Patient Medication Information: uses, side effects, how to take - ACH-Solifenacin Succinate
ABOUT THIS MEDICATION
What the medication is used for:
ACH-Solifenacin Succinate is used in the treatment of overactive bladder in adults with symptoms of frequent and urgent need to urinate (urinary frequency, urinary urgency) with urine leakage (urge urinary incontinence).
What it does:
ACH-Solifenacin Succinate is a urinary antispasmodic medication that helps to relax the smooth muscle of the bladder which leads to reduction of the symptoms caused by overactive bladder.
When it should not be used:
You should not take ACH-Solifenacin Succinate:
- If you are not able to empty your bladder (also called urinary retention).
- If you have End-Stage Kidney Disease and require dialysis.
- If you are not able to empty your stomach (also called gastroparesis).
- If you have narrow-angle glaucoma (high pressure and pain in the eyes).
- If you are allergic to solifenacin succinate or any of the other ingredients in ACH-Solifenacin Succinate. See ‘What the non-medicinal ingredients are’
What the medicinal ingredient is:
The medicinal ingredient in ACH-Solifenacin Succinate Tablet is ‘solifenacin succinate’.
What the non-medicinal ingredients are:
Each ACH-Solifenacin Succinate tablet contains the following inert ingredients: lactose monohydrate, maize starch, hypromellose, magnesium stearate, talc, polyethylene glycol and titanium dioxide with yellow ferric oxide (5 mg ACH-Solifenacin Succinate tablet) or red ferric oxide (10 mg ACH-Solifenacin Succinate tablet).
What dosage form it comes in:
ACH-Solifenacin Succinate is available in 5 and 10 mg tablets
WARNINGS AND PRECAUTIONS
Before you use ACH-Solifenacin Succinate, talk to your doctor or pharmacist if you:
- Have stomach problems affecting passage and digestion of food, or severe constipation.
- Have glaucoma.
- Have difficulty urinating, or weak urine stream.
- Have heart disease
- Have a rare heart problem called QT/QTc prolongation or family history of QT/QTc prolongation.
- Have kidney or liver problems.
- Have reduced ability to sweat.
Are pregnant or planning to become pregnant. Women who might get pregnant should use an effective birth control method while taking ACH-Solifenacin Succinate.
- Are breastfeeding or plan to breastfeed.
ACH-Solifenacin Succinate should not be given to children or adolescents.
ACH-Solifenacin Succinate may cause blurred vision and drowsiness. Do not drive a car, operate any machinery, or engage in any activities that require accurate vision and full attention.
In hot weather, ACH-Solifenacin Succinate can cause heat prostration (fever and heat stroke due to decreased sweating). Do not stay long in a hot environment while taking the drug. If you have any symptoms of heat prostration, keep yourself cool and drink a lot of water.
Angioedema (the symptoms include swelling of the face or tongue, difficulty breathing) and anaphylactic reactions (the symptoms include hives, difficulty breathing, abdominal cramps, rapid heartbeat and feeling faint), which could be life-threatening, have been reported in some patients taking solifenacin succinate. If you experience any of these symptoms, stop taking ACH-Solifenacin Succinate and see your doctor immediately.
INTERACTIONS WITH THIS MEDICATION
Before and while taking ACH-Solifenacin Succinate you should tell your doctor about your other medications, even the medicine you bought without prescription including vitamins and herbal supplements.
ACH-Solifenacin Succinate is known to have drug interactions with the following drugs: Drugs known to prolong the QT/QTc interval and/or cause torsade de pointes, drugs that decrease electrolyte levels, anticholinergic drugs, drugs that stimulate the motility of the gut such as metoclopramide, ketoconazole, clarithromycin, erythromycin, diclofenac, nefazodone, verapamil.
Drinking grapefruit juice with ACH-Solifenacin Succinate may increase your blood level of solifenacin.
PROPER USE OF THIS MEDICATION
Usual Dose:
5 mg daily. The daily dose may be increased to 10 mg following consultation with your doctor. Swallow the tablet whole with water.
ACH-Solifenacin Succinate can be taken with or without food.
Overdose:
| If you think you have taken too much ACH-Solifenacin Succinate, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If a dose is missed, the next tablet should be taken as planned.
Doses should not be doubled to make up for a missed dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The following side effects have been reported in clinical trials with solifenacin succinate:
Most common side effects: dry mouth and constipation
Common side effects: dry eyes, urinary retention, blurred vision, nausea, abdominal pain, indigestion, urinary tract infection.
The following side effects have been reported with the use of solifenacin succinate in worldwide post-marketing experience, although the frequency of events or a causal relationship with solifenacin succinate could not always be confirmed:
acid reflux, change in sense of taste decreased appetite, delirium, dizziness, dry skin, fast or irregular heartbeat, feeling sleepy, glaucoma, hallucination, headache, high potassium levels, hypersensitivity reactions, intestinal blockage, itchiness, kidney ailment, liver problems, muscle weakness, nasal dryness, voice disorder, severe skin scaling and redness, itching (exfoliative dermatitis), severe skin rash, itchiness and fever (erythema multiforme), swelling in the lower limbs and vomiting.
Tell your doctor or pharmacist if you have any side effects while taking ACH-Solifenacin Succinate. This includes any side effects not listed above.
| SERIOUS SIDE EFFEC TS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| Rare | Abdominal pain | √ | ||
| Constipation for more than 3 days | √ | |||
| Urinary retention | √ | |||
| Very rare | Swelling of the face or tongue, difficulty breathing | √ | ||
| Fast or irregular heartbeat | √ | |||
| Anaphylactic reactions (severe allergic reactions) | √ | |||
HOW TO STORE IT
Keep ACH-Solifenacin Succinate and all other medications out of the reach and sight of children.
Store between 15°C - 30°C.
Do not keep medicine that is out of date or that you no longer need.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
If you want more information about ACH-Solifenacin Succinate:
- Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.
Accord Healthcare Inc.
3535 boul. St. Charles, suite 704,
Kirkland, QC, H9H 5B9,
Canada