Patient leaflet - Solifenacin Succinate Hec Pharm 10 mg film-coated tablets
1. What Solifenacin succinate HEC Pharm is and what it is used for
The active substance of Solifenacin succinate HEC Pharm belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder.
Solifenacin succinate HEC Pharm is used to treat the symptoms of a condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time.
2. What you need to know before you take Solifenacin succinate HEC Pharm
Do not take Solifenacin succinate HEC Pharm
- if you have an inability to pass water or to empty your bladder completely (urinary retention),
- if you have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis),
- if you suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles,
- if you suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma),
- if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6),
- if you have severe kidney disease or you are undergoing kidney dialysis,
- if you have moderate or severe liver disease,
- if you are being treated with medicines that may decrease the removal of solifenacin from the body (for example, ketoconazole). Your doctor or pharmacist will have informed you if this is the case.
Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Solifenacin succinate HEC Pharm starts.
Warnings and precautions
Talk to your doctor before taking Solifenacin succinate HEC Pharm.
- if you have trouble emptying your bladder (bladder obstruction) or have difficulty in passing urine (e.g. a thin urine flow). Risk of accumulation of urine in the bladder (urinary retention) is much higher.
- if you have some obstruction of the digestive system (constipation).
- if you are at risk of your digestive system slowing down (stomach and bowel movements). Your doctor will have informed you if this is the case.
- if you have a stomach tear (hiatus hernia) or heartburn.
- if you have a nervous disorder (autonomic neuropathy).
Children and adolescents
Solifenacin succinate HEC Pharm is not to be used in children or adolescents under 18 years.
Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Solifenacin succinate HEC Pharm starts.
Before starting Solifenacin succinate HEC Pharm, your doctor will assess whether there are other causes for your need to pass urine frequently (for example heart failure [insufficient pumping power of the heart] or kidney disease). If you have a urinary tract infection, your doctor will prescribe you an antibiotic (a treatment against particular bacterial infections).
Other medicines and Solifenacin succinate HEC Pharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important to inform your doctor if you are taking:
- other anticholinergic medicines, effects and side effects of both medications can be enhanced.
- cholinergics as they can reduce the effect of Solifenacin succinate HEC Pharm.
- medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin succinate HEC Pharm can reduce their effect.
- medicines, like ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which decrease the rate at which Solifenacin succinate HEC Pharm is broken down by the body.
- medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solifenacin succinate HEC Pharm is broken down by the body.
- medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).
Solifenacin succinate HEC Pharm with food and drink
Solifenacin succinate HEC Pharm can be taken with or without food, depending on your preference.
Pregnancy and breast-feeding
You should not use Solifenacin succinate HEC Pharm if you are pregnant unless clearly necessary.
Do not use Solifenacin succinate HEC Pharm if you are breast-feeding as solifenacin may get into your breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planing to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Solifenacin succinate HEC Pharm may cause blurred vision and sometimes sleepiness or tiredness. If you suffer from any of these side effects, do not drive or operate machinery.
Solifenacin succinate HEC Pharm contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicinal product.
3. How to take Solifenacin succinate HEC Pharm
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
You should swallow the whole tablet with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.
The usual dose is 5 mg per day for which other products are available. The dose is 10 mg per day in case your doctor has decided that you need this higher dose.
If you take more Solifenacin succinate HEC Pharm than you should
If you have taken too much Solifenacin succinate HEC Pharm or if a child has accidentally taken Solifenacin succinate HEC Pharm, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perceiving things that are not there (hallucinations), over-excitability, seizures (convulsions), difficulty breathing, elevated heart rate (tachycardia), accumulation of urine in the bladder (urinary retention) and dilated pupils (mydriasis).
If you forget to take Solifenacin succinate HEC Pharm
If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take your next dose. Never take more than one dose per day. If you are in doubt, always consult your doctor or pharmacist.
If you stop taking Solifenacin succinate HEC Pharm
If you stop taking Solifenacin succinate HEC Pharm, your symptoms of overactive bladder may return or worsen. Always consult your doctor, if you are considering stopping the treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor or pharmacist immediately.
Angioedema (skin allergy that results in the swelling that occurs in the tissue just below the surface of the skin) with airway obstruction (difficulty in breathing) has been reported in some patients on solifenacin succinate. If angioedema occurs, solifenacin succinate should be discontinued immediately and appropriate therapy and/or measures should be taken.
Solifenacin succinate HEC Pharm may cause the following other side effects:
Very common (may affect more than 1 in 10 people)
- dry mouth
Common (may affect up to 1 in 10 people)
- blurred vision
- constipation, nausea, indigestion with symptoms such as abdominal fullness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort
Uncommon (may affect up to 1 in 100 people)
- urinary tract infection, bladder infection
- sleepiness
- impaired sense of taste (dysgeusia)
- dry (irritated) eyes
- dry nasal passages
- reflux disease (gastro-oesophageal reflux)
- dry throat
- dry skin
- difficulty in passing urine
- tiredness
- accumulation of fluid in the lower legs (oedema)
Rare (may affect up to 1 in 1,000 people)
- lodging of a large amount of hardened stool in the large intestine (faecal impaction)
- build up of urine in the bladder due to inability to empty the bladder (urinary retention)
- dizziness, headache
- vomiting
- itching, rash
Very rare (may affect up to 1 in 10,000 people)
- hallucinations, confusion
- allergic rash
Not known (frequency cannot be estimated from the available data)
- decreased appetite, high levels of blood potassium which can cause abnormal heart rhythm
- increased pressure in the eyes
- changes in the electrical activity of the heart (ECG), irregular heartbeat, feeling your heartbeat, faster heart beat
- voice disorder
- liver disorder
- muscle weakness
- renal disorder
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or
Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Solifenacin succinate HEC Pharm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Solifenacin succinate HEC Pharm contains
The active substance is solifenacin succinate.
Each film-coated tablet contains 10 mg of solifenacin succinate corresponding to 7.5 mg solifenacin.
The other ingredients are:
Tablet core: lactose anhydrous (see warnings in section 2), hypromellose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide,
Tablet coating: lactose monohydrate (see warnings in section 2), hypromellose 2910, titanium dioxide, triacetin.
What Solifenacin succinate HEC Pharm looks like and contents of the pack
Solifenacin succinate HEC Pharm 10 mg film-coated tablets are white or almost white round film-coated tablets of 7.5 mm in width, biconvex, debossed with “C77” on one side and blank on the other side.
Solifenacin succinate HEC Pharm 10 mg film-coated tablets are supplied in blister packs of 10, 20, 30, 50 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
HEC Pharm GmbH
Wallstrasse 9-13,
10179 Berlin, Germany