5 mg and 10 mg film-coated tablets
solifenacin succinate
What Solifenacin Orion is and what it is used for
The active ingredient in Solifenacin Orion, 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 Orion is used to treating overactive bladder. Symptoms of overactive bladder include frequent bladder emptying, urges, and difficulty holding urine (urinary incontinence).
Solifenacin succinate contained in Solifenacin Orion 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 using Solifenacin Orion
Do not use Solifenacin Orion
- 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 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 have uncontrolled glaucoma ( glaucoma ) with a narrow chamber angle (increased pressure and pain in the eye)
- – 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 simultaneously use medicines that can reduce the breakdown of Solifenacin Orion in the body (e.g. ketoconazole ). Doctors 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 Orion
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Orion
- 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 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). 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 Orion.
Before you start treatment with Solifenacin Orion, your doctor will assess whether there are other causes of your urge to urinate (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 Orion should not be used by children and adolescents under the age of 18.
Other medicines and Solifenacin Orion
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
You must tell your doctor if you are taking:
- other anticholinergic drugs, because the effects and side effects of both drugs can be enhanced.
- cholinergic drugs, as they can reduce the effect of Solifenacin Orion.
- medicines such as metoclopramide and cisapride, which can make the gastrointestinal tract work faster. Solifenacin Orion can reduce the effect of these medicines.
- medicines containing ketoconazole, itraconazole (medicine to treat fungal infections), ritonavir, nelfinavir (medicine to treat HIV infection ), verapamil, or diltiazem (medicine to treat high blood pressure and heart disease). These medicines reduce the rate at which Solifenacin Orion breaks down in the body.
- medicines containing rifampicin (medicine to treat tuberculosis and other bacterial infections ), phenytoin, and carbamazepine (medicine to treat epilepsy ). They can increase the rate at which Solifenacin Orion breaks down in the body.
- medicines such as bisphosphonates, which can cause or increase inflammation in the esophagus ( oesophagitis ).
Solifenacin Orion with food, drink, and alcohol
It does not matter if Solifenacin Orion is taken with or without food.
Pregnancy and breastfeeding
Solifenacin Orion should not be used during pregnancy unless your doctor considers it necessary.
Solifenacin Orion can be excreted in breast milk. Therefore, do not use Solifenacin Orion if you are 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 taking this medicine.
Driving ability and use of machinery
Solifenacin Orion may cause blurred vision, dizziness, sleepiness, or tiredness. If you experience any of these side effects, avoid driving or operating machinery.
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 Orion contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to use Solifenacin Orion
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 daily. If necessary, your doctor can increase the dose up to 10 mg daily.
The tablets should be swallowed whole with liquid (e.g. a glass of water). The tablets can be taken with or without food. The tablets must not be crushed.
Use for children and adolescents
Solifenacin Orion should not be used by children and adolescents under the age of 18.
If you have used too much Solifenacin Orion
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 use Solifenacin Orion
If you forget to take the tablet, you can take it later the same day. If it is already time for the next dose, continue according to the normal dosage. If you are unsure, always consult a doctor or pharmacist. Do not take a double dose to make up for a missed dose.
If you stop using Solifenacin Orion
If you stop taking Solifenacin Orion, symptoms of overactive bladder may return or worsen. Always contact your doctor if you are considering stopping treatment.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Solifenacin Orion and contact your doctor immediately if you experience any of the following symptoms
- Allergic/hypersensitivity reactions, including severe anaphylactic reactions and skin reactions (eg, blistering and scaling of the skin) have been reported.
- Angioedema ( allergy with skin involvement; swelling of tissue one closest to the surface of the skin) with breathing difficulties ( airway obstruction ) has been reported in some patients using solifenacin.
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, stomach pain, belching and heartburn ( dyspepsia ), and feeling of discomfort in the stomach.
Uncommon (may affect up to 1 in 100 users)
- urinary tract infections, cystitis
- sleepiness, altered taste perception
- dry (irritated) eyes
- dryness of the nasal mucosa
- heartburn, dry throat
- dry skin
- difficulty throwing water
- fatigue, fluid swelling in the lower legs (edema).
Rare (may affect up to 1 in 1,000 users)
- dizziness, headache
- sluggish stomach and hard stools, vomiting
- itching, rash
- difficulty emptying the bladder when urinating.
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
- sudden confusion ( delirium )
- high eye pressure
- irregular heartbeat ( Torsades de pointes ), changes in the electrical activity of the heart ( ECG ), feeling your heartbeats, faster heartbeat
- voice problems
- blockage in the intestine, feeling of discomfort in the abdomen
- liver disease
- muscle weakness
- kidney disease.
How to store Solifenacin Orion
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton, blister, and label after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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
Solifenacin Orion 5 mg:
- The active substance is 5 mg solifenacin succinate, which corresponds to 3.8 mg.
- Other ingredients are:
- Tablet core: lactose monohydrate, corn starch, hypromellose, magnesium stearate, colloidal anhydrous silica.
- Film coating: hypromellose, macrogol 4000, titanium dioxide, talc, yellow iron oxide.
Solifenacin Orion 10 mg:
- The active substance is 10 mg solifenacin succinate, which corresponds to 7.5 mg solifenacin.
- Other ingredients are:
- Tablet core: lactose monohydrate, corn starch, hypromellose, magnesium stearate, colloidal anhydrous silica.
- Film coating: hypromellose, macrogol 4000, titanium dioxide, talc, red iron oxide.
Appearance and package sizes of the medicine
Film-coated tablet (tablet)
5 mg: light yellow, round, biconvex, film-coated tablet, marked with “CC” on one side and “31” on the other side. The diameter of the tablet is 7.6 mm.
10 mg: pale pink, round, biconvex, film-coated tablet, marked with “CC” on one side and “32” on the other side. The diameter of the tablet is 7.6 mm.
Package sizes:
Blisters containing 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Plastic jar containing 100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Orion Corporation
Orion Indie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orion Indie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information about this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma AB
medinfo@orionpharma.com