25 mg, 50 mg, 100 mg and 200 mg film-coated tablets
topiramate
What Topiramate Accord is and what it is used for
Topiramate Accord belongs to a group of medicines called anti-epileptic medicines. It is used:
- alone for the treatment of epileptic seizures in adults and children over 6 years of age
- together with other medicines for the treatment of epileptic seizures in adults and children 2 years of age or older
- to prevent migraine headaches in adults
Topiramate contained in Topiramate Accord 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 you take Topiramate Accord
Do not take Topiramate Accord:
- if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6).
- to prevent migraines: if you are pregnant or if you are a woman of childbearing potential unless you are using an effective method of contraception (see section “Pregnancy and breast-feeding” for further information). Talk to your doctor about the best method of contraception to use while you are taking Topiramate Accord.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Accord.
Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate Accord if you:
- have kidney problems, especially kidney stones, or receive kidney dialysis
- have had abnormalities in blood or body fluids (metabolic acidosis )
- have liver problems
- have eye problems, especially glaucoma
- have growth problems
- is on a high-fat diet (ketogenic diet)
- taking Topiramate Accord to treat epilepsy and you are pregnant or a woman of childbearing potential (see section ‘Pregnancy and breast-feeding for further information)
If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Topiramate Accord.
You mustn’t stop taking the medicine without first consulting a doctor.
You should also talk to your doctor before taking any medicine containing topiramate, which is given to you as an alternative to this medicine.
You may lose weight if you use topiramate, so your weight should be checked regularly while using this medicine. If you lose too much weight or if a child using this medicine does not gain enough weight, consult a doctor.
A small number of people who have been treated with anti-epileptic drugs, such as topiramate, have also had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.
Topiramate Accord can cause serious skin reactions. Tell your doctor immediately if you get a rash and/or blisters (see also section 4 “Possible side effects”).
Topiramate Accord can rarely cause high levels of ammonia in the blood (seen in blood tests). This can lead to altered brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. As this can be a serious condition, tell your doctor immediately if you experience the following symptoms (see also section 4 “Possible side effects”):
- have difficulty thinking, remembering information, or solving problems
- is less alert or attentive
- feeling very sleepy with low energy
At higher doses of Topiramate Accord, the risk of developing these symptoms may increase.
Other medicines and Topiramate Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topiramate Accord and some other medicines can affect each other. Sometimes the dose of one of your medicines or Topiramate Accord needs to be adjusted.
You must especially inform the doctor or pharmacist if you are taking:
- Other drugs that impair or impair thinking, concentration, or muscle coordination (e.g. drugs with a depressant effect on the central nervous system such as muscle relaxants and tranquilizers).
- Birth control pills: this medicine can make your birth control pills less effective. Talk to your doctor about the best method of contraception to use while you are taking Topiramate Accord.
Tell your doctor if your menstrual bleeding changes while you are taking the pill and topiramate.
For a list of all medicines that you take. Show this list to your doctor and pharmacist before starting a new medicine.
Other medicines that you should discuss with your doctor or pharmacist include other medicines for epilepsy, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John’s wort ( Hypericum perforatum ) (a (traditional) herbal medicine used to treat depression), blood thinner warfarin.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Accord.
Topiramate Accord with food and drink
You can take Topiramate with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate Accord. You should not drink alcohol while you are taking Topiramate Accord.
Pregnancy and breastfeeding
Migraine Prevention:
Topiramate Accord can harm an unborn baby. You must not use Topiramate Accord if you are pregnant. You must not use Topiramate Accord to prevent migraines if you are a woman of childbearing potential unless you are using an effective method of contraception. Talk to your doctor about which method of contraception is best and if Topiramate Accord is suitable for you. A pregnancy test must be done before starting treatment with Topiramate Accord.
Treatment of epilepsy:
If you are a fertile woman, you should talk to your doctor about other treatment options instead of Topiramate Accord. If the decision is to use Topiramate Accord, you must use an effective method of contraception. Talk to your doctor about the best method of contraception while taking Topiramate Accord. A pregnancy test must be done before starting treatment with Topiramate Accord.
Talk to your doctor if you are planning to have children.
As with other antiepileptic drugs, there is a risk of harm to the unborn child if topiramate is used during pregnancy. Make sure you fully understand the risks and benefits of using topiramate for epilepsy during pregnancy.
- If you take Topiramate Accord during pregnancy, the baby is at a higher risk of congenital malformations, especially cleft lip and palate. Newborn boys can also have a misshapen penis (hypospadias). These malformations can develop early in pregnancy, even before you know you are pregnant.
- If you take Topiramate Accord during pregnancy, your baby may be smaller than expected at birth. Talk to your doctor if you have any questions about this risk during pregnancy.
- There may be other drugs with a lower risk of malformations to treat your condition.
- Tell your doctor immediately if you become pregnant while taking Topiramate Accord. You and the doctor decide whether you should continue to take Topiramate Accord during pregnancy.
Breast-feeding
The active substance in Topiramate Accord (topiramate) is excreted in human breast milk. Effects on breastfed infants of treated mothers have been observed and include diarrhea, drowsiness, irritability, and poor weight gain. Therefore, the doctor will discuss with you whether you should refrain from breastfeeding or refrain from treatment with Topiramate Accord. The doctor will take into account the importance of the medicine for the mother and the risk to the child.
Mothers who are breastfeeding while taking topiramate must inform the doctor as soon as possible if the baby experiences anything unusual.
Driving ability and use of machinery
Dizziness, fatigue, and vision problems may occur during treatment with topiramate. Do not drive or use any tools or machinery without first talking to your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A 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.
Topiramate Accord contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Warning! Each bottle contains a drying capsule. This is a small capsule with the text “Do not eat”. Don’t eat this.
Topiramate Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is next to “sodium-free”.
How to take Topiramate Accord
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- The doctor will usually let you start with a low dose of topiramate and then slowly increase the dose until you find the dose that is best for you.
- Topiramate Accord tablets should be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
- Topiramate can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent the formation of kidney stones when you take topiramate.
If you have taken too much Topiramate Accord
- See a doctor immediately. Take the medicine package with you.
- You may feel sleepy, tired, or less alert, lack coordination, have difficulty speaking and concentrating, have double or blurred vision, feel dizzy due to low blood pressure, feel depressed or agitated, or have stomach pains or seizures.
Overdose can occur if you take other medicines together with topiramate.
If you have ingested too much medicine or if, 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 Topiramate Accord
If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.
Do not take a double dose (two doses at the same time) to make up for a missed dose.
If you stop taking Topiramate Accord
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may return. If your doctor decides to stop treatment with this medicine, the dose can be gradually reduced over a few days.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or see a doctor immediately if you experience the following side effects:
Very common (may affect more than 1 in 10 users)
- Depression (new or worsening)
Common (may affect up to 1 in 10 users)
- Convulsions (seizures)
- Anxiety, irritability, mood changes, confusion, disorientation
- Difficulty concentrating, impaired thinking, memory loss, memory problems (new, sudden change, or increased severity)
- Kidney stones, frequent or painful urination
Uncommon (may affect up to 1 in 100 users)
- Increased acidity of the blood (may cause troubled breathing including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and fast or irregular heartbeat)
- Decreased or lost ability to sweat (especially in young children exposed to high temperatures)
- Have thoughts of serious self-harm, attempt to cause serious self-harm
- Loss of part of the field of vision et
Rare (may affect up to 1 in 1,000 users)
- Glaucoma is a blockage of fluid in the eye and causes increased pressure in the eye, pain, or reduced vision
- Having difficulty thinking, remembering information, or solving problems, being less alert or attentive, and feeling very sleepy with low energy – these symptoms may be a sign of high levels of ammonia in the blood (hyperammonemia) which can lead to altered brain function (hyperammonemia encephalopathy )
- Serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may appear as a rash with or without blisters. Skin irritation, sores, or swelling in the mouth, throat, nose, eyes, and around the genitals. The skin rash can develop into serious widespread skin damage (skin detachment of the outer skin layers and superficial mucous membranes) with life-threatening consequences.
Has been reported (occurring in an unknown number of users):
- Eye inflammation ( uveitis ) with symptoms such as redness in the eye, pain, sensitivity to light, watery eyes, small dots in the field of vision, or blurred vision
Other side effects include the following. If they get worse, contact your doctor or pharmacist:
Very common (may affect more than 1 in 10 users)
- Stuffy, runny nose, or sore throat
- Tingling, pain, and/or numbness in various body parts
- Drowsiness, fatigue
- Dizziness
- Nausea, diarrhea
- Weight loss
Common (may affect up to 1 in 10 users)
- Anemia (low blood count)
- Allergic reactions (such as skin rash, redness, itching, facial swelling, hives)
- Loss of appetite decreased appetite
- Aggression, excitement, anger, abnormal behavior
- Difficulty falling asleep or staying asleep
- Problems with speech or speech difficulties, slurred speech
- Clumsiness or lack of coordination, feeling unsteady walking
- Decreased ability to complete routine tasks
- Decreased, loss of, or nonexistent sense of taste
- Involuntary tremors or shaking, rapid uncontrolled eye movements
- Visual disturbances such as double vision, blurred vision, reduced visual acuity, difficulty focusing
- Feeling of dizziness ( vertigo ), ringing in the ears, pain in the ears
- Respiratory distress
- Cough
- Nosebleed
- Fever, malaise, weakness
- Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
- Dry mouth
- Hair loss
- Itching
- Joint pain or swelling, muscle cramps or twitching, muscle pain or weakness, chest pain
- Weight gain
Uncommon (may affect up to 1 in 100 users)
- Reduced number of platelets ( blood cells that help stop bleeding), reduced number of white blood cells that help protect you against infection, reduced amount of potassium in the blood
- Increased liver enzymes, increase in eosinophils (a type of white blood cell ) in the blood
- Swollen glands in the neck, armpit, or groin
- Increased appetite
- Elevated mood
- Hearing, seeing, or feeling things that are not there, severe mental disorder ( psychosis )
- Not showing and/or feeling emotions, unusual suspiciousness, panic attack
- Reading, speaking, and writing difficulties
- Restlessness, overactivity
- Difficulty thinking reduced alertness or attention
- Reduced or slow body movements, involuntary abnormal or repetitive muscle movements
- Fainting
- Abnormal or reduced sensation
- Impaired, distorted, or no sense of smell
- Unusual feeling or sensation that may precede a migraine or a certain type of attack
- Dry eyes, light sensitivity, involuntary eyelid twitching, watery eyes
- Impaired or lost hearing, loss of hearing in one ear
- Slow or irregular heartbeat, feeling like your heart is pounding in your chest
- Low blood pressure when standing (so some people taking Topiramate Accord may feel weak, dizzy, or may faint when standing or sitting up suddenly)
- Redness, feeling of warmth
- Pancreatitis ( inflammation of the pancreas)
- Gas, heartburn, fullness, or bloating
- Bleeding gums, increased salivation, drooling, bad breath
- Intake of abnormally large amounts of fluid, increased thirst
- Discolored skin
- Muscle stiffness, pain in the side
- Blood in the urine, urinary incontinence (difficulty controlling the bladder), urge to urinate, pain in the side or kidney pain
- Difficulty getting or keeping an erection, sexual dysfunction
- Flu-like symptoms
- Cold fingers and toes
- Feeling of intoxication
- Learning difficulties
Rare (may affect up to 1 in 1,000 users)
- Abnormally elevated mood
- Unconsciousness
- Blindness in one eye, temporary blindness, night blindness
- Visual impairment
- Swelling in and around the eyes
- Numbness, tingling, and discoloration (white, blue, then red) in fingers and toes when exposed to cold
- Liver inflammation, liver failure
- The abnormal smell on the skin
- Discomfort in arms or legs
- Kidney disease
Has been reported (occurring in an unknown number of users)
- Maculopathy is a disease of the macula, the small spot on the retina where vision is sharpest. You should see a doctor if you notice a change or deterioration in your vision.
Children
Side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than in adults:
- Concentration problems
- Increased acidity in the blood
- Have thoughts of serious self-harm
- Fatigue
- Decreased or increased appetite
- Aggression, abnormal behavior
- Difficulty falling asleep or staying asleep
- The feeling of unsteady gait
- Feeling of illness
- Decreased amount of potassium in the blood
- Not showing and/or feeling emotions
- Watery eyes
- Slow or irregular heartbeats
Other side effects that may occur in children are:
Common (may affect up to 1 in 10 users)
- Dizziness ( vertigo )
- Vomiting
- Fever
Uncommon (may affect up to 1 in 100 users)
- Increase in eosinophils (a type of white blood cell ) in the blood
- Hyperactivity
- Feeling of warmth
- Learning problems
How to store Topiramate Accord
Keep this medicine out of the sight and reach of children. Use before the expiry date which is stated on the carton, bottle, or blister after EXP/EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25 ºC. Keep the container tightly closed. Moisture sensitive.
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 topiramate.
Each film-coated tablet contains 25 mg of topiramate.
Each film-coated tablet contains 50 mg of topiramate.
Each film-coated tablet contains 100 mg of topiramate.
Each film-coated tablet contains 200 mg of topiramate.
The other ingredients are lactose monohydrate (see section 2: Topiramate Accord contains lactose ), microcrystalline cellulose, pregelatinized starch (ie potato starch), croscarmellose sodium, and magnesium stearate.
- The 25 mg tablets are coated with hypromellose, titanium dioxide (E171), and macrogol
- The 50 mg and 100 mg tablets are coated with hypromellose, titanium dioxide (E171), macrogol, and yellow iron oxide (E172)
- The 200 mg tablets are coated with hypromellose, titanium dioxide (E171), macrogol, and red iron oxide (E172).
Appearance and package sizes of the medicine:
Film-coated tablet.
Topiramate Accord is available in four strengths containing either 25 mg, 50 mg, 100 mg, or 200 mg of topiramate.
25 mg film-coated tablets are round, biconvex film-coated tablets, approximately 6 mm in diameter, with beveled edges. The white tablets are debossed with TP on one side and 25 on the other side.’
50 mg film-coated tablets are round, biconvex film-coated tablets, approximately 7 mm in diameter, with beveled edges. The light yellow tablets are marked with TP on one side and 50 on the other side.
100 mg film-coated tablets are round, biconvex film-coated tablets, approximately 9 mm in diameter, with beveled edges. The dark yellow tablets are debossed with TP on one side and 100 on the other side.
200 mg film-coated tablets are round, biconvex film-coated tablets, approximately 12.7 mm in diameter, with beveled edges. The red tablets are embossed with TP on one side and 200 on the other side.
Topiramate Accord film-coated tablets are available in aluminum/aluminum blisters in pack sizes of 10, 14, 20, 28, 30, 50, 56, 60, 100, 120, and 200 film-coated tablets or in high-density polyethylene (HDPE) cans with a white opaque child-resistant polypropylene closure with a cotton swab with an induction seal supplied in cartons with pack sizes of 14, 30, 60, 100 and 200 film-coated tablets. Each jar contains a silica gel desiccant that should not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare Polska Sp.z o.o
ul. Lutomirska 50
95-200 Pabianice
Poland
or
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands