Consumer medicine information

1. Why am I taking NUPENTIN?

NUPENTIN contains the active ingredient gabapentin. NUPENTIN is used to control epilepsy and treat neuropathic pain. For more information, see Section 1. Why am I taking NUPENTIN? in the full CMI.

2. What should I know before I take NUPENTIN?

Do not take if you have ever had an allergic reaction to gabapentin 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 take NUPENTIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NUPENTIN 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 NUPENTIN?

• Your doctor will tell you how many NUPENTIN capsules you need to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.

• Swallow NUPENTIN whole with a full glass of water. More instructions can be found in Section 4. How do I take NUPENTIN? in the full CMI.

5. What should I know while taking NUPENTIN?

6. Are there any side effects?

Common side effects include dizziness, light-headedness, feeling tired, drowsy, unfriendliness, unusually overactive, forgetfulness, loss of concentration, confusion, difficulty speaking, weight change, constipation, diarrhoea, nausea, vomiting, indigestion, dry mouth, red swollen gums, muscle pain, cramps, back pain, swelling hands or feet, runny or blocked nose, fever, bronchitis, lung infection, sore throat, coughing. Serious side effects include unusual changes in mood or behaviour, increased irritability or agitation, depression, seeing or hearing things that are not there, blurred or double vision, uncontrollable jerky eye movements, difficulty seeing, fever, severe chills, sore throat or mouth ulcers, trouble breathing, loss of consciousness, severe seizures, chest pain, fast heart rate, sudden signs of allergy, severe skin rash, high body temperature enlarged lymph nodes. 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

Abuse potential or dependence. Nupentin is a potential drug of abuse and dependence. Nupentin poses risks of 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 abuse or dependence before prescribing and monitor the patient regularly during treatment, particularly amongst patients with current or past abuse or dependence of opioids and/or benzodiazepines (see Section 4.4 Special Warnings and Precautions for Use).

1 Name of Medicine

Gabapentin.

2 Qualitative and Quantitative Composition

Gabapentin is a white to off white crystalline solid. It is freely soluble in water and both basic and acidic aqueous solutions.
Each Nupentin capsule contains gabapentin 100 mg, 300 mg or 400 mg as the active ingredient.
Excipients with known effect. contains sugars as lactose and trace quantities of sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nupentin 100. Each 100 mg capsule contains gabapentin as the active ingredient, presented as a size 3 capsule with white body and white cap, "GP100" printed in black ink on the body and "G" on the cap.
Nupentin 300. Each 300 mg capsule contains gabapentin as the active ingredient, presented as a size 1 capsule with yellow body and yellow cap, "GP300" printed in black ink on the body and "G" on the cap.
Nupentin 400. Each 400 mg capsule contains gabapentin as the active ingredient, presented as a size 0 capsule with orange body and orange cap, "GP400" printed in black ink on the body and "G" on the cap.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. Symptoms of an overdose included somnolence, ataxia, dizziness, double vision, nystagmus, slurred speech, drowsiness, loss of consciousness, lethargy, mild hypotension and gastrointestinal symptoms including diarrhoea. Gabapentin overdose alone has not been reported to produce significant cardiotoxicity.
Overdoses as high as 108 g have been reported with full recovery following symptomatic therapy. Reduced absorption of gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, minimise toxicity from overdoses.
Treatment of overdosage. There is no specific antidote for gabapentin; treatment is symptomatic. The patient should be monitored closely and given supportive care where necessary to maintain vital functions. Overdoses may involve other concurrent medications and should be treated accordingly.
Activated charcoal may reduce absorption of the drug if given within one hour after 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.
Gabapentin can be removed by haemodialysis. Although haemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient's clinical state or in patients with significant renal impairment.
Ipecac induced emesis is not recommended because of the potential for CNS depression.
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. There is no evidence that gabapentin has genotoxic potential. It was not mutagenic in vitro in standard assays using bacterial or mammalian cells. Gabapentin did not induce structural chromosome aberrations in mammalian cells in vitro or in vivo, and did not induce micronucleus formation in the bone marrow of hamsters.
Carcinogenicity. Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000 and 2000 mg/kg/day for 2 years. A statistically significant increase in the incidence of pancreatic acinar cell adenoma and carcinoma was found only in male rats at the highest dose. Peak plasma gabapentin concentrations and areas under the concentration time curve in rats at 2000 mg/kg/day were 14 times higher than plasma concentrations in humans given the recommended maximum tolerated dose of 2400 mg/day. The pancreatic acinar cell tumours in male rats were low grade malignancies, which did not metastasise or invade surrounding tissue, and were similar to those seen in concurrent controls. The relevance of these pancreatic acinar cell tumours in male rats to carcinogenic risk in humans is unclear.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSGABAPE.gif Chemical name: 1-(aminomethyl) cyclohexaneacetic acid.
Molecular formula: C₉H₁₇NO₂.
Molecular weight: 171.24.
CAS number. 60142-96-3.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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