Skip to Content

PREBLACON XL 4 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): TOLTERODINE L-TARTRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Preblacon XL 4mg
Prolonged-release Capsules, hard
Tolterodine tartrate

• have a heart condition such as:
- an abnormal heart tracing (ECG)
- a slow heart rate (bradycardia)
- relevant pre-existing cardiac diseases such as:
c ardiomyopathy (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.

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 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.
•  The full name of this medicine is Preblacon XL 4mg Prolongedrelease Capsules, hard but within the leaflet it will be referred to
Preblacon capsules.

Other medicines and Preblacon capsules

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Tolterodine, the active substance of Preblacon capsules, may interact
with other medicinal products.

What is in this leaflet:
1 What Preblacon capsules are and what they are used
for
2  What you need to know before you take
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information

It is not recommended to use Preblacon capsules 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.
Preblacon capsules 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 Preblacon capsules
(antimuscarinic properties) or medicines with an opposite mode of
action to Preblacon capsules (cholinergic properties). The reduction in
gastric motility caused by antimuscarinics may affect the absorption of
other drugs. Ask your doctor if you are unsure.

1  What Preblacon capsules are and what they are used
for
The active substance in Preblacon capsules is tolterodine. Tolterodine
belongs to a class of medicinal products called antimuscarinics.
Preblacon capsules are 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
• need to rush to the toilet with no advance warning and/or go to the
toilet frequently.

Preblacon capsules with food and drink

Preblacon capsules can be taken before, after or during a meal.

Pregnancy and breast-feeding

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.

2  What you need to know before you take
Do not take Preblacon capsules if you

Pregnancy
You should not use Preblacon capsules when you are pregnant. Tell your
doctor immediately if you are pregnant, think you are pregnant or are
planning to become pregnant.

• 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).

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

Driving and using machines

Preblacon capsules 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 Preblacon 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 neurological disorders that affect your blood pressure,
bowel or sexual function (any neuropathy of the autonomic nervous
system)
• have a hiatus hernia (herniation of an abdominal organ)
• ever experience decreased bowel movements or suffer from severe
constipation (decreased gastro-intestinal motility)

Preblacon capsules 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.

Continued top of next column
AAAH4806

Continued over page

Preblacon XL (Tolterodine) 4mg PIL - UK
item no: AAAH4806

dimensions: 170 x 250

print proof no: 3

pharmacode:

origination date: 03.12.14

min pt size: 7

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
revision date: 17.12.14

Technical Approval

revised by: S.Anson

date sent: 03.12.14

supplier: Pharmathen

technically app. date:

Non Printing Colours
1.
2.
3.

• Headache
• Blurred vision
• Constipation
• Excessive amounts of air or gases in the stomach or the intestine
• Diarrhoea
• Tiredness.

3 How to take
Dosage
Always take this medicine exactly as your doctor or pharmacist 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.

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
• S ensation of pins and needles in the fingers and toes
• Memory impairment.

Adults
The recommended 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 2mg Preblacon capsules daily.
Use in children and adolescents
Preblacon capsules is not recommended for children.

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 you take more Preblacon capsules 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.

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 at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

If you forget to take Preblacon capsules

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 stop taking Preblacon capsules

Your doctor will tell you how long your treatment with Preblacon
capsules 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.

5 How to store
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.

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 medicine, ask your
doctor or pharmacist.

6 Contents of the pack and other information
What Preblacon capsules contains

4 Possible side effects

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

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

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), titanium dioxide (E171),
gelatin.
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid-ethyl
acrylate copolymer and 1,2-Propylene glycol.

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).

What Preblacon capsules look like and contents of the pack
Preblacon XL 4mg Prolonged-release Capsules, hard are hard
prolonged-release capsules designed for once daily dosing.
Preblacon XL 4mg Prolonged-release Capsules, hard are light
blue-opaque-light blue opaque.
Blister packs containing: 28 prolonged-release capsules.

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).

Marketing authorisation holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
Manufacturer
Pharmathen S.A ,
6, Dervenakion Str., 153 51 Pallini Attiki, Greece

The following side effects have been observed during treatment with
Preblacon capsules with the following frequencies.
Very common side effects (occurs in more than 1 in 10 patients) are
• Dry mouth.

Pharmathen International S.A
Sapes Industrial Park, Block 5, 69300 Rodopi, Greece

Common side effects (occurs in less than 1 in 10 patients) are
• Facial pain/pressure, congested or runny nose (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

This leaflet was last revised in December 2014

Continued top of next column
AAAH4806

Actavis, Barnstaple, EX32 8NS, UK

Preblacon XL (Tolterodine) 4mg PIL - UK
item no: AAAH4806

dimensions: 170 x 250

print proof no: 3

pharmacode:

origination date: 03.12.14

min pt size: 7

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
revision date: 17.12.14

Technical Approval

revised by: S.Anson

date sent: 03.12.14

supplier: Pharmathen

technically app. date:

Non Printing Colours
1.
2.
3.

Expand view ⇕

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