SILAMIL 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Silamil, 10 mg, Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Silamil and what is it used for
4. Important information before taking Silamil
   1. When not to take Silamil
   2. Warnings and precautions
   3. Silamil and other medicines
   4. Silamil with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to take Silamil
   1. Method of administration
   2. Adults
   3. Children and adolescents
   4. Silamil should not be used in children and adolescents under 18 years of age.
   5. Taking more than the recommended dose of Silamil
   6. Missing a dose of Silamil
   7. Stopping Silamil treatment
6. Possible side effects
   1. Severe side effects
   2. Other side effects:
   3. Very common (may affect more than 1 in 10 people)
   4. Common (may affect up to 1 in 10 people)
   5. Uncommon (may affect up to 1 in 100 people)
   6. Rare (may affect up to 1 in 1,000 people)
   7. Very rare (may affect up to 1 in 10,000 people)
7. How to store Silamil
8. Contents of the pack and other information
   1. What Silamil contains
   2. What Silamil looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Package Leaflet: Information for the Patient

Silamil, 10 mg, Coated Tablets

Solifenacin Succinate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Silamil and what is it 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 is Silamil and what is it used for

Solifenacin, the active substance of Silamil, belongs to a group of anticholinergic medicines. These medicines are used to reduce the activity of an overactive urinary bladder. This allows for less frequent use of the toilet and increases the amount of urine held in the bladder.
Silamil is used to treat symptoms associated with an overactive bladder.
These symptoms include: a sudden, urgent need to urinate without prior pressure on the bladder; frequent urination, incontinence due to the patient not being able to reach the toilet in time.

2. Important information before taking Silamil

When not to take Silamil

• if the patient is unable to urinate or empty the bladder completely (urinary retention)
• if the patient has severe stomach or intestinal disorders (including toxic megacolon, a complication of ulcerative colitis)
• if the patient has muscle disease (myasthenia gravis) that may cause significant weakness of some muscles
• if the patient has increased fluid pressure in the eyeball, with gradual loss of vision (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 dialysis
• if the patient has severe liver disease
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may delay the elimination of Silamil from the body (e.g. ketoconazole). The doctor or pharmacist will inform if this warning applies to the patient.

Before starting to take Silamil, tell your doctor if any of the above disorders are present or have occurred in the past.

Warnings and precautions

Before taking Silamil, discuss with your doctor or pharmacist if:

• the patient has difficulty emptying the urinary bladder (narrowing of the urine outflow from the bladder) or urinating (e.g. weak urine stream) - the risk of urine accumulation in the bladder (urinary retention) is significantly higher
• the patient has intestinal obstruction (constipation)
• the patient is at risk of slowing down the movement of the digestive tract (gastrointestinal motility) - the doctor will tell the patient if this warning applies
• the patient has severe kidney disease
• the patient has moderate liver disease
• the patient has a hiatus hernia or gastroesophageal reflux disease
• the patient has autonomic nervous system disorders (autonomic neuropathy).

If any of the above situations apply to the patient now or have applied in the past, inform the doctor before taking Silamil.
Before starting to take Silamil, the doctor will assess whether there are other causes of frequent urination (such as heart failure or kidney disease). If the patient has a urinary tract infection, the doctor will prescribe an antibiotic (a medicine that fights certain bacterial infections).

Silamil and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
It is especially important to inform the doctor about the use of such medicines as:

• other anticholinergic medicines (due to the possibility of increased action and side effects of both medicines).
• cholinomimetic medicines (they may weaken the action of Silamil).
• medicines that improve gastrointestinal motility, such as metoclopramide and cisapride (because Silamil may weaken their action).
• medicines such as ketoconazole, itraconazole (antifungal medicines), ritonavir and nelfinavir (used to treat HIV infection), verapamil and diltiazem (medicines used to treat heart disorders or high blood pressure) due to the possibility of slowing down the metabolism of Silamil.
• 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 to treat osteoporosis), as they may cause or exacerbate esophagitis.

Silamil with food and drink

Silamil can be taken with or without food.

Pregnancy and breastfeeding

Silamil should not be used during pregnancy, unless the doctor recommends it.
Silamil should not be used during breastfeeding, as solifenacin passes into breast milk.
Consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Silamil may cause blurred vision and sometimes drowsiness or fatigue. Patients who experience such symptoms should not drive or operate machinery.
Silamil contains lactose.The patient should not take this medicine if they have a rare hereditary intolerance to galactose, Lapp lactase deficiency or glucose-galactose malabsorption syndrome.

3. How to take Silamil

Method of administration

Adults

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
Tablets should be swallowed whole with a drink of water. Silamil can be taken with or without food. Do not crush the tablets.
Usually, a dose of 5 mg per day is used, unless the doctor recommends taking a dose of 10 mg per day.
Solifenacin 5 mg tablets in the form of succinate can be used for appropriate dosing.

Children and adolescents

Silamil should not be used in children and adolescents under 18 years of age.

Taking more than the recommended dose of Silamil

If the patient takes more Silamil than recommended or if a child accidentally swallows any of these tablets, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and vision disturbances, perception of non-existent things (hallucinations), excessive excitement, seizures, breathing difficulties, rapid heartbeat (tachycardia), urine accumulation in the bladder (urinary retention) and pupil dilation.

Missing a dose of Silamil

If the patient forgets to take the medicine at the usual time, they should take a 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 the doctor or pharmacist.
Do not take a double dose to make up for a missed dose.

Stopping Silamil treatment

Stopping Silamil treatment may cause the return or worsening of symptoms associated with an overactive bladder. The intention to stop treatment should always be discussed with a doctor.
If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

Severe side effects

Stop taking Silamil and contact a doctor immediately if any of the following symptoms occur:

• acute allergic reaction (skin rash, swelling around the eyes, lips, hands and feet; swelling of the mouth, throat or tongue, which may cause difficulty in breathing and swallowing), or severe skin reaction (such as blisters and skin peeling)
• angioedema (allergic skin reaction that causes swelling of the skin tissue) with narrowing of the airways (difficulty breathing).

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 feeling full, stomach pain, belching, nausea and heartburn, feeling of discomfort in the stomach

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness, taste disturbances
• eye dryness (irritation)
• nasal dryness
• gastroesophageal reflux disease, throat dryness
• skin dryness
• difficulty urinating
• fluid accumulation in the legs (edema)

Rare (may affect up to 1 in 1,000 people)

• accumulation of a large amount of hard stool in the large intestine (intestinal obstruction)
• urine accumulation 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 the available data)

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

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

5. How to store Silamil

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after the abbreviation "Lot"
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help 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: lactose anhydrous, hypromellose 2910 (5 mPA∙s), maize 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 tablets are light pink, round, coated with "RK76" embossed on one side and smooth on the other. The tablets are approximately 7.5 mm in length.
Silamil is packaged in PVC/PVDC/Aluminum blisters or an HDPE bottle with a capacity of 40 ml.
Sizes of packs containing blisters:
30, 50, 90 or 100 coated tablets
Sizes of packs containing a bottle:
30, 50, 90 or 100 coated tablets
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer

Marketing authorization holder:

Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw

Manufacturer/Importer

S.C. Terapia S.A.
Fabricii Street no. 124
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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Netherlands: Solifenacine sun
Germany: SOLIFENACIN BASICS
Spain: Solifenacina sun
United Kingdom (Northern Ireland): Solifenacin succinate
Date of last revision of the leaflet: 02.08.2024