SOLIFENACINA 5 mg Film-Coated Tablets

Зміст інструкції

1. Solifenacina Sandoz 5 mg film-coated tablets, 10 mg film-coated tablets
   1. What is Solifenacina Sandoz and what it is used for
   2. What you need to know before taking Solifenacina Sandoz
   3. How to take Solifenacina Sandoz
   4. Possible side effects
   5. How to store Solifenacina Sandoz
   6. Package contents and other information

Solifenacina Sandoz 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Solifenacina Sandoz and what it is used for

Solifenacina, the active substance of Solifenacina Sandoz, belongs to the group of anticholinergic medicines.
These medicines are used to reduce the activity of an overactive bladder. This
allows to delay the need to go to the bathroom and increases the amount of urine that can be
contained within your bladder.
Solifenacina Sandoz is used to treat the symptoms of a condition called overactive
bladder. These symptoms include:
a strong and sudden urge to urinate without preceding signals
the need to urinate frequently
wetting yourself because you cannot reach the bathroom in time

2. What you need to know before taking Solifenacina Sandoz

Do not take Solifenacina Sandoz
if:
you are allergic to solifenacin or any of the other ingredients of this medicine (listed
in section 6)
you have an inability to urinate or completely empty your bladder (urinary retention)
you have a severe problem with your stomach or intestines (including toxic megacolon, a
complication associated with ulcerative colitis)
you suffer from a muscle disease called myasthenia gravis, which causes extreme weakness of
some muscles
you suffer from increased eye pressure, with gradual loss of vision (glaucoma)
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you are undergoing renal dialysis
you suffer from severe liver disease
you suffer from severe kidney disease or moderate liver disease AND are simultaneously
treated with medicines that can reduce the elimination of Solifenacina Sandoz from the body (e.g.,
ketoconazole). Your doctor or pharmacist will inform you about this, if this condition
applies to you.
Tell your doctor if you suffer from or have suffered in the past from the conditions listed above before starting
treatment with Solifenacina Sandoz.

Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacina Sandoz
if you have problems emptying your bladder (bladder obstruction) or have difficulty urinating (e.g., a
reduced urine flow). The risk of urine accumulating in the bladder (urinary retention) is much
higher.
if you have obstructions of the digestive system (constipation).
if your gastrointestinal motility (stomach and intestinal movements) is at risk of
slowing down. The doctor will inform you about this possibility.
if you suffer from severe kidney disease.
if you suffer from moderate liver disease.
if you have a stomach lesion (hiatal hernia) or heartburn.
if you suffer from a nervous disorder (autonomic neuropathy).
Tell your doctor if you suffer from or have suffered in the past from the conditions listed above before starting
treatment with Solifenacina Sandoz.
Before starting treatment with Solifenacina Sandoz, the doctor must assess whether there are other causes for
your need to urinate frequently (e.g. heart failure (insufficient pumping power of the
heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an
antibiotic (a treatment for certain bacterial infections).

Children and adolescents
Solifenacina Sandoz should not be used in children or adolescents under the age of 18 years
of age.
Other medicines and Solifenacina Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
It is particularly important to inform your doctor if you are taking:
other anticholinergic medicines, as they can increase the effectiveness and unwanted effects of
both medicines.
cholinergics, as they can reduce the effect of Solifenacina Sandoz.
medicines, such as metoclopramide and cisapride, that speed up the activity of the digestive system.
Solifenacina Sandoz may reduce their effect.
medicines, such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, that
decrease the rate of elimination of Solifenacina Sandoz from the body
medicines such as rifampicin, phenytoin and carbamazepine, as they can increase the rate of
elimination of Solifenacina Sandoz from the body.
medicines such as bisphosphonates, which can cause or worsen inflammation of the esophagus
(esophagitis)
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Solifenacina Sandoz with food and drink
Solifenacina Sandoz can be taken with or without food, as you wish.

Pregnancy and breastfeeding
Pregnancy
You should not use Solifenacina Sandoz if you are pregnant, unless it is strictly
necessary.
Breastfeeding
Do not use Solifenacina Sandoz if you are breastfeeding, as solifenacin can pass into your milk.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Solifenacina Sandoz can cause blurred vision and sometimes drowsiness or fatigue. If
you experience these side effects, do not drive or use machines.

Solifenacina Sandoz contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this
medicine.

3. How to take Solifenacina Sandoz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is 5 mg per day, unless your doctor has told you to take 10 mg per
day.
Swallow the tablets whole with a glass of water, without chewing or crushing them.

Solifenacina Sandoz 10 mg film-coated tablets
The tablets can be divided into equal doses. Swallow the tablets or halves with a glass of
water, without chewing or crushing them.
Take the tablets at the same time each day. The tablets can be taken independently
of meals.

If you take more Solifenacina Sandoz than you should
If you have taken too much Solifenacina Sandoz or if a child has accidentally taken Solifenacina Sandoz,
consult your doctor or pharmacist immediately.
Symptoms of overdose may include:
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headache
dry mouth
dizziness
drowsiness and blurred vision
perception of non-existent objects (hallucinations)
overexcitement
seizures (convulsions)
difficulty breathing
increased heart rate (tachycardia)
retention of urine in the bladder (urinary retention)
dilated pupils (mydriasis).

If you forget to take Solifenacina Sandoz
If you forget to take a dose at the usual time, take it as soon as you remember, unless it is
already time to take the next dose. Never take more than one dose per day. If in doubt, always consult
your doctor or pharmacist

If you stop taking Solifenacina Sandoz
If you stop taking Solifenacina Sandoz, your overactive bladder symptoms may
reappear 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

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking Solifenacina Sandoz and
contact your doctor immediately:
Allergic reaction (signs may include swelling of the throat, face, lips and
mouth, difficulty breathing or swallowing) or a severe skin reaction (e.g. blistering and
peeling of the skin)
Angioedema (allergic skin manifestation consisting of swelling of the tissue just
below the skin surface) with airway obstruction (difficulty breathing) has been reported
in some patients treated with solifenacina.
Further side effects may occur with the following frequencies:

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 fullness, abdominal pain, belching, nausea and
heartburn (dyspepsia), stomach discomfort
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Uncommon,may affect up to 1 in 100 people
urinary tract infection, bladder infection
drowsiness, fatigue
altered sense of taste (dysgeusia)
dry eyes (irritated)
dry nose
reflux disease (gastroesophageal reflux)
dry throat
dry skin
difficulty urinating
fluid accumulation in the lower legs (edema).

Rare,may affect up to 1 in 1000 people
accumulation of large amounts of hardened stool in the colon (fecaloma)
increased urine formation within the bladder caused by the 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 skin rash

Not known,the frequency cannot be estimated from the available data
decreased appetite, high levels of potassium in the blood which can cause heart
rhythm abnormalities
increased eye pressure
changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, fast
heartbeat.
voice disorders
liver disease
muscle weakness
kidney disorders

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 through the national
reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Solifenacina Sandoz

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 package, bottle and blister
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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The shelf life after first opening of the polyethylene bottle is 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Solifenacina Sandoz contains
Solifenacina Sandoz 5 mg film-coated tablets
The active ingredientis solifenacina succinate. Each film-coated tablet contains 5 mg of
solifenacina succinate equivalent to 3.8 mg of solifenacina.
The other ingredients are lactose monohydrate, hypromellose, pregelatinized starch, magnesium
stearate, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172)
Solifenacina Sandoz 10 mg film-coated tablets
The active ingredientis solifenacina succinate. Each film-coated tablet contains 10 mg of
solifenacina succinate equivalent to 7.5 mg of solifenacina.
The other ingredients are lactose monohydrate, hypromellose, pregelatinized starch, magnesium
stearate, macrogol 6000, talc, titanium dioxide (E 171), red iron oxide (E 172)

Description of the appearance of Solifenacina Sandoz and contents of the pack
Solifenacina Sandoz 5 mg film-coated tablets are film-coated tablets of light yellow
colour, round, 6 mm in diameter, with the inscription 05 imprinted on one side.
Solifenacina Sandoz 10 mg film-coated tablets are film-coated tablets of light pink
colour, round, 8 mm in diameter, with the inscription 10 imprinted on one side, with a fracture line on the other side.
The tablet can be divided into equal doses.
The tablets in PVC/Al blisters contain 10, 20, 30, 50, 90 or 100 film-coated tablets
packaged in a carton.
Polyethylene bottles (with a polypropylene screw cap/desiccant) contain 30, 56, 60, 84,
90, 100, 105 or 250 film-coated tablets packaged in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
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Lek Pharmaceuticals d. d.
Verovškova ulica 57,
1526 Ljubljana
Slovenia
Lek Pharmaceuticals d. d.
Trimlini 2D
9220 Lendava
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Belgium Solifenacin Sandoz 5 mg film-coated tablets
Solifenacin Sandoz 10 mg film-coated tablets
France SOLIFENACINE SANDOZ 5 mg, coated tablet
SOLIFENACINE SANDOZ 10 mg, coated tablet
Ireland Solifenacin succinate Rowex 5 mg Film-coated tablets
Solifenacin succinate Rowex 10 mg Film-coated tablets
Italy Solifenacina Sandoz
Germany Solifenacin HEXAL 5 mg Film-coated tablets
Solifenacin HEXAL 10 mg Film-coated tablets
Netherlands Solifenacinesuccinaat Sandoz 5 mg, film-coated tablets
Solifenacinesuccinaat Sandoz 10 mg, film-coated tablets
United Kingdom Solifenacin succinate 5 mg Film-coated Tablets
Solifenacin succinate 10 mg Film-coated Tablets
Romania Solifenacin Sandoz 5 mg film-coated tablets
Solifenacin Sandoz 10 mg film-coated tablets
Slovenia Solifenacin Sandoz 5 mg film-coated tablets
Solifenacin Sandoz 10 mg film-coated tablets
Sweden Solifenacin Sandoz 5 mg film-coated tablet
Solifenacin Sandoz 10 mg film-coated tablet
Hungary Solifenacin Sandoz 5 mg film tablet
Solifenacin Sandoz 10 mg film tablet
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