Silamil

Package leaflet: Information for the patient

Silamil, 10 mg, film-coated tablets
Solifenacin succinate
Read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of contents:

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

1. What Silamil is and what it is used for

Solifenacin, the active substance in Silamil, belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows less frequent trips to the toilet and increases the amount of urine the bladder can hold.
Silamil is used in the treatment of symptoms associated with the so-called overactive bladder.
These symptoms include: a sudden, strong need to urinate without prior bladder pressure;
frequent urination; and urinary incontinence due to not being able to reach the toilet in time.

2. Important information before using Silamil

When not to use Silamil

• if the patient is unable to pass urine or completely empty the bladder (urinary retention)
• if the patient has severe stomach or intestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis)
• if the patient has a muscle disease (myasthenia gravis) that may cause significant weakness of certain muscles
• if the patient has increased pressure of fluid in the eyeball, with gradual loss of vision (glaucoma)
• if the patient is allergic to solifenacin or to any of the other ingredients of this medicine (listed in section 6)
• if the patient is undergoing dialysis
• if the patient has severe liver disease
• if the patient has severe kidney disease or moderate liver disease and is also taking medicines that may delay elimination of Silamil from the body (e.g. ketoconazole). The doctor or pharmacist will advise whether this warning applies to the patient.

Before starting treatment with Silamil, inform the doctor if any of the above conditions currently exist or have occurred in the past.

Warnings and precautions

Before using Silamil, discuss with the doctor or pharmacist if:

• the patient has difficulty emptying the bladder (obstruction of urinary outflow from the bladder) or difficulty passing urine (e.g. weak urine stream) – the risk of urine retention (urinary retention) is then significantly higher
• the patient has gastrointestinal obstruction (constipation)
• the patient is at risk of slowed gastrointestinal motility (stomach and intestinal movements) – the doctor will advise whether this warning applies
• if the patient has severe kidney disease
• if the patient has moderately severe liver disease
• if the patient has severe stomach pain (hiatal hernia) or heartburn
• if the patient has nervous system disorders (autonomic neuropathy).

If any of the above conditions currently apply or have applied in the past, inform the doctor before using Silamil.

Before starting treatment with Silamil, the doctor will assess whether there are other possible causes of frequent urination [such as heart failure (inadequate pumping ability of the heart muscle) or kidney disease]. If the patient has a urinary tract infection, the doctor will prescribe an antibiotic (a medicine to treat specific bacterial infections).

Silamil with other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use.

It is especially important to inform the doctor about the use of the following medicines:

• other anticholinergic medicines (due to possible increased effect and side effects of both medicines)
• cholinomimetic medicines (they may reduce the effect of Silamil)
• medicines improving gastrointestinal motility, such as metoclopramide and cisapride (because Silamil may reduce their effect)
• medicines such as ketoconazole, itraconazole (antifungal medicines), ritonavir and nelfinavir (used in the treatment of HIV infection), verapamil and diltiazem (medicines used to treat heart disorders or hypertension), due to possible slowing of Silamil metabolism
• medicines such as rifampicin (an antibacterial medicine), phenytoin and carbamazepine (antiepileptic medicines), as they may accelerate the metabolism of Silamil
• medicines such as bisphosphonates (used in the treatment of osteoporosis), as they may cause or worsen oesophagitis.

Silamil with food and drink

Silamil may be taken independently of meals.

Pregnancy and breastfeeding

Silamil should not be used during pregnancy unless advised by a doctor.

Silamil should not be used during breastfeeding, as solifenacin passes into breast milk.

Consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Silamil may cause blurred vision and occasionally drowsiness or fatigue. Patients experiencing these symptoms should not drive or operate machinery.

Silamil contains lactose. The patient should not take this medicine if he or she has been diagnosed with rare hereditary galactose intolerance, Lapp-type lactase deficiency, or glucose-galactose malabsorption syndrome.

3. How to take Silamil

Instructions for use
Adults
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult your
doctor or pharmacist.
Tablets should be swallowed whole with liquid. The medicine may be taken regardless of
meals. Do not crush the tablets.
The usual dose is 5 mg once daily, unless the doctor prescribes a dose of 10 mg once daily.
Tablets containing 5 mg of solifenacin succinate may be used for appropriate dosing adjustment.
Children and adolescents
Silamil must not be used in children and adolescents under 18 years of age.
Taking more Silamil than recommended
If a patient takes too much Silamil or if a child accidentally swallows any tablets of this medicine, contact a doctor or pharmacist immediately.
Symptoms of overdose may include, among others: headache, dry mouth, dizziness, drowsiness and visual disturbances, perception of non-existent things (hallucinations), excessive excitation, seizures, breathing difficulties, rapid heartbeat (tachycardia), urine retention in the bladder (urinary retention), and pupil dilation.
Missed dose of Silamil
If a patient forgets to take the medicine at the usual time, they should take the tablet as soon as they remember, unless it is almost time for the next dose. Never take more than one dose per day. If in doubt, consult your doctor or pharmacist.
Do not take a double dose to make up for a missed dose.
Stopping Silamil treatment
Discontinuing treatment with Silamil may cause recurrence or worsening of symptoms related to overactive bladder. Any decision to stop treatment should always be discussed with the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions
Stop taking the medicine and contact your doctor immediately if any of the following symptoms occur:

• severe allergic reaction (skin rash, swelling around the eyes, lips, hands and feet; swelling of the mouth, throat or tongue, which may cause difficulty breathing and swallowing), or severe skin reaction (e.g. blistering and peeling of the skin)
• angioedema (skin allergy causing swelling of the subcutaneous tissue) with narrowing of the airways (difficulty breathing).

Other adverse reactions:
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, dyspepsia with symptoms such as feeling of fullness, abdominal pain, belching, nausea and heartburn, discomfort in the stomach

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness, taste disturbances
• dry (irritated) eyes
• dry nose
• reflux disease (gastroesophageal reflux), dry throat
• dry skin
• difficulty passing urine
• fluid accumulation in legs (oedema)

Rare (may affect up to 1 in 1000 people)

• accumulation of hard stool in the colon (colonic obstruction)
• urine retention 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

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

• decreased appetite, high potassium levels in blood which may cause heart rhythm disturbances
• increased pressure of fluid in the eyeballs
• changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, increased heart rate
• voice disturbances
• liver function disorders
• muscle weakness
• kidney function disorders

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

5. How to store Silamil medicine

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after the
abbreviation "EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This practice helps protect the environment.

6. Contents of the pack and other information

What Silamil contains

• The active substance is solifenacin succinate (10 mg).
• The other ingredients are: anhydrous lactose, hypromellose 2910 (5 mPa·s), corn starch, magnesium stearate, macrogol 6000, titanium dioxide (E 171), talc, and iron oxide, red (E 172).

What Silamil looks like and contents of the pack
Silamil 10 mg film-coated tablets are light pink, round, coated tablets with the imprint "RK76" on one side and smooth on the other. The tablets are approximately 7.5 mm in diameter.
Silamil is packaged in PVC/PVDC/Aluminium blisters or in HDPE bottles with a capacity of 40 ml.
Pack sizes containing blisters:
30, 50, 90 or 100 film-coated tablets
Pack sizes containing bottles:
30, 50, 90 or 100 film-coated tablets
Not all pack types and sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16 Street
00-710 Warsaw, Poland

Manufacturer/Importer:
S.C. Terapia S.A.
Fabricii nr. 124 Street
400 632 Cluj Napoca
Romania
Alkaloida Chemical Company Zrt.
Kabay János u. 29
4440 Tiszavasvári
Hungary
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Netherlands: Solifenacinesuccinaat SUN
Germany: SOLIFENACIN BASICS
Spain: Solifenacina SUN
United Kingdom (Northern Ireland): Solifenacin succinate