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SEYLACINE 10 MG FILM COATED TABLET

Active substance(s): SOLIFENACIN SUCCINATE / SOLIFENACIN SUCCINATE

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Package leaflet: Information for the user
Seylacine 5 mg film coated tablet
Seylacine 10 mg film coated tablet

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.
- 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 SEYLACINE is and what it is used for
2. What you need to know before you take SEYLACINE
3. How to take SEYLACINE
4. Possible side effects
5. How to store SEYLACINE
6. Content of the pack and other information
1.
What SEYLACINE is and what it is used for
The active substance of solifenacin belongs to the group of 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 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 SEYLACINE

Do not take SEYLACINE
- if you have an 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 allergic to solifenacin or any of the other ingredients of this medicine (listed in
section 6)
- 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 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 starts.
Warnings and precautions
Talk to your doctor or pharmacist before taking SEYLACINE
- 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
(urinary retention) 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).

Children and adolescents
SEYLACINE is not to be used in children or adolescents under 18 years.
Inform your doctor if you have or ever had any of the above mentioned conditions before
treatment with SEYLACINE starts.
Before starting SEYLACINE, 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).
Other medicines and SEYLACINE
Please tell your doctor or pharmacist if you are taking or have recently taken or might take
other medicines.
It is especially important to inform your doctor if you are taking:
-

other anticholinergic medicines, effects and side effects of both medications can be
enhanced.
cholinergics as they can reduce the effect of solifenacin.
medicines, like metoclopramide and cisapride, which make the digestive system work
faster. Solifenacin can reduce their effect.
medicines, like ketoconazole, ritonavir, nelfinavir, intraconazole, verapamil and
diltiazem, which decrease the rate at which solifenacin is broken down by the body
medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate
at which solifenacin is broken down by the body.
medicines such as bisphosphonates, that can cause or exacerbate inflammation of the
gullet (oesophagitis).

Pregnancy and, breast-feeding and fertility
You should not use SEYLACINE if you are pregnant unless clearly necessary.
Do not use SEYLACINE if you are breast-feeding as solifenacin may get into your breast
milk.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
SEYLACINE may cause blurred vision and sometimes sleepiness or tiredness. If you suffer
from any of these side effects, do not drive or operate machinery.
SEYLACINE 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.

3.

How to take SEYLACINE

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
You should swallow the whole tablet with some liquid. It can be taken with or without food,
according to your preference. Do not crush the tablets.
The usual dose is 5 mg per day, unless your doctor told you to take 10 mg per day.
If you take more SEYLACINE than you should
If you have taken too much SEYLACINE or if a child has accidentally taken SEYLACINE,
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 SEYLACINE
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.
If you stop taking SEYLACINE
If you stop taking SEYLACINE, 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 product, ask your doctor or pharmacist.
4.

Possible side effects

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.
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. If angioedema occurs, solifenacin succinate should be
discontinued immediately and appropriate therapy and/or measures should be taken.
SEYLACINE may cause the following other side effects:
Very common (may affect more than 1 in 10 people)
-

dry mouth

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

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)

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, feeling your
heartbeat, faster heart beat

-

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 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.
5.

How to store SEYLACINE

Keep this medicine out of the sight and reach of children.
Do not use SEYLACINE after the expiry date which is stated on the carton or blister after
EXP. The expiry date refers to the last day of that month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.
6.

Contents of the pack and other information

What SEYLACINE contains
-

The active substance is solifenacin succinate 5 mg or 10 mg.
The other ingredients are lactose monohydrate, maize starch, hydroxypropyl cellulose,
magnesium stearate and hypromellose, titanium dioxide (E 171) and macrogol.

What SEYLACINE looks like and contents of the pack
SEYLACINE 5 mg film-coated tablet is a round, white to off-white tablet engraved with ‘’
5’’ on one side and plain on other side and 7.6 mm of diameter and 3.4 mm of thickness.
SEYLACINE 10 mg film-coated tablet is a round, white to off-white tablet engraved with
‘’10’’ on one side and plain on other side and 9.6 mm of diameter and 4.3 mm of thickness.
SEYLACINE tablets are supplied in blister packs of 10, 20, 30, 50, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
INOPHARM LIMITED
Warwick House,
Plane Tree Crescent,
Feltham, TW13 7HF United Kingdom
Manufacturer
Medreich PLC

Warwick House
Plane Tree Crescent
Feltham TW13 7 HF
United Kingdom
Or
MEDIS INTERNATIONAL A.S.
Vyrobni Zavod Bolatice
Prumyslova 961/16
747 23 Bolatice
Czech Republic
This medicinal product is authorised in the Member States of the EEA under the
following names:
DK: Seylacine 5 & 10 mg Filmovertrukne tablette
UK: Seylacine 5 & 10 mg film coated tablet
SE: Seylacine 5 & 10 mg filmdragerad tablett
ES : Seylacine 5 & 10 mg comprimidos recubiertos con película
This leaflet was last revised in 06/2017

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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