Consumer medicine information

Gabapentin Sandoz 400 mg Capsules

Gabapentin

BRAND INFORMATION

Brand name

Gabapentin Sandoz

Active ingredient

Gabapentin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Gabapentin Sandoz 400 mg Capsules.

1. Why am I using Gabapentin Sandoz?


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

2. What should I know before I use Gabapentin Sandoz?


Do not use 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 use Gabapentin Sandoz? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Gabapentin Sandoz 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 use Gabapentin Sandoz?

  • Your doctor will tell you how many 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 the capsules whole with a full glass of water.

More instructions can be found in Section 4. How do I use Gabapentin Sandoz? in the full CMI.

5. What should I know while using Gabapentin Sandoz?

Things you should do
  • Remind any Remind any doctor, dentist or pharmacist, surgeon, or anaesthetist you visit that you are using Gabapentin Sandoz.
  • Tell your doctor immediately if you have any thoughts of suicide or self-harm, any unusual changes in mood or behaviour, or show signs of depression.
Things you should not do
  • Do not stop taking Gabapentin Sandoz or lower the dose without checking with your doctor.
Driving or using machines
  • Do not drive, operate machinery, ride a bike as Gabapentin Sandoz may cause drowsiness, dizziness, light-headedness or sleepiness in some people.
Drinking alcohol
  • Avoid alcohol as it can make you more sleepy, dizzy or light-headed.
Looking after your medicine
  • Keep your medicine in a cool dry place where the temperature stays below 30°C.
  • Keep your capsules in the pack until it is time to take them.

For more information, see Section 5. What should I know while using Gabapentin Sandoz? in the full CMI.

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 hand 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.

BRAND INFORMATION

Brand name

Gabapentin Sandoz

Active ingredient

Gabapentin

Schedule

S4

 

Boxed Warnings

Abuse potential or dependence. Gabapentin Sandoz is a potential drug of abuse and dependence. Gabapentin Sandoz 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

Each Gabapentin Sandoz 100 mg capsule contains 100 mg of gabapentin.
Each Gabapentin Sandoz 300 mg capsule contains 300 mg of gabapentin.
Each Gabapentin Sandoz 400 mg capsule contains 400 mg of gabapentin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Gabapentin Sandoz 100 mg* capsules. Size 3 hard gelatin capsules with white body and cap.
Gabapentin Sandoz 300 mg capsules. Size 1 hard gelatin capsules with yellow body and cap.
Gabapentin Sandoz 400 mg capsules. Size 0 hard gelatin capsules with brown body and cap.
* Gabapentin Sandoz 100 mg capsules are not marketed in Australia.

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.
Overdose 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. 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. Overdose may involve other concurrent medication and should be treated accordingly.
Activated charcoal may reduce absorption of the drug if given 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.
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 131126 (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 2,000 mg/kg/day and to rats at 250, 1,000 and 2,000 mg/kg/day for two 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 drug concentrations and areas under the concentration time curve in rats at 2,000 mg/kg/day are 14 times higher than plasma concentrations in humans given the recommended maximum tolerated dose of 2,400 mg/day. The pancreatic acinar cell tumours in male rats were low grade malignancies, 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

Gabapentin is a white to off white crystalline solid. It is freely soluble in water and both basic and acidic aqueous solutions.
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)

S4 - Prescription Only Medicine.

Summary Table of Changes

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