Valprease®

Valprease®

Active ingredient: sodium valproate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Valprease. 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 Valprease.

Where to find information in this leaflet:

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

1. Why am I using Valprease?

Valprease contains the active ingredient sodium valproate. Valprease belongs to a group of medicines called anticonvulsants.

Valprease is used to treat epilepsy in adults and children.

Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.

Valprease may also be used to control mania, a mental condition with episodes of overactivity, elation or irritability. Valprease may be used alone or in combination with other medicines to treat your condition. Your doctor, however, may have prescribed Valprease for another reason.

There is no evidence that Valprease is addictive.

2. What should I know before I use Valprease?

Warnings

Do not use Valprease if:

• you are allergic to sodium valproate, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• you have or have had any of the following medical conditions:
  – liver disease (hepatic dysfunction) or severe hepatitis.
  – a family history of hepatitis, especially when caused by medicines. Medicines used in the treatment of epilepsy, including Valprease may have adverse effects on the liver and the kidneys
  – a urea cycle disorder or a family history of urea cycle disorders.
  – a family history of unexplained infant deaths.
  – porphyria which is a rare blood disease of blood pigments.
  – known ornithine transcarbamylase deficiency or a family history of ornithine transcarbamylase deficiency.
  – known or suspected of having a genetic problem causing a mitochondrial disorder.
  – you are pregnant, unless your doctor has determined no alternative treatment works for you.

Check with your doctor if you:

• have any other medical conditions, especially the following:
  – liver problems (hepatic insufficiency, hepatic damage)
  – kidney problems
  – urea cycle disorders
  – ornithine transcarbamylase (OTC) deficiency
  – an inborn deficiency in carnitine (a very rare metabolic disease) that is untreated, also called carnitine palmitoyltransferase (CPT) type II deficiency
  – an inborn deficiency in carnitine and are taking carnitine
  – have impaired dietary intake in carnitine, found in meat and dairy products, especially in children less than 10 years old
  – systemic lupus erythematosus (SLE) (a disease affecting the skin, joints and kidneys)
  – family history of a genetic problem causing mitochondrial disorder
• take any medicines for any other condition

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

Tell your doctor immediately if you are pregnant or intend to become pregnant.

You must not use Valprease if you are pregnant, unless your doctor has determined that no alternative treatment works for you.

If you are a girl or woman of childbearing age, make sure that you talk to your doctor about the risks associated with taking Valprease during pregnancy.

You must not take Valprease unless you use an effective method of birth control (contraception) at all times during your treatment with Valprease. Do not stop taking Valprease or your contraception until you have discussed this with your doctor. Your doctor will advise you further.

If you are a parent or carer, tell your doctor when your child using Valprease experiences her first period.

Valprease can be harmful to unborn children when taken by a woman during pregnancy. It can cause serious birth defects and can affect physical and mental development of the child as it grows after birth. Also, children born to mothers who take Valprease throughout their pregnancy may be at risk of impaired cognitive development or withdrawal syndrome.

However, do not stop taking Valprease unless your doctor says so as there are risks to the mother and child from uncontrolled epilepsy or uncontrolled mania episodes.

Your doctor may want to adapt your treatment and/or prescribe dietary supplements of folate.

Your doctor will discuss the risks and benefits of taking it if you are pregnant including when valproate is used in combination with other medicines to treat epilepsy.

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

Medicines used in the treatment of epilepsy, including Valprease, pass into breast milk. Your doctor will discuss the risks and benefits of taking Valprease if you are breastfeeding or planning to breastfeed.

Contraception use

Use an effective method of contraception and consult your doctor before planning pregnancy.

Valprease can seriously harm an unborn child when taken during pregnancy. If you are a girl or woman of childbearing age, you must use at least one effective method of birth control (contraception) without interruption during your entire treatment with Valprease. Your doctor should discuss with you the most appropriate method of contraception for you.

Valprease should have little effect on the oral contraceptive pill, however, you should let your doctor know that you are taking it.

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 Valprease and affect how it works. These include:

• aspirin (and other salicylates)
• medicines used to prevent clots (anticoagulants) e.g. warfarin.
• other medicines used to treat epilepsy e.g. phenobarbital (phenobarbitone), methylphenobarbitone, primidone, phenytoin, carbamazepine, clonazepam, felbamate, lamotrigine, topiramate, diazepam, lorazepam, oxcarbamazepine, rifunamide and ethosuximide
• medicines used to treat depression e.g. monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants
• benzodiazepines (medicines used as sedatives or to treat anxiety)
• oral contraceptives. Valprease should have little effect on the oral contraceptive pill, however, you should let your doctor know that you are taking it.
• zidovudine or any other anti-viral medications
• cannabidiol (used to treat epilepsy and other conditions)
• neuroleptic agents including clozapine (a medicine used to treat schizophrenia)
• quetiapine or olanzapine (medicines used to treat bipolar disorder and schizophrenia)
• mefloquine (a medicine used to treat malaria)
• propofol (a medicine used before and during general anaesthesia)
• nimodipine (a medicine used to help blood flow to the brain)
• cimetidine (used to treat stomach ulcers)
• erythromycin, rifampicin and carbapenem antibiotics such as Invanz and Merrem
• colestyramine (Questran Lite)
• acetazolamide (Diamox)
• metamizole (a medicine used to treat pain and fever)
• methotrexate (used to treat cancer and inflammatory diseases)
• some anti-infectives that contain pivalate (e.g., pivampicillin, adefovir dipivoxil)

These medicines and others may be affected by Valprease, 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.

Tell your doctor or pharmacist if your child is taking any other medicines before you start giving them Valprease, for example, aspirin or any other drugs used to treat epilepsy.

Children, especially young children, can be more sensitive to some of the side effects of Valprease.

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

4. How do I use Valprease?

How much to take

• Your doctor will tell you how much to take and in what form (liquids or tablets) you should take it. 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 Valprease and slowly increase the dose to the lowest amount needed to control your condition.
• Ask your doctor or pharmacist if you are unsure of the correct dose for you.
• They will tell you exactly how much to take
• Follow the instructions provided and use Valprease until your doctor tells you to stop.
• If you take the wrong dose, Valprease may not work as well.

When to take Valprease

• Valprease should be taken at about the same time each day.
• Taking your tablets at the same time each day will have the best effect. It will help you remember when to take the tablets.
• Continue taking your medicine for as long as your doctor tells you.
• Valprease helps control your condition but does not cure it. Therefore, you must take it every day.

How to take Valprease

Valprease Tablets

• Valprease tablets may be taken twice a day.
• Swallow the tablets whole with a full glass of water or other liquid or take them with food.
  The tablets have a special coating If you crush or chew them the coating is destroyed.

Do not take them with “fizzy” water, soda or soft drinks.

If you forget to use Valprease

Valprease should be used regularly at the same time each day. If you miss your dose at the usual time, take your next dose as usual.

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 unwanted side effects.

• Always remember to take your prescribed dose otherwise you may find that either your seizures or manic symptoms may return.
• If you are not sure what to do, ask your doctor or pharmacist.
• If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you use too much Valprease

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

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26 in Australia), or (by calling 0800 764 766 in New Zealand) 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.

If you take too much Valprease, you may experience:

• reduction in consciousness possibly leading into coma
• shortness of breath
• muscle weakness
• shrinking of the pupil in the eye
• too much acid in the body, causing fast breathing, confusion, tiredness, headache, yellowing of the skin (jaundice) and increased heart rate
• dizziness, lightheadedness
• collapse due to very low blood pressure
• convulsions
• severe headache, blurred vision, blind spot or vision loss
• tiredness, confusion, excessive thirst
• death

5. What should I know while using Valprease?

Things you should do

• If you are about to be started on any new medicine, tell your doctor that you are taking Valprease.
• If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.
• Be sure to keep all of your doctors’ 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 prevent unwanted side effects.

Call your doctor straight away if you:

• If you become pregnant while you are taking this medicine

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

All mentions of suicide or violence must be taken seriously. Tell your doctor or a mental health professional immediately if you have any suicidal thoughts or other mental/mood changes.

Things you should not do

• Do not stop using this medicine suddenly, or lower the dosage, without checking with your doctor.
• Do not take more than the recommended dose unless your doctor tells you to.
• Do not give this medicine to anyone else, even if they have the same condition as you.
• Do not use this medicine to treat any other complaints unless your doctor tells you to.

Driving or using machines

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

Valprease may cause drowsiness or light-headedness in some people, especially at the beginning of treatment. 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 drowsy or light-headed.

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

Valprease may cause drowsiness, dizziness or sleepiness in some people and affect alertness.

Diabetics are advised that Valprease Syrup contains 3.6 g/5 mL of sucrose (sugar).

Drinking alcohol

Tell your doctor if you drink alcohol.

If you have more than 2 drinks per day, you may be putting yourself at risk of a seizure, or fit.

The effects of alcohol could be made worse while taking Valprease.

Combining Valprease and alcohol can make you more sleepy, dizzy or lightheaded. Your doctor may suggest you avoid alcohol while you are being treated with Valprease

Looking after your medicine

• Keep your tablets in the blister pack until it is time to take them.
• If you take the tablets out of the box or the blister pack they may not keep well.
• Keep Valprease a tablets in a cool dry place where the temperature stays below 30°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.

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 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 (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well.

Do not use it if the packaging is torn or shows signs of tampering.

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

Gastrointestinal related: nausea or vomiting abdominal cramps or pain changes in appetite changes in your weight diarrhoea Mouth related: bleeding, tender or enlarged gums Head and neurology related: headache unusual movements, including tremor and shaking rapid uncontrollable movements of the eye or double vision unsteadiness when walking, dizziness or light-headedness depression feeling tired or drowsy memory impairment confusion hallucinations disturbance in attention changes in behaviour including aggression and agitation Hormone related: irregular menstrual periods Other side effects: hair loss nail and nail bed disorders loss of bladder control decrease in carnitine levels (shown in blood or muscular tests)

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

Gastrointestinal related: severe upper stomach pain, often with nausea and vomiting Blood related: blood clotting problems spontaneous bruising or bleeding signs of decreased white blood cells or bone marrow problems such as fever and breathing difficulty signs of increased ammonia in the blood such as problems with balance and co-ordination, feeling lethargic or less alert, vomiting Head and neurology related: more frequent or more severe seizures (fits) fainting bizarre behaviour suicidal thoughts suicide attempts Liver related: signs of liver and pancreas problems such as vomiting, loss of appetite, generally feeling unwell, tiredness, yellowing of the skin and/or eyes, dark urine or blood in urine, pain in the abdomen Other side effects: rashes joint pain passing a lot of urine and feeling thirsty (Fanconi syndrome) swelling of the feet and legs, weight increase due to fluid build up

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 or if you have any thoughts of harming yourself or committing suicide. You may need urgent medical attention or hospitalisation.

Additional side effects in children signs of liver damage or inflammation of the pancreas (pancreatitis). Signs may include repeated vomiting, extreme tiredness, loss of appetite, severe upper stomach pain, nausea, jaundice (yellowing of the skin or whites of the eyes), swelling of the legs or worsening of your epilepsy or a general feeling of being unwell aggression agitation disturbance in attention abnormal behaviour hyperactivity learning disorder Some side effects of valproate occur more frequently in children or are more severe compared to adults.

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. Your child may need urgent medical attention or hospitalisation.

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.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects as follows: Australia: 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 Valprease contains

Active ingredient (main ingredient)	Valprease EC200 – 200 mg sodium valproate Valprease EC500 – 500 mg sodium valproate
Other ingredients (inactive ingredients)	povidone magnesium stearate microcrystalline cellulose colloidal anhydrous silica sodium starch glycollate purified talc citric acid Opadry white AMB OY-B-28920 Eudragit L30 D-55 triethyl citrate Opadry II 85F60017 purple
Potential allergen	–

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

What Valprease looks like

200 mg: a purple, round, coated, biconvex tablet.

500 mg: a purple, round, coated, biconvex tablet, approximately 13 mm in diameter.

The tablets are available in boxes of 100 tablets.

Who distributes Valprease

Distributed in Australia by:

Arrotex Pharmaceutical Pty Ltd
15-17 Chapel St
Cremorne VIC 3121

Australian registration numbers:

Valprease 200 – AUST R 153053
Valprease 500 – AUST R 153054

This leaflet was prepared in December 2022