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.
Neditol XL 2mg, prolonged-release capsules, hard
⚠ 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 The active substance in Neditol XL is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics. Neditol 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.
What you need to know before you take it
e Neditol XL Do not take Neditol XL if you:
- are allergic to tolterodine or any of the other ingredients of this medicine.
- are unable to pass urine from the bladder (urinary retention).
- have an uncontrolled high pressure in the eyes with loss of eyesight that is not being adequately treated (narrow-angle glaucoma).
- suffer from excessive weakness of the muscles (myasthenia gravis).
- suffer from severe ulceration and inflammation of the colon (ulcerative colitis).
- suffer from acute dilatation of the colon (a toxic megacolon). Warnings and Precautions Talk to your doctor or pharmacist before taking Neditol 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 neurological disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system).
- if you have a hiatus 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: a weak heart muscle (cardiomyopathy), reduced blood flow to the heart (myocardial ischaemia), an irregular heartbeat (arrhythmia) and heart failure.
- if you have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in your blood. Other medicines and Neditol XL Tell your doctor if you are taking, have recently taken or might take any other medicines. Tolterodine, the active substance of Neditol XL, may interact with other medicines. It is not recommended to use tolterodine 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. Neditol 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 Neditol XL (antimuscarinic properties) or medicines with an opposite mode of action to Neditol XL (cholinergic properties). Ask your doctor if you are unsure. Neditol XL with food and drink Neditol 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 Neditol XL when you are pregnant. Breast-feeding It is not known if tolterodine, the active substance of Neditol XL, is excreted in the mother's breast milk. Breast-feeding is not recommended during administration of Neditol XL. Driving and using machines Neditol XL may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected. Neditol 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. Neditol XL contains sodium This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially 'sodium-free'.
How to take it
Neditol XL Dose: Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The prolonged-release hard capsules are for oral use and should be swallowed whole. Do not chew the capsules. Adults: The recommended dose is one 4mg prolonged-release hard capsule daily. Patients with liver or kidney problems or troublesome side effects: Your doctor may reduce your dose to one 2mg Neditol XL daily. Use in children: Neditol XL is not recommended for children. If you take more Neditol 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 Neditol 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 Neditol XL Your doctor will tell you how long your treatment with Neditol 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. 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.
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 an allergic reaction, such as:
- swollen face, tongue or throat.
- difficulty to swallow.
- hives and difficulty in 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 tolterodine with the following frequencies. Very common side effects (may affect more than 1 in 10 people):
- Dry mouth Common side effects (may affect up to 1 in 10 people):
- Inflammation of nasal sinus (sinusitis)
- Dizziness, sleepiness, headache
- Dry eyes, blurred vision
- Indigestion (dyspepsia), constipation, abdominal pain, excessive amount 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):
- 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, severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue (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 (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
Neditol 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 and blister or bottle after 'EXP'. 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.
Contents of the pack and other information
What Neditol XL contains The active substance in Neditol XL 2mg prolonged-release capsules, hard is 2mg of tolterodine tartrate, equivalent to 1.37mg of tolterodine. The active substance in Neditol XL 4mg prolonged-release capsules, hard is 4mg of tolterodine tartrate, equivalent to 2.74mg of tolterodine. The other ingredients are: lactose monohydrate, cellulose microcrystalline, poly(vinyl acetate), povidone, silica, sodium lauryl sulphate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose. Capsule composition: indigo carmine (E132), quinoline yellow (only in 2mg) (E104), titanium dioxide (E171), gelatin. Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid – ethyl acrylate copolymer, 1,2-Propylene glycol. What Neditol XL looks like and contents of the pack Neditol XL is a hard prolonged-release capsule designed for once daily dosing. Neditol XL 2mg prolonged-release hard capsules are opaque, green, size 1 hard gelatin capsules containing two white, round, biconvex coated tablets. Neditol XL 4mg prolonged-release hard capsules are light blue, opaque, size 1 hard gelatin capsules containing four white, round, biconvex coated tablets. Neditol XL 2mg prolonged-release hard capsules are available in the following pack sizes: Blister packs containing: 14, 28, 56, 84 prolonged-release hard capsules. HDPE bottles containing: 30, 100 and 200 prolonged-release hard capsules. Neditol XL 4mg prolonged-release hard capsules are available in the following pack sizes: Blister packs containing: 7, 14, 28, 49, 56, 84, 98 prolonged-release hard capsules. HDPE bottles containing: 30, 100 and 200 prolonged-release hard capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Aspire Pharma Ltd Unit 4, Rotherbrook Court Bedford Road, Petersfield Hampshire, GU32 3QG, United Kingdom Manufacturer: Pharmathen SA 6 Dervenakion str., 153 51 Pallini, Attiki, Greece or Pharmathen International SA., Sapes Industrial Park, Block 5, 69300 Rodopi, Greece This leaflet was last revised in 07/2022
1010082-P9.1
Frequently asked questions about Neditol XL 2mg, prolonged-release capsules, hard
How do I take Neditol XL 2mg, prolonged-release capsules, hard?
Neditol XL 2mg, prolonged-release capsules, hard comes as capsule containing 2mg. 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 Neditol XL 2mg, prolonged-release capsules, hard?
The active substance in Neditol XL 2mg, prolonged-release capsules, hard is tolterodine tartrate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Neditol XL 2mg, prolonged-release capsules, hard, 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 Neditol XL 2mg, prolonged-release capsules, hard 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 the elderly):
The recommended dose is 4 mg once daily except in patients with impaired liver function or severely impaired renal function (GFR ≤30 ml/min) for whom the recommended dose is 2 mg once daily (see sections 4.4 and 5.2). In case of troublesome adverse reactions the dose may be reduced from 4 mg to 2 mg once daily.
The effect of treatment should be re-evaluated after 2-3 months (see section 5.1).
Paediatric population:
The efficacy of tolterodine has not been demonstrated in children (see section 5.1). Therefore, Neditol XL is not recommended for children.
Method of administration
The prolonged-release capsules can be taken with or without food and must be swallowed whole.
4.3. Contraindications
Tolterodine is contraindicated in patients with:
- Urinary retention
- Uncontrolled narrow angle glaucoma
- Myasthenia gravis
- Known hypersensitivity to tolterodine or excipients (see section 6)
- 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 sections 4.2 and 5.2)
- Hepatic disease (see sections 4.2 and 5.2)
- Autonomic neuropathy
- Hiatus hernia
- Risk of 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 medicinal products 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).
Urinary retention
As with all treatments for symptoms of urgency and urge incontinence, organic reasons for urge and frequency should be considered before treatment.
Excipient Information
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say 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 (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 overdose (see section 4.4).
Concomitant medication with other medicinal products that possess antimuscarinic properties may result in more pronounced therapeutic effect and adverse reactions. 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.
Medicinal product 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 active substances 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 medicine 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 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.
Table 1 below reflects the data obtained with tolterodine in clinical trials and from post marketing experience. The most commonly reported adverse reaction was dry mouth, which occurred in 23.4 % of patients treated with tolterodine and in 7.7 % of placebo-treated patients.
Tabulated list of adverse reactions
The adverse drug reactions listed in the table below are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: 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) and not known (cannot be estimated from available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1: Adverse drug reactions
System Organ Class
Very Common
(≥1/10)
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1000 to <1/100)
Not known
(cannot be estimated from the available data)
Infections and infestations
Sinusitis
Immune system disorders
Hypersensitivity not otherwise specified
Anaphylactoid reactions
Psychiatric disorders
Nervousness
Confusion, hallucinations, disorientation
Nervous system disorders
Dizziness, somnolence, headache
Paresthesia, memory impairment
Eye disorders
Dry eyes, abnormal vision (including abnormal accommodation)
Ear and labyrinth disorders
Vertigo
Cardiac disorders
Palpitations, cardiac failure, arrhythmia
Tachycardia
Vascular disorders
Flushing
Gastrointestinal disorders
Dry mouth
Dyspepsia, constipation, abdominal pain, flatulence, diarrhoea
Gastroesophageal reflux, vomiting
Skin and subcutaneous tissue disorders
Angioedema, dry skin
Renal and urinary disorders
Dysuria
Urinary retention
General disorders and administration site conditions
Fatigue, peripheral oedema
Chest pain
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 3randomised, 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: tolterodine 1.6 %, placebo 0.4 %) (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 the Yellow Card Scheme (www.mhra.gov.uk/yellowcard) 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 a single dose of the immediate release formulation. 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 catheterisation
- 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- UROFLOW 1 prescriptionTOLTERODINUM · taken by mouth
- UROFLOW 2 prescriptionTOLTERODINUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- RanolterilTolterodini tartras · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Neditol XL 2mg, prolonged-release capsules, hard. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
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.