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MARIOSEA XL 2 MG PROLONGED-RELEASE CAPSULES

Active substance(s): TOLTERODINE L-TARTRATE

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TEVA UK Ref:

231-30-11602-E LEA TOLTERODINE TARTRATE (MARIOSEA XL) CAPS TUK Dimensions:
Length:
Width:
Depth:

500 mm
170 mm

Version:

3

Colours Used:

18 April 2016
PANTONE® GREEN C

Template

Package leaflet: Information for the patient

MARIOSEA XL 2 mg AND 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.
In this leaflet:
1. What Mariosea XL Prolonged-release Capsules are and what they are used for
2. What you need to know before you take Mariosea XL Prolonged-release Capsules
3. How to take Mariosea XL Prolonged-release Capsules
4. Possible side effects
5. How to store Mariosea XL Prolonged-release Capsules
6. Contents of the pack and other information

1. WHAT MARIOSEA XL PROLONGED-RELEASE CAPSULES ARE AND WHAT THEY ARE
USED FOR
The active substance in Mariosea XL is tolterodine. Tolterodine belongs to a class of medicines
called antimuscarinics.
Mariosea 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 MARIOSEA XL
PROLONGED-RELEASE CAPSULES
Do not take Mariosea 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).

500 mm

Warnings and precautions
Talk to your doctor or pharmacist before taking Mariosea XL 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)
• 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
• have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or
magnesium (hypomagnesaemia) in your blood.
Other medicines and Mariosea XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tolterodine, the active substance of Mariosea XL, may interact with other medicines.
It is not recommended to take Mariosea XL in combination with:
• some antibiotics (containing e.g. erythromycin, clarithromycin)
• medicines used for the treatment of fungal infections (containing e.g. ketoconazole,
itraconazole)
• medicines used for the treatment of HIV.
Mariosea 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 Mariosea XL (antimuscarinic properties) or
medicines with an opposite mode of action to Mariosea XL (cholinergic properties). The
reduction in gastric motility caused by antimuscarinics may affect the absorption of other
drugs.
Mariosea XL with food
Mariosea XL 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.
Pregnancy
You should not take Mariosea XL when you are pregnant.
Breast-feeding
It is not known if tolterodine, the active substance of Mariosea XL, is excreted in the mother’s
breast milk. Breast-feeding is not recommended during administration of Mariosea XL.
Driving and using machines
Mariosea 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.
Mariosea 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 medicine.

3. HOW TO TAKE MARIOSEA XL PROLONGED-RELEASE CAPSULES
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Adults
The recommended 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 Mariosea XL
daily.
Use in children
Mariosea XL is not recommended for children.
Method of administration
The prolonged-release capsules, hard 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 Mariosea 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.

BLACK

TEVA UK Ref:

231-30-11602-E LEA TOLTERODINE TARTRATE (MARIOSEA XL) CAPS TUK Dimensions:
Length:
Width:
Depth:

500 mm
170 mm

Version:

Colours Used:

3

18 April 2016
PANTONE® GREEN C
BLACK

Template

If you take more Mariosea 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 Mariosea 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 dose.
If you stop taking Mariosea XL
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.

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 Mariosea XL 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
• Diarrhoea
• Extra fluid in the body causing swelling (e.g. in the ankles)
• Tiredness.
Uncommon side effects (may affect up to 1 in 100 people) are:
• Allergic reactions
• Heart failure
• Nervousness
• Irregular heartbeat, palpitations
• Chest pain
• Inability to empty the bladder
• Sensation of pins and needles in the fingers and toes
• Vertigo
• Memory impairment.

500 mm

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 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.

5. HOW TO STORE MARIOSEA XL PROLONGED-RELEASE CAPSULES
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 Mariosea XL Prolonged-release Capsules contains
The active substance is tolterodine tartrate.
Each 2 mg prolonged-release capsule, hard contains 2 mg of tolterodine tartrate, equivalent to
1.37 mg of tolterodine.
Each 4 mg prolonged-release capsule, hard contains 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
laurilsulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose
2 mg
Capsule composition: indigo carmine (E132), quinoline yellow (E104), titanium dioxide (E171),
gelatin
4 mg
Capsule composition: indigo carmine (E132), titanium dioxide (E171), gelatin
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer,
1, 2-Propylene glycol.
What Mariosea XL Prolonged-release Capsules look like and contents of the pack
Mariosea XL Prolonged-release Capsules are prolonged-release capsule designed for once
daily dosing.
Mariosea XL 2 mg Prolonged-release Capsules are opaque green-opaque green.
Mariosea XL 4 mg Prolonged-release Capsules are light blue-opaque-light blue opaque.
Mariosea XL Prolonged-release Capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 30, 49, 50, 80, 84, 90, 98, 100, 160, 200, 280
prolonged-release capsules.
HDPE bottles containing: 30, 60, 100, 200 capsules.
Not all pack sizes may be marketed.
Marketing authorisation
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom.
Manufacturer
Pharmathen International S.A,
Sapes Industrial Park, Block 5, 69300
Rodopi, Greece
This leaflet was last revised in 04/2016.
PL 00289/1772
PL 00289/1773

11602-E

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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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