VESACIN 5 мг Фильм-coated таблетки

Содержание инструкции

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

Vesacin 5 mg film-coated tablets
Vesacin 10 mg film-coated tablets
Solifenacin succinate
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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Vesacin and what it is used for

The active substance of Vesacin belongs to the group of anticholinergic drugs. These medicines are
used to reduce the activity of an overactive bladder. This allows delaying the need to go to the
bathroom and increases the amount of urine that can be contained within your bladder.
Vesacin 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, a need to urinate
frequently, or wetting yourself because you cannot reach the bathroom in time.

2. What you need to know before taking Solifenacina Sigillata

Do not take Solifenacina Sigillata

• 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 urinate or complete emptying of the bladder (urinary retention)
• if you have a severe problem with your stomach or intestines (including toxic megacolon, a complication associated with ulcerative colitis)
• if you suffer from a muscle disease called myasthenia gravis, which causes extreme weakness of some muscles
• if you suffer from increased eye pressure, with gradual loss of vision (glaucoma)
• if you are undergoing renal dialysis
• if you suffer from severe liver disease
• if you suffer from severe kidney disease or moderate liver disease AND are simultaneously treated with medicines that can reduce the elimination of

Vesacindall’organismo (from the body) (for example, ketoconazole). Your doctor or pharmacist will inform you
about this, if this condition applies to you.
Tell your doctor if you have or have ever had any of the aforementioned conditions before starting treatment
with Solifenacina Sigillata.

Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacina Sigillata.

• 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 very high.
• if you have obstructions of the digestive system (e.g. constipation).
• if your gastrointestinal motility (movements of the stomach and intestines) is at risk of slowing down. Your doctor will inform you of this possibility, if this condition applies to you.
• 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).

Children and adolescents
Vesacinnon must be used in children or adolescents under 18 years of
age.
Tell your doctor if you suffer or have suffered in the past from the conditions listed above before starting
treatment with Solifenacina Sigillata.
Before starting treatment with Solifenacina Sigillata, your 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 you an antibiotic (a treatment for certain bacterial infections).

Other medicines and Solifenacina Sigillata
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
It is particularly important to inform your doctor if you are taking:

• other anticholinergic medicines, as the effectiveness and side effects of both medicines may increase.
• cholinergics, as they may reduce the effect of Solifenacina Sigillata.
• medicines, such as metoclopramide and cisapride, that speed up the activity of the digestive system, may reduce their effect on Solifenacina Sigillata.
• medicines, such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which decrease the rate of elimination of Vesacindall’organismo.
• medicines such as rifampicin, phenytoin and carbamazepine, as they may increase the rate of elimination of Vesacindall’organismo.
• medicines such as bisphosphonates which may cause or worsen inflammation of the esophagus (esophagitis).

Vesacinwith food and drink
Vesacinmay be taken with or without food, according to your preference.

Pregnancy, breastfeeding and fertility
You should not use Vesacinif you are pregnant, unless it is strictly necessary. Do not
use Vesacinif you are breastfeeding, as solifenacin may pass into your milk.
Ask your doctor or pharmacist for advice before taking this medicine.

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

Vesacincontains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Solifenacina Sigillata

Instructions for proper use
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
You must swallow the tablet whole with liquids. You can take it with or without food, as you prefer.
Do not crush the tablets.
The recommended dose is 5 mg per day, unless your doctor has told you to take 10 mg per
day.

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

If you forget to take Solifenacina Sigillata
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 Sigillata
If you stop taking Solifenacina Sigillata, your overactive bladder symptoms may
reappear or worsen.
Always consult your doctor if you are considering stopping 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 experience an allergic reaction or a severe skin reaction (e.g. blistering and
peeling of the skin) you should inform your doctor or pharmacist immediately.
In some patients treated with solifenacin succinate, angioedema has been reported
(allergic skin manifestation consisting of swelling of the tissue just below the
skin surface) with airway obstruction (difficulty breathing). If angioedema occurs,
Vesacindemust be immediately discontinued and appropriate therapies and/or measures must be taken.
Vesacin can cause the following additional 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, belching, nausea and heartburn (dyspepsia), stomach discomfort.

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection or bladder infection
• drowsiness, altered sense of taste (dysgeusia)
• dry (irritated) eyes
• dry nose
• reflux disease (gastroesophageal reflux), dry throat
• dry skin
• difficulty urinating
• fatigue, fluid retention in the lower legs (edema).

Rare (may affect up to 1 in 1,000 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 rash

Not known (frequency cannot be estimated from available data)

• decreased appetite, high levels of potassium in the blood that can cause heart rhythm abnormalities
• increased pressure inside the eyes
• changes in the heart's electrical activity (ECG), irregular heartbeat (torsades de pointes), feeling your heartbeat, faster heartbeat
• voice disorders
• liver disorders
• muscle weakness
• kidney disorders

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at http://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 Sigillata

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 pack after EXP. The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Solifenacina Sigillata contains

• The active ingredient is solifenacin succinate 5 mg or 10 mg
• The other ingredients are:

Tablet core: microcrystalline cellulose, povidone, crospovidone, anhydrous lactose, colloidal anhydrous
silica, magnesium stearate.

Tablet coating:
Vesacin 5 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene
glycol 3350, talc (E553b), yellow iron oxide (E172).
Vesacin 10 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene
glycol 3350, talc (E553b), carmine (E120), red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Vesacine and contents of the pack
Vesacin 5 mg film-coated tablets are film-coated tablets, from light yellow to yellow, of
standard round convex shape, with “S5” imprinted on one side of the tablet and smooth on the other side.
Vesacin 10 mg film-coated tablets are film-coated tablets, from light pink to pink, of
standard round convex shape, with “S10” imprinted on one side of the tablet and smooth on the other side.
Vesacin 5 mg film-coated tablets are available in blister packs of 30 tablets.
Vesacin 10 mg film-coated tablets are available in blister packs of 20 tablets.
Blister packs made of aluminum-aluminum.
Blister packs made of polymeric materials.
Not all pack sizes may be marketed.

Marketing authorisation holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Rome, Italy

Manufacturer
Teva Pharma B.V.
Swensweg 5,
2031GA Haarlem,
Netherlands;
PLIVA Hrvatska d.o.o
Prilaz baruna Filipovica 25,
10 000 Zagreb,
Croatia

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
DK: SOLIFENACINSUCCINAT SIGILLATA
IT: VESACIN