Topamax 25mg Film-Coated Tablets
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
PACKAGE LEAFLET: INFORMATION FOR THE USER TOPAMAX® 25MG FILM-COATED TABLETS (Topiramate)
The name of your medicine is Topamax® 25mg film-coated Tablets, but will be referred to as Topamax throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.
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
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
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. T opamax and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or T opamax 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 T opamax 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 T opamax 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.
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.
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
