Topiramate Accord 50 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Topiramate Accord 25 mg film-coated tablets
Topiramate Accord 50 mg film-coated tablets Topiramate Accord 100 mg film-coated tablets Topiramate Accord 200 mg film-coated tablets
Topiramate
Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Topiramate is and what it is used for
2. Before you take Topiramate
3. How to take Topiramate
4. Possible side effects
5. How to store Topiramate
6. Further information
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1. What Topiramate is and what it is used for
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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. Before you take Topiramate
Do NOT take Topiramate
• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topiramate (see section 6, Further information).
• to prevent a migraine headache if you are pregnant, think you may be pregnant or are of child-bearing age and not using an effective method of contraception.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using topiramate.
Take special care with Topiramate
Check with 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 to 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 anti-epileptic medicines such as topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, vitamins and herbal 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
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using topiramate.
Taking Topiramate with food and drink
You can take topiramate with or without food.
It is recommended not to drink alcohol whilst you are taking topiramate as this can increase the risk of side effects.
It is important to drink plenty of water whilst you are taking topiramate especially if you are taking exercise or the weather is hot.
Pregnancy and breast-feeding Talk to your doctor before using topiramate if you are pregnant, trying to become pregnant or breast-feeding. 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 breastfeed 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
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Warning! Each tablet bottle contains a desiccant capsule. This a small canister on which “Do not eat” is written. Do not eat this.
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3. How to take Topiramate
Always take Topiramate exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
• Take topiramate exactly as prescribed. 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 or tired, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heart beats or fits.
Overdose can happen if you are taking other medicines together with topiramate.
Signs and symptoms of over dosage may include convulsions, drowsiness, speech disturbances, double vision, impaired thinking, abnormal coordination, dulling of consciousness, low blood pressure, abdominal pain, agitation, dizziness and depression.
If you forget to take Topiramate
Take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose but simply take your next dose at the normal time. If you miss two or more doses, contact your doctor.
Do not take a double dose to make up for the one you missed.
If you stop taking Topiramate
You may have more fits or sudden worsening of the headaches. It is important that you keep taking your tablets until your doctor tells you to stop. If the doctor decides to stop your treatment with topiramate they will usually do so gradually over a period of a few weeks. It is important that you follow what the doctor tells you to do.
If you have any further questions on the use of this product, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, Topiramate can cause side effects, although not everybody gets them.
If you notice a rash, itching, blistering or other effects on the skin, eyes, mouth or genitals or you get a high temperature, you should stop taking the tablets and contact your doctor immediately.
Patients taking topiramate can have thoughts of harming themselves or taking their own lives. If you get these thoughts at any time, contact your doctor or go to a hospital immediately.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
The following side effects have been reported: Very common side effects (probably affecting more than 1 in 10 people):
• weight loss
• tingling in the arms and legs
• drowsiness or sleepiness
• dizziness
• diarrhoea
• nausea (feeling sick)
• stuffy, runny nose and sore throat
• tiredness
• depression
Common side effects (probably affecting fewer than 1 in 10 people):
• Changes in mood or behaviour, including anger, nervousness, sadness
• Weight gain
• Decrease or loss of appetite
• Reduced number of red blood cells
• Changes in thinking and alertness, including confusion, problems with concentration, memory or slowness in thinking
• Slurred speech
• Clumsiness, or problems with walking
• Involuntary shaking in the arms, hands or legs
• Reduced sense of touch or sensation
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• Involuntary movement of the eyes
• Distorted sense of taste
• Visual disturbance, blurred vision, double vision
• Ringing sound in the ears
• Ear pain
• Shortness of breath
• Nose bleeds
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Dry mouth
• Tingling or numbness of the mouth
• Kidney stones
• Frequent urination
• Painful urination
• Hair loss
• Skin rash and/or itchy skin.
• Joint pain
• Muscle spasms, muscle twitching or muscle weakness
• Chest pain
• Fever
• Loss of strength
• General feeling of feeling unwell
• Allergic reaction
Uncommon side effects (probably affecting fewer than 1 in 100 people):
• Crystals in the urine
• Abnormal blood counts, including reduced white blood cell count or platelet count, or increased eosinophils
• Irregular heartbeat or slowness of the heart beat
• Swollen glands in the neck armpit or groin
• Increase in seizures
• Problems with verbal communication
• Drooling
• Restlessness or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slow or diminished movements
• Disturbed or poor quality sleep
• Impaired or distorted sense of smell
• Problems with handwriting
• 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 in the mouth
• Bleeding gums
• Fullness or bloating
• Painful or burning sensations in the mouth
• Breath odour
• Leakage of urine and/or stools
• Urgent desire to urinate
• Pain in the kidney area and/or bladder caused by kidney stones
• Decrease or loss of sweating
• Skin discolouration
• Localized swelling in the skin
• Swelling of the face.
• Swelling of the joints.
• Musculoskeletal stiffness
• Increased acid levels in the blood
• 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)
• Problems with learning
• Disturbances in sexual function (erectile dysfunction, loss of libido)
• Hallucinations
• Decreased verbal communication
• Increase in liver enzymes
Rare side effects (probably affecting fewer than 1 in 1,000 people):
• Excessive skin sensitivity
• Impaired sense of smell
• Glaucoma which is a blockage of fluid in the eye causing increased pressure in the eye, pain and decreased vision
• Renal tubular acidosis
• Inflammation of the liver, Liver failure
• Severe skin reaction, including Stevens-Johnson syndrome, a life threatening skin condition in which the upper layer of the skin separates from the lower, and erythma multiforme, a condition of raised red spots that can blister
• 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).
5. How to store Topiramate tablets
Keep out of the reach and sight of children.
Do not use Topiramate tablets after the expiry date, which is stated on the carton and bottle or blister after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the container tightly closed in order to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Topiramate tablets contains
The active substance is topiramate.
Topiramate Accord 25mg Film-coated tablet: Each film coated tablet contains 25 mg topiramate. Topiramate Accord 50mg Film-coated tablet: Each film coated tablet contains 50 mg topiramate. Topiramate Accord 100mg Film-coated tablet: Each film coated tablet contains 100 mg topiramate. Topiramate Accord 200mg Film-coated tablet: Each film coated tablet contains 200 mg topiramate.
The other ingredients are lactose monohydrate (see section 2: important information about some of the ingredients of Topiramate tablets), Cellulose microcrystalline, Starch, Pregelatinised (i.e. potato starch), croscarmellose sodium, magnesium stearate.
• The 25 mg tablets are coated with hypromellose, titanium dioxide (E171) and macrogol 6000.
• The 50 mg and 100 mg tablets are coated with hypromellose, titanium dioxide (E171), macrogol 6000 and iron oxide yellow (E172)
• The 200 mg tablets are coated with hypromellose, titanium dioxide (E171), macrogol 6000 and iron oxide red (E172).
What Topiramate tablets looks like and content of the pack
Film-coated tablet.
The 25 mg film-coated tablets are white round and biconvex, with bevelled edges and embossed TP on one side and 25 on the other.
The 50 mg film-coated tablets are light yellow round and biconvex with bevelled edges and embossed TP on one side and 50 on the other.
The 100 mg film-coated tablets are dark yellow round and biconvex, with bevelled edges and embossed TP on one side and 100 on the other.
The 200 mg film-coated tablets are red, round and biconvex, with bevelled edges and embossed TP on one side and 200 on the other.
Topiramate film-coated tablets are available in aluminium/aluminium blisters in packs sizes of 10, 14, 20, 28, 30, 50, 56, 60, 100, 120 and 200 film-coated tablets or in high density polyethylene (HDPE) bottles fitted with a white opaque polypropylene child resistant closure with wad having induction sealing liner supplied in cardboard cartons in pack sizes of 14,30,60,100 and 200 film-coated tablets. In each container there is a desiccant canister, which should not be swallowed.
Not all pack sizes may be marketed.
Topiramate is available in four strengths containing either 25 mg, 50 mg, 100 mg and 200 mg topiramate.
Marketing authorization holder
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow, Middlesex,
HA1 4HF, United Kingdom
Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow, Middlesex,
HA1 4HF, United Kingdom or
Cemelog BRS Limited,
2040 Budaors, Vasut u. 13., Hungary.
This leaflet was last approved in 01/2014
Side effects of unknown frequency
• 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.
• Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson syndrome (see uncommon side effects).
Paediatric population (ADRs reported more frequently (>2-fold) in children than in adults):
• Decreased appetite
• Increased appetite
• Hyperchloraemic acidosis
• Hypokalaemia
• Abnormal behaviour
• Aggression
• Apathy
• Initial insomnia
• Suicidal ideation
• Disturbance in attention
• Lethargy
• Circadian rhythm sleep disorder
• Poor quality sleep
• Lacrimation increased
• Sinus bradycardia
• Feeling abnormal
• Gait disturbance
ADRs that were reported in children but not in adults:
• Eosinophilia
• Psychomotor hyperactivity
• Vertigo
• Vomiting
• Hyperthermia
• Pyrexia
• Learning disability
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.