Active ingredient
- topiramate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00427/0245.
Topiramate Rosemont 10mg/ml Oral Suspension
Package Leaflet: Information for the User
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.
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
1. What Topiramate Rosemont is and what it is used for
The name of your medicine is Topiramate Rosemont 10mg/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:
2. What you need to know before you take Topiramate Rosemont
Do not take topiramate if:
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:
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 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.
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:
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, glyburide, 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
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.
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:
3. How to take Topiramate Rosemont
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.
Taking this medicine
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) : 0.5ml Amount of topiramate (mg) 5mg
Measured Amount (ml) : 1ml Amount of topiramate (mg) 10mg
Measured Amount (ml) : 1.5ml Amount of topiramate (mg) 15mg
Measured Amount (ml) : 2ml Amount of topiramate (mg) 20mg
Measured Amount (ml) : 2.5ml Amount of topiramate (mg) 25mg
Measured Amount (ml) : 3ml Amount of topiramate (mg) 30mg
If you take more topiramate than you should
Overdose can happen if you are taking other medicines together with topiramate.
If you forget to take topiramate
If you stop taking topiramate
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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):
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):
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)
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):
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:
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)
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.
5. How to store Topiramate Rosemont
6. Contents of the pack and other information
What Topiramate Rosemont 10mg/ml Oral Suspension contains
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
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 07/2020.
I6HD1RBJ4
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
+44 (0)113 245 3567
+44 (0)7836 557 879