5 mg, 10 mg film-coated tablets
solifenacin succinate
What Solifenacin Krka is and what it is used for
The active ingredient in Solifenacin Krka 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 of urine that the bladder can hold increases.
Solifenacin Krka 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 Krka 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 Krka
Do not use Solifenacin Krka
- 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 stomach or intestinal disease (including toxic megacolon, a condition that can occur in some cases in association 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 moderately impaired liver function AND if you simultaneously use medicines that can reduce the breakdown of Solifenacin Krka in the body (e.g. ketoconazole ). Your doctor or pharmacist has informed 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 Krka.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Krka.
- 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 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). Your doctor has informed you if you belong to this risk group.
- if you have severe kidney disease
- if you have moderately impaired liver function
- if you have a hiatus hernia or acid reflux
- 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 Krka.
Before starting treatment with Solifenacin Krka, 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 ).
Children and young people
Solifenacin Krka should not be used by children and adolescents under the age of 18.
Other medicines and Solifenacin Krka
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, the effects and side effects of both drugs can be enhanced
- cholinergic drugs, as they can reduce the effect of Solifenacin Krka
- medicines such as metoclopramide and cisapride, which can make the gastrointestinal tract work faster. Solifenacin Krka can reduce the effect of these medicines.
- medicines containing ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, or diltiazem, as can reduce the rate of breakdown of Solifenacin Krka in the body.
- medicines containing rifampicin, phenytoin, and carbamazepine, as they can increase the rate of breakdown of Solifenacin Krka in the body.
- medicines such as bisphosphonates, which can cause or increase inflammation in the esophagus ( oesophagitis )
Solifenacin Krka with food and drink
Solifenacin Krka can be taken with or without food, depending on your preferences.
Pregnancy and breastfeeding
Solifenacin Krka should not be used during pregnancy unless necessary.
Do not use Solifenacin Krka 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 Krka 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 Krka contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to use Solifenacin Krka
Instructions for proper use
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The tablets should be swallowed whole with liquid. The tablets can be taken with or without food. Solifenacin Krka can be taken with or without food, depending on your preferences. Do not crush the tablets.
The recommended dose is 5 mg per day unless your doctor has told you to take 10 mg per day.
If you have used too much Solifenacin Krka
If you have ingested too much medicine or if, for example, if 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 b headache, dry mouth, dizziness, drowsiness, blurred vision, experiencing things that are not there (hallucinations), easily upset, convulsions (seizures), breathing problems, heart palpitations ( tachycardia ), accumulation of urine in the bladder ( urinary retention ) and enlarged pupils (mydriasis).
If you forget to take Solifenacin Krka
If you forget to take a dose at the usual time, take it as soon as you remember, but not if it is almost 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 Krka
If you stop taking Solifenacin Krka, 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 Krka and contact your doctor immediately if you experience any of the following symptoms:
- allergic attack 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 blocked airways (difficulty breathing) has been reported in some patients using solifenacin succinate (Solifenacin Krka)
Solifenacin Krka can 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
- somnolence
- 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
- high eye pressure
- changes in the heart’s electrical activity ( ECG ), irregular heartbeat, feeling your heartbeats, faster heartbeat
- voice problems
- liver disease
- muscle weakness
- kidney disease
How to store Solifenacin Krka
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Tablet jar after first opening
Store at a maximum of 25°C.
After first opening the can, the contents must be consumed within 12 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. Solifenacin Krka 5 mg film-coated tablets: one film-coated tablet contains 5 mg solifenacin succinate, which corresponds to 3.8 mg solifenacin.Solifenacin Krka 10 mg film-coated tablets: one film-coated tablet contains 10 mg solifenacin succinate, which corresponds to 7.5 mg solifenacin.
- Other ingredients are tablet core: lactose monohydrate, povidone, and magnesium stearate. See section 2 “Solifenacin Krka contains lactose”.film coating: hypromellose, talc, titanium dioxide (E171), triacetin, and red iron oxide (E172) (only in 10 mg tablets).
Appearance and package sizes of the medicine
Solifenacin Krka 5 mg film-coated tablets
White to off-white, round, slightly convex, film-coated tablets with beveled edges. Tablet diameter: 7.5 mm.
Solifenacin Krka 10 mg film-coated tablets
Pinkish-white, round, slightly convex film-coated tablets with beveled edges. Tablet diameter: 7.5 mm.
Packs of 10, 30, 50, 60, 90, or 100 film-coated tablets in blisters are available.
Packs of 250 film-coated tablets in tablet containers are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany