Tolterodine Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

TOLTERODINE DOC Generics 1 mg film-coated tablets, 2 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine.

• 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• 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 TOLTERODINE DOC Generics is and what it is used for
2. Before you take TOLTERODINE DOC Generics
3. How to take TOLTERODINE DOC Generics
4. Possible side effects
5. How to store TOLTERODINE DOC Generics
6. Further information

1. WHAT TOLTERODINE DOC Generici IS AND WHAT IT IS USED FOR

Tolterodine belongs to a class of medicines called antimuscarinics.
TOLTERODINE DOC Generics is used for the symptomatic treatment of overactive bladder syndrome.
If you have overactive bladder syndrome, you may experience an inability to control urination, a frequent need to rush to the toilet, and/or a lack of warning signals.

2. BEFORE TAKING TOLTERODINE DOC Generics

Do not take TOLTERODINE DOC Generics

• If you are allergic (hypersensitive) to tolterodine or to any of the excipients of the medicine (see section 6 “Further information”).
• If you have difficulty urinating (urinary retention).
• If you have untreated high eye pressure (uncontrolled narrow-angle glaucoma).
• If you suffer from a type of muscle weakness (myasthenia gravis).
• If you have ulcer and inflammation of the colon (severe ulcerative colitis).
• If you suffer from acute dilation of the colon (toxic megacolon).

Take special care with TOLTERODINE DOC Generics

• If you have difficulty urinating and/or have a weak urine stream.
• If you have gastrointestinal disorders that affect the passage and/or digestion of food.
• If you have kidney problems.
• If you have liver problems.
• If you suffer from neurological diseases affecting blood pressure, the intestine or sexual function (autonomic neuropathy).
• If part of your stomach protrudes through the diaphragm (hiatal hernia).
• If you suffer from reduced intestinal motility or severe constipation.
• If you have heart problems such as: changes in the heart trace (ECG)

slowing of the heartbeat (bradycardia)
significant pre-existing heart diseases (weakening of the heart muscle (cardiomyopathy), reduced blood flow to the heart (myocardial ischemia), irregular heartbeat (arrhythmia), and heart failure).

• If you have particularly low levels of potassium, calcium or magnesium in the blood.
• If you are taking any medicines for the treatment of irregular heartbeat (see “Taking other medicines”).

If you think you fall into any of these categories, consult your doctor or pharmacist before starting treatment with TOLTERODINE DOC Generics.

Taking TOLTERODINE DOC Generics with other medicines

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

Tolterodine may interact with other medicines.

The use of tolterodine in combination with the following is not recommended:

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

Tolterodine should be used with caution when taken in combination with:

• medicines affecting food transit (containing e.g. metoclopramide and cisapride)
• medicines used to treat irregular heartbeat (containing e.g. amiodarone, sotalol, quinidine, procainamide) (see “Take special care with TOLTERODINE DOC Generics”)
• other medicines with a mechanism of action similar to TOLTERODINE DOC Generics (antimuscarinic properties) or with an opposite mechanism of action to TOLTERODINE DOC Generics (cholinergic properties).

Taking TOLTERODINE DOC Generics with food and drinks

TOLTERODINE DOC Generics may be taken before, after or during meals.

Pregnancy and breastfeeding

Pregnancy

Experience with the use of TOLTERODINE DOC Generics during pregnancy is insufficient. You must not use TOLTERODINE DOC Generics if you are pregnant, as TOLTERODINE DOC Generics could harm the unborn child.

Contact your doctor immediately if you are pregnant, think you might be pregnant, or are planning a pregnancy.

Breastfeeding

It is not known whether tolterodine passes into breast milk.

Breastfeeding is not recommended during treatment with TOLTERODINE DOC Generics.

Driving and using machines

TOLTERODINE DOC Generics may cause dizziness, fatigue or affect vision. If you experience any of these effects, you must not drive or operate heavy machinery.

Important information about some excipients of TOLTERODINE DOC Generics

This medicine contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE TOLTERODINE DOC Generics

Always take TOLTERODINE DOC Generics exactly as instructed by your doctor. If you
have any doubts, consult your doctor or pharmacist.
Adults
The usual dose is 2 mg twice daily.
Patients with liver or kidney problems
If you have liver or kidney problems, your doctor may reduce your dose to 1 mg twice daily.
Children
TOLTERODINE DOC Generics is not recommended for use in children.
The tablets are for oral use and must be swallowed whole.
The benefits of treatment should be re-evaluated after 2 or 3 months.
If you take more TOLTERODINE DOC Generics than you should
If you or someone else has taken too many tablets, contact your doctor or pharmacist immediately. Symptoms
of overdose include effects on the central nervous system (seizures, hallucinations), difficulty
breathing, heart problems (increased heart rate), difficulty urinating, and abnormal dilation of the pupils.
If you forget to take TOLTERODINE DOC Generics
Do not take a double dose to make up for the missed dose. 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, continue with your regular dosing schedule.
If you stop taking TOLTERODINE DOC Generics
Your doctor will advise you on how long to use TOLTERODINE DOC Generics. Do not stop treatment early just because you do not notice an immediate effect. The bladder needs time to adapt. Complete the full course of treatment as prescribed by your doctor. If by that time you have not noticed any improvement, discuss this with your doctor.
Always consult your doctor if you are considering stopping treatment.
If you have any questions about the use of TOLTERODINE DOC Generics, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, TOLTERODINE DOC Generici may cause adverse reactions, although not
all people experience them.
Seek immediate medical attention or go to the emergency room if symptoms of
angioedema (allergic reaction) occur, such as:

• swelling of the face, tongue, or pharynx
• difficulty swallowing
• urticaria and breathing difficulties, or if symptoms of heart failure appear:
• chest pain
• shortness of breath or tendency to tire easily (even at rest)
• difficulty breathing while lying down at night
• swelling in the legs.

Immediate contact with a doctor is also necessary if a hypersensitivity reaction occurs (e.g. itching, skin rash, urticaria, breathing difficulties).
The following adverse reactions have been reported during treatment with TOLTERODINE DOC Generici, with the following frequencies:

Very common:
Dry mouth Headache

Common:
Bronchitis Dizziness
Drowsiness Tingling sensation in hands and feet
Dry eyes Blurred vision
Sensation of spinning Palpitations
Indigestion (dyspepsia) Constipation
Abdominal pain Excessive air or gas in the stomach or intestines
Malaise (nausea/vomiting) Dry skin
Diarrhoea Inability to empty the bladder
Painful or difficult urination Chest pain
Fatigue Weight gain
Excess body fluids causing swelling (e.g. in ankles) Dizziness

Uncommon:
Allergic reactions Irregular heartbeat
Nervousness Heartburn
Increased heart rate Memory impairment
Heart failure

Not known:
Confusion Skin redness
Disorientation Severe allergic reactions
Hallucinations (seeing, hearing, feeling, tasting, or smelling things that are not there) Angioedema

Worsening of dementia symptoms has also been reported in patients receiving treatment for dementia.

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

5. HOW TO STORE TOLTERODINE DOC Generici

Keep out of the reach and sight of children.
Do not use TOLTERODINE DOC Generici after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
No special storage precautions are required.
Medicines must 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 TOLTERODINE DOC Generici contains
The active substance is tolterodine L-tartrate.
Each film-coated tablet of TOLTERODINE DOC Generici 1 mg contains 1 mg of
tolterodine L-tartrate (equivalent to 0.68 mg of tolterodine).
Each film-coated tablet of TOLTERODINE DOC Generici 2 mg contains 2 mg of
tolterodine L-tartrate (equivalent to 1.37 mg of tolterodine).
The excipients are:
Tablet core: microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate.
Tablet coating: hypromellose, monohydrate lactose, polyethylene glycol, titanium dioxide (E171).

Description of the appearance of TOLTERODINE DOC Generici and contents of the pack
The 1 mg film-coated tablets are white, round, biconvex, with "1" engraved on one side.
The 2 mg film-coated tablets are white, round, biconvex, with "2" engraved on one side and a score line on the other side.
The score line is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into two equal doses.

PVC/PE/PVDC-Aluminum blister.
Pack sizes of 14, 20, 28, 30, 50, 56, 60 and 100 film-coated tablets.
HDPE bottle with child-resistant PP screw cap.
Pack size of 60 film-coated tablets.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturers
Pharmathen S.A.
6, Dervenakion Str.,
153 51 Pallini Attiki
Greece
and
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:
FR: Tolterya 1mg / 2mg comprimé pelliculé.
EL: Cinterol 1mg / 2mg Film coated tablets.
IT: TOLTERODINA DOC Generici 1 mg / 2 mg compresse rivestite con film.
LT: Tolterodine Portfarma 1mg / 2mg plėvele dengtos tabletės.
UK: Tolterodine 1mg / 2mg film-coated tablets.

This Patient Information Leaflet was approved in April 2013.