Topiramate 25-200mg Insert Open Size: 180 x 420 mm (Fldg. Size: 180 x 35 mm) (Paper: 40 gsm Bible Paper) Date: 02.05.2014 (Front) V2

(Remarks: var to add 200’s blister pack GPEL a/ws)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Topiramate Glenmark 25mg film-coated tablets Topiramate Glenmark 50mg film-coated tablets Topiramate Glenmark 100mg film-coated tablets Topiramate Glenmark 200mg film-coated 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. See section 4.

What is in this leaflet:

1.    What Topiramate tablets are and what they are used for

2.    What you need to know before you take Topiramate tablets

3.    How to take Topiramate tablets

4.    Possible side effects

5.    How to store Topiramate tablets

6.    Contents of the pack and other information

1. WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY ARE 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 aged 2 years and above

•    to prevent migraine headaches in adults

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE TABLETS

Do not take Topiramate tablets

•    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 breastfeeding’ for further information).

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine 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 this medicine.

It is important that you do not stop taking your medicine without first consulting your doctor.

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-epileptics such as topiramate have had thoughts of harming or killing themselves. If at any time you have thoughts like this, immediately contact your doctor.

Topiramate might decrease perspiration, especially in children, causing body temperature to rise during exercise and exposure to warm environments. Therefore, it is important to drink plenty of water during the treatment with topiramate, especially if you are taking exercise or the weather is hot to reduce the risk of heat-related adverse events, like headache and nausea.

Other medicines and Topiramate tablets

Tell your doctor or your pharmacist if you are taking, have recently taken or might take 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, 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 this medicine.

Topiramate tablets with food and drink

You can take the tablets with or without food. Drink plenty of

fluids during the day to prevent kidney stones while taking

topiramate.You should avoid drinking 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 anti-epilepsy 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.

Topiramate tablets contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Topiramate tablets 50mg film-coated tablets contain sunset yellow which may cause allergic reactions.

The bottles of Topiramate tablets contain a canister of silica gel desiccant. The desiccant canister must not be swallowed.

3. HOW TO TAKE TOPIRAMATE TABLETS

Always take Topiramate tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

•    Take Topiramate tablets 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 tablets can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking these tablets.

If you take more Topiramate tablets than you should

•    See a doctor right away. Take the medicine pack with you.

•    You may feel sleepy, tired or 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, have abdominal pain or seizures (fits).

Overdose can happen if you are taking other medicines together with Topiramate tablets If you forget to take Topiramate tablets

•    If you forget to take a dose, take it as soon as you remember. 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 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 ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Topiramate tablets 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, changes in mood, confusion, disorientation

•    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

Uncommon (may affect up to 1 in 100 people)

•    Increased acid level in the blood (may cause troubled breathing including shortness of breath, loss of apetite, 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 1,000 people)

•    Glaucoma - blockage of fluid in eye causing increased pressure in the eye, pain or decreased vision

Other side effects include the following, if they get serious, please tell your doctor or pharmacist:

Very common (may affect more than 1 in 10 people)

•    Stuffy, runny nose or sore throat

•    Tingling, pain and/or numbness of various body parts

•    Sleepiness, tiredness

•    Dizziness

•    Nausea, diarrhoea

•    Weight loss

Common (may affect up to 1 in 10 people)

•    Anaemia (low blood count)

•    Allergic reaction (such as skin rash, redness, itching, facial swelling, hives)

•    Loss of appetite, decreased appetite

•    Aggression, agitation, anger

•    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

•    Decreased, loss of, or no sense of taste

•    Involuntary trembling or shaking; rapid, uncontrollable movements of the eyes

•    Visual disturbance, such as double vision, blurred vision, decreased vision, difficulty focusing

•    Sensation of spinning (vertigo), ringing in the ears, ear pain

•    Shortness of breath

•    Nose bleeds

•    Fever, not feeling well, weakness

•    Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection

•    Dry mouth

•    Hair loss

•    Itching

•    Joint pain or swelling, muscle spasms or twitching, muscle aches or weakness, chest pain

•    Weight gain

Uncommon (may affect up to 1 in 100 people)

•    Decrease in platelets (blood cells that help stop bleeding), decrease in white blood cells that help to protect you against infection, decrease in potassium level in the blood

•    Increase in liver enzymes, increase in 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)

•    Showing and/or feeling no emotion, unusual suspiciousness, panic attack

•    Problems with reading, speech disorder, problems with handwriting

•    Restlessness, hyperactivity

•    Slowed thinking, decreased wakefulness or alertness

•    Reduced or slow body movements, involuntary abnormal or repetitive muscle movements

•    Fainting

•    Abnormal sense of touch; impaired sense of touch

•    Impaired, distorted, or no sense of smell

•    Unusual feeling or sensation that may precede a migraine or a certain type of seizure

•    Dry eye, sensitivity of the eyes to light, eyelid twitching, watery eyes

•    Decreased or loss of hearing, loss of hearing in one ear

•    Slow or irregular heartbeat, feeling your heart beating in your chest

•    Low blood pressure, low blood pressure upon standing (consequently, some people taking Topamax may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)

•    Flushing, feeling warm

•    Pancreatitis (inflammation of the pancreas)

•    Excessive passing of gas or wind, heartburn, abdominal fullness or bloating

•    Bleeding gums, increased saliva, drooling, breath odour

•    Excessive intake of fluids, thirst

•    Skin discolouration

•    Muscle stiffness, pain in side

•    Blood in urine, incontinence (lack of control) of urine, urgent desire to urinate, flank or kidney pain

•    Difficulty getting or keeping an erection, sexual dysfunction

•    Flu-like symptoms

•    Cold fingers and toes

•    Feeling drunk

•    Learning disability

Rare :(may affect up to 1 in 1,000 people)

•    Abnormally elevated mood

•    Loss of consciousness

•    Blindness in one eye, temporary blindness, night blindness

•    Lazy eye

•    Swelling in and around the eyes

•    Numbness, tingling and colour change (white, blue then red) in fingers and toes when exposed to the cold

•    Inflammation of the liver, liver failure

•    Stevens Johnson syndrome, a potentially life-threatening condition that may present with sores in multiple mucosal sites (such as the mouth, nose, and eyes), a skin rash, and blistering

•    Abnormal skin odour

•    Discomfort in your arms or legs

•    Kidney disorder

•    Increased acid level in the blood

•    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.

•    Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson syndrome, characterized by widespread blistering and sloughing of the outer layers of the skin (see rare side effects)

•    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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 TABLETS

Keep this medicine out of the sight and reach of children.

Do not use Topiramate tablets after the expiry date which is stated on the blister/bottle and the outer carton. The expiry date refers to the last day of that month.

Plastic bottles

•    Do not store above 25°C.

•    Keep the container tightly closed in order to protect from moisture.

Blisters