Skip to Content

TOLOTEX XL 2 MG PROLONGED-RELEASE CAPSULES

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tolotex XL 2 mg prolonged-release capsules, hard
Tolotex XL 4 mg prolonged-release capsules, hard
Tolterodine tartrate
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you:

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. It may harm them,
even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
What is in this leaflet:
1.
What Tolotex XL is and what it is used for
2.
Before you take Tolotex XL
3.
How to take Tolotex XL
4.
Possible side effects
5.
How to store Tolotex XL
6.
Further information

1.

What Tolotex XL is and what it is used for

The active substance in Tolotex XL is tolterodine. Tolterodine belongs to a class of medicinal
products called antimuscarinics.
Tolotex XL is used for the treatment of the symptoms of overactive bladder syndrome. If
you have overactive bladder syndrome, you may find that:

you are unable to control urination

you need to rush to the toilet with no advance warning and/or go to the toilet frequently

2.

What you need to know before you take Tolotex XL

Do not take Tolotex XL:

if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in Tolotex
XL (see section 6 for a list of the ingredients)

if you are unable to pass urine from the bladder (urinary retention)

if you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of
eyesight that is not being adequately treated)

if you suffer from myasthenia gravis (excessive weakness of the muscles)

if you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)

if you suffer from a toxic megacolon (acute dilatation of the colon).

Take special care with Tolotex XL:

If you have difficulties in passing urine and/or a poor stream of urine.

If you have a gastro-intestinal disease that affects the passage and/or digestion of food.

If you suffer from kidney problems (renal insufficiency).

If you have a liver condition.

If you suffer from neurological disorders that affect your blood pressure, bowel or sexual
function (any neuropathy of the autonomic nervous system).

If you have a hiatus hernia (herniation of an abdominal organ).

If you ever experience decreased bowel movements or suffer from severe constipation
(decreased gastro-intestinal motility).

If you have a heart condition such as:
- an abnormal heart tracing (ECG)
- a slow heart rate (bradycardia)
- relevant pre-existing cardiac diseases such as: cardiomyopathy (weak heart muscle),
myocardial ischaemia (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 your blood.
Talk to your doctor or pharmacist before starting your treatment with Tolotex XL if you think
any of these might apply to you.
Other medicines and Tolotex XL
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Tolterodine, the active substance of Tolotex XL, may interact with other medicinal products.
It is not recommended to use tolterodine in combination with:

some antibiotics (containing e.g. erythromycin, clarithromycin)

medicinal products used for the treatment of fungal infections (containing e.g.
ketoconazole, itraconazole)

medicinal products used for the treatment of HIV
Tolotex XL should 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

other medicines with a similar mode of action to Tolotex XL(antimuscarinic properties) or
medicines with an opposite mode of action to Tolotex XL (cholinergic properties).
The reduction in gastric motility caused by antimuscarinics may affect the absorption of
other drugs. Ask your doctor if you are unsure.
Taking Tolotex XL with food and drink
Tolotex XL can be taken before, after or during a meal.

Pregnancy and breast-feeding
Pregnancy
You should not use Tolotex XL w hen you are pregnant. Tell your doctor immediately if you
are pregnant, think you are pregnant or are planning to become pregnant.
Breast-feeding
It is not known if tolterodine, the active substance of Tolotex XL, is excreted in the mother’s
breast milk. Breast-feeding is not recommended during administration of Tolotex XL.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Tolotex XL may make you feel dizzy, tired or affect your sight. If you experience any of
these effects then you should not drive your car or operate heavy machinery.
Tolotex XL contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. How to take Tolotex XL
Dosage:
Always take Tolotex XL exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The prolonged-release hard capsules are for oral use and should be swallowed whole.
Do not chew the capsules.
Adults:
The usual dose is one 4 mg prolonged-release hard capsule daily.
Patients with liver or kidney problems:
In patients with liver or kidney problems your doctor may reduce your dose to 2 mg Tolotex XL
daily.
Children:
Tolotex XL is not recommended for children.
If you have taken more Tolotex XL than you should:
If you or somebody else takes too many prolonged-release capsules, contact your doctor or
pharmacist immediately. Symptoms in case of overdose include hallucinations, excitation, a
heartbeat faster than usual, dilation of the pupil and inability to urinate or breathe normally.
If you forget to take Tolotex XL:
If you forget to take a dose at the usual time, take it as soon as you remember unless it is
almost time for your next dose. In that case, omit the forgotten dose and follow the normal
dose schedule.
Do not take a double dose to make up for a forgotten one.

Duration of treatment  Your doctor will tell you how long your treatment with Tolotex XL
will last. Do not stop treatment early because you do not see an immediate effect. Your
bladder will need some time to adapt. Finish the course of prolonged-release capsules prescribed
by your doctor. If you have not noticed any effect by then, talk to your doctor.
The benefit of the treatment should be re-evaluated after 2 or 3 months. Always consult your
doctor if you are thinking of stopping the treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Tolotex XL can cause side effects, although not everybody gets them.
You should see your doctor immediately or go to the casualty department if you experience
symptoms of angioedema, such as:

swollen face, tongue or pharynx

difficulty to swallow

hives and difficulty in breathing
You should also seek medical attention if you experience a hypersensitivity reaction (for
example itching, rash, hives, difficulty breathing). This occurs uncommonly (occurs in less than
1 in 100 patients).
Tell your doctor immediately or go to the casualty department if you notice any of the
following:

chest pain, difficulty breathing or getting tired easily (even at rest), difficulty
breathing at night, swelling of the legs.
These may be symptoms of heart failure. This occurs uncommonly (occurs in less than 1 in
100 patients).
The following side effects have been observed during treatment with Tolotex with the
following frequencies.
Very common side effects (occurs in more than 1 in 10 patients) are:


Dry mouth

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






Sinusitis
Sleepiness
Dry eyes
Difficulty with digestion
(dyspepsia)
Abdominal pain






Dizziness
Headache
Blurred vision
Constipation



excessive amounts of air or gases
in the stomach or the intestine




Painful or difficult urination
Extra fluid in the body causing
swelling (e.g. in the ankles)




Diarrhoea
Tiredness

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





Allergic reactions
Nervousness
Palpitations
Inability to empty the bladder








Vertigo



Heart failure
Irregular heartbeat
Chest pain
Sensation of pins and needles in
the fingers and toes
Memory impairment

Additional reactions reported include severe allergic reactions, confusion, hallucinations,
increased heart rate, flushed skin, heart burn, vomiting, angioedema, dry skin, and
disorientation. There have also been reports of worsening symptoms of dementia in patients
being treated for dementia.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Tolotex XL
Keep Tolotex XL out of the reach and sight of children.
Do not use Tolotex XL after the expiry date which is stated on the label/carton. The expiry
date refers to the last day of that month.
Do not store above 25°C
HDPE bottle: Shelf life after first opening is 200 days
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to protect
the environment.

6. Further information
What Tolotex XL contains
The active substance in Tolotex XL 2 mg prolonged-release capsules, hard is 2 mg of
tolterodine tartrate, equivalent to 1.37mg of tolterodine.
The active substance in Tolotex XL 4 mg prolonged-release capsules, hard is 4 mg of
tolterodine tartrate, equivalent to 2,74 mg of tolterodine.

The other ingredients are:
 Lactose monohydrate, cellulose microcrystalline,  poly(vinyl acetate), povidone, silica, sodium
laurilsulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose Capsule
composition: indigo carmine (E132), quinoline yellow (only in 2 mg) (E104), titanium dioxide
(E171), gelatin
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate
copolymer, 1,2-Propylene glycol
What Tolotex XL looks like and contents of the pack
Tolotex XL is a hard prolonged-release capsule designed for once daily dosing.
Tolotex XL 2 mg prolonged-release hard capsules are opaque green-opaque-green.
Tolotex XL 4 mg prolonged-release hard capsules are light blue-opaque-light blue opaque.
Tolotex XL 2 mg prolonged-release hard capsules are available in the following pack
sizes:
Blister packs containing: 14, 28, 56, 84 prolonged-release capsules
HPDE bottles containing: 30, 100, 200 capsules
Tolotex XL 4 mg prolonged-release hard capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 49, 56, 84, 98 prolonged-release capsules
HPDE bottle sizes containing: 30, 100, 200 capsules
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Apotex Europe B.V., Darwinweg 20, 2333 CR Leiden, The Netherlands
Manufacturer:
Pharmathen S.A., 6, Dervenakion Str., 153 51 Pallini Attiki, Greece
Pharmathen International S.A., Sapes Industrial Park, Block 5, 69300 Rodopi, Greece
Apotex Nederland B.V., Archimedesweg 2, 2333 CN Leiden, The Netherlands
Portfarma ehf, Borgartúni 26, 105 Reykjavík, Iceland
Pharmadox Healthecare Ltd., KW20A Kordin Industrial Park, Paola, PLA 3000, Malta
Pharmacare Premium Ltd., HHF 003, Hal Far Industrial Estate, Birzebbugia BBG3000, Malta
This leaflet was last revised in 08/2012.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide