Solifenacin Medreg

Package Leaflet: Information for the Patient

Solifenacin Medreg, 5 mg, film-coated tablets

Solifenacin Medreg, 10 mg, film-coated tablets

Solifenacin succinate

Before taking the medicine, you should read the contents of this leaflet carefully, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

The active substance of Solifenacin Medreg belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This action allows for longer intervals between visits to the toilet and increases the amount of urine held in the bladder. Solifenacin Medreg is used to treat the symptoms of an overactive bladder. These symptoms include: urgent urination, which are episodes of sudden, urgent need to urinate, frequent urination, and involuntary loss of urine, related to the fact that the patient did not have time to use the toilet.

2. Important information before taking Solifenacin Medreg.

When not to take Solifenacin Medreg:

• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6),
• if you have difficulty urinating or cannot empty your bladder (urinary retention),
• if you have severe gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis),
• if you have a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles,
• if you have increased pressure in the eyeball, which can lead to gradual vision loss (narrow-angle glaucoma),
• if you are undergoing dialysis,
• if you have severe liver dysfunction,
• if you have severe kidney disease or moderate liver disease and are taking medicines that may delay the elimination of Solifenacin Medreg from the body (e.g., ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with Solifenacin Medreg, you should inform your doctor if any of the above situations apply or have applied in the past.

Warnings and precautions

Before starting to take Solifenacin Medreg, you should 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 (peristalsis, stomach and intestinal movements). Your doctor will provide information on this,
• if you have severe kidney dysfunction,
• if you have moderate liver dysfunction,
• if you have a burning stomach pain (hiatal hernia) or heartburn,
• if you have nervous system disorders (autonomic nervous system neuropathy). The objective and subjective symptoms of autonomic neuropathy vary depending on which part of the autonomic nervous system is affected. They may include: dizziness, fainting, irregular heartbeat, decreased blood pressure, when changing position to standing, abnormal sweating, vision disturbances, digestive disturbances, urinary problems, sexual dysfunction, intolerance to physical exertion, burning sensation.

You should consult a doctor, even if the above warnings apply to current or past situations, before starting to take Solifenacin Medreg. Before starting treatment with Solifenacin Medreg, 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 Medreg should not be used in children or adolescents under 18 years of age.

Solifenacin Medreg and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any 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 Medreg may lead to an increase in both the therapeutic effect and the side effects of both medicines,
• cholinergic receptor agonist medicines, as they may weaken the effect of Solifenacin Medreg,
• gastrointestinal motility enhancers, such as metoclopramide and cisapride, as Solifenacin Medreg may weaken their effect,

Solifenacin Medreg may weaken their effect,

• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Solifenacin Medreg in the body,
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Solifenacin Medreg in the body,
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Solifenacin Medreg with food and drink

Solifenacin Medreg can be taken during meals or independently of meals, depending on the patient's preferences.

Pregnancy and breastfeeding

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

Driving and using machines

Solifenacin Medreg may cause blurred vision and sometimes drowsiness or fatigue. If such side effects occur, you should not drive or operate any machinery.

Solifenacin Medreg contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Solifenacin Medreg.

3. How to take Solifenacin Medreg

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. The usual dose is 5 mg once daily, unless your doctor advises you to take a dose of 10 mg. The tablet should be swallowed whole, with a drink of water. Solifenacin Medreg can be taken during meals or independently of meals, depending on the patient's preferences. The tablets should not be crushed.

Overdose of Solifenacin Medreg

If you have taken too many Solifenacin Medreg tablets or if a child has accidentally taken Solifenacin Medreg, you should immediately consult a doctor or pharmacist. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures, breathing difficulties, rapid heartbeat, and urinary retention.

Missed dose of Solifenacin Medreg

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

Stopping Solifenacin Medreg treatment

If you stop taking Solifenacin Medreg, the symptoms of an overactive bladder may return or worsen. You should always consult your doctor if you are considering stopping treatment. If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Solifenacin Medreg 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), you should immediately inform your doctor or pharmacist. Some patients taking solifenacin succinate (Solifenacin Medreg) have reported 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). If you experience angioedema, you should immediately stop taking solifenacin succinate (Solifenacin Medreg) and initiate appropriate treatment and/or take appropriate corrective measures. Solifenacin Medreg may cause other side effects, including:

• 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 a feeling of fullness in the abdominal cavity, abdominal pain, belching, nausea, and heartburn (indigestion), abdominal discomfort.

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

• urinary tract infection, cystitis,
• drowsiness,
• taste disturbances,
• dry eye syndrome,
• dry nose,
• gastroesophageal reflux disease (gastroesophageal reflux),
• dry throat,
• dry skin,
• difficulty urinating,
• fatigue,
• swelling of the lower limbs.

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

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

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

• hallucinations, disorientation,
• hives.

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 pressure in the eyeball, changes in ECG, irregular heartbeat (torsades de pointes),palpitations, rapid heartbeat, voice disorders, liver dysfunction, muscle weakness, kidney dysfunction, abdominal discomfort, intestinal obstruction (lack of movement in the intestines, which can lead to intestinal obstruction), widespread redness and peeling of the skin, confusion.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell 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 181C, 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 Medreg

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Solifenacin Medreg contains

• The active substance of Solifenacin Medreg is solifenacin succinate. Solifenacin Medreg, 5 mg, film-coated tablets: Each tablet contains 5 mg of solifenacin succinate, which corresponds to 3.8 mg of solifenacin. Solifenacin Medreg, 10 mg, film-coated tablets: Each tablet contains 10 mg of solifenacin succinate, which corresponds to 7.5 mg of solifenacin.
• The other ingredients are: Tablet core: lactose monohydrate, lactose monohydrate (spray-dried), corn starch, talc, magnesium stearate. Tablet coating: Solifenacin Medreg, 5 mg, film-coated tablets: Opadry yellow OY 32823 (hypromellose 6cP (E 464), titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), red iron oxide (E 172)). Solifenacin Medreg, 10 mg, film-coated tablets: Opadry white 03B28796 (hypromellose 6cP (E 464), titanium dioxide (E 171), macrogol 400, Opadry brown 02F23883 (hypromellose 5cP (E 464), titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), red iron oxide (E 172)).

What Solifenacin Medreg looks like and contents of the pack

Solifenacin Medreg 5 mg: yellow, round, biconvex, film-coated tablet, approximately 6 mm in diameter. Solifenacin Medreg 10 mg: pink, round, biconvex, film-coated tablet, approximately 7 mm in diameter. The film-coated tablets are packaged in aluminum/OPA/aluminum/PVC blisters, in a cardboard box. Pack sizes: 10, 20, 30, 50, 60, 90, 98, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder Medreg s.r.o. Na Florenci 2116/15, Nové Město 110 00 Prague 1 Czech Republic Manufacturer Saneca Pharmaceuticals a.s. Nitrianska 100 920 27 Hlohovec Slovakia

Date of last revision of the leaflet: 05/2023