sodium valproate

WARNING
Ergenyl ( valproate ) can seriously harm an unborn baby when taken during pregnancy. If you are a pregnant woman, you must use an effective contraceptive without interruption throughout the treatment with Ergenyl. Your doctor will discuss this with you, but you must also follow the instructions in section 2 of this leaflet. Tell your doctor immediately if you want to get pregnant or if you think you may be pregnant. Do not stop using Ergenyl unless your doctor tells you to as your condition may get worse.

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Ergenyl is and what it is used for 
2. What you need to know before taking Ergenyl 
3. How to take Ergenyl 
4. Possible side effects 
5. How to store Ergenyl 6. Contents of the pack 
and other ingredients information 

1. What Ergenyl is and what it is used for

Ergenyl is a medicine used to treat epilepsy.

Sodium valproate contained in Ergenyl may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

The mechanism of action is not fully understood, but it is believed that Ergenyl prevents or attenuates impulses in the brain that trigger epileptic seizures.

What you need to know before you take Ergenyl

Do not take Ergenyl:

  • if you have liver disease or impaired liver function
  • in porphyria (increased accumulation of certain blood dyes)
  • if you are allergic to sodium valproate or any of the other ingredients of this medicine (listed in section 6).
  • 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, ie. disturbance in urea turnover.

Epilepsy

  • For epilepsy, you must not use Ergenyl 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 unless you are using an effective contraceptive throughout treatment with Ergenyl. Do not stop taking Ergenyl 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 requires close monitoring with a call to blood tests for liver and pancreatic functions and platelets. You must go for these checks. This is especially true at the beginning of treatment, as well as during surgeries.

The use of acetylsalicylic acid (for pain, 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 diseases) or if you easily get bruises or bleeding, the doctor should be informed about this. Always follow the doctor’s prescription carefully! Consult a doctor if you are unsure.

There is a risk of weight gain when taking Ergenyl. Contact a doctor if you need help checking your weight.

A small number of people who are treated with antiepileptic drugs such as valproate have 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, and fatigue, which sometimes occur 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 forms of epilepsy (especially children with brain damage, developmental disorders, genetic and/or metabolic diseases) and combination therapy with other antiepileptic drugs. See also section 4 Possible side effects.

Talk to your doctor if you know that there is a hereditary problem in your family 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 your doctor.

Other medicines and Ergenyl 100, 300 and 500 mg enteric tablets, 60 mg / ml oral solution, 200 mg / ml oral drops, solution

Ergenyl 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, 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 )

You, therefore, need to tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ergenyl is unlikely to affect the effect of birth control pills.

Ergenyl with alcohol

Alcohol should not be consumed during treatment, as Ergenyl increases the effect of alcohol.

Pregnancy, breastfeeding, and fertility

Important advice for women

Epilepsy

  • For epilepsy, you must not use Ergenyl 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 unless you are using an effective contraceptive throughout treatment with Ergenyl. Do not stop taking Ergenyl 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 who have been 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 in women taking valproate, about 10 children out of 100 will have birth defects. 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 and there is some support that children who have been 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
  • I TAKE ERGENYL BUT I DON’T PLAN TO HAVE CHILDREN
  • I TAKE ERGENYL AND PLAN TO HAVE CHILDREN
  • I AM PREGNANT AND I TAKE ERGENYL

I BEGIN TREATMENT WITH ERGENYL

If this is the first time you have been prescribed Ergenyl, 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. 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.
  • You must use an effective contraceptive throughout the treatment with Ergenyl.
  • You must discuss appropriate methods of birth control (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 epilepsy  During this visit, your doctor should make sure that you are well aware of and have understood all the risks and advice related to the use of 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 BUT I DON’T PLAN TO HAVE CHILDREN

If you continue treatment with Ergenyl but do not plan to have children, make sure you use an effective contraceptive without interruption throughout the treatment with Ergenyl. Talk to your doctor or midwife if you need contraceptive advice.

Main message:

  • You must use an effective contraceptive throughout the treatment with Ergenyl.
  • You must discuss contraception (birth control) with your doctor. Your doctor will give you information on how to prevent 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 in treating epilepsy. During this visit, your doctor should make sure that you are well aware of and have understood all the risks and advice related to the use of 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 AND PLAN TO HAVE CHILDREN

If you are planning to have a baby, make an appointment with your doctor.

Do not stop taking Ergenyl 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 who has experience in treating 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 your dose of Ergenyl or switch to another medicine, or stop your treatment with Ergenyl, 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 that it will reduce the risk of birth defects associated with valproate use.

Main message:

  • Do not stop taking Ergenyl unless your doctor tells you to.
  • Do not stop using your contraceptive until you have talked to your doctor and worked out a plan together 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 have understood all the risks and advice related to the use of valproate during pregnancy.
  • Your doctor will try to switch you to another medicine or stop taking Ergenyl well in advance of your pregnancy.
  • Tell your doctor immediately if you are pregnant or think you may be pregnant.

I AM PREGNANT AND I TAKE ERGENYL

Do not stop taking Ergenyl 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 doctor who has experience in treating epilepsy so that other treatment options can be evaluated.

In the exceptional circumstances when Ergenyl is the only available treatment option during pregnancy, you will be examined very carefully both in terms of your medical condition and to check how your unborn baby is developing. You and your partner can get advice and support regarding pregnancy that is exposed 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 that it will 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 unless your doctor tells you to.
  • Make sure you are referred to a specialist with experience in the treatment of epilepsy to evaluate the need for alternative treatment options.
  • You must receive careful advice on the risks of Ergenyl 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 that you will receive from your doctor. Your doctor will discuss the annual risk confirmation form and will 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. Although hypoglycemia (low blood glucose) and hypothyroidism (malfunction of the thyroid gland, which can cause tiredness and weight increase) may occur in the newborn.

Withdrawal symptoms may occur in newborns whose mothers have taken Ergenyl during the last third of pregnancy.

Breast-feeding

Valproate passes into breast milk. Talk to your doctor before using Ergenyl during breast-feeding.

Fertility

Ergenyl may reduce fertility in both men and women. However, available information indicates that fertility returns to normal when treatment with Ergenyl is stopped.

Driving and using machines

You are responsible for assessing whether you are fit to drive motor vehicles or perform risky work. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found under other headings in the package leaflet. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ergenyl contains sorbitol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ergenyl oral solution.

Ergenyl oral solution contains preservatives

Ergenyl oral solution contains preservatives, which may cause an allergic reaction(possibly delayed).

Ergenyl oral solution contains ethanol

Ergenyl oral solution contains small amounts of ethanol (alcohol) less than 100 mg per dose.

How to take Ergenyl

Ergenyl treatment must be initiated and supervised by a doctor who specializes in the treatment of epilepsy.

Dose one should be determined by a doctor, who will tailor it individually for you.

The daily dose can vary greatly depending on age, body weight, and the severity of the seizures.

The packages with an oral solution and oral drops contain dosing syringes to facilitate dosing (see instructions for use below).

The oral solution contains sweeteners and has the taste of raspberries and cherries.

The oral drops have a bitter taste. They can be given on a spoon together with a little fruit puree or similar.

Gastro-resistant is to be swallowed whole.

Do not stop treatment without consulting your doctor. Otherwise, the disease may worsen.

Instructions for use for the plastic cap on the bottles with an oral solution and oral drops, solution

  1. Open the cap on the bottle and attach the adapter to the bottle opening.
  2. Insert the dosing syringe into the hole on the adapter.
  3. Turn the bottle upside down. Withdraw the prescribed amount of medicine into the syringe.
  4. Turn the bottle upside down and release the syringe.
  5. Empty the syringe into the patient’s mouth or a spoon.
  6. Remove the adapter and close the bottle with the cap. Store the bottle according to the storage instructions (see section 5 “How to store Ergenyl”).
  7. Rinse the syringe and adapter immediately after use. Pull the entire flask out of the syringe and wash the syringe, flask, and adapter separately under cold, running water. Do not use hot water or detergent.

The graduation of the dosing syringes is designed so that the correct amount can be measured in units of 1 ml for oral solution and 0.1 ml for oral drops.

If you take more Ergenyl then you should

If you have ingested too much medicine, always contact a doctor, hospital, or the Poison Information Center.

If you forget to take Ergenyl

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 side effects

Like all medicines, this medicine can cause side effects, 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, and fatigue, which sometimes occur 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 more 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 of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with 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 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 special enzyme deficiency, CPT type II.)

Lyell’s syndrome ( toxic epidermal necrolysis ) 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 as well as 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/or 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 urination, impaired renal 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 vesicles than normal)
  • Biotin deficiency (b-vitamin component)
  • Obesity
  • In very rare cases, severe brain effects have been reported, especially with concomitant treatment with topiramate or phenobarbital, or with 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

Oral solution and oral drops are stored at a maximum of 25 ºC.

The enteric tablets are sensitive to moisture and must be stored in the original packaging.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Ergenyl 100 mg, 300 mg, and 500 mg gastro s

1 entero-tablet contains:

  • The active substance is 100, 300, and 500 mg sodium valproate respectively.
  • The other ingredients are povidone, calcium silicate, talc, magnesium stearate, partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, polyvinyl acetate phthalate, sodium bicarbonate, triethyl citrate, stearic acid, sodium alginate, anhydrous colloidal silicon dioxide.

Ergenyl 100 mg and 300 mg enteric tablets are available in glass jars of 100 and 300 tablets.

Ergenyl 500 mg is available in glass jars of 100 and 200 tablets.

Not all pack sizes may be marketed.

Ergenyl 60 mg / ml oral solution

1 ml oral solution contains:

  • The active substance is 60 mg sodium valproate.
  • The other ingredients are sorbitol (sweetener), saccharin sodium (sweetener), preservative (methylparaben E 218 and propylparaben E 216), cherry essence (contains ethanol ), and raspberry flavor (contains ethanol ).

Ergenyl oral solution is available in a 200 ml glass bottle, a dosing syringe is included in the package.

Ergenyl 200 mg / ml oral drops, solution

1 ml oral drops, the solution contains:

  • The active substance is 200 mg sodium valproate
  • The other ingredients are purified water.

Ergenyl oral drops the s, the solution is available in a glass bottle with 100 ml, a dosing syringe is included in the package.

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.

Muhammad Nadeem

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