AFENIX 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Afenix, 5 mg, film-coated tablets
3. Afenix, 10 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Afenix and what is it used for
5. Important information before taking Afenix
   1. When not to take Afenix:
   2. Warnings and precautions
   3. Children and adolescents
   4. Afenix and other medicines
   5. Afenix with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Afenix contains lactose monohydrate, sodium
6. How to take Afenix
   1. What to do if you take more Afenix than you should
   2. What to do if you miss a dose of Afenix
   3. What to do if you stop taking Afenix
7. Possible side effects
   1. Reporting side effects
8. How to store Afenix
9. Contents of the pack and other information
   1. What Afenix contains
   2. What Afenix looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Afenix, 5 mg, film-coated tablets

Afenix, 10 mg, film-coated tablets

Solifenacin succinate

Read the 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Afenix and what is it 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 is Afenix and what is it used for

The active substance of Afenix belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive urinary bladder. This action allows for longer intervals between trips to the toilet and increases the amount of urine held in the bladder. Afenix is used to treat the symptoms of an overactive bladder. These symptoms include: urgency, which means episodes of sudden, urgent need to urinate, frequent urination, and involuntary urination, which occurs when the patient cannot reach the toilet in time.

2. Important information before taking Afenix

When not to take Afenix:

• if you are allergic to solifenacin succinate or any of the other ingredients of this medicine (listed in section 6);
• if you have difficulty emptying your bladder or cannot empty your bladder (urinary retention);
• if you have severe gastrointestinal disorders (toxic megacolon, a complication of ulcerative colitis);
• if you have a muscle disease called myasthenia gravis, which can cause significant weakness of certain muscles;
• if you have increased pressure in the eye, which can lead to gradual loss of vision (glaucoma);
• if you are undergoing hemodialysis;
• if you have severe liver function disorders;
• if you have severe kidney disease or moderate liver disease and are taking medicines that may delay the elimination of Afenix from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you about this.

if you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially 'sodium-free'.

Warnings and precautions

Before starting treatment with Afenix, discuss it with your doctor or pharmacist. Before starting treatment with Afenix, tell your doctor if you have or have had any of the following:

• difficulty emptying your bladder or urinating (narrowing of the urethra) or a weak urine stream. In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher;
• gastrointestinal disorders (constipation);
• a risk of slowed gastrointestinal motility (movement of the stomach and intestines). Your doctor will inform you about this;
• severe kidney disease;
• moderate liver disease;
• a hiatal hernia (a condition where part of the stomach bulges up into the chest, which can cause heartburn or chest pain);
• autonomic nervous system disorders (autonomic neuropathy).

Before starting treatment with Afenix, your 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, your doctor will prescribe an antibiotic (an antibacterial medicine). If you are taking other medicines, tell your doctor or pharmacist.

Children and adolescents

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

Afenix and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. In particular, tell your doctor if you are taking:

• other anticholinergic medicines, as taking such a medicine with Afenix may increase both the therapeutic and adverse effects of both medicines;
• cholinergic receptor agonists, as they may weaken the effect of Afenix;
• gastrointestinal motility enhancers, such as metoclopramide and cisapride, as Afenix may weaken their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they 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 exacerbate esophagitis.

Afenix with food and drink

Afenix can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Afenix during pregnancy, unless it is absolutely necessary. You should not take Afenix during breastfeeding, as solifenacin passes into breast milk.

Driving and using machines

Afenix may cause blurred vision, sometimes drowsiness, and fatigue. If you experience these side effects, do not drive or operate any machinery.

Afenix contains lactose monohydrate, sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially 'sodium-free'.

3. How to take Afenix

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Adults

• The usual dose is 5 mg once daily, unless your doctor advises you to take a dose of 10 mg once daily.
• Swallow the tablet whole with a drink of water. You can take Afenix with or without food. Do not crush the tablets.

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

What to do if you take more Afenix than you should

If you take too many Afenix tablets or a child accidentally swallows some, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, seeing things that are not there (hallucinations), excessive excitement, seizures, difficulty breathing, rapid heartbeat (tachycardia), and urinary retention.

What to do if you miss a dose of Afenix

If you miss a dose, take the next dose as soon as possible, unless it is almost time for your next dose. Do not take more than one dose in 24 hours. If you are unsure, ask your doctor or pharmacist.

What to do if you stop taking Afenix

If you stop taking Afenix, your overactive bladder symptoms may return or worsen. If you want to stop treatment, consult 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, Afenix can cause side effects, although not everybody gets them. If you experience symptoms of an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), contact your doctor immediately. Some patients taking solifenacin succinate have reported angioedema (a type of allergic skin reaction that causes swelling of the tissue just below the skin surface) with swelling of the airways (difficulty breathing, wheezing). If you experience angioedema, stop taking Afenix and contact your doctor, who will provide appropriate treatment. Afenix may cause other side effects, including:

• Very common (more than 1 in 10 people): dry mouth.

Common (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 abdomen.

Uncommon (less than 1 in 100 people):

• 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 legs (edema).

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

• impaction of large amounts of hard stool in the colon (fecal impaction),
• difficulty urinating despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

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

• hallucinations, confusion,
• allergic rash.

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

• decreased appetite, increased potassium levels in the blood, which can cause heart rhythm disturbances,
• increased eye pressure, glaucoma,
• ECG changes, irregular heartbeat (torsade de pointes), atrial fibrillation, palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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. You can also report side effects 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 Afenix

Keep this medicine out of the 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 that month. The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. 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 Afenix contains

• The active substance is solifenacin succinate. Afenix 5 mg: each film-coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.77 mg of solifenacin. Afenix 10 mg: each film-coated tablet contains 10 mg of solifenacin succinate, which corresponds to 7.54 mg of solifenacin.
• The other ingredients are: Tablet core: maize starch, lactose monohydrate, sodium stearyl fumarate. Tablet coating: Afenix 5 mg: hypromellose (6 mPas), titanium dioxide (E 171), lactose monohydrate, macrogol (MW 3350), triacetin, yellow iron oxide (E 172). Afenix 10 mg: hypromellose (6 mPas), titanium dioxide (E 171), lactose monohydrate, macrogol (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, film-coated tablets: light yellow, round, biconvex film-coated tablet. Afenix 10 mg, film-coated tablets: pink, round, biconvex film-coated tablet. The tablets are packaged in aluminum/PVC blisters. Pack sizes: 3, 5, 10, 20, 30, 50, 60, 90, 100, 200 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization 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 Plant in Nowa Dęba, ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: