Topiramate Rosemont 10mg/ml Oral Suspension

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 Topiramate Rosemont is and what it is used for
2. What you need to know before you take Topiramate Rosemont
3. How to take Topiramate Rosemont
4. Possible side effects
5. How to store Topiramate Rosemont
6. Contents of the pack and other information

Do not take topiramate 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 topiramate.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking topiramate.

Warnings and precautions

Talk to your doctor or pharmacist before taking topiramate if:

• you have kidney problems, especially kidney stones or are getting kidney dialysis
• you have a history of blood and body fluid abnormality (metabolic acidosis)
• you have liver problems
• you have eye problems, especially glaucoma
• you have a growth problem
• you are on a high fat diet (ketogenic diet)
• you are taking topiramate to treat epilepsy and you are pregnant or a woman of childbearing potential (see section ‘pregnancy and breast-feeding’ for further information).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking topiramate.

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 Topiramate Rosemont.

You may lose weight if you use topiramate 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 topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Topiramate can cause serious skin reactions, tell your doctor immediately if you develop a skin rash and/or blisters (see also section 4 ’Possible side effects’).

Topiramate 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 topiramate, the risk of developing these symptoms may increase.

Other medicines and topiramate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Topiramate and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or topiramate 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. Topiramate 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 topiramate.

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

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, flunarizine, St. John's wort (Hypericum perforatum) (a herbal preparation used to treat depression) and 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 topiramate.

Topiramate with food, drink and alcohol

• Topiramate can be taken with or without food.
• Drink plenty of fluids during the day to prevent kidney stones while taking topiramate.
• You should avoid drinking alcohol when taking topiramate.

Pregnancy and breast-feeding

Migraine prevention:

Topiramate can harm an unborn baby. You must not use topiramate if you are pregnant. You must not use Topiramate 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 topiramate is suitable for you. Before the start of treatment with topiramate 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 topiramate. If the decision is made to use topiramate, you should use effective contraception. Talk to your doctor about the best kind of contraception to use while you are taking topiramate. Before the start of treatment with topiramate 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 topiramate is used during pregnancy. Make sure you are very clear about the risks and the benefits of using topiramate for epilepsy during pregnancy.

• If you take topiramate 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 topiramate 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 topiramate. You and your doctor should decide if you will continue to take topiramate while you are pregnant.

Breast-feeding

The active substance in Topiramate Rosemont (topiramate) passes into breast milk. Effects have been seen in breastfed babies of treated mothers, including diarrhoea, 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 topiramate. 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 topiramate 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 topiramate. Do not drive or use any tools or machines without talking to your doctor first.

Topiramate Rosemont contains sodium methyl and sodium ethyl hydroxybenzoate, glycerol, benzoic acid and sodium:

• sodium methyl (E219) and sodium ethyl hydroxybenzoate (E215). May cause allergic reactions (possibly delayed).
• glycerol (E422). This may cause headache, stomach upset and diarrhoea.
• benzoic acid (0.001 mg per 1 ml dose), which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
• sodium (E210). This medicine contains 4.29 mg sodium (main component of cooking/table salt) in each 1 ml dose. This is equivalent to 0.2% of the recommended maximum daily dietary intake of sodium for an adult.

Taking this medicine

• This medicine contains 10mg of topiramate in each 1ml of suspension.
• Take this medicine by mouth.
• Always shake the bottle before using it.
• Always use the syringe supplied with the pack.
• Topiramate can be taken before, during or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking topiramate.

Measuring your dose

Instructions for use of the syringe

1. To open the bottle, press the cap down and turn it anti-clockwise (figure 1).
2. Put the syringe adaptor into the bottle neck (figure 2).
3. Take the syringe and put it into the adaptor opening (figure 3).
4. Turn the bottle upside down (figure 4).
5. Fill the syringe with a small amount of solution by pulling the plunger down (figure 4A). Then push the plunger upward in order to remove any possible bubbles (figure 4B). Finally, pull the plunger down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor. The top flat edge of the piston should be in line with the graduation mark you are measuring to (Figure 4C).
6. Turn the bottle the right way up (Figure 5A).
7. Remove the syringe from the adaptor (Figure 5B).
8. Put the end of the syringe into your mouth and push the plunger slowly back in to take the medicine (Figure 6).
9. Wash the syringe with water and let it dry before you use it again.
10. Close the bottle with the plastic screw cap - leave the syringe adaptor in the bottle.

The table below will help you measuring the exact dose prescribed by your doctor:

Each 0.1 ml = 1 mg

Measured Amount (ml) Amount of topiramate (mg)

0.5 ml 5 mg

1 ml 10 mg

1.5 ml 15 mg

2 ml 20 mg

2.5 ml 25 mg

3 ml 30 mg

If you take more topiramate 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, have abdominal pain or seizures (fits).

Overdose can happen if you are taking other medicines together with topiramate.

If you forget to take topiramate

• If you forget to take a dose, take it as soon as you remember it. However, if it almost time to take the 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 topiramate

• 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.

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 side effects (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).
• serious skin reactions, such as Steven-Johnson syndrome and toxic epidermal necrolysis- these may appear as rashes with or without blisters. Skin irritation, sores or swelling in the mouth, throat, nose, eyes and around the genitals. The skin rashes may develop into serious widespread skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.

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 topiramate 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
• abnormal skin odour
• discomfort in your arms or legs
• kidney disorder.

Not known (frequency cannot be estimated from 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

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: 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.

What Topiramate Rosemont 10mg/ml Oral Suspension contains

• The active substance is topiramate. Each 1ml of the suspension contains 10mg topiramate.
• The other ingredients are citric acid monohydrate (E330), disodium phosphate dihydrate (E339), simethicone emulsion (including benzoic acid (E210)), sucralose (E955), blackcurrant flavour, sodium methyl and sodium ethyl hydroxybenzoates (E219 and E215), dilute hydrochloric acid (E507), xanthan gum (E415), glycerol (E422) and purified water.

What Topiramate Rosemont 10mg/ml Oral Suspension looks like and contents of the pack

Topiramate Rosemont is a colourless or off-white suspension. It comes in a brown glass bottle holding 150ml or 280ml of suspension with a 3ml purple syringe and bottle adaptor.

The Marketing Authorisation Holder and Manufacturer is