25 mg, 50 mg, 100 mg and 200 mg film-coated tablets
topiramate
What Topiramate Orion is and what it is used for
Topiramate Orion belongs to a group of medicines called antiepileptic 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
What you need to know before you take Topiramate Orion
Do not take Topiramate Orion
– if you are allergic to topiramate or any other ingredient in this medicine (listed in section 6).
– prevention against migraine if you are pregnant or if you are a woman of childbearing age unless you are using an effective contraceptive method (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 Orion.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Orion.
Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate Orion 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 Orion 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 any of the above apply to you, talk to your doctor or pharmacist before using Topiramate Orion.
You mustn’t stop taking your medication without first consulting your doctor.
You should also talk to your doctor before taking any medicine containing topiramate, which is given to you as an alternative to Topiramate Orion.
You may lose weight if you use Topiramate Orion, 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 your doctor.
A small number of people treated with anti-epileptic drugs such as Topiramate Orion have had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.
Topiramate Orion can rarely cause high levels of ammonia in the blood (detected 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 Orion, the risk of developing these symptoms may increase.
Note! The package contains a bag of desiccant. The desiccant should not be ingested.
Other medicines and Topiramate Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topiramate Orion and some other medicines can interact. Sometimes the dose of one of your medicines or Topiramate Orion needs to be adjusted.
You must especially inform the doctor or pharmacist if you are taking:
- other drugs that cause impaired or impaired thinking ability, concentration, or muscle coordination (e.g. drugs with a depressing effect on the central nervous system such as muscle relaxants and sedatives)
- birth control pills. Topiramate Orion 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 Orion.
Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and Topiramate Orion.
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, (traditional) herbal medicines containing St. John’s wort ( Hypericum perforatum ) (used for mild depression and mild anxiety), blood thinner warfarin .
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Topiramate Orion.
Topiramat Orion with food and drink
You can take Topiramat Orion with or without food. Drink plenty of fluids during the day to prevent kidney stones when you take Topiramate Orion. You should avoid drinking alcohol while taking Topiramate Orion.
Pregnancy and breastfeeding
Migraine Prevention:
Topiramate Orion can harm an unborn baby. You must not use Topiramate Orion if you are pregnant. You must not use Topiramate Orion prophylactically against migraine if you are a woman of childbearing age unless you are using an effective contraceptive method. Talk to your doctor about which method of contraception is best and whether Topiramate Orion is suitable for you. A pregnancy test must be done before starting treatment with Topiramate Orion.
Treatment of epilepsy:
If you are a woman of childbearing age, you should talk to your doctor about other treatment options instead of Topiramate Orion. If the decision is to use Topiramate Orion, you must use an effective contraceptive method. Talk to your doctor about the best method of contraception while taking Topiramate Orion. A pregnancy test must be done before starting treatment with Topiramate Orion.
Talk to your doctor if you are planning to become pregnant.
As with other anti- epileptic drugs , there is a risk of harm to the unborn child if Topiramate Orion is used during pregnancy. Make sure you fully understand the risks and benefits of using Topiramate Orion for epilepsy during pregnancy.
- If you take Topiramate Orion during pregnancy, the baby runs a higher risk of congenital malformations, especially cleft lip and palate . Newborn boys can also have a misshapen penis (hypospadia). These malformations can develop early in pregnancy, even before you know you are pregnant.
- If you take Topiramate Orion 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.
- For your condition, there may be other drug treatments that have a lower risk of malformations.
- Tell your doctor immediately if you become pregnant while taking Topiramate Orion. You and the doctor decide whether you should continue to take Topiramate Orion during pregnancy.
Breast-feeding
The active substance in Topiramate Orion (topiramate) is excreted in human breast milk. Effects in breastfed infants of treated mothers have been observed and include diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether you should refrain from breastfeeding or refrain from treatment with Topiramate Orion. 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 Orion 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 Orion. Do not drive or use any tools or machinery without first talking to your doctor.
You yourself 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 . 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 Orion contains lactose
If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
Other ingredients
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, i.e. it is almost ‘sodium-free’.
How to take Topiramate Orion
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- Your doctor will usually let you start with a low dose of Topiramate Orion and slowly increase the dose until you have found the best dose for you.
- Topiramate Orion tablets should be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
- Topiramate Orion can be taken before, during or after a meal. Drink plenty of fluids during the day to prevent kidney stones from forming when you take Topiramate Orion.
If you have taken too much Topiramate Orion
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.
- Seek medical attention 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 Orion.
If you forget to use Topiramate Orion
- 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 Orion
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 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.
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 ) :
- 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 1000 users ):
- Glaucoma which 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, 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 (hyperammonemic encephalopathy ).
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, feeling unwell, 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 ):
- Decreased number of platelets ( blood cells that help stop bleeding), decreased number of white blood cells that help protect you against infection , decreased potassium in the blood
- Increased liver enzymes, increased 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 Orion 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 saliva, drooling, bad breath
- Intake of abnormally large amounts of fluid, increased thirst
- Discolored skin
- Muscle stiffness, pain in the side
- Blood in the urine, incontinence (lack of control) of urine, 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 problems
Rare (may affect up to 1 in 1000 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
- Stevens-Johnson syndrome , a potentially life-threatening condition that may present with ulcers of multiple mucous membranes (eg, mouth, nose, and eyes), skin rash, and blisters
- Abnormal smell in 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.
- Toxic epidermal necrolysis , a life-threatening condition related to, but more serious than, Stevens-Johnson syndrome , characterized by widespread blistering and crusting of the outer skin layers (see rare side effects ).
- 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.
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
- Feeling of unsteady gait
- Feeling of not feeling well
- Decreased 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
- Vomiting
- Fever
Uncommon (may affect up to 1 in 100 users)
- Increased eosinophils (a type of white blood cell ) in the blood
- Overactivity
- Feeling of warmth
- Learning problems
How to store Topiramate Orion
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the box or can. The expiration date is the last day of the specified month.
Store at a maximum of 30ºC.
Do not use this medicine if you notice any discoloration or other signs of deterioration.
The medicine must not be thrown into the drain or among 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, 50 mg, 100 mg or 200 mg topiramate.
– Other ingredients in the tablet core are: microcrystalline cellulose, lactose monohydrate , pregelatinized corn starch, sodium starch glycolate (type A), magnesium stearate.
– Other ingredients in the film coating are: hypromellose, titanium dioxide (E 171), macrogol 400, polysorbate 80; as well as additional yellow iron oxide (E 172) in 50 mg and 100 mg tablets and red iron oxide (E 172) in 200 mg tablets.
Appearance and package sizes of the medicine
Round, biconvex film-coated tablets marked with “E” on one side.
Topiramate Orion 25 mg : white tablets marked with “22” on the other side.
Topiramate Orion 50 mg: light yellow tablets marked with “33” on the other side.
Topiramate Orion 100 mg: dark yellow tablets with beveled edges and marked with “23” on the other side.
Topiramate Orion 200 mg: pink tablets with beveled edges and marked with “24” on the other side.
Pack size: 60 and 100 film-coated tablets in HDPE can.
Not all pack sizes may be marketed.
Orion Corporation
Orion Intie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orion Intie 1
FI-02200 Espoo
Finland
For further information about this medicine, contact the local representative of the marketing authorization holder
Orion Pharma AB, Danderyd
medinfo@orionpharma.com
This medicine is approved in the European Economic Area under the names:
| Czech Republic: | Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg potahované tablety |
| Denmark: | Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets |
| Estonia: | Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg sugar-coated tablets |
| Finland: | Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg tabletti, kalvovärvementinen; Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablet |
| Germany: | TopiCare 25 mg, 50 mg, 100 mg, 200 mg The film-coated tablet |
| Hungary: | Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablet |
| Latvia: | Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg அதுக்குட்டை tabletes |
| Lithuania: | Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg plėvele dengtos tabletės |
| Poland: | Oritop 25 mg, 50 mg, 100 mg, 200 mg, tabletki powlekane |
| Slovakia: | Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg filmom obalene tablety |
| Sweden: | Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablet |