Ergenyl Retard 100 mg, 250 mg, 500 mg prolonged-release granules sodium valproate
1. What Ergenyl Retard Is, And What Is It Used For
The mechanism of action of Ergenyl Retard is not fully understood, but it is believed that the drug prevents or attenuates impulses in the brain that trigger epileptic seizures.
Ergenyl Retard is a medicine used to treat epilepsy and mania. Mania means a state of strong arousal, elation, agitation, enthusiasm, or hyperactivity. Mania occurs in a disease called bipolar disorder. Ergenyl Retard can be used when you can not take lithium.
Sodium valproate contained in Ergenyl Retard may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before Taking Ergenyl Retard
Do not take Ergenyl Retard granules:
- If you have liver disease or impaired liver function.
- If you are allergic to sodium valproate or any of the other ingredients of this medicine (listed in section 6).
- If you have porphyria (increased accumulation of certain blood dyes).
- If you have a hereditary problem that causes a disturbance in the cells’ energy supply (eg, Alpers-Huttenlocher syndrome).
- If you have a known metabolic disease, i.e., disturbance in urea turnover.
Bipolar disease
- For bipolar disorder, do not use Ergenyl Retard if you are pregnant.
- For bipolar disorder, if you are a woman who may have children, do not take Ergenyl Retard unless you are using an effective contraceptive throughout treatment with Ergenyl Retard. Do not stop taking Ergenyl Retard or your contraceptive until you have discussed it with your doctor. Your doctor will give you further advice (see below under “Pregnancy, breast-feeding and fertility – Important advice for women”).
Epilepsy
- For epilepsy, do not use Ergenyl Retard if you are pregnant, except when nothing else works for you.
- For epilepsy, if you are a woman who may have children, do not take Ergenyl Retard unless you are using an effective contraceptive throughout treatment with Ergenyl Retard. Do not stop taking Ergenyl Retard or your contraceptive until you have discussed it with your doctor. Your doctor will give you further advice (see below under “Pregnancy, breast-feeding and fertility – Important advice for women”).
Warnings And Cautions
Treatment with Ergenyl Retard requires close monitoring, with a call for blood tests regarding liver and pancreatic functions and platelets. It would help if you went for these checks. This is especially true at the beginning of treatment and during surgeries.
The use of acetylsalicylic acid (for pain and fever) in children under 3 years of age should be avoided due to the risk of liver damage.
In case of blood disease, certain skin diseases ( SLE ), impaired kidney function, metabolic disease (especially hereditary enzyme deficiency), or if you easily get bruises or bleeding, the doctor should be informed about this. Always follow the doctor’s prescription carefully! Consult your doctor if you are unsure.
There is a risk of weight gain when taking Ergenyl Retard. Contact a doctor if you need help checking your weight.
Many people treated with antiepileptic drugs such as valproate have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
Always consult a doctor if the following symptoms occur:
- Loss of appetite
- Nausea
- Drowsiness
- Fatigue sometimes occurs with repeated vomiting or abdominal pain, jaundice, swelling in the legs or feet, and the case of sudden impaired seizure control. This can be a sign of a serious effect on the liver or pancreas. This is especially true in infants and children under 3 years of age with severe epilepsy (especially children with brain damage, developmental disorders, genetic and metabolic diseases) and combination therapy with other antiepileptic drugs. See also section 4, Possible side effects.
Talk to your doctor if you know that your family has a hereditary problem that is disrupting the cells’ energy supply.
As with other antiepileptic medicines, seizures may worsen or occur more often when you take this medicine. Contact a doctor immediately if this happens.
You should not stop the medication abruptly, as the risk of seizures may increase. Never change the prescribed dose yourself without consulting a doctor.
Children And Young People
Ergenyl Retard should not be used in children and adolescents under 18 years of age to treat mania.
Other Medicines And Ergenyl Retard
Ergenyl Retard may affect or be affected by other medicines, such as:
- Painkillers ( acetylsalicylic acid )
- Agent against gastric ulcers (cimetidine)
- drugs against cardiovascular disease (nimodipine)
- Agents against epilepsy (ethosuximide, felbamate, phenobarbital, phenytoin, carbamazepine, lamotrigine, primidone, rufinamide, topiramate)
- Anti-anxiety drugs (lorazepam)
- Anti-malarial drugs (mefloquine)
- Anesthetic (propofol)
- Agents for viral infections (zidovudine)
- Remedies for psychosis and certain other mental illnesses
- Antidepressants and sleeping pills
- Certain blood thinners ( warfarin )
- Certain antibiotics (erythromycin, rifampicin, carbapenems such as ertapenem, imipenem, meropenem, and panipenem)
- Certain lipid-lowering drugs (cholestyramine)
- Certain anti-glaucoma drugs (acetazolamide)
- Treatment with antibiotics containing pivalic acid (pivampicillin, pivmecillinam) should be avoided.
- Estrogen-containing agents (including some birth control pills )
Therefore, you need to tell your doctor or pharmacist if you have taken, have recently taken, or might take any other medicines.
Ergenyl Retard is unlikely to affect the effect of birth control pills.
Ergenyl Retard With Food And Drink
- Do not use granules with hot food or drink.
- Alcohol should not be consumed during treatment, as Ergenyl Retard increases the effect of alcohol.
Pregnancy, Breastfeeding, And Fertility
Important advice for women
Bipolar disease
- For bipolar disorder, do not use Ergenyl Retard if you are pregnant.
- For bipolar disorder, if you are a woman who may have children, do not take Ergenyl Retard unless you use an effective contraceptive throughout treatment with Ergenyl Retard Do not stop taking Ergenyl Retard or your contraceptive until you have discussed it with your doctor. Your doctor will give you further advice.
Epilepsy
- For epilepsy, do not use Ergenyl Retard if you are pregnant, except when nothing else works for you.
- For epilepsy, if you are a woman who may have children, do not take Ergenyl Retard unless you are using an effective contraceptive throughout treatment with Ergenyl Retard. Do not stop taking Ergenyl Retard or your contraceptive until you have discussed it with your doctor. Your doctor will give you further advice.
The risks of valproate when taken during pregnancy (regardless of the disease for which valproate is used):
- Tell your doctor immediately if you are planning to become pregnant or are pregnant.
- Valproate is a risk if taken during pregnancy. The higher the dose, the higher the risk, but all doses involve a risk.
- It can cause serious birth defects and can affect how the baby develops as it grows. Fetal injuries that have been reported include spina bifida (where the bones of the spine are not properly developed), malformations of the face and skull, heart, kidney, urinary tract, and malformations of the genitals as well as malformations of the extremities er. Hearing problems or deafness have been reported in children exposed to valproate during pregnancy.
- If you take valproate during pregnancy, you are at greater risk than other women of having a child with birth defects that require medical treatment. Since valproate has been used for many years, we know that about 10 children out of 100 will have birth defects in women taking valproate. This compares with 2 to 3 children in 100 born to women without epilepsy.
- It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development. Affected children may be late to walk and talk, have a lower intellectual ability than other children, and have difficulty with language and memory.
- Autism spectrum disorders are more commonly diagnosed in children exposed to valproate during pregnancy. There is some support that children exposed to valproate during pregnancy have a higher risk of developing ADHD (Attention Deficit Hyperactivity Disorder).
- Before you are prescribed this medicine, your doctor will have explained what can happen to your baby if you become pregnant while taking valproate. If you later decide to have a child, do not stop taking your medicine or contraceptive until you have discussed it with your doctor.
- If you are the parent or caregiver of a girl treated with valproate, consult your doctor when your child using valproate gets his first period.
- Some birth control pills (estrogen-containing birth control pills ) can lower the valproate levels in your blood. Make sure you talk to your doctor about which contraceptive (birth control) is most suitable for you.
- Talk to your doctor about taking folic acid when trying to conceive. Folic acid can lower the overall risk of spina bifida and early miscarriage that occurs with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects in connection with valproate use.
Please select and read the situations that apply to you from the situations described below:
- I BEGIN TREATMENT WITH ERGENYL RETARD
- I TAKE ERGENYL RETARD, BUT I DON’T PLAN TO HAVE CHILDREN
- I TAKE ERGENYL RETARD AND PLAN TO HAVE CHILDREN
- I AM PREGNANT, AND I TAKE ERGENYL RETARD
I BEGIN TREATMENT WITH ERGENYL RETARD
If this is the first time you have been prescribed Ergenyl Retard, your doctor will explain the risks to an unborn baby if you become pregnant. If you can have children, you must ensure that you use an effective method of contraception without interruption during your treatment with Ergenyl Retard. Talk to your doctor or midwife if you need contraceptive advice.
Main message:
- Pregnancy must be ruled out as a result of a pregnancy test, which has been confirmed by your doctor before starting treatment with Ergenyl Retard.
- You must use an effective contraceptive throughout the treatment with Ergenyl Retard.
- You must discuss appropriate birth control methods (contraception) with your doctor. Your doctor will give you information on how to prevent pregnancy and can refer you to a specialist doctor for advice on birth control.
- You must have regular (at least annual) appointments with a specialist doctor who has experience in treating bipolar disorder or epilepsy. During this visit, your doctor should make sure that you are well aware of and understand all the risks and advice related to using valproate during pregnancy.
- Tell your doctor if you want to get pregnant.
- Tell your doctor immediately if you are pregnant or think you may be pregnant.
I TAKE ERGENYL RETARD, BUT I DON’T PLAN TO HAVE CHILDREN
If you continue treatment with Ergenyl Retard but do not plan to have children, make sure you use an effective contraceptive without interruption throughout the treatment with Ergenyl Retard. Talk to your doctor or midwife if you need contraceptive advice.
Main message:
- You must use an effective contraceptive throughout the treatment with Ergenyl Retard.
- It would help if you discussed contraception (birth control) with your doctor. Your doctor will give you information on preventing pregnancy and may refer you to a specialist for birth control advice.
- You must have regular (at least annual) appointments with a specialist doctor who has experience treating bipolar disorder or epilepsy. During this visit, your doctor should make sure that you are well aware of and understand all the risks and advice related to using valproate during pregnancy.
- Tell your doctor if you want to get pregnant.
- Tell your doctor immediately if you are pregnant or think you may be pregnant.
I TAKE ERGENYL RETARD AND PLAN TO HAVE CHILDREN
If you plan to have a baby, make an appointment with your doctor.
Do not stop taking Ergenyl Retard or your contraceptive until you have discussed it with your doctor. Your doctor will give you further advice.
Children born to mothers who have taken valproate have a serious risk of birth defects and developmental disorders that can be severely impaired. Your doctor will refer you to a specialist with experience treating bipolar disorder or epilepsy so that other treatment options can be evaluated early. Your specialist doctor can take several measures 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 specialist doctor may decide to change the dose of Ergenyl Retard or switch to another medicine, or stop your treatment with Ergenyl Retard, well in advance of your pregnancy – to ensure that your disease is stable.
Consult your doctor about taking folic acid when planning to have children. Folic acid can lower the overall risk of spina bifida and early miscarriage that occurs with all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with valproate use.
Main message:
- Do not stop taking Ergenyl Retard unless your doctor tells you to.
- Do not stop using your contraceptive until you have talked to your doctor and worked out a plan to ensure that your condition is stable and that the risks to your child are reduced.
- Book an appointment with your doctor. During this visit, your doctor should make sure that you are well aware of and understand all the risks and advice related to using valproate during pregnancy.
- Your doctor will try to switch to another medicine or stop your treatment with Ergenyl Retard well before you become pregnant.
- Tell your doctor immediately if you are pregnant or think you may be pregnant.
I AM PREGNANT, AND I TAKE ERGENYL RETARD
Do not stop taking Ergenyl Retard unless your doctor tells you that your condition may be getting worse. Tell your doctor immediately if you are pregnant or think you may be pregnant. Your doctor will give you further advice.
Children born to mothers who have taken valproate have a serious risk of birth defects and developmental disorders that can be severely impaired.
You will be referred to a specialist with experience treating bipolar disorder or epilepsy so that other treatment options can be evaluated.
In the exceptional circumstances when Ergenyl Retard is the only available treatment option during pregnancy, you will be examined very carefully regarding your illness and to check how your unborn baby is developing. You and your partner can get advice and support regarding pregnancy exposure to valproate.
Ask your doctor for folic acid. Folic acid can lower the overall risk of spina bifida and early miscarriage that occurs with all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with valproate use.
Main message:
- Tell your doctor immediately if you are pregnant or think you may be pregnant.
- Do not stop taking Ergenyl Retard unless your doctor tells you to.
- Make sure you are referred to a specialist with experience treating a bipolar disorder or epilepsy to evaluate the need for alternative treatment options.
- You must get detailed advice on the risks of Ergenyl Retard during pregnancy, including the risk of birth defects and developmental disorders in children.
- Make sure you are referred to a “prenatal monitoring” specialist to detect possible birth defects in the unborn baby.
Make sure you read the patient information brochure you will receive from your doctor. Your doctor will discuss the annual risk confirmation form and ask you to sign and keep it. You will also receive a patient card from your doctor to remind you of the risks of valproate during pregnancy.
Extremely rare cases of blood coagulation problems have been reported in neonates whose mothers were treated with valproate during pregnancy. However, hypoglycemia (low blood glucose) and hypothyroidism (thyroid gland malfunction, which can cause tiredness and weight increase) may occur in the newborn.
Withdrawal symptoms may occur in newborns whose mothers took Ergenyl Retardduring the last third of pregnancy.
Breast-feeding
Valproate passes into breast milk. Talk to your doctor before using Ergenyl Retardduring breastfeeding.
Fertility
Ergenyl Retard may reduce fertility in both men and women. However, available information indicates that fertility returns to normal when treatment with Ergenyl Retard is stopped.
Driving And Using Machines
You are responsible for assessing whether you can drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ergenyl Retard Contains Sodium
- 100 mg:
- Consult a physician or pharmacist if you need 45 sachets or more daily for an extended period, especially if you have been prescribed a low-salt (sodium-poor) diet.
- 250 mg:
- Consult a physician or pharmacist if you need 18 sachets daily for an extended period, especially if you have been prescribed a low-salt (sodium-poor) diet.
- 500 mg:
- Consult your doctor or pharmacist if you need 9 sachets or more daily for an extended period, especially if you have been prescribed a low-salt (sodium-poor) diet.
3. How To Take Ergenyl Retard
- Treatment with Ergenyl Retard must be initiated and supervised by a doctor who specializes in the treatment of bipolar disorder or epilepsy.
- Ergenyl Retard granules should be taken regularly according to your doctor’s instructions.
- The granules are tasteless and only intended to be taken by mouth.
- Ergenyl Retard prolonged-release granules are a formulation that is specially adapted for children (when they can swallow easily chewed food) and for adults with difficulty swallowing. Granules have a so-called modified release. This means that the body absorbs the active ingredient for a longer period, giving the drug a more even level. Because granules have a modified release, they also contain inert ingredients that are insoluble. These are not absorbed by the body but disappear with feces, where they can sometimes be seen.
- Epilepsy:
- The daily dose can vary greatly depending on age, body weight, and the severity of the seizures.
- A usual starting dose for adults is 10-15 mg/kg body weight daily.
- The usual maintenance dose is 20-30 mg/kg body weight daily.
- Granules can also be used for children where appropriate. The usual dose for children is around 30 mg/kg body weight daily.
- Mania:
- The daily dose should be determined and monitored individually by your doctor.
- Starting dose
- The recommended daily starting dose is 750 mg.
- Average daily dose
- The recommended daily dose is usually between 1000 mg and 2000 mg.
- Dose one can be increased or decreased depending on the patient’s reaction.
- Dose one can be given once or twice daily.
- The sachet is intended to be used on a single occasion. It must not be shared and saved for later use.
- Granules are sprinkled on or mixed into food or drink (e.g., yogurt, juice, softened ice cream, cream ), which is cold or at room temperature. Granules can also be poured directly into the mouth and rinsed with a cold drink.
- Granules should not be given hot food or drink (e.g., soup, coffee, tea).
- Ergenyl Retard granules should not be given in baby bottles because granules can block the hole in the pacifier.
- When granules are given together with liquid, the glass should be rinsed afterward with a small amount of water so that no grains get stuck.
- Mixture one should be swallowed immediately and not chewed. It must not be saved for later intake.
Always take Ergenyl Retard granules exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist. Do not stop treatment without consulting your doctor. Otherwise, the disease may worsen.
If you have the impression that the effect of Ergenyl Retard granules is too strong or too weak, talk to your doctor or pharmacist.
If You Take More Ergenyl Retard, Then You Should
If you take too much medicine, always contact a doctor, hospital, or the Poison Information Center.
If You Forget To Take Ergenyl Retard
If you forget to take your medicine, take a dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.
4. Possible Ergenyl Retard Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Angioedema Uncommon (may affect up to 1 in 100 people):
Stop taking Ergenyl and contact a doctor immediately if you get any of the following symptoms ( angioedema ):
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives and difficulty breathing
Severe effects on the liver or pancreas Uncommon (may affect up to 1 in 100 people):
Contact a doctor immediately if the following symptoms occur:
- Loss of appetite
- Nausea
- Drowsiness
- Fatigue sometimes occurs with repeated vomiting or abdominal pain, jaundice, swelling in the legs or feet, and the case of sudden impaired seizure control. This can be a sign of a serious effect on the liver or pancreas (sometimes fatal). This has usually affected children under the age of 3 with several disabilities, children who have received high doses in combination with other antiepileptic drugs, and rare children who only take Ergenyl.
Agranulocytosis Rare (may affect up to 1 in 1,000 people):
Ergenyl can, in rare cases, affect the white blood cells so that the defense against infection deteriorates. Get an infection with symptoms such as fever with severe general deterioration or local infection symptoms such as sore throat/throat/mouth or difficulty urinating. You should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then provide information about your medication.
Rhabdomyolysis Rare (may affect up to 1 in 1,000 people):
Stop taking Ergenyl and contact your doctor as soon as possible if you experience unexplained muscle pain, muscle cramps, or muscle weakness. (There is an increased risk of rhabdomyolysis in people with a certain enzyme deficiency, CPT type II.)
Lyell’s syndrome ( toxic epidermal necrolysis ) is Rare (may affect up to 1 in 1,000 people):
Contact a doctor immediately if you get serious widespread skin damage (skin peeling of the epidermis and superficial mucous membranes).
Stevens-Johnson syndrome Rare (may affect up to 1 in 1,000 people):
An extremely severe allergic reaction with skin rash, usually in the form of blisters or sores in the oral cavity and eyes and other mucous membranes, such as genitals.
Contact a doctor immediately if you get such a reaction.
Other side effects that may occur
Very common (may affect more than 1 user in 10):
- Tremors
- Nausea
Common (may affect up to 1 in 10 people):
- Stomach upset in the form of pain, vomiting, and diarrhea
- Gum problems, inflammation of the oral mucosa
- Transient and dose-dependent hair loss
- Problems with nails and nail bed
- Allergic skin reactions
- Increased appetite, abnormal weight gain, loss of appetite, and weight loss
- Confusion, hallucinations, aggression, agitation, problems with attention
- Dizziness
- Extrapyramidal symptoms
- Stiffness
- Drowsiness
- Cramps
- Impaired memory
- Headache
- Rapid and uncontrolled eye movements
- Increased tendency to bleed due to decreased platelet count ( thrombocytopenia ) or prolonged bleeding time, bleeding, anemia
- Painful menstruation
- Deafness
- Liver damage, the effect on liver function with a change in liver function values
- Reduced amount of sodium in the blood, which i.a. can lead to confusion
- Urinary incontinence (accidental urination)
Uncommon (may affect up to 1 in 100 people):
- Difficulty sleeping
- An ant crawling and tingling, disorders of coordination (ability to coordinate), transient parkinsonism (shaking, stiffness), unsteady gait, decreased level of consciousness, coma, effects on the brain, aggravated seizures that may occur more often.
- Reduction in the number of white blood cells ( leukopenia ), shortage of all types of blood cell s
- More frequent urinary incontinence impaired kidney function
- Swelling of the legs or feet ( edema ), water in the lung sac, increased amount of fluid in the body
- Lowered body temperature
- Fatigue
- Hair problems (change in hair color, hair structure, hair growth)
- Irregular or missed periods, too high levels of male sex hormones
- Inflammation of the pancreas
- Inflammation of a vessel wall ( vasculitis )
- Skeletal diseases, e.g., reduced bone density, osteoporosis, and bone fractures. Contact your doctor or pharmacist if you have been treated with epilepsy medication for a long time, if you know you have osteoporosis or if you are on medication with steroids.
Rare (may affect up to 1 in 1,000 people):
- Prolonged bleeding time, abnormal coagulation tests, increased white blood cell count, impaired bone marrow function, which includes very severe anemia (pure red cell aplasia), conditions where normal blood formation is disturbed, anemia with enlarged red blood cells
- SLE (a severe autoimmune disease)
- Psychosis, behavioral disorders, hyperactivity, learning disabilities, memory impairment, transient dementia, double vision
- Constipation
- Severe liver effects in older children
- Elevated levels of ammonium ions in the blood
- Bedwetting, inflammation of the kidneys, transient renal impairment (Fanconi syndrome)
- Impaired thyroid function
- Infertility in men, polycystic ovaries (ovaries produce more blisters than normal)
- Biotin deficiency (b-vitamin component)
- Obesity
- In rare cases, severe brain effects have been reported, especially with concomitant treatment with topiramate or phenobarbital or a sudden increase in the sodium valproate dose.
- A condition with drug-induced skin rash, enlarged lymph nodes, and the possible deterioration of other organs has been reported.
5. How To Store Ergenyl Retard
- Do not store above 25 ° C.
- Store in a cold place.
- Granules should not be exposed to heat.
- Store in the original package. Moisture sensitive.
- Do not use this medicine after the expiry date stated on the carton/sachet (EXP). The expiration date is the last day of the specified month.
- Do not use this medicine if granules appear to have melted or clumped together.
- Keep out of sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. Contents of the packaging And Other Information
Content Declaration
- The active substances are sodium valproate and valproic acid corresponding to 100 mg, 250 mg, and 500 mg sodium valproate.
- The other ingredients are solid paraffin, glycerol behenate, and colloidal aqueous silica.
Marketing Authorisation Holder:
Sanofi AB, Box 30052, 104 25 Stockholm
Detailed and updated information about this product is available by scanning the QR code contained in the package leaflet with a smartphone.