TOLTERODINA 2 мг Пролонгированные капсулы

Содержание инструкции

1. TOLTERODINA DOC 2 mg prolonged-release hard capsules, 4 mg prolonged-release hard capsules
   1. What is TOLTERODINA DOC and what is it used for
   2. Before taking TOLTERODINA DOC
   3. How to take TOLTERODINA DOC
   4. Possible side effects
   5. How to store TOLTERODINA DOC
   6. Package contents and other information

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

Generic medicine

Read this leaflet carefully before you start taking this medicinebecause 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 you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active ingredient 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 an overactive bladder, you will experience

• an inability to control urine leakage
• the need to rush to the bathroom without warning and/or frequent trips to the bathroom.

2. Before taking TOLTERODINA DOC

Do not take TOLTERODINA DOC if:

• you are allergic to the active ingredient 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 visual ability that is 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 particular care with TOLTERODINA DOC:

• if you have difficulty urinating and/or have a reduced urine flow
• if you have a gastro-intestinal disease that alters the passage and/or digestion of food
• if you suffer from kidney problems (renal insufficiency)
• if you have liver problems
• if you suffer from a neurological disease that affects blood pressure, intestinal or sexual function (any autonomic nervous system neuropathy)
• if you have a hiatal hernia (a hernia of an abdominal organ)
• if you sometimes have reduced bowel mobility or suffer from severe constipation (reduced gastro-intestinal motility)
• if you have a heart problem such as:
• abnormal heart tracing (ECG)
• slow heartbeat (bradycardia)
• significant pre-existing heart conditions 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 (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in the blood.

Talk to your doctor or pharmacist before taking TOLTERODINA DOC if
you think that any of these conditions apply to you.

Other medicines and TOLTERODINA DOC
Tell your doctor if you are taking, have recently taken or might take
any other medicines.
Tolterodine, the active ingredient of TOLTERODINA DOC, can interact with other
medicines.
The use of tolterodine is not recommended 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.

TOLTERODINA DOC must be used with caution together with:

• medicines that affect the passage of food (containing e.g. metoclopramide and cisapride)
• medicines for the treatment of irregular heartbeats (containing e.g. amiodarone, sotalol, quinidine, procainamide)
• other medicines with a similar mechanism of action to that of TOLTERODINA DOC (antimuscarinic properties) or medicines with an opposite mechanism of action to TOLTERODINA DOC (cholinergic properties). Ask your doctor if you are not sure.

TOLTERODINA DOC with food and drink
TOLTERODINA DOC can be taken before, during and after a meal.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.

Pregnancy
You should not use TOLTERODINA DOC when you are pregnant.

Breastfeeding
It is not known whether tolterodine, the active ingredient of TOLTERODINA DOC, is excreted into
breast milk. Breastfeeding during the administration of TOLTERODINA DOC is not
recommended.

Driving and using machines
TOLTERODINA DOC may cause you to feel dizzy, tired or have blurred vision; your
ability to drive or operate machinery may be impaired.

TOLTERODINA DOC contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before
taking this medicine.

TOLTERODINA 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 controlled sodium diet.

3. How to take TOLTERODINA DOC

Dosage:
Take this medicine following exactly the instructions of your doctor. If you have
any doubts, 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 prolonged-release hard capsule of 4 mg per day.
Patients with liver or kidney problems or with troublesome side effects:
Your doctor may reduce the dose to 2 mg of TOLTERODINA DOC per day.
Use in children:
TOLTERODINA DOC is not recommended for children.

If you take more TOLTERODINA 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 heartbeat than normal, dilated pupils and inability to urinate
and breathe normally.

If you forget to take TOLTERODINA DOC
If you forget to take a dose at the usual time, take it as soon as you remember, unless
it is almost time to take the next dose. In this case, skip the forgotten dose
and follow your normal treatment schedule.
Do not take a double dose to make up for a missed tablet.

If you stop taking TOLTERODINA DOC
Your doctor will tell you how long your treatment with TOLTERODINA
DOC should last. Do not stop treatment prematurely because you do not notice an immediate effect. The
bladder needs some time to adjust. Finish the cycle of prolonged-release capsules
that your doctor has prescribed. If you do not notice any 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 thinking of stopping treatment.
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.
Go to your doctor immediately or to the nearest hospital emergency room if you
experience any of the symptoms of angioedema, such as:

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria and difficulty breathing.

You should also see a doctor in case of hypersensitivity reactions (for example, itching,
skin rash, urticaria, difficulty breathing). This is not common (occurs in less than 1 in 100 patients).
Consult your doctor immediately or go to the emergency room if you notice
any of the following symptoms:

• chest pain, difficulty breathing or feeling tired easily (even at rest), difficulty breathing at night, swelling of the legs. These may be symptoms of heart failure. This is not common (occurs in less than 1 in 100 patients).

The following side effects have been observed during treatment with tolterodine, with
the frequencies indicated.

Very common side effects(occur in more than 1 in 10 patients) are:

• Dry mouth

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

• Sinusitis
• Drowsiness
• Dry eyes
• Digestive difficulties (dyspepsia)
• Abdominal pain
• Fluid retention causing swelling (for example, in the ankles)
• Pain or difficulty urinating
• Dizziness
• Headache
• Blurred vision
• Constipation
• Excessive amount of air or gas in the stomach and intestines
• Diarrhea
• Fatigue

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

• Allergic reactions
• Nervousness
• Palpitations
• Inability to empty the bladder
• Vertigo
• Heart failure
• Irregular heartbeat
• Chest pain
• Pins and needles sensation in the fingers of the hands and feet
• Memory impairment

Other reactions reported include severe allergic reactions, confusion, hallucinations,
increased heart rate, hot flushes, heartburn, vomiting,
angioedema, dry skin and disorientation. Cases of worsening dementia symptoms in patients treated for dementia have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
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 TOLTERODINA DOC

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 pack/blister/bottle after “Exp.”. The expiry date refers to the last day of the month.
Do not store above 25°C.
HDPE bottle: the validity after first opening is 200 days.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to eliminate medicines that you no longer use. This will help protect
the environment.

6. Package contents and other information

What TOLTERODINA DOC contains
The active ingredient of TOLTERODINA DOC 2 mg prolonged-release hard capsules is 2
mg of tolterodine tartrate, equivalent to 1.37 mg of tolterodine.
The active ingredient of TOLTERODINA DOC 4 mg prolonged-release hard capsules is 4
mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
The excipients are:
lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, silica, sodium
lauryl sulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose.

Capsule composition:indigotine (E132), quinoline yellow (only in 2 mg)
(E104), titanium dioxide (E171), gelatin.

Coating of the 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 a single daily
dose.
TOLTERODINA DOC 2 mg prolonged-release hard capsules are hard gelatin
capsules of size 1, opaque green-opaque green in color, containing two white, round,
biconvex coated tablets.
TOLTERODINA DOC 4 mg prolonged-release hard capsules are hard gelatin
capsules of size 1, opaque light blue – opaque light blue in color, containing four
white, round, biconvex coated tablets.
TOLTERODINA DOC 2 mg prolonged-release hard capsules are available in the
following packs:

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

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

• 7, 14, 28, 49, 84, 98 prolonged-release hard capsules in blisters
• 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 authorised in the Member States of the European Economic
Area with the following denominations:
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