5 mg, 10 mg film-coated tablets
solifenacin succinate
What Solifenacin Teva is and what it is used for
The active substance in Solifenacin Teva, solifenacin succinate, belongs to the drug group anticholinergics. These drugs suppress the overactivity of the bladder. Urinary urges become fewer and weaker and the ability to hold urine improves.
Solifenacin Teva is used to treat the symptoms of a condition called overactive bladder. Symptoms of overactive bladder include frequent voiding, urges, and difficulty holding urine (urinary incontinence).
Solifenacin succinate contained in Solifenacin Teva may also be approved to treat other conditions not mentioned in this product information. 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 take Solifenacin Teva
Do not take Solifenacin Teva:
- if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
- if you have difficulty urinating or completely emptying the bladder when urinating ( urinary retention )
- if you have any serious gastrointestinal disease (including toxic megacolon, a condition that can occur in some cases in association with ulcerative colitis )
- if you have myasthenia gravis (a muscle disease with weakness in certain muscles)
- if you suffer from increased pressure in the eyes with a gradually reduced vision – glaucoma ( glaucoma )
- if you are undergoing dialysis
- if you have severe liver disease
- if you have severe kidney disease or moderately impaired liver function AND if you are simultaneously using medicines that can reduce the breakdown of Solifenacin Teva in the body (e.g. ketoconazole ). Your doctor or pharmacist will inform you if this is the case.
Tell your doctor if you have or have had any of the above conditions before starting treatment with Solifenacin Teva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Teva
- if you have difficulty emptying your bladder or urinating (e.g. have a weak stream of urine). The risk of urine accumulating in the bladder is then much greater.
- if you have problems from the gastrointestinal tract that cause difficulty emptying the bowels (constipation)
- if you belong to a risk group where the digestive organs may start to work more slowly (stomach and bowel movements). If you belong to this risk group, you have been told by your doctor.
- if you have severely impaired kidney function
- if you have moderately impaired liver function
- if you have a hernia in the upper stomach mouth ( hiatus hernia) and/or problems with heartburn
- if you have a nerve disease (autonomic neuropathy ).
Tell your doctor if you have or have had any of the above conditions before starting treatment with Solifenacin Teva.
Before starting treatment with Solifenacin Teva, your doctor will assess whether there are other causes of your urinary urgency (eg heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic medicine.
Children and young people
Solifenacin Teva should not be used by children and adolescents under the age of 18.
Other medicines and Solifenacin Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are taking:
- other anticholinergic drugs, the effects and side effects of both drugs can be enhanced
- cholinergic medicines, as they can reduce the effect of Solifenacin Teva
- medicines such as metoclopramide and cisapride, which can make the gastrointestinal tract work faster. Solifenacin Teva can reduce the effect of these medicines
- medicines containing ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, as they can reduce the rate at which Solifenacin Teva is broken down in the body
- medicines containing rifampicin, phenytoin, and carbamazepine because they can increase the rate at which Solifenacin Teva is broken down in the body
- medicines such as bisphosphonates, which can cause or increase inflammation in the esophagus ( oesophagitis ).
Solifenacin Teva with food
You can take Solifenacin Teva with or without food, depending on your preferences.
Pregnancy and breastfeeding
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.
Solifenacin Teva should not be used during pregnancy unless necessary.
Solifenacin can be excreted in breast milk. Therefore, do not use Solifenacin Teva if you are breastfeeding.
Driving ability and use of machinery
Solifenacin Teva can cause blurred vision and sometimes drowsiness 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 Teva contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to take Solifenacin Teva
Always take this medicine as directed by your doctor. 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.
The tablets should be swallowed whole with a little liquid. The tablets can be taken with or without food, depending on your personal preference. The tablets must not be crushed.
If you have taken too much Solifenacin Teva
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 can be a headache, dry mouth, dizziness, drowsiness, visual effects, hallucinations, mood effects (overactivity), tremors (convulsions), breathing difficulties, increased heart rhythm (palpitations), accumulation of urine in the bladder ( urinary retention ) and enlarged pupils ( mydriasis ).
If you forget to take Solifenacin Teva
If you forget to take a dose at the usual time, take it as soon as you remember unless it is time for the next dose. Never take more than one dose per day. If you are unsure, always consult a doctor or pharmacist.
If you stop taking Solifenacin Teva
If you stop taking Solifenacin Teva, 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 have an allergic attack or a serious skin reaction (eg blisters and peeling of the skin), you must tell your doctor or pharmacist immediately.
Angioedema ( allergy with skin involvement; swelling of tissue closest to the surface of the skin) with difficulty breathing ( airway obstruction ) has been reported in some patients using solifenacin succinate.
Stop taking Solifenacin Teva and contact your doctor immediately if you experience any of the following symptoms ( angioedema ): swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
Solifenacin Teva may cause the following other 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 infections, cystitis
- sleepiness, altered taste perception ( dysgeusia )
- dry (irritated) eyes
- dryness of the nasal mucosa
- heartburn ( gastroesophageal reflux ), dry throat
- dry skin
- difficulty throwing water
- fatigue, fluid swelling in the lower part of the legs (edema)
Rare (may affect up to 1 in 1,000 users):
- accumulation of large amounts of hard feces in the large intestine ( 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 skin rashes
Has been reported (occurring in an unknown number of users):
- decreased appetite, and high level of potassium in the blood which can cause abnormal heart rhythm
- increased pressure in the eyes
- changes in the electrical activity of the heart ( EKG ), irregular heartbeat ( Torsades de pointes ), feeling your heartbeats, faster heartbeat
- voice problems
- liver disease
- muscle weakness
- kidney disease
How to store Solifenacin Teva
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated after EXP. The expiration date is the last day of the specified month.
Blisters
No special storage instructions.
Cans
No special temperature instructions. Close the jar well. Moisture sensitive.
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 succinate.
- Each film-coated tablet contains either 5 mg or 10 mg of solifenacin succinate, corresponding to either 3.8 mg or 7.5 mg of solifenacin. The exact amount is indicated on the carton.
- Other ingredients are
- Tablet core: microcrystalline cellulose, povidone, crospovidone, lactose, colloidal anhydrous silica, magnesium stearate.
- Film coating:
- Solifenacin Teva 5 mg: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol polyethylene glycol 3350, talc (E553b), yellow iron oxide (E172)
- Solifenacin Teva 10 mg: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol polyethylene glycol 3350, talc (E553b), carminic acid (E120), red iron oxide (E172), yellow iron oxide (E172)
Appearance and package sizes of the medicine
Solifenacin Teva 5 mg is a light yellow to yellow, round, convex, film-coated tablet with a diameter of 8 mm, debossed with “S5” on one side of the tablet and plain on the other side of the tablet.
Solifenacin Teva 10 mg is a pale pink to pink, round, convex, film-coated tablet with a diameter of 8 mm, debossed with “S10” on one side of the tablet and plain on the other side of the tablet.
Solifenacin Teva film-coated tablets are available in blister packs of 3, 5, 10, 20, 30, 30×1, 50, 60, 90, 100 or 200 tablets and in cans of 30, 100 or 200 (2×100) tablets.
Possibly not all pack sizes will be marketed.