TOLTERODINA 1 mg Film-Coated Tablets

Зміст інструкції

1. TOLTERODINA DOC Generici 1 mg film-coated tablets, 2 mg film-coated tablets
   1. WHAT IS TOLTERODINA DOC Generici AND WHAT IS IT USED FOR
   2. BEFORE TAKING TOLTERODINA DOC Generici
   3. HOW TO TAKE TOLTERODINA DOC Generici
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TOLTERODINA DOC Generici
   6. FURTHER INFORMATION

TOLTERODINA DOC Generici 1 mg film-coated tablets, 2 mg film-coated tablets

Generic medicine

Read all of this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects gets worse, or if you notice any side effect

Contents of this leaflet:

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

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

Tolterodine belongs to a class of medicines called antimuscarinics.
TOLTERODINA DOC Generici is used in the symptomatic treatment of overactive bladder syndrome. If you suffer from overactive bladder syndrome, you will notice an inability to control urination,
the need to rush to the toilet frequently and/or without any warning signal.

2. BEFORE TAKING TOLTERODINA DOC Generici

Do not take TOLTERODINA DOC Generici

• If you are allergic (hypersensitive) to tolterodine or any of the other ingredients of this medicine (see section 6 “Further information”).
• If you have difficulty urinating (urinary retention).
• If you have an elevated eye pressure that is not adequately treated (uncontrolled narrow-angle glaucoma).
• If you suffer from a type of muscle weakness (myasthenia gravis).
• If you suffer from ulcer and inflammation of the colon (severe ulcerative colitis).
• If you suffer from acute dilation of the colon (toxic megacolon).

Take particular care with TOLTERODINA DOC Generici

• If you have difficulty urinating and/or have a poor urine flow.
• If you have gastrointestinal disorders that alter the passage and/or digestion of food.
• If you suffer from kidney problems.
• If you have liver problems.
• If you suffer from neuronal diseases that affect blood pressure, the intestines or sexual function (autonomic neuropathy).
• If a part of your stomach protrudes through the diaphragm (hiatal hernia).
• If you suffer from reduced intestinal motility or suffer from severe constipation.
• If you have heart problems such as: alteration of the cardiac tracing (ECG)

slowing of the heartbeat (bradycardia)
significant pre-existing heart disease (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 medication for the treatment of irregular heartbeat (see “Taking other medicines”).

If you think any of these apply to you, ask your doctor or pharmacist before starting
treatment with TOLTERODINA DOC Generici.

Taking TOLTERODINA DOC Generici with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

Tolterodine can interact with other medicines.
The use of tolterodine in combination with the following is not recommended:
some antibiotics (containing e.g. erythromycin, clarithromycin)
medicines for the treatment of fungal infections (containing e.g. ketoconazole,
itraconazole)
medicines used for the treatment of HIV.

Tolterodine must 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) (see “Take particular care with TOLTERODINA
DOC Generici”)
other medicines with a similar mechanism of action to TOLTERODINA DOC Generici (antimuscarinic properties) or with an opposite mechanism of action to TOLTERODINA DOC Generici
(cholinergic properties).

Taking TOLTERODINA DOC Generici with food and drink
TOLTERODINA DOC Generici can be taken before, after or during meals.

Pregnancy and breastfeeding

Pregnancy
Experience with the use of TOLTERODINA DOC Generici during pregnancy is insufficient. Do not
use TOLTERODINA DOC Generici if you are pregnant as TOLTERODINA DOC
Generici may harm the baby you are carrying.
Contact your doctor immediately if you are pregnant, think you may be pregnant or are planning
a pregnancy.

Breastfeeding
It is not known whether tolterodine passes into breast milk.
Breastfeeding is not recommended during the administration of TOLTERODINA DOC
Generici.

Driving and operating machinery
TOLTERODINA DOC Generici can cause dizziness, fatigue or affect your vision. If you experience
any of these effects, do not drive vehicles or operate heavy machinery.

Important information about some of the excipients of TOLTERODINA DOC Generici
This medicine contains lactose (a type of sugar). If your doctor has diagnosed
an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE TOLTERODINA DOC Generici

Always take TOLTERODINA DOC Generici exactly as your doctor has instructed. If you have
any doubts, consult your doctor or pharmacist.
Adults
The usual dose is 2 mg twice a day.
Patients with liver or kidney problems
If you have liver or kidney problems, your doctor may reduce the dose to 1 mg twice a day.
Children
TOLTERODINA DOC Generici is not recommended for 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 TOLTERODINA DOC Generici than you should
If you or another person has taken too many tablets, contact your doctor or pharmacist immediately. The symptoms
of overdose include effects on the central nervous system (convulsions, hallucinations), difficulty
breathing, heart problems (increased heart rate), difficulty urinating, abnormal
pupil dilation.

If you forget to take TOLTERODINA DOC Generici
Do not take a double dose to make up for a missed dose. If you forget to take
a dose at the usual time, you can take it as soon as you remember unless it is too close to the time
of the next dose. In this case, continue with the normal dosage schedule.

If you stop takingTOLTERODINA DOC Generici
Your doctor will tell you how long to use TOLTERODINA DOC Generici. Do not stop the
treatment prematurely because you do not see an immediate effect. The bladder will need
time to adjust. Complete the treatment cycle of the tablets prescribed by your doctor. If
by that date you have not noticed any effect, talk to your doctor.
Always consult your doctor if you are thinking of stopping treatment.
If you have any further questions about the use of TOLTERODINA DOC Generici, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, TOLTERODINA DOC Generici can cause side effects, although not everyone
will experience them.
Seek immediate medical attention or go to the emergency room if symptoms of
angioedema (allergic reaction) appear, such as:

• swelling of the face, tongue or throat
• difficulty swallowing
• hives and difficulty breathing or if symptoms of heart failure appear:
• chest pain
• difficulty breathing or feeling easily tired (even at rest)
• difficulty breathing at night
• swelling of the legs.

You should also contact your doctor immediately if you experience a
hypersensitivity reaction (e.g. itching, skin rash, hives, difficulty breathing).
The following side effects have been reported during treatment with TOLTERODINA 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
Feeling of spinning Palpitations
Difficulty digesting food (dyspepsia) Constipation
Abdominal pain Excessive amount of air or gas in the
stomach or intestines
Feeling unwell (vomiting) Dry skin
Diarrhea Inability to empty the bladder
Painful or difficult urination Chest pain
Fatigue Weight gain
Presence of excess body fluids Swelling (e.g. in the ankles) causing edema

Uncommon:
Allergic reactions Irregular heartbeat
Nervousness Heartburn
Increased heart rate Impaired memory
Heart failure

Not known:
Confusion Skin redness
Disorientation Severe allergic reactions
Hallucinations (seeing, hearing, having the Angioedema
sensation, smelling or tasting things that are not there)
Cases of worsening dementia symptoms have also been reported in patients undergoing
treatment for dementia.
If any of these side effects get worse, or if you notice any other effects

5. HOW TO STORE TOLTERODINA DOC Generici

Keep out of the reach and sight of children.
Do not use TOLTERODINA DOC Generici after the expiry date which is stated on the packaging.
The expiry date refers to the last day of the month.
There are no special storage precautions.

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. FURTHER INFORMATION

What TOLTERODINA DOC Generici contains
The active ingredient is tolterodine L-tartrate.
Each film-coated tablet of TOLTERODINA DOC Generici 1 mg contains 1 mg of
tolterodine L-tartrate (equivalent to 0.68 mg of tolterodine).
Each film-coated tablet of TOLTERODINA 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, lactose monohydrate, polyethylene glycol, titanium dioxide
(E171).

Description of the appearance of TOLTERODINA DOC Generici and contents of the pack
The 1 mg film-coated tablets are white, round, biconvex, with “1” imprinted on one side.
The 2 mg film-coated tablets are white, round, biconvex, with “2” imprinted on one side and
with a score line on the other side.
The score line is only intended to facilitate breaking the tablet to aid
swallowing and not to divide it into two equal doses.
PVC/PE/PVDC-Aluminum blisters.
Pack sizes of 14, 20, 28, 30, 50, 56, 60 and 100 film-coated tablets.
HDPE bottle with a child-resistant screw cap.
Pack size of 60 film-coated tablets.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
FR: Tolterya 1mg / 2mg film-coated tablet.
EL: Cinterol 1mg / 2mg Film coated tablets.
IT: TOLTERODINA DOC Generici 1 mg / 2 mg film-coated tablets.
LT: Tolterodine Portfarma 1mg / 2mg film-coated tablets.
UK: Tolterodine 1mg / 2mg film-coated tablets.