25 mg, 50 mg, 100 mg, 200 mg film-coated tablet
topiramate
What Topiramate 1A Farma is and what it is used for
Topiramate 1A Farma belongs to a group of drugs called antiepileptic drugs. 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 over 2 years of age
- to prevent migraine headaches in adults.
The topiramate contained in Topiramat 1A Farma may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Topiramate 1A Farma
Do not take Topiramate 1A Farma
- if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6).
- Migraine prevention: if you are pregnant or if you are a woman of childbearing age unless you are using an effective contraceptive method (see section “Pregnancy, breast-feeding and fertility” for further information). Talk to your doctor about the best method of contraception to use while taking Topiramate 1A Farma.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate 1A Farma.
Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate 1A Farma 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)
- are taking Topiramate 1A Farma to treat epilepsy and you are pregnant or a woman of childbearing potential (more information in the section “Pregnancy, breast-feeding and fertility”).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Topiramate 1A Farma.
It is essential that you do not stop taking your medication without first consulting your doctor.
You should also talk to your doctor before taking any medication containing topiramate, which is given to you as an alternative to Topiramate 1A Farma.
You may lose weight if you use Topiramate 1A Farma, 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 who have been treated with anti-epileptic drugs, such as Topiramate 1A Farma, have also had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.
Topiramate 1A Farma can in rare cases cause high levels of ammonia in the blood (detected in blood samples). 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 1A Farma, the risk of developing these symptoms may increase.
Other medicines and Topiramate 1A Farma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topiramate 1A Farma and some other medicines can affect each other. Sometimes the dose of one of your medicines or Topiramate 1A Farma 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 1A Farma can make your birth control pills less effective. Talk to your doctor about the best method of contraception to use while taking Topiramate 1A Farma.
Tell your doctor if your menstrual bleeding changes while you are taking the pill and Topiramate 1A Farma.
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, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine and St. John’s wort ( Hypericum perforatum ) (a (traditional) herbal medicine for mild depression), 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 1A Farma
Topiramate 1A Farma with food, drink, and alcohol
You can take Topiramate 1A Farma with or without food. Drink plenty of fluids during the day to prevent kidney stones when you take Topiramate 1A Farma. You should avoid drinking alcohol while taking Topiramate 1A Farma.
Pregnancy, breastfeeding, and fertility
Migraine Prevention:
Topiramate 1A Farma can harm an unborn child. You must not use Topiramate 1A Farma if you are pregnant. You must not use Topiramate 1A Farma preventively 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 if Topiramate 1A Farma is suitable for you. A pregnancy test must be done before starting treatment with Topiramate 1A Farma.
Treatment of epilepsy:
If you are a woman of childbearing age, you should talk to your doctor about other treatment options instead of Topiramate 1A Farma. If the decision is to use Topiramate 1A Farma, you must use an effective contraceptive method. Talk to your doctor about which method of contraception is best when you are taking Topiramate 1A Farma. A pregnancy test must be done before starting treatment with Topiramate 1A Farma.
Talk to your doctor if you are planning to become pregnant.
As with other medicines against epilepsy, there is a risk of harm to the unborn child if Topiramate 1A Farma is used during pregnancy. Make sure you fully understand the risks and benefits of using Topiramate 1A Farma for epilepsy during pregnancy.
- If you take Topiramate 1A Farma during pregnancy, the baby runs 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 1A Farma 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 1A Farma. You and the doctor decide whether you should continue taking Topiramate 1A Farma during pregnancy.
Breast-feeding
The active substance in Topiramat 1A Farma (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 1A Farma. 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 1A Farma must inform the doctor as soon as possible if the baby suffers from anything unusual.
Driving ability and use of machinery
Dizziness, fatigue, and vision problems may occur during treatment with Topiramate 1A Farma. 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 1A Farma contains lactose and sodium
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is almost ‘sodium-free’.
How to take Topiramate 1A Farma
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- Your doctor will usually let you start with a low dose of Topiramate 1A Farma and slowly increase the dose until you have found the best dose for you.
- Topiramate 1A Farma tablets should be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
- Topiramate 1A Farma 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 1A Farma.
If you have taken too much Topiramat 1A Farma
- 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. Take the medicine package with you.
- You may feel sleepy, tired, or less alert, have abnormal coordination, have difficulty speaking or concentrating have double or blurred vision, feel dizzy due to low blood pressure, feel depressed or agitated, or have abdominal pain or seizures.
Overdose can occur if you take other medicines together with Topiramate 1A Farma.
If you forget to take Topiramate 1A Farma
- 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 1A Farma
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 seek medical attention immediately, if you experience any of 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
- anxiety, irritability, mood swings, confusion, disorientation
- problems concentrating, slow thinking, memory loss, problems with memory (new problems, sudden changes, or worsening problems)
- kidney stones, frequent or painful urination.
Uncommon (may affect up to 1 in 100 users)
- the increased amount of acid in the blood (can cause problems with breathing such as shortness of breath, as well as decreased appetite, nausea, vomiting, pronounced fatigue, and fast or irregular pulse )
- reduced or lost ability to sweat (especially in young children exposed to high temperatures)
- thoughts of harming oneself, trying to harm oneself
- loss of part of the field of vision et.
Rare (may affect up to 1 in 1,000 users)
- glaucoma ( glaucoma ) – a blockage of fluid flow in the eye that leads to 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 ).
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.
In addition, the following side effects may occur. Tell your doctor or pharmacist if they get serious:
Very common (may affect more than 1 in 10 users)
- nasal congestion, runny nose, or sore throat
- tingling, pain, and/or numbness in different parts of the body
- sleepiness, fatigue
- dizziness
- nausea, diarrhea
- weight loss.
Common (may affect up to 1 in 10 users)
- anemia ( lack of blood )
- allergic reaction (eg skin rash, redness, itching, facial swelling, hives )
- loss or decreased appetite
- aggressiveness, agitation, anger, abnormal behavior
- difficulty falling asleep or staying asleep
- speech difficulties or speech disorder, slurred speech
- clumsiness or impaired coordination, a feeling of unsteadiness when walking
- impaired ability to perform routine tasks
- lost, impaired, or no sense of taste
- involuntary tremors or shaking, rapid and uncontrollable eye movements
- visual disturbances such as double vision, blurred vision, reduced vision, difficulty focusing
- a spinning sensation ( vertigo ), ringing in the ears, ear pain
- shortness of breath
- 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, lowered potassium level in the blood
- elevated liver enzymes, increased number of eosinophils (a type of white blood cell ) in the blood
- swollen glands on the neck, in the armpits, or the groin
- increased appetite
- elevated mood
- hearing, seeing, and feeling things that are not there, severe mental disorder ( psychosis )
- not showing any emotions and/or lack of emotions, unusual suspiciousness, panic attacks
- problems with reading, speech disorders, problems with handwriting
- restlessness, hyperactivity
- slow thinking reduced alertness and attention
- decreased or slow body movements, involuntary abnormal or repetitive muscle movements
- fainting
- abnormal or reduced sensation to touch
- impaired, distorted, or lost sense of smell
- unusual feeling or sensation that may precede a migraine attack or a certain type of seizure
- dry eyes, sensitivity to light, twitching of the eyelids, watery eyes
- impaired or lost hearing, loss of hearing in one ear
- slow or irregular pulse, feeling the heartbeat in the chest
- low blood pressure, low blood pressure when standing (some people taking Topiramate 1A Farma may therefore feel weak, dizzy, or may faint if they suddenly sit or stand up)
- redness, feeling of warmth
- pancreatitis ( inflammation of the pancreas)
- the increased amount of intestinal gases, heartburn, feeling of fullness or bloating
- bleeding gums, increased amount of saliva, drooling, bad breath
- abnormally large fluid intake, thirst
- discolored skin
- muscle stiffness, pain in the side
- blood in the urine, urinary incontinence, strong urges, pain in the renal tract or kidneys
- 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 high mood
- unconsciousness
- blindness in one eye, temporary blindness, night blindness
- poor vision in one eye (amblyopia)
- swelling in and around the eyes
- numbness, tingling, and color change (white, blue, and then red) in fingers and toes when cold
- inflammation of the liver, liver failure
- Stevens-Johnson syndrome, is a condition that can be life-threatening and can manifest as sores on the mucous membranes in multiple places (eg in the mouth, nose, and eyes), skin rashes, and blisters
- the abnormal odor from 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 eye.
- toxic epidermal necrolysis, a life-threatening condition related to but more serious than Stevens-Johnson syndrome. The symptoms are extensive blistering and peeling of the outermost layers of the skin (see rare side effects ).
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
- the 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 Topiramat 1A Farma should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister/label and carton after EXP.
The expiration date is the last day of the specified month.
Blisters:
Store at a maximum of 25 °C. Store in the original packaging. Moisture sensitive.
Can:
Store at a maximum of 25 °C. Close the jar well. Moisture sensitive.
Shelf life after first opening the can: 200 days.
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.
Topiramate 1A Farma 25 mg film-coated tablet
1 film-coated tablet contains 25 mg of topiramate.
Topiramate 1A Farma 50 mg film-coated tablet
1 film-coated tablet contains 50 mg of topiramate.
Topiramate 1A Farma 100 mg film-coated tablet
1 film-coated tablet contains 100 mg of topiramate.
Topiramate 1A Farma 200 mg film-coated tablet
1 film-coated tablet contains 200 mg of topiramate.
Other ingredients are:
lactose monohydrate, microcrystalline cellulose, starch, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol, polysorbate 80,
As well as for 50 mg and 200 mg: of yellow iron oxide (E172).
Appearance and package sizes of the medicine
25 mg and 100 mg:
White, round, film-coated tablet, plain on both sides.
50 mg and 200 mg:
Yellow, round, film-coated tablet, plain on both sides.
The film-coated tablets are packed in Al/Al blisters or HDPE tablet jars with PP lids, containing silica gel as a desiccant. The cans are packed in a cardboard box.
Blisters: 5, 6, 10, 20, 60 and 100 film-coated tablets.
Can: 20, 28, 50, 60, 100 and 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
1A Farma A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Lek Pharmaceuticals dd, Verovškova 57, SI-1526 Ljubljana, Slovenia