Solifenacin Succinate Tablets 10mg Taj Pharma

Solifenacin Succinate Tablets 10mg

  1. Name of the medicinal product

Solifenacin Tablets 5mg Taj Pharma
Solifenacin Tablets 10mg Taj Pharma

  1. Qualitative and quantitative composition

Each film-coated tablet contains
Solifenacin succinate  5mg

Each film-coated tablet contains
Solifenacin succinate  10mg

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film-coated tablet.

  1. Clinical particulars

4.1 Therapeutic indications

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

4.2 Posology and method of administration

Posology

Adults, including the elderly

The recommended dose is 5mg solifenacin succinate once daily. If needed, the dose may be increased to 10mg solifenacin succinate once daily.

Paediatric population

The safety and efficacy of solifenacin in children have not yet been established. Therefore, Solifenacin should not be used in children.

Patients with renal impairment

No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5mg once daily (see Section 5.2).

Patients with hepatic impairment

No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child Pugh score of 7 to 9) should be treated with caution and receive no more than 5mg once daily (see Section 5.2).

Potent inhibitors of cytochrome P450 3A4

The maximum dose of solifenacin should be limited to 5mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors e.g. ritonavir, nelfinavir, itraconazole (see Section 4.5).

Method of administration

Solifenacin should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.

4.3 Contraindications

Solifenacin is contraindicated in patients with urinary retention, severe gastrointestinal condition (including toxic megacolon), myasthenia gravis or narrow angle glaucoma and in patients at risk for these conditions.

– Patients hypersensitive to the active substance or to any of the excipients listed in section 6.1.

– Patients undergoing haemodialysis (see Section 5.2).

– Patients with severe hepatic impairment (see Section 5.2).

– Patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole (see Section 4.5)

4.4 Special warnings and precautions for use

Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with solifenacin. If urinary tract infection is present, an appropriate antibacterial therapy should be started. solifenacin should be used with caution in patients with:

– Clinically significant bladder outflow obstruction at risk of urinary retention.

– Gastrointestinal obstructive disorders.

– Risk of decreased gastrointestinal motility.

– Severe renal impairment (creatinine clearance ≤ 30 ml/min; see Section 4.2 and 5.2), and doses should not exceed 5mg for these patients.

– Moderate hepatic impairment (Child Pugh score of 7 to 9; see Section 4.2 and 5.2), and doses should not exceed 5mg for these patients.

– Concomitant use of a potent CYP3A4 inhibitor, e.g. ketoconazole (see 4.2 and 4.5).

– Hiatus hernia/gastro oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.

– Autonomic neuropathy.

QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as preexisting long QT syndrome and hypokalaemia.

Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor over activity.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Angioedema with airway obstruction has been reported in some patients on solifenacin succinate. If angioedema occurs, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.

Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.

The maximum effect of solifenacin can be determined after 4 weeks at the earliest.

4.5 Interaction with other medicinal products and other forms of interaction

Pharmacological interactions

Concomitant medication with other medicinal products with anticholinergic properties may result in more pronounced therapeutic effects and undesirable effects. An interval of approximately one week should be allowed after stopping treatment with solifenacin, before commencing other anticholinergic therapy. The therapeutic effect of solifenacin may be reduced by concomitant administration of cholinergic receptor agonists. Solifenacin can reduce the effect of medicinal products that stimulate the motility of the gastrointestinal tract, such as metoclopramide and cisapride.

Pharmacokinetic interactions

In vitro studies have demonstrated that at therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes. Therefore, solifenacin is unlikely to alter the clearance of drugs metabolised by these CYP enzymes.

Effect of other medicinal products on the pharmacokinetics of solifenacin

Solifenacin is metabolised by CYP3A4. Simultaneous administration of ketoconazole (200mg/day), a potent CYP3A4 inhibitor, resulted in a twofold increase of the AUC of solifenacin, while ketoconazole at a dose of 400mg/day resulted in a threefold increase of the AUC of solifenacin. Therefore, the maximum dose of solifenacin should be restricted to 5mg, when used simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole) (see Section 4.2).

Simultaneous treatment of solifenacin and a potent CYP3A4 inhibitor is contraindicated in patients with severe renal impairment or moderate hepatic impairment.

The effects of enzyme induction on the pharmacokinetics of solifenacin and its metabolites have not been studied as well as the effect of higher affinity CYP3A4 substrates on solifenacin exposure. Since solifenacin is metabolised by CYP3A4, pharmacokinetic interactions are possible with other CYP3A4 substrates with higher affinity (e.g. verapamil, diltiazem) and CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepin).

Effect of solifenacin on the pharmacokinetics of other medicinal products

Oral Contraceptives

Intake of solifenacin showed no pharmacokinetic interaction of solifenacin on combined oral contraceptives (ethinylestradiol/levonorgestrel).

Warfarin

Intake of solifenacin did not alter the pharmacokinetics of R-warfarin or S-warfarin or their effect on prothrombin time.

Digoxin

Intake of solifenacin showed no effect on the pharmacokinetics of digoxin.

4.6 Fertility, pregnancy and lactation

Pregnancy

No clinical data are available from women who became pregnant while taking solifenacin. Animal studies do not indicate direct harmful effects on fertility, embryonal / foetal development or parturition (see Section 5.3). The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.

Breastfeeding

No data on the excretion of solifenacin in human milk are available. In mice, solifenacin and/or its metabolites was excreted in milk, and caused a dose dependent failure to thrive in neonatal mice (see Section 5.3). The use of solifenacin should therefore be avoided during breastfeeding.

4.7 Effects on ability to drive and use machines

Since solifenacin, like other anticholinergics may cause blurred vision, and, uncommonly, somnolence and fatigue (see section 4.8. undesirable effects), the ability to drive and use machines may be negatively affected.

4.8 Undesirable effects

Summary of the safety profile

Due to the pharmacological effect of solifenacin, solifenacin may cause anticholinergic undesirable effects of (in general) mild or moderate severity. The frequency of anticholinergic undesirable effects is dose related. The most commonly reported adverse reaction with solifenacin was dry mouth. It occurred in 11% of patients treated with 5mg once daily, in 22% of patients treated with 10mg once daily and in 4% of placebo treated patients. The severity of dry mouth was generally mild and did only occasionally lead to discontinuation of treatment. In general, medicinal product compliance was very high (approximately 99%) and approximately 90% of the patients treated with solifenacin completed the full study period of 12 weeks treatment.

Tabulated list of adverse reactions

MedDRA system organ class Very common ≥1/10 Common ≥1/100, <1/10 Uncommon ≥1/1000, <1/100 Rare ≥1/10000, <1/1000 Very rare <1/10,000 Not known (cannot be estimated from the available data)
Infections and infestations Urinary tract infection

Cystitis

Immune system disorders Anaphylactic reaction*
Metabolism and nutrition disorders Decreased appetite*

Hyperkalaemia*

Psychiatric disorders Hallucinations*

Confusional state*

Delirium*
Nervous system disorders Somnolence

Dysgeusia

Dizziness*

Headache*

Eye disorders Blurred vision Dry eyes Glaucoma*
Cardiac disorders Torsade de Pointes*

Electrocardiogram QT prolonged*

Atrial fibrillation*

Palpitations*

Tachycardia*

Respiratory, thoracic and mediastinal disorders Nasal dryness Dysphonia*
Gastro intestinal disorders Dry mouth Constipation Nausea

Dyspepsia

Abdominal Pain

Gastrooesophageal reflux diseases Dry throat Colonic obstruction

Faecal impaction,

Vomiting*

Ileus*

Abdominal discomfort*

Hepatobiliary disorders Liver disorder*

Liver function test abnormal*

Skin and Sub cutaneous tissue disorders Dry skin Pruritus*,

Rash*

Erythema multiforme*, Urticaria*

Angioedema*

Exfoliative dermatitis*
Musculo skeletal and connective tissue disorders Muscular weakness*
Renal and urinary disorders Difficulty in micturition Urinary retention Renal impairment*
General disorders and administration site conditions Fatigue

Peripheral oedema

*observed post marketing

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms

Over dosage with solifenacin succinate can potentially result in severe anticholinergic effects. The highest dose of solifenacin succinate accidentally given to a single patient was 280mg in a 5 hour period, resulting in mental status changes not requiring hospitalization.

Treatment

In the event of overdose with solifenacin succinate the patient should be treated with activated charcoal. Gastric lavage is useful if performed within 1 hour, but vomiting should not be induced.

As for other anticholinergics, symptoms can be treated as follows:

– Severe central anticholinergic effects such as hallucinations or pronounced excitation: treat with physostigmine or carbachol.

– Convulsions or pronounced excitation: treat with benzodiazepines.

– Respiratory insufficiency: treat with artificial respiration.

– Tachycardia: treat with betablockers.

– Urinary retention: treat with catheterisation.

– Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room.

As with other antimuscarinics, in case of overdosing, specific attention should be paid to patients with known risk for QT prolongation (i.e.hypokalaemia, bradycardia and concurrent administration of medicinal products known to prolong QT interval) and relevant preexisting cardiac diseases (i.e. myocardial ischaemia, arrhythmia, congestive heart failure).

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Urinary antispasmodics.

Mechanism of action

Solifenacin is a competitive, specific cholinergic receptor antagonist.

The urinary bladder is innervated by parasympathetic cholinergic nerves. Acetylcholine contracts the detrusor smooth muscle through muscarinic receptors of which the M3 subtype is predominantly involved. In vitro and in vivo pharmacological studies indicate that solifenacin is a competitive inhibitor of the muscarinic M3 subtype receptor. In addition, solifenacin showed to be a specific antagonist for muscarinic receptors by displaying low or no affinity for various other receptors and ion channels tested.

Pharmacodynamic effects

Treatment with Solifenacin in doses of 5mg and 10mg daily was studied in several double blind, randomised, controlled clinical trials in men and women with overactive bladder.

As shown in the table below, both the 5mg and 10mg doses of Solifenacin produced statistically significant improvements in the primary and secondary endpoints compared with placebo. Efficacy was observed within one week of starting treatment and stabilises over a period of 12 weeks. A long term open label study demonstrated that efficacy was maintained for at least 12 months. After 12 weeks of treatment approximately 50% of patients suffering from incontinence before treatment were free of incontinence episodes, and in addition 35% of patients achieved a micturition frequency of less than 8 micturitions per day. Treatment of the symptoms of overactive bladder also results in a benefiton a number of Quality of Life measures, such as general health perception, incontinence impact, role limitations, physical limitations, social limitations, emotions, symptom severity, severity measures and sleep/energy.

Results (pooled data) of four controlled Phase 3 studies with treatment duration of 12 weeks.

Placebo Solifenacin 5mg o.d. Solifenacin 10mgo.d. Tolterodine 2mg b.i.d.
No. of micturitions/24 h
Mean baseline 11.9 12.1 11.9 12.1
Mean reduction from baseline 1.4 2.3 2.7 1.9
% change from baseline (12%) (19%) (23%) (16%)
n 1138 552 1158 250
pvalue* <0.001 <0.001 0.004
No. of urgency episodes/24 h
Mean baseline 6.3 5.9 6.2 5.4
Mean reduction from baseline 2.0 2.9 3.4 2.1
% change from baseline (32%) (49%) (55%) (39%)
n 1124 548 1151 250
pvalue* <0.001 <0.001 0.031
No. of incontinence episodes/24 h
Mean baseline 2.9 2.6 2.9 2.3
Mean reduction from baseline 1.1 1.5 1.8 1.1
% change from baseline (38%) (58%) (62%) (48%)
n 781 314 778 157
pvalue* <0.001 <0.001 0.009
No. of nocturia episodes/24 h
Mean baseline 1.8 2.0 1.8 1.9
Mean reduction from baseline 0.4 0.6 0.6 0.5
% change from baseline (22%) (30%) (33%) (26%)
n 1005 494 1035 232
pvalue* 0.025 <0.001 0.199
Volume voided/micturition
Mean baseline 166 ml 146 ml 163 ml 147 ml
Mean increase from baseline 9 ml 32 ml 43 ml 24 ml
% change from baseline (5%) (21%) (26%) (16%)
n 1135 552 1156 250
p-value* <0.001 <0.001 <0.001
No. of pads/24 h
Mean baseline 3.0 2.8 2.7 2.7
Mean reduction from baseline 0.8 1.3 1.3 1.0
% change from baseline (27%) (46%) (48%) (37%)
n 238 236 242 250
p-value* <0.001 <0.001 0.010

Note:  In 4 of the pivotal studies, solifenacin 10mg and placebo were used. In 2 out of the 4 studies also solifenacin 5mg was used and one of the studies included tolterodine 2mg bid.

Not all parameters and treatment groups were evaluated in each individual study. Therefore, the numbers of patients listed may deviate per parameter and treatment group.

* P-value for the pair wise comparison to placebo

5.2 Pharmacokinetic properties

Absorption

After intake of solifenacin tablets, maximum solifenacin plasma concentrations (Cmax) are reached after 3 to 8 hours. The tmax is independent of the dose. The Cmax and area under the curve (AUC) increase in proportion to the dose between 5 to 40mg. Absolute bioavailability is approximately 90%. Food intake does not affect the Cmax and AUC of solifenacin.

Distribution

The apparent volume of distribution of solifenacin following intravenous administration is about 600L. Solifenacin is to a great extent (approximately 98%) bound to plasma proteins, primarily α1acid glycoprotein.

Biotransformation

Solifenacin is extensively metabolised by the liver, primarily by cytochrome P450 3A4 (CYP3A4). However, alternative metabolic pathways exist, that can contribute to the metabolism of solifenacin. The systemic clearance of solifenacin is about 9.5 L/h and the terminal half life of solifenacin is 45-68hours. After oral dosing, one pharmacologically active (4R-hydroxy solifenacin) and three inactive metabolites (N- glucuronide, N-oxide and 4R- hydroxyl -N-oxide of solifenacin) have been identified in plasma in addition to solifenacin.

Elimination

After a single administration of 10mg [14Clabelled] solifenacin, about 70% of the radioactivity was detected in urine and 23% in faeces over 26 days. In urine, approximately 11% of the radioactivity is recovered as unchanged active substance; about 18% as the N- oxide metabolite, 9% as the 4R-hydroxy-N-oxide metabolite and 8% as the 4R-hydroxy metabolite (active metabolite).

Linearity/non-linearity

Pharmacokinetics are linear in the therapeutic dose range.

Other special populations

Elderly

No dosage adjustment based on patient age is required. Studies in elderly have shown that the exposure to solifenacin, expressed as the AUC, after administration of solifenacin succinate (5mg and 10mg once daily) was similar in healthy elderly subjects (aged 65 through 80 years) and healthy young subjects (aged less than 55 years). The mean rate of absorption expressed as tmax was slightly slower in the elderly and the terminal half life was approximately 20% longer in elderly subjects. These modest differences were considered not clinically significant.

The pharmacokinetics of solifenacin has not been established in children and adolescents.

Gender

The pharmacokinetics of solifenacin is not influenced by gender.

Race

The pharmacokinetics of solifenacin is not influenced by race.

Renal impairment

The AUC and Cmax of solifenacin in mild and moderate renally impaired patients, was not significantly different from that found in healthy volunteers. In patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) exposure to solifenacin was significantly greater than in the controls with increases in Cmax of about 30%, AUC of more than 100% and t½ of more than 60%. A statistically significant relationship was observed between creatinine clearance and solifenacin clearance. Pharmacokinetics in patients undergoing haemodialysis have not been studied.

Hepatic impairment

In patients with moderate hepatic impairment (Child Pugh score of 7 to 9) the Cmax is not affected, AUC increased with 60% and t½ doubled. Pharmacokinetics of solifenacin in patients with severe hepatic impairment have not been studied.

5.3 Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, fertility, embryo fetal development, genotoxicity, and carcinogenic potential. In the pre and postnatal development study in mice, solifenacin treatment of the mother during lactation caused dose dependent lower postpartum survival rate, decreased pup weight and slower physical development at clinically relevant levels. Dose related increased mortality without preceding clinical signs occurred in juvenile mice treated from day 10 or 21 after birth with doses that achieved a pharmacological effect and both groups had higher mortality compared to adult mice. In juvenile mice treated from postnatal day 10, plasma exposure was higher than in adult mice; from postnatal day 21 onwards, the systemic exposure was comparable to adult mice. The clinical implications of the increased mortality in juvenile mice are not known.

  1. Pharmaceutical particulars

6.1 List of excipients

Tablet core:

Lactose monohydrate, Maize starch, Hypromellose, Silica colloidal anhydrous

Magnesium stearate

Tablet-coating

Hypromellose, Macrogol, Titanium dioxide, Talc, Yellow iron oxide

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Solifenacin film-coated tablets are available in clear PVC- Aluminium foil blister pack and white opaque round HDPE container closed with white opaque polypropylene stock ribbed closure.

Blister packs:  10, 30, 50, 60, 70, 90 and 200 film-coated tablets

HDPE Packs: 100, 250 and 500 film-coated tablets

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

 

Solifenacin Succinate Tablets 5mg, 10mg

 

Package leaflet: Information for the user

Solifenacin 5mg film-coated tablets Taj Pharma

Solifenacin 10mg film-coated tablets Taj Pharma

Solifenacin succinate

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

–   Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as
  • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section
What is in this leaflet
  1. What Solifenacin is and what it is used for
  2. What you need to know before you take Solifenacin
  3. How to take Solifenacin
  4. Possible side effects
  5. How to store Solifenacin
  6. Contents of the pack and other information

 

  1. What Solifenacin is and what it is used for

 

The active substance of Solifenacin 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 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.

 

  1. What you need to know before you take Solifenacin

 

Do not take Solifenacin
  • If you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
  • 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 undergoing kidney dialysis
  • If you have severe liver disease
  • If you suffer from severe kidney disease or moderate liver disease AND at the same time 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

Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Solifenacin starts.

Warnings and precautions

Talk to your doctor or pharmacist before taking Solifenacin

  • 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
  • If you suffer from severe kidney
  • If you have moderate liver
  • If you have a stomach tear (hiatus hernia) or heartburn.
  • If you have a nervous disorder (autonomic neuropathy).
Children and adolescents

Solifenacin 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 starts.

Before starting Solifenacin, 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

Tell your doctor 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
  • Medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin can reduce their effect.
  • Medicines, like ketoconazole, ritonavir, nelfinavir, intraconazole, verapamil and diltiazem, which decrease the rate at which Solifenacin is broken down by the body
  • Medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solifenacin is broken down by the
  • Medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).

Solifenacin with food, drink and alcohol Solifenacin can be taken with or without food, depending on your preference.

Pregnancy, breast-feeding and fertility You should not use Solifenacin if you are pregnant unless clearly necessary. Do not use Solifenacin 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 planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Solifenacin 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 contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicinal product

3.   How to take Solifenacin

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 recommended dose is 5mg per day, unless your doctor told you to take 10mg per day.

If you take more Solifenacin than you should

If you have taken too much Solifenacin or if a child has accidentally taken Solifenacin, 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

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.

Do not take a double dose to make up for a forgotten dose. If you are in doubt, always consult your doctor or pharmacist.

If you stop taking Solifenacin

If you stop taking Solifenacin, 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 medicine, 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 (Solifenacin).

If angioedema occurs, solifenacin succinate (Solifenacin) should be discontinued immediately and appropriate therapy and/or measures should be taken.

Solifenacin 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.

5.   How to store Solifenacin

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 label, carton and bottle after EXP. The expiry date refers to the last day of that month.

This medicine 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.

 

  1. Contents of the pack and other information

What Solifenacin contains

  • The active substance is solifenacin succinate.

Each film-coated tablet contains 5mg of solifenacin succinate.

Each film-coated tablet contains 10mg of solifenacin succinate.

The other ingredients are

Tablet core: Lactose monohydrate, maize starch, hypromellose (5 cp), silica colloidal anhydrous, magnesium stearate.

Tablet coating: Hypromellose (6 cp), macrogol (PEG 4000), titanium dioxide (E 171), talc, yellow iron oxide (E 172) (for

5mg only), red iron oxide (E 172) (for 10mg only).

What Solifenacin looks like and contents of the pack

Film-coated tablet.

Blister packs: 10, 30, 50, 60, 70, 90 and

200 film-coated tablets

HDPE Packs: 100, 250 and 500 film-coated tablets

Not all pack sizes may be marketed.

 

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com