PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Topiramate Sandoz 15 mg Capsules, hard Topiramate Sandoz 25 mg Capsules, hard Topiramate Sandoz 50 mg Capsules, hard

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 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 ofthe pack and other information

A SANDOZ

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What Topiramate is and what it is 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

What you need to know before you take Topiramate

Do not take Topiramate:

•    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 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 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 breast-feeding” 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.

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.

You may lose weight if you use Topiramate so your weight should be checked regularly when using this medicine. Ifyou 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 have had thoughts of harming or killing themselves. Ifat 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 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 Topiramate.

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, 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 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 breast-feed while taking Topiramate must tell their doctor as soon as possible if the baby experiences anything unusual.

Ask your doctor or pharmacist for advice before taking this 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 Capsules contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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How to take Topiramate

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

•    Your doctor will usually start you on a low dose ofTopiramate and slowly increase your dose until the best dose is found for you.

•    Topiramate hard capsules are to be swallowed whole. Avoid chewing the capsules 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.

•    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.

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.

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Possible side effects

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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 morethan 1in10 people)

•    Depression (new or worse).

Common (may affect upto1 in10 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 to1in100 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

•    Weight loss

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

•    Sleepiness, tiredness

•    Dizziness

•    Nausea, diarrhoea

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

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.

•    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

Ifyou 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 viaYellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effectsyou can help provide more information on the safety of this medicine.

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 movement 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

•    Cough

•    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 to1in100 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 oftouch; 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

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How to store Topiramate

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

Do not use Topiramate after the expiry date, which is stated on the label and the outer carton. The expiry date refers to the last day of the month.

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

PP container with LDPE cap: Do not store above 30°C. Keep the container tightly closed in order to protect from moisture.

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 Capsules contain

The active substance is topiramate.

Topiramate Sandoz 15 mg Capsules, hard: Each capsule contains 15 mg topiramate.

Topiramate Sandoz 25 mg Capsules, hard: Each capsule contains 25 mg topiramate.

Topiramate Sandoz 50 mg Capsules, hard: Each capsule contains 50 mg topiramate.

The other ingredients are Sucrose, maize starch, povidone K-30, ammonio methacrylate copolymer type A (30% dispersion), ammonio methacrylate copolymer type B (30% dispersion), triethyl citrate, talc, silicon dioxide, gelatin, titanium dioxide (E 171).

What Topiramate Capsules look like and contents of the pack

Capsule, hard

Topiramate Sandoz 15 mg Capsules, hard: The body of the capsule consists of two parts, one is transparent and clear and the other white. The capsules contain white or nature white granulates.

Topiramate Sandoz 25 mg Capsules, hard: The body of the capsule consists of two parts, one is transparent and clear and the other white. The capsules contain white or nature white granulates.

Topiramate Sandoz 50 mg Capsules, hard: Hard gelatine capsules. Both parts of the body ofthe capsule are white. The capsules contain white or nature white granulates.

Pack sizes: OPA/Al/PVC//Al blister: 5, 6, 10, 20 and 60 capsules, hard PP container with LDPE cap: 20, 60, 100 and 200 capsules, hard

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MarketingAuthorisation Holder:

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Lek Pharmaceuticals d.d, Verovskova 57, SI 1526 Ljubljana, Slovenia or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,39179 Barleben, Germany or

Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany or LEK S.A., ul. Domaniewska 50 C, 02-674 Warsaw, Poland.

This leafletwas last revised in 08/2014.

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