Afenix

Package leaflet: Information for the patient

Afenix, 5 mg, film-coated tablets
Afenix, 10 mg, film-coated tablets
Solifenacin succinate
Please read this leaflet carefully before using 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Afenix is and what it is used for

The active substance in Afenix belongs to the group of cholinolytic medicines. These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between toilet visits and increases the amount of urine the bladder can hold.
Afenix is used to treat the symptoms of overactive bladder. These include urgent need to urinate, frequent urination, and urinary incontinence, occurring because the patient could not reach the toilet in time.

2. Important information before using Afenix

When not to use Afenix:

• if the patient is allergic to solifenacin succinate or any of the other ingredients of this medicine (listed in section 6);
• if the patient is unable to pass urine or empty the bladder (urinary retention);
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• if the patient has a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles;
• if the patient has increased pressure of fluid in the eye leading to gradual loss of vision (glaucoma);
• if the patient is undergoing haemodialysis;
• 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 Afenix from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Warnings and precautions

Before starting treatment with Afenix, discuss this with your doctor or pharmacist. Before starting treatment with Afenix, tell your doctor if any of the following conditions apply or have occurred in the past:

• if the patient has difficulty emptying the bladder (obstruction of urinary outflow from the bladder) or difficulty passing urine (weak urinary stream). In such cases, the risk of urine retention in the bladder (urinary retention) is much higher;
• if the patient suffers from gastrointestinal motility disorders (constipation);
• if there is a risk of slowed gastrointestinal motility (stomach and intestinal movements). Your doctor will provide further information on this;
• if the patient has severe kidney disease;
• if the patient has moderate liver disease;
• if the patient has a hiatal hernia (manifesting as burning stomach pain or heartburn);
• if the patient has disorders of the nervous system (autonomic neuropathy).

Before starting treatment with Afenix, your doctor will assess whether there are other causes of frequent urination (e.g. heart failure – insufficient cardiac muscle strength to pump blood effectively, or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (a bactericidal agent effective against the specific bacteria).

Children and adolescents

Afenix must not be used in children or adolescents under 18 years of age.

Afenix with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

It is especially important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as using such medicines together with Afenix may increase both the therapeutic effects and adverse reactions of both medicines;
• medicines belonging to the group of cholinergic receptor agonists, as they may reduce the effect of Afenix;
• medicines enhancing gastrointestinal motility, such as metoclopramide and cisapride, as Afenix may reduce their effectiveness;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they may slow down the metabolism of Afenix;
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Afenix;
• medicines such as bisphosphonates, as they may worsen oesophagitis.

Afenix with food and drink

Afenix can be taken during meals or independently of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Afenix must not be used during pregnancy unless absolutely necessary.

Afenix must not be used during breastfeeding, as solifenacin passes into breast milk.

Driving and operating machinery

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

Afenix contains monohydrate lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Afenix

This medicine should always be taken as instructed by the doctor. In case of doubt, consult a doctor or pharmacist.

Adults

• The usual dose is 5 mg once daily, unless the doctor advises using a dose of 10 mg once daily.
• The tablet should be swallowed whole with liquid. The medicine can be taken during or regardless of meals. Tablets must not be crushed.

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

Taking more Afenix than recommended
If too many Afenix tablets have been taken or if a child has accidentally swallowed the tablets, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and vision disturbances, seeing non-existent things (hallucinations), excessive excitement, seizures, breathing difficulties, rapid heartbeat (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils.

Missing a dose of Afenix
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. In case of doubt, consult a doctor or pharmacist.

Stopping Afenix
If treatment with Afenix is stopped, symptoms of overactive bladder may return or worsen. If the patient intends to discontinue treatment, they should consult their doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences symptoms of allergy or a severe skin reaction (e.g. blistering
and peeling of the outer layer of skin), contact a doctor immediately.
In some patients taking solifenacin succinate, angioedema (a type of allergic skin reaction causing swelling of tissue just beneath the skin surface) with swelling of the airways (difficulty breathing, wheezing) has been reported. If angioedema occurs, treatment with Afenix should be stopped immediately and the patient should contact a doctor, who will initiate appropriate treatment.
The Afenix medicine may cause other adverse effects listed below:
Very common (occurs in more than 1 in 10 people):

• dry mouth.

Common (occurs in less than 1 in 10 people):

• blurred vision,
• constipation, nausea, indigestion with symptoms such as bloating, abdominal pain, belching, nausea and heartburn (dyspepsia), discomfort in the abdominal area.

Uncommon (occurs in less than 1 in 100 people):

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

Rare (occurs in less than 1 in 1,000 people):

• faecal impaction (accumulation of hard stool in the colon),
• difficulty passing urine despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

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

• hallucinations, confusion,
• allergic rash.

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

• decreased appetite, increased blood potassium levels which may cause cardiac arrhythmias,
• increased intraocular pressure, glaucoma,
• changes in ECG, irregular heartbeat (torsade de pointes), atrial fibrillation, palpitations, rapid heartbeat,
• voice disorders,
• liver function abnormalities,
• muscle weakness,
• kidney function disorders.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can 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 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Afenix

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and the abbreviation Lot/LOT indicates the batch number.
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 Afenix contains

• The active substance is solifenacin succinate. Afenix 5 mg: each coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.77 mg of solifenacin. Afenix 10 mg: each coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.54 mg of solifenacin.
• Other ingredients are:
  Tablet core: pregelatinized corn starch, monohydrate lactose, sodium stearyl fumarate.
  Tablet coating:
  Afenix 5 mg: hypromellose (6 mPas), titanium dioxide (E 171), monohydrate lactose, polyethylene glycol (MW 3350), triacetin, yellow iron oxide (E 172).
  Afenix 10 mg: hypromellose (6 mPas), titanium dioxide (E 171), monohydrate lactose, polyethylene glycol (MW 3350), triacetin, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Afenix looks like and contents of the pack
Afenix 5 mg, coated tablets: light yellow, round, biconvex coated tablet.
Afenix 10 mg, coated tablets: pink, round, biconvex coated tablet.
Tablets are packed in blisters made of Aluminium/PVC foil. Pack sizes: 3, 5, 10, 20, 30, 50, 60, 90, 100, 200 coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba