20 mg/ml oral suspension
carbamazepine
What Tegretol is and what it is used for
Tegretol belongs to a group of medicines called antiepileptics. It works by preventing the spread of the signals in the brain that trigger an epileptic seizure, thereby making it more difficult for seizures to occur.
Tegretol is used in the treatment of epilepsy, certain forms of facial pain ( trigeminal neuralgia ), and alcohol withdrawal.
The carbamazepine contained in Tegretol may also be approved to treat 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.
What you need to know before taking Tegretol
Do not take Tegretol
- if you are allergic to carbamazepine, any of the other ingredients of this medicine (listed in section 6) or closely related medicines (e.g. some medicines for depression)
- if you suffer from porphyria (disorder in the formation of porphyrin, i.e. a pigment important for liver function and blood formation)
- if you have a certain type of heart disease ( AV block )
- if you previously had a certain type of blood disorder
Warnings and precautions
Consult your doctor before using Tegretol:
- if you use antidepressants from the group of monoamine oxidase inhibitors ( MAO inhibitors ). Treatment with MAO inhibitors must have been completed for at least 14 days before you can start treatment with Tegretol.
- if you have heart or vascular disease.
- if you have kidney or liver disease.
- if you have glaucoma or difficulty passing water (urinating) or experience pain when urinating.
- if you have previously shown signs of hypersensitivity (got a rash or other signs of allergy ) to the substance oxcarbazepine or phenytoin. For people who are hypersensitive to carbamazepine, the risk is that about one in four patients (25%) will also have an allergic reaction to oxcarbazepine (Trileptal).
- Contact your doctor if you become pregnant or plan to become pregnant. There is a risk of harm to the unborn child if Tegretol is used during pregnancy. Women of childbearing potential should use effective contraception during treatment with Tegretol and for two weeks after the last dose (see section Pregnancy and breast-feeding ).
- If you take hormonal contraceptives, e.g. birth control pills, Tegretol can cause your contraceptive to not work. Use another or a complementary (non-hormonal) method of contraception while taking Tegretol to prevent unwanted pregnancy. Contact your doctor immediately if you experience irregular bleeding or breakthrough bleeding. Ask your doctor or another healthcare professional if you have any questions about this.
- if you have kidney problems associated with low sodium levels in the blood, or if you have kidney problems and at the same time take certain medicines that lower the sodium level in the blood ( diuretics, eg hydrochlorothiazide, furosemide ). You may need to have a blood test to check the level of sodium in your blood.
- if you experience dizziness, drowsiness, reduced blood pressure, or confusion due to treatment with Tegretol which may lead to you falling.
Serious skin rashes ( Stevens-Johnson syndrome, toxic epidermal necrolysis ) have been reported with the use of carbamazepine. It may begin as red-violet target-like or round spots with central blistering, often symmetrically distributed, on the trunk. Often the rash can include sores in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes).
These severe skin rashes are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash can develop into extensive blistering over large areas and scaling of the skin or peeling. The risk of serious skin side effects occurring is greatest during the first months of treatment.
These serious skin reactions may be more common in people from certain Asian countries (eg, Taiwan, Malaysia, and the Philippines) and patients of Chinese or Thai descent. The risk of these side effects in patients of Han Chinese or Thai origin can be determined by a blood test in these patients. Doctors should be able to tell you if a blood test is necessary before you start taking carbamazepine. Therefore consult your doctor before starting treatment with Tegretol if you are of Chinese or Thai descent.
If you develop a rash or these skin symptoms described here, stop taking medicines containing carbamazepine and contact your doctor immediately and tell them you are taking this medicine. If you have suffered from Stevens-Johnson syndrome or toxic epidermal necrolysis when using the carbamazepine contained in Tegretol, you must never use medicines containing carbamazepine again.
A small number of people who are treated with anti-epileptic drugs such as carbamazepine have also had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.
As Tegretol can cause dry mouth, careful oral hygiene should be observed (tooth brushing with fluoride toothpaste twice daily).
Other medicines and Tegretol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using antidepressants from the group of monoamine oxidase inhibitors ( MAO inhibitors ), that treatment must have ended at least 14 days before you can start taking Tegretol.
The treatment effect can be affected if you take Tegretol together with other medicines. Treating physicians must therefore be aware of all other medications. This applies to both prescription and non-prescription drugs. In particular, it applies to certain pain-relieving drugs (eg dextropropoxyphene ). But many other different medicines can also mean that your Tegretol dose needs to be adjusted.
In addition, the effect of other medicines can be affected by Tegretol, in particular, this applies to:
- sedative drugs (eg midazolam)
- heart medicines (eg ivabradine )
- cholesterol-lowering drugs (eg simvastatin )
Therefore, always tell the doctor who prescribes another medicine for you that you are using Tegretol.
Hormonal contraceptives (eg birth control pills, patches, injections, or implants ): Tegretol can affect how hormonal contraceptives work and make them less effective at preventing pregnancy. Talk to your doctor to choose together the type of contraception that is most suitable when you are taking Tegretol. See section Warnings and precautions.
Natural remedies containing St. John’s wort ( Hypericum perforatum ) should not be used during medication with Tegretol. If you are already taking a St. John’s wort preparation, you should contact your doctor before you stop taking this preparation.
Tegretol with food, drink, and alcohol
You should not drink alcohol during treatment with Tegretol as the medicine may reduce the ability to tolerate alcohol.
You should not drink grapefruit juice during treatment with Tegretol.
Pregnancy and breastfeeding
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.
Pregnancy
Tegretol can cause serious birth defects. If you take Tegretol during 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 epilepsy. Severe malformations have been reported, such as neural tube defects (opening in the spine), malformations of the face (eg, cleft lip and palate ), skull, heart, penis, and urinary opening (hypospadias), and fingers. Your unborn baby should be monitored closely if you have taken Tegretol during pregnancy.
Problems with the child’s neurological development (development of the brain) have been reported in children of women who have used Tegretol during pregnancy. Some 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. It cannot be ruled out that carbamazepine can affect the child’s neurological development.
If you are a fertile woman and do not plan to become pregnant, you must use effective contraception during treatment with Tegretol. Tegretol can affect how hormonal contraceptives, e.g. birth control pills, work and make them less effective in preventing pregnancy. Talk to your doctor, who will discuss with you what type of birth control is most appropriate to use while you are taking Tegretol. If treatment with Tegretol is stopped, you must continue to use effective contraception for another two weeks after stopping treatment.
If you are a fertile woman and planning to become pregnant, you should – before stopping contraception and before becoming pregnant – talk to your doctor about switching to other suitable treatments. This is to avoid exposing the unborn child to carbamazepine.
If you are pregnant or think you may be pregnant, tell your doctor immediately. Do not stop taking the medicine until you have discussed this with the doctor. If you stop taking the medicine without consulting the doctor, it can cause epileptic seizures which can be dangerous for you and your unborn baby. The doctor may decide that the treatment should be changed.
If you take Tegretol during pregnancy, your baby is also at risk of bleeding problems immediately after birth. Your doctor can give you and your child medicine to prevent this.
Breast-feeding
Carbamazepine passes into breast milk. Consult a doctor or pharmacist before taking Tegretol while breastfeeding
Driving ability and use of machinery
Tegretol may 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 should therefore be taken into account when increased attention is required, e.g. when driving a car or other vehicle, using machinery, or performing other activities that require increased vigilance.
You are responsible for assessing whether you are fit to 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. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tegretol contains sodium, sorbitol (E 420), propylene glycol (E 1520) and parahydroxybenzoates
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. it is almost ‘sodium-free’.
Sorbitol (E 420): This medicine contains 175 mg of sorbitol per ml of oral suspension. Sorbitol is a source of fructose. If you (or your child) have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that makes it impossible to break down fructose, consult a doctor before using this medicine.
Sorbitol can cause stomach/intestinal discomfort and can have a mild laxative effect.
Propylene glycol (E 1520): This medicine contains 25 mg of propylene glycol per ml.
If your child is younger than 4 weeks, consult a doctor or pharmacist before the child uses the medicine, especially if the child uses other medicines that contain propylene glycol or alcohol.
Parahydroxybenzoates: This medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate which can cause an allergic reaction (possibly delayed).
How to take Tegretol
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The dose is determined by the doctor, who adjusts it individually for you. Carefully follow the doctor’s prescription. This is especially important in the case of epilepsy so that you get adequate seizure protection. Initially, a lower dose is given which is then gradually increased until an effective maintenance dose is reached.
Usual maintenance dose for adults
800-1200 mg per day divided into 2-3 doses.
The usual dose for children
10-20 mg per kg of body weight per day divided into 2-3 doses.
How to take Tegretol
Take Tegretol during or after a meal and with some liquid.
If you have taken too much Tegretol
If you have ingested too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Tegretol
If you have forgotten to take a dose, take it as soon as you remember. However, if it is time for the next dose, do not take the one you forgot. Continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.
If you stop taking Tegretol
When treating epilepsy, you should not suddenly stop your medication because the risk of seizures then increases. Never change your treatment yourself without consulting your doctor.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. Seek immediate medical attention if you experience any of the following:
Agranulocytosis (rare side effect ):
In rare cases, Tegretol can affect the white blood cells so that the defense against infection deteriorates. If you get an infection with 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 white blood cells can be ruled out via a blood test ( agranulocytosis ). It is important that you then have information about your medication.
Angioedema (very rare side effect ):
Swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing.
Toxic epidermal necrolysis (very rare side effect ):
Severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes) see section 2.
Stevens-Johnson syndrome (very rare side effect ):
An extremely strong allergic reaction with 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.
Liver disease (rare side effect ):
For example. jaundice (yellowing of the skin or whites of the eyes).
Decrease in the number of platelets or blood cells (common side effect ):
Showing signs such as tiredness, shortness of breath with light exertion, paleness, headache, chills, dizziness, repeated infections with fever, sore throat, mouth ulcers, bleeding or bruising that occurs more easily than usual, nosebleeds, reddish or purple-red marks on the skin or unexplained patchy skin rash.
SLE -like disease (rare side effect ):
Causes red, patchy skin rashes, mainly on the face, which can appear at the same time as fatigue, fever, nausea, or loss of appetite.
Porphyria disease (rare side effect ):
This leads to increased excretion of blood dyes in the urine, which becomes dark.
Effect on kidney function (rare side effect ):
Severe decrease in the amount of urine, or blood, in the urine.
Pancreatitis (very rare side effect ):
Severe pain in the upper stomach area, vomiting, loss of appetite
Low amount of sodium in the blood (rare side effect ):
Showing signs such as lethargy, confusion, muscle twitching, or significant worsening of the seizures (these symptoms may be signs of low sodium in the blood)
Meningitis (rare side effect ):
Showing signs such as fever, and nausea. Vomiting, headache, stiff neck, and extreme sensitivity to bright light.
Neuroleptic malignant syndrome (very rare side effect ):
Causes a sudden rise in body temperature, very high blood pressure, and severe convulsions.
Cardiac effects (rare side effects ):
For example. irregular heartbeat, chest pain.
Colon inflammation (has been reported):
Showing signs such as diarrhea, abdominal pain, and fever.
Cases (have been reported):
If you fall due to dizziness, drowsiness, decreased blood pressure, or confusion.
The following side effects can also occur when using Tegretol:
Very common (may affect more than 1 in 10 users)
- Difficulty coordinating muscle movements, dizziness
- Vomiting, nausea
- Fatigue
- Elevated liver function values
Common (may affect up to 1 in 10 users)
- Increase in the number of blood cells
- Fluid retention decreased appetite
- Double vision, difficulty seeing up close
- Dry mouth
- Hives, skin rash
- Elevation of certain enzymes (alkaline phosphatases) in the blood
Uncommon (may affect up to 1 in 100 users)
- Headache, involuntary movements (eg tremors, twitching), eye twitching ( nystagmus ), painful facial movements
- Diarrhea, constipation
Rare (may affect up to 1 in 1,000 users)
- Delayed hypersensitivity reaction
- Breast enlargement in men, milk flow from the breasts even without breastfeeding
- Folate deficiency
- Hallucinations, depression, aggression, violent agitation, restlessness, confusion, and activation of psychotic symptoms
- Eye movement disorder, speech disorders, nerve inflammation in the arms and legs, ants crawling, muscle weakness
- Clouding of the eye lens, eye inflammation
- Tinnitus, increased sensitivity to sound
- Increase or decrease in blood pressure et, inflammation of a blood vessel that causes pain ( thrombophlebitis )
- Allergic lung problems that may resemble pneumonia,
- Abdominal pain, taste disturbances, inflammation of the tongue or oral mucosa
- Allergic skin reactions, hypersensitivity reaction to sunlight, changed skin pigmentation, small bleeding in the skin, itching, acne, sweating, hair loss, increased hair (including women)
- Calcification of bone tissue and osteoporosis after long-term treatment, joint pain, muscle pain, muscle cramps
- Difficulty or increased need to pass water
- Sexual disability
- Fever decreased thyroid function
Very rare (may affect up to 1 in 10,000 users)
- Impaired hearing, change in tone perception
- Increase in breast milk stimulating hormone ( prolactin ) in the blood
Has been reported (occurring in an unknown number of users)
- Anemia is, a reduced number of antibodies (gammaglobulin) in the blood
- Male infertility
- Increased pressure in the eye
- Reactivation of human herpesvirus 6 infections, bone marrow failure
- Sedation, memory impairment
- Hypersensitivity syndrome involves an allergic reaction with rash, fever, and abnormal blood values (DRESS)
- AGEP ( acute generalized exanthematous pustulosis ) can present with a sudden onset of fever with large reddened, small heavily red-dotted rashes, with very small blisters
- Thickening of the skin, loss of nails, fracture
- High levels of ammonia in the blood (hyperammonemia). Symptoms of hyperammonemia may include irritability, confusion, vomiting, loss of appetite, and sleepiness.
There have been reports of bone diseases, e.g. reduced bone density in the skeleton, osteoporosis, and bone fractures. Contact a doctor or pharmacist if you are being treated with epilepsy medicine for a long time, if you know you have osteoporosis or if you are taking steroids.
How to store Tegretol
Keep this medicine out of the sight and reach of children.
Store in the original packaging. Light sensitive.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is carbamazepine 20 mg/ml.
- Other ingredients are microcrystalline cellulose, carmellose sodium, caramel flavor 52929A (flavor), methyl parahydroxybenzoate (E 218), macrogol stearate, propylene glycol (E 1520), propyl parahydroxybenzoate (E 216), saccharin sodium, sorbic acid ( preservative ), liquid sorbitol (E 420) (non- crystallizing), hydroxyethyl cellulose and water.
Appearance and package sizes of the medicine
Tegretol oral suspension is white.
Tegretol oral suspension is supplied in an amber glass bottle containing 300 ml of oral suspension. Measuring spoon 5 ml (graduated 1.25; 2.5 and 5 ml) included.