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SANTIZOR XL 4MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): TOLTERODINE TARTRATE

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NERO

These may be symptoms of heart failure. This occurs uncommonly (may affect up to 1
in 100 people).

Package leaflet: Information for the user

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

Santizor XL 4mg

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

Very common: (may affect more than 1 in 10 people)
• Dry mouth
Common: (may affect up to 1 in 10 people)
• 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: (may affect up to 1 in 100 people)
• 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
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.

1. What Santizor XL is and what it is used for
Santizor XL contains the active substance tolterodine. Tolterodine belongs to a class
of medicinal products called antimuscarinics.
Santizor 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.

If you get any of the side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
5. How to store Santizor XL
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 carton, bottle label
and blister after EXP. The expiry date refers to the last day of that month.

2. What you need to know before you take Santizor XL
Do not take Santizor XL:
• If you are allergic (hypersensitive) to tolterodine or any of the other ingredients of
this medicine (listed in section 6)
• If you are unable to pass urine from the bladder (urinary retention)
• If you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with
loss of eyesight that is not being adequately treated)
• If you suffer from myasthenia gravis (excessive weakness of the muscles)
• If you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
• If you suffer from a toxic megacolon (acute dilatation of the colon).
Warnings and precautions
Talk to your doctor or pharmacist before taking Santizor 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 neuronal disorders that affect your blood pressure, bowel or
sexual function (any neuropathy of the autonomic nervous system)
• If you have a hiatal 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.
Children and adolescents
Efficacy of Santizor XL has not been demonstrated in children. Therefore, Santizor XL
is not recommended for children.
Other medicines and Santizor XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tolterodine, the active substance of Santizor XL, 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.
Santizor 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 Santizor XL (antimuscarinic
properties) or medicines with an opposite mode of action to Santizor XL (cholinergic
properties).

Do not store above 25°C.
Bottle: Store in the original container in order to protect from light.
Blisters: Keep the blister in the outer carton in order to protect from light.
Do not use this medicine if you notice the capsules are damaged.
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 Santizor XL contains
The active substance is tolterodine.
Each capsule contains 4 mg tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
The other ingredients are:
Capsule contents: Sugar spheres (containing sucrose and maize starch), hypromellose,
ethylcellulose, medium chain triglycerides and oleic acid.
Capsule shell: Gelatine and colorants.
Colorants:
Blue 4 mg prolonged-release capsule: Indigo carmine (E132) and titanium dioxide
(E171).
Printing ink: Shellac glaze, titanium dioxide (E171), propylene glycol and simeticone.
What Santizor XL looks like and contents of the pack
Santizor XL is a hard prolonged-release capsule designed for once daily dosing.
Santizor XL 4 mg prolonged-release capsules are blue and marked with white printing
(symbol and 4).
Santizor XL 4 mg prolonged-release capsules are available in blister packs of 7, 14, 28,
49, 84, 98 and 280 capsules.
And bottles containing 30, 100 and 200 capsules.
Hospital packs are available in packs of 80, 160 and 320 capsules.
Not all pack sizes may be marketed.
Marketing authorisation holder and Manufacturer
Marketing authorisation holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer:
Pfizer Italia S.r.l
Località Marino del Tronto
63100 Ascoli Piceno
Italy
This leaflet was last revised in: 07/2012
Ref: dDT 2_0

Santizor XL with food and drink
Santizor 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 use Santizor XL when you are pregnant.
Breast-feeding
It is not known if tolterodine, the active substance of Santizor XL, is excreted in the
mother’s breast milk. Breast-feeding is not recommended during administration of
Santizor XL.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Santizor XL may make you feel dizzy, tired or affect your sight; your ability to drive or
operate machinery may be affected.
Santizor XL contains sucrose (a type of sugar)
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
3. How to take Santizor XL
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 recommended 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 tolterodine tartrate daily.
Method of administration:
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 Santizor 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.
If you take more Santizor XL 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 Santizor 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 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.
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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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