5 mg, 10 mg film-coated tablets
solifenacin succinate
What Solifenacin Sandoz is and what it is used for
Solifenacin, the active ingredient in Solifenacin Sandoz, belongs to the drug group 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 bladder can hold larger amounts of urine.
Solifenacin Sandoz is used to treating the symptoms of a condition called overactive bladder. These symptoms include:
- a strong, sudden need to urinate without warning
- need to urinate frequently
- urine leakage because you didn’t make it to the toilet.
Solifenacin succinate contained in Solifenacin Sandoz 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 taking Solifenacin Sandoz
Do not take Solifenacin Sandoz
if you:
- are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6).
- have difficulty urinating or completely emptying the bladder when urinating ( urinary retention )
- have a severe stomach or intestinal disease (including toxic megacolon, a complication that can occur in ulcerative colitis )
- have a muscle disease called myasthenia gravis, which can cause weakness in certain muscles
- have uncontrolled glaucoma ( glaucoma ) with a narrow chamber angle (increased pressure and pain in the eye)
- undergoing dialysis
- have severe liver disease
- have severe kidney disease or moderately impaired liver function AND if you are simultaneously treated with medicines that can reduce the breakdown of Solifenacin Sandoz in the body (e.g. ketoconazole ). Your doctor or pharmacist will inform you if this is the case.
Tell the doctor if you have or have had any of the above conditions before starting treatment with Solifenacin Sandoz.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Sandoz
- if you have difficulty emptying your bladder (bladder obstruction) or urinating (e.g. have a weak stream of urine). The risk of urine accumulating in the bladder ( urinary retention ) is much greater.
- if you have problems with the gastrointestinal tract causing difficulty in 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). The doctor will inform you if this is the case.
- if you have severe kidney disease
- if you have moderately impaired liver function
- if you have a diaphragmatic hernia or heartburn
- if you have a nerve disease (autonomic neuropathy ).
Tell the doctor if you have or have had any of the above conditions before starting treatment with Solifenacin Sandoz.
Before starting treatment with Solifenacin Sandoz, the doctor will assess whether there are other reasons why you need to urinate so often (eg heart failure [the heart cannot pump] or kidney disease). If you have a urinary tract infection, the doctor will prescribe an antibiotic (a medicine against certain bacterial infections).
Children and young people
Solifenacin Sandoz should not be used in children and adolescents under the age of 18.
Other medicines and Solifenacin Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must inform the doctor if you are taking:
- other anticholinergic drugs, as the effects and side effects of both drugs, can be enhanced
- cholinergic medicines, as they can reduce the effect of Solifenacin Sandoz
- medicines such as metoclopramide and cisapride, which can make the gastrointestinal tract work faster. Solifenacin Sandoz can reduce their effect
- medicines containing ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, or diltiazem, as they can reduce the rate of breakdown of Solifenacin Sandoz in the body
- medicines such as rifampicin, phenytoin, and carbamazepine as they can increase the rate at which Solifenacin Sandoz is broken down in the body
- medicines such as bisphosphonates, which can cause or worsen the inflammation of the esophagus ( oesophagitis ).
Solifenacin Sandoz with food and drink
Solifenacin Sandoz can be taken with or without food, depending on your preference.
Pregnancy, breastfeeding, and fertility
Pregnancy
Solifenacin Sandoz should not be used during pregnancy unless necessary.
Breast-feeding
Do not take Solifenacin Sandoz 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 Sandoz can cause blurred vision and sometimes drowsiness or tiredness. If you get 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 Sandoz contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to take Solifenacin Sandoz
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The usual dose is 5 mg per day unless your doctor has told you to take 10 mg per day.
Swallow the tablets with a glass of water, without chewing or crushing them.
Solifenacin Sandoz 10 mg film-coated tablets
The tablet can be divided into two equal doses. Swallow the tablet whole or half with a glass of water, without chewing or crushing it.
Take the tablets at the same time every day. The tablets can be taken with or without food.
If you have taken too much Solifenacin Sandoz
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.
The symptoms of overdose may be:
- headache
- dry mouth
- dizziness
- drowsiness and blurred vision
- experience of things that are not there (hallucinations)
- affect on mood (overactivity)
- convulsions
- breathing difficulties
- palpitations ( tachycardia )
- accumulation of urine in the bladder ( urinary retention )
- enlarged pupils ( mydriasis ).
If you forget to take Solifenacin Sandoz
If you have forgotten to take a dose when you usually take it, you can 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 Sandoz
If you stop taking Solifenacin Sandoz, symptoms of overactive bladder may return or worsen. Always consult a 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.
Stop taking Solifenacin Sandoz and contact your doctor immediately if you experience any of the following side effects:
- allergic attack ( signs may include swelling of the throat, face, lips, and mouth, difficulty breathing or swallowing ) or a severe skin reaction (eg blisters and scaling)
- angioedema ( allergy with skin involvement leading to swelling of tissue closest to the surface of the skin) with breathing difficulties has been reported in some patients taking solifenacin.
Other side effects may occur with the following frequencies:
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 bloating, abdominal pain, belching, nausea, and heartburn ( dyspepsia ).
Uncommon (may affect up to 1 in 100 users)
- urinary tract infection, bladder infection
- sleepiness, fatigue
- altered taste perception ( dysgeusia )
- dry (irritated) eyes
- dryness of the nasal mucosa
- reflux disease ( gastroesophageal reflux i.e. regurgitation)
- dryness of the throat
- dry skin
- trouble urinating
- 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 large intestine (fecal clumping)
- blockage in the large intestine
- accumulation of urine in the bladder due to difficulty emptying the bladder when urinating ( urinary retention )
- dizziness, headache
- vomiting
- itching, rash.
Very rare (may affect up to 1 in 10,000 users)
- hallucinations, confusion
- allergic rash.
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
- high eye pressure
- changes in the electrical activity of the heart ( ECG ), irregular heartbeat, palpitations, faster heartbeat
- voice problems
- liver disease, abnormal values in liver function tests
- muscle weakness
- kidney disease
- the feeling of discomfort in the stomach, irritable bowel (absence of bowel movements which can lead to a blockage in the bowel)
- widespread redness and scaling of the skin
- severe confusion ( delirium ).
How to store Solifenacin Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Shelf life after opening the can is 6 months.
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. One Solifenacin Sandoz 5 mg film-coated tablet contains 5 mg solifenacin succinate corresponding to 3.8 mg solifenacin. One Solifenacin Sandoz 10 mg film-coated tablet contains 10 mg solifenacin succinate corresponding to 7.5 mg solifenacin.
- Other ingredients are lactose monohydrate, hypromellose, pregelatinized starch, magnesium stearate, macrogol 6000, talc, titanium dioxide (E 171), iron oxide yellow (E 172) (Solifenacin Sandoz 5 mg), iron oxide red (E 172) (Solifenacin Sandoz 10 mg).
Appearance and package sizes of the medicine
Solifenacin Sandoz 5 mg film-coated tablets are pale yellow, round, film-coated tablets with a diameter of 6 mm and 05 debossed on one side.
Solifenacin Sandoz 10 mg film-coated tablets are light pink, round, film-coated tablets with a diameter of 8 mm and 10 debossed on one side and scored on the other side.
10 mg film-coated tablets can be divided into two equal doses.
PVC/Al blister packs contain 10, 20, 30, 50, 90, or 100 film-coated tablets packed in a carton.
Polyethylene cans (with polypropylene screw cap and desiccant) contain 30, 56, 60, 84, 90, 100, 105, or 250 film-coated tablets packed in a carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovškova ulica 57, 1526 Ljubljana, Slovenia