Topamax 100 Mg Film-Coated Tablets

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Package leaflet: Information for the user © ^J-C2015 GB - ^aw_¹⁰⁹³⁸⁶

Topamax® 25, 50, 100 and 200 mg film-coated tablets

Topiramate

Topamax is registered trademark

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 Topamax is and what it is used for

2 What you need to know before you take Topamax

3 How to take Topamax

4 Possible side effects

5 How to store Topamax

6 Contents of the pack and other information

1 What Topamax is and what it is used for

Topamax 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

2 What you need to know before you take Topamax

Do not take Topamax

• 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 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 Topamax.

Warnings and precautions

Talk to your doctor or pharmacist before taking Topamax 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 applies to you, talk to your doctor or pharmacist before using Topamax.

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 Topamax.

You may lose weight if you use Topamax 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 Topamax have had thoughts of harming or killing themselves.

If at any time you have these thoughts, immediately contact your doctor.

Other medicines and Topamax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Topamax and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topamax 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. Topamax may make your birth control pills less effective

Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and Topamax.

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 Topamax.

Topamax with food and drink

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

Pregnancy and breast-feeding

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 discuss use of contraceptives with you, as well as discussing whether Topamax is suitable for you. As with other anti-epileptic medicines, there is a risk of harm to the unborn child if Topamax is used during pregnancy. Make sure you are very clear about the risks and the benefits of using Topamax for epilepsy during pregnancy.

You should not take Topamax 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 Topamax 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 Topamax. Do not drive or use any tools or machines without talking to your doctor first.

Topamax 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 Topamax

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 of Topamax and slowly increase your dose until the best dose is found for you

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

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

If you take more Topamax 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 Topamax.

If you forget to take Topamax

• 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 Topamax

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 product, ask your doctor or pharmacist.

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 (particularly in young children who are exposed to high temperatures)

• Having thoughts of serious self-harm, trying to cause serious self-harm

• Loss of part of the field of vision

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

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4 Possible side effects (continued)

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, abnormal behaviour

• 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

• 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 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 Topamax 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

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

The side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than adults:

• Problems with concentration

• Increased acid level in the blood

• Having thoughts of serious self-harm

• Tiredness

• Decreased or increased appetite

• Aggression, abnormal behaviour

• Difficulty falling or staying asleep

• Feeling of unsteadiness when walking

• Not feeling well

• Decrease in potassium level in the blood

• Showing and/or feeling no emotion

• Watery eyes

• Slow or irregular heartbeat

Other side effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vertigo)

• Vomiting

• Fever

Uncommon (may affect up to 1 in 100 people)

• Increase in eosinophils (a type of white blood cell) in the blood

• Hyperactivity

• Feeling warm

• Learning disability

Reporting of side effects

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

In the UK, you can also report side effects

directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

In Ireland, you can also report side effects

directly via: HPRA Pharmacovigilance, Earlsfort

Terrace, IRL - Dublin 2, Tel: +353 1 6764971,

Fax: +353 1 6762517, Website: www.hpra.ie,

E-mail: medsafety@hpra.ie

By reporting side effects you can help provide

more information on the safety of this medicine.

5 How to store Topamax

• 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/bottle/carton. The expiry date refers to the last day of that month.

• Do not store above 25°C. Store the tablets in the original package (blister or bottle) to protect from moisture. Keep the bottle tightly closed to protect the tablets 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

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

Austria Belgium Bulgaria Cyprus

Czech Republic Denmark Estonia Finland

France

Germany

Greece

Hungary

Iceland

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Norway

Poland

Portugal

Romania

Slovak Republic

Slovenia

Spain

Sweden

United Kingdom

What Topamax contains

The active substance is topiramate.

Each Topamax film-coated tablet contains 25, 50, 100 or 200 mg of topiramate.

The other ingredients of Topamax are listed below.

Core tablet:

Lactose Monohydrate, Pregelatinized Maize Starch, Microcrystalline Cellulose, Sodium Starch Glycolate (Type A), Magnesium Stearate. Film-coating:

OPADRY® White, Yellow, Pink¹, Carnauba Wax. ¹OPADRY contains Hypromellose, Macrogol, Polysorbate 80 and as colourants Titanium Dioxide E171 (all strengths), Iron Oxide yellow E172 (50 and 100 mg), and iron oxide red E172 (200 mg)

What Topamax looks like and contents of the pack

Description of the product

25 mg: White round tablets, 6 mm in diameter,

“TOP” on one side, “25” on the other.

50 mg: Light yellow round tablets, 7 mm in diameter, “TOP” on one side, “50” on the other. 100 mg: Yellow round tablets, 9 mm in diameter, “TOP” on one side, “100” on the other.

200 mg: Salmon round tablets, 10 mm in diameter, “TOP” on one side, “200” on the other.

Opaque plastic bottle with tamper-evident closure containing 20, 28, 30, 50, 56, 60, 100 or 200 (2 x100) tablets. In each bottle there is a desiccant canister which should not be swallowed.

Blister pack of an aluminium/aluminium foil in strips. Pack sizes of 10, 20, 28, 30, 50, 56, 60, 100 or 200 (2 x100) tablets.

Individual (alu/alu) blister strips are packed inside a folding box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The product licence is held by:

JAnSsEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Bucks HP12 4EG, UK

Topamax film-coated tablets are made by: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Janssen-Cilag S.p.A., 04100 Borgo S. Michele, Latina, Italy OR

McGregor Cory Limited, Middleton Close, Banbury, Oxfordshire OX16 4RS, UK

Topamax - Filmtabletten

Topamax tabletten

TOPAMAX

TOPAMAX tabs

Topamax

Topimax

TOPAMAX

Topimax tabletti,

kalvopaallysteinen

EPITOMAX, COMPRIME

PELLICULE

Topamax

25<50><100><200> mg Filmtabletten

TOPAMAC

Topamax film-coated tablet Topimax filmuhuSaSar toflur Topamax Tablets TOPAMAX compresse rivestite con film, 60 compresse Topamax coated tablets Topamax

Topamax comprimes Topamax

Topamax, filmomhulde tabletten

Topimax Tabletter filmdrasjert Topamax tabletki powlekane Topamax TOPAMAX tablets Topamax

TOPAMAX filmsko oblozene tablete

TOPAMAX Comprimidos recubiertos Topimax tabletter, filmdragerade Topamax Tablets

For information in large print, tape, CD or Braille, telephone 0800 7318450 (UK) or 1800 709122 (IRE).

This leaflet was last revised in November 2015.

janssen y

III

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