Detrusitol Tablets

How do I take it?

Detrusitol tablets

• Detrusitol tablets are usually taken twice a day, morning and evening. However, follow the instructions given by your doctor regarding how many tablets to take and how often to take them.
• Try to take your tablets at the same times each day; this will help you to remember them.
• The tablets should be swallowed with a drink. They can be taken either with or without food.
• If you forget to take a dose take it as soon as you remember, unless it is nearly time for you next dose. In this case just leave out the missed dose and take your next dose as usual when it is due. Do not take a double dose to make up for a missed dose.

Detrusitol XL capsules

• Detrusitol XL capsules are taken once a day. Try to take your capsule at the same time each day.
• Detrusitol XL capsules must be swallowed whole with a drink and not opened, crushed or chewed. They can be taken either with or without food.
• If you forget to take a dose take it as soon as you remember, unless it is nearly time for your next dose. In this case just leave out the missed dose and take your next dose as usual when it is due. Do not take a double dose to make up for a missed dose.
• It may take a few weeks of taking this medicine before you see an improvement in your symptoms. It is important to keep taking the medicine regularly, even if you don't notice the benefit at first. You doctor may want to see you after two to three months to check the medicine is working for you. Your doctor should reassess you on a regular basis to check if you still need to keep taking this medicine.

Warning!

• This medicine may make you sleepy or cause blurred vision and so may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• Tolterodine is not licensed for use in children and for this reason the information leaflets provided with the medicine will say that the medicine is not recommended for children. However, specialists do sometimes prescribe tolterodine off-licence to treat certain urinary problems in children. If your child has been prescribed this medicine and you want further information you should ask your doctor or pharmacist.

Not to be used in

• People who cannot completely empty their bladder (urinary retention).
• Closed angle glaucoma.
• A condition called myasthenia gravis in which there is abnormal muscle weakness.
• People with severe inflammation of the bowel and back passage (ulcerative colitis).
• People with a sudden expansion of the large intestine, seen in advanced ulcerative colitis or Crohn's disease (toxic megacolon).
• Pregnancy.
• Breastfeeding.

Detrusitol XL capsules contain sucrose and so are not suitable for people with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Use with caution in

• Elderly people.
• People with decreased kidney function.
• People with decreased liver function.
• People with any obstruction to the outflow of urine from the bladder, causing problems with passing urine.
• People with any blockage or decreased activity in the stomach or intestines; symptoms might include constipation.
• People with disorders of the nerves that control involuntary processes in the body such as blood pressure, heart rate, digestion, bowel and bladder emptying (autonomic neuropathy).
• People with a hiatus hernia.
• Heart disease, for example angina, heart failure, irregular heartbeats (arrhythmias) or very slow heart rate (bradycardia).
• People with a personal or family history of a type of abnormal heart rhythm, seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
• People taking medicines that increase the risk of a prolonged QT interval (your doctor will know, but see end of factsheet for some examples).
• People with disturbances in the normal levels of salts (electrolytes) in their blood, for example low magnesium, potassium or calcium levels.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• There is no information available about the safety of this medicine during pregnancy. It is not recommended for use during pregnancy. Seek further medical advice from your doctor.
• It is not known if this medicine passes into breast milk. For this reason, it is not recommended for use by breastfeeding mothers. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. Some of these side effects may occur less frequently with Detrusitol XL capsules than with Detrusitol tablets.

Very common (affect more than 1 in 10 people)

• Dry mouth.
• Headache.

Common (affect between 1 in 10 and 1 in 100 people)

• Dry eyes.
• Blurred vision.
• Constipation.
• Indigestion.
• Abdominal pain.
• Excess gas in the stomach and intestines (flatulence or wind).
• Vomiting.
• Difficulty passing urine.
• Dizziness or spininng sensation.
• Pins and needles sensations (paraesthesia).
• Sleepiness.
• Fatigue.
• Dry skin.
• Swelling of the legs and ankles due to excess fluid retention (peripheral oedema).
• Awareness of your heartbeat (palpitations).
• Chest pain.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Nervousness.
• Irregular heartbeats (arrhythmias).
• Increased heart rate (tachycardia).
• Heart failure.
• Memory problems.

Frequency not known

• Confusion.
• Hallucinations.
• Feeling disorientated.
• Flushing.
• Allergic reactions such as swelling of the face, throat and tongue (angioedema).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, ask your doctor or pharmacist before taking any new medicines while taking this one, so they can check that the combination is safe.

The following medicines are not recommended for use in combination with tolterodine, as they may increase the blood level of tolterodine and increase the risk of its side effects:

• macrolide antibiotics such as clarithromycin and erythromycin
• the antifungals ketoconazole and itraconazole
• protease inhibitors for HIV infection, eg amprenavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

There may be an increased risk of side effects such as dry mouth, blurred vision, constipation and difficulty passing urine if this medicine is taken with other medicines that have antimuscarinic effects, for example the following:

• amantadine
• antimuscarinic medicines for Parkinson's symptoms, eg procyclidine, orphenadrine, trihexiphenidyl
• antipsychotic medicines, eg haloperidol, chlorpromazine, clozapine
• antispasmodic medicines, eg hyoscine, atropine, propantheline
• codeine
• disopyramide
• MAOI antidepressants, eg phenelzine, tranylcypromine
• nefopam
• sedating antihistamines, eg brompheniramine, chlorphenamine, promethazine
• tricyclic antidepressants, eg amitriptyline, clomipramine.

If you experience a dry mouth as a side effect of this medicine you may find that medicines that are designed to dissolve and be absorbed from under the tongue, eg sublingual glyceryl trinitrate (GTN) tablets, become less effective. This is because the tablets do not dissolve properly in a dry mouth. To resolve this, drink a mouthful of water before taking sublingual tablets.

This medicine may reduce the effects of the following medicines on the gut:

• cisapride
• domperidone
• metoclopramide.

There may be an increased risk of abnormal heart rhythms (as a result of prolonged QT interval on the heart monitoring trace or ECG) if this medicine is used in combination with other medicines that are associated with this potential side effect, such as the following:

• arsenic trioxide
• certain antimalarials, eg halofantrine, chloroquine, quinine, Riamet
• certain antimicrobials, eg erythromycin (IV), clarithromycin, moxifloxacin, voriconazole or pentamidine
• certain antipsychotics, eg thioridazine, chlorpromazine, sertindole, haloperidol, pimozide, droperidol
• cisapride
• medicines to treat abnormal heart rhythms, eg amiodarone, procainamide, quinidine, disopyramide, dronedarone, sotalol
• ranolazine
• saquinavir
• sildenafil
• the antihistamines astemizole, terfenadine or mizolastine
• vardenafil.

References:

https://www.drugs.com/uk/detrusitol-2mg-tablets-leaflet.html

https://www.hpra.ie/img/uploaded/swedocuments/2131661.PPA1463_040_001.0b8670a1-e96b-4ed8-914c-0d34ab149583.000001IT%20Detrusitol%20PIL%20IP.130524.pdf

http://patient.info/medicine/tolterodine-detrusitol

http://www.netdoctor.co.uk/medicines/liver-kidney-and-urinary-system/a6546/detrusitol-tolterodine/

http://www.news-medical.net/drugs/Detrusitol.aspx