Caredalud S.R. 6 mg F.C. scored tab

General information

  • Company Name: Arab caps for gelatin and pharmaceutical products For PharmaCare Egypt for Trading Agency.
  • Trade Name: Caredalud S.R. 6 mg film coated scored tablets
  • Generic Name: Tizanidine

Caredalud : Composition

 Each F.C. Scored S.R. tablet contains:

Active substance: Tizanidine, 6 mg as the hydrochloride

Excipients: Silicon dioxide colloidal, stearic acid,microcrystalline cellulose, lactose monohydrate, and anhydrous lactose.

Pharmaceutical form

F.C. Scored S.R. tablets containing tizanidine hydrochloride.

Pharmacological actions

Tizanidine is centrally acting as muscle relaxant/anti spasticity agent. Its principle site of action is the spinal cord.

Tizanidine is effective in both acute painful muscle spasms and chronic spasticity of spinal and cerebral origin. It reduces resistance to passive movement, alleviates spasms and clonus, and improves voluntary strength.

Sustained release of the active ingredient from Tizanidine S.R. tablets means that high initial peaks are avoided and therapeutic plasma concentrations maintained over 24 hours.

Pharmacokinetics

Sustained release of Tizanidine from S.R. tablet results in a smoother Pharmacokinetics profile by avoiding high initial peaks in the plasma. Under steady – state conditions, peak plasma concentrations are attained within approx. 6 hours; they correspond to approx. 40 of the peak plasma concentrations attained after the same daily doses of Tizanidine in tablet form are given in three divided doses. Therapeutic plasma levels are maintained for 24 hours.

Caredalud : Indication I potential Uses

  1. Painful muscles spasms.
  2. Spasticity due to multiple sclerosis.
  3. Spasticity due to spinal injury.
  4. Spasticity due to brain injury.

Dosage & Administration

Adults Relief of painful muscle spasms: 3 mg three times daily in tablet form. In severe cases an additional dose of 3 mg may be taken at bed time.

Adult Spasticity due to neurological disorders: The dosage should be adjusted to the needs of the individual patient. The recommended starting dose is one 6 mg S.R. Tablet once daily; if necessary, it may be increased stepwise by one 6 mg S.R.Tablet at half- weekly or weekly intervals.. The standard dose is 6 – 24 mg once daily.clinical experience has shown the optimum dose in most patients to be 2 mg once daily, 24 mg/day only being required in a rare case. One 12 mg tablet may be given instead of two 6 mg tablets.

Caredalud : Contraindications

  • Hypersensitivity to the active substance.
  • Significant impairment of liver function.
  • Concomitant administration of Trzanidine with fluvoxamine or dprofloxadn is contraindicated. (See interactions & Wamings and precautions).
  • Children and eldery patient.
  • Pregnancy and lactation.

Adverse effects / side effects

Adverse effects-such as drowsiness, fatigue, light head, dry mouth, reduced blood pressure, nausea, gastrointestinal disorders and elevated serum transaminases are usually mild and transient in patient using low doses, such as those recommended for treatment of painful muscle spams, With higher doses, such as those recommended for the treatment of spasticity, the above ­mentioned reaction are more pronounced, but seldom severe enough to require discontinuation of treatment. The following adverse effects may also occur hypotension, bradycardia, muscle weakness, insomnIa, sleep disorders, hallucinations, and hepatitis.

Caredalud : Interactions

  • Concomitant administration of tizanidine with fluvoxamine or ciprofloxacin, Which are both potent CYP1A2 Inhibitors in man, is contraindicated (see contraindications).
  • Concomitant administration of tizanidine with fluvoxamine resulted in, a 33-fold increase in the AUC of tizanidine while concomitant administration of tizanidine with ciprofloxacin , resulted in a 10-fold increase in the AUC of Tizanidine. This may lead to a clinically significant and prolonged drop in blood pressure, accompanied by drowsiness, light head and deaeased psychomotor performance (see contra indications).
  • Concomitant administration of other CYP1A2 inhibitors­ such as some antiarrhythmics (amiodarone, mexiletine, propafenone), cimetidine, some fluoroquinolones (enoxacin, pefloxacin., norfIoxacin), rofecoxib, oral contraceptives and ticlopidine is not recommended.
  • Concomitant use of tizanidine with antihypertensive agent, induding diuretics can occasionally cause hypotension and bradycardia.
  • Tizanidine may potentiate the effects of alcohol and sedatives.

Pregnancy & Lactation

Trzanidine is contraindicated in both cases.

Warnings & precautions

  • Concomitant administration of CYP1A2 inhibitors with tizanidine is not recommended (see interactions and contraindications) .
  • Liver function impairment has been reported in association with tizanidine, although rarely in patients receiving daily doses up to 12 mg. monitoring liver function is therefore recommended at monthly intervals during the first four months of therapy in patients receiving doses of 12 mg or more and in patients with clinical symptoms indicating liver function impairment (e.g. unexplained nausea, appetite loss, or fatigue).
  • Tizanidine therapy should be discontinued if serum ALT (SGPT) or AST (SGOT) remain at more than three times the normal level over a prolonged period.
  • In patients with impaired kidney function (creatinine clearance < 25 ml/minute) the recommended starting dose is 3 mg once daily. The dosage should subsequently be increased in small steps depending on efficacy and tolerability.
  • To achieve enhanced efficacy it is advisable to increase the size of the once-daily dose first before increasing the frequency of adminisiration.
  • Tizanidine tablets contain lactose. Patients with, rare hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not take tizanidine tablets.

Effects on ability to drive and use machines

Patients experiencing drowsiness or dizziness should refrain from activities requiring a high degree of alertness (e.g. driving, using machines).

Package & Storage

A carton box of 2 or 3 (ALU I PVC) strips each of 10 F.C. scored S.R. tablets.

Keep at room temperature.

Keep out of reach of children.

Other information to patients

  1. Follow strictly your physician prescription.
  2. Tablet should be swallowed with some water.
  3. Do not interrupt the treatment from yourself or repeat it.
  4. You can take Caredalud S.R. tablet with or without food.
  5. Shetf-life: Do not use after the expiry date (=E XP.) printed on the pack.

caredalud tablet patient information leaflet

Caredalud S.R. 6 mg F.C. scored tab
Caredalud S.R. 6 mg F.C. scored tab