TPWTI

TEVA UK LIMITED

Ref

231-30-87372-Y LEA TOPIRAMATE TEVA A/S TAB TUK

16 December 2013

Version:    1

Trackwise Parent:

245863

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245864

PL Number(s),    PL 00289/1053-8. TEVA UK Limited Licence, Teva Regulatory Team.

MA Holder & Packer: Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann 1030. Reason for revision:    V1: Text update: Product name change.

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Please refer to the latest version of the full base material specification: 92653, 92655, 92651

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1EUZ

Ref:

231-30-87372-Y LEA TOPIRAMATE A/S TAB TUK

16 December 2013

Version:    1

Trackwise Parent:

245863

Child

245864

PL Number(s),    PL 00289/1053-8. TEVA UK Limited Licence, Teva Regulatory Team.

MA Holder & Packer: Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann 1030. Reason for revision:    V1: Text update: Product name change.

Colours:

(PANTONE® is a registered trademark of Pantone, Inc.)

Please refer to the latest version of the full base material specification: 92653, 92655, 92651

PANTONE® GREEN C

BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

87372-Y 200 x 323

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TOPIRAMATE TEVA 25 mg FILM-COATED TABLETS TOPIRAMATE TEVA 50 mg FILM-COATED TABLETS TOPIRAMATE TEVA 100 mg FILM-COATED TABLETS TOPIRAMATE TEVA 200 mg FILM-COATED TABLETS TOPIRAMATE TEVA 300 mg FILM-COATED TABLETS TOPIRAMATE TEVA 400 mg FILM-COATED TABLETS Topiramate

PACKAGE LEAFLET INFORMATION FOR THE USER

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 is and what it is used for

2.    What you need to know before you take Topiramate

3.    How to take Topiramate

4.    Possible side effects

5.    How to store Topiramate

6.    Contents of the pack and any other information

OWHAT TOPIRAMATE IS AND WHAT IT IS USED FOR

Topiramate belongs to a group of medicines called "anti epileptic 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.

©WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE

Do NOT take Topiramate:

• if you are allergic (hypersensitive) to topiramate, 200 mg: allura red AC lake, or any of the other ingredients of Topiramate (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 breast-feeding' for further information).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Topiramate if you:

• have kidney problems, especially kidney stones or are having 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 using Topiramate.

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.

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.

Topiramate 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

Talk to your doctor before using Topiramate if you are pregnant, trying to become pregnant or breast-feeding. 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 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 breast-feed 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 contains lactose

This medicinal product 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.

200 mg: This medicinal product contains allura red AC lake and may cause allergic reactions.

^ HOW TO TAKE TOPIRAMATE

Always take Topiramate exactly as your doctor has told you. You should check with your doctor or pharmacist if you 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 for you.

•    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.

If you take more Topiramate than you should

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

•    Signs and symptoms of overdosage: you may feel sleepy, tired, depressed or restless, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, have dulling of consciousness, speech disturbances, double vision, impaired thinking, abdominal pain or have abnormal heart beats or fits.

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

If you 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.

If you stop taking Topiramate

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 or pharmacist.

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

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 and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topiramate will have to be adjusted.

4 ) POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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).

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Especially, tell your doctor or pharmacist if you are taking:

•    other medicines that impair or decrease your thinking, concentration or muscle co-ordination (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 anti-epileptic 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, talk to your doctor or pharmacist before using Topiramate.

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    322K114200513

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•    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

•    Wind

•    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

•    Localised 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

•    Increase in liver enzymes 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.

Rare side effects include:

•    Excessive skin sensitivity

•    Impaired sense of smell

•    Renal tubular acidosis

•    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.

•    Inflammation of the liver (hepatitis), liver failure

•    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

•    Cough

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

Side effects reported more frequently (>2 fold) in children than in adults in clinical studies include:

•    decreased appetite

•    increased appetite

•    increased acid levels with increased level of chlorine in the blood (acidosis hyperchloraemic)

•    low potassium levels in the blood (hypokalaemia)

•    abnormal behaviour

•    aggression

•    apathy

•    lying awake before you go asleep (initial insomnia)

•    thoughts about suicide (suicidal ideation)

•    disturbance in attention

•    lethargy

•    problems with normal sleep pattern (circadian rhythm sleep disorder)

•    poor quality sleep

•    increased tears secretion (lacrimation increased)

•    slow heart beat (sinus bradycardia)

•    feeling abnormal

•    gait disturbance.

Additional side effects that were reported in children but not in adults in clinical studies include

•    increased count of eosinophils in the blood (eosinophilia)

•    restlessness accompanied by an increase in motor activity including muscle spasms, tremors and twitching (psychomotor hyperactivity)

•    dizziness

•    vomiting

•    increased body temperature

•    fever

•    problems with learning.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

HOW TO STORE TOPIRAMATE

Keep out of the sight and reach of children.

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

Do not store above 30°C. Store in the original package in order to protect from moisture.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Topiramate Teva contains

The active substance is topiramate.

25 mg: Each film-coated tablet contains 25 mg topiramate.

50 mg: Each film-coated tablet contains 50 mg topiramate.

100 mg: Each film-coated tablet contains 100 mg topiramate.

200 mg: Each film-coated tablet contains 200 mg topiramate.

300 mg: Each film-coated tablet contains 300 mg topiramate.

400 mg: Each film-coated tablet contains 400 mg topiramate.

The other ingredients are lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171),

25, 300 and 400 mg: macrogol 4000, polydextrose and hypromellose.

50 mg: macrogol 3350, polyvinyl alcohol, talc and yellow iron oxide (E172).

100 mg: macrogol 4000, polydextrose, hypromellose, yellow iron oxide (E172), black iron oxide (E172).

200 mg: macrogol 4000, polydextrose, hypromellose, red iron oxide (E172), allura red AC lake (E129) and indigo carmine lake (E132).

What Topiramate Teva looks like and contents of the pack

Film-coated tablet

25 mg: White to off-white, film-coated, capsule-shaped tablet debossed "T25" on one side and plain on the other.

50 mg: Light yellow, film-coated, capsule-shaped tablet scored and debossed "T" and "50" on either side of the score on one side, and plain on the other side. The tablet can be divided into equal halves.

100 mg: Yellow, film-coated, capsule-shaped tablet scored and debossed "T" and "100" on either side of the score on one side, and plain on the other side. The tablet can be divided into equal halves.

200 mg: Salmon, film-coated, capsule-shaped tablet scored and debossed "T" and "200" on either side of the score on one side, and plain on the other side. The tablet can be divided into equal halves.

300 mg: White to off-white, film-coated, capsule-shaped tablet scored and debossed "T" and "300" on either side of the score on one side, and plain on the other side. The tablet can be divided into equal halves.

400 mg: White to off-white, film-coated, capsule-shaped tablet scored and debossed "T" and "400" on either side of the score on one side and plain on the other side. The tablet can be divided into equal halves.

Pack sizes:

Topiramate Teva 25 mg Film-coated Tablets Blisters: 10, 20, 28, 30, 50, 56, 60, 100 and 120 film-coated tablets.

Bottles: 60 film-coated tablets.

Topiramate Teva 50 mg/100 mg/ 200 mg Film-coated Tablets

Blisters: 10, 20, 28, 30, 50, 56, 60, 100, 120 and 200 film-coated tablets.

Bottles: 60 film-coated tablets.

Topiramate Teva 300 mg/400 mg Film-coated Tablets Blisters: 10, 28, 30, 50, 60, 100, 120 and 200 film-coated tablets.

Bottles: 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom.

This leaflet was last revised in December 2013.

PL 00289/1053-8

‘TTWTl

TEVA UK LIMITED

87218-Z 160x 434