Neditol XL 4mg, prolonged-release capsules, hard

• 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.

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

• 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).

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.

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 can be taken before, after or during a meal.

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.

Neditol XL may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.

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 or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately.

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.

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 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.

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.

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.

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