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CARISTENOL 2 MG PROLONGED-RELEASE CAPSULES

Active substance(s): TOLTERODINE TARTRATE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Tolterodine Tartrate

Market

UK

Language

UK

Size

170 x 550 mm (PIL)

Min. Font Size

8

Version No.

2 (Page 1 of 2)

Date

24~05~16 (Tolterodine Tartrate (ACC-UK)PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Package leaflet: Information for the user

Caristenol 2 mg
prolonged-release
capsules
Caristenol 4 mg
prolonged-release
capsules
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.
What is in this leaflet:
1. What Caristenol is and what it is used for
2. What you need to know before you take
Caristenol
3. How to take Caristenol
4. Possible side effects
5. How to store Caristenol
6. Contents of the pack and other information

1. What Caristenol is and what it
is used for
The active substance in Caristenol is tolterodine.
Tolterodine belongs to a class of medicinal
products called antimuscarinics. Caristenol 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 Caristenol
Do not take Caristenol 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).
Warnings and precautions
Tell your doctor before you take these capsules if
you:
- have difficulties in passing urine and/or a poor
stream of urine
- have a gastro-intestinal disease that affects the
passage and/or digestion of food
- suffer from kidney problems (renal insufficiency)
- have a liver condition
- suffer from neuronal disorders that affect your
blood pressure, bowel or sexual function (any
neuropathy of the autonomic nervous system)
- have a hiatal hernia (herniation of an abdominal
organ)
- ever experience decreased bowel movements
or suffer from severe constipation (decreased
gastro-intestinal motility)
- have a heart condition such as:
oan abnormal heart tracing (ECG);
oa slow heart rate (bradycardia);
orelevant pre-existing cardiac diseases such as:
 cardiomyopathy (weak heart muscle)
 myocardial ischaemia (reduced blood flow to
the heart)
 arrhythmia (irregular heartbeat)
 and heart failure
- 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 Caristenol if you think any of
these might apply to you.
Other medicines and Caristenol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Tolterodine, the active substance of Caristenol,
may interact with other medicinal products.
It is not recommended to use Caristenol 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.
Caristenol 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
Caristenol (antimuscarinic properties)
or
medicines with an opposite mode of action to
Caristenol (cholinergic properties). Ask your
doctor if you are unsure.

Approved By
Quality Assurance

Caristenol with food and drink
Caristenol can be taken before, after or during a
meal.
Pregnancy, breast-feeding and lactation
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
You should not use Caristenol when you are
pregnant.
Breast-feeding
It is not known if tolterodine, the active substance
of Caristenol, is excreted in the mother’s breast
milk. Breast-feeding is not recommended during
administration of Caristenol.
Driving and using machines
Caristenol may make you feel dizzy, tired or
affect your sight; your ability to drive or operate
machinery may be affected.

3. How to take Caristenol
Dosage
Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
The usual dose is one 4 mg prolonged-release
capsule daily, except for patients who have a
kidney or a liver condition or troublesome side
effects, in which case your doctor may reduce
your dose to 2 mg Caristenol daily.
Caristenol is not recommended for children.
The prolonged-release capsules are for oral use
and should be swallowed whole. Do not chew the
capsules.
Duration of treatment
Your doctor will tell you how long your treatment
with Caristenol 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 take more Caristenol than you should
If you or somebody else takes too many
prolonged-release capsules, contact your doctor
or pharmacist immediately.
If you forget to take Caristenol
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 dose.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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 (may affect up to 1 in
100 people).
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).
The following side effects have been observed
during treatment with Caristenol with the
following frequencies.
Very common side effects (may affect more
than 1 in 10 people) are:
- Dry mouth
Common side effects (may affect up to 1 in 10
people) are:
- Sinusitis
- Dizziness, sleepiness, headache
- Dry eyes, blurred vision
- Difficulty with digestion (dyspepsia),
constipation, abdominal pain, excessive
amounts of air or gases in the stomach or the
intestine
- Painful or difficult urination
- Tiredness
- Extra fluid in the body causing swelling (e.g. in
the ankles)
- Diarrhoea
Uncommon side effects (may affect up to 1 in
100 people) are:
- Allergic reactions
- Nervousness
- Sensation of pins and needles in the fingers
and toes
- Vertigo
- Palpitations, heart failure, irregular heartbeat
- Inability to empty the bladder
- Chest pain
- Memory impairment

Note: PIL is required centrally folded in bible paper

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Tolterodine Tartrate

Market

UK

Language

UK

Size

170 x 550 mm (PIL)

Min. Font Size

8

Version No.

2 (Page 2 of 2)

Date

24~05~16 (Tolterodine Tartrate (ACC-UK)PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

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.
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
United Kingdom
The Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.

Approved By
Quality Assurance

Netherland

Tolterodine Accord 2/4 mg
capsules met verlengde afgifte,
hard
Norway
Caristenol
Poland
Caristenol
Sweden
Tolterodine Accord 2/4 mg
Depotkapsel, hård
United Kingdom Caristenol 2/4 mg prolongedrelease capsules
Spain
Tolterodine Accord 2/4 mg
Cápsuladura de liberaciónpro
longada
This leaflet was last revised in 05/2016.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Caristenol
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any
special storage conditions.
Do not use this medicine after the expiry date
which is stated on the carton and on the blister
after “EXP”. The expiry date refers to the last day
of that month.
Do not use this medicine if you notice the pack
that is damaged or shows signs of tampering.
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 to protect the environment.

6. Contents of the pack and
other information
What Caristenol contains
The active substance is tolterodine.
For 2 mg: Each prolonged-release capsule
contains tolterodine tartrate 2 mg corresponding
to 1.37mg tolterodine.
For 4 mg: Each prolonged-release capsule
contains tolterodine tartrate 4 mg corresponding
to 2.74mg tolterodine.
The other ingredients are:
Capsule contents: Microcrystalline cellulose
spheres, hypromellose, talc, ethylcellulose,
medium chain triglycerides and oleic acid.
Capsule shell: Gelatin, indigo carmine (E132),
titanium dioxide (E171) and yellow iron oxide
(E172) (for 2mg only).
Printing ink [Shellac, titanium dioxide, propylene
glycol, potassium hydroxide and ammonium
hydroxide].
What Caristenol looks like and contents of the
pack
Caristenol 2 mg are dark green/dark green size
‘4’, approximately 14 mm in length, hard gelatin
capsule with imprinting bar lines on cap and
body.
Caristenol 4 mg are dark blue /dark blue size ‘3’,
approximately 16 mm in length, hard gelatin
capsule with imprinting bar lines on cap and
body.
Caristenol 2mg/4 mg are available in Aluminium
-PVC/PVdC blister pack.
Pack sizes: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60,
80, 84, 90, 98,100, 112, 160, 200, 280 or 320
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Wessling Hungary Kft
Fòti ùt 56., Budapest 1047,
Hungary
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Member States Invented Names
Austria
Tolterodine Accord 2/4 mg
Hartkapsel, retardiert
Bulgaria
Tolterodine Акорд 2/4 мг
Капсула с
удълженоосвобождаване,
твърда
Germany
Tolterodine Accord 2/4 mg
Hartkapsel, retardiert
Estonia
Tolterodine Accord
Finland
Tolterodine Accord 2mg/4mg
depotkapseli, kova
Ireland
Caristenol 2/4 mg prolongedrelease capsules
Lithuania
Tolterodine Accord 2/4 mg
pailginto atpalaidavimo
kietosios kapsulės
INP001
10 00000 0 000000

Note: PIL is required centrally folded in bible paper

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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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