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INCONEX XL 4 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): TOLTERODINE L-TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Inconex XL 2 mg Prolonged-release Capsules, Hard
Inconex XL 4 mg Prolonged-release Capsules, Hard
Tolterodine tartrate
Read all of this leaflet carefully before you start taking 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 only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
In this leaflet
1. What Inconex XL is and what it is used for
2. What you need to know before you take
Inconex XL
3. How to take Inconex XL
4. Possible side effects
5. How to store Inconex XL
6. Contents of the pack and other information

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of action to Inconex 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.

What Inconex XL is and what it is
used for

The active substance in Inconex XL is tolterodine.
Tolterodine belongs to a class of medicinal products
called antimuscarinics.

Inconex XL with food and drink
Inconex XL can be taken before, after or during a
meal.

Inconex 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.

Pregnancy, breast-feeding and fertility
Pregnancy
You should not use Inconex XL when you are
pregnant. Tell your doctor immediately if you are
pregnant, think you are pregnant or are planning to
become pregnant.

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Breast-feeding
It is not known if tolterodine, the active substance of
Inconex XL, is excreted in the mother’s breast milk.
Breast-feeding is not recommended during
administration of Inconex XL.

What you need to know before you
take Inconex XL

Do not take Inconex XL if you:
• are allergic to tolterodine or any of the other
ingredients Of this medicine (listed in section 6)
• 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)

Ask your doctor or pharmacist for advice before
taking any medicine.
Inconex 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.
Driving and using machines
Inconex 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Inconex 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 gastrointestinal 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.

How to take Inconex XL

Always take this medicine exactly as your doctor
has told you. 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 Inconex XL daily.
Children:
Inconex XL is not recommended for children.
If you take more Inconex 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 Inconex 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.

Talk to your doctor or pharmacist before starting
your treatment with Inconex XL if you think any of
these might apply to you.
Other medicines and Inconex XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

If you stop taking Inconex XL
Your doctor will tell you how long your treatment
with Inconex 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.

Tolterodine, the active substance of Inconex XL,
may interact with other medicinal products.
It is not recommended to use Inconex Xl 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

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.

Inconex 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 Inconex XL (antimuscarinic
properties) or medicines with an opposite mode

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If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Continued on the next page >>

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The other ingredients are:
Lactose monohydrate, cellulose microcrystalline,
poly (vinyl acetate), povidone, silica, sodium
laurylsulfate, docusate sodium, magnesium
stearate (E470b), hydroxypropylmethylcellulose

Possible side effects

Like all medicines, this midicine can cause side
effects, although not everybody gets them.

Capsule composition: indigo carmine (E132),
quinoline yellow (only in 2 mg) (E104), titanium
dioxide (E171), gelatin

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.

Inner tablet coating: ethylcellulose, triethyl citrate,
methacrylic acid - ethyl acrylate copolymer, 1,
2-Propylene glycol
What Inconex XL looks like and contents of the
pack
Inconex XL is a hard prolonged-release capsule
designed for once daily dosing.

You should also seek medical attention if you
experience a hypersensitivity reaction (for example
itching, rash, hives, difficulty breathing). This
occurs uncommonly (may affect up to 1 in 100
people).

Inconex XL 2 mg prolonged-release hard capsules
are opaque green-opaque-green containing two
white, round, biconvex coated tablets.

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 (may affect up to 1 in 100
people).

Inconex XL 4 mg prolonged-release hard capsules
are light blue-opaque-light blue opaque containing
four white, round, biconvex coated tablets.
Inconex XL 2 mg and 4 mg prolonged-release hard
capsules are available in the following pack sizes:

The following side effects have been observed
during treatment with Inconex XL with the following
frequencies.

Blister packs containing: 7, 14, 28, 30, 49, 50, 56,
80, 84, 90, 98, 100, 112, 160, 280, 320
prolonged-release hard capsules.

Very common side effects (may affect more than
1 in 10 people) are:
• Dry mouth

HPDE bottles containing: 30, 60, 100 and 200
prolonged-release hard capsules.
Not all pack sizes may be marketed.

Common side effects (may affect up to 1 in 10
people) are:















Marketing authorisation holder and
manufacturer

Sinusitis
Sleepiness
Dry eyes
Difficulty with digestion (dyspepsia)
Abdominal pain
Painful or difficult urination
Extra fluid in the body causing swelling
(e.g. in the ankles)
Dizziness
Headache
Blurred vision
Constipation
Excessive amounts of air or gases in the
stomach or the intestine
Diarrhoea
Tiredness

Marketing authorisation holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Pharmathen S.A ,
6, Dervenakion Str.,
153 51 Pallini Attiki,
Greece
or
Pharmathen International S.A,
Sapes Industrial Park,
Block 5, 69300 Rodopi,
Greece

Uncommon side effects (may affect up to 1 in
100 people) 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

or
Portfarma ehf,
Borgartúni 26, 105 Reykjavík,
Iceland
or
Pharmadox Healthecare Ltd,
KW20A Kordin Industrial Park,
Paola, PLA 3000,
Malta

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.

or
Pharmacare Premium Ltd,
HHF 003, Hal Far Industrial Estate,
Birzebbugia BBG3000,
Malta
or

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme:
www.mhra.gov.uk/yellowcard By reporting side
effects you can help provide more information on
the safety of this medicine.

5

Salutas Pharma GmbH,
Otto-von-Guericke Allee 1,
39179 Barleben,
Germany
or
Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia.

How to store Inconex XL

This leaflet was last revised in 04/2015.
Keep this medicine out of the sight and reach of
children.
Do not use this medicine 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.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6

Contents of the pack and other
information

What Inconex XL contains
The active substance in Inconex XL 2 mg
prolonged-release capsules, hard is 2 mg of
tolterodine tartrate, equivalent to 1.37 mg of
tolterodine.

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The active substance in Inconex XL 4 mg
prolonged-release capsules, hard is 4 mg of
tolterodine tartrate, equivalent to 2.74 mg of
tolterodine.

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SZ00000LT000

Artwork Proof Box
Ref: V017 - SPC & PIL Updated Text
Proof no.
003.1

Date prepared:
14/04/2015

Colours:
Black
Dimensions: 170 x 500 mm

Font size:
9pt
Fonts:
Helvetica

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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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