Topiramate Mylan 100 Mg Film-Coated Tablets
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Package leaflet: Information for the user
TOPIRAMATE MYLAN 25 mg, 50 mg,
100 mg, 200 mg FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any possible side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Topiramate is and what it is used for
2. What you need to know before you take Topiramate
3. How to take Topiramate
4. Possible side effects
5. How to store Topiramate
6. Contents of the pack and other information
1. What Topiramate is and what it is used for
Topiramate belongs to a group of medicines called “antiepileptic medicines." It is used:
• alone to treat seizures in adults and children over age 6
• with other medicines to treat seizures in adults and children over age 2
• to prevent migraine headaches in adults
2. What you need to know before you take Topiramate Do not take Topiramate
• if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6).
• for migraine prevention if you are pregnant or you are able to become pregnant but you are not using effective contraception (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 using Topiramate.
Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate if you:
• have kidney problems, especially kidney stones, or are getting kidney dialysis
• have a history of blood and body fluid abnormality (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have a growth problem
• are on a high fat diet (ketogenic diet)
• are pregnant or could become pregnant (see section 'pregnancy and breastfeeding' for further information)
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Topiramate.
It is important that you do not stop taking your medicine without first consulting your doctor.
You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramate.
You may lose weight if you use Topiramate so your weight should be checked regularly when using this medicine. If you are losing too much weight or a child using this medicine is not gaining enough weight, you should consult your doctor.
A small number of people being treated with antiepileptic medicines such as Topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Other medicines and Topiramate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Topiramate and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topiramate will have to be adjusted.
Especially, tell your doctor or pharmacist if you are taking:
• other medicines that impair or decrease your thinking, concentration, or muscle coordination (e.g. central nervous system depressant medicines such as muscle relaxants and sedatives).
• birth control pills. Topiramate may make your birth control pills less effective.
Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and Topiramate.
Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.
Other medicines you should discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine and St. John's wort (Hypericum perforatum) (a herbal preparation used to treat depression).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Topiramate.
Topiramate with food, drink and alcohol
You can take Topiramate with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate. You should avoid drinking alcohol when taking Topiramate.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide if you can take Topiramate. As with other antiepilepsy medicines, there is a risk of harm to the unborn child if Topiramate is used during pregnancy. Make sure you are very clear about the risks and the benefits of using Topiramate for epilepsy during pregnancy.
You should not take Topiramate for migraine prevention if you are pregnant or you are able to become pregnant and you are not using effective contraception.
Mothers who breast-feed while taking Topiramate must tell the doctor as soon as possible if the baby experiences anything unusual.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Dizziness, tiredness, and vision problems may occur during treatment with Topiramate. Do not drive or use any tools or machines without talking to your doctor first.
Important information about some of the ingredients of Topiramate
Topiramate (200 mg) contains sunset yellow aluminium lake (E110) and allura red aluminium lake (E129) which may cause allergic reactions.
3. How to take Topiramate
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Your doctor will usually start you on a low dose of Topiramate and slowly increase your dose until the best dose is found for you.
• Topiramate tablets are to 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 kidney stones while taking Topiramate.
If you take more Topiramate than you should
• See a doctor right away. Take the medicine pack with you.
• You may feel sleepy, tired, less alert; lack 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 (fits).
• Overdose can happen if you are taking other medicines together with Topiramate.
If you forget to take Topiramate
• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your 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 forgotten dose.
If you stop taking Topiramate
Do not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. If your doctor decides to stop this medication, your dose may be decreased gradually over a few days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. 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 have the following side
effects:
Very common (may affect more than 1 in 10 people)
• Depression (new or worse)
Common (may affect up to 1 in 10 people)
• Seizures (fits)
• Anxiety, irritability, confusion, disorientation, changes in mood or behaviour, including anger, nervousness, sadness,
• Problems with concentration, slowness of thinking, loss of memory, problems with memory (new onset, sudden change or increased severity)
• Kidney stone, frequent or painful urination
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives) and erythma multiforme, a condition of raised red spots that can blister.
Uncommon (may affect up to1 in 100 people)
• Increased acid level in the blood (may cause troubled breathing including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and fast or uneven heart beats)
• Decreased or loss of sweating
• Having thoughts of serious self-harm, trying to cause serious self-harm
Rare (may affect up to 1 in 1000 people)
• Glaucoma which is a blockage of fluid in the eye causing increased pressure in the eye, pain and decreased vision
• Severe skin reaction, including Stevens-Johnson syndrome, a life threatening skin condition in which the upper layer of the skin separates from the lower, that may present with sores in multiple mucosal sites (such as the mouth, nose, and eyes) and erythma multiforme, a condition of raised red spots that can blister.
Not known (frequency cannot be estimated from the available data)
• Inflammation of the liver, liver failure
• Toxic epidermal necrolysis, a life-threatening condition related to, yet more severe than Stevens-Johnson syndrome, characterised by widespread blistering and sloughing of the outer layers of the skin (see rare side effects)
Other side effects include:
Very common (may affect more than 1 in 10 people)
• Weight loss
• Tingling, pain and/or numbness of various body parts
• Drowsiness, sleepiness or tiredness
• Dizziness
• Diarrhoea
• Nausea
• Stuffy, runny nose and sore throat
Common (may affect up to 1 in 10 people)
• Weight gain
• Decrease or loss of appetite
• Reduced number of red blood cells
• Difficulty falling or staying asleep
• Problems with speech or speech disorder, slurred speech
• Clumsiness, or lack of coordination, feeling of unsteadiness when walking
• Decreased ability to complete routine tasks
• Involuntary trembling or shaking in the arms, hands or legs
• Reduced sense of touch or sensation
• Uncontrollable movement of the eyes
• Distorted sense of taste
• Visual disturbance, such as blurred vision, double vision, decreased vision, difficulty focussing
• Sensation of spinning, ringing sound in the ears, ear pain
• Shortness of breath
• Nose bleeds
• Vomiting
• Constipation
• Stomach pain or discomfort
• Indigestion
• Dry mouth
• Tingling or numbness of the mouth
• Hair loss
• Joint pain or swelling
• Muscle spasms, muscle twitching, muscle weakness or muscle pain
• Chest pain
• Fever
• Loss of strength
• General feeling of feeling unwell
Uncommon (may affect up to 1 in 100 people)
• Crystals in the urine
• Abnormal blood counts, including reduced white blood cell count or platelet count, or increased eosinophils
• Increase in liver enzymes
• Elevated mood
• Hearing, seeing or feeling things that are not there, severe mental disorder (psychosis)
• Showing and feeling no emotion, unusual suspiciousness, panic attack
• Irregular heartbeat or slowness of the heart beat
• Swollen glands in the neck, armpit or groin
• Problems with verbal communication
• Drooling
• Restlessness or increased mental and physical activity
• Slowed thinking, decreased wakefulness or alertness
• Unusual feeling or sensation that may precede a migraine or a certain type of seizure
• Loss of consciousness
• Fainting
• Excessive sleepiness
• Slow or diminished movements
• Disturbed or poor quality sleep
• Impaired or distorted sense of smell
• Problems with handwriting or speech
• Feeling of movement under the skin
• Eye problems including dry eyes, light sensitivity, involuntary twitching, tearing and decreased vision
• Decreased or loss of hearing.
• Hoarseness of the voice
• Inflammation of the pancreas
• Gas
• Heartburn
• Loss of sensitivity to touch
• Bleeding gums
• Fullness or bloating
• Painful or burning sensations in the mouth
• Breath odour
• Leakage of urine and/or stools, blood in urine
• Urgent desire to urinate
• Pain in the kidney area and/or bladder caused by kidney stones
• Skin discolouration
• Localized swelling in the skin
• Swelling of the face.
• Swelling of the joints.
• Musculoskeletal stiffness or muscle fatigue
• Low potassium levels in the blood
• Increased appetite
• Increased thirst and drinking abnormally large amounts of fluid
• Low blood pressure or decrease in blood pressure that occurs when you stand up
• Hot flushing
• Flu like illness
• Cold extremities (e.g. hands and face)
• Feeling drunk
• Problems with learning
• Disturbances in sexual function (erectile dysfunction, loss of libido)
• Hallucinations
• Decreased verbal communication
Rare (may affect up to 1 in 1,000 people)
• Excessive skin sensitivity
• Impaired sense of smell
• Renal tubular acidosis
• Odour
• Swelling in the tissues around the eye
• Raynaud's syndrome. A disorder affecting the blood vessels, in the fingers, toes, ears and causing pain and cold sensitivity
• Tissue calcification (calcinosis).
• Blood bicarbonate decreased
Not Known (frequency cannot be estimated from the available data)
• Maculopathy is a disease of the macula, the small spot in the retina where vision is keenest. You should call your doctor if you notice a change or decrease in your vision.
• Swelling of the conjunctiva of the eye.
• Cough
Children and adolescents
The side effects in children are generally similar to those seen in adults. However, some side effects are either seen more frequently in children and/or can be more severe in children than in adults. Side effects which may be more severe include decreased or loss of sweating and increase of the acid level in the blood. Side effects which may occur more frequently in children include upper respiratory tract illnesses.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine
5. How to store Topiramate
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not use this medicine if you notice discolouration of the tablets.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Topiramate contains
The active substance is topiramate. Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg topiramate per tablet.
The other ingredients are:
Tablet core: microcrystalline cellulose, povidone K29-32, silica colloidal anhydrous, sodium starch glycolate (type A), magnesium stearate.
Film-coat: titanium dioxide (E171), hypromellose (E464), macrogol 400, polysorbate 80 (E433) (25 mg only), iron oxide yellow (E172) (50 mg, 100 mg only), allura red aluminium lake (E129), sunset yellow aluminium lake (E110) and indigo carmine aluminium lake (E132) (200 mg only).
What Topiramate looks like and contents of the pack
Your medicine comes in the form of a film-coated tablet that should look like the following:
25 mg: White, round, biconvex, film-coated tablet marked with “G" on one side and “TO" over “25" on the other.
50 mg: Yellow, round, biconvex, film-coated tablet marked with “G" on one side and “TO" over “50" on the other.
100 mg: Yellow, round, biconvex, film-coated tablet marked with “G" on one side and “TO" over “100" on the other.
200 mg: Red, round, biconvex, film-coated tablet marked with “G" on one side and “TO" over “200" on the other.
The medicinal product is available in aluminium foil blisters in pack sizes of 10, 15, 20, 28, 30, 50, 60, 90, 100, 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers:
Generics [UK] Ltd, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
This leaflet was last revised in
August 2014
484362