•    Increased saliva

•    Skin discolouration, localised swelling in the skin

•    Swelling of the joints, musculoskeletal stiffness, pain in side

•    Crystals in the urine, blood in urine, leakage of urine and/or stools, urgent desire to urinate, pain in the kidney area and/or bladder caused by kidney stones

•    Disturbances in sexual function (erectile dysfunction, loss of libido)

•    Increase in body temperature, flu like illness

•    Cold extremities (e.g. hands and face)

•    Feeling drunk

•    Increase in liver enzymes

•    Problems with learning

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

•    Abnormally elevated mood

•    Excessive skin sensitivity

•    Night blindness, swelling in the tissues around the eye, lazy eye

•    Raynaud's syndrome. A disorder affecting the blood vessels, in the fingers, toes, ears and causing pain and cold sensitivity

•    Inflammation of the liver, liver failure

•    Skin odour

•    Discomfort in your arms or legs

•    Renal tubular acidosis

•    Tissue calcification (calcinosis)

Not known: (frequency cannot be estimated from the available data)

•    Swelling of the conjunctiva of the eye

•    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

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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov. uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

AAAH3845 50818118

| 5 HOWTO STORETOPIRAMATECAPSULES    |

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

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

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP: The expiry date refers to the last day of that month.

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 OFTHE PACKAND OTHER INFORMATION_

What Topiramate Capsules contain

The active substance is topiramate (each capsule contains 50mg of topiramate).

The other ingredients of Topiramate Capsules are sugar spheres (which contain sucrose, maize starch), povidone, aniseed flavour, saccharin sodium (E 954), magnesium stearate, gelatin, titanium dioxide (E-171) and Opadry-II-85F18378 White (which contains polyvinyl alcohol-part hydrolysed, macrogol, talc and titanium dioxide).

The black printing ink contains shellac, ethanol, isopropanol, butanol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide (E-172).

What Topiramate Capsules look like and contents of the pack:

Your medicine is in the form of hard gelatin capsules

The 50mg capsules are white with '50' printed in black on the body and '>' over 'Ti' on the cap.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Actavis Group PTC ehf., Reykjavfkurvegi 76-78, 220 Hafnarfjordur , Iceland

Manufacturer:

Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK

This leaflet was revised in August 2015

1. WHATTOPIRAMATE CAPSULES ARE AND WHAT THEYAREUSEDFOR_

Topiramate Capsules 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 CAPSULES_

Do not take Topiramate Capsules:

•    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 and breastfeeding' for further information).

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

Warnings and Precautions

Talk to your doctor or pharmacist before taking Topiramate Capsules 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, talk to your doctor or pharmacist before taking Topiramate Capsules.

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 Capsules.

You may lose weight if you use Topiramate Capsules so your weight should be checked regularly when using Topiramate Capsules. If you are losing too much weight or a child using Topiramate Capsules is not gaining enough weight, you should consult your doctor.

A small number of people being treated with antiepileptic medicines such as Topiramate Capsules have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Other medicines and Topiramate Capsules

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 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 Capsules 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 Capsules.

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 and flunarazine, St John's wort (Hypericum perforatum) (a herbal preparation used to treat depression).

Ifyou are not sure if any ofthe above applyto you, talk to your doctor or pharmacist before using Topiramate Capsules.

Topiramate Capsules with food, drink and alcohol

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

Pregnancy and breast-feeding

Ifyou are pregnant or breast feeding, thinkyou may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Aswith other antiepilepsy medicines, there is a risk of harm to the unborn child if Topiramate Capsules are used during pregnancy. Make sure you are very clear about the risks and the benefits of using topiramate for epilepsy during pregnancy.

You should nottake Topiramate Capsules for migraine prevention ifyou 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.

Driving and using machines

Dizziness, tiredness, and vision problems may occur during treatment with topiramate. Do not drive or use any tools or machines withouttalking to your doctor first.

Topiramate Capsules contain sucrose

This medicinal product contains sucrose. Ifyou have been told by your doctorthatyou have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOWTO TAKE TOPIRAMATE CAPSULES

Always take this medicine exactly asyour doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.

•    Take Topiramate Capsules exactly as prescribed. Your doctorwill usually start you on a low dose oftopiramate and slowly increase your dose until the best dose is found for you.

•    Topiramate Capsules may be swallowed whole or may be opened and sprinkled on a teaspoon of soft food

of any type. Examples are apple sauce, custard, ice cream, porridge, pudding or yogurt. Drink fluids right

after to make sure all ofthe food and medicine mixture is swallowed.

•    Hold the hard capsule upright so thatthe wording is the correct way up

•    Carefully twist off the top part (cap) ofthe capsule. You may find it bestto do this over the small portion of food onto which you will be pouring the sprinkles.

•    Sprinkle all ofthe capsule's contents onto a spoonful of soft food, taking care to see that the entire prescribed dosage is sprinkled onto the food.

•    Be sure to swallowthe entire spoonful ofthe sprinkle/ food mixture immediately. Avoid chewing.

•    Drink fluids immediately in order to make sure all ofthe mixture is swallowed.

•    Never store any medicine and food mixture for use at a later time.

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

Ifyou lake more Topiramate Capsules than you should

•    See a doctor right away. Take the medicine packwith 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 ifyou are taking other medicines togetherwith Topiramate Capsules.

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.

Ifyou forget to take Topiramate Capsules

Do nottake a double dose (two doses atthe same time) to make up for a forgotten dose.

Ifyou forgetto take a dose, take it as soon as you remember it. However if it's almost time foryour next dose, skip the missed dose and continue as usual. Ifyou miss two or more doses, contact your doctor.

Ifyou stop taking Topiramate Capsules

Do not stop taking Topiramate Capsules 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.

Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.

I i 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 orworse)

Common (may affect up to 1 in 10 people)

•    Seizures (fits)

•    Anxiety, irritability, changes in mood, confusion, disorientation

•    Problemswith concentration, slowness ofthinking, loss of memory, problems with memory (new onset, sudden change or increased severity)

•    Kidney stone, freguent 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

•    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 erythema multiforme, a condition of raised red spots that can blister

Not known (frequency cannot be estimated from the available data)

•    Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson syndrome (see rare side effects)

Other side effects include the following, if they get serious, please tell your doctor or pharmacist Very common side effects include: (may affect more than 1 in 10 people)

•    Stuffy, runny nose and sore throat

•    Tingling in the arms and legs

•    Drowsiness or sleepiness

•    Dizziness

•    Nausea, diarrhoea

•    Tiredness •Weight loss

Common side effects include: (may affect up to 1 in 10

people)

•    Reduced number of red blood cells

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

•    Decrease or loss of appetite

•    Aggression, agitation, anger

•    Difficulty in sleeping

•    Slurred speech

•    Involuntary shaking in the arms, hands or legs

•    Reduced sense of touch or sensation

•    Involuntary movements of the eyes

•    Distorted sense oftaste

•Visual disturbance, blurred vision, double vision

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

•    Shortness of breath

•    Nosebleeds

•Vomiting, constipation, stomach pain, indigestion

•    Dry mouth, tingling or numbness of the mouth

•    Hair loss

•    Skin rash and/or itchy skin

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

•    Fever, loss of strength, irritability, clumsiness, or problems with walking, general feeling of feeling unwell, weight gain

Uncommon side effects include: (may affect up to 1 in

100 people)

•    Abnormal blood counts, including reduced white blood cell count or platelet count, or increased eosinophils

•    Swollen glands in the neck, armpit or groin

•    Low potassium levels in the blood

•    Increased appetite, increased thirst and drinking abnormally large amounts offluid

•    Hallucinations, severe mental disorder (psychosis)

•    Decreased verbal communication, disturbed or poor quality sleep

•    Restlessness or increased mental and physical activity

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

•    Problemswith reading, speech disorder

•    Loss of consciousness

•    Problemswith verbal communication

•    Fainting

•    Abnormal sense of touch

•    Impaired or distorted sense of smell

•    Drooling

•    Excessive sleepiness

•    Slow or diminished movements, involuntary, abnormal or repetitive muscle movements

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

•    Problemswith 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

•    Irregular heartbeat or slowness of the heartbeat, feeling your heart beating in your chest

•    Low blood pressure or decrease in blood pressure that occurs when you stand up

•    Hot flushing

•    Hoarseness of the voice

•    Inflammation of the pancreas

•    Gas, heartburn, fullness or bloating

•    Loss of sensitivity to touch in the mouth, painful or burning sensations in the mouth, bleeding gums, breath odour

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