Absenor Enterotablett er 100 mg, 300 mg and 500 mg
Absenor Depot Depot Tablet er 300 mg and 500 mg
sodium valproate
1. What Absenor is and what it is used for
Absenor is a drug used to treat epilepsy and mania.
Absenor is used in various types of epilepsy, in the treatment of manic episodes, as well as a maintenance treatment or preventive treatment of manic-depressive illness in patients who do not improve with or do not tolerate lithium.
Mania means a state of strong arousal, elation, agitation, enthusiasm, or hyperactivity. Mania occurs in a disease called bipolar disorder. Absenor can be used when you can not take lithium.
Sodium valproate contained in Absenor may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
How does the drug work?
Absenor’s mode of action is not fully understood. One theory is that Absenor prevents or dampens impulses in the brain so that epileptic seizures and manic episodes are counteracted.
2. What you need to know before taking Absenor
Do not take Absenor
- if you are allergic to sodium valproate or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to peanuts or soy, do not take Absenor Depot
- if you have liver disease or impaired liver function
- in 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, ie. disturbance in urea turnover.
Bipolar disease
- For bipolar disorder, do not use Absenor if you are pregnant.
- For bipolar disorder, if you are a woman who may have children, do not take Absenor unless you are using an effective contraceptive throughout treatment with Absenor. Do not stop taking Absenor 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 Absenor if you are pregnant, unless otherwise indicated for you.
- For epilepsy, if you are a woman who may have children, do not take Absenor unless you are using an effective contraceptive throughout treatment with Absenor. Do not stop taking Absenor 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
Talk to your doctor before taking Absenor.
Treatment with Absenor requires close monitoring with a call to blood tests for liver and pancreatic functions and platelets. It is important that you 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 Absenor. 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 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, and fatigue, which sometimes occur with repeated vomiting or abdominal pain, jaundice, swelling in the legs or feet, and in 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 in 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 causing a disruption in 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
Absenor should not be used in children and adolescents under 18 years of age when treating mania.
Other medicines and Absenor
Absenor can affect or be affected by other drugs 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.
It is unlikely that Absenor will affect the effect of birth control pills.
Absence with food, drink, and alcohol
Absenor is taken with a meal. Alcohol should not be consumed during treatment, as Absenor increases the effect of alcohol.
Pregnancy, breastfeeding, and fertility
Pregnancy and fertility
Important advice for women
Bipolar disease
- For bipolar disorder, do not use Absenor if you are pregnant.
- For bipolar disorder, if you are a woman who may have children, do not take Absenor unless you are using an effective contraceptive throughout treatment with Absenor. Do not stop taking Absenor or your contraceptive until you have discussed it with your doctor. Your doctor will give you further advice.
Epilepsy
- For epilepsy, do not use Absenor if you are pregnant, unless otherwise indicated for you.
- For epilepsy, if you are a woman who may have children, do not take Absenor unless you are using an effective contraceptive throughout treatment with Absenor. Do not stop taking Absenor 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 greater the risk, but all doses involve a risk.
- It can cause serious birth defects and 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 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 taking valproate, about 10 children out of 100 will have birth defects. This compares with 2 to 3 in 100 born to women who do not have 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 and there is some support that children may be more likely to develop symptoms of 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 ABSENOR
- I TAKE ABSENOR BUT I DON’T PLAN TO HAVE CHILDREN
- I TAKE ABSENOR AND PLAN TO HAVE CHILDREN
- I AM PREGNANT AND I TAKE ABSENES
I BEGIN TREATMENT WITH ABSENOR
If this is your first time taking Absenor, 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 Absenor. 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 Absenor.
- You must use an effective contraceptive throughout the treatment with Absenor.
- 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 bipolar disorder or 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 ABSENOR BUT I DON’T PLAN TO HAVE CHILDREN
If you continue treatment with Absenor but do not plan to have children, make sure that you use an effective contraceptive without interruption throughout the treatment with Absenor. Talk to your doctor or midwife if you need contraceptive advice.
Main message:
- You must use an effective contraceptive throughout the treatment with Absenor.
- 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 bipolar disorder or 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 ABSENOR AND PLAN TO HAVE CHILDREN
If you are planning to have a baby, make an appointment with your doctor.
Do not stop taking Absenor 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 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 one of Absenor or switch to another medicine, or stop treatment with Absenor, in good time before you become pregnant – 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 Absenor 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 to another medicine or stop taking Absenor 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 ABSENES
Do not stop taking Absenor 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 who has experience in treating bipolar disorder or epilepsy so that other treatment options can be evaluated.
In the exceptional circumstances when Absenor 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 Absenor unless your doctor tells you to.
- Make sure you are referred to a specialist with experience in the treatment of epilepsy or bipolar disorder to evaluate the need for alternative treatment options.
- You must receive careful advice on the risks of Absenor during pregnancy, including the risk of birth defects and developmental disorders in children.
- Make sure you are referred to as 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 Absenor during the last third of pregnancy
Breast-feeding
Valproate passes into breast milk. Talk to your doctor before using Absenor during breast-feeding.
Fertility
Absence may reduce fertility in both men and women. However, available information indicates that fertility returns to normal when treatment with Absenor is stopped.
Driving and using machines
Absence can impair the ability to react, which should be kept in mind at times when sharper attention is required, e.g. while driving and precision work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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. 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.
Absenor contains
Absenor contains sodium
Absenor contains sodium (the main ingredient in table salt/table salt):
Enterotablett
100 mg – contains 14 mg of sodium per tablet. This corresponds to 0.7% of the highest recommended daily intake of sodium for adults.
300 mg – contains 42 mg of sodium per tablet. This corresponds to 2.1% of the highest recommended daily intake of sodium for adults.
500 mg – contains 70 mg of sodium per tablet. This corresponds to 3.5% of the maximum recommended daily intake of sodium for adults.
Prolonged-release tablet
300 mg – contains 42 mg of sodium per tablet. This corresponds to 2.1% of the highest recommended daily intake of sodium for adults.
500 mg – contains 69 mg of sodium per tablet. This corresponds to 3.5% of the maximum recommended daily intake of sodium for adults.
Talk to your doctor or pharmacist if your need for Absenor is 2800 mg per day or more for an extended period, especially if you have been prescribed a low-salt (sodium-poor) diet.
Absenor Depot prolonged-release tablets contain soy lecithin
If you are allergic to peanuts or soy, do not use this medicine.
3. How to take Absenor
Please note that your doctor may have prescribed Absenor for other uses and in a different dose than indicated in this leaflet. Always follow your doctor’s prescription the instructions on the medicine pack. Ask your doctor or pharmacist if you are unsure.
Treatment with Absenor must be initiated and supervised by a physician who specializes in the treatment of epilepsy or bipolar disorder.
Dose one should be determined by a doctor who adapts it individually for you.
The daily dose can vary greatly depending on age, body weight, and the severity of the disease.
Absenor is taken with a meal.
The prolonged-release tablets are swallowed whole with water or juice.
Gastro engines have a protective casing for tablets that are not dissolved until in the intestine, leading to fewer gastrointestinal side effects. In order for this casing to remain intact, the enteric tablets must be swallowed whole.
Epilepsy
Prolonged-release tablets:
The usual maintenance dose is 20-30 mg/kg body weight daily. This usually corresponds to 4-10 tablets (300 mg) or 2-6 tablets (500 mg) divided into 1-2 dosing times.
The prolonged-release tablets can also be used for children where appropriate. The usual dose for children is around 30 mg/kg body weight daily.
Entero-tablets:
The usual dose for adults in epilepsy: at the beginning of treatment 300 mg 3 times a day, dose one is then gradually increased until the seizures are under control.
The usual dose for children with epilepsy: at the beginning of treatment 20-40 mg/kg body weight divided into 2-3 doses is given. Dose one is then gradually increased until the seizures are under control.
Do not stop treatment without consulting your doctor. Otherwise, the disease may worsen.
Absenor can be combined with other medicines to treat epilepsy. Then pay extra attention if the following symptoms occur: fatigue, nausea, headache, altered eye, and muscle movements and consult a doctor as the dose may need to be adjusted.
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.
Signs of acute massive overdose are usually coma, with decreased muscle tension, weak reflexes, reduced pupils, impaired breathing, metabolic acidosis, low blood pressure, and the collapse of blood circulation.
If you forget to take Absenor
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 Absenor 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 in 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 Absenor.
Agranulocytosis Rare (may affect up to 1 in 1,000 people):
Absence 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 Absenor and contact a 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 a doctor or pharmacist if you are being 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.
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. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Absenor
Keep this medicine out of the sight and reach of children.
Store in the original package. Close the package tightly. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton. 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
Absenor gastro s
The active substance is sodium valproate 100 mg, 300 mg, and 500 mg.
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.
Absenor Depot release tablet s
The active substance is sodium valproate 300 mg and 500 mg.
The other ingredients are povidone, hypromellose, anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide (dye E 171), talc, lecithin (soy) (E322), xanthan gum.
The appearance of the drug
Absenor 100 mg enteric tablets are white, round, cupped, diameter 7.4 mm
Absenor 300 mg enteric tablets are white, round, cupped, diameter 10.4 mm
Absenor 500 mg enteric tablets are white, round, cupped, diameter 12.4 mm.
Absenor Depot 300 mg prolonged-release tablets are white, round, film-coated, convex, diameter 12.5 mm.
Absenor Depot 500 mg prolonged-release tablets are white, capsule-shaped, film-coated, size 9.9 x 20.8 mm.
The Absenor Depot package contains a desiccant capsule.
Pack sizes:
Gastro s 100 mg: 100 and 300 gastro s
Gastro s 300 mg: 100 and 300 gastro s
Gastro s 500 mg: 100 and 200 gastro s
Absenor XR 300 mg and 500 mg: 100 release tablet s
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland.
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com