Topamax Sprinkle 50mg Hard Capsules
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Topamax® Sprinkle 50mg hard capsules
(topiramate)
1. What Topamax is and what it is used for
Topamax belongs to a group of medicines called • with other medicines to treat seizures in
antiepileptic medicines. |t is used: adults and children aged 2 years and above
• alone to treat seizures in adults and children • to prevent migraine headaches in adults over age 6
2. What you need to know before you take Topamax
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.
Do not take Topamax
• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topamax (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)
The name of your medicine is Topamax Sprinkle 50mg hard capsules but it will be referred as Topamax throughout this leaflet. Please note that the product is also available in other strengths Topamax Sprinkle 15mg and 25mg hard capsules.
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
• 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, 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 Topamax. As with other antiepilepsy 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.
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 Topamax. Do not drive or use any tools or machines without talking to your doctor first.
Topamax 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 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 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
• Topamax can be taken before, during or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking Topamax
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
• 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
• Tingling, pain and/or numbness of various body parts
• Sleepiness, tiredness
• Dizziness
• Nausea, diarrhoea
• Weight loss
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.
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 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)
4. Possible side effects
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 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
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 any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects, you can help provide more information on the safety of this medicine
5. How to store Topamax
• Keep out of the sight and reach of children
• Do not use Topamax after the expiry date which is stated on the carton/ bottle label after ‘Exp'. The expiry date refers to the last day of that month
• Keep the container tightly closed in order to protect from moisture.
• Do not store above 25°C
• Medicines should not be disposed of via wastewater or household waste. These measures will help protect the environment. Return any leftover Topamax to your pharmacist
• If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
6. Contents of the pack and other information
What Topamax contains
The active substance in Topamax is topiramate. Each hard capsule contains 50mg topiramate. The other ingredients are sugar spheres (maize starch, sucrose), povidone, cellulose acetate Capsule shell contains: gelatin and titanium dioxide (E171)
Printing ink contains: black iron oxide (E 172), propylene glycol and shellac.
What Topamax looks like and contents of the pack
Topamax contains small white to off-white spheres in hard gelatin capsules with white opaque body marked with '50 mg' and a clear cap marked with 'TOP'.
Topamax is supplied in opaque plastic bottles containing 60 capsules.
Manufactured by:
Janseen-Cilag S.p.a., 04010 Borgo S. Michele Latina, Italy
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Topamax® Sprinkle 50mg hard capsules I POM I
PL No: 18799/2389
Leaflet date: 11.11.2014
Topamax is a registered trademark of Janssen Cilag.