Adablok

Package leaflet: Information for the user

Adablok, 5 mg, film-coated tablets
Adablok, 10 mg, film-coated tablets
Solifenacin succinate
Read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Adablok is and what it is 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 Adablok is and what it is used for

The active substance in Adablok belongs to the group of anticholinergic drugs. These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between bathroom visits and increases the amount of urine the bladder can hold.
Adablok is used in the treatment of symptoms of overactive bladder. These symptoms include urgency, which are sudden, compelling urges to pass urine, urinary frequency, and urinary incontinence, occurring when the patient is unable to reach the toilet in time.

2. Important information before using Adablok

When not to use Adablok:

• if the patient is unable to urinate or empty the urinary bladder (urinary retention);
• if the patient has severe gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• in patients suffering from a muscle disease called myasthenia, which may cause significant weakening of certain muscles;
• in patients with narrow-angle glaucoma (increased fluid pressure in the eyeball leading to gradual loss of vision);
• in patients with hypersensitivity (allergy) 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 also taking medicines that may delay elimination of Adablok from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with Adablok, inform your doctor if any of the above conditions are present or have occurred in the past.
Warnings and precautions
Before starting to take Adablok, discuss the following with your doctor or pharmacist:

• if the patient has difficulty emptying the bladder (obstruction of urine outflow from the bladder) or difficulty urinating (weak urine stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is significantly higher;
• if the patient has gastrointestinal motility disorders (constipation);
• if there is a risk of slowed gastrointestinal motility (peristalsis). Your doctor will provide further information;
• if the patient has severe kidney function disorders;
• if the patient has moderate liver function disorders;
• if the patient suffers from severe stomach pain (hiatal hernia) or heartburn;
• if the patient has disorders of the nervous system (autonomic neuropathy).

Children and adolescents
Adablok must not be used in children or adolescents under 18 years of age.
Before starting treatment with Adablok, inform your doctor if any of the above conditions are present or have occurred in the past.
Before initiating treatment with Adablok, the doctor will assess whether there are other possible causes of frequent urination (e.g. heart failure – insufficient cardiac muscle strength to pump blood adequately – or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).
Adablok with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient intends to use.
It is particularly important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as concomitant use with Adablok may enhance both the therapeutic effects and adverse reactions of both medicines;
• medicines belonging to cholinergic receptor agonists, as they may reduce the effectiveness of Adablok;
• medicines enhancing gastrointestinal motility, such as metoclopramide and cisapride, as Adablok may reduce their effectiveness;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they may 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 worsen esophagitis.

Adablok with food and drink
Adablok can be taken during meals or independently of food.
Pregnancy and breastfeeding
Solifenacin succinate should not be used during pregnancy unless absolutely necessary.
Adablok should not be used during breastfeeding, as solifenacin may pass into human milk.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery:
Adablok may cause blurred vision, and less frequently, drowsiness and fatigue. If these adverse effects occur, do not drive or operate any machinery.
Adablok contains lactose. Patients with the rare hereditary galactose intolerance, Lapp-type lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicine.

3. How to use Adablok

Instructions for proper use
Adablok should always be used as directed by the physician.
If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed whole with liquid. The medicine may be taken during meals or
independently of meals, depending on patient preference. Tablets must not be crushed.
The usual dose is 5 mg once daily, unless the physician recommends a dose of 10 mg once daily.
Use of a higher than recommended dose of Adablok
If too many Adablok tablets have been taken, or if Adablok has been accidentally swallowed by
a child, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and visual disturbances, hallucinations, excessive excitation, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils.
Missing a dose of Adablok
If a dose of the medicine 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 treatment with Adablok
If treatment with Adablok is discontinued, symptoms of overactive bladder may return or worsen. Discontinuation of the medicine should always be discussed with the 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 will experience 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.
In some patients taking solifenacin succinate (Adablok), angioedema (a type of allergic skin reaction causing swelling of tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has been reported. If angioedema occurs, treatment with solifenacin succinate (Adablok) must be stopped immediately and appropriate treatment and/or corrective measures should be initiated.
Adablok may cause the following adverse reactions:
Very common (may occur in more than 1 in 10 people):

• dry mouth.

Common (may occur in less than 1 in 10 people):

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

Uncommon (may occur in less than 1 in 100 people):

• urinary tract infection, cystitis,
• somnolence, taste disturbances,
• dry eye syndrome,
• nasal dryness,
• gastroesophageal reflux (heartburn), throat dryness,
• dry skin,
• difficulty in passing urine,
• fatigue, peripheral oedema.

Rare (may occur in less than 1 in 1000 people):

• faecal impaction; colonic obstruction,
• difficulty passing urine despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

Very rare (may occur in less than 1 in 10,000 people):

• hallucinations, confusion,
• urticaria.

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

• decreased appetite, increased blood potassium levels which may cause cardiac arrhythmia,
• increased intraocular pressure,
• changes in ECG, irregular heartbeat, palpitations, tachycardia,
• voice disorders,
• liver function abnormalities,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Adablok

PVC/PVDC/Aluminium and Aluminium/Aluminium blisters:
No special storage conditions required.
PVC/Aclar/Aluminium blisters:
Store below 30°C.
Keep this 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 the specified month. The batch number is indicated after “Lot”.
Do not use Adablok if the packaging is damaged or if there are any 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. These measures will help protect the environment.

6. Contents of the package 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: monohydrate lactose, corn starch, hypromellose, magnesium stearate
Coating of Adablok 5 mg tablet: hypromellose, macrogol 8000, talc, titanium dioxide (E171), and
yellow iron oxide (E172)
Coating of Adablok 10 mg tablet: hypromellose, macrogol 8000, talc, titanium dioxide (E171), and
red iron oxide (E172)

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

Marketing Authorisation Holder and Manufacturer/Importer:
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

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
Poland

This medicinal product is authorised in the European Economic Area member states 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 coated tablets
Adablok 10 mg coated tablets