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Libre Tizanidine Tablets

NAFDAC Reg. No. C4-0141 · Drug

Registered with NAFDAC — registration activeAs of 6 November 2026 · synced automatically from official sources.
Product
Libre Tizanidine Tablets
NAFDAC number
C4-0141
Active ingredient
Tizanidine (Tizanidine Hydrochloride)
Strength
2 mg
Form
Tablet
Pack size
1 x 10's (in Alu-PVC blister)
Manufacturer
Not listed
Applicant (holder)
Ralphones Pharmaceutical Company Limited
Approved
30 Apr 2025
Status
Active View on NAFDAC ↗
Registration valid to
29 Apr 2030
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Libre Tizanidine Tablets is on the NAFDAC register with an active registration (C4-0141). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Libre Tizanidine Tablets is used for

From the official U.S. FDA label for tizanidine (tizanidine hydrochloride), the active ingredient registered with NAFDAC.

What it is used for

Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration(2.1) ]. Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [ see Dosage and Administration (1) ].

Possible side effects

The following adverse reactions are described elsewhere in other sections of the prescribing information: • Hypotension [ see Warnings and Precautions (5.1) ] • Liver Injury [ see Warnings and Precautions (5.2) ] • Sedation [ see Warnings and Precautions (5.3) ] • Hallucinosis/Psychotic-Like Symptoms [ see Warnings and Precautions (5.4) ] • Hypersensitivity Reactions [ see Warnings and Precautions (5.6) ] The most common adverse reactions (greater than 2% of 264 patients taking tizanidine and greater than in placebo-treated patients in three multiple dose, placebo-controlled studies) were dry mouth, somnolence, asthenia, dizziness, urinary tract infection, constipation, liver function tests …

Do not use if

Tizanidine Tablets, USP is contraindicated in patientstaking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [ see Drug Interactions (7.1 , 7.2 ) ]. Concomitant use with potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin ( 4 , 5.5 , 7.1 , 7.2 )

Warnings

• Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives; Tizanidine Tablets, USP should not be used with other α 2 -adrenergic agonists ( 5.1 , 7.7 ) • Risk of liver injury: monitor ALTs; discontinue Tizanidine Tablets, USP if liver injury occurs ( 5.2 ) • Sedation: Tizanidine Tablets, USP may interfere with everyday activities; sedative effects of Tizanidine Tablets, USP, alcohol, and other CNS depressants are additive ( 5.3 , 7.5 , 7.6 ) • Hallucinations: consider discontinuation of Tizanidine Tablets, USP ( 5.4 ) • Less potent inhibitors of CYP1A2: may cause hypotension, bradycardia, or excessive drowsiness, use cautio …

Pregnancy & breastfeeding

8.1 Pregnancy Pregnancy Category C Tizanidine Tablets, USP has not been studied in pregnant women. Tizanidine Tablets, USP should be given to pregnant women only if the benefit outweighs the risk to the unborn fetus. Reproduction studies performed in rats at a dose of 3 mg/kg, equal to the maximum recommended human dose on a mg/m 2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m 2 basis, did not show evide …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Libre Tizanidine Tablets

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Libre Tizanidine Tablets

What is in Libre Tizanidine Tablets?

Libre Tizanidine Tablets contains Tizanidine (Tizanidine Hydrochloride) (2 mg), as tablet, according to its NAFDAC registration record.

Is Libre Tizanidine Tablets registered with NAFDAC?

Yes. Libre Tizanidine Tablets is listed on the NAFDAC register under registration number C4-0141, and its registration is active as of 6 November 2026.

Has Libre Tizanidine Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Libre Tizanidine Tablets in our automatically synced alert list.

How can I check that my pack of Libre Tizanidine Tablets is genuine?

Run a free authenticity scan with the NAFDAC number C4-0141, 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.

What is Libre Tizanidine Tablets used for?

Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration(2.1) ]. Tizanidine Tablets, USP is a central alpha-2-adrenergic agoni (Summarised from the official U.S. FDA label for tizanidine (tizanidine hydrochloride). Always follow your doctor or pharmacist.)

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