Solnatec

Solnatec

solifenacin

Nhà sản xuất:

One Pharma

Nhà phân phối:

Nafarma
Thông tin kê toa chi tiết tiếng Anh
Contents
Solifenacin succinate.
Description
The active substance is solifenacin succinate. Each tablet contains 5 mg or 10 mg solifenacin succinate, equivalent to 3.75 mg and 7.5 mg of solifenacin respectively.
Excipients/Inactive Ingredients: The other ingredients are: Tablet core: Lactose monohydrate, Hypromellose (Methocel E5), Maize Starch pregelatinized, Povidone, Aerosil (Silica Colloidal anhydrous), Magnesium stearate.
Film coating for 5 mg: Hypromellose, Titanium dioxide (E171), Macrogol/PEG, Talc, Yellow iron oxide (E172).
Film coating for 10 mg: Hypromellose, Titanium dioxide (E171), Macrogol/PEG, Talc, Red iron oxide (E172).
Action
The active substance of Solnatec belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This enables the patient to wait longer before having to go to the bathroom and increases the amount of urine that can be held by the bladder.
Indications/Uses
Solnatec 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 the patient wetting himself/herself because he/she could not get to the bathroom in time.
Dosage/Direction for Use
Solnatec with food and drink: Solnatec can be taken with or without food, depending on the patient's preference.
How to take Solnatec: Always take this medicine exactly as the doctor has prescribed. Check with the doctor or pharmacist if the patient is not sure.
The patient should swallow the whole tablet with some liquid. It can be taken with or without food, according to the patient's preference. Do not crush the tablets.
The usual dose is 5 mg per day, unless the doctor prescribed to take 10 mg per day.
If the patient takes more Solnatec than he/she should: If the patient has taken too much Solnatec or if a child has accidentally taken Solnatec, contact the 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 the patient forgets to take Solnatec: If the patient forgets to take a dose at the usual time, take it as soon as the patient remembers, unless it is time to take the next dose. Never take more than one dose per day. If the patient is in doubt, always consult the doctor or pharmacist.
If the patient stops taking Solnatec: If the patient stops taking Solnatec, the symptoms of overactive bladder may return or worsen. Always consult the doctor, if the patient is considering stopping the treatment.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Contraindications
Do not take Solnatec: if the patient has an inability to pass water or to empty the bladder completely (urinary retention); if the patient has a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis); if the patient suffers from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles; if the patient suffers from increased pressure in the eyes, with gradual loss of eye sight (glaucoma); if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in Description); if the patient is undergoing kidney dialysis; if the patient has severe liver disease; if the patient suffers from severe kidney disease or moderate liver disease AND at the same time is being treated with medicines that may decrease the removal of Solnatec from the body (for example, ketoconazole). The doctor or pharmacist will have informed the patient if this is the case.
Inform the doctor if the patient has or ever had any of the previously mentioned conditions before treatment with Solnatec starts.
Special Precautions
Talk to the doctor or pharmacist before taking Solnatec: if the patient has trouble emptying the bladder (= bladder obstruction) or has difficulty in passing urine (e.g. a thin urine flow). Risk of accumulation of urine in the bladder (urinary retention) is much higher; if the patient has some obstruction of the digestive system (constipation); if the patient is at risk of the digestive system slowing down (stomach and bowel movements). The doctor will have informed the patient if this is the case; if the patient suffers from severe kidney disease; if the patient has moderate liver disease; if the patient has a stomach tear (hiatus hernia) or heartburn; if the patient has a nervous disorder (autonomic neuropathy).
Important information about some of the ingredients of Solnatec: Solnatec contains lactose. If the patient has been told by the doctor that he/she has a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption he/she should not use this medicine.
Driving and using machines: Solnatec may cause blurred vision and sometimes sleepiness or tiredness. If the patient suffers from any of these side effects, do not drive or operate machinery.
Use in Children: Children and adolescents: Solnatec is not to be used in children or adolescents under 18 years.
Inform the doctor if the patient has or ever had any of the previously mentioned conditions before treatment with Solnatec starts.
Before starting Solnatec, the doctor will assess whether there are other causes for the need to pass urine frequently (for example heart failure (insufficient pumping power of the heart) or kidney disease). If the patient has a urinary tract infection, the doctor will prescribe an antibiotic (a treatment against particular bacterial infections).
Use In Pregnancy & Lactation
The patient should not use Solnatec if she is pregnant unless clearly necessary. Do not use Solnatec if the patient is breast-feeding as solifenacin may get into the breast milk.
Ask the doctor or pharmacist for advice before taking this medicine.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), he/she must inform the 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.
Solnatec 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 the heartbeat, faster heart beat; voice disorder; liver disorder; muscle weakness; renal disorder.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. The patient can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects the patient can help provide more information on the safety of this medicine.
Drug Interactions
Please tell the doctor or pharmacist if the patient is taking or has recently taken or might take other medicines.
It is especially important to inform the doctor if the patient is taking: Other anticholinergic medicines, effects and side effects of both medications can be enhanced.
Cholinergic as they can reduce the effect of Solnatec.
Medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solnatec can reduce their effect.
Medicines, like ketoconazole, ritonavir, nelfinavir, intraconazole, verapamil and diltiazem, which decrease the rate at which Solnatec is broken down by the body.
Medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solnatec is broken down by the body.
Medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Storage
There are no special precautions for storage.
ATC Classification
G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
FC tab 5 mg (yellow, round, biconvex) x 3's, 5's, 10's, 20's, 30's, 50's, 60's, 90's, 100's, 200's. 10 mg (pink, round, biconvex) x 3's, 5's, 10's, 20's, 30's, 50's, 60's, 90's, 100's, 200's.
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