Patient leaflet - TOLTERMA XL 4 MG PROLONGED-RELEASE CAPSULES HARD

Package leaflet: Information for the user

Tolterma XL 2mg prolonged-release capsules, hard

Tolterma XL 4mg prolonged-release capsules, hard

tolterodine tartrate

The name of this medicine is Tolterma XL 2mg and 4mg prolonged-release capsules, hard which will be referred to as “this medicine” throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Tolterma XL is and what it is used for

2. What you need to know before you take Tolterma XL

3. How to take Tolterma XL

4. Possible side effects

5. How to store Tolterma XL

6. Contents of the pack and other information

1. what tolterma xl is and what it is used for

The active substance in this medicine is tolterodine.

Tolterodine belongs to a class of medicines called antimuscarinics.

This medicine 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.

2. what you need to know before you take tolterma xl if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in this medicine (listed in section 6).

if you are unable to pass urine from the bladder (urinary retention)
if you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated)
if you suffer from myasthenia gravis (excessive weakness of the muscles)
if you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
if you suffer from a toxic megacolon (acute dilatation of the colon).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

have difficulties in passing urine and/or a poor stream of urine
have a gastro-intestinal disease that affects the passage and/or digestion of food
suffer from kidney problems (renal insufficiency)
have a liver condition
suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
have a hiatal hernia (herniation of an abdominal organ)
ever experienced decreased bowel movements or suffered from severe constipation (decreased gastro-intestinal motility)
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)

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 this medicine if you think any of these might apply to you.

Children and adolescents

This medicine is not recommended for children

Other medicines and Tolterma XL

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

Tolterodine, the active substance of this medicine, may interact with other medicines.

It is not recommended to use this medicine in combination with:

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

This medicine 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 this medicine (antimuscarinic properties) or medicines with an opposite mode of action to this medicine (cholinergic properties). Ask your doctor if you are unsure.

Tolterma XL with food and drink

This medicine can be taken before, after or during a meal.

Pregnancy and breast-feeding

You should not use this medicine when you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant.

Breast-feeding

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

Driving and using machines

This medicine may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.

Tolterma XL contains sucrose

This medicine contains sucrose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

3. how to take tolterma xlalways take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

The usual dose is one 4 mg prolonged-release capsule daily, except for patients who have a kidney or a liver condition or troublesome side effects, in which case your doctor may reduce your dose to one 2 mg capsule daily.

This medicine is not recommended for children.

The prolonged-release capsules are for oral use and should be swallowed whole. Do not chew the capsules.

Duration of treatment

Your doctor will tell you how long your treatment with this medicine 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.

5. How to store Tolterma XL

Always consult your doctor if you are thinking of stopping the treatment.

If you have taken more of this medicine than you should

If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately.

If you forget to take this medicine

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

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 (allergic) 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 this medicine 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
Dizziness, sleepiness, headache
Dry eyes, blurred vision
Difficulty in digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine
Painful or difficult urination
Tiredness
Extra fluid in the body causing swelling (e.g. in the ankles) Diarrhoea

Uncommon side effects (may affect up to 1 in 100 people) are:

Allergic reactions
Nervousness
Sensation of pins and needles in the fingers and toes
Vertigo
Palpitations, heart failure, irregular heartbeat
Inability to empty the bladder
Chest pain
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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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/carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30 °C

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 to protect the environment.

6. Contents of the pack and other information

The active substance is tolterodine tartrate

2 mg: Each prolonged-release capsule contains tolterodine tartrate 2 mg corresponding to 1.37mg tolterodine.

4 mg: Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74mg tolterodine.

The other ingredients are:

Capsule contents: Sugar spheres (containing sucrose and maize starch), hydroxypropylmethyl cellulose, talc, ethylcellulose dispersion Type B.

Capsule shell: Gelatin and sodium lauryl sulfate.

Colourants:

2 mg: Iron oxide yellow (E172), iron oxide red (E172), titanium dioxide(E171), FD & C Blue 1(E133)

4 mg: Iron oxide red (E172), titanium dioxide (E171), FD & C Blue 1 (E133)

Printing ink: Shellac (E904), dehydrated alcohol (E1510), isopropyl alcohol, butyl alcohol, propylene glycol (E1520), strong ammonia solution (E527), potassium hydroxide (E525), titanium Dioxide (E171).

What this medicine looks like and contents of the pack

This medicine is a hard prolonged-release capsule designed for once daily dosing.

2 mg: Blue green cap/ Blue green body size „4“ capsule containing off white to slight yellowish extended release pellets with ‚L 32‘ on cap and ‚2‘ on body imprinted with white ink.

4 mg: Blue cap/ Blue body size „3“ capsule containing off white to slight yellowish extended release pellets with ‚L 33‘ on cap and ‚4‘ on body imprinted with white ink.

This medicines 2 mg and 4 mg prolonged-release capsules are available in the following pack sizes:

Cold formed blister packs: Blister pack comprises of Aluminium foil and cold form laminate.

Pack sizes: 28, 49, 50, 56, 98 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

macLEOD^

iiiiiiiiiiiiiiiiiiiiiiiiini

Macleods Pharma UK Limited

Wynyard Park House, Wynyard Avenue,

Wynyard, Billingham, TS22 5TB, United Kingdom

Manufacturer

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

Swarzadz, 62–020

Poland

PL 34771/0212–0213

This leaflet was last revised in {01/2018}

Package leaflet: Information for the user

Tolterma XL 2mg prolonged-release capsules, hard

Tolterma XL 4mg prolonged-release capsules, hard

tolterodine tartrate

The name of this medicine is Tolterma XL 2mg and 4mg prolonged-release capsules, hard which will be referred to as “this medicine” throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Tolterma XL is and what it is used for
2. What you need to know before you take Tolterma XL
3. How to take Tolterma XL
4. Possible side effects
5. How to store Tolterma XL
6. Contents of the pack and other information

1. what tolterma xl is and what it is used for

The active substance in this medicine is tolterodine.

Tolterodine belongs to a class of medicines called antimuscarinics.

This medicine 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.

2. what you need to know before you take tolterma xldo not take this medicine: if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in this medicine (listed in section 6).

if you are unable to pass urine from the bladder (urinary retention)
if you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated)
if you suffer from myasthenia gravis (excessive weakness of the muscles)
if you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
if you suffer from a toxic megacolon (acute dilatation of the colon).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

have difficulties in passing urine and/or a poor stream of urine
have a gastro-intestinal disease that affects the passage and/or digestion of food
suffer from kidney problems (renal insufficiency)
have a liver condition
suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
have a hiatal hernia (herniation of an abdominal organ)
ever experienced decreased bowel movements or suffered from severe constipation (decreased gastro-intestinal motility)
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)

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 this medicine if you think any of these might apply to you.

Children and adolescents

This medicine is not recommended for children

Other medicines and Tolterma XL

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

Tolterodine, the active substance of this medicine, may interact with other medicines.

It is not recommended to use this medicine in combination with:

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

This medicine 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 this medicine (antimuscarinic properties) or medicines with an opposite mode of action to this medicine (cholinergic properties). Ask your doctor if you are unsure.

Tolterma XL with food and drink

This medicine can be taken before, after or during a meal.

Pregnancy and breast-feeding

Pregnancy

You should not use this medicine when you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant.

Breast-feeding

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

Driving and using machines

This medicine may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.

Tolterma XL contains sucrose

3. how to take tolterma xldosagealways take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

This medicine is not recommended for children.

The prolonged-release capsules are for oral use and should be swallowed whole. Do not chew the capsules.

Duration of treatment

The benefit of the treatment should be re-evaluated after 2 or 3 months.

5. How to store Tolterma XL

Always consult your doctor if you are thinking of stopping the treatment.

If you have taken more of this medicine than you should

If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately.

If you forget to take this medicine

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

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

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 this medicine 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
Dizziness, sleepiness, headache
Dry eyes, blurred vision
Difficulty in digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine
Painful or difficult urination
Tiredness
Extra fluid in the body causing swelling (e.g. in the ankles)
Diarrhoea

Uncommon side effects (may affect up to 1 in 100 people) are:

Allergic reactions
Nervousness
Sensation of pins and needles in the fingers and toes
Vertigo
Palpitations, heart failure, irregular heartbeat
Inability to empty the bladder
Chest pain
Memory impairment

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

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/carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30 °C

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 to protect the environment.

6. Contents of the pack and other information

What this medicine contains

The active substance is tolterodine tartrate

2 mg: Each prolonged-release capsule contains tolterodine tartrate 2 mg corresponding to 1.37mg tolterodine.

4 mg: Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74mg tolterodine.

The other ingredients are:

Capsule contents: Sugar spheres (containing sucrose and maize starch), hydroxypropylmethyl cellulose, talc, ethylcellulose dispersion Type B.

Capsule shell: Gelatin and sodium lauryl sulfate.

Colourants:

2 mg: Iron oxide yellow (E172), iron oxide red (E172), titanium dioxide(E171), FD & C Blue 1(E133)

4 mg: Iron oxide red (E172), titanium dioxide (E171), FD & C Blue

1 (E133)

What this medicine looks like and contents of the pack

This medicine is a hard prolonged-release capsule designed for once daily dosing.

2 mg: Blue green cap/ Blue green body size „4“ capsule containing off white to slight yellowish extended release pellets with ‚L 32‘ on cap and ‚2‘ on body imprinted with white ink.

4 mg: Blue cap/ Blue body size „3“ capsule containing off white to slight yellowish extended release pellets with ‚L 33‘ on cap and ‚4‘ on body imprinted with white ink.

This medicines 2 mg and 4 mg prolonged-release capsules are available in the following pack sizes:

Cold formed blister packs: Blister pack comprises of Aluminium foil and cold form laminate.

Pack sizes: 28, 49, 50, 56, 98 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

macLEOD^

iiiiiiiiiiiiiiiiiiiiiiiiini

Macleods Pharma UK Limited

Wynyard Park House, Wynyard Avenue,

Wynyard, Billingham, TS22 5TB, United Kingdom

Manufacturer

Heumann Pharma GmbH & Co. Generica KG

Sudwestpark 50 90449 Nurnberg

Germany

PL 34771/0212–0213

This leaflet was last revised in {06/2019}

■■

Package leaflet: Information for the user

Tolterma XL 2mg prolonged-release capsules, hard

Tolterma XL 4mg prolonged-release capsules, hard

tolterodine tartrate

The name of this medicine is Tolterma XL 2mg and 4mg prolonged-release capsules, hard which will be referred to as “this medicine” throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Tolterma XL is and what it is used for
2. What you need to know before you take Tolterma XL
3. How to take Tolterma XL
4. Possible side effects
5. How to store Tolterma XL
6. Contents of the pack and other information

1. what tolterma xl is and what it is used for

The active substance in this medicine is tolterodine.

Tolterodine belongs to a class of medicines called antimuscarinics. This medicine 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.

2. what you need to know before you take tolterma xldo not take this medicine: if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in this medicine (listed in section 6).

if you are unable to pass urine from the bladder (urinary retention)
if you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated)
if you suffer from myasthenia gravis (excessive weakness of the muscles)
if you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
if you suffer from a toxic megacolon (acute dilatation of the colon).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

have difficulties in passing urine and/or a poor stream of urine
have a gastro-intestinal disease that affects the passage and/or digestion of food
suffer from kidney problems (renal insufficiency)
have a liver condition
suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
have a hiatal hernia (herniation of an abdominal organ)
ever experienced decreased bowel movements or suffered from severe constipation (decreased gastro-intestinal motility)
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

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 this medicine if you think any of these might apply to you.

Children and adolescents

This medicine is not recommended for children

Other medicines and Tolterma XL

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

Tolterodine, the active substance of this medicine, may interact with other medicines.

It is not recommended to use this medicine in combination with:

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

This medicine 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 this medicine (antimuscarinic properties) or medicines with an opposite mode of action to this medicine (cholinergic properties). Ask your doctor if you are unsure.

Tolterma XL with food and drink

This medicine can be taken before, after or during a meal.

Pregnancy and breast-feeding

Pregnancy

You should not use this medicine when you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant. I I|T|tt11.L

Breast-feeding

It is not known if tolterodine, the active substance of this medicine, is excreted in the mother's breast milk. Breastfeeding is not recommended during administration of this medicine.

Driving and using machines

This medicine may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.

Tolterma XL contains sucrose

3. how to take tolterma xldosagealways take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

This medicine is not recommended for children.

The prolonged-release capsules are for oral use and should be swallowed whole. Do not chew the capsules.

Duration of treatment

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 taken more of this medicine than you should If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately.

If you forget to take this medicine

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

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

Tell your doctor immediately or go to the casualty department if you notice any of the following: uh 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 this medicine 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
Dizziness, sleepiness, headache
Dry eyes, blurred vision
Difficulty in digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine
Painful or difficult urination
Tiredness
Extra fluid in the body causing swelling (e.g. in the ankles)
Diarrhoea

Uncommon side effects (may affect up to 1 in 100 people) are:

Allergic reactions
Nervousness
Sensation of pins and needles in the fingers and toes
Vertigo
Palpitations, heart failure, irregular heartbeat
Inability to empty the bladder
Chest pain
Memory impairment

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

5. how to store tolterma 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/carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30 °C

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 to protect the environment.

6. contents of the pack and other informationwhat this medicine containsthe active substance is tolterodine tartrate

2 mg: Each prolonged-release capsule contains tolterodine tartrate 2 mg corresponding to 1.37mg tolterodine.

4 mg: Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74mg tolterodine.

The other ingredients are:

Capsule contents: Sugar spheres (containing sucrose and maize starch), hydroxypropylmethyl cellulose, talc, ethylcellulose dispersion Type B.

Capsule shell: Gelatin and sodium lauryl sulfate.

Colourants:

2 mg: Iron oxide yellow (E172), iron oxide red (E172), titanium dioxide(E171), FD & C Blue 1(E133)

4 mg: Iron oxide red (E172), titanium dioxide (E171), FD & C Blue

1 (E133)

Printing ink: Shellac (E904), dehydrated alcohol .___

(E1510), isopropyl alcohol, butyl alcohol,......... IKHHIIIII

propylene glycol (E1520), strong ammonia solution

(E527), potassium hydroxide (E525), titanium

Dioxide (E171).

What this medicine looks like and contents of the pack

This medicine is a hard prolonged-release capsule designed for once daily dosing.

2 mg: Blue green cap/ Blue green body size „4“ capsule containing off white to slight yellowish extended release pellets with ‚L 32‘ on cap and ‚2‘ on body imprinted with white ink.

4 mg: Blue cap/ Blue body size „3“ capsule containing off white to slight yellowish extended release pellets with ‚L 33‘ on cap and ‚4‘ on body imprinted with white ink.

This medicines 2 mg and 4 mg prolonged-release capsules are available in the following pack sizes:

Cold formed blister packs: Blister pack comprises of Aluminium foil and cold form laminate.

Pack sizes: 28, 49, 50, 56, 98 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

macLEOD^

iiiiiiiiiiiiiiiiiiiiiiiiini

Macleods Pharma UK Limited

Wynyard Park House, Wynyard Avenue,

Wynyard, Billingham, TS22 5TB, United Kingdom

Manufacturer

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

Swarzadz, 62–020

Poland

PL 34771/0212–0213

This leaflet was last revised in {01/2018}

Package leaflet: Information for the user

Tolterma XL 2mg prolonged-release capsules, hard

Tolterma XL 4mg prolonged-release capsules, hard

tolterodine tartrate

The name of this medicine is Tolterma XL 2mg and 4mg prolonged-release capsules, hard which will be referred to as “this medicine” throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Tolterma XL is and what it is used for
2. What you need to know before you take Tolterma XL
3. How to take Tolterma XL
4. Possible side effects
5. How to store Tolterma XL
6. Contents of the pack and other information

1. what tolterma xl is and what it is used for

The active substance in this medicine is tolterodine.

Tolterodine belongs to a class of medicines called antimuscarinics.

This medicine 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.
if you are unable to pass urine from the bladder (urinary retention)
if you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated)
if you suffer from myasthenia gravis (excessive weakness of the muscles)
if you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
if you suffer from a toxic megacolon (acute dilatation of the colon).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

have difficulties in passing urine and/or a poor stream of urine
have a gastro-intestinal disease that affects the passage and/or digestion of food
suffer from kidney problems (renal insufficiency)
have a liver condition
suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
have a hiatal hernia (herniation of an abdominal organ)
ever experienced decreased bowel movements or suffered from severe constipation (decreased gastro-intestinal motility)
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)

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 this medicine if you think any of these might apply to you.

Children and adolescents

This medicine is not recommended for children

Other medicines and Tolterma XL

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

Tolterodine, the active substance of this medicine, may interact with other medicines.

It is not recommended to use this medicine in combination with:

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

This medicine 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 this medicine (antimuscarinic properties) or medicines with an opposite mode of action to this medicine (cholinergic properties). Ask your doctor if you are unsure.

Tolterma XL with food and drink

This medicine can be taken before, after or during a meal.

Pregnancy and breast-feeding

Pregnancy

You should not use this medicine when you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant.

Breast-feeding

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

Driving and using machines

This medicine may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.

Tolterma XL contains sucrose

3. how to take tolterma xldosagealways take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

This medicine is not recommended for children.

The prolonged-release capsules are for oral use and should be swallowed whole. Do not chew the capsules.

Duration of treatment

The benefit of the treatment should be re-evaluated after 2 or 3 months.

5. How to store Tolterma XL

Always consult your doctor if you are thinking of stopping the treatment.

If you have taken more of this medicine than you should

If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately.

If you forget to take this medicine

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

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

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 this medicine 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
Dizziness, sleepiness, headache
Dry eyes, blurred vision
Difficulty in digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine
Painful or difficult urination
Tiredness
Extra fluid in the body causing swelling (e.g. in the ankles)
Diarrhoea

Uncommon side effects (may affect up to 1 in 100 people) are:

Allergic reactions
Nervousness
Sensation of pins and needles in the fingers and toes
Vertigo
Palpitations, heart failure, irregular heartbeat
Inability to empty the bladder
Chest pain
Memory impairment

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

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/carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30 °C

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 to protect the environment.

6. Contents of the pack and other information

What this medicine contains

The active substance is tolterodine tartrate

2 mg: Each prolonged-release capsule contains tolterodine tartrate 2 mg corresponding to 1.37mg tolterodine.

4 mg: Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74mg tolterodine.

The other ingredients are:

Capsule contents: Sugar spheres (containing sucrose and maize starch), hydroxypropylmethyl cellulose, talc, ethylcellulose dispersion Type B.

Capsule shell: Gelatin and sodium lauryl sulfate.

Colourants:

2 mg: Iron oxide yellow (E172), iron oxide red (E172), titanium dioxide(E171), FD & C Blue 1(E133)

4 mg: Iron oxide red (E172), titanium dioxide (E171), FD & C Blue

1 (E133)

What this medicine looks like and contents of the pack

This medicine is a hard prolonged-release capsule designed for once daily dosing.

2 mg: Blue green cap/ Blue green body size „4“ capsule containing off white to slight yellowish extended release pellets with ‚L 32‘ on cap and ‚2‘ on body imprinted with white ink.

4 mg: Blue cap/ Blue body size „3“ capsule containing off white to slight yellowish extended release pellets with ‚L 33‘ on cap and ‚4‘ on body imprinted with white ink.

This medicines 2 mg and 4 mg prolonged-release capsules are available in the following pack sizes:

Cold formed blister packs: Blister pack comprises of Aluminium foil and cold form laminate.

Pack sizes: 28, 49, 50, 56, 98 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

macLEOD^

iiiiiiiiiiiiiiiiiiiiiiiiini

Macleods Pharma UK Limited

Wynyard Park House, Wynyard Avenue,

Wynyard, Billingham, TS22 5TB, United Kingdom

Manufacturer

Heumann Pharma GmbH & Co. Generica KG

Sudwestpark 50 90449 Nurnberg

Germany

PL 34771/0212–0213

This leaflet was last revised in {06/2019}

■■

Package leaflet: Information for the user

Tolterma XL 2mg prolonged-release capsules, hard

Tolterma XL 4mg prolonged-release capsules, hard

tolterodine tartrate

The name of this medicine is Tolterma XL 2mg and 4mg prolonged-release capsules, hard which will be referred to as “this medicine” throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Tolterma XL is and what it is used for
2. What you need to know before you take Tolterma XL
3. How to take Tolterma XL
4. Possible side effects
5. How to store Tolterma XL
6. Contents of the pack and other information

1. what tolterma xl is and what it is used for

The active substance in this medicine is tolterodine.

you are unable to control urination,
you need to rush to the toilet with no advance warning and/or go to the toilet frequently.
if you are unable to pass urine from the bladder (urinary retention)
if you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated)
if you suffer from myasthenia gravis (excessive weakness of the muscles)
if you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
if you suffer from a toxic megacolon (acute dilatation of the colon).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

have difficulties in passing urine and/or a poor stream of urine
have a gastro-intestinal disease that affects the passage and/or digestion of food
suffer from kidney problems (renal insufficiency)
have a liver condition
suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
have a hiatal hernia (herniation of an abdominal organ)
ever experienced decreased bowel movements or suffered from severe constipation (decreased gastro-intestinal motility)
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

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 this medicine if you think any of these might apply to you.

Children and adolescents

This medicine is not recommended for children

Other medicines and Tolterma XL

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

Tolterodine, the active substance of this medicine, may interact with other medicines.

It is not recommended to use this medicine in combination with:

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

This medicine 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 this medicine (antimuscarinic properties) or medicines with an opposite mode of action to this medicine (cholinergic properties). Ask your doctor if you are unsure.

Tolterma XL with food and drink

This medicine can be taken before, after or during a meal.

Pregnancy and breast-feeding

Pregnancy

You should not use this medicine when you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant. I I|T|tt11.L

Breast-feeding

It is not known if tolterodine, the active substance of this medicine, is excreted in the mother's breast milk. Breastfeeding is not recommended during administration of this medicine.

Driving and using machines

This medicine may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.

Tolterma XL contains sucrose

3. how to take tolterma xldosagealways take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

This medicine is not recommended for children.

The prolonged-release capsules are for oral use and should be swallowed whole. Do not chew the capsules.

Duration of treatment

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 taken more of this medicine than you should If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately.

If you forget to take this medicine

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

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

Tell your doctor immediately or go to the casualty department if you notice any of the following: uh 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 this medicine 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
Dizziness, sleepiness, headache
Dry eyes, blurred vision
Difficulty in digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine
Painful or difficult urination
Tiredness
Extra fluid in the body causing swelling (e.g. in the ankles)
Diarrhoea

Uncommon side effects (may affect up to 1 in 100 people) are:

Allergic reactions
Nervousness
Sensation of pins and needles in the fingers and toes
Vertigo
Palpitations, heart failure, irregular heartbeat
Inability to empty the bladder
Chest pain
Memory impairment

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

5. how to store tolterma 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/carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30 °C

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 to protect the environment.

6. contents of the pack and other informationwhat this medicine containsthe active substance is tolterodine tartrate

2 mg: Each prolonged-release capsule contains tolterodine tartrate 2 mg corresponding to 1.37mg tolterodine.

4 mg: Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74mg tolterodine.

The other ingredients are:

Capsule contents: Sugar spheres (containing sucrose and maize starch), hydroxypropylmethyl cellulose, talc, ethylcellulose dispersion Type B.

Capsule shell: Gelatin and sodium lauryl sulfate.

Colourants:

2 mg: Iron oxide yellow (E172), iron oxide red (E172), titanium dioxide(E171), FD & C Blue 1(E133)

4 mg: Iron oxide red (E172), titanium dioxide (E171), FD & C Blue

1 (E133)

Printing ink: Shellac (E904), dehydrated alcohol .___

(E1510), isopropyl alcohol, butyl alcohol,......... IKHHIIIII

propylene glycol (E1520), strong ammonia solution

(E527), potassium hydroxide (E525), titanium

Dioxide (E171).

What this medicine looks like and contents of the pack

This medicine is a hard prolonged-release capsule designed for once daily dosing.

2 mg: Blue green cap/ Blue green body size „4“ capsule containing off white to slight yellowish extended release pellets with ‚L 32‘ on cap and ‚2‘ on body imprinted with white ink.
4 mg: Blue cap/ Blue body size „3“ capsule containing off white to slight yellowish extended release pellets with ‚L 33‘ on cap and ‚4‘ on body imprinted with white ink.

TOLTERMA XL 4 MG PROLONGED-RELEASE CAPSULES HARD - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - TOLTERMA XL 4 MG PROLONGED-RELEASE CAPSULES HARD

1. what tolterma xl is and what it is used for

2. what you need to know before you take tolterma xl if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in this medicine (listed in section 6).

3. how to take tolterma xlalways take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

5. How to store Tolterma XL

4. possible side effects

6. Contents of the pack and other information

macLEOD^

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

1. what tolterma xl is and what it is used for

2. what you need to know before you take tolterma xldo not take this medicine: if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in this medicine (listed in section 6).

Warnings and precautions

Children and adolescents

Other medicines and Tolterma XL

Tolterma XL with food and drink

Pregnancy and breast-feeding Pregnancy

Breast-feeding

Driving and using machines

Tolterma XL contains sucrose

3. how to take tolterma xldosagealways take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

Duration of treatment

5. How to store Tolterma XL

If you have taken more of this medicine than you should

If you forget to take this medicine

4. possible side effects

Reporting of side effects

6. Contents of the pack and other information

The other ingredients are:

Manufacturer

This leaflet was last revised in {06/2019}

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

1. what tolterma xl is and what it is used for

2. what you need to know before you take tolterma xldo not take this medicine: if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in this medicine (listed in section 6).

Warnings and precautions

Children and adolescents

Other medicines and Tolterma XL

Tolterma XL with food and drink

Pregnancy and breast-feeding Pregnancy

Breast-feeding

Driving and using machines

Tolterma XL contains sucrose

3. how to take tolterma xldosagealways take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

Duration of treatment

Always consult your doctor if you are thinking of stopping the treatment.

If you forget to take this medicine

4. possible side effects

Reporting of side effects

5. how to store tolterma xl

6. contents of the pack and other informationwhat this medicine containsthe active substance is tolterodine tartrate

The other ingredients are:

Marketing authorisation holder and manufacturer

macLEOD^

Manufacturer

This leaflet was last revised in {01/2018}

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

1. what tolterma xl is and what it is used for

Warnings and precautions

Children and adolescents

Other medicines and Tolterma XL

Tolterma XL with food and drink

Pregnancy and breast-feeding Pregnancy

Breast-feeding

Driving and using machines

Tolterma XL contains sucrose

3. how to take tolterma xldosagealways take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

Duration of treatment

5. How to store Tolterma XL

If you have taken more of this medicine than you should

If you forget to take this medicine

4. possible side effects

Reporting of side effects

6. Contents of the pack and other information What this medicine contains

The other ingredients are:

What this medicine looks like and contents of the pack

Manufacturer

This leaflet was last revised in {06/2019}

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

1. what tolterma xl is and what it is used for

Pregnancy and breast-feeding

Pregnancy

Pregnancy and breast-feeding

Pregnancy

Pregnancy and breast-feeding

Pregnancy

6. Contents of the pack and other information

What this medicine contains

Pregnancy and breast-feeding

Pregnancy