Description

Appilex Herbal Mixture is indicated for menstrual and abdominal pains

NAME OF PRODUCT: Appilex Herbal Mixture

DOSAGE FORM: Oral liquid ACTIVE INGREDIENTS: trichilia monadelpha, Tetrapleura tetraptera EXCIPIENTS: sodium Benzoate

INDICATION: This product is indicated for menstrual and abdominal pains

DOSAGE AND ADMINISTRATION Route of Administration: Appilex Herbal Mixture must be taken orally Dosage Adults (18 years and above) The usual dose is; Three (3) tablespoonfuls (45ml) three times (3X) daily for seven (7) days Children (12 years to 17 years) Two (2) tablespoonfuls (30ml) three times (3X) daily for seven (7) days If you forget to take a dose of Appilex Herbal Mixture, take the prescribed dose as soon as you remember and cortinue the rest of the dosage exactly as indicated above.     Do not take double dose to make up for forgotten dose.

SIDE EFFECTS Appilex Herbal Mixture is well tolerated. It has no Active ingredient known to cause drowsiness or dizziness. It therefore has no effect on driving or machinery operation.

WARNING/PRECAUTION Do not use Appilex Herbal Mixture if:

•  you are allergic to leaves, stem barks and roots of any of the Active Ingredients.
• your condition has not been diagnosed as Menstrual or Abdominal Pains Please inform your prescriber you are taking Appilex Herbal Mixture.
• when other drugs are going to be prescribed for you, including allopathic over-the-counter-medicines.

CONTRAINDICATIONS Appilex Herbal Mixture is not recommended for pregnant women, lactating mothers and individuals below twelve(12) years.

INTERACTION WITH FOOD AND DRUGS Appilex Herbal Mixture is well tolerated with food and should be taken preferably before meals. Please consult your doctor or Health Provider if you are taking any other medicines

OVER-DOSAGE AND MANAGEMENT If you take overdose of Appilex Herbal Mixture, drink plenty of water and consult your Health Care Provider immediately. Do not induce vomiting. The Observable Adverse Effect Level (OAEL) of Appilex Herbal Mixture is greater than five times (5X) the stated daily dose.

STORAGE AND HANDLING; Store Appilex Herbal Mixture in a cool dry place away from direct sunlight

CLINICAL PHARMACOLOGY Efficacy, Acute and Sub-Chronic Toxicity Test Analgesic and anti-inflammatoryeffect Prostaglandin E2, 0.2 ml {InM) was administered into the sub-planter region of the right hind paw of rats. The paw volume up to the ankle joints were measured plethysmographically before and after 30 min of the prostaglandin E2 stimulation. Each group was treated with either an extract from Applilex Mixture {30, 100 and 300 mg/kg, per os) or Diclofenac sodium {0.93 mg/kg, i.p). The control group received distilled water (1 ml/kg, per os). Paw edema was measured 0.5, 1, 1.5, 2 and 2.5 h post- treated and the percentage changes in paw volumes calculated and recorded. Gastric effect Five albino rats were fasted for 24 h but had access to water. They were then given 25 mg/kg indomethacin peros. After 6 h, they were sacrificed and their stomachs removed. Each stomach was dissected along the greater curvature, the content removed, and washed with normal saline. The appearance of ulcerative lesions was in indication of the formation of gastric ulcer. Experimental animals (fasted for 24 h) were put into five groups of fi ve. Group I (control) was given distilled wat er. Groups Il-IV, gastric ulceration was induced and animals were treated with 100. 250 or 500 mg/kg Applilex Mixture after 6 h. in Group V gastric ulceration was induced and animals were treated with 20 mg/kg esomeprazole after 6 h. drug treatment in all groups continued for 14 days. Rats were sacrificed and their stomach removed and examined for ulcerative lesions. The number of lesions in the stomach of rats in each group was determined . The maximum length of each lesion (in millimeters) was determined and the sum of the lengths of all lesions in each stomach was expressed as the Ulcer Index (UI). The curative ration (CR), expressed in percentage, was determined for each group using the formula: CR{%)= (UI of Control – Ui of treatment)/ Ul of Control x 100. RESULTS

APPILEX HERBAL MIXTURE

Analgesic and anti-inflammatory effect Having treated the rats with the reference drugs and Applilex mixture extracts, it was observed then on that the 30, 100 and 300 mg/ kg treated groups had significant reduction (P : S:0.01-0.0001) in paw edema in the prostaglandin-induced inflammation; All reference drugs caused very significant reductions (P: S:0.001). These observations signify that Applilex mixture have anti-inflammatory properties comparable to the reference drugs. Gastric effect The 100, 250 and 500 mg/ kgof Applilex mixture manifested very significant activity against indomethacin-induced gastric ulceration in a dose dependent fashion compared to control

(Table 1).

Table 1: The ulcer index and Curative ratio for rats pretreated with esomeprazole and Applilex mixture in indomethacin-induced ulceration.

NOAEL; No-Observable-Adverse-Effect Level REMARKS The OAEL is greater than five times the stated daily dosage indicated by the manufacturer. The recommended dose is thus within acceptable margin of safety.

PHYTOCHEMICAL PROPERTIES: Major chemical constituents in Appilex Herbal Mixture include; Reducing Sugars, Saponins, Tannins, Alkaloids and sterols. PHYSICOCHEMICAL DATA: PH (aq. Extract) –5.43 AVERAGE WT PER ML—1.0399 gm/ml DRYWTPERML– 0.0713gm/ ml DETAILS OF MANUFACTURE: PRODUCED IN GHANA BY: SOLAK BIOCHEMIST P. O. BOX SE 788, SUAME KUMASI ASHANTI REGION LOCATION: PLT. 37 BLK B, EKYEM-FUMESUA KUMASI, ASHANTI REGION, GHANA G.P.S ADDRESS: (AE-0533-2502) TEL/MOB.: 0261736263 / 0245616028