Solifenacin Tabletten

Solifenacin is used to treat urinary symptoms caused by an overactive bladder. In an overactive bladder, the bladder muscles are too tight, signalling that it's time to visit the bathroom, even though the bladder isn't full. The urge to urinate can be acute and intense, causing you to wet yourself because you could not get to the bathroom in time. This is referred to as urge incontinence.  

Urinary problems and incontinence are a common symptom of menopause. Menopause can also increase your risk of an overactive bladder. Solifenacin is used to treat the symptoms of an overactive bladder. The active ingredient relaxes the bladder muscles. This reduces the sense of urgency to urinate, which means fewer bathroom visits.  

Solifenacin tablets should be swallowed whole with some water. The tablets can be taken with or without food. Do not crush the tablets. 

Dosage 

The usual is dose is 5 mg per day, unless your doctor told you to take 10 mg per day. 

If you take more Solifenacin than you should 

If you have taken too many Solifenacin tablets or if a child has accidentally taken Solifenacin tablets, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perceiving things that are not there (hallucinations), over-excitability, seizures (convulsions), difficulty breathing, elevated heart rate (tachycardia), accumulation of urine in the bladder (urinary retention) and dilated pupils (mydriasis). 

If you forget to take Solifenacin 

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take your next dose. Do not take a double dose to make up for a forgotten tablet. If you are not sure about what to do, talk to your doctor or pharmacist. 

If you stop taking Solifenacin 

If you stop taking this medicine, your symptoms of overactive bladder may return or worsen. Always consult your doctor if you are considering stopping the treatment. 

Driving and using machines 

Solifenacin may cause blurred vision and sometimes drowsiness or fatigue. If you suffer from any of these side effects, do not drive or operate machinery. 

Pregnancy and breastfeeding 

You should not take this medicine during pregnancy, unless absolutely necessary and advised by your doctor. 

Do not use this medicine if you are breastfeeding because solifenacin succinate may pass into breast milk. 

Do not use this medicine if: 

• You are allergic any of the ingredients in this medicine (see section ‘Further information'). 

• You have an inability to pass water or to empty your bladder completely (urinary retention). 

• You have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis). 

• You suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles. 

• You suffer from increased pressure in the eyes, with gradual loss of eyesight (glaucoma). 

• You are undergoing kidney dialysis.  

• You have severe liver disease. 

• You suffer from severe kidney disease or moderate liver disease AND at the same time are being treated with medicines that may decrease the removal of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will have informed you if this is the case. 

Inform your doctor if you have or ever had any of the above-mentioned conditions before treatment with Solifenacin starts. 

When should this medicine be used with caution? 

Talk to your doctor or pharmacist before taking using Solifenacin if: 

• You have trouble emptying your bladder (= bladder obstruction) or have difficulty in passing urine (e.g., a thin urine flow). Risk of accumulation of urine in the bladder (urinary retention) is much higher. 

• You have some obstruction of the digestive system (constipation). 

• You are at risk of your digestive system slowing down (stomach and bowel movements). Your doctor will have informed you if this is the case. 

• You suffer from severe kidney disease. 

• You have moderate liver disease. 

• You have a stomach tear (hiatus hernia) or heartburn. 

• You have a nervous disorder (autonomic neuropathy). 

Other medicines and Solifenacin 

Tell your doctor if you are taking any other medicines, including any that you get without a prescription. Solifenacin can affect the way some medicines work and some medicines can have an effect on Solifenacin. See the package leaflet for more information. 

Like all medicines, Solifenacin can cause side effects, although not everybody gets them. 

If you experience an allergic attack, or a severe skin reaction (e.g., blistering and peeling of the skin), you must inform your doctor or pharmacist immediately. 

Angioedema (skin reaction characterised by an abrupt, localised swelling of the deeper layers of the skin) with airway obstruction (breathing difficulties) has been reported in some patients on solifenacin succinate. 

If angioedema occurs, stop taking the tablets and contact your doctor immediately. 

Solifenacin tablets can cause the following side effects: 

Very common (may affect more than 1 in 10 people) 

• Dry mouth. 

Common (may affect up to 1 in 10 people) 

• Blurred vision. 

• Constipation, nausea, indigestion with symptoms such as abdominal fullness, abdominal pain, burping and heartburn (dyspepsia), stomach discomfort. 

Uncommon (may affect up to 1 in 100 people) 

• Urinary infections, bladder infection (cystitis). 

• Sleepiness. 

• Impaired sense of taste (dysgeusia). 

• Dry (irritated) eyes. 

• Dry nasal passages. 

• Reflux disease (gastro-oesophageal reflux). 

• Dry throat. 

• Dry skin. 

• Difficulty in passing urine. 

• Fatigue. 

• Moisture accumulation in the lower limbs (oedema). 

Rare (may affect up to 1 in 1,000 people) 

• Lodging of a large amount of hardened stool in the large intestine (faecal impaction). 

• Build-up of urine in the bladder due to inability to empty the bladder (urinary retention). 

• Dizziness, headache. 

• Vomiting. 

• Itching, rash. 

This list is not exhaustive. For a complete list of side effects, see the package leaflet. If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. 

The active substance Solifenacin tablets is solifenacin succinate. 

• Solifenacin 5 mg: each film-coated tablet contains 5 mg solifenacin succinate. 

• Solifenacin 10 mg: each film-coated tablet contains 10 mg solifenacin succinate. 

The other ingredients are: 

• Tablet core: lactose monohydrate, maize starch, hypromellose (5 cp), anhydrous colloidal silica, magnesium stearate. 

• Film coating: hypromellose (6 cp), macrogol (PEG 4000), titanium dioxide (E 171), talc, iron oxide yellow (E172) (only 5 mg), iron oxide red (E172) (only 10 mg). 

The manufacturer of Solifenacin tablets is: 

APL Swift Services Limited 

HF26, Hal Far Industrial Estate, Hal Far 

Birzebbugia, BBG 3000 

Malta 

Read the package leaflet before use. The package leaflet contains important information on the use and the risks associated with Solifenacin tablets. The package leaflet for Solifenacin tablets is available for download here.

Lisez la notice avant utilisation. Elle contient des informations importantes sur l’utilisation et les risques des comprimés de solifénacine. Téléchargez la notice de solifénacine ici.