Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Tolterodine tartrate 1mg film-coated tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tolterodine tartrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 2. What you need to know before you take Tolterodine tartrate • medicinal products used for the treatment of HIV. Tolterodine should be used with caution when taken in 3. How to take Tolterodine tartrate combination with: 4. Possible side effects
- medicines that affect the passage of food (containing e.g. 5. How to store Tolterodine tartrate metoclopramide and cisapride) 6. Contents of the pack and other information
- medicines for the treatment of irregular heartbeat (containing e.g. amiodarone, sotalol, quinidine, procainamide) 1. WHAT TOLTERODINE TARTRATE IS AND • other medicinal products with a similar mode of action to WHAT IT IS USED FOR Tolterodine tartrate (antimuscarinic properties) or with an Tolterodine belongs to a class of medicinal products called opposite mode of action to Tolterodine tartrate antimuscarinics. (cholinergic properties). Tolterodine tartrate is used for the treatment of the symptoms Pregnancy and Breast-feeding of overactive bladder syndrome. If you have overactive bladder syndrome you may find that you are unable to control If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or urination, that you need to rush to the toilet with no advance pharmacist for advice before taking this medicine. warning and/or go to the toilet frequently. Pregnancy
What you need to know before you take it
E You should not use Tolterodine tartrate when you are pregnant. Tell your doctor immediately if you are pregnant, TOLTERODINE TARTRATE think you are pregnant or are planning to become pregnant. Do not take Tolterodine tartrate Breast-feeding
- If you are allergic to tolterodine or any of the other It is not known if tolterodine is excreted in the mother's ingredients in this medicine (see section 6. breast milk. Breast-feeding is not recommended while taking "Further information"). this medicine.
- If you are unable to pass urine from the bladder Driving and using machines (urinary retention).
- If you have an increased eye pressure that is not being Tolterodine tartrate may make you feel dizzy, tired or affect adequately treated (uncontrolled narrow angle glaucoma). your sight. Your ability to drive or operate machinery may be affected.
- If you suffer from a certain muscle weakness (myasthenia gravis). Tolterodine tartrate contains lactose:
- If you suffer from an ulceration and inflammation of the If you have been told that you have an intolerance to some colon (severe ulcerative colitis). sugars speak to your doctor before taking Tolterodine tartrate.
- If you suffer from an acute dilation of the colon Tolterodine tartrate contains sodium (toxic megacolon). This medicine contains less than 1mmol sodium (23mg) per Warnings and precautions 1mg and 2mg film-coated tablets, that is to say essentially Talk to your doctor or pharmacist before taking "sodium-free". Tolterodine Tartrate.
- If you have difficulties in passing urine and/or a poor
How to take it
TOLTERODINE TARTRATE stream of urine. Always take Tolterodine tartrate exactly as your doctor has told
- If you have a gastrointestinal disease that affects the you. You should check with your doctor or pharmacist if you passage and/or digestion of food. are not sure.
- If you suffer from kidney problems. Adults
- If you have a liver condition. The recommended dose is 2mg twice daily. If you have liver
- If you suffer from neuronal disorders that affect your blood or kidney problems, your doctor may reduce your dose to one pressure, bowel or sexual function (autonomic neuropathy). 1mg tablet twice daily.
- If a part of your stomach protrudes through the diaphragm Tolterodine tartrate is not recommended for children. (hiatus hernia). The tablets are for oral use and should be swallowed whole.
- If you experienced decreased bowel movements or suffer Tolterodine tartrate can be taken before, after or during a meal. from severe constipation. If you take more Tolterodine tartrate than you should:
- If you have a heart condition such as:
- an abnormal heart tracing (ECG) If you or somebody else takes too many tablets, contact your doctor or pharmacist immediately.
- a slow heart rate (bradycardia)
- relevant pre-existing cardiac diseases (weak heart muscle Symptoms in case of overdose include convulsions, [cardiomyopathy], reduced blood flow to the heart hallucinations, excitation, a heartbeat faster than usual, dilation [myocardial ischaemia], irregular heartbeat [arrhythmia] of the pupil and inability to urinate or breathe normally. and heart failure).
If you forget to take Tolterodine tartrate 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 the forgotten dose. If you stop taking Tolterodine tartrate Your doctor will tell you how long your treatment with Tolterodine tartrate 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 tablets 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 have any further questions on the use of this product, ask your doctor or pharmacist.
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 (allergic reaction), such as:
- swollen face, tongue or pharynx
- difficulty swallowing
- hives and difficulty in breathing This occurs uncommonly (occurs in less than 1 in 100 patients). 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). 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). The following side effects have been observed during treatment with Tolterodine tartrate with the following frequencies. Very common side effects (may affect more than 1 in 10 people):
- Dry mouth
- Headache Common side effects (may affect up to 1 in 10 people):
- Bronchitis
- Dizziness, sleepiness, sensation of pins and needles in the fingers and toes
- Dry eyes, blurred vision
- Vertigo
- Palpitations
- Difficulty with digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine, vomiting
- Dry skin
- Painful or difficult urination, inability to empty the bladder
- Tiredness, chest pain, extra fluid in the body causing swelling (e.g. in the ankles)
- Increased weight
- Diarrhoea Uncommon side effects (may affect up to 1 in 100 people):
- Allergic reactions
- Nervousness
- Increased heart rate, heart failure, irregular heartbeat
- Heart burn
- Memory impairment Additional reactions reported include severe allergic reactions, confusion, hallucinations, flushed skin, angioedema 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 of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
TOLTERODINE TARTRATE 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. No special precautions for storage. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Tolterodine tartrate contains The active substance is Tolterodine L-tartrate. Each 1mg film-coated tablet contains 1mg tolterodine L-tartrate (equivalent to 0.68mg of tolterodine). Each 2mg film-coated tablet contains 2mg tolterodine L-tartrate (equivalent to 1.37mg of tolterodine). The other ingredients are: Core: Microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate, silica colloidal anhydrous, magnesium stearate. Film-coating: Hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide (E171). What Tolterodine tartrate looks like and contents of the pack Tolterodine tartrate 1mg film-coated tablets are white, round biconvex film-coated tablets, embossed with "1" on one side. Tolterodine tartrate 2mg film-coated tablets are white, round biconvex film-coated tablets, embossed with "2" on one side and with a score line on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. PVC/PE/PVDC Aluminium blister: Pack sizes of 14, 20, 28, 30, 50, 56, 60 and 100 film-coated tablets. HDPE tablet container with a child-resistant PP screw cap: Pack sizes of 60 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: Aspire Pharma Ltd Unit 4, Rotherbrook Court, Bedford Rd Petersfield, Hampshire, GU32 3QG, United Kingdom Manufacturers: Pharmathen S.A 6, Dervenakion Str., 153 51 Pallini Attiki, Greece and Pharmathen International S.A Sapes Industrial Park, Block 5, 69300 Rodopi, Greece This leaflet was last revised: 05/2022
1010080-P6.1
Frequently asked questions about Tolterodine tartrate 1mg film-coated tablets
How do I take Tolterodine tartrate 1mg film-coated tablets?
Tolterodine tartrate 1mg film-coated tablets comes as tablet containing 1mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Tolterodine tartrate 1mg film-coated tablets?
The active substance in Tolterodine tartrate 1mg film-coated tablets is tolterodine tartrate.
Are there equivalent medicines to Tolterodine tartrate 1mg film-coated tablets?
Medicines with the same active substance, strength and form include: Detrusitol 1mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Tolterodine tartrate 1mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Tolterodine tartrate 1mg film-coated tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tolterodine tartrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
4.2. Posology and method of administration
Posology
Adults (including elderly)
The recommended dose is 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR ≤ 30 ml/min) for whom the recommended dose is 1 mg twice daily (see section 4.4). In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.
The effect of treatment should be re-evaluated after 2-3 months (see section 5.1).
Paediatric patients
Tolterodine tartrate is not recommended for use in children due to insufficient data on efficacy (see section 5.1).
4.3. Contraindications
Tolterodine is contraindicated in patients with:
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Urinary retention
• Uncontrolled narrow angle glaucoma
• Myasthenia gravis
• Severe ulcerative colitis
• Toxic megacolon
4.4. Special warnings and precautions for use
Tolterodine shall be used with caution in patients with:
• significant bladder outlet obstruction at risk of urinary retention
• gastrointestinal obstructive disorders, e.g. pyloric stenosis
• renal impairment (see section 4.2)
• hepatic disease. (see sections 4.2 and 5.2)
• autonomic neuropathy
• hiatus hernia
• risk for decreased gastrointestinal motility
Multiple oral total daily doses of immediate release 4 mg (therapeutic) and 8 mg (supratherapeutic) tolterodine have been shown to prolong the QTc interval (see section 5.1). The clinical relevance of these findings is unclear and will depend on individual patient risk factors and susceptibilities present.
Tolterodine should be used with caution in patients with risk factors for QT-prolongation including:
• congenital or documented acquired QT prolongation
• electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia
• bradycardia
• relevant pre-existing cardiac diseases (i.e. cardiomyopathy, myocardial ischaemia, arrhythmia, congestive heart failure)
• concomitant administration of drugs known to prolong QT-interval including Class IA (e. g. quinidine, procainamide) and Class III (e. g. amiodarone, sotalol) anti-arrhythmics
This especially holds true when taking potent CYP3A4 inhibitors (see section 5.1).
Concomitant treatment with potent CYP3A4 inhibitors should be avoided (see section 4.5).
As with all treatments for symptoms of urgency and urge incontinence, organic reasons for urge and frequency should be considered before treatment.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet. Patients on low sodium diets can be informed that this medicinal product is essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant systemic medication with potent CYP3A4 inhibitors such as macrolide antibiotics (e.g. erythromycin and clarithromycin), antifungal agents (e.g. ketoconazole and itraconazole) and antiproteases is not recommended due to increased serum concentrations of tolterodine in poor CYP2D6 metabolisers with (subsequent) risk of overdosage (see section 4.4).
Concomitant medication with other drugs that possess antimuscarinic properties may result in more pronounced therapeutic effect and side-effects. Conversely, the therapeutic effect of tolterodine may be reduced by concomitant administration of muscarinic cholinergic receptor agonists.
The effect of prokinetics like metoclopramide and cisapride may be decreased by tolterodine.
Concomitant treatment with fluoxetine (a potent CYP2D6 inhibitor) does not result in a clinically significant interaction since tolterodine and its CYP2D6-dependent metabolite, 5-hydroxymethyl tolterodine are equipotent.
Drug interaction studies have shown no interactions with warfarin or combined oral contraceptives (ethinyl estradiol/levonorgestrel).
A clinical study has indicated that tolterodine is not a metabolic inhibitor of CYP2D6, 2C19, 2C9, 3A4 or 1A2. Therefore an increase of plasma levels of drugs metabolised by these isoenzymes is not expected when dosed in combination with tolterodine.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of tolterodine in pregnant women.
Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Consequently, tolterodine is not recommended during pregnancy.
Breast-feeding
No data concerning the excretion of tolterodine into human milk are available. Tolterodine should be avoided during lactation.
4.7. Effects on ability to drive and use machines
Since this drug may cause accommodation disturbances and influence reaction time, the ability to drive and use machines may be negatively affected.
4.8. Undesirable effects
Summary of the safety profile
Due to the pharmacological effect of tolterodine it may cause mild to moderate antimuscarinic effects, like dryness of the mouth, dyspepsia and dry eyes.
The table below reflects the data obtained with tolterodine in clinical trials and from postmarketing experience. The most commonly reported adverse reaction was dry mouth, which occurred in 35% of patients treated with tolterodine and in 10% of placebo treated patients. Headaches were also reported very commonly and occurred in 10.1% of patients treated with tolterodine and in 7.4% of placebo treated patients.
Tabulated list of adverse reactions
The following adverse reactions have been reported in clinical trials and from postmarketing experience and are ranked using the following frequency: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
System Organ Class
Very common
Common
Uncommon
Not known
Infections and infestations
Bronchitis
Immune system disorders
Hypersensitivity not otherwise specified
Anaphylactoid reactions
Psychiatric disorders
Nervousness
Confusion , hallucinations disorientation
Nervous system disorders
Headaches
Dizziness, somnolence, paresthesia
Memory impairment
Eye disorders
Dry eyes, abnormal vision including abnormal accommodation
Ear and labyrinth disorders
Vertigo
Cardiac disorders
Palpitations
Tachycardia, cardiac failure, arrhythmia
Vascular disorders
Flushing
Gastrointestinal disorders
Dry mouth
Dyspepsia, constipation, abdominal pain, flatulence, vomiting, diarrhoea
Gastroesophageal reflux
Skin and subcutaneous tissue disorders
Dry skin
Angioedema
Renal and urinary disorders
Dysuria, urinary retention
General disorders and administration site conditions
Fatigue, chest pain, peripheral oedema
Investigations
Increased weight
Cases of aggravation of symptoms of dementia (e.g. confusion, disorientation, delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia.
Paediatric population
In two paediatric phase III randomised, placebo-controlled, double-blind studies conducted over 12 weeks where a total of 710 paediatric patients were recruited, the proportion of patients with urinary tract infections, diarrhoea and abnormal behaviour was higher in patients treated with tolterodine than placebo (urinary tract infection: tolterodine 6.8%, placebo 3.6%; diarrhoea: tolterodine 3.3%, placebo 0.9%; abnormal behaviour: tolterodine1.6 %, placebo0.4 %) (see section 5.1).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Yellow Card Scheme or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
The highest dose given to human volunteers of tolterodine tartrate is 12.8 mg as single dose. The most severe adverse events observed were accommodation disturbances and micturition difficulties.
In the event of tolterodine overdose, treat with gastric lavage and give activated charcoal. Treat symptoms as follows:
• Severe central anticholinergic effects (e.g. hallucinations, severe excitation): treat with physostigmine
• Convulsions or pronounced excitation: treat with benzodiazepines
• Respiratory insufficiency: treat with artificial respiration
• Tachycardia: treat with beta-blockers
• Urinary retention: treat with catheterization
• Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room
An increase in QT interval was observed at a total daily dose of 8 mg immediate release tolterodine (twice the recommended daily dose of the immediate release formulation and equivalent to three times the peak exposure of the prolonged release capsule formulation) administered over four days. In the event of tolterodine overdose, standard supportive measures for managing QT prolongation should be adopted.
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Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.