Consumer medicine information

1. Why am I taking Pregabalin DRLA?

Pregabalin DRLA contains the active ingredient, pregabalin. Pregabalin DRLA is taken to treat neuropathic pain, which is pain caused by an abnormality of, or damage to, the nerves.
For more information, see Section 1. Why am I taking Pregabalin DRLA? in the full CMI.

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

Do not take if you have ever had an allergic reaction to Pregabalin DRLA 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 (including benzodiazepines and opioids), or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take Pregabalin DRLA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Pregabalin DRLA 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 DRLA?

• Pregabalin DRLA should be administered once daily after an evening meal. It should be swallowed whole and should not be split, ushed or chewed.

5. What should I know while taking Pregabalin DRLA?

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Some common, less serious side effects include dizziness, feeling tired or drowsy, headache, unsteadiness when walking, reduced coordination, shaking or tremors, constipation, diarrhoea, nausea, dry mouth, blurred or double vision, abdominal pain, and increase in weight. Serious side effects include unusual changes in mood or behaviour, increased irritability, anxiety or depression, thoughts of suicide, swelling of the face, lips, tongue, hands, ankles or feet, unexplained muscle pain, tenderness and weakness, irritated red eyes that are sensitive to light, and shortness of breath, wheezing or difficulty breathing.
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.

Boxed Warnings

Misuse, abuse potential or dependence. Pregabalin-DRLA is a potential drug of misuse, abuse, and dependence. Pregabalin-DRLA 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-DRLA contains the active ingredient pregabalin. Pregabalin is an analogue of the neurotransmitter gamma-aminobutyric acid (GABA). It has analgesic and anticonvulsant activity. Pregabalin-DRLA capsules contain 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg pregabalin.
Excipient(s) with known effect. Sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pregabalin-DRLA 25 mg capsules: An opaque white hard gelatin capsule of size 4, imprinted 'RDY' on the cap and '291' on the body with black ink.
Pregabalin-DRLA 50 mg capsules: An opaque white hard gelatin capsule of size 3, imprinted 'RDY' on the cap and '292' on the body with black ink. The capsule body is also marked with a black band.
Pregabalin-DRLA 75 mg capsules: A hard gelatin capsule of size 4, imprinted 'RDY' on the opaque red coloured cap and '293' on the opaque white coloured body with black ink.
Pregabalin-DRLA 100 mg capsules: A hard gelatin capsule of size 3, imprinted 'RDY' on the opaque red coloured cap and '294' on the opaque red coloured body with black ink.
Pregabalin-DRLA 150 mg capsules: An opaque white hard gelatin capsule of size 2, imprinted 'RDY' on the cap and '295' on the body with black ink.
Pregabalin-DRLA 200 mg capsules: An opaque light red coloured hard gelatin capsule of size 1, imprinted 'RDY' on the cap and '296' on the body with black ink.
Pregabalin-DRLA 225 mg capsules: A hard gelatin capsule of size 1, imprinted 'RDY' on the opaque light red coloured cap and '297' on the opaque white coloured body with black ink.
Pregabalin-DRLA 300 mg capsules: A hard gelatin capsule of size 0, imprinted 'RDY' on the opaque red coloured cap and '298' on the opaque white coloured body with black ink.

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.
Recommended treatment. 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, 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 13 11 26 (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 freely 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)

Prescription Only Medicine - S4.

Summary Table of Changes

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