Asolfena

Package leaflet: Information for the patient

Asolfena, 5 mg, film-coated tablets
Asolfena, 10 mg, film-coated tablets
solifenacin succinate
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Asolfena is and what it is 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 pack and other information

1. What Asolfena is and what it is used for
The active substance in Asolfena belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows for longer intervals between needing to go to the toilet and increases the amount of urine the bladder can hold.
Asolfena is used to treat symptoms of a condition called "overactive bladder". These symptoms include: a sudden, strong urge to urinate without prior warning signs, frequent need to urinate, or involuntary leakage of urine due to not reaching the toilet in time.

2. Important information before taking Asolfena

When not to take Asolfena:

• if you are allergic to solifenacin or to any of the other ingredients of this medicine (listed in section 6),
• if you are unable to pass urine or completely empty your bladder (urinary retention),
• in case of severe stomach or intestinal disorders (including toxic megacolon, a complication of ulcerative colitis),
• if you suffer from myasthenia gravis – a muscle disease that may cause significant weakening of certain muscles,
• if you have increased pressure in the eyes associated with gradual loss of vision (glaucoma),
• if you are undergoing dialysis,
• if you have severe liver problems,
• if you have severe kidney disease or moderate liver disease
  and are also taking medicines that may reduce the elimination of Asolfena from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.
  Before starting treatment with Asolfena, inform your doctor about any of the above conditions.

Warnings and precautions
Talk to your doctor or pharmacist before taking Asolfena.

• If you have problems emptying your bladder (urinary obstruction) or difficulty passing urine (e.g. a weak urine stream). The risk of excessive urine accumulation in the bladder (urinary retention) is significantly higher.
• If you have gastrointestinal obstruction (constipation).
• If there is a risk of slowed gastrointestinal motility (peristalsis). Your doctor will advise you accordingly.
• If you have severe kidney disease.
• If you have moderate liver disease.
• If you suffer from severe stomach pain (hiatal hernia) or heartburn.
• If you have nervous system disorders (autonomic neuropathy).

Before starting treatment with Asolfena, inform your doctor about any of the above conditions.
Before starting treatment with Asolfena, your doctor will assess whether you have other causes for frequent urination, such as heart failure (inadequate pumping of blood by the heart) or kidney disease. If you have a urinary tract infection, your doctor will prescribe an antibiotic (treatment directed against specific bacterial infections).

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

Asolfena with other medicines
Tell your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or might take in the future.
It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines, as their effects and side effects may be intensified,
• cholinergic medicines, as they may reduce the effect of Asolfena,
• medicines such as metoclopramide and cisapride, which increase gastrointestinal motility. Asolfena may reduce their effectiveness,
• 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 worsen oesophagitis.

Taking Asolfena with food and drink
This medicine may be taken with or without food, depending on patient preference.

Pregnancy and breastfeeding
Do not take Asolfena unless your doctor considers it necessary. Do not take this medicine during breastfeeding, as solifenacin may pass into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and operating machinery
Asolfena may cause blurred vision and, occasionally, drowsiness or fatigue.
If you experience any of these side effects, do not drive or operate machinery.

Asolfena contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Asolfena

Instructions for proper use
This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Swallow the tablet whole with a drink. It may be taken with or without food. Do not crush or chew the tablets.
The recommended dose is 5 mg once daily, unless your doctor has prescribed 10 mg once daily.

Taking more Asolfena than you should
If you or someone else (especially a child) has taken too much Asolfena, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, restlessness, seizures (fits), difficulty breathing, increased heart rate (tachycardia), urinary retention (inability to pass urine), and dilated pupils (mydriasis).

If you forget to take a dose of Asolfena
If you miss a dose of Asolfena at your usual time, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose. If in doubt, always consult your doctor or pharmacist.

Stopping treatment with Asolfena
If you stop taking Asolfena, symptoms of overactive bladder may return or worsen. Always consult your doctor before stopping treatment.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Asolfena and seek immediate medical help if you experience any of the following side effects:

• anaphylactic reaction or severe skin reaction (e.g. blistering and peeling of the skin);
• angioedema (a type of allergic reaction causing swelling under the skin) with airway obstruction (difficulty breathing) has been reported in some patients taking solifenacin succinate.

Other possible side effects of Asolfena include:

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, dyspepsia (indigestion) with symptoms such as bloating, abdominal pain, belching, nausea and heartburn
• stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness
• taste disturbances (dysgeusia)
• dry (irritated) eyes
• dryness of the nasal passages
• gastro-oesophageal reflux (acid regurgitation from the stomach into the oesophagus), dry throat
• dry skin
• difficulty passing urine
• fatigue, fluid accumulation in the lower legs (oedema)

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

• accumulation of hard stool in the colon (constipation)
• urinary retention due to inability to empty the bladder
• dizziness, headache
• 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 available data)

• decreased appetite, high blood potassium levels which may cause heart rhythm disturbances
• increased intraocular pressure, changes in heart electrical activity (ECG), irregular heartbeat, palpitations, faster heartbeat
• voice disorders
• liver disorders
• muscle weakness
• kidney disorders

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Asolfena

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Tablet container after first opening
Do not store above 25 °C.
The shelf life after first opening is 12 months.
Medicines must 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 Asolfena contains

• The active substance is solifenacin succinate.
  Asolfena 5 mg, coated tablets: Each coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacine.
  Asolfena 10 mg, coated tablets: Each coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacine.
• Other ingredients are:
  Tablet core: monohydrate lactose, 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 off-white, round, slightly convex coated tablets with bevelled edges.
Tablet diameter: 7.5 mm.
Asolfena 10 mg, coated tablets
White to pinkish, round, slightly convex coated tablets with uneven edges.
Tablet diameter: 7.5 mm.
Cartons are available containing 10, 30, 50, 60, 90 and 100 coated tablets in blisters.
Cartons are available containing 250 coated tablets in tablet containers.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information on the product name in other countries of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
Tel. 22 57 37 500