5 mg & 10 mg film-coated tablets
solifenacin succinate
What Solifenacin STADA is and what it is used for
The active ingredient in Solifenacin Stada belongs to the drug group anticholinergics. These drugs suppress the overactivity of the 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 Stada is used for the treatment of overactive bladder. Symptoms of overactive bladder include frequent bladder emptying, urges, and difficulty holding urine (urinary incontinence).
Solifenacin contained in Solifenacin Stada 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 STADA
Do not use Solifenacin STADA
- if you have difficulty urinating or emptying the bladder completely ( urinary retention )
- if you have any serious stomach or intestinal 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 allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
- if you are undergoing dialysis
- if you have severe liver disease
- if you have serious kidney disease or moderate impaired liver function AND you are simultaneously using medicines that can reduce the breakdown of Solifenacin Stada in the body (e.g. ketoconazole ). The 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 receiving treatment with this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Stada
- if you have difficulty emptying your bladder or urinating (e.g. have a weak stream of urine). The risk of urine collecting in the bladder ( urinary retention ) 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 impaired liver function
- if you have a hernia in the upper stomach or 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 receiving treatment with this medicine.
Before you receive treatment with Solifenacin Stada, 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 (treatment against certain bacterial infections ).
Children and young people
Solifenacin Stada should not be used in children and adolescents under the age of 18.
Other medicines and Solifenacin STADA
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 because the effects and side effects of both drugs can be enhanced
- cholinergic drugs, as they can reduce the effect of Solifenacin Stada
- medicines, such as metoclopramide and cisapride, which can make the gastrointestinal tract work faster; Solifenacin Stada can reduce the effect of these medicines
- containing 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 Stada is broken down in the body
- medicines such as rifampicin (a medicine used to treat tuberculosis and other bacterial infections ), phenytoin and carbamazepine (a medicine used to treat epilepsy ) because they can increase the rate at which Solifenacin Stada is broken down in the body
- medicines such as bisphosphonates, which can cause or worsen the inflammation of the esophagus ( oesophagitis ). Ask your doctor if your medicine belongs to this group.
Solifenacin STADA with food, drink, and alcohol
It does not matter if this medicine is taken with or without food.
Pregnancy, breastfeeding, and fertility
You should not use Solifenacin Stada if you are pregnant unless your doctor considers it necessary. Do not use this medicine if you are breastfeeding because 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 Stada can affect the eye’s ability to judge distance, which must be taken into account at times when heightened attention is required, e.g. when driving. Drowsiness and fatigue may occur in rare cases, which should also be taken into account.
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 STADA contains lactose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
How to use Solifenacin STADA
Instructions for correct use
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Dosage
The recommended dose is 5 mg per day unless your doctor has told you to take 10 mg per day.
Mode of administration
You should swallow the tablet whole with a little liquid, e.g. a glass of water. The tablets can be taken with or without food. Do not crush the tablets.
Use for children and adolescents
Solifenacin Stada should not be used by children and adolescents under the age of 18.
If you have used too much Solifenacin STADA
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
Symptoms of overdose can be: headache, dry mouth, dizziness, sleepiness, and visual effects, experiencing things that are not there (hallucinations), effect on mood (overactivity), tremors (convulsions), difficulty breathing, increased heart rhythm (palpitations), accumulation of urine in the bladder ( urinary retention ) and dilated pupils (mydriasis).
If you forget to use Solifenacin STADA
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. Do not take a double dose to make up for a missed dose. Always consult a doctor or pharmacist if you are unsure.
If you stop using Solifenacin STADA
If you stop taking this medicine, 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.
Stop taking Solifenacin Stada and contact your doctor immediately if you experience any of the following symptoms
allergic reactions or a severe skin reaction (eg blisters and peeling of the skin)
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 taking solifenacin succinate.
Solifenacin Stada 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 ( dyspepsia ), and stomach pain.
Uncommon (may affect up to 1 in 100 users)
- urinary tract infection, cystitis
- somnolence
- altered taste perception ( dysgeusia )
- dry (irritated) eyes
- dryness of nasal mucosa
- reflux disease (gastroesophageal reflux)
- dry throat
- dry skin
- difficulty throwing water
- fatigue
- fluid swelling in arms and legs.
Rare (may affect up to 1 in 1,000 users)
- sluggish stomach and hard stools
- difficulty emptying the bladder when urinating
- 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
- high pressure in the eyes
- changes in the electrical activity of the heart ( ECG ), irregular heartbeat, feeling your heartbeats, faster heartbeats
- voice problems
- liver disease
- muscle weakness
- kidney disease.
How Solifenacin STADA should be stored
No special temperature instructions. Store in the original packaging. Moisture sensitive.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister after EXP. 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 succinate.
Each Solifenacin Stada 5 mg film-coated tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin.
Each Solifenacin Stada 10 mg film-coated tablet contains 10 mg of solifenacin succinate, corresponding to 7.5 mg of solifenacin.
Other ingredients are
Tablet core
Lactose monohydrate, corn starch, hypromellose, magnesium stearate.
Film coating
Hypromellose, titanium dioxide (E171), macrogol 8000, talc, yellow iron oxide (E172) (Solifenacin Stada 5 mg), red iron oxide (E172) (Solifenacin Stada 10 mg).
Appearance and package sizes of the medicine
Solifenacin Stada 5 mg film-coated tablets are round light yellow, biconvex film-coated tablets.
Solifenacin Stada 10 mg film-coated tablets are round light pink, biconvex film-coated tablets.
Solifenacin Stada film-coated tablets are supplied in blisters of 10, 20, 30, 40, 50, 60, 80, 90, 100, 105, 120, 150, 180 and 200 tablets.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Stada Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Centrafarm Services BV
Van de Reijtstraat 31-E
4814 NE Broad
Netherlands
Clonmel Healthcare Ltd
Waterford Road
Clonmel, Co. Tipperary
Ireland
Stada Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark