Asolfena

Leaflet attached to the packaging: patient information

Asolfena, 5 mg, coated tablets

Asolfena, 10 mg, coated tablets

solifenacin succinate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Asolfena and what is it used for

The active substance of Asolfena belongs to a group of anticholinergic medicines. These medicines are used to reduce the activity of an overactive bladder. This allows for longer intervals between trips to the bathroom and increases the amount of urine that can be held in the bladder. Asolfena is used to treat the symptoms of a condition called "overactive bladder". These symptoms include: a sudden, intense need to urinate without prior warning signs, frequent urination, or involuntary urination due to not being able to get to the bathroom on time.

2. Important information before taking Asolfena

When not to take Asolfena:

• if the patient is allergic to solifenacin or any of the other ingredients of the medicine (listed in section 6),
• if the patient is unable to urinate or completely empty the bladder (urinary retention),
• in case of severe stomach or intestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis),
• if the patient suffers from myasthenia - a muscle disease that can cause significant weakness of some muscles,
• if the patient has increased eye pressure with gradual vision loss (glaucoma),
• if the patient is undergoing dialysis,
• if the patient has severe liver disorders,
• if the patient has severe kidney disease or moderate liver disease

and is taking medicines that may reduce the elimination of Asolfena from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this. Before starting treatment with Asolfena, the patient should inform their doctor about all the above-mentioned conditions.

Warnings and precautions

Before taking Asolfena, the patient should consult a doctor or pharmacist.

• If the patient has problems with emptying the bladder (urinary retention) or difficulty urinating (e.g., a weak stream of urine). The risk of excessive urine accumulation in the bladder (urinary retention) is significantly higher.
• If the patient has gastrointestinal problems (constipation).
• If there is a risk of slowing down the movement of food through the digestive system (peristalsis). The doctor will inform the patient about this.
• If the patient has severe kidney disease.
• If the patient has moderate liver disease.
• If the patient has severe stomach pain (hiatal hernia) or heartburn.
• If the patient has nervous system disorders (autonomic neuropathy).

Before starting treatment with Asolfena, the patient should inform their doctor about all the above-mentioned conditions. Before starting treatment with Asolfena, the doctor will assess whether the patient has other causes of frequent urination, such as heart failure (insufficient blood pumping by the heart) or kidney disease. If the patient has a urinary tract infection, the doctor will prescribe an antibiotic (treatment aimed at specific bacterial infections).

Children and adolescents

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

Asolfena 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 about taking medicines such as:

• other anticholinergic medicines, as the effects and side effects of both medicines may be enhanced,
• cholinergic medicines, as they may weaken the effect of Asolfena,
• medicines such as metoclopramide and cisapride, which increase the speed of the digestive system. Asolfena may weaken their effect,
• medicines such as ketoconazole, ritonavir, nelfinavir, verapamil, diltiazem, as they may reduce the breakdown of Asolfena in the body,
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the breakdown of Asolfena in the body,
• medicines such as bisphosphonates, which may cause or exacerbate esophagitis.

Taking Asolfena with food and drink

This medicine can be taken with or without food, depending on the patient's preference.

Pregnancy and breastfeeding

Asolfena should not be used unless the doctor considers it necessary. This medicine should not be used during breastfeeding, as solifenacin may pass into breast milk. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Asolfena may cause blurred vision and sometimes drowsiness or fatigue. If these side effects occur, the patient should not drive or operate machinery.

Asolfena contains lactose

If the doctor has informed the patient that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Asolfena

Instructions for proper use

This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist. The patient should swallow the tablet whole and drink it with water. It can be taken with or without food. The tablets should not be crushed or chewed. The recommended dose is 5 mg per day, unless the doctor has prescribed 10 mg per day.

Taking a higher dose of Asolfena than recommended

If the patient has taken too much Asolfena or a child has accidentally swallowed Asolfena, they should immediately contact their doctor or pharmacist. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, restlessness, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), excessive urine accumulation in the bladder (urinary retention), and dilated pupils (mydriasis).

Missing a dose of Asolfena

If the patient misses a dose of Asolfena at the usual time, they should take it as soon as they remember, unless it is time for the next dose. The patient should never take more than one dose. If in doubt, they should always consult their doctor or pharmacist.

Stopping treatment with Asolfena

If the patient stops taking Asolfena, the symptoms of an overactive bladder may return or worsen. The patient should always consult their doctor if they plan to stop treatment. If the patient has any further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Asolfena can cause side effects, although not everybody gets them.

The patient should stop taking Asolfena and seek medical help immediately if they notice any of the following side effects:

• anaphylactic reaction or severe skin reaction (e.g., blistering and peeling of the skin);
• some patients taking solifenacin succinate have reported angioedema (a skin condition that causes swelling of the tissues just below the surface of the skin) with airway obstruction (difficulty breathing).

Asolfena may cause other side effects such as:
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 stomach, stomach pain, belching, nausea, and heartburn (dyspepsia), discomfort in the stomach.

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection,
• drowsiness,
• taste disorders (dysgeusia),
• dry eyes,
• dry nasal passages,
• acid reflux (gastroesophageal reflux), dry throat,
• dry skin,
• difficulty urinating,
• fatigue, swelling of the legs (edema).

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

• accumulation of large amounts of hard stool in the large intestine (constipation),
• excessive urine accumulation in the bladder due to inability to empty the bladder (urinary retention),
• dizziness, headaches,
• vomiting,
• itching, rash.

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

• hallucinations, confusion,
• allergic rash.

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

• decreased appetite, high potassium levels in the blood, which can cause heart rhythm disorders,
• increased eye pressure - changes in the electrical activity of the heart (ECG), irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver disorders,
• muscle weakness,
• kidney disorders.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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, more information can be gathered on the safety of the medicine.

5. How to store Asolfena

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month. This medicine does not require special storage conditions.

Tablet container after first opening

Do not store above 25°C. The shelf life after first opening is 12 months. 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 packaging and other information

What Asolfena contains

• The active substance is solifenacin succinate. Asolfena 5 mg, coated tablets: Each coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.8 mg of solifenacin. Asolfena 10 mg, coated tablets: Each coated tablet contains 10 mg of solifenacin succinate, which corresponds to 7.5 mg of solifenacin.
• The other ingredients are: tablet core: lactose monohydrate, povidone K25, magnesium stearate. See section 2 "Asolfena contains lactose". tablet coating: hypromellose 6 mPa s, talc, titanium dioxide (E 171), triacetin, iron oxide red (E 172) (only in 10 mg tablets).

What Asolfena looks like and contents of the pack

Asolfena 5 mg, coated tablets
White to brownish-white, round, slightly convex coated tablets with beveled edges. Tablet diameter: 7.5 mm.
Asolfena 10 mg, coated tablets
White-pink, round, slightly convex coated tablets with uneven edges. Tablet diameter: 7.5 mm.
Available in cardboard boxes containing 10, 30, 50, 60, 90, and 100 coated tablets in blisters. Available in cardboard boxes containing 250 coated tablets in tablet containers. Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information on the names of the medicine in other European Economic Area countries, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500
Date of last revision of the leaflet:27.10.2020