SodiumValproate for Injection 100mg/ml
Package leaflet: Information for the patient
This medicine is subject to additional monitoring.
This will allow quick identification of new safety information. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
WARNING
Valproate can cause birth fects and problems with the early development of the child fits given during pregnancy. If you are a female of childbearing age you should use an effective method of contraception throughout your treatment.
Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet. Tell your doctor at once if you become pregnant or think you might be pregnant.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects to talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section4.
What is in this leaflet
- What Sodium Valproate Injection is and what it is used for
- What you need to know before you are given Sodium Valproate Injection
- How Sodium Valproate Injection is given
- Possible side effects
- How to store Sodium Valproate Injection
- Contents of the pack and other information
1. What Sodium Valproate Injection is and what it is used for
The name of your medicine is Sodium Valproate 100mg/ml Solution for Injection or Infusion(called Sodium Valproate Injection in the rest of the leaflet). Sodium Valproate Injection contains a medicine called sodium valproate. This belongs to a group of medicines called anti-convulsants or anti-epileptic agents. It works by helping to calm the brain down.
SodiumValproate Injection is used to treat epilepsy (fits )in adults and children. The injection is given when it is not possible to have your medicine by mouth.
2. WhatyouneedtoknowbeforeyouaregivenSodiumValproateInjection
Do not have Sodium Valproate Injection and tell your doctor or nurse if:
- you are allergic (hypersensitive) to sodium valproate or any of the other ingredients of Sodium Valproate Injection (listedinseesection6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- you have liver problems or your family has a history of liver problems.
- you have a rare illness called porphyria.
- you have a genetic problem caused by a mitochondrial disorder (e.g.Alpers-Huttenlocher syndrome)
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Sodium Valproate Injection. Warnings and Precautions
A small number of people being treated with anti-epileptics such as sodium valproate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Check with your doctor or nurse before you are given this medicine if:
- you have diabetes. This medicine may affect the results of urine tests.
- you have kidney problems. Your doctor may give you a lower dose.
- you have fits(epilepsy), brain disease or a metabolic condition affecting your brain.
- you have a ?urea cycle disorder? where too much ammonia builds up in the body
- you have an illness called ?systemic lupus very the mitosis (SLE)? a disease of the immune system which affects skin, bones, joints and internal organs
- you know that there is a genetic problem caused by a mitochondrial disorder in your family.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having Sodium Valproate Injection.
Weight gain
Having Sodium Valproate Injection may make you put on weight. Talk to your doctor about how this will affect you.
Blood tests
Your doctor may wish to do blood tests before you start having SodiumValproate Injection and during your treatment.
Other medicines and Sodium Valproate Injection
Tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because of Sodium Valproate Injection can affect the way some of the medicines work. Also, some medicines can affect the way Sodium Valproate InjectionWorks.
The following medicines can increase the chance of you getting side effects when taken with Sodium ValproateInjection:
- Some medicines used for pain and inflammation (salicylates) such as aspirin
- Some other medicines used to treat fits (epilepsy) ? see Section3:
?Patients taking other medicines for fits?.This includes medicines such as phenobarbital, primidone, phenytoin, carbamazepine, topiramate, lamotrigine, and felbamate.
Sodium Valproate Injection may increase the effect of the following medicines:
- Medicines used for thinning the blood (such as warfarin)
- Zidovudine used to treat HIV infection
- Temozolomide used to treat cancer
- Medicines for depression
- Monoamine oxidase inhibitors (MAOI) such as moclobemide, selegiline, linezolid
- Medicines used to calm emotional and mental conditions such as diazepam and olanzapine.
The following medicines can affect the way Sodium Valproate Injection works:
- Some medicines used for the prevention and treatment of malaria such as mefloquine and chloroquine
- Cimetidine used for stomach ulcers
- Carbapenem agents (antibiotics used to treat bacterial infections) such as imipenem, meropenem, rifampicin, and erythromycin. The combination of Sodium Valproate Injection and carbapenems should be avoided because they may decrease the effectiveness of your medicine
- Colestyramine used to lower blood fat (cholesterol) levels. Sodium Valproate Injection with food, drink, and alcohol
Alcohol intake is not recommended during treatment.
Pregnancy, breastfeeding, and fertility Important advice for women
- Valproate can be harmful to unborn children when given to a woman during pregnancy.
- Valproate carries a risk if given during pregnancy. The higher the dose, the higher the risks but all doses carry a risk.
- It can cause serious birth defects and can affect the way in which the child develops as it grows. Birth defects that have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.
- If you are given valproate during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment. Because valproate has been used for many years, we know that in women who are given valproate around 10 babies in every 100 will have birth defects. This compares to 2-3 babies in every 100 born to women who don?t have epilepsy.
- It is estimated that up to 30-40% of preschool children whose mothers received valproate during pregnancy may have problems with early childhood development. Children affected can be slow to walk and talk, intellectually less able than other children, and have difficulty with language and memory.
- Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder(ADHD).
- If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.
- Before prescribing this medicine to you, your doctor will have explained what might happen to your baby if you become pregnant whilst having valproate. If you decide later you want to has a child you should not stop having your medicine until you have discussed this with your doctor and agreed on a plan for switching you onto another product if this is possible.
- Ask your doctor about taking folic acid when trying for a baby. Folic acid can lower the general risk of spina bifida a dear miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
FIRST PRESCRIPTION
If this is the first time you have been prescribed valproate your doctor will have explained the risks to an unborn child if you become pregnant. Once you are of childbearing age, you will need to make sure you use an effective method of contraception throughout your treatment. Talk to your doctor or family planning clinic if you need advice contraception.
Key messages:
- Make sure you are using an effective method of contraception.
- Tell your doctor at once if you are pregnant or think you might be pregnant.
CONTINUING TREATMENT AND NOT TRYING FOR A BABY
If you are continuing treatment with valproate but you don?t plan to have a baby make sure you are using an effective method of contraception. Talk to your doctor or family planning clinic need advice on contraception.
Key messages:
- Make sure you are using an effective method of contraception
- Tell your doctor at once if you are pregnant or think you might be pregnant.
CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY
If you are continuing treatment with valproate and you are now thinking of trying for a baby you must do not stop having your valproate or taking your contraceptive medicine until you have discussed this with your prescriber. You should talk to your doctor well before you become pregnant so that you can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.
Your doctor may decide to change the dose of valproate or switch you to another medicine before you start trying for a baby.
If you do become pregnant you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
Ask your doctor about taking folic acid when trying for a baby. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Key messages:
- Do not stop using your contraception before you have talked to your doctor and worked to get her on a plant to ensure your epilepsy is controlled and the risks to your baby are reduced.
- Tell your doctor at once when you know or think you might be pregnant.
UNPLANNED PREGNANCY WHILST CONTINUING TREATMENT
Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development which can be seriously debilitating. If you are having valproate and you think you are pregnant or might be pregnant contact your doctor at once.
Do not stop having your medicine until your doctor tells you to.
Ask your doctor about taking folic acid. Folic acid can lower the general risk of Spina Bifida a dear miscarriage that exists with all pregnancies.
However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Key messages:
- Tell your doctor at once if you know you are pregnant or think you might be pregnant.
- Do not stop having valproate unless your doctor tells you to.
Make sure you read the patient booklet and sign the Acknowledgment of Risk form which should be given to you and discussed with you by your doctor or pharmacist.
Breast-feeding
Very little SodiumValproate Injection gets into breast milk. However, talk to your doctor about whether you should breast-feed your baby.
Ask your doctor or nurse for advice before taking any medicine.
Driving and using machines
You may feel sleepy after having SodiumValproate Injection. If this happens to you, do not drive or use any tools or machines. Taking other medicines used to treat fits or calm emotional and mental health problems may increase sleepiness.
3. How Sodium Valproate Injection is given
SodiumValproate Injection is always given to you by a doctor or nurse. This is because it needs to be given as a slow injection or infusion into the vein. If you are not sure why you are being given Sodium Valproate Injection or have any questions about how much Sodium Valproate Injection is being given to you, speak to your doctor or nurse.
Your doctor will stop giving you Sodium Valproate Injection and change you to oral therapy (by mouth) as soon as possible.
Sodium Valproate Injection treatment must be started and supervised by a doctor specialized in the treatment of epilepsy.
How much will be given to you
- Your doctor will decide how much SodiumValproate Injection to give you depending on your illness. The amount of Sodium Valproate Injection is given to you or your child will depend on you or your child?s age or bodyweight
- If you have been taking Sodium Valproate by mouth your doctor may decide to give you the same amount of SodiumValproate Injection by continuous or repeated infusion.
If you have not had Sodium Valproate Injection before, the doctor will use the following doses:
Adults (including the elderly)
- The starting dose is usually between 400mg and 800mg daily (up to 10mg per kilogram of body weight)
- This is given as a slow intravenous injection over 3-5minutes
- This is followed by a continuous or repeated infusion, up to a maximum dose of 2500mg each day.
Children
- The usual dose is between 20mg and 30mg for each kilogram of body weight each day
- This may be increased to 40mg for each kilogram of body weight each day depending on your child?s illness.
Patients with kidney problems
- Your doctor may decide to adjust your or your child does
Patients taking other medicines for ?fits? (epilepsy)
- You or your child may be taking other medicines for epilepsy at the same time as Sodium ValproateInjection.If so, your doctor should gradually initiate treatment depending on your child condition
- Your doctor may increase the dose of Sodium Valproate Injection by 5 to10mg for each kilogram of body weight each day depending on which other medicines you are taking.
I have more Sodium Valproate Injection than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor will be checking your progress and checking the medicine that you are given. Always ask if you are not sure why
you are getting a dose of medicine.
Having too much Sodium Valproate Injection can lead to the following symptoms: feeling sick or being sick, pupils of the eye become smaller, dizziness, loss of consciousness, weak muscle, and poor reflexes, breathing problems, headaches, fits (seizures), confusion, memory loss, and unusual or inappropriate behavior.
If you forget to have Sodium Valproate Injection
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you think you may have missed a dose, then talk to your doctor or nurse.
If you stop receiving Sodium Valproate Injection
It is important for you to keep having Sodium Valproate Injection until your doctor decides to stop them. If you stop, your fits may come back.
Tests
Make sure you or your child keep your regular appointments for ac heck-up. They are very important as your or your child?s dose may need to be changed. Sodium Valproate Injection can change the levels of liver enzymes shown up in blood tests. This can mean that your or your child?s liver is not working properly.
If you or your child go into hospital or visit another doctor or a dentist, tell them you are having Sodium ValproateInjection.
If you have any further questions about receiving this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following serious side effects?you may need urgent medical treatment:
- You have an allergic reaction. The signs may include a rash, joint pain, fever (systemic lupus erythematosus), swallowing or breathing problems, swelling of your lips, face, throat or tongue. Hands, feet or genitals may also be affected. More severe allergic reactions can lead to lymph node enlargement and possible impairment of other organs.
- Liver problems and problems of the pancreas may show as a sudden illness which may happen in the first six months of treatment. This happens in a very small number of people having Sodium Valproate Injection. It includes feeling and being sick many times, being very tired, sleepy and weak, stomach pain including very bad upper stomach pain, jaundice (yellowing of the skin or whites of the eyes), loss of appetite, swelling(especially of the legs and feet but may include other parts of the body), worsening of your fits or a general feeling of being unwell.
Your doctor may stop giving you Sodium Valproate Injection immediately if you have these symptoms.
- You have a skin rash or skin lesions with a pink/red ring and a pale center which may be itchy, scaly or filled with fluid. Ther as he may appear especially on the palms or soles of your feet. The could design so serious allergy to the medicine called ?erythema multiform.?
- Blistering or bleeding of the skin around the lips, eyes, mouth, nose, and genitals. Also flu-like symptoms and fever.Thismaybesomethingcalled?Stevens-Johnsonsyndrome.?
- Severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may be something called ?Toxic epidermal necrolysis.?
- Bruising more easily and getting more infections than usual. This could be a blood problem called ?thrombocytopenia?. It can also be due to a fall in the number of white blood cells, bone marrow depression or another condition that affects red blood cells, white blood cells and platelets (pancytopenia) or how the blood clots.
- Blood clotting problems (bleeding for longer than normal), bruising or bleeding for no reason.
- Changes in mood, loss of memory, lack of concentration and deep loss of consciousness (coma).
- The underactive thyroid gland, which may cause tiredness or weight gain(hypothyroidism)
- Breathing difficulty and pain due to inflammation of the lungs (pleural effusion).
Tell your doctor as soon as possible if you have any of the following side effects:
- Changes in behavior including being very alert, and some times also aggressive, hyperactive
- and unusual or inappropriate behavior. This is more likely if other medicines to treat fits such as phenobarbital and topiramate are taken at the same time or if the Sodium Valproate Injection starting dose is high or has been suddenly increased.
- Changes in the amount of ammonia in the blood. Symptoms of this condition are being sick, problems with balance and coordination, feeling lethargic or less alert.
- Feeling shaky (tremor), sleepy or unsteady when walking or jerky muscle movements
- Feeling tired or confused with loss of consciousness some time accompanied by hallucinations or fits.
- Blisters with the skin flaking away.
- Rapid, uncontrollable movement of the eyes.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet:
- Feeling sick, stomach ache or diarrhea, especially when starting treatment.
- Fainting
- Hearing loss
- Skin problems such as rashes. These happen rarely, but more often people also taking lamotrigine
- Acne
- Hair loss is usually temporary. When it grows back it may be more curly than before
- Hair, including body or facial hair, grows more than normalin
- women
- Skin rash caused by narrow or blocked blood vessels(vasculitis)
- Changes in women?s periods and increased hair growth in women
- Breast enlargement in men
- Swelling of the feet and legs(edema)
- Weight gain ? as your appetite may be increased
- Kidney problems, bedwetting or increased need to pass urine
- Headache
- Aggression, agitation, disturbance inattention, abnormal behavior, restlessness/hyperactivity, and learning disorder
- Tingling or numbness of the hands or feet
Bone Disorders
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.
Blood tests
Sodium Valproate Injection can change levels of liver enzymes, salts or sugars shown up on blood, and urine tests.
Male fertility
Sodium Valproate Injection can be a contributing factor in male infertility.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sodium ValproateInjection
This medicine will be kept by your doctor or pharmacist in a safe place where children can not see or reach it.
Do not freeze. Only clear solutions free of particles should be used.
The contents of the ampoule are for single use only. Before infusion this medicine may be diluted in 0.9% saline, 5% dextrose or 0.9% saline + 5% dextrose. The hospital will ensure the medicine is diluted and stored appropriately. Chemical and physical in-use stability has been demonstrated at 2- 8?C for 24 hours only. From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately,in-use storage time and conditions are the responsibility of the user.
Do not use this medicine after the expiry date which is state don the label land carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sodium Valproate Injection contains
- The active substance is sodium valproate 100mg per ml.
- The other ingredients are Disodium Edetate and Water for injections.
What Sodium Valproate Injection look like and contents of the pack
Sodium Valproate Injection is a clear colorless solution. It is available in glass ampoules containing 3ml (300mg sodium valproate)of the solution for injection. Each pack contains 5 or 10 ampoules.
Not all pack sized may be marketed.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)