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: PL00427/0244.
Levetiracetam Rosemont 100mg/ml Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVETIRACETAM ROSEMONT 100mg/ml ORAL SOLUTION
Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Levetiracetam Rosemont is and what it is used for
2. What you need to know before you take Levetiracetam Rosemont
3. How to take Levetiracetam Rosemont
4. Possible side effects
5. How to store Levetiracetam Rosemont
6. Contents of the pack and other information
1. WHAT LEVETIRACETAM ROSEMONT IS AND WHAT IT IS USED FOR
Levetiracetam Rosemont 100mg/ml Oral Solution contains the active ingredient levetiracetam, which is an antiepileptic medicine (a medicine used to treat seizures in epilepsy)
Levetiracetam is used:
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVETIRACETAM ROSEMONT
Do not take levetiracetam
Warnings and precautions:
Talk to your doctor before taking levetiracetam
Children and adolescents
Levetiracetam Rosemont is not indicated in children and adolescents below 16 years on its own (monotherapy).
Other medicines and Levetiracetam Rosemont:
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.
Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.
Pregnancy and breast-feeding:
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
You should not stop your treatment without discussing this with your doctor. A risk of birth defects to your unborn child cannot be completely excluded. Breast-feeding is not recommended during treatment.
Driving and using machines:
Levetiracetam may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Levetiracetam Rosemont contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol:
Levetiracetam Rosemont includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Levetiracetam Rosemont also contains maltitol. 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 LEVETIRACETAM ROSEMONT
Always take Levetiracetam Rosemont exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day. Take the oral solution following your doctor’s instructions.
Dose in adults and adolescents from 16 years of age:
Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above. General dose: Levetiracetam Oral Solution is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).
When you first start taking levetiracetam, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
General dose: Levetiracetam Oral Solution is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).
Dose in children 6 months and older:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.
For children 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in the package.
For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.
General dose: Levetiracetam Oral Solution is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the child. (see table below for dose examples).
Dose in children 6 months and older:
Starting dose: 0.1 ml/kg twice daily, Maximum dose: 0.3 ml/kg twice daily
Weight: 6 kg, Starting dose: 0.6 ml twice daily, Maximum dose: 1.8 ml twice daily
Weight: 8 kg, Starting dose: 0.8 ml twice daily, Maximum dose: 2.4 ml twice daily
Weight: 10 kg, Starting dose: 1 ml twice daily, Maximum dose: 3 ml twice daily
Weight: 15 kg, Starting dose: 1.5 ml twice daily, Maximum dose: 4.5 ml twice daily
Weight: 20 kg, Starting dose: 2 ml twice daily, Maximum dose: 6 ml twice daily
Weight: 25 kg, Starting dose: 2.5 ml twice daily, Maximum dose: 7.5 ml twice daily
Weight: from 50 kg, Starting dose: 5 ml twice daily, Maximum dose: 15 ml twice daily
Dose in infants (1 month to less than 6 months):
For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
General dose: Levetiracetam Oral Solution is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant. (see table below for dose examples).
Dose in infants (1 month to less than 6 months):
Starting dose: 0.07 ml/kg twice daily, Maximum dose: 0.21 ml/kg twice daily
Weight: 4 kg, Starting dose: 0.3 ml twice daily, Maximum dose: 0.85 ml twice daily
Weight: 5 kg, Starting dose: 0.35 ml twice daily, Maximum dose: 1.05 ml twice daily
Weight: 6 kg, Starting dose: 0.45 ml twice daily, Maximum dose: 1.25 ml twice daily
Weight: 7 kg, Starting dose: 0.5 ml twice daily, Maximum dose: 1.5 ml twice daily
Method of administration:
After measuring the correct dose with an appropriate syringe, Levetiracetam Oral Solution may be diluted in a glass of water or baby’s bottle. You may take it with or without food. After oral administration the bitter taste of levetiracetam may be experienced.
Instructions for use:
Duration of treatment:
If you take more Levetiracetam Oral Solution than you should:
The possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more levetiracetam than you should. Your doctor will establish the best possible treatment of overdose.
If you forget to take Levetiracetam Oral Solution:
Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for a forgotten dose.
If you stop taking Levetiracetam Oral Solution:
If stopping treatment, levetiracetam should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam.
If you have any further questions on the use of this product, 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 immediately, or go to your nearest emergency department, if you experience:
The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.
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
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 the 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.
5. HOW TO STORE LEVETIRACETAM ROSEMONT
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP:.
The expiry date refers to the last day of the month. Do not use after 1 month of first opening the bottle. Store below 25°C. Store in the original bottle, in order to protect from light.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Levetiracetam Rosemont contains
The active substance is called levetiracetam. Each 1 ml contains 100 mg of levetiracetam.
The other ingredients are: Sodium citrate, Citric acid, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Ammonium glycyrrhizate, Glycerol (E422), Maltitol (E965), Acesulfame potassium (E950), Grape flavour, Purified water.
What Levetiracetam Rosemont looks like and contents of the pack
Levetiracetam Rosemont 100 mg/ml Oral Solution is a clear liquid. The 300 ml glass bottle of Levetiracetam Rosemont (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.
The 150 ml glass bottle of Levetiracetam Rosemont (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml syringe (graduated every 0.1 ml) and an adaptor for the syringe.
The 150 ml glass bottle of Levetiracetam Rosemont (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml syringe (graduated every 0.05 ml) and an adaptor for the syringe.
Marketing Authorisation Holder and Manufacturer:
PL Number: 00427/0244
This leaflet was last updated on 12/2018
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