gabapentin
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about GABAPENTIN ASPEN.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking GABAPENTIN ASPEN against the benefits they expect it will have for you.
Ask your doctor or pharmacist if you have any concerns about taking this medicine.
Keep this leaflet with the medicine. You may need to read it again.
What GABAPENTIN ASPEN is used for
GABAPENTIN ASPEN capsules contain gabapentin as the active ingredient.
GABAPENTIN ASPEN belongs to a group of medicines called anticonvulsants and is used to control epilepsy. It is also used in addition to current anti-epileptic therapy when the current treatment is no longer working as well. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe.
This medicine is also used to treat neuropathic pain, which is usually described as a shooting, stabbing or burning pain.
Anticonvulsants such as GABAPENTIN ASPEN are thought to work by controlling brain chemicals which send signals to nerves so that seizures are treated.
Ask your doctor if you have any questions about why GABAPENTIN ASPEN has been prescribed for you. Your doctor may have prescribed it for another reason.
There is no evidence that this medicine is addictive.
This medicine is available only with a doctor’s prescription.
It is not recommended for use in children under the age of 3 years to control epilepsy, as its safety and effectiveness in that age group have not been established. Also, the safety and effectiveness of GABAPENTIN ASPEN for the treatment of neuropathic pain in children under the age of 18 years have not been established.
Before you take it
When you must not take it
Do not take GABAPENTIN ASPEN if you have an allergy to:
- gabapentin
- any of the ingredients listed at the end of this leaflet.
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 it after the expiry date (EXP) printed on the pack. Do not take it if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
Talk to your doctor or pharmacist if you are not sure whether you should start taking GABAPENTIN ASPEN.
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 medical conditions, especially the following:
- kidney problems
- mixed seizure disorders.
Tell your doctor if you are pregnant or intend to become pregnant. This medicine 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 GABAPENTIN ASPEN, your doctor can help you decide whether or not to take it during pregnancy.
Tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will discuss the possible risks and benefits of using this medicine during breastfeeding.
If you do breastfeed, watch your baby carefully. If your baby develops a skin rash, becomes sleepy or has unusual symptoms, don’t breastfeed again until you speak to your doctor.
If you have not told your doctor about any of the above, tell them before you start taking GABAPENTIN ASPEN.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and GABAPENTIN ASPEN may interfere with each other. These include:
- some medicines used to treat stomach or duodenal ulcers, such as cimetidine
- antacids, medicines used to treat heartburn or reflux.
These medicines may be affected by GABAPENTIN ASPEN or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking GABAPENTIN ASPEN.
How to take it
How much to take
Your doctor will tell you how many capsules you will 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 and slowly increase the dose to the lowest amount needed to control your epilepsy/convulsions or neuropathic pain.
Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
How to take it
Swallow GABAPENTIN ASPEN whole with a full glass of water.
When to take it
Take your medicine at about the same time each day. Taking GABAPENTIN ASPEN at the same time each day will have the best effect. It will also help you remember when to take the capsules.
It does not matter if you take it before or after food.
If you forget to take it
If you have missed a dose by not more than 4 hours, take the dose as soon as you remember.
However, if you have missed a dose by more than 4 hours, you should skip the dose and then go back to taking your medicine 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.
How long to take it
Continue taking GABAPENTIN ASPEN for as long as your doctor tells you to. This medicine 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 GABAPENTIN ASPEN or lower the dosage, without checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays. Stopping GABAPENTIN ASPEN suddenly may cause unwanted effects or make your condition worse. Your doctor will slowly reduce your dose before you can stop taking it completely.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much GABAPENTIN ASPEN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of overdose include may include feeling drowsy, weak, unsteady when walking, double vision, slurred speech or diarrhoea.
While you are taking it
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking GABAPENTIN ASPEN.
If you are about to be started on any new medicine or before you have any surgery or emergency treatment, tell any other doctor, dentist or pharmacist that you are taking this medicine.
Tell your doctor if you feel GABAPENTIN ASPEN is not helping your condition. Your doctor may need to change your medicine.
Tell your doctor if, for any reason, you have not taken GABAPENTIN ASPEN exactly as prescribed. Otherwise, your doctor may change your treatment unnecessarily.
Tell your doctor if you become pregnant while taking this medicine.
Tell your doctor if you need to have any medical tests while you are taking it. GABAPENTIN ASPEN may affect the results of some tests.
Be sure to 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 give GABAPENTIN ASPEN to anyone else, even if their symptoms seem similar to yours or they have the same condition as you.
Do not take it to treat any other complaints unless your doctor tells you to.
Do not stop taking your medicine unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how GABAPENTIN ASPEN affects you. As with other anticonvulsant medicines, GABAPENTIN ASPEN may cause drowsiness, dizziness or sleepiness in some people and affect alertness.
Make sure you know how you react to it 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 taking it. If you drink alcohol, dizziness or light-headedness may be worse. Your doctor may suggest you avoid alcohol while you are being treated with GABAPENTIN ASPEN.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking GABAPENTIN ASPEN. This medicine helps most people with epilepsy or neuropathic pain, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. 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 GABAPENTIN ASPEN without first talking to your doctor or pharmacist.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- dizziness or light-headedness
- feeling tired or drowsy
- weakness, unsteadiness when walking, reduced co-ordination or slowed reactions
- decreased feeling in the skin or sensitivity
- mood changes such as restlessness, agitation, nervousness, irritability or excitement, depression
- seeing or hearing things that are not there, irrational thinking
- forgetfulness, loss of concentration or confusion
- difficulty speaking
- changes in appetite
- indigestion
- changes in your weight
- constipation, diarrhoea
- dry mouth
- coughing
- rash
- changes in breast size
- muscle pain or cramps
- swelling of the hands, ankles and feet
- blurred or double vision, uncontrollable jerky eye movements, difficulty seeing.
These are the more common side effects of GABAPENTIN ASPEN. Mostly these are mild and short-lived.
Tell your doctor immediately if you experience any of the following:
- suicidal thoughts
- suicide attempts.
Tell your doctor immediately or go to the Accident and Emergency department of your nearest hospital if you have any thoughts of harming yourself or committing suicide.
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, palpitation
- sudden signs of allergy such as rash (called anaphylactic reactions), itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing
- severe stabbing or throbbing pain in the head
- nausea, vomiting, loss of appetite and feeling generally unwell, together with fever, itching and yellowing of the eyes and skin
- dark coloured urine.
These are very serious, rare side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may happen in some people. Some of these side effects (for example, changes in thyroid function, structure of bones, high cholesterol 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 this list of possible side effects. You may not experience any of them.
After taking it
Storage
Keep your capsules in a cool dry place where the temperature stays below 25°C.
Do not store GABAPENTIN ASPEN or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car on hot days. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor or pharmacist tells you to stop taking this medicine or the capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
GABAPENTIN ASPEN capsules come in 3 strengths:
- GABAPENTIN ASPEN 100 – white capsule marked with “G 100” in blue ink containing a white crystalline powder.
- GABAPENTIN ASPEN 300 – yellow capsule marked with “G 300” in blue ink containing a white crystalline powder.
- GABAPENTIN ASPEN 400 – orange capsule marked with “G 400” in blue ink containing a white crystalline powder.
Each blister pack contains 100 capsules.
Ingredients
Active ingredient:
GABAPENTIN ASPEN capsules come in three strengths and contain either 100 mg, 300 mg or 400 mg of gabapentin.
Inactive ingredients:
The capsules also contain:
- lactose
- purified talc
- maize starch
- gelatin
- titanium dioxide
- iron oxide yellow (300 mg & 400 mg capsules only)
- iron oxide red (400 mg capsules only)
- TekPrint SB-6018 blue ink.
Sponsor
Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia
Australian Registration Numbers:
100 mg capsules: AUST R 107472
300 mg capsules: AUST R 107494
400 mg capsules: AUST R 107498
This leaflet was revised in July 2013.
Published by MIMS August 2014
