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SOLIFENACIN SUCCINATE 10 MG FILM-COATED TABLET

Active substance(s): SOLIFENACIN SUCCINATE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Solifenacin succinate

Market

UK-IE

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

3 (Page 1 of 2)

Date

10_02_16 (Solifenacin (ACC-UK-IE) PIL

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Package leaflet: information for the user

Solifenacin succinate
5 mg Film-coated Tablets
Solifenacin succinate
10 mg Film-coated Tablets
Solifenacin succinate

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 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 illness are the same as
yours.
• 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. See section
4.
What is in this leaflet
1. What Solifenacin succinate film-coated tablets
is and what it is used for
2. What you need to know before you take
Solifenacin succinate film-coated tablets
3. How to take Solifenacin succinate film-coated
tablets
4. Possible side effects
5. How to store Solifenacin succinate film-coated
tablets
6. Contents of the pack and other information

1. What Solifenacin succinate
film-coated tablets is and
what it is used for
The active substance of Solifenacin succinate
film-coated tablets belongs to the group called
anticholinergics. These medicines are used to
reduce the activity of an overactive bladder. This
enables you to wait longer before having to go to
the bathroom and increases the amount of urine
that can be held by your bladder.
Solifenacin succinate film-coated tablets is used
to treat the symptoms of a condition called
overactive bladder. These symptoms include:
having a strong, sudden urge to urinate without
prior warning, having to urinate frequently or
wetting yourself because you could not get to the
bathroom in time.

2. What you need to know
before you take Solifenacin
succinate film-coated tablets
Do not take Solifenacin succinate film-coated
tablets
• if you are allergic to solifenacin succinate or any
of the other ingredients of this medicine (listed
in section 6).
• if you have inability to pass water or to empty
your bladder completely (urinary retention).
• if you have a severe stomach or bowel
condition (including toxic megacolon, a
complication associated with ulcerative colitis).
• if you suffer from the muscle disease called
myasthenia gravis, which can cause an extreme
weakness of certain muscles.
• if you suffer from increased pressure in the
eyes, with gradual loss of eye sight (glaucoma).
• if you are undergoing kidney dialysis.
• if you have severe liver disease.
• if you suffer from severe kidney disease or
moderate liver disease AND at the same time
are being treated with medicines that may
decrease the removal of Solifenacin succinate
film-coated tablets from the body (for example,
ketoconazole). Your doctor or pharmacist will
have informed you if this is the case.
• Inform your doctor if you have or ever had any
of the above mentioned conditions before
treatment with Solifenacin succinate film-coated
tablets starts.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Solifenacin succinate film-coated tablets
• if you have trouble emptying your bladder
(bladder obstruction) or have difficulty in
passing urine, e.g. a thin urine flow. Risk of
accumulation of urine in the bladder is much
higher.
• if you have some obstruction of the digestive
system (constipation).
• if you are at risk of your digestive system
slowing down (stomach and bowel movements).
Your doctor will have informed you if this is the
case.
• if you suffer from severe kidney disease.
• if you have moderate liver disease.
• if you have a stomach tear (hiatus hernia) or
heartburn.
• if you have a nervous disorder (autonomic
neuropathy).

Approved By
Quality Assurance

• other anticholinergic medicines, as the effects
and side effects of both medications could be
increased.
• cholinergics, as they can reduce the effect of
Solifenacin succinate film-coated tablets.
• medicines, like metoclopramide and cisapride,
which make the digestive system work faster.
Solifenacin succinate film-coated tablets can
reduce their effect.
• medicines, like ketoconazole, itraconazole
(medicines used to treat fungal infections),
ritonavir, nelfinavir (medicines used to treat HIV
infections) and verapamil, diltiazem (medicines
used to treat high blood pressure and heart
diseases). These medicines decrease the rate
at which Solifenacin succinate film-coated
tablets is broken down by the body.
• medicines like rifampicin (medicine used to treat
tuberculosis and other bacterial infections) and
phenytoin, carbamazepine (medicines used to
treat epilepsy). They may increase the rate at
which Solifenacin succinate film-coated tablets
is broken down by the body.
• medicines such as bisphosphonates, that can
cause or exacerbate inflammation of the gullet
(oesophagitis).
Solifenacin succinate film-coated tablets with
food, drink and alcohol
Solifenacin succinate film-coated tablets can be
taken with or without food, depending on your
preference.
Pregnancy, breast-feeding and fertility
You should not use Solifenacin succinate
film-coated tablets if you are pregnant unless
your doctor thinks it is necessary. Do not use
Solifenacin succinate film-coated tablets if you
are breast-feeding as solifenacin may pass into
your breast milk.
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
Solifenacin succinate film-coated tablets may
cause blurred vision and sometimes sleepiness
or tiredness. If you suffer from any of these side
effects, do not drive or operate machinery.
Solifenacin succinate film-coated tablets
contains lactose monohydrate
If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicinal product.

3. How to take Solifenacin
succinate film-coated tablets
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 recommended dose is 5 mg per day, unless
your doctor has told you to take 10 mg per day.
You should swallow the tablet whole with some
liquid, e.g. a glass of water. It can be taken with
or without food, according to your preference. Do
not crush the tablets.
Use in children and adolescents
Solifenacin succinate film-coated tablets is not to
be used in children or adolescents under 18
years.
If you take more Solifenacin succinate
film-coated tablets than you should
If you have taken too much Solifenacin succinate
film-coated tablets or if a child has accidentally
taken Solifenacin succinate film-coated tablets,
contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache,
dry mouth, dizziness, drowsiness and blurred
vision, perceiving things that are not there
(hallucinations), over-excitability, seizures
(convulsions), difficulty breathing, elevated heart
rate (tachycardia), accumulation of urine in the
bladder (urinary retention) and dilated pupils
(mydriasis).
If you forget to take Solifenacin succinate
film-coated tablets
If you forget to take a dose at the usual time, take
it as soon as you remember, unless it is time to
take your next dose. Never take more than one
dose per day. If you are in doubt, always consult
your doctor or pharmacist. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Solifenacin succinate
film-coated tablets
If you stop taking Solifenacin succinate
film-coated tablets, your symptoms of overactive
bladder may return or worsen. Always consult
your doctor, if you are considering stopping the
treatment.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects

Children and adolescents
Solifenacin succinate film-coated tablets is
not to be used in children or adolescents under
18 years.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience an allergic attack, or a severe
skin reaction (e.g. blistering and peeling of the
skin), you must inform your doctor or pharmacist
immediately.

Inform your doctor if you have or ever had any of
the above mentioned conditions before treatment
with Solifenacin succinate film-coated tablets starts.
Before starting Solifenacin succinate film-coated
tablets, your doctor will assess whether there are
other causes for your need to pass urine
frequently, for example heart failure (insufficient
pumping power of the heart) or kidney disease. If
you have a urinary tract infection, your doctor will
prescribe you an antibiotic (a treatment against
particular bacterial infections).

Angioedema (skin allergy that results in the
swelling that occurs in the tissue just below the
surface of the skin) with airway obstruction
(difficulty in breathing) has been reported in some
patients on solifenacin succinate Solifenacin
succinate film-coated tablets. If angioedema
occurs, solifenacin succinate Solifenacin
succinate film-coated tablets should be
discontinued immediately and appropriate
therapy and/or measures should be taken.

Other medicines and Solifenacin succinate
film-coated tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
It is especially important to inform your doctor if
you are taking:

Solifenacin succinate film-coated tablets may
cause the following other side effects:
Very common (may affect more than 1 in 10
people)
• dry mouth

Note: PIL is required centrally folded in bible paper

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Solifenacin succinate

Market

UK-IE

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

3 (Page 2 of 2)

Date

10_02_16 (Solifenacin (ACC-UK-IE) PIL

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Common (may affect up to 1 in 10 people)
• blurred vision
• constipation, nausea, indigestion with
symptoms such as abdominal fullness,
abdominal pain, burping, nausea, and heartburn
(dyspepsia), stomach discomfort

Manufacturer

Uncommon (may affect up to 1 in 100 people)
• urinary tract infection, bladder infection
• sleepiness
• impaired sense of taste (dysgeusia)
• dry (irritated) eyes
• dry nasal passages
• reflux disease (gastro-oesophageal reflux)
• dry throat
• dry skin
• difficulty in passing urine
• tiredness
• accumulation of fluid in the lower legs (oedema)

Wessling Hungary Kft.
Fòti ùt 56., Budapest, 1047, Hungary

Approved By
Quality Assurance

Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom

Pharmacare Premium Ltd.
HHF003, Hal Far Industrial Estate, Birzebbugia,
BBG3000, Malta
This leaflet was approved in 02/2016

Rare (may affect up to 1 in 1,000 people)
• lodging of a large amount of hardened stool in
the large intestine (faecal impaction)
• build up of urine in the bladder due to inability to
empty the bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, rash
Very rare (may affect up to 1 in 10,000 people)
• hallucinations, confusion
• allergic rash
Not known (frequency cannot be estimated from
the available data)
• decreased appetite, high levels of blood
potassium which can cause abnormal heart
rhythm
• increased pressure in the eyes
• changes in the electrical activity of the heart
(ECG), irregular heartbeat (Torsade de
Pointes), feeling your heartbeat, faster
heartbeat
• voice disorder
• liver disorder
• muscle weakness
• renal disorder
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
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Solifenacin
succinate film-coated tablets
• This medicinal product does not require any
special storage conditions.
• 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 blister or carton after
EXP. The expiry date refers to the last day of
that month.
• Do not use this medicine if you notice the pack
that is damaged or shows signs of tampering.
• 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.

6. Contents of the pack and
other information
What Solifenacin succinate film-coated
tablets contains
The active substance is Solifenacin succinate
Each film-coated tablet contains 5 mg solifenacin
succinate, equivalent to 3.8 mg solifenacin.
Each film-coated tablet contains 10 mg
solifenacin succinate, equivalent to 7.5 mg
solifenacin.
The other ingredients are:
Tablet core: Lactose monohydrate, Maize starch,
Hypromellose (3 cps) (E464), Magnesium
stearate (E572)
Film-coating: Hypromellose (5cps) (E464), Talc
(E553b), Titanium Dioxide (E171), Macrogol 6000
(E1521), Iron oxide yellow (E172) (For 5 mg),
Iron oxide red (E172) (For 10 mg)
What Solifenacin succinate film-coated
tablets looks like and contents of the pack
Solifenacin succinate 5 mg film-coated tablets:
Light yellow colored, round, approximately 7.1 mm
in diameter, biconvex, film coated tablets,
debossed with “EG” on one side and “1” on other
side.
Solifenacin succinate 10 mg film-coated tablets:
Light pink colored, round, approximately 7.1 mm
in diameter, biconvex, film coated tablets,
debossed with “EG” on one side and “2” on other
side.
Solifenacin succinate film-coated tablets are
available in PVC/PVdC-Aluminium blister packs
of 3, 5, 10, 20, 30, 50, 60, 90,100 and 200
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom

Note: PIL is required centrally folded in bible paper

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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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