Solirest Film-Coated Tablets

Solirest contains the active ingredient solifenacin succinate which belongs to the group of anticholinergics. Solirest is used to reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder. Solirest is used to treat the symptoms of a condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time.

Do not take SOLIREST if :

• you are hypersensitive to solifenacin succinate or any of the other ingredients of Solirest (listed in section 6).
• if you have an inability to pass urine or to empty your bladder completely (urinary retention)
• if you have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis)
• if you suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles
• if you suffer from increased pressure in the eyes, with gradual loss of eyesight (glaucoma)
• if you are undergoing kidney dialysis
• if you have severe liver disease
• if you suffer from severe kidney disease or moderate liver disease and at the same time are being treated with medicines that may decrease the removal of Solirest from the body (for example, ketoconazole). Your doctor or pharmacist will have informed you if this is the case.

Warnings and precautions

Take special care with Solirest:

• if you have trouble emptying your bladder (= bladder obstruction) or have difficulty in passing urine (e.g. a thin urine flow). Risk of accumulation of urine in the bladder (urinary retention) is much higher.
• if you have some obstruction of the digestive system (constipation).
• if you are at risk of your digestive system slowing down (stomach and bowel movements). Your doctor will have informed you if this is the case.
• if you suffer from severe kidney disease.
• if you have moderate liver disease.
• if you have a stomach tear (hiatus hernia) or heartburn.
• if you have a nervous disorder (autonomic neuropathy).

Children and adolescents

Solirest is not to be used in children or adolescents under 18 years.

Other medicines and SOLIREST

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

• other anticholinergic medicines like scopolamine, orphenadrine and flavoxate, that prevents impulses responsible for muscle movement against someone’s will. These medicines can increase the effects and side effects of the anticholinergic medicines and Solirest.
• cholinergics medicines such as botulinum toxin, nicotine and atropine that prevents or improve the contraction of smooth muscles, opens blood vessels and increase body secretions and slow the heart rate. They can reduce the effect of Solirest.
• medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solirest can reduce their effect.
• medicines, like ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which decrease the rate at which Solirest is broken down by the body.
• medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solirest is broken down by the body.

SOLIREST with food

Solirest can be taken with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby please consult your doctor, pharmacist or other healthcare provider for advice before taking Solirest. You should not take Solirest if you are pregnant or breastfeeding your baby.

Driving and using machines

Solirest may cause blurred vision and sleepiness or tiredness. If you suffer from any of these side effects, do not drive or operate machinery. It is not always possible to predict to what extent Solirest may interfere with your daily activities. You should ensure that you do not engage in driving a vehicle or use machines until you are aware of the measure to which Solirest affects you.

SOLIREST contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this Solirest.

Do not share medicines prescribed for you with any other person. Always take Solirest 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 per day, unless your doctor told you to take 10 mg per day. Your doctor will tell you how long your treatment with Solirest will last. If you have the impression that the effect of Solirest is too strong or too weak, tell your doctor or pharmacist.

You should swallow the whole tablet with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

If you take more SOLIREST than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perceiving things that are not there (hallucinations), over-excitability, seizures (convulsions), difficulty breathing, elevated heart rate (tachycardia), accumulation of urine in the bladder (urinary retention) and dilated pupils (mydriasis).

If you forget to take SOLIREST

Do not take a double dose to make up for forgotten individual doses.

If you stop taking SOLIREST

Do not stop taking Solirest without speaking to your doctor.

Solirest can have side effects. Not all side-effects reported for Solirest are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Solirest, please consult your healthcare provider for advice. If any of the following happens, stop taking Solirest and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to Solirest. 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 any of the following:

• changes in the electrical activity of the heart (ECG), irregular heartbeat, feeling your heartbeat, faster heartbeat

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
• dry mouth
• constipation, nausea, indigestion with symptoms such as abdominal fullness and burping, stomach pain

Less frequent side effects

• urinary tract infection, bladder infection
• hallucinations, confusion
• sleepiness, impaired sense of taste (dysgeusia)
• dizziness, headache
• dry eyes
• dry nasal passages
• reflux disease (gastro-oesophageal reflux), dry throat
• blockage in the colon or rectum that prevents food or gas from passing through
• lodging of a large amount of hardened stool in the large intestine (faecal impaction)
• vomiting
• dry skin
• localised skin eruption with minimal or no mucosal involvement
• hives
• difficulty in passing urine
• tiredness
• accumulation of fluid in the lower legs (oedema)

Unknown frequency of side effects

• decreased appetite, high levels of blood potassium which can cause abnormal heart rhythm
• abrupt change in the brain that causes mental confusion and emotional disruption
• increased pressure in the eyes
• voice disorder
• a painful obstruction of the ileum or other part of the intestine
• liver disorder
• abnormal liver function tests
• widespread red and scaling of the skin
• muscle weakness
• renal disorder

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, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org), found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of Solirest.

Store all medicine out of reach of children. Store at or below 25 °C in the original package. Protect from moisture. Do not remove foil strips from carton until required for use. Do not use the tablets after the expiry date shown on the container. Return the expired medicine to your pharmacist for safe disposal.