Topiramate Lupin 100 Mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER Topiramate Lupin 25, 50, 100 and 200 mg Tablets
Topiramate
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 side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Topiramate Lupin Tablets are and what they are used for
2. What you need to know before you take Topiramate Lupin Tablets
3. How to take Topiramate Lupin Tablets
4. Possible side effects
5. How to store Topiramate Lupin Tablets
6. Contents of the pack and other information
1. WHAT TOPIRAMATE LUPIN TABLETS ARE AND WHAT THEY ARE USED FOR:
Topiramate Lupin Tablets belong to a group of medicines called “antiepileptic medicines.” They are 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 LUPIN TABLETS
Do not take Topiramate Lupin Tablets
• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topiramate Lupin Tablets (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 breastfeeding’ forfurther information).
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Lupin Tablets.
Warnings and precautions
Check with your doctor or pharmacist before taking Topiramate Lupin Tablets 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)
If you are not sure if any of the above apply to you, talkto your doctor or pharmacist before using Topiramate Lupin Tablets.
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 Lupin Tablets.
You may lose weight if you use Topiramate Lupin Tablets 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 Lupin Tablets have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Other medicines and Topiramate Lupin Tablets
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 Lupin Tablets and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topiramate Lupin Tablets 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 Lupin Tablets 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 Lupin Tablets.
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 apply to you, talkto your doctor or pharmacist before using Topiramate Lupin Tablets.
Taking Topiramate Lupin Tablets with food and drink
You can take Topiramate Lupin Tablets with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate Lupin Tablets. You should avoid drinking alcohol when taking Topiramate Lupin Tablets.
Pregnancy and breast-feeding
Talkto your doctor before using Topiramate Lupin Tablets if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you can take Topiramate Lupin Tablets. As with other antiepilepsy medicines, there is a risk of harm to the unborn child if Topiramate Lupin Tablets are used during pregnancy. Make sure you are very clear about the risks and the benefits of using Topiramate Lupin Tablets for epilepsy during pregnancy.
You should not take Topiramate Lupin Tablets 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 Lupin Tablets must tell the doctor as soon as possible if the baby experiences anything unusual.
Askyour doctor or pharmacist for advice before taking any medicine. Driving and using machines
Topiramate has minor or moderate influence on the ability to drive and use machines. Dizziness, tiredness, and vision problems may occur during treatment with Topiramate Lupin Tablets. Do not drive or use any tools or machines without talking to your doctor first. Topiramate Lupin Tablets contains lactose Topiramate Lupin Tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE TOPIRAMATE LUPIN TABLETS
Always take Topiramate Lupin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Take Topiramate Lupin Tablets exactly as prescribed. Your doctor will usually start you on a low dose of Topiramate Lupin Tablets and slowly increase your dose until the best dose is found for you.
• Topiramate Lupin Tablets are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• Topiramate Lupin Tablets can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate Lupin Tablets.
If you take more Topiramate Lupin Tablets 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 Lupin Tablets. 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 Lupin Tablets
• 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 Lupin Tablets
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 product, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Topiramate Lupin Tablets can cause side effects, although not everybody gets them.
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).
Very common side effects include:
• Weight loss
• Tingling in the arms and legs
• Drowsiness or sleepiness
• Dizziness
• Diarrhoea
• Nausea
• Stuffy, runny nose and sore throat
• Tiredness
• Depression
Common side effects include:
• 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
• 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 include:
• 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 include:
• Liver failure
• Hepatitis
• 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
• 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).
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).
• Cough
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.
5. HOW TO STORE TOPIRAMATE LUPIN TABLETS
Keep out of the reach and sight of children.
Do not use Topiramate Lupin Tablets after the expiry date which is on the label. The expiry date refers to the last day of that month.
Store below 25°C.
HDPE tablet containers: Keep container tightly closed.
Blisters: Store in the original package.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Topiramate Lupin Tablets contain
The active substance is topiramate.
• Each Topiramate Lupin Tablet contains 25, 50, 100, 200 mg of topiramate.
The other ingredients are listed below:
Lactose monohydrate, microcrystalline cellulose (E460) (Avicel PH 101), pregelatinised starch, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, Opadry White, Yellow, Pink, (depending on the colour, contains Hypromellose (E 464), Titanium dioxide (E
171) , Macrogol, Iron Oxide (E172) and polysorbate 80 (E 433) and Opacode Black.
OPACODE contains, Shellac Glaze in ethanol, Iron Oxide Black (E
172) , Isopropyl Alcohol, N-butyl alcohol, Propylene glycol (E 1520) and Ammonium hydroxide (E 527).
What Topiramate Lupin Tablets look like and contents of the pack
Topiramate Lupin 25 mg Tablets: White to off white, circular, biconvex film coated tablets, imprinted “25” (in black ink) on one side and plain on the other side.
Topiramate Lupin 50 mg Tablets: Light yellow, circular, biconvex film coated tablets, imprinted “50” (in black ink) on one side and plain on the other side.
Topiramate Lupin 100 mg Tablets: Dark yellow, circular, biconvex film coated tablets, imprinted “100” (in black ink) on one side and plain on the other side.
Topiramate Lupin 200 mg Tablets: Reddish pink, oval shaped, biconvex film coated tablets, imprinted “200” on one side and plain on other side.
Topiramate Lupin Tablets are packed in:
• Blisters
Pack Sizes: 10,14, 20, 28, 30, 50, 56, 60, 84, 90, 98,100,120, 200 tablets
• Bottle with child-resistant closure Pack Sizes: 60 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited Victoria Court Bexton Road Knutsford
Cheshire WA16 0PF United Kingdom.
This leaflet was last revised in January 2014
CODE NO. GO/DRUGS/654
ID#: 231917