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TOLTERODINE ARISTO 4 MG PROLONGED-RELEASE CAPSULES

Active substance(s): TOLTERODINE TARTRATE / TOLTERODINE TARTRATE / TOLTERODINE TARTRATE

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Package leaflet: Information for the patient
Tolterodine Aristo 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 Tolterodine Aristo is and what it is used for
2. What you need to know before you take Tolterodine Aristo
3. How to take Tolterodine Aristo
4. Possible side effects
5. How to store Tolterodine Aristo
6. Contents of the pack and other information

1.

What Tolterodine Aristo is and what it is used for

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

Do not take Tolterodine Aristo 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);
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ever experience decreased bowel movements or suffer from severe constipation (decreased
gastro-intestinal motility);
have a heart condition such as:
o an abnormal heart tracing (ECG)
o a slow heart rate (bradycardia)
o 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.

Talk to your doctor or pharmacist before taking Tolterodine Aristo if you think any of these might
apply to you.
Other medicines and Tolterodine Aristo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tolterodine, the active substance of Tolterodine Aristo, may interact with other medicinal products.
It is not recommended to use Tolterodine Aristo 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.
Tolterodine Aristo 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 Tolterodine Aristo (antimuscarinic properties)
or medicines with an opposite mode of action to Tolterodine Aristo (cholinergic properties). Ask
your doctor if you are unsure.
Tolterodine Aristo with food and drink
Tolterodine Aristo 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 Tolterodine Aristo when you are pregnant.
Breast-feeding
It is not known if tolterodine, the active substance of Tolterodine Aristo, is excreted in the mother’s
breast milk. Breast-feeding is not recommended during administration of Tolterodine Aristo.
Driving and using machines
Tolterodine Aristo may make you feel dizzy, tired or affect your sight; your ability to drive or operate
machinery may be affected.

3.

How to take Tolterodine Aristo
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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
Tolterodine Aristo daily.
Tolterodine Aristo 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 Tolterodine Aristo 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 Tolterodine Aristo 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 Tolterodine Aristo
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).
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The following side effects have been observed during treatment with Tolterodine Aristo 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
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 Yellow Card Scheme; website:
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 Tolterodine Aristo

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 Tolterodine Aristo 4 mg prolonged-release capsules contain
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The active substance is tolterodine.
Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74 mg
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) and titanium dioxide (E171)
Printing ink: Shellac, titanium dioxide, propylene glycol, potassium hydroxide and ammonium
hydroxide
What Tolterodine Aristo 4 mg prolonged-release capsules look like and contents of the pack
Tolterodine Aristo 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.
Tolterodine Aristo 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
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
Tel.: +49 30 71094-4200
Fax: +49 30 71094-4250

This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany
Tolterodin Aristo® 4 mg Retardkapseln
United Kingdom Tolterodine Aristo 4 mg prolonged-release capsules

This leaflet was last approved in December 2016.

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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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