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TOLTRAT XL 4MG PROLONGED RELEASE CAPSULES

Active substance(s): TOLTERODINE L-TARTRATE / TOLTERODINE L-TARTRATE / TOLTERODINE L-TARTRATE

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PACKAGELEAFLET: INFORMATION FOR THE USER
Toltrat XL 2 mg prolonged-release capsules, hard
Toltrat 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 or nurse. See Section 4.
What is in this leaflet:
1.
What Toltrat XL is and what it is used for
2.
Before you take Toltrat XL
3.
How to take Toltrat XL
4.
Possible side effects
5.
How to store Toltrat XL
6.
Further information

1.What Toltrat XL is and what it is used for
The active substance in Toltrat XL is tolterodine. Tolterodine belongs to a class of medicinal
products called antimuscarinics.
Toltrat 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 Toltrat XL
Do not take Toltrat XL:

if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in
[Tolterodine] (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 eye sight 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)
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if you suffer from atoxic megacolon (acute dilatation of the colon).

Take special care with Toltrat 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)
- as low heart rate (bradycardia)
- relevant pre-existing cardiac diseases such as: cardiomyopathy (weak heart muscle),
myocardial ischaemia (reduced blood flow to the heart), arrhythmia (irregular heart beat)
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 Toltrat XL if you think any
of these might apply to you.
Other medicines and Toltrat 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 Toltrat 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, traconazole)

medicinal products used for the treatment of HIV
Toltrat 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 heart beat (containing e.g. amiodarone, sotalol,
quinidine, procainamide
• Other medicines with a similar mode of action to Toltrat XL (antimuscarinic properties) or
medicines with an opposite mode of action to Toltrat 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.
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Taking Toltrat XL with food and drink
Toltrat XL can be taken before, after or during a meal.
Pregnancy and breast-feeding
Pregnancy
You should not use Toltrat 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 Toltrat XL, is excreted in the mother’s breast
milk. Breast-feeding is not recommended during administration of Toltrat XL .
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Toltrat 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.
Toltrat 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 Toltrat XL Dosage:
Always take Toltrat 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 4mg 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 Toltrat XL
daily.
Children:
Toltrat XL is not recommended for children.
If you have taken more Toltrat 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 Toltrat XL:
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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 Toltrat 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 Toltrat 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 inbreathing
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 Toltrat XL 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 than1 in 10 patients) are:





Sinusitis
Sleepiness
Dry eyes
Difficulty with digestion






Dizziness
Headache
Blurred vision
Constipation
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(dyspepsia)
Abdominal pain
Painful or difficult urination
Extra fluid in the body causing
swelling (e.g. in the ankles)





Excessive amounts of air or gases
in the stomach or the intestine
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 heart beat
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, heartburn, vomiting, angioedema, dry skin, and disorientation.
There have also been reports of worsening symptoms of dementia in patients being treated for
dementia.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Toltrat XL
Keep Toltrat XL out of the reach and sight of children.
Do not use Toltrat 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 Toltrat XL contains
The active substance in Toltrat XL 2 mg prolonged-release capsules, hard is 2 mg of tolterodine
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tartrate, equivalent to 1,37 mg of tolterodine.
The active substance in Toltrat 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
laurel sulfate, sodium docusate, magnesium stearate, hydroxypropylmethyl cellulose
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 Toltrat XL looks like and contents of the pack
Toltrat XL is a hard prolonged-release capsule designed for once daily dosing.
Toltrat XL 2mg prolonged-release hard capsules are opaque green-opaque-green.
Toltrat XL 4 mg prolonged-release hard capsules are light blue-opaque-light blue opaque.
Toltrat XL 2 mg prolonged-release hard capsules are available in the following pack sizes:
Blister packs containing: 28, 30, 100 prolonged-release capsules
HDPE bottles containing 30, 100 capsules
Toltrat XL 4 mg prolonged-release hard capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 30, 49, 56, 84, 98, 100, 112, 126 prolonged-release
HDPE bottles containing: 30, 100 capsules
Marketing authorization holder and manufacturer
Marketing authorization holder:
STADA Arzneimittel AG
Stadastraße 2 -18
61118 Bad Vilbel
Germany
Manufacturer:
STADA Arzneimittel AG
Stadastraße 2 -18
61118 Bad Vilbel
Germany
And
Pharmathen S.A
6, Dervenakion Str.,
6

153 51 Pallini Attiki
Greece
And
Pharmathen International S.A
Sapes Industrial Park
Block 5, 69300 Rodopi
Greece
And
Eurogenerics N.V.
Heizel Esplanade B22
1020 Brussels
Belgium
And
LAMP SAN PROSPERO S.p.A.
Via della Pace, 25/A
41030 San Prospero (Modena)
Italy
And
PharmaCoDane ApS
Marielundvej 46 A,
DK-2730 Herlev
Denmark
And
Clonmel Healthcare Ltd
Waterford Road,
Clonmel, Co. Tipperary
Ireland

This medicinal product is authorized in the Member States of the EEA under the following
names:
UK: Toltrat XL 2 mg/4 mg Prolonged-release Capsules
DK: Tolterodin “Stada”
ES: Tolterodina Neo STADA 4 mg cápsulas duras de liberación prolongada EFG
IE: Toltertan SR 2 mg/4 mg Prolonged-Release Capsules
SE : Tolterodin STADA depotkapsel, hård
This leaflet was last revised in 09/2016.
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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.

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