Patient Leaflet Updated 02-Feb-2023 | Rosemont Pharmaceuticals Limited
Topiramate Rosemont 20mg/ml Oral Suspension
Topiramate Rosemont 20mg/ml Oral Suspension
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
The name of your medicine is Topiramate Rosemont 20mg/ml Oral Suspension. In this leaflet the shorter name topiramate is used.
Topiramate belongs to a group of medicines called anti-epileptics.
Topiramate can be used:
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.
Talk to your doctor or pharmacist before taking topiramate if:
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’):
At higher doses of topiramate, the risk of developing these symptoms may increase.
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:
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.
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. If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant.
If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the epilepsy medicine you are taking might pose to your unborn baby. You and your doctor should decide if you will continue to take topiramate while you are pregnant.
You should not stop your treatment without discussing this with your doctor. Suddenly stopping may lead to breakthrough seizures which may harm you and your unborn baby. It is important that your epilepsy remains well controlled.
As with other anti-epileptic medicines, there is a risk of harm to the unborn child if topiramate is used during pregnancy.
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.
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.
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 topiramate and slowly increase your dose until the best dose is found for you.
If low doses are required, the 10mg/ml strength product is the most suitable presentation.
If high doses are required, the 20mg/ml strength product is the most suitable presentation.
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 0.25 ml = 5 mg Each 0.5 ml = 10 mg
Measured Amount (ml) : 1ml Amount of topiramate (mg) 20mg
Measured Amount (ml) : 1.25ml Amount of topiramate (mg) 25mg
Measured Amount (ml) : 2ml Amount of topiramate (mg) 40mg
Measured Amount (ml) : 2.5ml Amount of topiramate (mg) 50mg
Measured Amount (ml) : 3ml Amount of topiramate (mg) 60mg
Measured Amount (ml) : 3.75ml Amount of topiramate (mg) 75mg
Measured Amount (ml) : 4ml Amount of topiramate (mg) 80mg
Measured Amount (ml) : 5ml Amount of topiramate (mg) 100mg
Overdose can happen if you are taking other medicines together with topiramate.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data)
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from available data):
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:
Other side effects that may occur in children are:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
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.
Topiramate Rosemont is a colourless or off-white suspension. It comes in a brown glass bottle holding 150ml or 280ml of suspension with a 5ml purple syringe and bottle adaptor.
Other sources of information
This leaflet is also available in other formats for blind and partially-sighted patients.
For large print and Braille, please go to www.xpil.medicines.org
For an audio version, please go to www.rosemontpharma.com/products
This leaflet was last revised in 07/2022.
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