Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.
From the official U.S. FDA label for tolterodine tartrate, the active ingredient registered with NAFDAC.
1. INDICATIONS AND USAGE Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14) ] . Tolterodine tartrate extended-release capsules, USP are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
6. ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (incidence > 4% and >placebo) were dry mouth, headache, constipation, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Inventia Healthcare Limited, at 1-800-270-7585 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
4. CONTRAINDICATIONS Tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine [see WARNINGS …
5. WARNINGS AND PRECAUTIONS Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate extended-release capsules. ( 5.1 ) Urinary Retention: use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ( 5.2 ) Gastrointestinal Disorders: use caution in patients with gastrointestinal obstructive disorders or decreased gastrointestinal motility because of the risk of gastric retention. ( 5.3 ) Controlled Narrow-Angle Glaucoma: use caution in patients being treated for narrow-angle glaucoma. …
8.1 Pregnancy Risk Summary There are no available data with tolterodine tartrate extended-release capsules use in pregnant women to inform drug-associated risks. In animal reproduction studies, oral administration of tolterodine and its 5-HMT metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the clinical exposure at a dose of 20 mg/kg/day; however, higher doses pro …
Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.
Roliten Tablets 2 mg contains Tolterodine Tartrate (2 mg), as tablet, according to its NAFDAC registration record.
Yes. Roliten Tablets 2 mg is listed on the NAFDAC register under registration number A4-1498, and its registration is active as of 5 November 2026.
No WHO falsified or substandard medical product alert currently matches Roliten Tablets 2 mg in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number A4-1498, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
1. INDICATIONS AND USAGE Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14) ] . Tolterodine tartrate extended-release capsules, USP are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urg (Summarised from the official U.S. FDA label for tolterodine tartrate. Always follow your doctor or pharmacist.)
Reviews are personal experiences from RxVerify users, not medical advice. Report side effects to your doctor and to NAFDAC.