5 mg, 10 mg film-coated tablet
solifenacin succinate
What Solifenacin Glenmark is and what it is used for
The active ingredient in Solifenacin Glenmark 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 Glenmark is used to treat overactive bladder. Symptoms of overactive bladder include frequent bladder emptying, urges, and difficulty holding urine (urinary incontinence).
The solifenacin contained in Solifenacin Glenmark 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 Glenmark
2. What you need to know before taking Solifenacin Glenmark
Do not take Solifenacin Glenmark:
- 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 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 undergoing dialysis
- if you have severe liver disease
- if you have severe kidney disease or moderate liver dysfunction AND you are simultaneously using medicines that can reduce the breakdown of Solifenacin Glenmark 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 or nurse before taking Solifenacin Glenmark.
- 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 Glenmark, 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 Glenmark should not be used in children and adolescents under 18 years of age.
Other medicines and Solifenacin Glenmark
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 medicines, as they can reduce the effect of Solifenacin Glenmark
- medicines, such as metoclopramide and cisapride, which can make the gastrointestinal tract work faster; Solifenacin Glenmark 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 Glenmark 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 ) as they may increase the rate at which Solifenacin Glenmark 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 Glenmark with food and drink
It does not matter if this medicine is taken with or without food.
Pregnancy, breastfeeding, and fertility
You should not use Solifenacin Glenmark 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 Glenmark can affect vision and sometimes cause drowsiness and tiredness. If you experience any of these effects, do 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 Glenmark contains lactose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
How to use Solifenacin Glenmark
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
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.
The recommended dose is 5 mg per day unless your doctor has told you to take 10 mg per day.
Use for children and adolescents
Solifenacin Glenmark should not be used in children and adolescents under 18 years of age.
If you have taken too much Solifenacin Glenmark
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 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 take Solifenacin Glenmark
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. Always consult a doctor or pharmacist if you are unsure. Do not take a double dose to make up for a missed dose.
If you stop taking Solifenacin Glenmark
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 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 Glenmark 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 Glenmark 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 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 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 to store Solifenacin Glenmark
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister or carton 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 film-coated tablet contains 5 mg of solifenacin succinate.
Each film-coated tablet contains 10 mg of solifenacin succinate.
Other ingredients are:
Tablet core: Maize starch, lactose monohydrate, hypromellose (E464), magnesium stearate (E572)
Film coating: Hypromellose (E464), macrogol, talc (E553b), titanium dioxide (E171) and yellow iron oxide (E172), red iron oxide (E172)
Appearance and package sizes of the medicine
Solifenacin Glenmark 5 mg film-coated tablets are round, light yellow, and marked with “390” on one side of the tablet.
Solifenacin Glenmark 10 mg film-coated tablets are round, light pink, and marked with “391” on one side of the tablet.
Solifenacin Glenmark 5 mg and 10 mg film-coated tablets are supplied in blister packs of 10, 30, 50, 90, or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Glenmark Arzneimittel GmbH
Industrystr. 31
82194 Gröbenzell
Germany
Manufacturer
Zentiva sa
Bd Theodor Pallady No. 50
032266 Bucharest
Romania