, although not
glycerol and titanium dioxide
everybody gets them.
(E171) and indigo carmine
aluminium lake (E132).
Some side effects could be serious
Serious allergic reactions including
What Tovedeso looks like and
angioedema occurred rarely. You
contents of the pack
should stop taking Tovedeso and
contact your doctor immediately if Tovedeso 3.5 mg Prolonged-release
you develop swelling of the face,
Tablets are light blue, oval,
mouth or throat.
biconvex, film-coated, with
dimensions of 11.6 mm x 6.35 mm
Other side effects
and embossed on one side with
Very common: may affect more than ‘3.5’.
Tovedeso 7 mg Prolonged-release
1 in 10 people
You may get a dry mouth. This effect Tablets are blue, oval, biconvex,
film-coated, with dimensions of
is usually mild or moderate. This
may lead to a greater risk of dental 11.6 mm x 6.35 mm and embossed
caries. Therefore, you should brush on one side with ‘7’.
your teeth regularly twice daily and
Tovedeso is available in blister
see a dentist when in doubt.
packs of 14, 28, 56, 84, 98 or
100 prolonged-release tablets.
Common: may affect up to 1 in 10
Please note that not all the above
people
pack sizes may be marketed.
• dry eye
• constipation
Marketing Authorisation Holder
• trouble digesting food
TEVA UK Limited, Eastbourne,
(dyspepsia)
BN22 9AG, UK
• straining or pain when emptying
the bladder (dysuria)
Manufacturer
• dizziness
Merckle GmbH,
• headache
Ludwig-Merckle-Strasse 3,
• pain in the stomach
Blaubeuren, Baden-Wuerttemberg,
• diarrhoea
89143, Germany
• feeling sick (nausea)
This leaflet was last revised in
• difficulty sleeping (insomnia)
07/2017
• dry throat.
PL 00289/2063-2064
Uncommon: may affect up to 1 in
100 people
• urinary tract infection
• sleepiness (somnolence)
• difficulty tasting (dysgeusia)
• vertigo
• rash
• dry skin
• itching
• an uncomfortable feeling in the
stomach
• wind (flatulence)
• difficulty in completely emptying
the bladder (urinary retention)

EAS1274a

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.

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