Topamax 15mg sprinkle capsules

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Topiramate
Available from:
CST Pharma Ltd
ATC code:
N03AX11
INN (International Name):
Topiramate
Dosage:
15mg
Pharmaceutical form:
Capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04080100; GTIN: 5055946805252

Package leaflet: Information for the user

Topamax

®

sprinkle 15mg 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.

The name of your medicine is Topamax sprinkle 15mg capsules

but will be referred as Topamax throughout this leaflet. Please

note that this leaflet also contains information about other

strengths Topamax sprinkle 25mg and 50mg 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

Topamax 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

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 if you are a

woman of childbearing potential unless you are using effective

contraception (see section ‘pregnancy and breast-feeding’ for

further information). You should talk to your doctor about the

best kind of contraception to use while you are taking

Topamax.

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 taking Topamax to treat epilepsy and you are pregnant or a

woman of childbearing potential (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 anti-epileptic

medicines such as Topamax have had thoughts of harming or

killing themselves. If at any time you have these thoughts,

immediately contact your doctor.

Topamax may in rare cases cause high levels of ammonia in the

blood (seen in blood tests) which can lead to a change in brain

function, especially if you are also taking a medicine called valproic

acid or sodium valproate. Since this may be a severe condition, tell

your doctor immediately if the following symptoms occur (see also

section 4 'Possible side effects'):

difficulty thinking, remembering information, or solving

problems

being less alert or aware

feeling very sleepy with low energy

At higher doses of Topamax, the risk of developing these

symptoms may increase.

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.

You should talk to your doctor about the best

kind of contraception to use while you are taking Topamax.

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 anti-epileptic medicines, risperidone, lithium,

hydrochlorothiazide, metformin, pioglitazone, glibenclamide,

amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine,

St. John's wort (Hypericum perforatum) (a herbal preparation used

to treat depression), warfarin used to thin the blood.

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

Migraine prevention:

Topamax can harm an unborn baby. You must not use Topamax if

you are pregnant. You must not use Topamax for migraine

prevention if you are a woman of childbearing potential unless you

are using effective contraception. Talk to your doctor about the

best kind of contraception and whether Topamax is suitable for

you. Before the start of treatment with Topamax a pregnancy test

should be performed.

Treatment of epilepsy:

If you are a woman of childbearing potential you should talk to your

doctor about other possible treatments instead of Topamax. If the

decision is made to use Topamax, you should use effective

contraception. Talk to your doctor about the best kind of

contraception to use while you are taking Topamax. Before the

start of treatment with Topamax a pregnancy test should be

performed.

Talk to your doctor if you wish to become pregnant. 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.

If you take Topamax during pregnancy, your baby has a higher

risk for birth defects, particularly, cleft lip (split in the top lip)

and cleft palate (split in the roof of the mouth). Newborn boys

may also have a malformation of the penis (hypospadia).

These defects can develop early in pregnancy, even before

you know you are pregnant.

If you take Topamax during pregnancy, your baby may be

smaller than expected at birth. Talk to your doctor if you have

questions about this risk during pregnancy.

There may be other medicines to treat your condition that have

a lower risk of birth defects.

Tell your doctor straight away if you become pregnant while

taking Topamax. You and your doctor should decide if you will

continue to take Topamax while you are pregnant.

Breast-feeding

The active substance in Topamax (topiramate) passes into human

milk. Effects have been seen in breastfed babies of treated

mothers, including diarrhea, feeling sleepy, feeling irritable, and

poor weight gain. Therefore, your doctor will discuss with you

whether you abstain from breast-feeding or whether to abstain

from treatment with Topamax. Your doctor will take into account

the importance of the medicine to the mother and the risk for the

baby.

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 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.

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.

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.

1

What Topamax is and what it is used for

2

2

What you need to know before you take Topamax

3

How to take Topamax

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

Difficulty thinking, remembering information, or solving

problems, being less alert or aware, feeling very sleepy with

low energy – these symptoms may be a sign of a high level of

ammonia in the blood (hyperammonemia), which can lead to a

change in brain function (hyperammonemic encephalopathy).

Not known (frequency cannot be estimated from the

available data)

Inflammation of the eye (uveitis) with symptoms such as

eye redness, pain, sensitivity to light, runny eyes, seeing small

dots or getting blurred 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

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. You can

also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in

the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on

the safety of this medicine.

Keep out of the sight and reach of children.

Do not store above 25°C.

Keep the bottle tightly closed in order to protect from moisture.

Do not take capsules after the expiry date which is stated on the

carton and bottle labels after 'Exp'. The expiry date refers to the

last day of that month.

If the capsule becomes discoloured or shows any signs of

deterioration, seek the advice of your pharmacist.

Remember if your doctor tells you to stop taking this medicine,

return any unused medicine to your pharmacist for safe disposal.

Only keep this medicine if your doctor tells you to.

Medicines should not be disposed of via wastewater or household

waste. Ask your pharmacist how to dispose of medicines no longer

required. These measures will help to protect the environment.

What Topamax contains

The active ingredient in the Topamax is topiramate.

Each capsule contains 15mg of topiramate.

The other ingredients are sugar spheres (starch and sucrose),

povidone and cellulose acetate. The capsule consists of gelatin,

titanium dioxide (E171) and black ink (iron oxide black (E172),

shellac and propylene glycol).

What Topamax looks like and contents of the pack

Topamax are small, white to off-white spheres in gelatin capsules

consisting of white bodies with clear (natural) caps marked ‘TOP’

on the cap and ‘15mg’ on the capsule body in black

Topamax is available in an opaque plastic bottle with tamper

evident closure containing 60 hard capsules.

Manufactured by:

Janssen-Cilag S.p.a., 04100 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 15mg capsules; PL 18799/0842

Leaflet date: 30.12.2019

Topamax is a registered trademark of Johnson & Johnson.

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0208 515 3763 to obtain the

leaflet in a format suitable for

you.

POM

4

Possible side effects

5

How to store Topamax

6

Contents of the pack and other information

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