Fensiglen 5 mg/10 mg Film-Coated Tablets

FENSIGLEN belongs to a group of medicines known as anticholinergics. It is used to treat the symptoms of a condition called overactive bladder syndrome, including the following:

• A frequent need to urinate (usually defined as needing to go more than 8 times in 24 hours)
• Sudden frequent urges to urinate (urinary urgency) and/or
• Leaking accidents (urinary incontinence or urge incontinence).

Do not take FENSIGLEN:

• If you are hypersensitive (allergic) to solifenacin succinate or any of the other ingredients of FENSIGLEN (see section 6)
• If you have an inability to pass water or to empty your bladder completely
• If you have uncontrolled increased pressure inside of your eyes (uncontrolled narrow angle glaucoma)
• If you suffer from myasthenia gravis, a muscle disease which can cause extreme weakness of certain muscles, difficulty swallowing, eye weakness and facial expression weakness
• If you have a severe bowel condition causing your intestines to expand or dilate known as toxic megacolon (a complication associated with ulcerative colitis)
• If you are undergoing kidney dialysis (a process used to clean your blood when your kidneys are not functioning normally)
• If you have a severe liver disease
• If you suffer from a severe kidney disease or a moderate liver disease and you are being treated with medicines that may decrease the removal of FENSIGLEN from your body (such as ketoconazole, used to treat fungal infections)
• If you have fast, irregular heartbeats
• If you are pregnant or breastfeeding your baby

Warnings and precautions

Special care should be taken with FENSIGLEN:

• If you have trouble emptying your bladder (bladder obstruction) or have difficulty in passing urine (weak urine flow)
• If you have some obstruction of your digestive system (such as constipation)
• If you are at risk of your digestive system slowing down (decreased stomach and bowel movements)
• If you have a condition causing inflammation or ulcers on the lining of your intestines, known as ulcerative colitis (diarrhoea, pain or cramping in your stomach area, loss of body mass or uncomfortable or painful bowel movements)
• If you suffer from a severe kidney disease
• If you have a moderate liver disease
• If you are taking ketoconazole (see Taking other medicines with FENSIGLEN)
• If you are male and you have an enlarged prostate which is causing difficulty to urinate
• If you have a fever or increased body temperature
• If you have any other heart condition, or you have to have a heart procedure done, that causes your heart to beat faster than normal
• If you have had a heart attack
• If you have high blood pressure
• If you have Down’s syndrome or albinism (absence of pigment in your skin)
• If you are an elderly person. FENSIGLEN may cause confusion.
• If you have angioedema (a skin allergy that results in swelling that occurs in the tissue just below the surface of your skin) with difficulty in breathing. Stop FENSIGLEN immediately and contact a doctor
• If you have a nervous disorder that is causing bladder problems

Do not share medicines prescribed for you with any other person. Always take FENSIGLEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is 5 mg daily taken with or without food. Your doctor may increase your dose to 10 mg daily. You should swallow the tablet whole with some liquid. Do not crush or chew the tablets.

If you take more FENSIGLEN than you should

In the event of an overdosage you may experience any of the side effects listen below.

• Headache
• Dry mouth
• Dizziness
• Drowsiness
• Blurred vision

In the event of overdosage, consult your doctor or pharmacist. If neither is available, consult the nearest hospital or poison centre.

If you forget to take FENSIGLEN

If you have missed your dose by only a few hours, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take FENSIGLEN at the next regularly scheduled time. Do not take a double dose to make up for the forgotten individual doses.

If you stop taking FENSIGLEN

Do not stop taking FENSIGLEN early, as this might cause the medicine to be ineffective. Your symptoms of overactive bladder may return or worsen. Always consult your doctor if you are considering stopping treatment.

FENSIGLEN can have side effects. Not all side effects reported for FENSIGLEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FENSIGLEN, please consult your healthcare provider for advice.

If any of the following happens, stop taking FENSIGLEN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• A severe, potentially life-threatening allergic reaction (anaphylaxis) which can present as swelling of the face and throat area, skin rash, nausea, vomiting, difficulty breathing and shock. These are all very serious side effects. If you have them, you may have had a serious reaction to FENSIGLEN. You may need urgent medical attention or hospitalisation.
• Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice the following:
• Erythema Multiforme (a skin reaction that can be triggered by an infection or some medicines). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Blurred vision (loss of sharpness of eyesight)
• Dry mouth
• Constipation (Passing less than three bowel movements a week or has difficult bowel movements)
• Nausea (a queasy sensation including an urge to vomit)
• Dyspepsia (upper abdominal discomfort such as a burning sensation, bloating or gassiness, nausea or feeling full too quickly after starting to eat)
• Abdominal pain (stomach pain)

Less frequent side effects:

• Urinary tract infection (an infection in any part of the urinary system, the kidneys, bladder or urethra)
• Cystitis (inflammation of the bladder)
• Hallucinations (seeing or hearing things that are not real)
• Confusional state (serious disturbance in mental abilities that results in confused thinking and reduced awareness of surroundings)
• Somnolence (sleepiness, drowsiness)
• Dysgeusia (altered perception of taste)
• Dizziness (altered sense of balance and place, possibly described as lightheaded, feeling faint or as if head is spinning)
• Headache (a painful sensation in any part of the head, ranging from sharp to dull)
• Nasal dryness
• Gastro-oesophageal reflux diseases
• Dry throat
• Obstruction of your colon
• Faecal impaction (hardened stool that's stuck in the rectum or lower colon due to chronic constipation)
• Dry skin
• Pruritus (an uncomfortable, irritating sensation that creates an urge to scratch that can involve any part of the body)
• Rash (widespread eruptions or skin lesions)
• Urticaria (a raised, itchy rash that appears on the skin)
• Angioedema (swelling underneath the skin) (painless swelling under the skin, triggered by an allergy)
• Difficulty in micturition (difficulty urinating can be a result of anatomical abnormalities within the genitourinary tract)
• Urinary retention (difficulty urinating and completely emptying the bladder)
• Fatigue (overall tiredness or lack of energy)
• Peripheral oedema (swelling of your lower legs or hands)

Side effects with unknown frequency:

• Decreased appetite
• Hyperkalaemia (high level potassium in the blood)
• Delirium (serious disturbance in mental abilities that results in confused thinking and reduced awareness of surroundings)
• Glaucoma (a group of eye disorders causing blindness)
• Torsade de Pointes (disturbance of the heart’s rhythm)
• Electrocardiogram QT prolonged
• Dysphonia (disorders of the voice)
• Ileus (a temporary lack of the normal muscle contractions of the intestines)
• Abdominal discomfort
• Liver disorder, liver function test abnormal
• Exfoliative dermatitis (a severe skin condition that causes extreme shedding of the top layers of your skin)
• Muscle weakness
• Renal impairment (kidney failure or damage)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FENSIGLEN.

Store all medicines out of reach of children. Store at or below 25 °C. Store in the outer container until required for use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).