Tolterodine Doc Generici

Package leaflet: Information for the user

TOLTERODINE DOC 2 mg prolonged-release hard capsules, 4 mg prolonged-release hard capsules

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, because it may be harmful for them.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TOLTERODINE DOC is and what it is used for
2. What you need to know before taking TOLTERODINE DOC
3. How to take TOLTERODINE DOC
4. Possible side effects
5. How to store TOLTERODINE DOC
6. Contents of the pack and other information

1. What TOLTERODINA DOC is and what it is used for

The active substance of TOLTERODINA DOC is tolterodine. Tolterodine belongs to
a class of medicinal products called antimuscarinics.
TOLTERODINA DOC is used for the treatment of symptoms of overactive bladder syndrome. If you have overactive bladder, you may experience

• inability to control urine leakage
• sudden urge to urinate and/or frequent need to go to the bathroom.

2. Before taking TOLTERODINE DOC

Do not take TOLTERODINE DOC if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• you are unable to urinate (urinary retention)
• you have uncontrolled acute-angle glaucoma (high pressure in the eye with loss of vision not adequately treated)
• you suffer from myasthenia gravis (excessive muscle weakness)
• you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
• you suffer from severe toxic megacolon (acute dilation of the colon).

Warnings and precautions
Take special care with TOLTERODINE DOC:

• if you have difficulty urinating and/or have a reduced urine flow
• if you have a gastrointestinal disease affecting the passage and/or digestion of food
• if you have kidney problems (renal failure)
• if you have liver problems
• if you suffer from a neurological disease affecting blood pressure, intestinal or sexual function (any autonomic neuropathy)
• if you have a hiatal hernia (a hernia involving an abdominal organ)
• if you occasionally have reduced intestinal motility or suffer from severe constipation (reduced gastrointestinal motility)
• if you have a heart condition such as:
  • abnormal heart trace (ECG)
  • slow heart rate (bradycardia)
  • significant pre-existing heart diseases such as: cardiomyopathy (weak heart muscle), myocardial ischemia (reduced blood flow to the heart), arrhythmia (irregular heartbeat), and heart failure
• if you have abnormally low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in the blood.

Talk to your doctor or pharmacist before taking TOLTERODINE DOC if
you think any of these conditions apply to you.
Other medicines and TOLTERODINE DOC
Tell your doctor if you are taking, have recently taken, or might take
any other medicine.
Tolterodine, the active ingredient in TOLTERODINE DOC, may interact with other
medicines.
The use of tolterodine is not recommended with:

• certain antibiotics (containing e.g. erythromycin, clarithromycin)
• medicines used to treat fungal infections (containing e.g. ketoconazole, itraconazole)
• medicines used to treat HIV.

TOLTERODINE DOC should be used with caution together with:

• medicines affecting gastrointestinal motility (containing e.g. metoclopramide and cisapride)
• medicines used to treat irregular heartbeats (containing e.g. amiodarone, sotalol, quinidine, procainamide)
• other medicines with a similar mechanism of action to TOLTERODINE DOC (antimuscarinic properties) or medicines with an opposite mechanism of action to TOLTERODINE DOC (cholinergic properties). Ask your doctor if you are unsure.

TOLTERODINE DOC with food and drink
TOLTERODINE DOC can be taken before, during, or after a meal.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking
this medicine.
Pregnancy
You must not use TOLTERODINE DOC during pregnancy.
Breastfeeding
It is not known whether tolterodine, the active ingredient of TOLTERODINE DOC, is excreted in
breast milk. Breastfeeding during treatment with TOLTERODINE DOC is not
recommended.
Driving and using machines
TOLTERODINE DOC may cause dizziness, tiredness, or visual disturbances; your ability to drive or use machines may be impaired.
TOLTERODINE DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
TOLTERODINE DOC contains sodium
This medicine contains 0.00404 mmol (or 0.092988 mg) of sodium per dose. This should be taken into consideration in patients on a sodium-controlled diet.

3. How to take TOLTERODINE DOC

Dosage:
Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The prolonged-release hard capsules are for oral use only and must be swallowed whole.
Do not chew the capsules.

Adults:
The recommended dose is one 4 mg prolonged-release hard capsule daily.

Patients with liver or kidney problems or experiencing bothersome side effects:
Your doctor may reduce the dose to 2 mg of TOLTERODINE DOC daily.

Use in children:
TOLTERODINE DOC is not recommended for use in children.

If you take more TOLTERODINE DOC than you should
If you or someone else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately. Symptoms of overdose include hallucinations, excitement, faster than normal heartbeat, dilated pupils, inability to urinate, and difficulty breathing normally.

If you forget to take TOLTERODINE DOC
If you forget to take a dose at your usual time, 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 the forgotten dose.

If you stop taking TOLTERODINE DOC
Your doctor will tell you how long your treatment with TOLTERODINE DOC should last. Do not stop treatment early just because you do not notice an immediate effect. The bladder needs some time to adapt. Complete the course of prolonged-release capsules prescribed by your doctor. If you still notice no effect by then, inform your doctor.
The benefit of treatment should be re-evaluated after 2 or 3 months. Always consult your doctor if you are considering stopping treatment.

If you have any further questions about 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 everyone gets them.
Go immediately to your doctor or the nearest hospital emergency department if you experience any of the symptoms of angioedema, such as:

• swelling of the face, tongue or pharynx
• difficulty swallowing
• hives and difficulty breathing.

You should also contact your doctor if you experience hypersensitivity reactions (for example itching, rash, hives, breathing difficulties). These occur uncommonly (in less than 1 out of 100 patients).
Contact your doctor immediately or go to the emergency department if you notice any of the following symptoms:

• chest pain, shortness of breath or tendency to tire easily (even at rest), difficulty breathing at night, swelling of the legs. These may be symptoms of heart failure. This occurs uncommonly (in less than 1 out of 100 patients).

The following adverse reactions have been observed during treatment with tolterodine, with the frequencies indicated below.
Very common side effects (occur in more than 1 out of 10 patients) are:

• Dry mouth

Common side effects (occur in less than 1 out of 10 patients) are:

• Sinusitis – Dizziness
• Drowsiness – Headache
• Dry eyes – Blurred vision
• Digestive difficulties (dyspepsia) – Constipation
• Abdominal pain – Excessive gas or air in the stomach and intestines
• Fluid retention causing swelling (e.g. in the ankles) – Diarrhoea
• Pain or difficulty urinating – Fatigue

Uncommon side effects (occur in less than 1 out of 100 patients) are:

• Allergic reactions – Irregular heartbeat
• Nervousness – Chest pain
• Palpitations – Tingling or pins and needles in hands and feet
• Inability to empty the bladder – Dizziness
• Memory impairment – Heart failure

Other reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, skin flushing, heartburn, vomiting, angioedema, dry skin and disorientation. Cases of worsening dementia symptoms have also been reported in patients being treated for dementia.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TOLTERODINE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blister pack/bottle after "Exp.". The expiry date refers to the last day of the month.
Do not store above 25°C.
HDPE bottle: the shelf life after first opening is 200 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TOLTERODINA DOC contains
The active substance in TOLTERODINA DOC 2 mg prolonged-release hard capsules is 2
mg of tolterodine tartrate, equivalent to 1.37 mg of tolterodine.
The active substance in TOLTERODINA DOC 4 mg prolonged-release hard capsules is 4
mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
The excipients are:
monohydrate lactose, microcrystalline cellulose, poly(vinyl acetate), povidone, silica, sodium
lauryl sulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose.
Capsule shell composition: indigo carmine (E132), quinoline yellow (only in 2 mg)
(E104), titanium dioxide (E171), gelatin.
Coating of tablets inside: ethylcellulose, triethyl citrate, methacrylic acid -
ethyl acrylate copolymer, 1,2-propylene glycol.

Description of the appearance of TOLTERODINA DOC and package contents
TOLTERODINA DOC are prolonged-release hard capsules for once-daily dosing.
TOLTERODINA DOC 2 mg prolonged-release hard capsules are opaque green – green hard gelatin capsules of size 1 containing two white, round, biconvex coated tablets.
TOLTERODINA DOC 4 mg prolonged-release hard capsules are opaque blue – blue hard gelatin capsules of size 1 containing four white, round, biconvex coated tablets.

TOLTERODINA DOC 2 mg prolonged-release hard capsules are available in the following pack sizes:

• 14, 28, 30, 50, 84, 100 prolonged-release hard capsules in blister packs
• 30, 100 and 200 prolonged-release hard capsules in HDPE bottles.

TOLTERODINA DOC 4 mg prolonged-release hard capsules are available in the following pack sizes:

• 7, 14, 28, 49, 84, 98 prolonged-release hard capsules in blister packs
• 30, 100 and 200 prolonged-release hard capsules in HDPE bottles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.
Manufacturer
Pharmathen S.A. - 6, Dervenakion Str. - 153 51 Pallini Attiki - Greece
Pharmathen International S.A. - Sapes Industrial Park - Block 5, 69300 Rodopi - Greece

This medicinal product is authorized in the European Economic Area countries
under the following names:
UK: Tolthen XL 2mg, 4mg prolonged release capsules
DE: Tolterodin-Aristo 4 mg Hartkapseln, retardiert
PL: Titlodine 2mg, 4mg prolonged release capsules
IT: TOLTERODINA DOC
BE: Urolina 2mg, 4mg prolonged release capsules
LU: Urolina 2mg, 4mg prolonged release capsules
NL: Uroline 2mg, 4mg prolonged release capsules