ADABLOK 5 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 of the Leaflet:
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 and 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:
   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:

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.
• 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 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 medicines called antimuscarinics. 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. Adablok is used to treat 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 Adablok

When not to take Adablok:

• if the patient has difficulty emptying the bladder (urinary retention) or cannot empty the bladder;
• if the patient has severe gastrointestinal disorders (toxic megacolon, a complication of ulcerative colitis);
• in patients with a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles;
• if the patient has narrow-angle glaucoma (increased pressure in the eye leading to gradual loss of vision);
• 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, inform your doctor if any of the above situations apply or have applied in the past.

Warnings and precautions

Before starting to take Adablok, discuss with your doctor or pharmacist:

• if the patient has difficulty emptying the 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 disorders (constipation);
• if there is a risk of slowed gastrointestinal motility (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 chest pain (hiatus hernia) or heartburn;
• if the patient has nervous system disorders (autonomic nervous system neuropathy).

Children and adolescents

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

Before starting treatment with Adablok, inform your 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

Inform your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. It is especially important to inform your doctor if you are taking:

• other antimuscarinic medicines, as taking such a medicine with Adablok may lead to increased therapeutic and adverse effects of both medicines;
• cholinergic receptor agonists, as they may weaken the effect of Adablok;
• gastrointestinal motility enhancers, 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 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, consult your doctor or pharmacist.

Driving and using machines:

Adablok may cause blurred vision, and less often, drowsiness and fatigue. If such side effects occur, do 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 your doctor. If you are unsure, consult your doctor or pharmacist. The tablet should be swallowed whole, with a drink of water. The medicine can be taken with or without food, as preferred. Do not crush the tablets. The usual dose is 5 mg once daily, unless your doctor advises you to take a dose of 10 mg once daily.

Taking a higher dose of Adablok than recommended

If you have taken too many Adablok tablets or if a child has accidentally swallowed Adablok, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures, breathing difficulties, rapid heartbeat, urine accumulation in the bladder, and dilated pupils.

Missing a dose of Adablok

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

Stopping treatment with Adablok

If you stop taking Adablok, the symptoms of an overactive bladder may return or worsen. Stopping treatment with Adablok should always be discussed with your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Adablok 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 (Adablok), angioedema (a form of allergic skin reaction that causes swelling of the tissue just below the surface of the skin) with swelling of the airways has been reported. If you experience angioedema, stop taking solifenacin succinate (Adablok) immediately and take appropriate treatment and/or measures. Adablok may cause the following side effects:

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

• dry mouth.

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

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

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

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

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

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

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

• hallucinations, confusion,
• hives.

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

• decreased appetite, increased potassium levels in the blood, which may 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 you experience any side effects, including those not listed in this leaflet, please inform your 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, you can help provide more information on the safety of this 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. Keep the medicine out of the 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 "Lot". Do not use Adablok if the packaging is damaged or shows signs of tampering. 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 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, maize starch, hypromellose, magnesium stearate Adablok 5 mg tablet coating: hypromellose, macrogol 8000, talc, titanium dioxide (E171), and iron oxide yellow (E172) Adablok 10 mg tablet coating: 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:

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