Toviaz

How do I take it?

• Toviaz tablets should be taken once a day, preferably at the same time each day.
• The tablets should be swallowed whole with a drink and not broken, crushed or chewed. They can be taken either with or without food.
• If you forget to take a tablet you should take it as soon as you remember. However if this means taking two tablets in a day then you should skip the forgotten dose. Don't take a double dose to make up for a missed dose.
• You should avoid drinking grapefruit juice or eating grapefruit while taking this medicine, as it could affect the amount of the medicine in your blood.

Warning!

• Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance. This medicine may make you feel sleepy or dizzy and so may reduce your ability to drive or operate hazardous machinery safely. If you do experience drowsiness this may be made worse by drinking alcohol.
• It can take two to eight weeks for this medicine to have its full effect. You doctor may want to see you after eight weeks of treatment to check it is working for you. Your doctor should reassess whether you still need treatment with this medicine every three to six months.
• This medicine can rarely cause an allergic reaction called angioedema. Stop taking this medicine and consult your doctor immediately if you experience difficulty breathing or swallowing, or swelling of your face, lips, tongue or throat while taking this medicine.

Use with caution in

• People with decreased kidney function.
• People with decreased liver function.
• People with obstruction of the outflow of urine from the bladder, for example due to an enlarged prostate gland.
• People with obstruction or decreased motility of the stomach or intestines.
• Gastro-oesophageal reflux.
• People taking medicines such as bisphosphonates that can cause inflammation of the foodpipe (oesophagitis).
• 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).
• Closed angle glaucoma.
• Heart disease, such as heart failure, angina, very slow heart rate (bradycardia) or irregular heart beats (arrhythmias).
• 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 or potassium levels.

Not to be used in

• People who are unable to pass urine (urinary retention).
• People with slow stomach emptying (gastric retention).
• People with severe inflammation of the bowel and back passage (ulcerative colitis).
• People with sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease (toxic megacolon).
• Uncontrolled closed angle glaucoma.
• Abnormal muscle weakness (myasthenia gravis).
• People with severely decreased liver function.
• Pregnancy.
• Breastfeeding.
• People who are allergic to peanuts or soya (Toviaz tablets contain soya oil).

This medicine contains lactose and is not suitable for people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
There is insufficient information regarding the safety and efficacy of this medicine in children and adolescents under 18 years of age. It is not recommended for children under 18 years old.
This medicine should not be used if you are allergic to 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.

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 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 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 does not mean that all people using this medicine will experience that or any side effect.

Very common (affects more than 1 in 10 people)

• Dry mouth.

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

• Headache.
• Dizziness.
• Dry eyes.
• Dry throat.
• Pain or difficulty urinating (dysuria).
• Difficulty sleeping (insomnia).
• Disturbances of the gut, such as abdominal pain, indigestion, constipation, diarrhoea, nausea.

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

• Change in taste.
• Drowsiness.
• Blurred vision.
• Sensation of spinning (vertigo).
• Faster than normal heart rate (tachycardia).
• Awareness of your heartbeat (palpitations).
• Throat pain.
• Cough.
• Dry nose.
• Flatulence (wind).
• Stomach acid reflux (heartburn).
• Fatigue.
• Urinary tract infections.
• Difficulty completely emptying the bladder (urinary retention).
• Hesitation when trying to pass urine.
• Skin reactions such as dry skin, rash.
• Changes in levels of liver enzymes.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Allergic reaction called angioedema (see warning section above).
• Nettle-type rash (urticaria or hives).
• Confusion.

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 can increase the amount of fesoterodine in the blood and thus increase the risk of its side effects:

• the antibiotics clarithromycin, telithromycin and erythromycin
• the antifungals ketoconazole, itraconazole and fluconazole
• aprepitant
• diltiazem
• nefazodone
• protease inhibitors for HIV infection, eg amprenavir, fosamprenavir, atazanavir, indinavir, nelfinavir, ritonavir, saquinavir
• verapamil.

If you are taking any of these medicines your doctor may need to prescribe you a lower dose of Toviaz. If you have problems with your liver or kidneys you may not be able to take some of these medicines in combination with Toviaz.

Toviaz is not recommended for use in combination with the following medicines, because these can increase the breakdown of fesoterodine, making it less effective:

• carbamazepine
• rifampicin
• phenobarbital
• phenytoin
• the herbal remedy St John's wort (Hypericum perforatum).

There may be an increased risk of antimuscarinic 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
• certain antipsychotic medicines, eg haloperidol, chlorpromazine, clozapine
• antispasmodic medicines, eg hyoscine
• antihistamines, eg brompheniramine, chlorphenamine
• anticholinergic medicines for Parkinson's symptoms, eg procyclidine, orphenadrine, trihexiphenidyl
• MAOI antidepressants, eg phenelzine, tranylcypromine
• 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:

• metoclopramide
• cisapride
• domperidone.

References:

http://www.netdoctor.co.uk/medicines/liver-kidney-and-urinary-system/a8752/toviaz-fesoterodine/

https://www.drugs.com/toviaz.html

http://www.toviaz.com

https://en.wikipedia.org/wiki/Fesoterodine

http://patient.info/medicine/fesoterodine-tablets-toviaz