Consumer medicine information

Gabacor

Gabapentin

BRAND INFORMATION

Brand name

Gabacor

Active ingredient

Gabapentin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Gabacor.

GABACOR

GABACOR


 Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


 1. Why am I using GABACOR?

GABACOR contains the active ingredient Gabapentin. GABACOR is used to treat epilepsy. For more information, see Section 1. Why am I using GABACOR? in the full CMI.

Do not use if you have ever had an allergic reaction to gabapentine or any of the ingredients listed at the end of the CMI.

 2. What should I know before I use GABACOR?

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or intend to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use GABACOR? in the full CMI.

 3. What if I am taking other medicines?

Tell your doctor if you have previously taken or are currently taking medicines containing fumaric acid (creams or tablets/ capsules).

You should not take GABACOR together with these medicines. Some medicines and GABACOR may interfere with each other 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 GABACOR?

Follow all directions given to you by your doctor or pharmacist carefully.

The recommended starting dose of GABACOR is 300 mg taken once daily.

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

 5. What should I know while using GABACOR?

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking GABACOR.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking GABACOR.

If you are going to have surgery or emergency treatment, tell the surgeon or anaesthetist that you are taking GABACOR.

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.

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

 6. Are there any side effects?

Common side effects of GABACOR include: dizziness or light-headedness, feeling tired or drowsy, unfriendliness, unusually overactive, forgetfulness, loss of concentration or confusion 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.


GABACOR

Active ingredient(s): Gabapentine


 Consumer Medicine Information (CMI)

This leaflet answers some common questions about GABACOR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using GABACOR.

Where to find information in this leaflet:

1. Why am I using GABACOR?
2. What should I know before I use GABACOR?
3. What if I am taking other medicines?
4. How do I use GABACOR?
5. What should I know while using GABACOR?
6. Are there any side effects?
7. Product details

1. Why am I using GABACOR?

What GABACOR does

GABACOR is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe.

GABACOR is also used to treat neuropathic pain, a type of pain caused by damage to the nerves.

This medicine belongs to a group of medicines called anticonvulsants.

How GABACOR works

This medicine is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain.

GABACOR also has pain relieving effects.

Your doctor may have prescribed GABACOR in addition to other medicines that you may be taking. This may be necessary if your current treatment is no longer working as well.

Your doctor may have prescribed GABACOR for another reason.

GABACOR may lead to dependence on this medicine.

Ask your doctor if you have any questions about why GABACOR has been prescribed for you.

This medicine is available only with a doctor's prescription.

Use in children

There is not enough information to recommend the use of this medicine in children:

  • under the age of 3 years to control epilepsy, or
  • under the age of 18 years to treat neuropathic pain.
2. What should I know before I use GABACOR?

When you must not take it

Do not take GABACOR if you have an allergy to:

  • any medicine containing gabapentin, the active ingredient in GABACOR
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not take GABACOR after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking GABACOR, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

  • any other medicines, especially barbiturates or any other anticonvulsant medicines
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • kidney problems
  • mixed seizure disorders that include absence seizures.

Tell your doctor if you have a history of drug abuse.

GABACOR poses risks of abuse and dependence. Your body may become used to you taking GABACOR and this may result in physical dependence. It means that you may experience withdrawal symptoms if you stop taking GABACOR suddenly. So it is important to strictly follow the directions given by your doctor.

Tell your doctor if you are pregnant or plan to become pregnant.

GABACOR may affect your developing baby if you take it during pregnancy. However, it is very important to control your fits while you are pregnant. If it is necessary for you to take GABACOR, your doctor can help you decide whether or not to take it during pregnancy.

Tell your doctor if you are breastfeeding or plan to breast-feed.

GABACOR passes into breast milk.

The effect on your breast fed baby is unknown.

If you do breast-feed, watch your baby carefully.

If your baby develops a skin rash, becomes sleepy or has unusual symptoms, don't breast-feed again until you speak to your doctor.

Your doctor can discuss the risks and benefits of breast-feeding with you.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking GABACOR.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including:

  • all prescription medicines
  • all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.

Some medicines may be affected by GABACOR or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor or pharmacist will advise you accordingly.

GABACOR and certain other medicines may influence each other

Using GABACOR with other medicines that can make you feel drowsy, such as sleeping tablets and other pain relievers (e.g. benzodiazepines and opioids), antihistamines, antidepressants, antipsychotics, cannabis, and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death.

Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation.

Tell your doctor or pharmacist if you are taking any of the following:

  • cimetidine, a medicine used to treat stomach or duodenal ulcers
  • antacids, medicines used to treat heartburn or reflux
  • opioids, medicines used to treat severe pain e.g. morphine.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking GABACOR.

4. How do I use GABACOR?

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

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.

Your doctor may recommend that you start with a low dose of GABACOR and slowly increase the dose to the lowest amount needed to control your epilepsy /convulsions or neuropathic pain.

How to take it

Swallow GABACOR whole with a full glass of water.

When to take it

Take GABACOR at about the same time each day.

Taking it at the same time each day will have the best effect. It will also help you remember when to take the capsules.

If you are taking GABACOR three times a day, do not allow more than 12 hours between doses. It does not matter if you take this medicine before or after food.

How long to take it

Continue taking your medicine for as long as your doctor tells you to.

GABACOR helps control your condition, but does not cure it.

Therefore you must take your medicine every day, even if you feel well.

Do not stop taking GABACOR, or lower the dose, without checking with your doctor. Do not let yourself run out of medicine over the weekend or holidays.

Stopping GABACOR suddenly may worsen your condition or increase your chance of experiencing withdrawal symptoms, such as sleeplessness, headache, nausea (feeling sick), anxiety, excessive sweating or diarrhoea (runny stools). If appropriate, your doctor will slowly reduce your dose before you can stop taking it completely.

If you forget to take it

If it is almost time for your next dose (within 4 hours), skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking GABACOR as you would normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take GABACOR, ask your pharmacist for help.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much GABACOR.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include you falling unconscious, feeling drowsy, weak, unsteady when walking, having double vision, slurred speech or diarrhoea.

5. What should I know while using GABACOR?

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking GABACOR.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking GABACOR.

If you are going to have surgery or emergency treatment, tell the surgeon or anaesthetist that you are taking GABACOR.

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.

Some people being treated with antiepileptics such as GABACOR have had thoughts of harming or killing themselves.

Patients and caregivers should be alert and monitor for signs and symptoms of suicide, these include:

  • thoughts or talk of death or suicide
  • thoughts or talk of self-harm or harm to others
  • any recent attempts of self-harm
  • new or an increase in aggressive behaviour, irritability or agitation
  • new onset of or worsening of depression.

Mention of suicide or violence must be taken seriously.

If you or someone you know is demonstrating these warning signs and symptoms of suicide while taking GABACOR, contact your doctor or a mental health professional right away.

Tell your doctor if you feel GABACOR is not helping your condition.

Your doctor may need to change your medicine.

Tell your doctor if, for any reason, you have not taken GABACOR exactly as prescribed.

Otherwise, your doctor may change your treatment unnecessarily.

If you become pregnant while taking GABACOR, tell your doctor immediately.

If you need to have any medical tests while you are taking GABACOR, tell your doctor.

It may interfere with the results of some tests.

If you are going to have any surgery or procedure, including dental surgery, tell your surgeon, doctor or dentist that you are taking this medicine.

Keep all of your doctor's appointments so that your progress can be checked.

Your doctor will check your progress and may want to take some tests from time to time. This helps to prevent unwanted side effects.

Things you must not do

Do not take GABACOR to treat any other complaints unless your doctor tells you to.

Do not give GABACOR to anyone else, even if their symptoms seem similar to yours or they have the same condition as you.

Do not stop taking GABACOR or lower the dosage without checking with your doctor.

Stopping GABACOR suddenly, if you have epilepsy, may cause unwanted effects or make your condition worse. Your doctor will slowly reduce your dose before you can stop taking it completely.

Things to be careful of

Be careful driving or operating machinery until you know how GABACOR affects you.

As with other anticonvulsant medicines, this medicine may cause drowsiness dizziness, lightheadedness, or sleepiness in some people.

Make sure you know how you react to GABACOR before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive.

Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling drowsy or sleepy.

Be careful when drinking alcohol while you are taking GABACOR.

Combining GABACOR and alcohol can make you more sleepy, dizzy or light-headed. Your doctor may suggest you avoid alcohol while you are being treated with GABACOR.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking GABACOR.

All medicines can have side effects. Sometimes these are serious, but most of the time these are not. You may need medical attention if you get some side effects.

It can be difficult to tell whether side effects are the result of taking GABACOR; of your condition; or side effects of other medicines you may be taking, for this reason it is important to tell your doctor of any change in your condition.

If you are over 65 years of age you may have an increased chance of getting side effects.

Ask your doctor or pharmacist to answer any questions you may have.

If you get any side effects, do not stop taking GABACOR without first talking to your doctor or pharmacist.

Tell your doctor if...

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • dizziness* or light-headedness
  • feeling tired or drowsy*
  • unfriendliness*
  • unusually overactive*
  • forgetfulness, loss of concentration or confusion
  • difficulty speaking
  • changes in your weight*
  • constipation, diarrhoea
  • nausea and/or vomiting*, indigestion
  • dry mouth, red swollen gums
  • muscle pain or cramps, back pain
  • swelling of the hands or feet
  • runny or blocked nose
  • fever*
  • bronchitis*, lung infection*
  • sore throat and discomfort when swallowing, coughing.

The above list includes the more common side effects of GABACOR. They are usually mild and short-lived.

Tell your doctor as soon as possible if...

Tell your doctor as soon as possible if you notice any of the following:

  • weakness, unsteadiness when walking including falling, reduced co-ordination or slowed reactions
  • unusual changes in mood* or behaviour such as restlessness, nervousness, or excitement
  • signs of new onset of, or increased irritability or agitation
  • signs of depression
  • seeing or hearing things that are not there, irrational thinking
  • blurred or double vision, uncontrollable jerky eye movements, difficulty seeing
  • Signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers.
  • Trouble breathing or shallow breaths(respiratory depression)
  • Loss of consciousness

The side effects in the above lists marked * have been specifically reported in children taking GABACOR.

Go to hospital if...

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • more frequent or more severe seizures (fits)
  • chest pain, a very fast heart rate
  • sudden signs of allergy such as rash, itching or hives, fever, swollen lymph glands, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Some of these side effects (for example, changes in thyroid function, structures of bones, high cholesterol, level of sugar in your blood or blood pressure) can only be found when your doctor does blood tests from time to time to check your progress.

Do not be alarmed by the list of possible side effects.

You may not experience any of them.

7. Product details

Storage

Keep your capsules in the pack until it is time to take them.

If you take the capsules out of the pack they may not keep well.

Keep your capsules in a cool dry place where the temperature stays below 25°C.

Do not store GABACOR or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking GABACOR or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

What it looks like

Capsules

100 mg - white hard gelatin capsule imprinted "216" on body with blue ink

300 mg - Yellow hard gelatin capsule imprinted "215" on body with blue ink

400 mg - Orange hard gelatin capsule imprinted "214" on body with blue ink

Ingredients

Active ingredient:

  • GABACOR 100 mg - 100 mg gabapentin
  • GABACOR 300 mg - 300 mg gabapentin
  • GABACOR 400 mg - 400 mg gabapentin

Other capsule ingredients:

  • Maize Starch
  • Anhydrous lactose
  • Purified talc
  • Gelatin
  • Sodium Lauryl Sulfate
  • Titanium dioxide
  • Iron oxide yellow
  • Iron oxide red

GABACOR does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

GABACOR is supplied in Australia by:

Pharmacor Pty Ltd.
Suite 803, Level 8, Tower A
The Zenith, 821 Pacific Highway,
Chatswood, NSW 2067,
Australia

Australian Registration Numbers:

100 mg capsules: 204498

300 mg capsules: 204501

400 mg capsules: 204485

This leaflet was prepared in 12/2022

Published by MIMS April 2023

BRAND INFORMATION

Brand name

Gabacor

Active ingredient

Gabapentin

Schedule

S4

 

Boxed Warnings

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

Gabacor contains the active ingredient gabapentin.
Gabacor 100 mg capsules. Each capsule contains gabapentin 100 mg.
Gabacor 300 mg capsules. Each capsule contains gabapentin 300 mg.
Gabacor 400 mg capsules. Each capsule contains gabapentin 400 mg.
Excipient with known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Capsules, hard.
Gabacor 100 mg capsules. Size "4" white hard gelatin capsule imprinted "216" on body with blue ink.
Gabacor 300 mg capsules. Size "1" yellow hard gelatin capsule imprinted "215" on body with blue ink.
Gabacor 400 mg capsules. Size "0" orange hard gelatin capsule imprinted "214" on body with blue ink.

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 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 2000 mg/kg/day and to rats at 250, 1000 and 2000 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 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 human 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.
The structural formula of gabapentin is shown below:
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. CAS Registry Number: 60142-96-3.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only medicine.

Summary Table of Changes

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