Solifenacin sanexcel

Patient Information Leaflet

Solifenacin SaneXcel, 5 mg, film-coated tablets
Solifenacin SaneXcel, 10 mg, film-coated tablets
Solifenacini succinas
Please read the entire leaflet before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents:

1. What Solifenacin SaneXcel is and what it is used for
2. Important information before taking Solifenacin SaneXcel
3. How to take Solifenacin SaneXcel
4. Possible side effects
5. How to store Solifenacin SaneXcel
6. Contents of the pack and other information

1. What Solifenacin SaneXcel is and what it is used for

The active substance in Solifenacin SaneXcel belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between bathroom visits and increases the amount of urine the bladder can hold.
Solifenacin SaneXcel is used to treat symptoms of overactive bladder. These include:
urgency, which are sudden, compelling urges to pass urine; frequent urination; and urinary incontinence, resulting from the inability to reach the toilet in time.

2. Important information before using Solifenacin SaneXcel

When not to use Solifenacin SaneXcel:

• if the patient is unable to pass urine or empty the bladder (urinary retention)
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis)
• if the patient suffers from a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles
• if the patient has increased intraocular pressure leading to gradual vision loss (glaucoma)
• if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
• if the patient is undergoing kidney dialysis
• if the patient has severe liver function impairment
• if the patient has severe kidney function impairment or moderate liver function impairment and is simultaneously taking medicines that may delay the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will provide further information on this.

Before starting treatment with Solifenacin SaneXcel, inform your doctor if any of the above conditions are currently present or have occurred in the past.

Warnings and precautions

Before starting Solifenacin SaneXcel, discuss with your doctor, pharmacist, or nurse:

• if the patient has difficulty emptying the bladder (obstruction of urinary outflow) or difficulty passing urine (weak urine stream). In such cases, the risk of urine retention in the bladder (urinary retention) is significantly higher.
• if the patient has gastrointestinal motility disorders (constipation).
• if there is a risk of slowed gastrointestinal motility (gastric and intestinal movements). Your doctor will provide further information on this.
• if the patient has severe kidney function impairment.
• if the patient has moderate liver function impairment.
• if the patient suffers from severe stomach pain (hiatal hernia) or heartburn (gastroesophageal reflux).
• if the patient has nervous system disorders (autonomic neuropathy).

Children and adolescents

Solifenacin SaneXcel must not be used in children or adolescents under 18 years of age.

Before starting treatment with Solifenacin SaneXcel, inform your doctor if any of the above conditions are currently present or have occurred in the past.

Before starting Solifenacin SaneXcel, your doctor will assess whether there are other possible causes of frequent urination (e.g. heart failure – insufficient cardiac muscle strength to pump blood effectively, or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial medicine effective against the specific bacterial infection).

Solifenacin SaneXcel and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

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

• other anticholinergic medicines, as their effects and side effects may be intensified.
• cholinergic medicines, as they may reduce the effectiveness of solifenacin.
• medicines such as metoclopramide and cisapride, which increase gastrointestinal motility. Solifenacin may reduce their effectiveness.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, as they may slow down the metabolism of Solifenacin SaneXcel in the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the metabolism of Solifenacin SaneXcel in the body.
• medicines such as bisphosphonates, as they may cause esophagitis or worsen existing esophageal inflammation.

Solifenacin SaneXcel with food and drink

Solifenacin SaneXcel may be taken with or without food, according to patient preference.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Solifenacin SaneXcel should not be used during pregnancy unless absolutely necessary.

Breastfeeding

Solifenacin SaneXcel should not be used during breastfeeding, as solifenacin passes into human milk.

Driving and operating machinery

Solifenacin may cause blurred vision and occasionally drowsiness or fatigue. If these side effects occur, the patient should not drive or operate machinery.

Solifenacin SaneXcel contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before using this medicine.

3. How to use Solifenacin SaneXcel

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The tablet should be swallowed whole with liquid. Solifenacin SaneXcel can be taken with or without
food, depending on patient preference. Do not crush the tablets.
The usual dose is 5 mg once daily, unless the doctor recommends a dose of 10 mg once daily.
Taking more Solifenacin SaneXcel than prescribed
If too much Solifenacin SaneXcel is taken or if a child accidentally swallows Solifenacin SaneXcel,
contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and vision disturbances,
perception of things that are not present (hallucinations), excessive excitation, seizures (convulsions),
breathing difficulties, rapid heartbeat (tachycardia), urine retention (urinary retention), and pupil dilation.
Missing a dose of Solifenacin SaneXcel
If a dose is missed, take the next dose as soon as possible, unless it is almost time for the next dose.
Do not take Solifenacin SaneXcel more often than once daily. If in doubt, consult a doctor or pharmacist.
Stopping Solifenacin SaneXcel treatment
If treatment with Solifenacin SaneXcel is stopped, symptoms of overactive bladder may return or worsen.
Always consult a doctor if considering discontinuation of treatment.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering and peeling of the outer layer of skin), a doctor or pharmacist should be informed immediately.
Angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has been reported in some patients taking solifenacin succinate. If angioedema occurs in the patient, treatment with Solifenacin SaneXcel should be stopped immediately and appropriate treatment and/or corrective measures should be initiated.
The medicine Solifenacin SaneXcel may cause other adverse reactions listed below:

Very common (may occur in more than 1 in 10 people):

• dry mouth

Common (may occur in up to 1 in 10 people):

• blurred vision
• constipation, nausea, dyspepsia with symptoms such as bloating, abdominal pain, belching and heartburn (dyspepsia), abdominal discomfort

Uncommon (may occur in up to 1 in 100 people):

• urinary tract infection, bladder infection
• somnolence
• taste disturbances
• dry (irritated) eye syndrome
• dryness of the nasal passages
• gastroesophageal reflux disease (acid reflux), dryness of the throat
• dry skin
• difficulty passing urine
• fatigue, fluid accumulation in the lower limbs (oedema)

Rare (may occur in up to 1 in 1,000 people):

• accumulation of hard stool in the colon (obstruction)
• difficulty passing urine despite a full bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, rash

Very rare (may occur in up to 1 in 10,000 people):

• hallucinations, disorientation
• allergic rash

Frequency not known (frequency cannot be estimated from available data):

• decreased appetite, high blood potassium levels which may cause heart rhythm disturbances
• increased intraocular pressure
• changes in the electrical activity of the heart (ECG), irregular heartbeat, palpitations, rapid heartbeat
• voice disorders
• liver function abnormalities
• decreased muscle strength
• kidney function disorders

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Solifenacin SaneXcel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Solifenacin SaneXcel contains

• The active substance is solifenacin succinate. Each 5 mg coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.

Each 10 mg coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg
of solifenacin.

• The other ingredients are:
  Tablets 5 mg:
  Tablet core: maize starch, monohydrate lactose, hypromellose, and magnesium stearate
  Tablet coating: hypromellose, talc, titanium dioxide (E 171), macrogol, and yellow iron oxide (E 172)

Tablets 10 mg:
Tablet core: maize starch, monohydrate lactose, hypromellose, and magnesium stearate
Tablet coating: hypromellose, talc, titanium dioxide (E 171), macrogol, and red iron oxide (E 172)

What Solifenacin SaneXcel looks like and contents of the pack
5 mg: Yellow, round, biconvex coated tablets.
10 mg: Light pink, round, biconvex coated tablets.
Solifenacin SaneXcel coated tablets are available in blisters containing 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua de Tapada Grande 2, Abrunheira
2710-228 Sintra
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Solifenacin SaneXcel
Poland: Solifenacin SaneXcel
Portugal: Solifenacina JJ Bishop
Slovakia: Solifenacin SaneXcel