ADABLOK 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Adablok, 5 mg, coated tablets
3. Adablok, 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:
4. What is Adablok and what is it used for
5. Important information before taking Adablok
   1. When not to take Adablok:
   2. Warnings and precautions
   3. Children and adolescents
   4. Adablok should not be used in children or adolescents under 18 years of age.
   5. Adablok and other medicines
   6. Adablok with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines:
6. How to take Adablok
   1. Instructions for proper use
   2. Taking a higher dose of Adablok than recommended
   3. Missing a dose of Adablok
   4. Stopping treatment with Adablok
7. Possible side effects
8. How to store Adablok
9. Contents of the pack and other information
   1. What Adablok contains
   2. What Adablok looks like and contents of the pack
   3. Marketing authorization holder and manufacturer/importer:
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Malta:
   8. Czech Republic:
   9. Slovakia:
   10. Poland:

Package Leaflet: Information for the User

Adablok, 5 mg, coated tablets

Adablok, 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.
• In case of any doubts, 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents:

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

1. What is Adablok and what is it used for

The active substance of Adablok belongs to a group of cholinolytic medicines. These medicines reduce the activity of an overactive urinary bladder. This action allows for longer intervals between trips to the toilet and increases the amount of urine held in the bladder. Adablok is used to treat symptoms of an overactive bladder. These include: urgent urination, frequent urination, and incontinence associated with not being able to get to the toilet in time.

2. Important information before taking Adablok

When not to take Adablok:

• if the patient is unable to urinate or empty their bladder (urinary retention);
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• in patients with a muscle disease called myasthenia gravis, which can cause significant weakness of certain muscles;
• if the patient has glaucoma with a narrow angle of filtration (increased pressure of the fluid in the eyeball, which can lead to gradual vision loss);
• in patients allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• if the patient is undergoing hemodialysis;
• if the patient has severe liver function disorders;
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may delay the elimination of Adablok from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

Before starting treatment with Adablok, the patient should inform their doctor if any of the above situations apply or have applied in the past.

Warnings and precautions

Before starting to take Adablok, the patient should discuss it with their doctor or pharmacist:

• if the patient has difficulty emptying their 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 the patient has gastrointestinal motility disorders (constipation);
• if there is a risk of slowing down the movement of the digestive tract (peristalsis). The doctor will provide information on this;
• if the patient has severe kidney function disorders;
• if the patient has moderate liver function disorders;
• if the patient has a tearing stomach pain (hiatal hernia) or heartburn;
• if the patient has nervous system disorders (autonomic nervous system neuropathy).

Children and adolescents

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

Before starting to take Adablok, the patient should inform their doctor if any of the above situations apply or have applied in the past. Before starting treatment with Adablok, the 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, the doctor will prescribe an antibiotic (an antibacterial medicine).

Adablok and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is especially important to inform the doctor if the patient is taking:

• other cholinolytic medicines, as taking such a medicine with Adablok may lead to an increase in both the therapeutic effect and side effects of both medicines;
• medicines from the group of cholinergic receptor agonists, as they may weaken the effect of Adablok;
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Adablok may weaken their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Adablok;

such medicines slow down the metabolism of Adablok;

• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Adablok;
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Adablok with food and drink

Adablok can be taken with or without food.

Pregnancy and breastfeeding

Solifenacin succinate should not be used during pregnancy, unless it is absolutely necessary. Adablok should not be used during breastfeeding, as solifenacin may pass into breast milk. Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines:

Adablok may cause blurred vision, and less frequently, drowsiness and fatigue. If such side effects occur, the patient should not drive or operate any machinery. Adablok contains lactose.Patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type), or glucose-galactose malabsorption syndrome should not take this medicine.

3. How to take Adablok

Instructions for proper use

Adablok should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The tablet should be swallowed whole, with a liquid. The medicine can be taken with or without food, depending on the patient's preference. The tablets should not be crushed. The usual dose is 5 mg once daily, unless the doctor recommends a dose of 10 mg once daily.

Taking a higher dose of Adablok than recommended

In case of taking too many Adablok tablets or if a child accidentally swallows Adablok, the patient should immediately contact their doctor or pharmacist. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures, breathing difficulties, rapid heartbeat, urinary retention, and dilated pupils.

Missing a dose of Adablok

In case of missing a dose, the patient should take the next dose as soon as possible, unless it is almost time for the next dose. The medicine should not be taken more than once a day. In case of doubts, the patient should consult their doctor or pharmacist.

Stopping treatment with Adablok

If treatment with Adablok is stopped, the symptoms of an overactive bladder may return or worsen. Stopping treatment with Adablok should always be consulted with the doctor. In case of any further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Very common(may affect more than 1 in 10 people) side effects include:

• dry mouth.

Common(may affect up to 1 in 10 people) side effects include:

• blurred vision,
• constipation, nausea, indigestion with symptoms such as: feeling of a full stomach, abdominal pain, belching, nausea, heartburn, feeling of discomfort in the abdominal cavity.

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

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

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

• accumulation of a large amount 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) side effects include:

• hallucinations, confusion,
• 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 eye pressure,
• ECG changes, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects If side effects occur, including any not listed in the leaflet, the patient should inform their doctor or 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: Al. Jerozolimskie 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 collected on the safety of the medicine.

5. How to store Adablok

PVC/PVDC/Aluminum and Aluminum/Aluminum blisters: There are no special precautions for storage. PVC/Aclar/Aluminum blisters: Store below 30°C The medicine should be stored out of sight and reach of children. Do not use Adablok after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month. The batch number is stated after the abbreviation "Lot". Do not use Adablok if the packaging is damaged or there are signs of attempted opening. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Adablok contains

The active substance is solifenacin succinate. One coated tablet contains 5 mg of solifenacin succinate. One coated tablet contains 10 mg of solifenacin succinate. The other ingredients are: Tablet core: lactose monohydrate, corn starch, hypromellose, magnesium stearate Coating of Adablok 5 mg tablet: hypromellose, macrogol 8000, talc, titanium dioxide (E171), and iron oxide yellow (E172) Coating of Adablok 10 mg tablet: hypromellose, macrogol 8000, talc, titanium dioxide (E171), and iron oxide red (E172)

What Adablok looks like and contents of the pack

Adablok 5 mg coated tablet: yellow, round tablet, approximately 8 mm in length, with the symbol "390" embossed on one side. Adablok 10 mg coated tablet: pink, round tablet, approximately 8 mm in length, with the symbol "391" embossed on one side. Adablok 5 mg and 10 mg coated tablets are available in blister packs containing 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer:

Marketing authorization holder:

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Manufacturer:

S.C. Zentiva S.A. B-dul Theodor Pallady nr.50, sector 032266 Bucharest Romania Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Malta:

Osolfenacare 5 mg Pillolamiksijab’rita Osolfenacare 10 mg Pillolamiksijab’rita

Czech Republic:

Soliflow 5 mg Potahované tablety Soliflow 10 mg Potahované tablety

Slovakia:

Soliflow 5 mg Filmomobalené tablety Soliflow 10 mg Filmomobalené tablety

Poland:

Adablok 5 mg tabletki powlekane Adablok 10 mg tabletki powlekane

Date of last revision of the leaflet:03.2023