150 mg, 200 mg, and 400 mg\u00a0prolonged-release tablets\u00a0are
carbamazepine<\/p>\n\n\n\n
Trimoniwl\u00a0retard\u00a0prevents signals that trigger an epileptic seizure from spreading in the brain and therefore makes the onset of seizures more difficult.\u00a0This also applies to alcohol withdrawal in cases where there is a risk of an epileptic seizure.\u00a0The pain-relieving effect of Trimonil\u00a0retard\u00a0is probably due to a dampening effect on the nerves in the brain involved in the transmission of pain from the\u00a0trigeminal nerve\u00a0in the face.<\/p>\n\n\n\n
Trimonil retard is used for epilepsy and certain forms of facial pain ( trigeminal neuralgia ), as well as for alcohol withdrawal.<\/p>\n\n\n\n
The carbamazepine contained in Trimonil\u00a0retard\u00a0may also be approved to treat other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n
Talk to your doctor before taking Trimonil\u00a0retard.<\/p>\n\n\n\n
In rare cases, Trimonil\u00a0retard\u00a0can affect the white\u00a0blood cells\u00a0so that the defense against infection deteriorates or cause liver damage.\u00a0Contact your doctor immediately if you develop symptoms such as fever, sore throat<\/a>, skin rash with swollen\u00a0lymph nodes\u00a0and\/or\u00a0flu-like symptoms, small blood spots on the skin, easy bruising, or signs of liver inflammation such as tiredness, loss of appetite, nausea or yellowing of the skin and eyes during treatment with Trimonil\u00a0retard.<\/p>\n\n\n\n Skin reactions, which can be life-threatening (\u00a0Stevens-Johnson syndrome\u00a0and\u00a0toxic epidermal necrolysis\u00a0) or\u00a0hypersensitivity reactions\u00a0(eg DRES’s syndrome with rash, swollen\u00a0lymph nodes, fever, and possible involvement of other organs), have been reported when using Trimonil\u00a0retard.\u00a0It may begin as red-violet target-like or round spots with central blistering, often symmetrically distributed, on the trunk.\u00a0Additional signs to watch out for are sores in the mouth, throat, nose, genitals, or eye inflammation<\/a> (red and swollen eyes).<\/p>\n\n\n\n The skin reactions, which can be life-threatening, are often followed by\u00a0flu-like symptoms.\u00a0The rash can develop into blisters over large areas or skin peeling.<\/p>\n\n\n\n The risk of serious skin reactions is greatest during the first weeks of treatment.<\/p>\n\n\n\n If you have suffered from\u00a0Stevens-Johnson\u00a0syndrome or\u00a0toxic epidermal necrolysis\u00a0when using Trimonil\u00a0retard, you must never use Trimonil\u00a0retard\u00a0again.<\/p>\n\n\n\n If you develop a rash or signs of these skin reactions, stop taking Trimonil\u00a0retard immediately, and contact your doctor immediately and tell them that you are taking this medicine.<\/p>\n\n\n\n These serious skin reactions may be more common in people from certain Asian countries. The risk of these side effects in patients of Han Chinese or Thai origin can be determined by a blood test. Doctors should be able to tell you if a blood test is necessary before you start taking carbamazepine.<\/p>\n\n\n\n A small number of people treated with anti-epileptic drugs\u00a0such as carbamazepine have also had thoughts of harming themselves or committing suicide.\u00a0If you ever have these thoughts, contact your doctor immediately.<\/p>\n\n\n\n Natural remedies containing\u00a0St. John’s wort\u00a0(Hypericum perforatum)<\/em>\u00a0should not be used during medication with Trimonil\u00a0retard.<\/p>\n\n\n\n You should protect yourself from strong sunlight, as you are more susceptible to skin damage from the sun during treatment with Trimonil\u00a0retard.<\/p>\n\n\n\n Treatment with Trimonil\u00a0retard\u00a0requires regular monitoring by your doctor about blood, liver, and kidney function.\u00a0If you are a glaucoma patient, the pressure in your eye should also be checked regularly.\u00a0You must participate in these checks.<\/p>\n\n\n\n If you are treated with thyroid hormone, your doctor will want to check your thyroid function at the beginning and after finishing treatment with Trimonil retard and adjust the dose of thyroid hormone if necessary.<\/p>\n\n\n\n Since Trimonil\u00a0retard\u00a0can cause\u00a0dry mouth, careful oral hygiene should be observed (tooth brushing with fluoride toothpaste twice daily).<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n If you are using antidepressants from the group of\u00a0monoamine oxidase\u00a0inhibitors (\u00a0MAO inhibitors\u00a0), that treatment must have ended at least 14 days before you can start taking Trimonil\u00a0retard.<\/p>\n\n\n\n The treatment effect can be affected if you take Trimonil retard together with other medicines. Treating physicians must therefore be aware of all<\/strong> other medications. This applies to both prescription and non-prescription drugs.<\/p>\n\n\n\n Certain pain medicines (\u00a0dextropropoxyphene\u00a0), depression (nefazodone), anesthesia (midazolam), and natural medicines containing\u00a0St. John’s wort\u00a0(Hypericum perforatum)\u00a0should be avoided in connection with Trimonil\u00a0retard\u00a0treatment.\u00a0If you are already taking a\u00a0St. John’s wort preparation, you should contact your doctor before you stop taking this natural medicine.<\/p>\n\n\n\n Other medicines can increase or decrease the level of carbamazepine in the blood.\u00a0Increased levels of carbamazepine in the blood can cause\u00a0side effects\u00a0(eg dizziness, sleepiness, problems coordinating movements, double vision).\u00a0Decreased levels of carbamazepine in the blood may cause a worsening of your illness, e.g.\u00a0recurrent epileptic seizures or feeling pain in the face, mouth, or throat. Therefore, consult your doctor before using other medicines at the same time. This applies in particular to the following medicines:<\/p>\n\n\n\n Do not drink grapefruit juice while taking Trimonil\u00a0retard, as the level of carbamazepine in the blood may increase, leading to an increased risk of\u00a0side effects.<\/p>\n\n\n\n You may be more affected by alcohol than usual.\u00a0You should therefore not drink alcohol during treatment with Trimonil\u00a0retard.<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.<\/p>\n\n\n\n Pregnancy The active substance carbamazepine passes into breast milk in only small amounts.\u00a0It is therefore usually possible to breastfeed the child during the treatment.\u00a0However, if your child shows poor weight gain or is abnormally sleepy, or suffers from other\u00a0side effects\u00a0such as diarrhea, vomiting, skin rash, or yellowing of the skin and eyes, breastfeeding should be discontinued.\u00a0In any case, consult your doctor if you use Trimonil\u00a0retard\u00a0while breastfeeding.<\/p>\n\n\n\n Fertility in men<\/p>\n\n\n\n Very rare cases of reduced male fertility (low sperm count and\/or low sperm motility) have been reported.<\/a><\/p>\n\n\n\n Trimonil retard can make you feel sleepy or dizzy. You may also experience blurred vision, double vision, or difficulty coordinating muscle movements, especially at the beginning of your treatment or after a dose increase. This may affect your ability to drive, use machinery or perform other activities that require increased vigilance.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’. Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n The dose\u00a0must be determined by the doctor, who adjusts it individually for the patient.\u00a0The usual\u00a0dose\u00a0for adults is 800 – 1200 mg per day for epilepsy treatment and 600 – 800 mg per day for the other indications divided into 2 dosing occasions.<\/p>\n\n\n\n The usual\u00a0dose\u00a0for children is 10 – 20 mg per kg of body weight per day divided into 2 dosing occasions.\u00a0In children under 6 years of age and especially when increasing the\u00a0dose, rapid-release\u00a0pharmaceutical forms are recommended instead of\u00a0prolonged-release tablets.<\/p>\n\n\n\n Instructions for use<\/p>\n\n\n\n Trimonil\u00a0retard\u00a0prolonged-release tablets\u00a0can be split but must not be crushed.\u00a0Swallow the tablets whole with a small amount of liquid either with a meal or between meals.\u00a0Carefully follow the doctor’s\u00a0prescription.\u00a0This is especially important in\u00a0epilepsy\u00a0to get adequate seizure protection.<\/p>\n\n\n\n If you have ingested too much medicine or if, for example,\u00a0a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.<\/p>\n\n\n\n If you forget to take a\u00a0dose, take it as soon as you remember and then continue as usual. Do not take a double\u00a0dose\u00a0to make up for the missed\u00a0dose.\u00a0If you forget several\u00a0doses, contact your doctor.<\/p>\n\n\n\n When Trimonil\u00a0retard\u00a0is used against\u00a0epilepsy, you should not suddenly stop the treatment.\u00a0Never change the\u00a0dose\u00a0or stop using your medication without first consulting your doctor, as this may worsen your illness.<\/p>\n\n\n\n If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Side effects occur more often with combination therapy and usually occur at the beginning of treatment.<\/p>\n\n\n\n Some side effects can be serious. Seek immediate medical attention if you experience any of the following:<\/strong><\/p>\n\n\n\n Agranulocytosis (rare side effect ):<\/em><\/p>\n\n\n\n In rare cases, Trimonil\u00a0retard\u00a0can affect the white\u00a0blood cells\u00a0so that the defense against infection deteriorates.\u00a0If you get an\u00a0infection\u00a0with symptoms such as fever with a greatly worsened general condition or fever with local symptoms of infection such as sore throat\/pharynx\/mouth or difficulty urinating, you should see a doctor as soon as possible so that a lack of\u00a0white blood cells\u00a0can be ruled out via a blood test (\u00a0agranulocytosis\u00a0).\u00a0It is important that you then information about your medication.<\/p>\n\n\n\n Severe allergic reactions ( anaphylaxis ) (very rare side effect )<\/em><\/p>\n\n\n\n Sudden\u00a0itching, rash, difficulty breathing up to\u00a0shock.<\/p>\n\n\n\n Angioedema (very rare side effect ):<\/em><\/p>\n\n\n\n Stop taking Trimonil\u00a0retard\u00a0and contact a doctor immediately if you develop swelling of the face, tongue, or throat;\u00a0difficulty swallowing;\u00a0hives,\u00a0and difficulty breathing.<\/p>\n\n\n\n Hypersensitivity reaction (rare side effect ) <\/em>:<\/em><\/p>\n\n\n\n Hypersensitivity reactions\u00a0with fever, skin rash,\u00a0inflammation\u00a0of the blood vessels, changes in the lymph nodes, joint pain<\/a>, and altered blood levels can occur in various combinations and can affect other organs (e.g. liver, lungs, kidneys,\u00a0pancreas, heart muscle, large intestine).<\/p>\n\n\n\n Toxic epidermal necrolysis (rare side effect ):<\/em><\/p>\n\n\n\n Severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes) see section 2.<\/p>\n\n\n\n Stevens-Johnson syndrome (rare side effect ):<\/em><\/p>\n\n\n\n An extremely strong\u00a0allergic reaction\u00a0with a skin rash is usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as the genitals, see section 2.<\/p>\n\n\n\n DRES’s syndrome (frequency not known)<\/em><\/p>\n\n\n\n A syndrome consisting of skin rash, enlarged\u00a0lymph nodes, fever, and possibly affecting other organs.<\/p>\n\n\n\n Liver disease (rare to very rare side effect ):<\/em><\/p>\n\n\n\n Contact your doctor immediately if you develop signs of liver disease such as dullness, loss of appetite, nausea, or yellow-colored skin during treatment with Trimonil\u00a0retard.<\/p>\n\n\n\nOther medicines and Trimonil retard<\/h2>\n\n\n\n
Hormonal contraceptives (e.g.\u00a0birth control pills,\u00a0patches,\u00a0injections,\u00a0or\u00a0implants\u00a0): Trimonil\u00a0retardcan affect how hormonal contraceptives work and make them less effective at preventing pregnancy.\u00a0Talk to your doctor to choose together the type of contraceptive that is most suitable when you take Trimonil\u00a0retard.
In addition, the effect of other drugs can be affected by Trimonil\u00a0retard.\u00a0Therefore, always tell the doctor who prescribes another medicine for you\u00a0that you are using Trimonil\u00a0retard.<\/strong><\/p>\n\n\n\nTrimonil retard with food, drink, and alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Trimonil\u00a0retard\u00a0can cause serious malformations.\u00a0If you take Trimonil\u00a0retard\u00a0during pregnancy, your child is up to 3 times more likely to have a malformation than children of women who do not take any medicine against\u00a0epilepsy.\u00a0Severe malformations have been reported, such as neural tube defects (opening in the spine), malformations of the face (eg, cleft lip and\u00a0palate\u00a0), skull, heart, penis, urinary opening (hypospadias), and fingers.\u00a0Your unborn child should be closely monitored if you have taken Trimonil\u00a0retard\u00a0during pregnancy.
Problems with the child’s neurological development (development of the brain) have been reported in children of women who have used Trimonil\u00a0retard\u00a0during pregnancy.\u00a0Some studies have shown that carbamazepine negatively affects the neurological development of children exposed to carbamazepine during pregnancy, while other studies have found no such effect.\u00a0It cannot be ruled out that carbamazepine can affect the child’s neurological development.
If you are a\u00a0fertile\u00a0woman and do not plan to become pregnant, you must use effective contraception during treatment with Trimonil\u00a0retard.\u00a0Trimonil\u00a0retard\u00a0can affect how hormonal contraceptives, e.g.\u00a0birth control pills, work and make them less effective in preventing pregnancy.\u00a0Talk to your doctor, who will discuss with you what type of contraception is most appropriate to use while you are taking Trimonil\u00a0retard.\u00a0If treatment with Trimonil\u00a0retard\u00a0is stopped, you must continue to use effective contraception for another two weeks after stopping treatment.
If you are a\u00a0fertile\u00a0woman and planning to become pregnant, you should – before stopping contraception and before becoming pregnant – talk to your doctor about changing to other suitable treatments.\u00a0This is to avoid\u00a0exposing\u00a0the unborn child to carbamazepine.
If you are pregnant or think you may be pregnant, tell your doctor immediately.\u00a0Do not stop taking the medicine until you have discussed this with the doctor.\u00a0If you stop taking the medicine without consulting the doctor, it can cause epileptic seizures which can be dangerous for you and your unborn baby.\u00a0The doctor may decide that the treatment should be changed.
Folic acid deficiency can be caused by Trimonil\u00a0retard\u00a0and contribute to the development of malformations.\u00a0Therefore, intake of\u00a0folic acid\u00a0is recommended before and during pregnancy.\u00a0If you take Trimonil\u00a0retard\u00a0during pregnancy, your baby is also at risk of bleeding problems immediately after birth.\u00a0Your doctor can give you and your child medicine to prevent this.
Breast-feeding<\/p>\n\n\n\nDriving ability and use of machinery<\/h2>\n\n\n\n
Trimonil retard contains sodium<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nHow to take Trimonil retard<\/h2>\n\n\n\n
If you have taken too much Trimonil retard<\/h2>\n\n\n\n
If you forget to take Trimonil retard<\/h2>\n\n\n\n
If you stop taking Trimonil retard<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n