SUMMARY CMI

SOLICARE

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using SOLICARE?

SOLICARE contains the active ingredient solifenacin succinate. SOLICARE is used to treat the symptoms of overactive bladder.

For more information, see Section 1. Why am I using SOLICARE? in the full CMI.

2. What should I know before I use SOLICARE?

Do not use if you have ever had an allergic reaction to SOLICARE or any of the ingredients listed at the end of the CMI.

There are a number of circumstances in which a person should not use this medicine or may need to use caution. It is important to understand if these apply to you before taking SOLICARE (see Section 2. What should I know before I use SOLICARE? in the full CMI for more details)

3. What if I am taking other medicines?

Some medicines may interfere with SOLICARE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use SOLICARE?

• The usual dose is 5 to 10 mg of SOLICARE once a day. Your doctor will decide the most suitable dose for you.
• Talk to your doctor or pharmacist if you feel that the effect of SOLICARE is too strong or too weak.

More instructions can be found in Section 4. How do I use SOLICARE? in the full CMI.

5. What should I know while using SOLICARE?

For more information, see Section 5. What should I know while using SOLICARE? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur (see the full CMI for more details). The most common and serious side effects are allergic reactions including swelling of the face, lips, throat or tongue, difficulty breathing; chest pain or tightness; swelling of the feet or legs; changes in electrical activity of the heart (ECG), irregular heartbeat (Torsade de Points).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

SOLICARE

Active ingredient(s): solifenacin succinate

Consumer Medicine Information (CMI)

This leaflet provides important information about using SOLICARE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using SOLICARE.

Where to find information in this leaflet:

1. Why am I using SOLICARE?
2. What should I know before I use SOLICARE?
3. What if I am taking other medicines?
4. How do I use SOLICARE?
5. What should I know while using SOLICARE?
6. Are there any side effects?
7. Product details

1. Why am I using SOLICARE?

SOLICARE contains the active ingredient solifenacin succinate.

SOLICARE is used to treat the symptoms of overactive bladder. These symptoms include needing to rush to the toilet to urinate without warning, needing to urinate frequently, or wetting yourself because you did not get to the toilet in time.

SOLICARE belongs to a group of medicines called anticholinergic medicines. It works by acting on specialised cells to reduce the activity of your bladder and help you control your bladder.

Your doctor may have prescribed SOLICARE for another reason. Ask your doctor if you have any questions about why SOLICARE has been prescribed for you.

SOLICARE is available only with a doctor's prescription.

There is no evidence that SOLICARE is addictive.

2. What should I know before I use SOLICARE?

Warnings

Do not use SOLICARE if:

• you are allergic to solifenacin, or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath. Always check the ingredients to make sure you can use this medicine.
• you suffer from urinary retention (inability to urinate or empty your bladder completely)
• you are undergoing haemodialysis
• you have severe kidney disease or moderate liver disease and are also taking medicines that can decrease the removal of SOLICARE from the body (see Section 3. What if I am taking other medicines?)
• you have severe liver disease
• you have uncontrolled glaucoma (high pressure in the eyes, with gradual loss of eye sight)
• you have myasthenia gravis, a disease of the muscles causing drooping eyelids, double vision, difficulty in speaking or swallowing and sometimes muscle weakness in the arms or legs
• you have a blocked gastro-intestinal tract or other gastro-intestinal disorders such as ulcerative colitis or toxic megacolon.
• the expiry date (Exp.) printed on the pack has passed.
• the packaging is torn or shows signs of tampering.

Check with your doctor if you:

• are allergic to any other medicines, foods, dyes or preservatives.

Do not give SOLICARE to children.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant.

SOLICARE may affect your developing baby if you take it during pregnancy. Your doctor will decide if you should take it.

Do not take SOLICARE if you are breastfeeding.

Tell your doctor if you have, or have had, any medical conditions, especially the following:

• low potassium levels or a family history of heart rhythm problems. SOLICARE may have an effect on the electro-cardiogram (ECG - a heart tracing) and may add to the effect of other medicines on the ECG. You should advise your doctor of any other medicines you are currently taking, particularly those affecting the heart rhythm. Your doctor may wish to perform an ECG if you have any risks of having an abnormal heart rhythm.
• blockage to your bladder that causes difficulty urinating
• obstruction of the digestive system (constipation)
• glaucoma (high pressure in the eyes, with gradual loss of eye sight)
• hiatus hernia or gastric reflux or are currently being treated with some medicines (such as bisphosphonates) which may make your reflux worse
• autonomic neuropathy, a nerve problem which sometimes occurs with diabetes and can lead to diarrhoea, impotence or low blood pressure
• severe kidney disease
• moderate liver disease.

If you have not told your doctor about any of the above, tell him/her before you start taking SOLICARE.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may be affected by SOLICARE, or may affect how well it works.

Some medicines can slow down the removal of SOLICARE from the body. If you are taking any of the following, 5 mg a day is the maximum recommended dosage:

• some antifungal medicines such as ketoconazole, itraconazole
• ritonavir and nelfinavir, medicines to treat HIV infection.

If you are taking any of the above medicines and you also have severe kidney disease or moderate liver disease, you should not take SOLICARE.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking SOLICARE.

4. How do I use SOLICARE?

How much to take

• The usual dose is 5 to 10 mg of SOLICARE once a day.
  Your doctor will decide the most suitable dose for you.
• Talk to your doctor or pharmacist if you feel that the effect of SOLICARE is too strong or too weak.

Follow all directions given to you by your doctor and pharmacist carefully.

When to take SOLICARE

• Try and take SOLICARE at the same time each day.

How to take SOLICARE

• SOLICARE is taken by mouth. It can be taken with or without food.
• Swallow the tablets whole with a glass of water.
• Do not crush or chew the tablets.
• If you crush or chew SOLICARE tablets, they may not work as well.

If you forget to take SOLICARE

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

How long to take SOLICARE for

To properly control your condition, SOLICARE must be taken every day.

Keep taking SOLICARE for as long as your doctor recommends.

If you use too much SOLICARE (overdose)

If you think that you have used too much SOLICARE, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using SOLICARE?

Things you should do

Before starting any new medicine, tell your doctor or pharmacist that you are taking SOLICARE.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking SOLICARE.

If you become pregnant while taking SOLICARE, tell your doctor.

Visit your doctor regularly so they can check on your progress.

Things you should not do

• Do not stop taking SOLICARE, or lower the dose, without checking with your doctor.
• Do not use SOLICARE to treat any other conditions unless your doctor tells you to.
• Do not give SOLICARE to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how SOLICARE affects you.

SOLICARE may cause dizziness in some people

Do not drive or operate machinery if you suffer from any of these side effects.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Keep it where young children cannot reach it.
• A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
• Keep your tablets in a cool dry place where the temperature stays below 30°C.
• Do not store SOLICARE or any other medicine in the bathroom or near a sink.
• Do not leave SOLICARE in the car or on window sills.
  Heat and dampness can destroy some medicines.

Getting rid of any unwanted medicine

If your doctor tells you to stop taking SOLICARE, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SOLICARE.

Like all other medicines, SOLICARE may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Less serious side effects

Serious side effects

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

Some of these side effects (for example, changes in electrical activity of the heart or liver function) can only be found when your doctor does tests from time to time to check your progress.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What SOLICARE contains

Do not take this medicine if you are allergic to any of these ingredients.

What SOLICARE looks like

SOLICARE comes in two strengths of tablets:

• SOLICARE 5 mg tablets (AUST R 248408) are yellow coloured, round, biconvex, film coated tablets with ‘SOL’ debossed on one side and ‘5’ on the other side.
• SOLICARE 10 mg tablets (AUST R 248407) are pink coloured round, biconvex, film coated tablets with ‘SOL’ debossed on one side and ‘10’ on the other side.
• Each blister pack contains 10,30 tablets.

Who distributes SOLICARE

Arrotex Pharmaceuticals Pty Ltd
15 -17 Chapel Street; Cremorne
VIC 3121

This leaflet was prepared in February 2025.

Published by MIMS April 2025

1 Name of Medicine

Solifenacin succinate.

2 Qualitative and Quantitative Composition

Solicare 5 mg film-coated tablet: each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin.
Solicare 10 mg film-coated tablet: each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin.

List of excipients with known effect.

3 Pharmaceutical Form

5 mg film-coated tablet.

10 mg film-coated tablet.

4 Clinical Particulars

4.1 Therapeutic Indications

Solicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

4.2 Dose and Method of Administration

Adults, including the elderly.

Children and adolescents.

Special populations.

Patients with renal impairment.

Patients with hepatic impairment.

Co-medication.

Method of administration.

4.3 Contraindications

Solifenacin is contraindicated in:
patients with urinary retention;
patients with uncontrolled narrow-angle glaucoma;
patients who have demonstrated hypersensitivity to the drug substance or other components of the product;
severe gastro-intestinal condition (including toxic megacolon and gastric retention);
myasthenia gravis;
patients undergoing haemodialysis;
patients with severe hepatic impairment;
patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole.

4.4 Special Warnings and Precautions for Use

Solicare should be used with caution in patients:
with clinically significant bladder outflow obstruction at risk of urinary retention;
with gastrointestinal obstructive disorders;
with risk of decreased gastrointestinal motility;
being treated for narrow-angle glaucoma;
with hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products that can cause or exacerbate oesophagitis;
with autonomic neuropathy;
with known risk factors for QT prolongation, such as pre-existing long QT syndrome and hypokalaemia.

Angioedema.

Anaphylactic reaction.

QT prolongation and torsade de pointes.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

In vitro studies have demonstrated that at therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes. Therefore, solifenacin succinate is not likely to interact with the CYP mediated metabolism of co-administered drugs.

Effect of other medicinal products on the pharmacokinetics of solifenacin.

Effect of solifenacin on the pharmacokinetics of other medicinal products.

Oral contraceptives.

Warfarin.

Digoxin.

Drugs which prolong the QT/QTc interval.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Since solifenacin, like other anticholinergics may cause blurred vision, and uncommonly somnolence and fatigue, the ability to drive and use machines may be negatively affected (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

In the four 12-week double blind clinical trials 3027 patients were involved (1811 on solifenacin and 1216 on placebo), and approximately 90% of these patients completed the 12-week studies. The most frequent reason for discontinuation due to an adverse event was dry mouth, 1.5%. There were three intestinal serious adverse events in patients all treated with solifenacin 10 mg (one faecal impaction, one colonic obstruction, and one intestinal obstruction).
Table 1 lists the adverse events reported in ≥ 1.0% of the patients in the 12 week studies. The relationship to study medication for most of these events is uncertain; many are thought to represent spontaneous events reported by patients with bladder dysfunction (and other concomitant diseases) and are not necessarily causally related to solifenacin.
Adverse reactions reported in the clinical trials with a frequency of occurrence less than 1% are:

Gastrointestinal disorders.

Infections and infestations.

Nervous system disorders.

General disorders and administration site disorders.

Renal and urinary disorders.

Respiratory, thoracic and mediastinal disorders.

Investigations.

Musculoskeletal and connective tissue disorders.

Skin and subcutaneous tissue disorders.

Vascular disorders.

Post marketing experience.

Cardiac disorders.

Eye disorders.

Gastrointestinal disorders.

General disorders and administration site conditions.

Hepatobiliary disorders.

Immune system disorders.

Investigations.

Metabolism and nutrition disorders.

Musculoskeletal and connective tissue disorders.

Nervous system disorders.

Psychiatric disorders.

Renal and urinary disorders.

Respiratory, thoracic and mediastinal disorders.

Skin and subcutaneous tissue disorders.

Reporting suspected adverse effects.

4.9 Overdose

Overdosage with solifenacin succinate can potentially result in severe anticholinergic effects (headache, dry mouth, dizziness, drowsiness and blurred vision) and should be treated accordingly. The highest dose of solifenacin succinate accidentally given to a single patient was 280 mg in a 5 hour period, resulting in mental status changes not requiring hospitalization.
Overdosage with solifenacin succinate may prolong the QTc interval, therefore, in the event of overdosage, ECG monitoring is recommended and standard supportive measures for managing QT prolongation should be adopted.

Treatment of overdosage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Urinary antispasmodics, ATC code: G04B D08.

Mechanism of action.

Clinical trials.

Clinical QT interval data.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Dose proportionality.

Renal impairment.

Hepatic impairment.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Core tablet: lactose monohydrate, maize starch, hypromellose, colloidal anhydrous silica, magnesium stearate.
Film coating: Opadry complete film coating system 03F12967 Yellow (ARTG 11591) (5 mg) and Opadry complete film coating system 03F14895 Pink (ARTG 11590) (10 mg).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Container: The tablets are packed in PVC/Aluminium blisters.
Pack size: 10 tablets/ 30 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes