5 mg and 10 mg film-coated tablets
solifenacin succinate
What Solifenacin Accord is and what it is used for
The active substance in Solifenacin Accord belongs to a group of medicines called anticholinergics. These drugs are used to reduce the activity of an overactive bladder. This means that you can wait longer before you need to go to the toilet and that the amount that the bladder can hold increases.
Solifenacin Accord is used to treat symptoms of a condition called overactive bladder. These symptoms include a strong, sudden urge to urinate without warning, needing to urinate frequently, or leaking urine because you didn’t make it to the toilet in time.
Solifenacin contained in Solifenacin Accord may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Solifenacin Accord
Do not take Solifenacin Accord
- if you are allergic to solifenacin succinate or any of the other ingredients of this medicine (listed in section 6)
- if you have difficulty urinating or emptying the bladder completely ( urinary retention )
- if you have a severe stomach or intestinal disease (including toxic megacolon, a complication associated with ulcerative colitis )
- if you have a muscle disease called myasthenia gravis, which can cause extreme weakness in certain muscles
- if you have increased pressure in the eyes with progressive loss of vision ( glaucoma )
- if you are undergoing dialysis
- if you have severe liver disease
- if you have severe kidney disease or moderate liver disease AND you are simultaneously receiving treatment with medicines that can reduce the breakdown of Solifenacin Accord in the body (e.g. ketoconazole ). The doctor or pharmacist has informed you if this is the case.
Tell the doctor if you have or have had any of the above conditions before receiving treatment with Solifenacin Accord.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Accord
- if you have difficulty emptying your bladder (bladder obstruction) or difficulty urinating, e.g. a weak stream of urine; the risk of urine collecting in the bladder is much greater
- if you have obstructions in the digestive system (constipation)
- -if you are at risk of the digestive system starting to work more slowly (stomach and bowel movements); the doctor has informed you if this is the case
- if you have severe kidney disease
- if you have moderate liver disease
- if you have a hernia in the stomach ( hiatus hernia ) or heartburn
- if you have a nerve disease (autonomic neuropathy ).
Children and young people
Solifenacin Accord should not be used in children and adolescents under 18 years of age.
Tell the doctor if you have or have had any of the conditions listed above before receiving treatment with Solifenacin Accord.
Before you receive treatment with Solifenacin Accord, the doctor will check if there are other reasons why you need to urinate so often, e.g. heart failure (the heart cannot pump enough blood to the body) or kidney disease. If you have a urinary tract infection, the doctor will prescribe an antibiotic (treatment against certain bacterial infections ).
Other medicines and Solifenacin Accord
Tell your doctor or pharmacist if you y taken, or might take any other medicines.
You must tell the doctor if you are taking:
- other anticholinergics because the effects and side effects of both drugs can be enhanced
- cholinergic, as they can reduce the effect of Solifenacin Accord
- medicines, such as metoclopramide and cisapride, which can cause the digestive system to work faster; Solifenacin Accord can reduce their effect.
- medicines such as ketoconazole, itraconazole (a medicine used to treat fungal infections), ritonavir, nelfinavir (a medicine used to treat HIV infection ) and verapamil, diltiazem (a medicine used to treat high blood pressure and heart disease); these medicines reduce the rate at which Solifenacin Accord is broken down in the body.
- medicines such as rifampicin (medicine used to treat tuberculosis and other bacterial infections ) phenytoin and carbamazepine (a medicine used to treat epilepsy ); can increase the rate at which Solifenacin Accord is broken down in the body.
- medicines such as bisphosphonates, which can lead to or worsen the inflammation of the esophagus ( oesophagitis ).
Solifenacin Accord with food, drink, and alcohol
Solifenacin Accord can be taken with or without food, depending on your preferences.
Pregnancy, breastfeeding, and fertility
You should not use Solifenacin Accord if you are pregnant unless your doctor considers it necessary. Do not use Solifenacin Accord if you are breastfeeding as solifenacin can pass into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
Solifenacin Accord can cause blurred vision and sometimes drowsiness and or tiredness. If you have any of these side effects, you should not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Solifenacin Accord contains lactose monohydrate
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to use Solifenacin Accord
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 5 mg per day unless your doctor has told you to take 10 mg per day.
You should swallow the tablet whole with a little liquid, e.g. a glass of water. You can take it with or without food, depending on your preferences. Do not crush the tablets.
Use for children and adolescents
Solifenacin Accord should not be used by children and adolescents under the age of 18.
If you have taken too much Solifenacin Accord tablet
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Symptoms of overdose may include; headache, dry mouth, dizziness, sleepiness, blurred vision, experiencing things that are not there (hallucinations), being easily upset (high excitability ), convulsions (seizures), breathing difficulties, increased heart rate ( tachycardia ), accumulation of urine in the bladder ( urinary retention ) and dilated pupils (mydriasis).
If you forget to take Solifenacin Accord
If you forget to take a dose at the usual time, take it as soon as you remember unless it is almost time for the next dose. Never take more than one dose per day. Always consult a doctor or pharmacist if you are unsure. Do not take a double dose to make up for a missed dose.
If you stop taking Solifenacin Accord
If you stop taking Solifenacin Accord, symptoms of overactive bladder may return or worsen. Always contact your doctor if you are considering stopping treatment.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you suffer from an allergic attack or a severe skin reaction (e.g. skin blistering or skin peeling), you must contact your doctor or pharmacist immediately.
Angioedema (skin allergy leading to swelling of tissue just below the surface of the skin) with airway obstruction (breathing problems) has been reported in some patients treated with Solifenacin Accord. If angioedema occurs, treatment with Solifenacin Accord should be stopped immediately and appropriate treatment and/or measures instituted.
Solifenacin Accord can cause the following side effects:
Very common (may affect more than 1 in 10 users)
- dry mouth
Common (may affect up to 1 in 10 users)
- blurred vision
- constipation, nausea, indigestion with symptoms such as feeling full, abdominal pain, belching, nausea and heartburn ( dyspepsia ), stomach discomfort
Uncommon (may affect up to 1 in 100 users)
- urinary tract infection, bladder infection
- somnolence
- altered sense of taste ( dysgeusia )
- dry (irritated) eyes
- dry nasal mucosa
- reflux disease (gastroesophageal reflux)
- dry throat
- dry skin
- difficulty urinating
- fatigue
- accumulation of fluid in the lower legs ( edema )
Rare (may affect up to 1 in 1,000 users)
- accumulation of large amounts of hard feces in the colon ( fecal impaction)
- accumulation of urine in the bladder due to the inability to empty the bladder ( urinary retention )
- dizziness, headache
- vomiting
- itching, rash
Very rare (may affect up to 1 in 10,000 users)
- hallucinations, confusion
- allergic rashes
Not known frequency (cannot be calculated from available data).
- decreased appetite, and high levels of potassium in the blood which can lead to abnormal heart rhythms
- increased pressure in the eyes
- changes in the electrical activity of the heart ( EKG ), irregular heartbeats ( torsade de pointes ), palpitations, faster heartbeats
- voice problems
- liver disease
- muscle weakness
- kidney disease
How to store Solifenacin Accord
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister or carton after EXP and Issue date respectively. The expiration date is the last day of the specified month.
Do not use this medicine if the packaging is damaged or if there are signs of tampering.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is solifenacin succinate5 mg: One film-coated tablet contains 5 mg solifenacin succinate corresponding to 3.8 mg solifenacin10 mg: One film-coated tablet contains 10 mg solifenacin succinate equivalent to 7.5 mg solifenacin
- Other ingredients are:Tablet core: Lactose monohydrate , maize starch, hypromellose (3 cps) (E464), magnesium stearate (E572)Film coating: Hypromellose (5 cps) (E464), talc (E553b), titanium dioxide (E171), macrogol 6000 (E1521), yellow iron oxide (E172) (for 5 mg), red iron oxide (E172) (for 10 mg)
Appearance and package sizes of the medicine
Solifenacin Accord 5 mg film-coated tablets: Light yellow, round, approximately 7.1 mm in diameter, biconvex, film-coated tablets, debossed with “EG” on one side and “1” on the other side.
Solifenacin Accord 10 mg film-coated tablets: Light pink, round, approximately 7.1 mm in diameter, biconvex, film-coated tablets, debossed with “EG” on one side and “2” on the other side.
Solifenacin Accord is supplied in PVC/PVdC aluminum blister packs of 3, 5, 10, 20, 30, 50, 60, 90, 100 and 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House
319, Pinner Road
North Harrow
Middlesex HA1 4 HF
UK
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Paradox healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z oo,
ul. Lutomirska 50,95-200 Pabianice, Poland