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Document: Topimax capsule, hard ENG PL change

• Topimax capsule, hard PL
• Topimax capsule, hard ENG PL

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Package leaflet: Information for the user

Topimax 15 mg hard capsules

Topimax 25 mg hard capsules

Topimax 50 mg hard capsules

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 Topimax is and what it is used for

2. What you need to know before you take Topimax

3. How to take Topimax

4. Possible side effects

5. How to store Topimax

6. Contents of the pack and other information

1. What Topimax is and what it is used for

Topimax 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 aged 2 years and above

• to prevent migraine headaches in adults

2. What you need to know before you take Topimax

Do not take Topimax

• 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 breastfeeding’ for further information).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Topimax 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 breastfeeding’ for further information)

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

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 Topimax.

You may lose weight if you use Topimax 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 anti-epileptic medicines such as Topimax have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Other medicines and Topimax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Topimax and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topimax 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. Topimax may make your birth control pills less effective.

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

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, 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 Topimax.

Topimax with food and drink

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

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 Topimax is suitable for you. As with other anti‑epileptic medicines, there is a risk of harm to the unborn child if Topimax is used during pregnancy. Make sure you are very clear about the risks and the benefits of using Topimax for epilepsy during pregnancy.

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

Topimax 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.

3. How to take Topimax

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 Topimax and slowly increase your dose until the best dose is found for you.

• Topimax hard capsules may be swallowed whole or may be opened and sprinkled on a teaspoon of soft food of any type. Examples are applesauce, custard, ice cream, porridge, pudding or yogurt. Drink fluids right after to make sure all of the food and medicine mixture is swallowed.

• Hold the hard capsule upright so that you can read the word “TOP.”

• Carefully twist off the clear portion of the capsule. You may find it best to do this over the small portion of food onto which you will be pouring the sprinkles.

• Sprinkle all of the 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 swallow the entire spoonful of the sprinkle/food mixture immediately. Avoid chewing. Drink fluids immediately in order to make sure all of the mixture is swallowed.

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

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

If you take more Topimax 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 Topimax.

If you forget to take Topimax

• 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 Topimax

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)

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)

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, 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 Topimax 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

• Tiredeness

• 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. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Topimax

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

Do not store above 25°C. Keep the bottle tightly closed to protect the capsules 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 Topimax contains

• The active substance is topiramate.

• Each Topimax hard capsule contains 15, 25, or 50 mg of topiramate.

The other ingredients of Topimax are listed below:

Sugar spheres (maize starch, sucrose), povidone, cellulose acetate.

Capsule

Gelatine, titanium dioxide (E171)

Printing ink

Black ink (iron oxide black (E172), shellac and propylene glycol).

What Topimax looks like and contents of the pack

15 mg capsules: Small white to off-white spheres in hard gelatine capsules with white opaque body marked ‘15 mg’ and clear cap marked 'TOP'.

25 mg capsules: Small white to off-white spheres in hard gelatine capsules with white opaque body marked ‘25 mg’ and clear cap marked 'TOP'.

50 mg capsules: Small white to off-white spheres in hard gelatine capsules with white opaque body marked ‘50 mg’ and clear cap marked 'TOP'.

Opaque plastic bottle of HDPE with tamper-evident closure containing 20, 28, 60 or 100 capsules with granules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

Manufacturer

[To be completed nationally]

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

Austria Topamax – Granulat in Kapseln

Belgium Topamax harde capsules

Bulgaria TOPAMAX

Cyprus TOPAMAX Sprinkles

Czech Republic Topamax

Denmark Topimax

Finland Topimax kapseli, kova

France EPITOMAX, GELULE

Germany Topamax 25<50> Hartkapseln

Greece TOPAMAC

Iceland Topimax hylki, hörð

Ireland TOPAMAX Sprinkle Capsules

Italy TOPAMAX capsule rigide, 60 capsule

Latvia Topamax sprinkle capsules

Luxembourg Topamax gélules

Malta Topamax

Netherlands Topamax Sprinkle, harde capsules

Norway Topimax Kapsel, hard

Poland Topamax kapsulki

Portugal Topamax

Romania TOPAMAX sprinkle caps

Slovak Republic Topamax cps

Slovenia TOPAMAX kapsule

Spain TOPAMAX DISPERSABLE, cápsulas

Sweden Topimax kapslar, hårda

United Kingdom TOPAMAX Sprinkle Capsules

This leaflet was last revised in 2015-10-28