Detrusitol

PATIENT LEAFLET: INFORMATION FOR THE USER

Detrusitol 1 mg and 2 mg film-coated tablets

Tolterodine

Read this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others, as it may be harmful to them, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Detrusitol is and what it is used for
2. Before you take Detrusitol
3. How to take Detrusitol
4. Possible side effects
5. How to store Detrusitol
6. Further information

1. WHAT DETRUSITOL IS AND WHAT IT IS USED FOR

The active substance in Detrusitol is tolterodine. Tolterodine belongs to a class of medicines called antimuscarinics.
Detrusitol is used for the symptomatic treatment of Overactive Bladder Syndrome.
If you suffer from overactive bladder syndrome, you may experience an inability to control urination, and a frequent need to rush to the toilet without any warning signals.

2. BEFORE TAKING DETRUSITOL

Do not take Detrusitol

• If you are allergic (hypersensitive) to tolterodine or to any of the excipients of the medicine
• If you have difficulty passing urine from the bladder (urinary retention)
• If you have uncontrolled narrow-angle glaucoma (elevated intraocular pressure with vision loss, not adequately treated)
• If you have severe myasthenia gravis (excessive muscle weakness)
• If you have severe ulcerative colitis (ulceration and inflammation of the colon)
• If you have toxic megacolon (acute dilation of the colon)

Take special care with Detrusitol

• If you have difficulty passing urine and/or have a weak urine stream
• If you have gastrointestinal disorders affecting the passage and/or digestion of food
• If you have kidney problems (renal impairment)
• If you have liver problems
• If you suffer from neurological diseases affecting blood pressure, the intestines or sexual function (any autonomic neuropathy)
• If you have a hiatus hernia (herniation of an abdominal organ)
• If you suffer from reduced intestinal motility or severe constipation (reduced gastrointestinal motility)
• If you have heart problems such as:
  o Altered heart tracing (ECG)
  o Slow heart rate (bradycardia)
  o Significant pre-existing heart diseases, such as:
  • cardiomyopathy (weakening of the heart muscle)
  • myocardial ischemia (reduced blood flow to the heart)
  • arrhythmia (irregular heartbeat)
  • heart failure
• If you have particularly low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in the blood.
  If any of these apply to you, inform your doctor or pharmacist before starting treatment.

Taking other medicines
Tolterodine, the active substance in Detrusitol, may interact with other medicines.
The use of tolterodine is not recommended with:

• certain antibiotics (containing, for example, erythromycin, clarithromycin);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medicines used to treat HIV.
  Detrusitol should be used with caution when taken together with:
• medicines affecting gastrointestinal motility (containing, for example, metoclopramide and cisapride)
• medicines used to treat irregular heartbeat (containing, for example, amiodarone, sotalol, quinidine, procainamide)
• other medicines with a mechanism of action similar to Detrusitol (antimuscarinic properties) or medicines with an opposite mechanism of action to Detrusitol (cholinergic properties).
  If you have any doubts, consult your doctor.

Inform your doctor if you are taking or have recently taken any other medicines, including those
not requiring a prescription.
Taking Detrusitol with food and drink
Detrusitol can be taken before, after, or during meals.
Pregnancy and breastfeeding
Pregnancy
Detrusitol must not be taken during pregnancy. Contact your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Breastfeeding
There are no data available on the excretion of tolterodine in human breast milk.
Breastfeeding is not recommended during treatment with Detrusitol.
Consult your doctor or pharmacist for advice before taking any medicine.
Driving and operating machinery
Detrusitol may cause dizziness, fatigue, or affect vision. Your ability to drive or operate machinery may be impaired.

3. HOW TO TAKE DETRUSITOL

Dosage
Always take Detrusitol exactly as directed by your doctor. If you have any doubts, discuss them with your doctor or pharmacist.
The usual dose is one 2 mg tablet twice daily, except for patients who have kidney or liver problems or experience adverse effects, for whom the doctor may reduce the dose to one 1 mg tablet twice daily.
Detrusitol is not recommended for children.
The tablets are for oral use and must be swallowed whole.

Duration of treatment
Your doctor will tell you how long to use Detrusitol. Do not stop treatment earlier than planned, even if you do not notice an immediate effect. The bladder needs time to adapt. Complete the full course of treatment prescribed by your doctor. If by that time you have not noticed any improvement, speak with your doctor.
The benefits of treatment should be re-evaluated after 2 or 3 months.
Always consult your doctor if you are considering stopping treatment.

If you take more Detrusitol than you should:
If you or someone else has taken too many tablets, contact your doctor or pharmacist immediately.

If you forget to take Detrusitol:
If you forget to take a dose at the usual time, you may take it as soon as you remember, unless it is almost time for the next dose. In that case, skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose to make up for a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Detrusitol can cause adverse reactions, although not everyone experiences them.
Seek immediate medical attention or go to the emergency room if you experience symptoms of angioedema such as:
• swelling of the face, tongue or pharynx
• difficulty swallowing
• hives and breathing difficulties

You should also contact your doctor if you experience hypersensitivity reactions (for example itching, rash, hives, breathing difficulties). These occur uncommonly (in fewer than 1 in 100 patients).

Contact your doctor immediately or go to the emergency room if you notice any of the following symptoms:
• chest pain, breathing difficulties or easy fatigue (even at rest), nighttime breathing difficulties, leg swelling.
These may be symptoms of heart failure. This occurs uncommonly (in fewer than 1 in 100 patients).

The following adverse reactions have been reported during treatment with Detrusitol, with the following frequency:

Very common adverse reactions (occur in more than 1 out of 10 patients):

• Dry mouth
• Headache

Common adverse reactions (occur in fewer than 1 out of 10 patients):

• Bronchitis
• Dizziness, drowsiness, tingling sensation in hands and feet
• Dry eyes, blurred vision
• Vertigo
• Palpitations
• Indigestion (dyspepsia), constipation, abdominal pain, excessive gas in the stomach or intestines, vomiting
• Dry skin
• Painful or difficult urination, inability to empty the bladder
• Fatigue, chest pain, fluid retention causing swelling (e.g. in the ankles)
• Weight gain
• Diarrhea

Uncommon adverse reactions (occur in fewer than 1 out of 100 patients):

• Allergic reactions
• Nervousness
• Increased heart rate, heart failure, irregular heartbeat
• Heartburn
• Memory impairment

Other reported reactions include severe allergic reactions, confusion, hallucinations, skin redness, angioedema and disorientation. Worsening of dementia symptoms has also been reported in patients being treated for dementia.

If any of these adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE DETRUSITOL

Keep out of the reach and sight of children.
Do not use Detrusitol after the expiry date stated on the pack. The expiry date refers to the last day of the month.
No special storage precautions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Detrusitol contains
The active substance is tolterodine tartrate.
Each Detrusitol 1 mg tablet contains 1 mg of tolterodine tartrate, equivalent to
0.68 mg of tolterodine.
Each Detrusitol 2 mg tablet contains 2 mg of tolterodine tartrate, equivalent to
1.37 mg of tolterodine.
The excipients are:
Core:
Microcrystalline cellulose
Dibasic calcium phosphate dihydrate
Sodium starch glycolate (type B)
Magnesium stearate
Anhydrous colloidal silica
Film coating:
Hypromellose
Microcrystalline cellulose
Stearic acid
Titanium dioxide (E171)

Description of the appearance of Detrusitol and contents of the pack
Detrusitol 1 mg tablets are white, round, biconvex tablets with notches above and below the letters “TO”.
Detrusitol 2 mg tablets are white, round, biconvex tablets with notches above and below the letters “DT”.
Detrusitol 1 mg and 2 mg tablets are available in the following pack sizes:
Blister packs containing:

• 20 tablets (2 x 10)
• 30 tablets (3 x 10)
• 50 tablets (5 x 10)
• 100 tablets (10 x 10)
• 14 tablets (1 x 14)
• 28 tablets (2 x 14)
• 56 tablets (4 x 14)
• 280 tablets
• 560 tablets
  Bottles containing 60 or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Established Medicine Italy S.r.l., Via Isonzo, 71 – 04100 Latina, Italy
Manufacturer
Pfizer Italia S.r.l., Via del Commercio 25-27, 63046 Marino del Tronto (AP), Italy

This medicinal product is authorized in the following European Economic Area Member States under the name “Detrusitol”:
Austria, Belgium, Luxembourg, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom.

This patient information leaflet was last reviewed in 10/2020

PACKAGE LEAFLET: INFORMATION FOR THE USER

Detrusitol Retard 2 mg and 4 mg prolonged-release hard capsules

Tolterodine
Please read this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others; it may be harmful to them, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Detrusitol Retard is and what it is used for
2. Before you take Detrusitol Retard
3. How to take Detrusitol Retard
4. Possible side effects
5. How to store Detrusitol Retard
6. Further information

1. WHAT DETRUSITOL RETARD IS AND WHAT IT IS USED FOR

The active substance of Detrusitol Retard is tolterodine. Tolterodine belongs to a class of medicines called antimuscarinics.
Detrusitol Retard is used for the symptomatic treatment of Overactive Bladder Syndrome. If you suffer from overactive bladder syndrome, you may experience an inability to control urination, and a frequent need to rush to the toilet without any warning signals.

2. BEFORE TAKING DETRUSITOL RETARD

Do not take Detrusitol Retard

• If you are allergic (hypersensitive) to tolterodine or to any of the excipients of the medicine
• If you have difficulty passing urine from the bladder (urinary retention)
• If you have uncontrolled narrow-angle glaucoma (elevated intraocular pressure with vision loss, not adequately treated)
• If you suffer from severe myasthenia gravis (excessive muscle weakness)
• If you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
• If you suffer from toxic megacolon (acute dilation of the colon)

Take special care with Detrusitol Retard

• If you have difficulty passing urine and/or weak urinary stream
• If you have gastrointestinal disorders affecting the passage and/or digestion of food
• If you have kidney problems (renal impairment)
• If you have liver problems
• If you suffer from neurological disorders affecting blood pressure, intestine, or sexual function (any autonomic neuropathy)
• If you have a hiatal hernia (herniation of an abdominal organ)
• If you suffer from reduced intestinal motility or severe constipation (reduced gastrointestinal motility)
• If you have heart problems such as:
  • Altered heart tracing (ECG)
  • Slow heart rate (bradycardia)
  • Significant pre-existing heart diseases, such as:
    • Cardiomyopathy (weakening of the heart muscle)
    • Myocardial ischemia (reduced blood flow to the heart)
    • Arrhythmia (irregular heartbeat)
    • Heart failure
• If you have particularly low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in the blood

If any of these apply to you, inform your doctor or pharmacist before starting treatment.

Taking other medicines

Tolterodine, the active substance in Detrusitol Retard, may interact with other medicines.

The use of tolterodine is not recommended with:

• Certain antibiotics (containing, for example, erythromycin, clarithromycin)
• Medicines used to treat fungal infections (for example, ketoconazole, itraconazole)
• Medicines used to treat HIV

Detrusitol Retard should be used with caution when taken together with:

• Medicines affecting food passage (containing, for example, metoclopramide and cisapride)
• Medicines used to treat irregular heartbeat (containing, for example, amiodarone, sotalol, quinidine, procainamide)
• Other medicines with a mechanism of action similar to Detrusitol Retard (antimuscarinic properties) or medicines with an opposite mechanism of action to Detrusitol Retard (cholinergic properties). If you have any doubts, consult your doctor.

Inform your doctor if you are taking or have recently taken any other medicines, including those not requiring a prescription.

Taking Detrusitol Retard with food and drink

Detrusitol Retard can be taken before, after, or during meals.

Pregnancy and breastfeeding

Pregnancy

Detrusitol Retard must not be taken during pregnancy. Contact your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy.

Breastfeeding

There are no data available on the excretion of tolterodine in human breast milk. Breastfeeding is not recommended during treatment with Detrusitol Retard.

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

Driving and using machines

Detrusitol Retard may cause dizziness, fatigue, or affect vision. Your ability to drive or operate machinery may be impaired.

Important information about some of the excipients in Detrusitol Retard

This medicine contains sucrose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine. Patients with rare hereditary problems of galactose intolerance, such as galactosemia, or glucose-galactose malabsorption should not take this medicine.

3. HOW TO TAKE DETRUSITOL RETARD

Dosage
Always take Detrusitol Retard exactly as instructed by your doctor. If you have any doubts, discuss them with your doctor or pharmacist.
The usual dose is one prolonged-release capsule of 4 mg daily, except for patients who have kidney or liver problems or experience adverse effects, for whom the doctor may reduce the dose to one prolonged-release capsule of 2 mg daily.
Detrusitol Retard is not recommended for children.
The prolonged-release capsules are for oral use and must be swallowed whole. Do not chew the capsules.

Duration of treatment
Your doctor will tell you how long to take Detrusitol Retard. Do not stop treatment earlier than planned, even if you do not notice an immediate effect. The bladder needs time to adapt. Complete the full course of prolonged-release capsules as prescribed by your doctor. If by that time you have noticed no improvement, discuss this with your doctor.
The benefits of treatment should be reassessed after 2 or 3 months.
Always consult your doctor if you consider stopping treatment.

If you have taken more Detrusitol Retard than you should:
If you or someone else has taken too many prolonged-release capsules, contact your doctor or pharmacist immediately.

If you forget to take Detrusitol Retard:
If you forget to take a dose at your usual time, you may take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose to make up for a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Detrusitol Retard can cause adverse reactions, although not everyone experiences them.
Seek immediate medical attention or go to the emergency room if you experience symptoms of angioedema, such as:
• swelling of the face, tongue or pharynx
• difficulty swallowing
• urticaria and breathing difficulties

You should also contact your doctor promptly if you experience hypersensitivity reactions (e.g. itching, skin rash, urticaria, breathing difficulties). These occur uncommonly (in fewer than 1 in 100 patients).

Contact your doctor immediately or go to the emergency room if you notice any of the following symptoms:
• chest pain, breathing difficulties or unusual tiredness (even at rest), nighttime breathing difficulties, leg swelling.
These may be symptoms of heart failure. This occurs uncommonly (in fewer than 1 in 100 patients).

The following adverse reactions have been reported during treatment with Detrusitol Retard, according to the frequencies listed below.

Very common adverse reactions (occur in more than 1 in 10 patients):
• Dry mouth

Common adverse reactions (occur in fewer than 1 in 10 patients):
• Sinusitis
• Dizziness, drowsiness, headache
• Dry eyes, blurred vision
• Digestive difficulties (dyspepsia), constipation, abdominal pain, excessive gas or bloating in the stomach or intestines
• Painful or difficult urination
• Fatigue
• Fluid retention causing swelling (e.g. in the ankles)
• Diarrhea

Uncommon adverse reactions (occur in fewer than 1 in 100 patients):
• Allergic reactions
• Nervousness
• Tingling sensation in hands and feet
• Vertigo
• Palpitations, heart failure, irregular heartbeat
• Inability to empty the bladder
• Chest pain
• Memory impairment

Other reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, skin redness, heartburn, vomiting, angioedema, dry skin and disorientation. Worsening of dementia symptoms has also been reported in patients receiving treatment for dementia.

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE DETRUSITOL RETARD

Keep out of the reach and sight of children.
Do not use Detrusitol Retard after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store below 30°C.
Bottles: store in the original container.
Blister packs: store the blister pack in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Detrusitol Retard contains
The active substance in Detrusitol Retard 2 mg prolonged-release capsules is 2 mg of
tolterodine tartrate, equivalent to 1.37 mg of tolterodine.
The active substance in Detrusitol Retard 4 mg prolonged-release capsules is 4 mg of
tolterodine tartrate, equivalent to 2.74 mg of tolterodine.

The excipients are:
Capsule contents:
Sugar spheres (containing sucrose and maize starch), hypromellose, and Surelease E-7-19010 clear (containing ethylcellulose, medium-chain triglycerides and oleic acid).
Capsule shell contents:
Gelatin and colorants.
Colorants:
Blue-green in the 2 mg prolonged-release capsule: indigo carmine (E132), iron oxide yellow (E172), titanium dioxide (E171).
Blue in the 4 mg prolonged-release capsule: indigo carmine (E132), titanium dioxide (E171).
Printing ink: Shellac, titanium dioxide (E171), propylene glycol, simethicone.

Description of the appearance of Detrusitol Retard and contents of the pack
Detrusitol Retard prolonged-release capsules are coded according to daily dosage.
The 2 mg hard prolonged-release capsule is blue-green with white print (symbol and 2).
The 4 mg hard prolonged-release capsule is blue with white print (symbol and 4).

Detrusitol Retard 2 mg and 4 mg prolonged-release capsules are available in the following pack sizes:
Cartons containing:
7 prolonged-release capsules
14 prolonged-release capsules
28 prolonged-release capsules
49 prolonged-release capsules
84 prolonged-release capsules
98 prolonged-release capsules
280 prolonged-release capsules
Bottles containing 30, 100 and 200 capsules.
Hospital packs containing 80, 160 and 320 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Established Medicine Italy S.r.l.
Via Isonzo, 71 – 04100 Latina
Manufacturer
Pfizer Italia S.r.l., Località Marino del Tronto 63100 – Ascoli Piceno (AP)

This medicinal product is authorized in the European Economic Area countries under the following names:
Detrusitol Retard: Austria, Belgium, Luxembourg, Denmark, Germany, Iceland, Italy and Portugal
Detrusitol SR: Finland, Greece, Ireland, Netherlands, Norway and Sweden
Detrusitol LP: France
Detrusitol Neo: Spain
Detrusitol XL: United Kingdom

This Patient Information Leaflet was last approved in 10/2020