Solifenacin pmcs

Package leaflet: Information for the user

Solifenacin PMCS, 5 mg, film-coated tablets
Solifenacin PMCS, 10 mg, film-coated tablets
Solifenacini succinas
Read the entire leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

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

The active substance in Solifenacin PMCS belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between toilet visits and increases the amount of urine the bladder can hold.
Solifenacin PMCS is used to treat the symptoms of overactive bladder. These include urgency, which is a sudden, compelling need to pass urine, urinary frequency, and urge incontinence, where the person is unable to reach the toilet in time.

2. Important information before using Solifenacin PMCS

When not to use Solifenacin PMCS

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

Before starting treatment with Solifenacin PMCS, inform your doctor if any of the above situations apply or have occurred in the past.

Warnings and precautions

Before starting treatment with Solifenacin PMCS, discuss this with your doctor or pharmacist.

• 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 accumulation in the bladder (urinary retention) is much higher;
• if the patient has gastrointestinal motility disorders (constipation);
• if there is a risk of slowed gastrointestinal tract function (stomach and intestinal movements). Your doctor will provide information on this;
• if the patient has severe kidney disease;
• if the patient has moderate liver disease;
• if the patient has severe stomach pain (hiatal hernia) or heartburn (gastroesophageal reflux);
• if the patient has nervous system disorders (autonomic neuropathy).

Before starting treatment with Solifenacin PMCS, inform your doctor if any of the above situations apply or have occurred in the past.

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

Children and adolescents

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

Solifenacin PMCS and other medicines

Tell your doctor about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.

It is especially important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as using such medicines together with Solifenacin PMCS may enhance both the therapeutic effects and adverse reactions of both drugs;
• medicines belonging to the group of cholinergic receptor agonists, as they may reduce the effect of Solifenacin PMCS;
• medicines enhancing gastrointestinal motility, such as metoclopramide and cisapride, as Solifenacin PMCS may reduce their effectiveness;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, which slow down the metabolism of Solifenacin PMCS;
• medicines such as rifampicin, phenytoin, carbamazepine, which may accelerate the metabolism of Solifenacin PMCS;
• medicines such as bisphosphonates, as they may worsen oesophagitis.

Solifenacin PMCS with food and drink

Solifenacin PMCS may be taken with food or independently of meals, depending on patient preference. During treatment with Solifenacin PMCS, grapefruit juice should not be consumed, as it increases the blood concentration of solifenacin, which may increase the risk of toxic effects.

Pregnancy and breastfeeding

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

Solifenacin PMCS must not be used during pregnancy unless absolutely necessary. Solifenacin PMCS must not be used during breastfeeding, as solifenacin passes into breast milk.

Driving and operating machinery

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

Solifenacin PMCS contains lactose

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

3. How to use Solifenacin PMCS

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is 5 mg, unless your doctor recommends a dose of 10 mg.
The tablet should be swallowed whole with liquid. Solifenacin PMCS may be taken during meals or independently of meals, according to patient preference. The tablets must not be crushed.

Taking more Solifenacin PMCS than prescribed
If too many tablets of Solifenacin PMCS are taken, or if a child accidentally swallows Solifenacin PMCS, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and visual disturbances, seeing things that are not real (hallucinations), excessive excitement, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), urine retention (urinary retention), and dilated pupils.

Missing a dose of Solifenacin PMCS
If a dose is missed, take the next dose as soon as possible, unless it is almost time for the next scheduled dose. Do not take the medicine more often than once daily. If in doubt, consult your doctor or pharmacist.

Stopping Solifenacin PMCS
If treatment with Solifenacin PMCS is discontinued, symptoms of overactive bladder may return or worsen. If the patient intends to stop treatment, they should consult their 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.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering
and peeling of the 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 respiratory tract (difficulty breathing) has been reported in some patients taking solifenacin succinate. If angioedema occurs in the patient, treatment with Solifenacin PMCS should be stopped immediately and appropriate treatment and/or corrective measures should be initiated.
Solifenacin PMCS may cause other adverse reactions listed below:
Very common (may affect more than 1 in 10 people):

• dry mouth.

Common (may affect more than 1 in 10 people):

• blurred vision,
• constipation, nausea, dyspepsia with symptoms such as feeling of fullness in the abdomen, abdominal pain, belching, heartburn (dyspepsia), feeling of discomfort in the abdomen.

Uncommon (may affect more than 1 in 100 people):

• urinary tract infection, cystitis,
• somnolence,
• taste disturbances,
• dry eye syndrome,
• nasal dryness,
• gastroesophageal reflux (heartburn),
• throat dryness,
• skin dryness,
• difficulty in urination,
• fatigue,
• fluid accumulation in the lower limbs (oedema).

Rare (may affect more than 1 in 1000 people):

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

Very rare (may affect more than 1 in 10,000 people):

• hallucinations, confusion,
• allergic rash.

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

• decreased appetite, increased blood potassium levels which may cause heart rhythm disturbances,
• increased intraocular pressure,
• changes in ECG, irregular heartbeat (torsade de pointes), palpitations, rapid heartbeat,
• voice disorders,
• liver function abnormalities,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Solifenacin PMCS

Keep this medicine out of the sight and reach of children.
No special precautions for storage of the medicinal product are required.
Do not use this medicine after the expiry date stated on the carton/blister after: Expiry
date (EXP)/EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Solifenacin PMCS contains

• The active substance is solifenacin succinate.
  Solifenacin PMCS, 5 mg: each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
  Solifenacin PMCS, 10 mg: each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• Other ingredients are:
  Tablet core: lactose monohydrate, corn starch, talc, magnesium stearate

Tablet coating:
Solifenacin PMCS, 5 mg: Opadry yellow OY 32823 [hypromellose 6cP, titanium dioxide (E171),
polyethylene glycol 400, iron oxide yellow (E172), iron oxide red (E172)].
Solifenacin PMCS, 10 mg: Opadry white 03B28796 [hypromellose 6cP, titanium dioxide (E171),
polyethylene glycol 400], Opadry brown 02F23883 [hypromellose 5cP, titanium dioxide (E171), polyethylene glycol 6000, iron oxide yellow (E172), iron oxide red (E172)].

What Solifenacin PMCS looks like and contents of the pack
Solifenacin PMCS, 5 mg: yellow, round, biconvex film-coated tablet with a diameter of 6 mm.
Solifenacin PMCS, 10 mg: pink, round, biconvex film-coated tablet with a diameter of 7 mm.
Pack sizes: 10, 20, 30, 50, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
PRO.MED.CS Praha a.s.
Telčská 377/1
Michle, 140 00 Prague 4
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria (RMS) Solifenacin PMCS 5 mg Filmtabletten
Solifenacin PMCS 10 mg Filmtabletten
Czech Republic Solifenacin PMCS
Solifenacin PMCS
Estonia Solifenacin PMCS 5 mg
Solifenacin PMCS 10 mg
Lithuania Solifenacin PMCS 5 mg plėvele dengta tabletė
Solifenacin PMCS 10 mg plėvele dengta tabletė
Latvia Solifenacin PMCS 5 mg apvalkotās tabletes
Solifenacin PMCS 10 mg apvalkotās tabletes
Poland Solifenacin PMCS
Solifenacin PMCS
Slovak Republic Solifenacin PMCS 5 mg
Solifenacin PMCS 10 mg