PHARMACOR GABAPENTIN

WARNING:

Before taking PHARMACOR GABAPENTIN tell your doctor if you have a history of drug abuse. PHARMACOR GABAPENTIN poses risks of abuse and dependence. Using PHARMACOR GABAPENTIN 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 awar eness, breathing problems, coma and death. If you have any concern about taking this medicine, speak to your doctor.

PHARMACOR GABAPENTIN

Active ingredient(s): gabapentin (gab-a-pen-tin)

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Consumer Medicine Information (CMI)

This leaflet provides important information about using PHARMACOR GABAPENTIN. 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 PHARMACOR GABAPENTIN.

Where to find information in this leaflet:

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

1. Why am I using PHARMACOR GABAPENTIN?

PHARMACOR GABAPENTIN contains the active ingredient gabapentin. PHARMACOR GABAPENTIN belongs to a group of medicines called anticonvulsants.

PHARMACOR GABAPENTIN 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.

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

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

PHARMACOR GABAPENTIN also has pain relieving effects.

Your doctor may have prescribed PHARMACOR GABAPENTIN 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 PHARMACOR GABAPENTIN for another reason.

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

2. What should I know before I use PHARMACOR GABAPENTIN?

Warnings

Do not use PHARMACOR GABAPENTIN if:

• You are allergic to gabapentin, or any of the ingredients listed at the end of this leaflet
• Always check the ingredients to make sure you can use this medicine
• Some of the symptoms of an allergic reaction may include:
  – Shortness of breath
  – Wheezing or difficulty in breathing
  – Swelling of the face, lips, tongue or other parts of the body
  – Rash, itching or hives on the skin
• The packaging is torn or shows signs of tampering

Check with your doctor if you:

• Have or have had any other medical conditions, in particular:
  – Kidney problems
  – Mixed seizure disorders that include absence seizures
• Have a history of drug abuse and/or psychiatric disorders. PHARMACOR GABAPENTIN poses risks of abuse and dependence. Your body may become used to you taking PHARMACOR GABAPENTIN and this may result in physical dependence. It means that you may experience withdrawal symptoms if you stop taking PHARMACOR GABAPENTIN suddenly. So it is important to strictly follow the directions given by your doctor.
• Have allergies to:
  – Any other medicines, especially barbiturates or any other anticonvulsant medicines
  – Any other substances, such as foods, preservatives, or dyes
• Take any medicines for any other condition

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

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

PHARMACOR GABAPENTIN may lead to dependence on this medicine.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

PHARMACOR GABAPENTIN 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 PHARMACOR GABAPENTIN, your doctor can help you decide whether or not to take it during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

PHARMACOR GABAPENTIN passes into breast milk. The effect on your breast-fed baby is unknown.

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. Your doctor will discuss the risks and benefits of breastfeeding with you.

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

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with PHARMACOR GABAPENTIN and affect how 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.

PHARMACOR GABAPENTIN and certain other medicines may influence each other.

Using PHARMACOR GABAPENTIN 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 PHARMACOR GABAPENTIN.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PHARMACOR GABAPENTIN.

4. How do I use PHARMACOR GABAPENTIN?

How much to take / use

• Your doctor will tell you how many tablets 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 of gabapentin and slowly increase the dose to the lowest amount needed to control your epilepsy/convulsions or neuropathic pain.
• Follow the instructions provided and use PHARMACOR GABAPENTIN until your doctor tells you to stop
• Note: PHARMACOR GABAPENTIN is available as 600mg and 800 mg unscored tablets and should not be broken into half

When to take / use PHARMACOR GABAPENTIN

• PHARMACOR GABAPENTIN should be used at about the same time each day
• Taking PHARMACOR GABAPENTIN at the same time each day will have the best effect. It will also help you remember when to take it.
• If you are taking PHARMACOR GABAPENTIN three times a day, do not allow more than 12 hours between doses.
• It does not matter if you take PHARMACOR GABAPENTIN before or after food
• Swallow PHARMACOR GABAPENTIN whole with a full glass of water
• Continue taking PHARMACOR GABAPENTIN for as long as your doctor tells you to. PHARMACOR GABAPENTIN helps control your condition but does not cure it. Therefore, you must take your medicine every day, even if you feel well.

If you forget to use PHARMACOR GABAPENTIN

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 your medicine as you would normally.

Do not take a double dose to make up for the dose 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 your medicine, ask your pharmacist for some hints.

If you use too much PHARMACOR GABAPENTIN

If you think that you have used too much PHARMACOR GABAPENTIN, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

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

5. What should I know while using PHARMACOR GABAPENTIN?

Things you should do

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.

Call your doctor straight away 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 anti-epileptics such as gabapentin 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 to self-harm
  – New or an increase in aggressive behaviour, irritability or agitation
  – New onset or worsening of depression
• Or someone you know is demonstrating these warning signs and symptoms of suicide while taking PHARMACOR GABAPENTIN. Mention of suicide or violence must be taken seriously.
• Feel PHARMACOR GABAPENTIN is not helping your condition. Your doctor may need to change your medicine.
• Have not taken PHARMACOR GABAPENTIN exactly as prescribed, for any reason. Otherwise, your doctor may change your treatment unnecessarily.
• Become pregnant while taking PHARMACOR GABAPENTIN
• Need to have any medical tests while you are taking PHARMACOR GABAPENTIN. It may interfere with the results of some tests.

Remind any doctor, dentist or pharmacist you visit that you are using PHARMACOR GABAPENTIN.

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

If you are going to have surgery, including dental surgery, or emergency treatment, tell the surgeon, doctor, dentist or anaesthetist that you are taking PHARMACOR GABAPENTIN.

Things you should not do

• Do not stop using this medicine suddenly, or lower the dosage, without checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays. Stopping PHARMACOR GABAPENTIN 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.
• Do not take PHARMACOR GABAPENTIN to treat any other complaints unless your doctor tells you to
• Do not give PHARMACOR GABAPENTIN to anyone else, even if their symptoms seem similar to yours or they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PHARMACOR GABAPENTIN affects you.

As with other anticonvulsant medicines, PHARMACOR GABAPENTIN may cause dizziness, light-headedness, tiredness, drowsiness or sleepiness in some people. Make sure you know how you react to PHARMACOR GABAPENTIN 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.

Drinking alcohol

Tell your doctor if you drink alcohol.

Be careful when drinking alcohol while taking PHARMACOR GABAPENTIN. Combining PHARMACOR GABAPENTIN and alcohol can make you more sleepy, dizzy or light-headed. Your doctor may suggest you avoid alcohol while you are being treated with PHARMACOR GABAPENTIN.

Looking after your medicine

• Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they will not keep well
• Keep your tablets in a cool dry place where the temperature stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat and dampness may destroy some medicines.

Keep it where young children cannot reach it.

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

Getting rid of any unwanted medicine

If your doctor or pharmacist tells you to stop taking PHARMACOR GABAPENTIN or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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 PHARMACOR GABAPENTIN.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

It can be difficult to tell whether side effects are the result of taking PHARMACOR GABAPENTIN; 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.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

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

Less serious side effects

Less serious side effects

What to do

Head and neurology: Dizziness* or lightheadedness Feeling tired or drowsy* Forgetfulness, loss of concentration or confusion Difficulty speaking Mood related: Unfriendliness* Unusually overactive* Gastrointestinal: Constipation, diarrhoea Nausea and/or vomiting*, indigestion Respiratory: Runny or blocked nose Bronchitis*, lung infection* Mouth and throat: Dry mouth, red swollen gums Sore throat and discomfort when swallowing, coughing. General body: Changes in your weight* Muscle pain or cramps, back pain Swelling of the hands or feet Fever* The side effects in the above list marked * have been specifically reported in children taking PHARMACOR GABAPENTIN. The above list includes the more common side effects of PHARMACOR GABAPENTIN. They are usually mild and short lived.

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Head and neurology: Weakness, unsteadiness when walking including falling, reduced coordination or slowed reactions Seeing or hearing things that are not there, irrational thinking Blurred or double vision, uncontrollable jerky eye movements, difficulty seeing Loss of consciousness More frequent or more severe seizures (fits) Mood related: 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 Infection related: Signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers Chest and respiratory: Chest pain, a very fast heart rate Trouble breathing or shallow breaths (respiratory depression) Allergy related: 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 side effects in the above list marked * have been specifically reported in children taking PHARMACOR GABAPENTIN.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. These side effects are very rare.

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

Other side effects not listed here may occur in some people.

Some of these side effects (for example, changes in thyroid function, structure of bones, high cholesterol, levels 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 this list of possible side effects.

You may not experience any of them.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What PHARMACOR GABAPENTIN contains

Active ingredient (main ingredient)	gabapentin
Other ingredients (inactive ingredients)	starch maize copovidone poloxamer ethanol hydroxypropyl cellulose magnesium stearate talc-purified
Potential allergens	PHARMACOR GABAPENTIN does not contain sucrose, gluten, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What PHARMACOR GABAPENTIN looks like

PHARMACOR GABAPENTIN is available in two strengths.

PHARMACOR GABAPENTIN 600 (AUST R 156107) – White to off white, oval shaped, film coated tablets plain on both sides.

PHARMACOR GABAPENTIN 800 (AUST R 156108) – White to off white, capsule shaped, film coated tablets plain on both sides.

Each pack contains 100 tablets.

Who distributes PHARMACOR GABAPENTIN

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

This leaflet was prepared in December 2022.