What Inconex XL is and what it is used for

of action to Inconex XL (cholinergic properties). The reduction in gastric motility caused by antimuscarinics may affect the absorption of other drugs. Ask your doctor if you are unsure.

The active substance in Inconex XL is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics.

Inconex XL with food and drink

Inconex XL can be taken before, after or during a meal.

Inconex XL is used for the treatment of the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may find that:

• you are unable to control urination
• you need to rush to the toilet with no advance warning and/or go to the toilet frequently.

What you need to know before you take Inconex XL

Do not take Inconex XL if you:

• are allergic to tolterodine or any of the other ingredients Of this medicine (listed in section 6)
• are unable to pass urine from the bladder (urinary retention)
• have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated)
• suffer from myasthenia gravis (excessive weakness of the muscles)
• suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
• suffer from a toxic megacolon (acute dilatation of the colon)

Warnings and precautions

Talk to your doctor or pharmacist before taking Inconex XL.

• If you have difficulties in passing urine and/or a poor stream of urine.
• If you have a gastro-intestinal disease that affects the passage and/or digestion of food.
• If you suffer from kidney problems (renal insufficiency).
• If you have a liver condition.
• If you suffer from neurological disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system).
• If you have a hiatus hernia (herniation of an abdominal organ).
• If you ever experience decreased bowel movements or suffer from severe constipation (decreased gastrointestinal motility).
• If you have a heart condition such as:

• – an abnormal heart tracing (ECG)

• – a slow heart rate (bradycardia)

• – relevant pre-existing cardiac diseases such as: cardiomyopathy (weak heart muscle), myocardial ischaemia (reduced blood flow to the heart), arrhythmia (irregular heartbeat) and heart failure

• If you have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in your blood.

Talk to your doctor or pharmacist before starting your treatment with Inconex XL if you think any of these might apply to you.

Other medicines and Inconex XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tolterodine, the active substance of Inconex XL, may interact with other medicinal products.

It is not recommended to use Inconex XL in combination with:

• some antibiotics (containing e.g. erythromycin, clarithromycin)
• medicinal products used for the treatment of fungal infections (containing e.g. ketoconazole, itraconazole)
• medicinal products used for the treatment of HIV

Inconex XL should be used with caution when taken in combination with:

• medicines that affect the passage of food (containing e.g. metoclopramide and cisapride)
• medicines for the treatment of irregular heartbeat (containing e.g. amiodarone, sotalol, quinidine, procainamide), other medicines with a similar mode of action to Inconex XL (antimuscarinic properties) or medicines with an opposite mode

Pregnancy, breast-feeding and fertility

Pregnancy

You should not use Inconex XL when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to become pregnant.

Breast-feeding

It is not known if tolterodine, the active substance of Inconex XL, is excreted in the mother’s breast milk. Breast-feeding is not recommended during administration of Inconex XL.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Inconex XL may make you feel dizzy, tired or affect your sight. If you experience any of these affects then you should not drive your car or operate heavy machinery.

Inconex XL contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per prolonged release hard capsule, that is to say essentially ‘sodium-free’.

3

How to take Inconex XL

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The prolonged-release hard capsules are for oral use and should be swallowed whole.

Do not chew the capsules.

Adults:

The usual dose is one 4 mg prolonged-release hard capsule daily.

Patients with liver or kidney problems:

In patients with liver or kidney problems your doctor may reduce your dose to 2 mg Inconex XL daily.

Children:

Inconex XL is not recommended for children.

If you take more Inconex XL than you should:

If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately. Symptoms in case of overdose include hallucinations, excitation, a heartbeat faster than usual, dilation of the pupil and inability to urinate or breathe normally.

If you forget to take Inconex XL:

If you forget to take a dose at the usual time, take it as soon as you remember unless it is almost time for your next dose. In that case, omit the forgotten dose and follow the normal dose schedule.

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

If you stop taking Inconex XL

Your doctor will tell you how long your treatment with Inconex XL will last. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Finish the course of prolonged-release capsules prescribed by your doctor. If you have not noticed any effect by then, talk to your doctor.

The benefit of the treatment should be re-evaluated after 2 or 3 months. Always consult your doctor if you are thinking of stopping the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should see your doctor immediately or go to the casualty department if you experience symptoms of angioedema, such as:

• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulty in breathing.

You should also seek medical attention if you experience a hypersensitivity reaction (for example itching, rash, hives, difficulty breathing). This occurs uncommonly (may affect up to 1 in 100 people).

Tell your doctor immediately or go to the casualty department if you notice any of the following:

• chest pain, difficulty breathing or getting tired easily (even at rest), difficulty breathing at night, swelling of the legs.

These may be symptoms of heart failure. This occurs uncommonly (may affect up to 1 in 100 people).

The following side effects have been observed during treatment with Inconex XL with the following frequencies.

Very common side effects (may affect more than 1 in 10 people) are:

• Dry mouth

Common side effects (may affect up to 1 in 10 people) are:

• Sinusitis
• Sleepiness
• Dry eyes
• Difficulty with digestion (dyspepsia)
• Abdominal pain
• Painful or difficult urination
• Extra fluid in the body causing swelling (e.g. in the ankles)
• Dizziness
• Headache
• Blurred vision
• Constipation
• Excessive amounts of air or gases in the stomach or the intestine
• Diarrhoea
• Tiredness
• Allergic reactions
• Nervousness
• Palpitations
• Inability to empty the bladder
• Vertigo
• Heart failure
• Irregular heartbeat
• Chest pain
• Sensation of pins and needles in the fingers and toes
• Memory impairment

Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, flushed skin, heart burn, vomiting, angioedema, dry skin, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia.

laurilsulfate, sodium docusate, magnesium stearate, hydroxypropyl­methylcellulo­se, indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171), gelatin, ethylcellulose, triethyl citrate, methacrylic acid – ethyl acrylate copolymer, 1,2-Propylene glycol.

• 4 mg prolonged release hard capsules:

• – The other ingredients are lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, colloidal anhydrous silica, sodium laurilsulfate, sodium docusate, magnesium stearate, hydroxypropyl­methylcellulo­se, indigo carmine (E 132), titanium dioxide (E 171), gelatin, ethylcellulose, triethyl citrate, methacrylic

acid – ethyl acrylate copolymer, 1,2-Propylene glycol.

What Inconex XL looks like and contents of the pack

Inconex XL 2 mg prolonged-release hard capsules: Opaque green-opaque green hard gelatin capsules containing two white, round, biconvex tablets.

Inconex XL 4 mg prolonged-release hard capsules: Light blue opaque-light blue opaque hard gelatin capsules containing four white, round, biconvex tablets.

The prolonged release hard capsules are packed in Alu/PVC/PE/PVDC blister, or are packed in a HDPE bottle with a tamper-evident closure and inserted in a carton.

Pack sizes:

Blister: 7, 14, 28, 30, 49, 50, 56, 80, 84, 90, 98, 100, 112, 160, 280, 320 prolonged release hard capsules

Bottle: 30, 60, 100 and 200 prolonged release hard capsules

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Sandoz Ltd,

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Pharmathen S.A

6, Dervenakion Str., 153 51 Pallini Attiki

Greece

or

Pharmathen International S.A

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57, 1526 Ljubljana

Slovenia

This leaflet was last revised in 09/2019.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: By reporting side effects you can help provide more information on the safety of this medicine.

5

How to store Inconex XL

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C

Shelf life after first opening:

HDPE bottle: 200 days

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

These measures will help protect the environment.

Contents of the pack and other information

What Inconex XL contains

The active substance is tolterodine tartrate.

Each prolonged-release hard capsule contains either 2 mg or 4 mg of tolterodine tartrate.

2 mg prolonged release hard capsules:

– The other ingredients are lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, colloidal anhydrous silica, sodium

Artwork Proof Box

Ref: V021: Excipient update

Proof no. Date prepared: Font size:

005.0 18/09/2019 9pt

Colours: Fonts:

• ■ Black □ Helvetica

□ □

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should see your doctor immediately or go to the casualty department if you experience symptoms of angioedema, such as:

• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulty in breathing.

You should also seek medical attention if you experience a hypersensitivity reaction (for example itching, rash, hives, difficulty breathing). This occurs uncommonly (may affect up to 1 in 100 people).

Tell your doctor immediately or go to the casualty department if you notice any of the following:

• chest pain, difficulty breathing or getting tired easily (even at rest), difficulty breathing at night, swelling of the legs.

These may be symptoms of heart failure. This occurs uncommonly (may affect up to 1 in 100 people).

The following side effects have been observed during treatment with Inconex XL with the following frequencies.

Very common side effects (may affect more than 1 in 10 people) are:

• Dry mouth

Common side effects (may affect up to 1 in 10 people) are:

• Sinusitis
• Sleepiness
• Dry eyes
• Difficulty with digestion (dyspepsia)
• Abdominal pain
• Painful or difficult urination
• Extra fluid in the body causing swelling (e.g. in the ankles)
• Dizziness
• Headache
• Blurred vision
• Constipation
• Excessive amounts of air or gases in the stomach or the intestine
• Diarrhoea
• Tiredness
• Allergic reactions
• Nervousness
• Palpitations
• Inability to empty the bladder
• Vertigo
• Heart failure
• Irregular heartbeat
• Chest pain
• Sensation of pins and needles in the fingers and toes
• Memory impairment

Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, flushed skin, heart burn, vomiting, angioedema, dry skin, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia.

laurilsulfate, sodium docusate, magnesium stearate, hydroxypropyl­methylcellulo­se, indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171), gelatin, ethylcellulose, triethyl citrate, methacrylic acid – ethyl acrylate copolymer, 1,2-Propylene glycol.

• 4 mg prolonged release hard capsules:

• – The other ingredients are lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, colloidal anhydrous silica, sodium laurilsulfate, sodium docusate, magnesium stearate, hydroxypropyl­methylcellulo­se, indigo carmine (E 132), titanium dioxide (E 171), gelatin, ethylcellulose, triethyl citrate, methacrylic

acid – ethyl acrylate copolymer, 1,2-Propylene glycol.

What Inconex XL looks like and contents of the pack

Inconex XL 2 mg prolonged-release hard capsules: Opaque green-opaque green hard gelatin capsules containing two white, round, biconvex tablets.

Inconex XL 4 mg prolonged-release hard capsules: Light blue opaque-light blue opaque hard gelatin capsules containing four white, round, biconvex tablets.

The prolonged release hard capsules are packed in Alu/PVC/PE/PVDC blister, or are packed in a HDPE bottle with a tamper-evident closure and inserted in a carton.

Pack sizes:

Blister: 7, 14, 28, 30, 49, 50, 56, 80, 84, 90, 98, 100, 112, 160, 280, 320 prolonged release hard capsules

Bottle: 30, 60, 100 and 200 prolonged release hard capsules

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Sandoz Ltd,

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Pharmathen S.A

6, Dervenakion Str., 153 51 Pallini Attiki

Greece

or

Pharmathen International S.A

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57, 1526 Ljubljana

Slovenia

This leaflet was last revised in 09/2019.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Inconex XL

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C

Shelf life after first opening:

HDPE bottle: 200 days

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

These measures will help protect the environment.

Contents of the pack and other information

What Inconex XL contains

The active substance is tolterodine tartrate.

Each prolonged-release hard capsule contains either 2 mg or 4 mg of tolterodine tartrate.

2 mg prolonged release hard capsules:

– The other ingredients are lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, colloidal anhydrous silica, sodium

Artwork Proof Box

Ref: V021: Excipient update

Proof no. Date prepared: Font size:

005.0 18/09/2019 9pt

Colours: Fonts:

• ■ Black □ Helvetica

• □ □