Consumer medicine information

1. Why am I using Pregabalin Apotex?

Pregabalin Apotex contains the active ingredient pregabalin. Pregabalin Apotex is used to treat neuropathic pain, which is pain caused by an abnormality of, or damage to, the nerves. Pregabalin Apotex is also used to control epilepsy which is a condition where you have repeated seizures (fits). For more information, see Section 1. Why am I using Pregabalin Apotex? in the full CMI.

2. What should I know before I use Pregabalin Apotex?

Do not use if you have ever had an allergic reaction to Pregabalin Apotex or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Pregabalin Apotex? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Pregabalin Apotex and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take Pregabalin Apotex?

The usual dose range is 150 mg per day to 600 mg per day given in two divided doses. Swallow the capsules whole with a full glass of water. More instructions can be found in Section 4. How do I use Pregabalin Apotex? in the full CMI.

5. What should I know while using Pregabalin Apotex?

6. Are there any side effects?

Tell your doctor or pharmacist if you notice any of the following less serious side effect and they worry you: dizziness, feeling tired or drowsy, constipation, diarrhoea, nausea, headache, increase in weight, unsteadiness when walking, reduced co-ordination, shaking or tremors, dry mouth or blurred or double vision. Tell your doctor as soon as possible if you notice any of the following more serious side effects: unusual changes in mood or behaviour, signs of new or increased irritability or agitation, signs of depression, confusion, swelling of the hands, ankles or feet, enlargement of breasts, unexplained muscle pain, tenderness and weakness, passing little to no urine, trouble breathing, shallow breaths. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Notes

Distributed by Apotex Pty Ltd

Boxed Warnings

Misuse, abuse potential or dependence. Pregabalin APOTEX is a potential drug of misuse, abuse, and dependence. Pregabalin APOTEX poses risks of misuse, abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants. Assess the patient's risk of misuse, abuse or dependence before prescribing and monitor the patient regularly during treatment, particularly amongst patients with current or past misuse, abuse or dependence of opioids and/or benzodiazepines (see Section 4.4 Special Warnings and Precautions for Use).

1 Name of Medicine

Pregabalin.

2 Qualitative and Quantitative Composition

Pregabalin APOTEX capsules contain the active ingredient pregabalin.
Excipients with known effect. Sugars as lactose (25 and 50 mg strengths).
Lactose (all other strengths).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pregabalin APOTEX 25 mg capsules. Size: 4 Hard gelatin capsule, cap: light grey, body: light grey with "25" printed in black ink.
Pregabalin APOTEX 50 mg capsules*. Size: 3 Hard gelatin capsule, cap: light grey, body: light grey with "50" and a black line printed in black ink.
Pregabalin APOTEX 75 mg capsules. Size: 4 Hard gelatin capsule, cap: light red, body: light grey with "75" printed in black ink.
Pregabalin APOTEX 100 mg capsules*. Size: 3 Hard gelatin capsule, cap: red, body: red with "100" printed in black ink.
Pregabalin APOTEX 150 mg capsules. Size: 2 Hard gelatin capsule, cap: light grey, body: light grey with "150" printed in black ink.
Pregabalin APOTEX 200 mg capsules*. Size: 1 Hard gelatin capsule, cap: red, body: red with "200" printed in black ink.
Pregabalin APOTEX 225 mg capsules*. Size: 1 Hard gelatin capsule, cap: red, body: light grey with "225" printed in black ink.
Pregabalin APOTEX 300 mg capsules. Size: 0 Hard gelatin capsule, cap: red, body: light grey with "300" printed in black ink.
*Non-marketed presentations.

4 Clinical Particulars

4.9 Overdose

Symptoms. In overdoses up to 15 g, no unexpected adverse effects were reported.
In post-marketing experience, the most commonly reported adverse events observed when pregabalin was taken in overdose included affective disorder, somnolence, confusional state, depression, agitation and restlessness. Seizures were also reported.
Management. There is no specific antidote for pregabalin. Treatment of pregabalin overdose should be symptomatic and supportive.
Consider administration of activated charcoal in the event of a potentially toxic ingestion. Activated charcoal is most effective when administered within one hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected.
Haemodialysis may be useful in patients with severe toxicity or those with significant renal impairment (see Section 4.2 Dose and Method of Administration, Use in renal impairment). Standard haemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours). Emesis is not recommended because of the potential for CNS depression and seizures.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Pregabalin is not genotoxic based on results of in vitro and in vivo tests. It was not mutagenic in bacteria or in mammalian cells in vitro, not clastogenic in mammalian systems in vitro and in vivo, and did not induce unscheduled DNA synthesis in mouse or rat hepatocytes.
Carcinogenicity. Two-year carcinogenicity studies with pregabalin were conducted in rats and mice. No increased incidence of tumours was observed in rats at exposures (plasma AUC) up to 25 times the expected human exposure at the maximum recommended clinical dose of 600 mg/day. In mice, no increased incidence of tumours was found at exposures similar to the expected maximum human exposure, but an increased incidence of haemangiosarcoma was observed at exposures 6 to 33 times the expected maximum human exposure. The precise non-genotoxic mechanism of pregabalin-induced tumour formation is not fully characterised. However, available data show that platelet changes associated with the formation of this tumour in mice are not seen in rats, monkeys or humans. Although long-term data in humans are limited, these findings in mice are thought not to pose a risk to humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Pregabalin is a white to off-white solid. It is sparingly soluble in water and basic and acidic aqueous solutions.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPREGAB.gif Chemical name: (S)-3-(aminomethyl)-5-methylhexanoic acid.
Molecular formula: C₈H₁₇NO₂.
Molecular weight: 159.23.
CAS number. 148553-50-8.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PREGAPST.gif