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, pharmacist or nurse.

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section

4.

What is in this leaflet:

1.    What Topiramate Morningside is and what it is used for

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

3.    How to take Topiramate Morningside

4.    Possible side effects

5.    How to store Topiramate Morningside

6.    Contents of the pack and other information

1. WHAT TOPIRAMATE MORNINGSIDE IS AND WHAT IT IS USED FOR

Topiramate Morningside 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 MORNINGSIDE

Do not take Topiramate Morningside

•    if you are allergic (hypersensitive) 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, breast-feeding and fertility' for further information).

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Topiramate Morningside

Check with your doctor or pharmacist before taking Topiramate Morningside 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, breast-feeding and fertility” for further information)

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

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 Morningside.

You may lose weight if you use Topiramate Morningside 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 Morningside have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Other medicines and Topiramate Morningside

Tell your doctor or 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 Morningside and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topiramate Morningside 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 Morningside 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 Morningside.

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 apply to you, talk to your doctor or pharmacist before using Topiramate Morningside.

Topiramate Morningside with food and drink

You can take Topiramate Morningside with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate Morningside. You should avoid drinking alcohol when taking Topiramate Morningside.

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 this medicine. As with other antiepilepsy medicines there is a risk of harm to the unborn child, if Topiramate Morningside is used during pregnancy. Make sure that you are very clear about the risks and benefits of using Topiramate Morningside for epilepsy during pregnancy.

You should not take Topiramate Morningside 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 Morningside 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

Topiramate Morningside has minor or moderate influence on the ability to drive and use machines. Dizziness, tiredness, and vision problems may occur during treatment with Topiramate Morningside. Do not drive or use any tools or machines without talking to your doctor first.

Topiramate Morningside 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.

3. HOW TO TAKE TOPIRAMATE MORNINGSIDE

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

•    Take Topiramate Morningside exactly as prescribed. Your doctor will usually start you on a low dose of Topiramate Morningside and slowly increase your dose until the best dose is found for you.

•    Topiramate Morningside tablets are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.

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

If you take more Topiramate Morningside 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; or have abdominal pain, or seizures (fits).

Overdose can happen if you are taking other medicines together with Topiramate Morningside.

If you forget to take Topiramate Morningside

•    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 Morningside

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, pharmacist or nurse.

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, 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 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 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 topiramate 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.

•    Cough

•    Toxic epidermal necrosis, a life-threatening condition related to, yet more severe than, Stevens-Johnson syndrome, characterized by widespread blistering and sloughing of the outer layers of the skin (see rare side effects)

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE TOPIRAMATE MORNINGSIDE

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 after “EXP”. The expiry date refers to the last day of that month.

This medical product does not require any special precautions for storage.

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 Morningside contains

Topiramate Morningside 25 mg Film-coated tablets

•    The active substance(s) is topiramate. Each film-coated tablet contains 25 mg topiramate.

•    The other ingredients are (tablet nucleus): lactose monohydrate, pregelatinized maize starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate and (tablet coating) basic butylated methacrylate copolymer, sodium laurilsulfate, magnesium stearate, stearic acid, talc and titanium dioxide (E171).

Topiramate Morningside 50 mg Film-coated tablets

•    The active substance(s) is topiramate. Each film-coated tablet contains 50 mg topiramate.

•    The other ingredients are (tablet nucleus): lactose monohydrate, pregelatinized maize starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate and (tablet coating) basic butylated methacrylate copolymer, sodium laurilsulfate, magnesium stearate, stearic acid, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Topiramate Morningside 100 mg Film-coated tablets

•    The active substance(s) is topiramate. Each film-coated tablet contains 100 mg topiramate.

•    The other ingredients are (tablet nucleus): lactose monohydrate, pregelatinized maize starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate and (tablet coating) basic butylated methacrylate copolymer, sodium laurilsulfate, magnesium stearate, stearic acid, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Topiramate Morningside 200 mg Film-coated tablets

•    The active substance(s) is topiramate. Each film-coated tablet contains 200 mg topiramate.

•    The other ingredients are (tablet nucleus): lactose monohydrate, pregelatinized maize starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate and (tablet coating) basic butylated methacrylate copolymer, sodium laurilsulfate, magnesium stearate, stearic acid, talc, titanium dioxide (E171) and iron oxide (E172).

What Topiramate Morningside looks like and contents of the pack

Topiramate Morningside is available as film coated tablets.

Topiramate Morningside 25 mg Film-coated tablets Topiramate Morningside 25 mg Film-coated tablets are white, round and convex

Topiramate Morningside 50 mg Film-coated tablets Topiramate Morningside 50 mg Film-coated tablets are yellow, round and convex.

Topiramate Morningside 100 mg Film-coated tablets

Topiramate Morningside 100 mg Film-coated tablets are yellow, round and convex.

Topiramate Morningside 200 mg Film-coated tablets

Topiramate Morningside 200 mg Film-coated tablets are yellow, round and convex.

Topiramate Morningside is available in packages with 10 and 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Ltd 115 Narborough Road Leicester.

LE3 0PA UK

Manufacturers

West Pharma Produgoes de Especialidades Farmaceuticas, S.A.

Rua Joao de Deus, n°11, Venda Nova, 2700-486 Amadora

Rafarm SA

Thesi Pousi-Xatzi Agiou Louka,

Paiania Attiki, 19002,

Greece

This medicinal product is authorised in the Member States of the EEA under the following names:

Italy: Topiramato Tecnigen 25, 50, 100, 200 mg Compresse rivestite con film Greece: JADIX® 25, 50, 100, 200 mg ETTiKaAuppeva pe Aettto up£vio SioKia Portugal: Topiramato Clindonim United Kingdom: Topiramate Morningside 25, 50, 100, 200 mg Film-coated tablets

This leaflet was last revised in May 2014