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Topiramate Ranbaxy 25mg Film-Coated Tablets

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Read all of this leaflet carefully before you start taking this medicine because It contains important information foryou.

• Keep this leaflet. You may need to read it again.

• If you have further questions, please ask your doctor or pharmacist.

•This medicine has been prescribed foryou 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.

PACKAGE LEAFLET: INFORMATION FORTHE USER

Topiramate Ranbaxy 25 mg Film-coated Tablets Topiramate Ranbaxy 50 mg Film-coated Tablets Topiramate RanbaxylOO mg Film-coated Tablets Topiramate Ranbaxy 200 mg Film-coated Tablets

Topiramate

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. Howtotake Topiramate

4. Possible side effects

5. HowtostoreTopiramate

6. Contents of the pack and other information

1. WHAT TOPIRAMATE IS AND WHAT IT IS USED FOR

Topiramate belongs to a group of drugs called

“antiepileptic medicines”.

Topiramate 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 aftercareful evaluation of possible alternative treatment options. Topiramate is not intended to treat an individual migraine attack.

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 pregnantoryou 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 doctoror pharmacist before using Topiramate.

Warnings and precautions

Talk to your doctor or pharmacist before taking Topiramate

• 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 (ketogenicdiet)

There have been reports of impairment of cognitive function (problem in thought processes) in adults on topiramate therapy. In this case your doctor may discontinue or decrease the dose of this medicine.

While taking this medicine if you develop:

• deep and labored breathing, difficulty in breathing, loss of appetite, nausea, vomiting, excessive tiredness, changes in the rhythm or rate of the heart beat. These symptoms may be due to metabolic acidosis. Your doctorwould monitoryourserum bicarbonate level.

• decreased sweating and rise in body temperature. These may occur especially in young children exposed to high ambient temperature. Inform your doctor as soon as possible.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Topiramate.

It is important that you do not stop taking your medicine withoutfirst 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 consultyourdoctor.

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 relaxantsand 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, flunarizine.

If you are not sure if any of the above apply to you, talkto your doctor or pharmacist before using Topiramate.

Topiramate tablets with food and drink

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 and breast-feeding

Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advise 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 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 yourdoctorfirst.

Topiramate contains lactose monohydrate

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

3. HOWTO TAKE TOPIRAMATE

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist ifyou 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 foryou.

• 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.

Ifyou take more Topiramate than you should

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

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. Overdose can happen ifyou are taking other medicines together with Topiramate.

Ifyou 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.

Ifyou stop taking Topiramate

Do not stop taking this medicine unless told to do by your doctor. Your symptoms may return. Ifyourdoctordecides to stop this medication, your dose may be decreased gradually overafew days.

If you have any further questions on the use of this medicine, askyour doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Weight loss

• Tingling in thearmsand legs

• Drowsiness or sleepiness

• Dizziness

• Diarrhoea

• Nausea

• Stuffy, runny nose and sore throat

• Tiredness

• Depression

Common side effects (may affect up to 1 in 10 people)

• Changes in mood or behaviour, including anger,

nervousness, sadness	• Decreased appetite
• Weight gain	• Increased appetite
• Decrease or loss of appetite	• Hyperchloraemic acidosis (increased acid levels in the
• Reduced numberofred blood cells	blood)
• Changes in thinking and alertness, including confusion,	• Hypokalaemia (low potassium levels in the blood)
problems with concentration, memory or slowness in	•Abnormal behaviour
thinking	•Aggression
• Slurred speech	• Apathy (sadness)
• Clumsiness, or problems with walking	• Initial insomnia (trouble sleeping)
• Involuntary shaking in the arms, handsor legs	• Suicidal ideation
• Reducedsenseoftouchorsensation	• Disturbance in attention
• Involuntary movement of the eyes	• Lethargy (feeling of tiredness)
• Distorted sense of taste	• Circadian rhythm sleep disorder (a group of sleep
• Visual disturbance, blurred vision, double vision	disorderaffecting thetiming of sleeps)
• Ringing sound in the ears	• Poorquality sleep
• Ear pain	• Lacrimation increased (eye problems like increased
• Shortnessofbreath	tearing)
• Nosebleeds	• Sinus bradycardia (slowness of the heart beat)
• Vomiting	• Feeling abnormal
• Constipation	• Gait disturbance (problems with walking)
• Stomach pain
• Indigestion	Side effects that were reported in children but not in
• Dry mouth	adults in double-blind controlled studies include:
• Tinglingornumbnessofthemouth	• Eosinophilia (abnormal blood counts, increased
• Kidney stones	eosinophils)
• Frequent urination	• Psychomotor hyperactivity (restlessness or increased
• Painful urination	mental and physical activity)
• Hair loss	• Vertigo (dizziness)
• Skin rash and/or itchy skin.	• Vomiting (being sick)
• Joint pain	• Hyperthermia (extremely high body temperature)
• Muscle spasms, muscle twitching or muscle weakness	• Pyrexia (feveror high temperature)
• Chest pain	• Learning disability
• Fever	If you get any side effects, talk to your doctor of
• Loss of strength	pharmacist. This includes any possible side effects not
• General feeling of feeling unwell	listed in this leaflet.
• Allergic reaction
• Feeling abnormal	5. HOW TO STORE TOPIRAMATE
Uncommon side effects (may affect up to 1 in 100
people)	Keep this medicine out of the sight and reach of children
• Crystals in the urine	Do not use this medicine after the expiry date which is
• Abnormal blood counts, including reduced white blood	stated on the label. The expiry date refers to the last day
cell count or platelet count, or increased eosinophils,	of that month.
increase in liver enzymes	This medicinal product does not require any special
• Irregular heartbeat orslownessof the heart beat	storage conditions.
• Swollen glands in the neckarmpit or groin	Do not use if the tablets do not have the appearance
• Increase in seizures	described below.
• Problems with verbal communication	Keep the bottle tightly sealed.
• Drooling	Do not throw away any medicines via wastewater or
• Restlessness or increased mental and physical activity	household waste. Ask your pharmacist how to throw
• Loss of consciousness	away medicines you no longer use. These measures will
• Fainting	help to protect the environment.
• Slow or diminished movements
• Disturbed or poorquality sleep	6. CONTENTS OF THE PACK AND OTHER
• Impaired or distorted sense of smell	INFORMATION
• Problemswith handwriting
• Feeling of movement underthe skin	WhatTopiramate Film-coated Tablets contains:
• Eye problems including dry eyes, light sensitivity,	The active substance is topiramate
involuntary twitching, tearing and decreased vision	Each film-coated tablet contains 25 mg topiramate
• Decreased or loss of hearing.	Each film-coated tablet contains 50 mg topiramate
• Hoarseness of the voice	Each film-coated tablet contains 100 mg topiramate
• Inflammation of the pancreas	Each film-coated tablet contains 200 mg topiramate
• Gas
• Heartburn	The other ingredients are:
• Loss of sensitivity to touch in the mouth	Tablet core
• Bleeding gums	Lactose monohydrate, starch pregelatinised,
• Fullness or bloating	microcrystalline cellulose, sodium starch glycolate (Type
• Painful or burning sensations in the mouth	A), magnesium Stearate.
• Breath odour
• Leakageofurineand/orstools	Tablet coating
• Urgent desire to urinate	Hypromellose, titanium dioxide (E171), macrogol 400,
• Pain in the kidney area and/or bladder caused by	polysorbate 80 and iron oxide yellow (E172) (50 mg, 100
kidney stones	mg), iron oxide red E172 (200 mg)
• Decrease or loss of sweating
• Skin discolouration	What Topiramate film-coated tablets looks like and
• Localized swelling in the skin	contents of the pack
• Swelling of theface.	Topiramate Ranbaxy 25 mg Film-coated Tablet Is
• Swelling of thejoints.	White, film-coated, circular tablets debossed with 'TPT
• Musculoskeletal stiffness	on one side and plain on the other side.
• Increased acid levels in the blood	Topiramate Ranbaxy 50 mg Film-coated Tablet Is
• Low potassium levels in the blood	Yellow-coloured, film-coated, circular
• Increased appetite	tablets debossed with 'TP2' on one side and plain on the
• Increased thirst and drinking abnormally large amounts	otherside.
of fluid	Topiramate Ranbaxy 100 mg Film-coated Tablet Is
• Low blood pressure or decrease in blood pressure that	Yellow-coloured, film-coated,
occurs when you stand up	circular tablets debossed with 'TP3' on one side and plain
• Hotflushing	onthe other side.
• Flu like illness	Topiramate Ranbaxy 200 mg Film-coated Tablet Is
• Cold extremities (e.g. hands and face)	Peach-coloured, film-coated,
• Problemswith learning	circular tablets debossed with 'TP4' on one side and plain
• Disturbances in sexual function (erectile dysfunction,	onthe other side.
loss of libido)	Topiramate is available in HDPE bottle pack containing
• Hallucinations	20,28,30,50,60,100,120,200 tablets
• Decreased verbal communication
• Suicidal thoughts	Not all pack sizes may be marketed.
Rare side effects (may affect up to 1 in 1,000 people)	Marketing Authorisation Holderand Manufacturer
• Excessive skin sensitivity
• Impaired sense of smell	MarketinaAuthorisation Holder
• Glaucoma which is a blockage of fluid in the eye	Ranbaxy (UK) Limited
causing increased pressure in the eye, pain and	Building 4, Chiswick Park
decreased vision	566 ChiswickHighRoad
• Renal tubularacidosis	London, W45YE
• Severe skin reaction, including Stevens-Johnson	United Kingdom
syndrome, a life threatening skin condition in which the
upper layer of the skin separates from the lower, and	Manufacturer
erythema multiforme, a condition of raised red spots	Ranbaxy Ireland Limited
that can blister	Spafield, Cork Road
• Odour	Cashel, Co.Tipperary,
• Swelling in the tissues around the eye	Ireland
• Raynaud's syndrome. A disorder affecting the blood
vessels, in the fingers, toes, ears and causing pain and	This leaflet was last revised in January 2014.
cold sensitivity
• Inflammation of the liver, liverfailure
• Tissue calcification (calcinosis).
Unknown frequency (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 ifyou 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
Children and adolescents	CO LO
Side effects reported more frequently (>2-fold) in	h- CO
children than in adults in double-blind controlled studies	LO
include: