Solifenacin Pmcs

Package Leaflet: Information for the User

Solifenacin PMCS, 5 mg, film-coated tablets

Solifenacin PMCS, 10 mg, film-coated tablets

Solifenacin succinate

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

• Keep this package 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

The active substance of Solifenacin PMCS belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive urinary bladder. This action allows for longer intervals between visits to the toilet and increases the amount of urine held in the bladder. Solifenacin PMCS is used to treat the symptoms of an overactive bladder. These symptoms include: sudden urges to urinate, frequent urination, and involuntary loss of urine, because the patient cannot get to the toilet in time.

2. Important information before taking Solifenacin PMCS

When not to take Solifenacin PMCS

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have difficulty emptying your bladder (urinary retention);
• if you have severe gastrointestinal disorders (toxic megacolon, a complication of ulcerative colitis);
• if you have a muscle disease called myasthenia gravis, which can cause significant weakness of certain muscles;
• if you have increased pressure in the eye, which can lead to a gradual loss of vision (glaucoma);
• if you are undergoing hemodialysis;
• if you have severe liver function disorders;
• if you have severe kidney disease or moderate liver disease and are 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 applied in the past.

Warnings and precautions

Before starting to take Solifenacin PMCS, discuss it with your doctor or pharmacist.

• if you have difficulty emptying your bladder (narrowing of the urethra) or urinating (weak urine stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher;
• if you have gastrointestinal disorders (constipation);
• if there is a risk of slowing down the movement of the digestive tract (gastrointestinal motility). Your doctor will provide information on this;
• if you have severe kidney disease;
• if you have moderate liver disease;
• if you have a burning stomach pain (hiatus hernia) or heartburn;
• if you have nervous system disorders (autonomic nervous system neuropathy).

Before starting treatment with Solifenacin PMCS, inform your doctor if any of the above situations apply or have applied 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 strength of the heart muscle to pump blood - or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial medicine).

Children and adolescents

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

Solifenacin PMCS and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, and about medicines you plan to take. It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines, as taking such a medicine with Solifenacin PMCS may lead to an increase in both the therapeutic and adverse effects of both medicines;
• cholinergic receptor agonists, as they may weaken the effect of Solifenacin PMCS;
• gastrointestinal motility enhancers, such as metoclopramide and cisapride, as Solifenacin PMCS may weaken their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Solifenacin PMCS;
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Solifenacin PMCS;
• medicines such as bisphosphonates, as they may exacerbate esophagitis.

Solifenacin PMCS with food and drink

Solifenacin PMCS can be taken with or without food, depending on the patient's preference. During treatment with Solifenacin PMCS, do not drink grapefruit juice, as it can increase the concentration of solifenacin in the blood, which may lead to an increased risk of its toxic effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Do not take Solifenacin PMCS during pregnancy, unless it is absolutely necessary. Do not take Solifenacin PMCS during breastfeeding, as solifenacin passes into breast milk.

Driving and using machines

Solifenacin PMCS may cause blurred vision, sometimes drowsiness, and fatigue. If such side effects occur, do not drive or operate any machines.

Solifenacin PMCS contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Solifenacin PMCS

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual dose is 5 mg, unless your doctor has prescribed a dose of 10 mg. Swallow the tablet whole with a drink of water. Solifenacin PMCS can be taken with or without food, depending on the patient's preference. Do not crush the tablets.

Take more Solifenacin PMCS than prescribed

If you have taken too many Solifenacin PMCS tablets or if a child has accidentally taken Solifenacin PMCS, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, seeing things that are not there (hallucinations), excessive excitement, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), and urinary retention, as well as dilated pupils.

Miss a dose of Solifenacin PMCS

If you miss a dose, take the next dose as soon as possible, unless it is almost time for the next dose. Do not take more than one dose per day. If you are unsure, consult your doctor or pharmacist.

Stop taking Solifenacin PMCS

If you stop taking Solifenacin PMCS, the symptoms of an overactive bladder may return or worsen. If you plan to stop treatment, consult your doctor. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Solifenacin PMCS can cause side effects, although not everybody gets them. If you experience an allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin), inform your doctor or pharmacist immediately. In some patients taking solifenacin succinate, angioedema (a form of allergic skin reaction that causes swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has been reported. If you experience angioedema, stop taking Solifenacin PMCS immediately and initiate appropriate treatment and/or take appropriate measures. Solifenacin PMCS may cause other side effects, including:

• Very common(may affect more than 1 in 10 people): dry mouth.

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

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

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

• urinary tract infection, cystitis,
• drowsiness,
• taste disturbances,
• dry eye syndrome,
• dry nose,
• gastroesophageal reflux (heartburn),
• dry throat,
• dry skin,
• difficulty urinating,
• fatigue,
• fluid accumulation in the lower limbs (edema).

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

• accumulation of large amounts of hard stool in the colon (fecal impaction),
• difficulty urinating despite a full bladder (urinary retention),
• dizziness, headaches,
• vomiting,
• itching, rash.

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

• hallucinations (seeing or hearing things that are not there), confusion,
• allergic rash.

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

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. 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, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solifenacin PMCS

Keep this medicine out of the sight and reach of children. There are no special precautions for storage of the medicinal product. Do not use this medicine after the expiry date stated on the carton/blisters after EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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.
• The other ingredients are: Tablet core: lactose monohydrate, maize starch, talc, magnesium stearate.

Tablet coating:

Solifenacin PMCS, 5 mg: Opadry yellow OY 32823 [hypromellose 6cP, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172), iron oxide red (E172)].

Solifenacin PMCS, 10 mg: Opadry white 03B28796 [hypromellose 6cP, titanium dioxide (E171), macrogol 400, Opadry brown 02F23883 [hypromellose 5cP, titanium dioxide (E171), macrogol 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, 6 mm in diameter.

Solifenacin PMCS, 10 mg: pink, round, biconvex film-coated tablet, 7 mm in diameter.

Pack sizes: 10, 20, 30, 50, 60, 90, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s.

Telčská 377/1

Michle, 140 00 Prague 4

Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area 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 dengtos tabletės

Solifenacin PMCS 10 mg plėvele dengtos tabletės

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

Date of last revision of the package leaflet: 27.02.2023