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TOLTHEN XL 4 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): TOLTERODINE L-TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
[Tolterodine] 2 mg prolonged-release capsules, hard
[Tolterodine] 4 mg prolonged-release capsules, hard
Tolterodine tartrate
Read all of this leaflet carefully before you start using 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. 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.
In this leaflet:
1.
What [Tolterodine] is and what it is used for
2.
Before you take [Tolterodine]
3.
How to take [Tolterodine]
4.
Possible side effects
5.
How to store [Tolterodine]
6.
Further information

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

are allergic (hypersensitive) to tolterodine or any of the other ingredients in
[Tolterodine] (see section 6 for a list of the ingredients)

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

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

suffer from myasthenia gravis (excessive weakness of the muscles)

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

suffer from a toxic megacolon (acute dilatation of the colon).
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Take special care with [Tolterodine]:

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.
Contains approximately 67.2mg lactose (33.6mg glucose and 33.6mg galactose) per dose. This
should be taken into account in patients with diabetes mellitus.
This medicinal product contains 0.00404 mmol (or 0.092988 mg) sodium per dose. To be taken
into consideration by patients on a controlled sodium diet.
Talk to your doctor or pharmacist before starting your treatment with [Tolterodine] if you think
any of these might apply to you.
Taking other medicines
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 [Tolterodine], 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
[Tolterodine] 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 [Tolterodine]
(antimuscarinic properties) or medicines with an opposite mode of action to
[Tolterodine] (cholinergic properties). The reduction in gastric motility caused by
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antimuscarinics may affect the absorption of other drugs. Ask your doctor if you are unsure.
Taking [Tolterodine] with food and drink
[Tolterodine] can be taken before, after or during a meal.
Pregnancy and breast-feeding
Pregnancy
You should not use [Tolterodine] 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 [Tolterodine], is excreted in the mother’s
breast milk. Breast-feeding is not recommended during administration of [Tolterodine].
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
[Tolterodine] may make you feel dizzy, tired or affect your sight. If you experience any of
these affects then you should not drive your car or operate heavy machinery.
3. How to take [Tolterodine]

Dosage:
Always take [Tolterodine] exactly as your doctor has told you.
doctor or pharmacist if you are not sure.

You should check with your

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 [Tolterodine]
daily.
Children:
[Tolterodine] is not recommended for children.
If you have taken more [Tolterodine] 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.
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If you forget to take [Tolterodine]:
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.
If you stop taking [Tolterodine]
Your doctor will tell you how long your treatment with [Tolterodine] 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, [Tolterodine] 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 [Tolterodine] 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




Dizziness
Headache
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Dry eyes
Difficulty with digestion
(dyspepsia)
Abdominal pain




Blurred vision
Constipation



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




Painful or difficult urination

Extra fluid in the body causing 
swelling (e.g. in the ankles)
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 [Tolterodine]
Keep [Tolterodine] out of the reach and sight of children.
Do not use [Tolterodine] 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 [Tolterodine] contains
The active substance in [Tolterodine] 2 mg prolonged-release capsules, hard is 2 mg of
tolterodine tartrate, equivalent to 1.37 mg of tolterodine.
The active substance in [Tolterodine] 4 mg prolonged-release capsules, hard is 4 mg of
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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 [Tolterodine] looks like and contents of the pack
[Tolterodine] is a hard prolonged-release capsule designed for once daily dosing.
[Tolterodine] 2 mg prolonged-release hard capsules are opaque green-opaque-green.
[Tolterodine] 4 mg prolonged-release hard capsules are light blue-opaque-light blue opaque.
[Tolterodine] 2 mg prolonged-release hard capsules are available in the following pack sizes:
Blister packs containing: 14, 28, 30, 50, 84, 100 prolonged-release hard capsules

[Tolterodine] 4 mg prolonged-release hard capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 49, 84, 98 prolonged-release hard capsules
For 2mg and 4mg:
HPDE bottles containing: 30, 100 and 200 prolonged-release hard capsules.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:

Manufacturer:
Pharmathen S.A
6, Dervenakion Str., Pallini Attiki, 153 51, Greece
Pharmathen International S.A
Sapes Industrial Park, Block 5, Rodopi, 69300, Greece

This medicinal product is authorized in the Member States of the EEA under the following
names:
UK
DE
PL

Toldone XL 2mg, 4mg prolonged release capsules
Tolterodin-Hormosan 4mg Hartkapseln, retardiert
Titlodine 2mg, 4mg prolonged release capsules
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IT
BE
LU
NL

Tolterodina Doc
Urolina 2mg, 4mg prolonged release capsules
Urolina 2mg, 4mg prolonged release capsules
Uroline 2mg, 4mg prolonged release capsules

This leaflet was last approved in

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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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