Active ingredient
- tolterodine tartrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 35533/0148.
Neditol XL 2mg, 4mg prolonged-release capsules, hard
PACKAGE LEAFLET: INFORMATION FOR THE USER
Neditol XL 2mg prolonged-release capsules, hard
Neditol 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
What is in this leaflet:
1. What Neditol XL is and what it is used for
2. What you need to know before you take Neditol XL
3. How to take Neditol XL
4. Possible side effects
5. How to store Neditol XL
6. Contents of the pack and other information
1. What Neditol XL is and what it is used 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:
2. What you need to know before you take Neditol XL
Do not take Neditol XL if you:
Warnings and Precautions
Talk to your doctor or pharmacist before taking Neditol XL:
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:
Neditol XL should be used with caution when taken in combination with:
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 0.00404 mmol (or 0.092988mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
3. How to take 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 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.
Symptoms in case of overdose include hallucinations, excitation, a heartbeat faster than usual, dilation of the pupil and inability to urinate or breathe normally.
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.
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 an allergic reaction, such as:
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:
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):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
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.
5. How to store 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.
6. 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:
Manufacturer:
or
This leaflet was last revised in 09/2018
1010082-P7.2
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148