WP Gabapentin

WARNING: Before taking WP Gabapentin, tell your doctor if you have a history of drug abuse. gabapentin poses risks of abuse and dependence. Using 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. If you have any concern about taking this medicine, speak to your doctor.

WP Gabapentin

Active ingredient(s): Gabapentin

---

Consumer Medicine Information (CMI)

This leaflet provides important information about using WP 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 WP Gabapentin.

Where to find information in this leaflet:

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

1. Why am I using WP Gabapentin?

WP Gabapentin contains the active ingredient gabapentin.

WP 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. WP Gabapentin 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.

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

WP Gabapentin also has pain relieving effects.

Your doctor may have prescribed WP 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 WP Gabapentin for another reason.

WP Gabapentin may lead to dependence on this medicine.

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

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

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 WP Gabapentin?

Warnings

Do not use WP Gabapentin if:

• you are allergic to gabapentin, or any of the ingredients listed at the end of this leaflet.
  Always check the in 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 WP Gabapentin 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 WP Gabapentin talk to your doctor or pharmacist.

Check with your doctor if you:

• have any kidney problems
• have any mixed seizure disorders that include absence seizures.
• take any medicine for any other condition especially barbiturates or any other anticonvulsant medicines.
• take any other substances, such as foods, preservatives or dyes.

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?

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

Pregnancy and breastfeeding

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

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

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

WP Gabapentin 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 WP Gabapentin.

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 be affected by WP Gabapentin 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.

WP Gabapentin and certain other medicines may influence each other.

Using WP 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

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

4. How do I use WP Gabapentin?

How much to take / use

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 WP Gabapentin and slowly increase the dose to the lowest amount needed to control your epilepsy/convulsions or neuropathic pain.

How to take WP Gabapentin

• Swallow WP Gabapentin whole with a full glass of water.

When to take / use WP Gabapentin

• Take WP Gabapentin at about the same time each day.
• Taking WP Gabapentin 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 WP Gabapentin three times a day, do not allow more than 12 hours between doses.

It does not matter if you take WP Gabapentin before or after food

How long to take it

• Continue taking your medicine for as longas your doctor tells you to.
• WP Gabapentin helps control yourcondition, but does not cure it.
• Therefore you must take your medicineevery day, even if you feel well.
• Do not stop taking WP Gabapentin, or lower the dose, without checking with your doctor. Do not let yourself run out ofmedicine over the weekend or holidays
• Stopping WP Gabapentin suddenly may cause unwanted side effects or make your condition worse. Your doctor will slowly reduce your dose before you can stop taking it completely.

If you forget to use WP 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 WP Gabapentin 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 WP Gabapentin, ask your pharmacist for help.

If you use too much WP Gabapentin

If you think that you have used too much WP Gabapentin, 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 diarrhea.

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.

5. What should I know while using WP Gabapentin?

Things you should do

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

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

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

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 WP 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 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 WP Gabapentin, contact your doctor or a mental health professional right away.

Tell your doctor if you feel WP Gabapentin is not helping your condition.

Your doctor may need to change your medicine.

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

Otherwise, your doctor may change your treatment unnecessarily.

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

If you need to have any medical tests while you are taking WP Gabapentin, 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.

Call your doctor straight away if you:

• If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking WP Gabapentin.
• Tell any other doctors, dentists, and pharmacists who treat you that you are taking WP Gabapentin.

Remind any doctor, dentist or pharmacist you visit that you are using WP Gabapentin.

Things you should not do

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

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

Do not stop taking WP Gabapentin, or lower the dose, without checking with your doctor.

Stopping WP Gabapentin suddenly, if you have epilepsy, 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 unwanted side effects or make your condition worse.

Your doctor will slowly reduce your dose before you can stop taking it completely.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how WP Gabapentin affects you.

As with other anticonvulsant medicines, WP Gabapentin may cause drowsiness, dizziness, lightheadedness or sleepiness in some people. Make sure you know how you react to WP 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 whileyou are taking this medicine.

Combining WP 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 WP Gabapentin

Looking after your medicine

• 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 30°C

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 can destroy some medicines.

Keep it where young children cannot reach it.

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

When to discard your medicine

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

Getting rid of any unwanted medicine

If you no longer need to use this medicine 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 WP 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 WP 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.

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

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

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

Less serious side effects

Less serious side effects

What to do

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.

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

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

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

Less serious side effects

What to do

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 newonset of, or increased irritability or agitation signs of depression seeing or hearingthings that are not there, irrational thinking blurred or double vision, uncontrollable jerky eye movements, difficulty seeing signs of frequentinfections such as fever, severe chills, sore throat or mouth ulcers. loss of consciousness

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.

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

Serious side effects

Very Serious side effects	What to do
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. chills, sore throat	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.

The above list includes very serious side effects. You may need urgent medical attention or hospitalization. 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, structures 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 the 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 WP Gabapentin contains

Active ingredient (main ingredient)	Gabapentin
Other ingredients (inactive ingredients)	maize starch purified talc gelatin titanium dioxide sodium lauryl sulphate iron oxide yellow (300 mg & 400 mg) iron oxide red (400 mg).

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

What WP Gabapentin looks like

Capsules

• Gabapentin Capsules, 100mg: Size ‘3’ hard gelatin capsule with white body and white cap, containing 100 mg of gabapentin. Available in blister packs (PVC/PVdC-Aluminium) of 100 capsules.
• Gabapentin Capsules, 300mg: Size ‘1’ hard gelatin capsule with yellow body and yellow cap, containing 300 mg of gabapentin. Available in blister packs (PVC/PVdC-Aluminium) of 100 capsules.
• Gabapentin Capsules, 400mg: Size ‘0’ hard gelatin capsule with orange body and orange cap, containing 400 mg of gabapentin. Available in blister packs (PVC/PVdC-Aluminium) of 100 capsules.

Australian Registration Numbers:

100 mg capsules: AUST R 272673 (blister packs)

300 mg capsules: AUST R 272675 (blister packs)

400 mg capsules: AUST R 272671 (blister packs)

Who distributes WP Gabapentin

MedTAS PTY LTD
PO Box 4767
North Rocks
NSW 2151
Australia
Email: mohit.gupta@medtas.com.au

This leaflet was prepared in Feb 2023.