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TOLTERODINE ARISTO 4 MG PROLONGED-RELEASE CAPSULES

Active substance(s): TOLTERODINE TARTRATE

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PA C K A G E L E A F L E T: I N F O R M AT I O N F O R T H E PAT I E N T

Tolterodine

Produkt

Tolterodin Aristo
4 mg Filmtabletten

Land

United Kingdom (UK)

Größe

210 x 290 mm

Schriftgröße

9 pt

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
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);
- 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.
Talk to your doctor or pharmacist before taking Tolterodine Aristo
if you think any of these might apply to you.

4. Possible side effects
5. How to store Tolterodine Aristo
6. Contents of the pack and other information
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
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.

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
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

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

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.

The following side effects have been observed during treatment
with Tolterodine Aristo with the following frequencies.

Tolterodine Aristo 4  mg are available in Aluminium-PVC/PVdC
blister pack.

Very common side effects (may affect more than 1 in 10 people)
are:
- Dry mouth

Pack sizes: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 80, 84, 90, 98,100,
112, 160, 200, 280 or 320 capsules

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
GIXXXXXXX-XX/UK/XXXX

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin, Germany
Tel.: +49 30 71094-4200
Fax: +49 30 71094-4250
Manufacturer
Accord Healthcare Limited
Ground floor, 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:
Germany
Tolterodin Aristo® 4 mg Retardkapseln
United Kingdom Tolterodine Aristo 4 mg prolonged-release capsules
This leaflet was last approved in May 2016.

Code xxx

XXXXXXXXX/X

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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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