Ospolot
Italy
Table of Contents
Patient Information Leaflet
Ospolot, 20 mg/ml, oral suspension
sultiame
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Ospolot is and what it is used for
- What you need to know before taking Ospolot
- How to take Ospolot
- Possible side effects
- How to store Ospolot
- Contents of the pack and other information
1. What Ospolot is and what it is used for
Ospolot contains the active substance sultiame, an antiepileptic used in the treatment of a specific type of epilepsy.
Ospolot is used to treat self-limited epilepsy with centrotemporal spikes (SeLECTS, Self-Limited Epilepsy with Centrotemporal Spikes, previously known as rolandic epilepsy) in children from the age of 3 years and in adolescents who do not respond to or are intolerant of other treatments, or who have no therapeutic alternatives.
2. What you should know before taking Ospolot
Do not take Ospolot
if you are allergic to sultiame, to other sulfonamides, or to any of the other ingredients of this
medicinal product (listed in section 6)
if you have hyperactive thyroid gland
if you have high blood pressure
if you suffer from acute porphyria (a congenital or acquired disease in which the body is unable to
produce enough red blood pigment).
Warnings and precautions
Talk to your doctor before taking Ospolot,
if your kidney function is impaired,
if you suffer from psychiatric disorders.
Contact your doctor immediately and have your blood count checked if you notice allergic reactions
with fever, sore throat, skin rash with swollen lymph nodes and/or flu-like symptoms
during treatment with Ospolot. If you experience severe allergic reactions, your doctor may consider
it necessary to discontinue Ospolot.
Initial blood count, liver enzyme, and kidney function tests are recommended
before starting treatment with Ospolot, weekly during the first month of treatment, and
subsequently at monthly intervals. After six months of treatment, two to four check-ups per year are sufficient.
A small number of patients treated with antiepileptic medicines such as sultiame have had suicidal thoughts or self-harming behaviour. If you experience such thoughts at any time, contact your doctor immediately.
Other medicines and Ospolot
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ospolot and the following medicines or categories of medicines may interact with each other during combined treatment.
Combination of Ospolot with medicines used to treat epilepsy:
- Phenytoin: blood levels of phenytoin may increase significantly. This combination requires careful monitoring. Your doctor will therefore perform frequent blood tests to monitor phenytoin levels, especially if kidney function is impaired.
- Lamotrigine: in individual cases, blood levels of lamotrigine may increase. Blood levels of lamotrigine should therefore be monitored more frequently at the beginning of such combined treatment.
- Primidone: the side effects of Ospolot may be enhanced. In particular, it may cause unsteady gait, dizziness, and drowsiness.
- Carbamazepine: there are indications of reduced blood levels of sultiame when taken concomitantly with carbamazepine.
When sultiame is taken together with other carbonic anhydrase inhibitors (e.g.
topiramate used to treat epilepsy and migraine, or acetazolamide used to treat increased intraocular pressure),
the risk of side effects may increase due to carbonic anhydrase inhibition.
Ospolot and alcohol
During treatment with Ospolot, you must not drink alcohol, as alcohol may unpredictably alter and enhance the effect of Ospolot.
Ospolot, when interacting with alcohol, may in some cases cause a very unpleasant reaction, including dilation of blood vessels, throbbing headache, breathing difficulties, nausea, vomiting, rapid heartbeat, drop in blood pressure, blurred vision, confusion, shock-like reactions, heart rhythm disturbances, loss of consciousness, and seizures. The nature and duration of these symptoms may vary considerably.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There is an increased risk that this medicine may harm the unborn baby. Therefore, you must not use
this medicine during pregnancy unless specifically prescribed by your doctor. If you are of childbearing age and are taking Ospolot, you must use an effective method of contraception.
Do not stop treatment with Ospolot before consulting your doctor. Any sudden interruption of treatment or dose reduction without medical supervision may cause the recurrence of epileptic seizures, which could harm you and/or the unborn baby.
Breastfeeding
It is not known whether the active substance in Ospolot passes into breast milk. For this reason, you must not
take Ospolot during breastfeeding.
Driving and using machines
Even when used according to instructions, this medicine may affect your reaction ability to such an extent that, for example, your ability to drive vehicles or operate machinery may be impaired. This is particularly true when combined with alcohol.
Ospolot contains sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), sulfur dioxide (E220), sodium, fructose, glucose, and sucrose
Sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) may cause allergic reactions (including delayed reactions).
Sulfur dioxide (E220) may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains 0.0026 mg of fructose per ml.
Glucose and sucrose: if your doctor has told you that you have an intolerance to certain sugars, contact him or her before taking this medicine.
Glucose, fructose, and sucrose may be harmful to teeth.
This medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e. it is essentially "sodium-free".
3. How to take Ospolot
Treatment with Ospolot must be initiated and managed under the supervision of physicians experienced in
the treatment of epilepsy.
Take this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist.
Dose
Your doctor will usually start with a low dose and gradually increase it over the course of one
week until reaching a dose suitable for you (called maintenance dose). The usual maintenance dose is 5–10 mg (0.25–0.5 ml) per kilogram of body weight per day.
The daily dose should preferably be divided into three individual doses.
Table 1: examples of dosing for an initial dose of 2.5 mg of sultiame per kg per day:
| Patient weight | Initial dose: 2.5 mg* of sultiame per kg per day | |
| Single dose (administered three times daily) | Total daily dose | |
| 12 - 18 kg | 0.5 – 0.75 ml (equivalent to 10 – 15 mg of sultiame) | 1.5 – 2.25 ml (equivalent to 30 – 45 mg of sultiame) |
| 18 - 24 kg | 0.75 – 1.0 ml (equivalent to 15 – 20 mg of sultiame) | 2.25 – 3.0 ml (equivalent to 45 – 60 mg of sultiame) |
| 24 - 30 kg | 1.0 – 1.25 ml (equivalent to 20 – 25 mg of sultiame) | 3.0 – 3.75 ml (equivalent to 60 – 75 mg of sultiame) |
| 30 - 36 kg | 1.25 – 1.5 ml (equivalent to 25 – 30 mg of sultiame) | 3.75 – 4.5 ml (equivalent to 75 – 90 mg of sultiame) |
| 36 – and above | 1.5 ml and above (equivalent to 30 mg of sultiame and above) | 4.5 ml and above (equivalent to 90 mg of sultiame and above) |
Table 2: examples of dosing for a maintenance dose of 5 mg of sulthiame per kilogram
and per day:
| Patient weight | Maintenance dose: 5 mg* of sultiame per kg per day | |
| Single dose (administered 3 times daily) | Total daily dose | |
| 12 - 18 kg | 1.0 – 1.5 ml (equivalent to 20 – 30 mg of sultiame) | 3.0 – 4.5 ml (equivalent to 60 – 90 mg of sultiame) |
| 18 - 24 kg | 1.5 – 2.0 ml (equivalent to 30 – 40 mg of sultiame) | 4.5 – 6.0 ml (equivalent to 90 – 120 mg of sultiame) |
| 24 - 30 kg | 2.0 – 2.5 ml (equivalent to 40 – 50 mg of sultiame) | 6.0 – 7.5 ml (equivalent to 120 – 150 mg of sultiame) |
| 30 - 36 kg | 2.5 – 3.0 ml (equivalent to 50 – 60 mg of sultiame) | 7.5 – 9.0 ml (equivalent to 150 – 180 mg of sultiame) |
| 36 – and above | 3.0 ml and above (equivalent to 60 mg of sultiame and above) | 9.0 ml and above (equivalent to 180 mg of sultiame and above) |
Note: For single doses of 10 ml or more, tablets may be used.
Method and route of administration
Ospolot is for oral use.
Ospolot can be taken directly from the oral syringe, or
Ospolot can be drunk immediately after mixing, preferably with a small amount of
water, or alternatively with orange juice, milk, yoghurt, or wheat porridge, or
Ospolot can be administered via a feeding tube.
Instructions for use
Read these instructions carefully to learn how to use this medicine.
Components of the medicine kit
The medicine kit includes three parts:
- A plastic adapter
- A 10 ml oral syringe that fits into the plastic adapter.
- A bottle containing the oral suspension, with child-resistant cap. Always replace the cap after use.
Preparing a dose of medicine
- Shake the bottle vigorously for 30 seconds while inverted. If sediment is visible at the bottom of the bottle, shake for an additional 30 seconds.
- Open the child-resistant cap by pressing down firmly and turning it counterclockwise (see the top of the cap).
Note: Keep the cap within reach to
close the bottle after each use.
- Place the bottle upright on a table. Firmly and completely push the plastic adapter with the oral syringe into the bottle opening until it cannot go any further.
Note: You may not be able to push
the adapter fully in at this stage, but it will be forced
into the bottle when you screw back the cap.
After first use, the adapter remains in the
bottle.
- Hold the oral syringe firmly and carefully invert the bottle. Slowly pull back the plunger to fill the oral syringe with the suspension. Then push the plunger fully back in to remove any large air bubbles that may be present inside the oral syringe.
- Withdraw the prescribed dose: slowly pull back the syringe plunger until the top of the wider part of the plunger reaches exactly the mark on the syringe barrel indicating the prescribed dose.
Ask your pharmacist if you have any doubts.
- Carefully rotate the bottle and oral syringe upwards. Remove the oral syringe from the adapter by gently unscrewing it.
The adapter must always remain in the bottle.
- Administer the dose directly into the patient's mouth, with the patient sitting in an upright position. Press the plunger slowly so that the patient can swallow easily. Immediately after administration, the patient should drink a glass of water, juice, or milk.
Additionally, immediately before administration,
the dose may be mixed
preferably with a small amount
of water or, alternatively, with orange
juice, milk, yoghurt, or wheat porridge.
Do not take carbonated beverages or hot foods
together with the suspension to avoid
eructation or difficulty swallowing. Mix and take
immediately, consuming the entire mixture.
- After use, replace the child-resistant cap, leaving the adapter in place.
- Cleaning: after each use, rinse the syringe thoroughly with running water and clean the outside with a clean, dry wipe.
You may take Ospolot with food, or independently of meals. If possible, you should
maintain a consistent routine for taking Ospolot.
The oral suspension may also be administered via a feeding tube, which should be
flushed with at least 15 ml of water immediately after administration. If using this
administration method, the dose must be prepared as described above, immediately
before administration.
For how long should you take Ospolot?
Antiepileptic treatment is essentially long-term therapy. In each individual case, a paediatric neurologist (neurologist experienced in epilepsy treatment) must decide how to adjust the treatment, how long it should last, and when to discontinue it. Ospolot must not be stopped abruptly.
If you take more Ospolot than you should
The side effects mentioned in the section "Possible side effects" may be more pronounced. In case of overdose, consult a doctor/emergency physician as soon as possible and, if possible, show them the medicine and this package leaflet.
If you forget to take Ospolot
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time, as prescribed by your doctor. Your physician should be informed.
If you stop treatment with Ospolot
If you wish to stop or end treatment with Ospolot, consult your doctor first. Do not discontinue treatment with this medicine on your own without consulting a doctor, as this could jeopardize the treatment's success and cause the recurrence of epileptic seizures. The duration of treatment varies from individual to individual and will be determined by the doctor.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Very common side effects (may affect more than 1 in 10 people):
- stomach ache (e.g. nausea, vomiting)
Common side effects (may affect up to 1 in 10 people):
breathing difficulties and respiratory distress (dose-dependent)
chest tightness, rapid heartbeat
tingling of the arms, legs or face (dose-dependent)
dizziness, headache
double vision
hiccups, weight loss or loss of appetite
Uncommon side effects (may affect up to 1 in 100 people):
hallucinations, anxiety, lethargy
muscle weakness, joint pain
increased seizures, status epilepticus
Not known (frequency cannot be estimated from available data):
delayed hypersensitivity reaction affecting multiple organs, with fever, skin rash,
inflammation of blood vessels (vasculitis), swollen lymph nodes, joint pain, abnormal white blood cell count, as well as enlargement of the liver or spleen and severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
acute kidney failure
worsening of vision, even significant, polyneuritis (inflammation of multiple nerves)
toxic liver reactions and/or increased liver enzyme levels
depressed mood/depression, personality changes, abnormal behaviour (e.g.
aggressiveness, irritability, mood swings) and impaired cognitive function
diarrhoea
In a patient with treatment-resistant epilepsy receiving long-term therapy, administration of Ospolot caused increased weakness of the limbs, increased salivation, confused speech, and increased drowsiness progressing to coma. Symptoms resolved within a few hours after discontinuation of Ospolot.
Sultiame belongs to a class of active substances (carbonic anhydrase inhibitors) which may cause kidney stone formation, changes in blood composition (metabolic acidosis, haemodilution, and alterations in serum electrolyte levels such as reduced blood calcium levels), as well as fatigue/exhaustion.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Ospolot
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the carton after EXP. The expiry date refers to the last day of that month.
After first opening the bottle, do not use for more than 3 months.
Do not use this medicine if you notice any damage to the bottle, closure, or carton.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Ospolot contains
The active substance is sultiame.
The other components are: methyl parahydroxybenzoate sodium (E219), propyl parahydroxybenzoate sodium (E217), sucralose (E955), sodium docusate, xanthan gum (E415), disodium dihydrogen phosphate dihydrate (E339), dipotassium phosphate (E340), strawberry flavour (containing acacia E414), sweetening flavour (containing fructose, glucose, sucrose, sulfur dioxide (E220)), masking flavour (containing sucralose E955, maltodextrin (potato)), phosphoric acid 85% (E338) (for pH adjustment), purified water.
Description of the appearance of Ospolot and contents of the pack
Ospolot oral suspension is a white suspension.
The glass bottle with child-resistant closure contains 200 ml or 250 ml of oral suspension. It is packaged in a cardboard box containing a 10 ml oral syringe graduated every 0.25 ml and an adapter.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Desitin Arzneimittel GmbH
Weg beim Jäger 214
22335 Hamburg
Germany
Manufacturers
Desitin Arzneimittel GmbH
Weg beim Jäger 214
22335 Hamburg
Germany
This medicinal product is authorized in the European Economic Area member states under the following names:
BE Ospolot 20 mg/ml suspensie voor oraal gebruik / solution buvable / Suspension zum Einnehmen
CZ Ospolot
DK Ospolot
DE Ospolot 20 mg/ml Suspension zum Einnehmen
EE Ospolot
ES Ospolot 20 mg/ml Suspensión oral
FI Ospolot 20 mg/ml Oraalisuspensio
IE Ospolot 20 mg/ml oral suspension
IT Ospolot
LU Ospolot
NL: Ospolot 20 mg/ml Suspensie voor oraal gebruik
NO Ospolot 20 mg/ml Mikstur, suspensjon
PL Sultiame Desitin
PT Ospolot 20 mg/ml Suspensão oral
RO Ospolot 20 mg/ml Suspensie orală
SE Ospolot 20 mg/ml Oral suspension
SK Ospolot