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SOLIFENACIN 10 MG FILM-COATED TABLETS

Active substance(s): SOLIFENACIN SUCCINATE

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P15XXXXX

Solifenacin film-coated
tablets

Solifenacin film-coated
tablets

P15XXXXX

• If you have a stomach tear (hiatus hernia) or heartburn.
• If you have a nervous disorder (autonomic neuropathy).
Package leaflet: Information for the user

Solifenacin 5 mg film-coated tablets
Solifenacin 10 mg film-coated tablets
Solifenacin succinate

Children and adolescents
Solifenacin 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 Solifenacin starts.

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.

Before starting Solifenacin, 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).

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

It is especially important to inform your doctor if you are taking:

1. What Solifenacin is and what it is used for

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).

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 Solifenacin
Do not take Solifenacin
• If you are allergic to solifenacin or any of the other ingredients of
this medicine (listed in section 6)
• 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 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 Solifenacin

• 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.

Black

Other medicines and Solifenacin
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

• 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,

Solifenacin with food, drink and alcohol
Solifenacin can be taken with or without food, depending on your
preference.
Pregnancy, breast-feeding and fertility
You should not use Solifenacin if you are pregnant unless clearly
necessary. Do not use Solifenacin if you are breast-feeding as
solifenacin may get 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 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 contains lactose monohydrate. 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 Solifenacin
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 recommended dose is 5 mg per day, unless your doctor told you
to take 10 mg per day.
If you take more Solifenacin than you should
If you have taken too much Solifenacin or if a child has accidentally
taken Solifenacin, 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
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.
Do not take a double dose to make up for a forgotten dose. If you
are in doubt, always consult your doctor or pharmacist.
If you stop taking Solifenacin
If you stop taking Solifenacin, your symptoms of overactive bladder
may return or worsen. Always consult your doctor, if you are
considering stopping the treatment.

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 Solifenacin
Keep this medicine out of the sight and reach of children.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Do not use this medicine after the expiry date which is stated on the
label, carton and bottle after EXP. The expiry date refers to the last
day of that month.

4. Possible side effects

This medicine does not require any special storage conditions.

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 (Solifenacin).
If angioedema occurs, solifenacin succinate (Solifenacin) should be
discontinued immediately and appropriate therapy and/or measures
should be taken.
Solifenacin 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

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 contains
- The active substance is solifenacin succinate.
Each film-coated tablet contains 5 mg of solifenacin succinate.
Each film-coated tablet contains 10 mg of solifenacin succinate.
The other ingredients are
Tablet core: Lactose monohydrate, maize starch, hypromellose (5
cp), silica colloidal anhydrous, magnesium stearate.
Tablet coating: Hypromellose (6 cp), macrogol (PEG 4000), titanium
dioxide (E 171), talc, yellow iron oxide (E 172) (for 5 mg only), red
iron oxide (E 172) (for 10 mg only).
What Solifenacin looks like and contents of the pack
Film-coated tablet.
Solifenacin 5 mg film-coated tablets:
Light yellow colored, round shaped [diameter 7.6 mm], biconvex, film
coated tablets, debossed with ‘CC’ on one side and ‘31’ on the other
side.
Solifenacin 10 mg film-coated tablets:
Light pink colored, round shaped [diameter: 7.6 mm], biconvex, film
coated tablets, debossed with ‘CC’ on one side and ‘32’ on the other
side.
Solifenacin film-coated tablets are available in clear PVC- Aluminium
foil blister pack and white opaque round HDPE container closed with
white opaque polypropylene stock ribbed closure.
Blister packs: 10, 30, 50, 60, 70, 90 and 200 film-coated tablets
HDPE Packs: 100, 250 and 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 02/2016.

P15XXXXX

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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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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