WARNING: Before taking Noumed Pregabalin, tell your doctor if you have a history of drug abuse. Pregabalin poses risks of misuse, abuse and dependence. Using Noumed Pregabalin 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.
Noumed Pregabalin
Active ingredient(s): Pregabalin
Consumer Medicine Information (CMI)
This leaflet provides important information about taking Noumed Pregabalin. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking Noumed Pregabalin.
Where to find information in this leaflet:
1. Why am I taking Noumed Pregabalin?
2. What should I know before I take Noumed Pregabalin?
3. What if I am taking other medicines?
4. How do I take Noumed Pregabalin?
5. What should I know while taking Noumed Pregabalin?
6. Are there any side effects?
7. Product details
1. Why am I taking Noumed Pregabalin?
Noumed Pregabalin contains the active pregabalin. Noumed Pregabalin is an anticonvulsant. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.
Noumed Pregabalin is used to treat neuropathic pain, which is pain caused by an abnormality of, or damage to, the nerves.
Noumed Pregabalin 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.
Noumed Pregabalin also has pain relieving effects.
Noumed Pregabalin may be used alone, or in combination with other medicines, to treat your condition.
Your doctor may prescribe Noumed Pregabalin in addition to your current therapy when your current treatment is no longer working as well as before.
Ask your doctor if you have any questions about why Noumed Pregabalin has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor’s prescription.
2. What should I know before I take Noumed Pregabalin?
Warnings
Do not take Noumed Pregabalin if:
- you are allergic to pregabalin, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
- have any other medical conditions such as 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, congestive heart failure, kidney problems, diabetes, depression
Tell your doctor if you have a history of drug abuse.
Pregabalin poses risks of misuse, abuse and dependence. Your body may become used to you taking Noumed Pregabalin and this may result in physical dependence. It means that you may experience withdrawal symptoms if you stop taking Noumed Pregabalin suddenly. So it is important to strictly follow the directions given by your doctor.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Noumed Pregabalin is not recommended for use during pregnancy. However, if you have epilepsy, it is very important to control your fits while you are pregnant.
The active ingredient in Noumed Pregabalin passes into breast milk and its safety in infants is unknown. It is recommended that you do not breast-feed while taking Noumed Pregabalin.
Use in Children.
- There is not enough information to recommend the use of this medicine in children under the age of 18 years.
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 herbal supplements that you buy without a prescription from your pharmacy, supermarket, naturopath or health food shop.
Tell your doctor or pharmacist if you are taking any other medicines, including all prescription medicines, any other medicines, especially barbiturates or any other anticonvulsant medicines, any other substances, such as foods, preservatives or dyes.
Some medicines may interfere with Noumed Pregabalin and affect how it works.
- You may need different amounts of your medicines, or you may need to take different medicines. Your doctor will advise you.
- Some medicines may be affected by Noumed Pregabalin 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 will advise you.
- Noumed Pregabalin and certain other medicines may influence each other.
- Taking Noumed Pregabalin 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.
- Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Noumed Pregabalin.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Noumed Pregabalin.
4. How do I take Noumed Pregabalin?
How much to take
- The usual dose range is 150 mg per day to 600 mg per day given in two divided doses.
- 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 Noumed Pregabalin and slowly increase the dose to the lowest amount needed to control your epilepsy/convulsions or neuropathic pain.
When to take Noumed Pregabalin
- Noumed Pregabalin should be taken at 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 it.
How to take Noumed Pregabalin
- Swallow the capsules whole with a full glass of water.
- It does not matter if you take this medicine before or after food
If you forget to take Noumed Pregabalin
Noumed Pregabalin should be taken regularly at the same time each day. If you miss your dose at the usual time.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
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 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
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much Noumed Pregabalin
If you think that you have taken too much Noumed Pregabalin, 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 with Noumed Pregabalin may include mood changes, feeling tired, confusion, depression, agitation, restlessness or seizures.
5. What should I know while taking Noumed Pregabalin?
Things you should do
If you are about to be started on any new medicine, remind your doctor, dentist or pharmacist that you are taking Noumed Pregabalin.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine, even if you feel well.
Do not stop taking Noumed Pregabalin, or lower the dosage, without checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.
Stopping Noumed Pregabalin 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.
Call your doctor straight away if you:
- experience any changes in your vision
- have blurring or other changes in eyesight. Your doctor may ask you to stop taking Noumed Pregabalin to improve these symptoms
- have any thoughts of suicide or self-harm, any unusual changes in mood or behaviour, or show signs of depression
Remind any doctor, dentist or pharmacist you visit that you are using Noumed Pregabalin.
Some people taking medicines to treat convulsions, such as Noumed Pregabalin, have had thoughts of harming themselves or taking their life.
Patients and caregivers should be alert and monitor for these effects.
Signs and symptoms of suicidal risk 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 or worsening depression.
Mention of suicide or violence must be taken seriously.
If you or someone you know is demonstrating these warning signs of suicide while taking Noumed Pregabalin, contact your doctor or a mental health professional right away.
Tell your doctor immediately if you experience trouble breathing or shallow breaths.
If you have nervous system or respiratory disorders, kidney problems, or you are older than 65, your doctor may adjust your dose.
Tell your doctor if you feel Noumed Pregabalin is not helping your condition.
Your doctor may need to change your medicine.
Tell your doctor if, for any reason, you have not taken Noumed Pregabalin exactly as prescribed.
Otherwise, your doctor may change your treatment unnecessarily.
If you become pregnant while taking Noumed Pregabalin, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Things you should not do
- Do not stop using this medicine suddenly or lower the dosage without checking with your doctor
- Do not take Noumed Pregabalin to treat any other complaints unless your doctor tells you to.
- Do not give your medicine 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 Noumed Pregabalin affects you.
Noumed Pregabalin may cause dizziness in some people, with other anticonvulsant medicines. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may cause symptoms such as dizziness and drowsiness may be worse.
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.
- Heat and dampness can destroy some medicines.
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.
- Keep your capsules in a cool dry place where the temperature stays below 25°C.
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.
When to discard your medicine
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If the capsules have expired or the pack is damaged, return to your pharmacist for disposal.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Discard any remaining capsules 45 days after first opening of bottle packs.
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?
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.
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 |
If you are over 65 years of age you may have an increased chance of getting side effects |
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 |
|
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. |
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 blood pressure) can only be found when your doctor does tests from time to time to check your progress
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 Noumed Pregabalin contains
| Active ingredient (main ingredient) |
Pregabalin |
| Other ingredients (inactive ingredients) |
Starch, Talc The capsule shells (cap and body) contain: 25 mg, 75 mg, 150 mg and 300 mg capsule Gelatin, 75 mg and 300 mg capsule FD&C Blue 1, Printing ink contains: Black iron oxide, |
Do not take this medicine if you are allergic to any of these ingredients.
What Noumed Pregabalin looks like
25 mg – white to off white powder filled in size ‘4’ hard gelatin white opaque and white opaque capsule linear printed in black ink with ‘Cipla 25 mg’ on the cap and ‘677’ on the body.
75 mg – white to off white powder filled in size ‘4’ hard gelatin orange opaque and white opaque capsule linear printed in black ink with ‘Cipla 75 mg’ on the cap and ‘679’ on the body.
150 mg – white to off white powder filled in size ‘2’ hard gelatin white opaque and white opaque capsule linear printed in black ink with ‘Cipla 150 mg’ on the cap and ‘682’ on the body.
300 mg – white to off white powder filled in size ‘0’ hard gelatin orange opaque and white opaque capsule linear printed in black ink with ‘Cipla 300 mg’ on the cap and ‘685’ on the body.
Each carton contains 56 capsules.
Blister pack-
AUST R 378955,
AUST R 378956,
AUST R 378957,
AUST R 378958
Who distributes Noumed Pregabalin
Avallon Pharmaceuticals
Level 5, 7 Eden Park Drive,
Macquarie Park, NSW 2113
Australia
Phone: 1800 930 999
This leaflet was prepared in November 2021
