TIMIRIL Capsule Ref.[51193] Active ingredients: Pregabalin

Source: Health Products Regulatory Authority (ZA)  Publisher: Strides Pharma SA (Pty) Ltd, 106 16<sup>th</sup> Road, Building 2, Midrand, 1685, South Africa

Product name and form

TIMIRIL 25 (Capsules).

TIMIRIL 50 (Capsules).

TIMIRIL 75 (Capsules).

TIMIRIL 100 (Capsules).

TIMIRIL 150 (Capsules).

Pharmaceutical Form

Capsules.

TIMIRIL 25: Hard gelatin capsule with a white coloured cap and white coloured body, printed with “S” on cap and “466” on body with black ink containing a white to off-white crystalline powder.

TIMIRIL 50: Hard gelatin capsule with a white coloured cap and white coloured body, printed with “S” on cap and “467” on body with black ink containing a white to off-white crystalline powder.

TIMIRIL 75: Hard gelatin capsule with an orange coloured cap and white coloured body, printed with “S” on cap and “468” on body with black ink containing a white to off-white crystalline powder.

TIMIRIL 100: Hard gelatin capsule with an orange coloured cap and orange coloured body, printed with “S” on cap and “469” on body with black ink containing a white to off-white crystalline powder.

TIMIRIL 150: Hard gelatin capsule with a white coloured cap and white coloured body, printed with “S” on cap and “470” on body with black ink containing a white to off-white crystalline powder.

Qualitative and quantitative composition

TIMIRIL 25: Each capsule contains 25 mg pregabalin.

TIMIRIL 50: Each capsule contains 50 mg pregabalin.

TIMIRIL 75: Each capsule contains 75 mg pregabalin.

TIMIRIL 100: Each capsule contains 100 mg pregabalin.

TIMIRIL 150: Each capsule contains 150 mg pregabalin.

For full list of excipients, see section 6.1.

Sugar free.

Active Ingredient Description
Pregabalin

Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.

List of Excipients

TIMIRIL 25, 50 & 150 contains the following excipients:

Capsule content:

Pregelatinized starch
Talc

Capsule cap and body:

Gelatin
Titanium dioxide (E171)

TIMIRIL 75, & 100 contains the following excipients:

Capsule content:

Pregelatinized starch
Talc

Capsule cap and body:

Gelatin
Titanium dioxide (E171)
Red iron oxide (E172)

Printing ink for TIMIRIL 25, 50, 75, 100 & 150 contains:

Black iron oxide (E172)
Potassium hydroxide
Propylene glycol
Shellac
Strong ammonia solution

Pack sizes and marketing

TIMIRIL 25: White HDPE bottle sealed with a white child resistant cap containing 90 capsules.

TIMIRIL 50: Clear PVC/Aluminium blisters containing 100 capsules. Blisters are enclosed in a cardboard carton. White HDPE bottle sealed with a white child resistant cap containing 90 capsules.

TIMIRIL 75: Clear PVC/Aluminium blisters containing 100 capsules. Blisters are enclosed in a cardboard carton. White HDPE bottle sealed with a white child resistant cap containing 90 capsules.

TIMIRIL 100: Clear PVC/Aluminium blisters containing 100 capsules. Blisters are enclosed in a cardboard carton. White HDPE bottle sealed with a white child resistant cap containing 90 capsules.

TIMIRIL 150: Clear PVC/Aluminium blisters containing 100 capsules. White HDPE bottle sealed with a white child resistant cap containing 90 capsules. Blisters are enclosed in a cardboard carton. Not all pack sizes may be marketed.

Not all pack sizes may be marketed.

Marketing authorization holder

Strides Pharma SA (Pty) Ltd, 106 16th Road, Building 2, Midrand, 1685, South Africa

Marketing authorization dates and numbers

Timiril 25: 54/2.5/0767
Timiril 50: 54/2.5/0768
Timiril 75: 54/2.5/0769
Timiril 100: 54/2.5/0770
Timiril 150: 54/2.5/0771

05 July 2022

Drugs

Drug Countries
TIMIRIL South Africa

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