Vesitirim (solifenacin) Tablets

How do I take it?

• The usual dose is one 5mg Vesitirim tablet taken once a day. If this doesn't control your symptoms your doctor may increase this to one 10mg tablet taken once a day. You should try to take your tablet at the same time each day.
• Vesitirim tablets should be swallowed whole 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. However, if you don't remember until your next dose is due just leave out the forgotten dose. Do not take a double dose to make up for a missed dose.

Warning!

• This medicine may cause blurred vision, fatigue and sleepiness, which may affect your ability to perform potentially hazardous tasks. If affected you should avoid driving or operating machinary.

Use with caution in

• People with decreased kidney function.
• People with decreased liver function.
• People with a blockage to the outflow of urine from the bladder, for example men with an enlarged prostate gland.
• People with a blockage in the stomach or intestines.
• People who are constipated or at risk of decreased muscle contraction in the muscles of the stomach or intestines.
• Gastro-oesophageal reflux disease.
• People taking medicines that can cause or worsen reflux oesophagitis, eg bisphosphonates such as alendronate.
• People with a hiatus hernia.
• People with a disorder of the involuntary nervous system, usually causing weakness and numbness (autonomic neuropathy).
• People with a personal or family history of an abnormal heart rhythm, see on an ECG as a 'prolonged QT interval'.
• People with a slow heartbeat.
• People with low levels of potassium in their blood (hypokalaemia).

The safety and effectiveness of this medicine in people whose overactive bladder is caused by a problem with the nervous system (neurogenic bladder disorder) has not yet been established.

Not to be used in

• People who have difficulty passing urine or can't fully empty their bladder (urinary retention).
• People with severe disorders of the stomach or intestines, for example sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease (toxic megacolon).
• People with severely decreased liver function.
• People having haemodialysis for kidney failure.
• People with severely decreased kidney function or moderately decreased liver function who are taking ketoconazole, itraconazole, ritonavir or nelfinavir.
• People with a condition called myasthenia gravis in which there is abnormal muscle weakness.
• Closed angle glaucoma.
• Breastfeeding.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Vesicare tablets contain lactose).
• The safety and effectivness of this medicine have not been studied in children. It should not be used in children.
• 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.

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.

• The safety of this medicine in pregnancy has not been established. It should be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the developing baby. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. The manufacturer recommends that it is avoided in 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, it does not mean that all people using this medicine will experience that or any side effect.

Very common 

• Dry mouth.

Common 

• Blurred vision.
• Constipation.
• Feeling sick.
• Indigestion.
• Abdominal pain.

Uncommon 

• Sleepiness.
• Fatigue.
• Difficulty passing urine.
• Urinary tract infection or cystitis.
• Dry eyes.
• Dry skin.
• Dry nose or throat.
• Taste disturbance.
• Gastro-oesophageal reflux.
• Ankle swelling due to fluid retention.

Rare 

• Dizziness.
• Headache.
• Vomiting.
• Bowel obstruction.
• Inability to empty the bladder (urinary retention).
• Rash or itching.

Very rare

• Confusion.
• Hallucinations.
• Swelling of the face, throat and tongue (angioedema). Get medical assistance straight away if you experience this.

Unknown frequency

• Decreased appetite.
• Glaucoma.
• Muscle weakness.
• Abnormal heartbeat.
• Abnormal liver or kidney function.
• Raised level of potassium in the blood.

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, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

The following medicines may reduce the breakdown of solifenacin by the liver and so may increase the amount of the medicine in the blood. If you are taking any of these, your daily dose of this medicine should not be more than 5mg:

• itraconazole
• ketoconazole
• nelfinavir
• ritonavir.

The medicines listed above should not be taken in combination with this medicine if you have severely decreased kidney function or moderately decreased liver function. 

The following medicines may potentially decrease the blood level of this medicine and could make it lesss effective:

• carbamazepine
• phenobarbital
• phenytoin
• primidone
• rifampicin.

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, such as the following:

• amantadine
• antimuscarinic medicines for Parkinson's symptoms, eg procyclidine, orphenadrine, trihexiphenidyl
• antihistamines, eg brompheniramine, chlorphenamine
• antipsychotic medicines, eg haloperidol, chlorpromazine, clozapine
• antispasmodic medicines, eg hyoscine, atropine
• disopyramide
• other antimuscarinic medicines for urinary incontinence, eg tolterodine, oxybutynin, propiverine
• MAOI antidepressants, eg phenelzine, tranylcypromine
• tricyclic antidepressants, eg amitriptyline, clomipramine.
• Medicines such as pilocarpine that work by stimulating muscarinic receptors may make this medicine less effective.

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

• cisapride
• domperidone
• metoclopramide.

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 the sublingual tablets.

References:

https://patient.info/medicine/solifenacin-tablets-vesicare

http://www.netdoctor.co.uk/medicines/liver-kidney-and-urinary-system/a8602/vesicare-solifenacin/

http://www.emedicinehealth.com/drug-solifenacin/article_em.htm

https://www.drugs.com/cdi/solifenacin.html

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

https://medlineplus.gov/druginfo/meds/a605019.html