Israel - English - Ministry of Health
Patient leaflet in accordance with the Pharmacists'
Regulations (Preparations) - 1986
This medicine is to be supplied by physician’s prescription only
Each tablet contains:
Sulthiame 200 mg
Each tablet contains 50 mg lactose monohydrate.
Read the entire leaflet carefully before you start using this medicine. This leaflet contains essential information
about this medicine. If you have any further questions, refer to the physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems
to you that their illness is similar.
Ospolot is an anti-epileptic medicine with an anticonvulsant activity for the treatment of epilepsy.
What is this medicine used for?
Ospolot is indicated for the treatment of epilepsy in adults and in treatment of the so called focal benign epilepsy of
children, when other medication was not adequate.
Therapeutic group: Carbonic anhydrase inhibitors.
Before using this medicine
Special warnings regarding the use of this medicine
Do not use this medicine without consulting your physician prior to commencing treatment:
If you suffer or have previously suffered from impaired renal function
If you suffer or have previously suffered from psychiatric disorders
If you are pregnant, planning to become pregnant or breastfeeding
Consult your attending physician immediately if any one or more of the following appear:
Fever, sore throat, allergic skin reaction accompanied by lymph node swelling and/or occurance of flu-like
symptoms during treatment with Ospolot.
Changes in blood test results such as decrease in white blood cell count or platelet count (leucopenia or
thrombocytopenia) that occur with other symptoms such as fever and sore throat. Your physician may decide to
stop treatment with Ospolot immediately.
In case of severe allergic reaction, Ospolot must be discontinued immediately.
It is advisable to have your blood, liver function, and renal function tested before starting treatment with Ospolot;
once a week during the first month of treatment with Ospolot, and once a month after that. After the first six
months of treatment with Ospolot it is advisable to have these tests at least two to four times a year.
There are reports of some patients who were treated with anti-epileptic medicines such as Ospolot, who
expressed a wish to harm themselves, or experienced suicidal thoughts. If you have had such thoughts at any
time during treatment with Ospolot, consult your physician immediately.
Do not use this medicine if:
You have a known sensitivity to the active ingredient (Sulthiame), or to medicines from the sulphonamide
group, and/or to any of the other ingredients of this medicine (please refer to “Additional information”).
You suffer from hyperthyroidism.
You suffer or have previously suffered from acute porphyria.
You suffer from high blood pressure.
If you are taking or have recently taken other medicines, including non-prescription medications and
nutritional supplements, inform your physician or pharmacist.
In particular, inform the physician or the pharmacist
if you are taking:
Medicines for treating epilepsy:
Phenytoin - Levels of phenytoin in your blood may rise significantly. You must regularly have blood tests
during combination therapy with Ospolot and this medicine to monitor phenytoin levels in your blood. This
is particularly important if you have impaired renal function.
Lamotrigine - Levels of lamotrigine in your blood may rise. You must regularly have blood tests during
combination therapy with Ospolot and this medicine to monitor lamotrigine levels in your blood. This is
particularly important if you have impaired renal function.
Primidone - Combination therapy with Ospolot and primidone may cause severe side effects, especially
in children. These include dizziness, unstable gait, drowsiness, and psychotic reactions.
Carbamazepine - Combination therapy with Ospolot and carbamazepine may cause a decrease in
Ospolot levels in your blood.
Phenobarbitone - Ospolot may cause an increase in phenobarbitone levels in your blood.
Combination therapy with Ospolot and other carbonic anhydrase inhibitors, such as topiramate (used to treat
epilepsy and migraine) or acetazolamide (used to treat intraocular pressure) can increase the risk of side effects
Taking Ospolot and food
Ospolot can be taken with or without food. There are no restrictions on the types of food and drink you can have.
Taking Ospolot and alcohol
Do not drink alcoholic beverages during treatment with Ospolot.
Drinking alcoholic beverages during treatment with Ospolot can have an unexpected influence on the way Ospolot
affects you. It can also cause vasodilatation, pulsating headache, shortness of breath, nausea, vomiting, tachycardia,
hypotension, blurred vision, confusion, shock reaction, cardiac arrhythmia, loss of consciousness, and seizures.
Pregnancy and breastfeeding
Do not take Ospolot if you are pregnant or breastfeeding.
If you think you might be pregnant or you are planning to become pregnant, inform your physician so that he or she
may consider whether to stop treatment with Ospolot.
Ospolot passes into breast milk so do not take Ospolot if you are breastfeeding.
Driving and using machines
This medicine can cause changes in your reactions, so using Ospolot requires caution when driving a car,
operating dangerous machines and any other activity that requires alertness. Children must be warned from
riding bicycles, playing near roads, etc.
This warning applies especially when combining Ospolot with alcohol.
Important information about some of the medicine’s ingredients
Ospolot contains lactose. If you are intolerant to certain sugars consult your physician before starting treatment with
How should you use the medicine?
Always use according to the physician's instructions. You should check with the physician or with the pharmacist if you
are not sure.
The dosage and manner of treatment will be determined only by the physician. The recommended dose is
The accepted maintenance dosage is 5-10 mg per kilogram body weight, a day. This dose must be reached
gradually over the first week of Ospolot treatment.
Switching to Ospolot from another medicine or another combination must be done gradually, not all at once.
The tablets may be split on the score line.
Swallow the tablets with at least one glass of water.
Your daily dosage can be divided into three doses taken during the day.
Do not take Ospolot lying down.
If you have accidentally taken a higher dose, or if a child has accidentally swallowed the medicine, go
immediately to a hospital emergency room or to a physician and bring the medicine package with you. If this occurs,
the side effects listed in this leaflet can be intensified.
If you forget to take the medicine at the scheduled time, take the next dose at the usual time. Do not take a double
dose to compensate for the forgotten dose and inform your physician about it.
If you stop taking Ospolot you may compromise the success of your treatment and the seizures may return.
Do not stop treatment without consulting your physician about it. Treatment duration and dosage may vary between
patients; only your attending physician will determine duration and dosage.
If you have any further questions regarding the use of this medicine, consult the physician or the pharmacist.
As with any medicine, the use of Ospolot may cause side effects in some users. Do not be alarmed by reading the list
of side effects. You may not experience any of them.
Please pay special attention to those side effects which require you to consult a physician immediately and/or
stop treatment immediately and that are listed in the section "Before using this medicine" under the heading
"Special warnings regarding the use of this medicine".
Very common side effects:
gastrointestinal disturbances, anorexia, breathing difficulties that may develop into shortness of breath
Common side effects:
chest pressure, palpitations
tingling in the limbs and in the face
persistent hiccups, weight loss
Uncommon side effects:
hallucinations, anxiety, lack of motivation, depression, behavioral problems such as: aggressiveness, irritability,
muscle weakness, joint pain
increased number of seizures, grand-mal-status
leucopenia (low number of white blood cells)
Side effects of unknown frequency:
acute renal failure
polyneuritis, significant deterioration of vision
toxic reactions of the liver, abnormal levels of enzymes related to liver function
In one case, administration of Ospolot led to an increasing weakness of the limbs, hypersalivation, slurred speech and
drowsiness up to coma.
These symptoms disappeared within hours of Ospolot discontinuation.
Ospolot is a medicine from the carbonic anhydrase inhibitor group; this group causes side effects such as renal stones
and changes in blood composition (metabolic acidosis, hemodilution, changes in blood serum electrolyte values).
If any side effect appears, if any of the side effects worsens, or if you suffer from a side effect not mentioned in this
leaflet, consult with the physician.
Reporting side effects:
Side effects can be reported to the Ministry of Health (MoH) by clicking on the "Report on side effects due to
medication therapy" link on the MoH home page (www.health.gov.il) which refers to the online form for side effects
reporting, or by entering the link
How to store the medicine?
Avoid poisoning! This medicine and any other medicine should be kept in a close place out of the reach of children
and/or infants in order to avoid poisoning. Do not induce vomiting without an explicit instruction from the physician.
Do not take medicines in the dark! Check the label and the dose each time you take the medicine. Wear glasses if
you need them.
Do not use the medicine after the expiry date (exp. date) appearing on the outer package. The expiry date refers to
the last day of that month.
Do not store at a temperature above 25°C.
Use the medicine within 12 weeks after first opening.
Keep the container tightly closed.
Do not use the medicine if you notice that the color of the tablets has changed or if the tablets have swelled or seem
In addition to the active ingredient Sulthiame the medicine also contains:
Maize starch, Lactose monohydrate, Talc, Colloidal anhydrous silica, Gelatin, Magnesium stearate,
Hypromellose, Macrogol 4000, Titanium dioxide.
Each tablet contains 50 mg lactose monohydrate.
What does the medicine look like and what are the contents of the package:
Plastic or glass bottle containing 50 round, slightly curved, white film-coated tablets with a score line on one side and
the number "200" on the other side.
Registration holder and his address: MegaPharm Ltd., P.O.B. 519, Hod Hasharon 4510501.
Manufacturer and his address: Desitin Arzneimittel GmbH, Hamburg, Germany.
This leaflet was checked and approved by the Ministry of Health in January 2016.
Registration number of the medicine in the National Drug Registry of the Ministry of Health:
Summary of Product Characteristics (SPC)
1. NAME OF THE MEDICINAL PRODUCT
200 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 200 mg sulthiame.
Excipient(s) with known effect: one tablet contains 50.0 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White, round, slightly domed film-coated tablet with a dividing groove on one side and
marked “200” on the other side. The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of epilepsy in adults and in treatment of the so called focal benign epilepsy of
children, when other medication was not adequate
Treatment with Ospolot
should only be conducted by a paediatric neurologist with
sufficient experience in treating epilepsy.
Efficacy and safety of Ospolot
in the above-mentioned indication have not been
investigated in controlled studies. Prior to starting treatment with sulthiame, a thorough
differential diagnostic procedure regarding other types of childhood epilepsies is indicated.
Rolandic epilepsies demonstrate a high percentage of spontaneous remissions – even
without drug treatment – and usually show a favourable course of disease and a good
4.2 Posology and method of administration
The dosage must be established and monitored by the doctor on an individual basis. The
maintenance dose is about 5 to 10 mg/kg body weight/day. It should be built up step-wise
(tapered in) over a one-week period. Ospolot
200 mg film-coated tablets have a dividing
Due to the short half-life of sulthiame, the daily dose should as far as possible be spread
over three single doses. If the daily dose is spread over the day in this way, constant
plasma levels are to be expected after five to six days. Therapeutic plasma concentrations
of sulthiame have not yet been determined.
Method of administration
The film-coated tablets should be swallowed whole (unchewed) with plenty of liquid
(approx. one glass of water), as far as possible spread over 3 single doses.
A change from another medication or from combination treatment should be done
should not be discontinued abruptly. A paediatric neurologist
experienced in treating epilepsy should decide on dose adjustment, the duration of
treatment and discontinuation on an individual basis.
If therapy is not successful, treatment with sulthiame should be discontinued after about
one to two months.
It is recommendable to monitor the blood count, liver enzymes and renal function
parameters before treatment with Ospolot
, then at weekly intervals in the first month of
treatment, and thereafter at monthly intervals. After six months of treatment, two to four
checks per year are sufficient.
may not be used in cases of
known hypersensitivity to sulthiame, other sulphonamides or to any of the excipients
listed in section 6.1.
Sulthiame should not be used in patients with
known acute porphyria
hyperthyroidism or arterial hypertension.
4.4 Special warnings and precautions for use
Sulthiame should not be administered, or only administered with special caution and
in patients with impaired renal function
in patients with a history of psychiatric disorders
during pregnancy and lactation (see also section 4.6)
The patients, their caregivers, and families should be instructed to consult the attending
doctor immediately if fever, sore throat, allergic skin reactions with lymph node swelling
and/or flu-like symptoms occur during treatment with Ospolot. Progressive
thrombocytopenias or leukopenias that are accompanied by clinical symptoms, such as
fever or sore throat, require interruption of treatment. In cases of severe allergic reactions,
Ospolot must be discontinued immediately. Treatment should also be interrupted if a
lasting increase in creatinine occurs. The blood count, liver enzymes and urine should be
checked regularly (see also section 4.2).
Patients with rare hereditary problems of galactose intolerance, lactase deficiency or
glucose-galactose malabsorption should not take Ospolot®.
Suicidal ideation and suicidal behaviour
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic
agents in several indications. A meta-analysis of randomised placebo controlled trials of
anti-epileptic drugs has also shown a small increased risk of suicidal ideation and
behaviour. The mechanism of this risk is not known and the available data do not exclude
the possibility of an increased risk for sulthiame.
Therefore patients treated with any antiepileptic drug (AED) for any indication should be
monitored for the emergence or worsening of depression, suicidal thoughts or behaviour,
and / or any unusual changes in mood or behaviour and appropriate treatment should be
considered. Patients (and caregivers of patients) should be advised to seek medical
advice should signs of suicidal ideation or behaviour emerge.
Anyone considering prescribing sulthiame or any other AED must balance this risk with
the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are
prescribed are themselves associated with morbidity and mortality and an increased risk
of suicidal thoughts and behaviour. Should suicidal thoughts and behaviour emerge during
treatment, the prescriber needs to consider whether the emergence of these symptoms in
any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that AEDs increase the risk of
suicidal thoughts and behaviour and should be advised of the need to be alert for the
emergence or worsening of the signs and symptoms of depression, any unusual changes
in mood or behaviour, or the emergence of suicidal thoughts, behaviour, or thoughts about
self-harm. Behaviours of concern should be reported immediately to the treating doctor.
Effect on Laboratory Tests
Sulthiame may interfere with the estimation of barbiturates in laboratory tests on blood.
4.5 Interaction with other medicinal products and other forms of interaction
Prior to starting treatment with Ospolot
, the patient should be asked about other
medicines, including OTC products, he/she is using.
The concomitant use of sulthiame and primidone may lead to severe side-effects,
especially in children, including dizziness, unstable gait, drowsiness and psychotic
There are indications that sulthiame serum levels may decrease if carbamazepine is taken
If sulthiame is combined with phenytoin, the plasma levels of phenytoin can be markedly
elevated. This combination requires especially strict monitoring and frequent controls of
phenytoin plasma levels, particularly in the case of impaired renal function.
Phenobarbitone: Sulthiame may also induce a rise in the serum level of phenobarbitone.
In combination with lamotrigine, an elevation of lamotrigine levels in the blood has also
been observed in individual cases. Therefore, lamotrigine levels should be checked more
frequently at the beginning of such a treatment.
Concomitant use of sulthiame and other carbonic anhydrase inhibitors (e.g. topiramate,
acetazolamide) may increase the risk of undesirable effects due to carbonic anhydrase
inhibition (see also section 4.8).
During treatment with sulthiame, the patient should abstain from alcohol, since
sulphonamides have an effect similar to that of disulfiram, and sulthiame, as a
sulphonamide derivative, can theoretically have a similar effect. These symptoms include
a very unpleasant, although generally self-limiting systemic reaction caused by
vasodilatation, with pulsating headache, respiratory depression, nausea, vomiting,
tachycardia, hypotension, amblyopia, confusion, shock reactions, arrhythmias, loss of
consciousness and seizures. The degree and duration of these symptoms can vary to a
4.6 Fertility, pregnancy and lactation
No systematically gained experience on administration of sulthiame in humans during
pregnancy and lactation is available, in animal studies, embryotoxic effects have been
revealed (see also section 5.3). Therefore Ospolot
may not be used during pregnancy
4.7 Effects on ability to drive and use machines
Even when used as directed, these medicinal products can affect reactions to such an
extent - especially at the start of treatment - that the ability to drive a vehicle or use
machines may be impaired. This applies to a greater extent in combination with alcohol.
4.8 Undesirable effects
The following frequency categories are used for the evaluation of undesirable effects:
1/10,000 to < 1/1,000)
Not known (frequency cannot be estimated from the available data)
Metabolism and nutrition disorders
Very common: anorexia
hallucinations, anxiety, lack of drive, psychic changes, depression,
behavioural anomaly (e.g. aggressiveness, irritability, mood swings)
Nervous system disorders
ataxia, paraesthesias in the extremities and in the face (dose
dependent), dizziness (giddiness),
headache, myasthenic phenomena, grand-mal status, increased
seizure activity, drooling, insomnia
Not known: significant deterioration of vision
Respiratory, thoracic and mediastinal disorders
Very common: hyperpnoea, dyspnoea
tachypnoea, , singultus
gastric complaints (in about 10% of patients)
Uncommon: abdominal pain, nausea
hepatotoxic reactions, increase of liver enzymes
Skin and subcutaneous disorders
Uncommon: Stevens-Johnson syndrome,
Not Known: Rash, Lyell's syndrome
Musculoskeletal and connective tissue disorders
Renal and urinary disorders
acute renal failure
Blood and lymphatic system disorders
In one case, administration of Ospolot
led to progressive weakness of the limbs,
hypersalivation, slurred speech, increasing drowsiness up to coma. The symptoms abated
within hours of Ospolot
Sulthiame is a carbonic anhydrase inhibitor. Therefore, undesirable effects of carbonic
anhydrase inhibition, such as renal stone formation, metabolic acidosis, haemodilution
and changes in serum electrolyte values, cannot be excluded during administration of
sulthiame (see also section 4.5).
Disturbances in calcium and Vitamin D metabolism have been occasionally reported in
association with long-term anticonvulsant therapy.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
Any suspected adverse events should be reported to the Ministry of Health according to
the National Regulation by using an online form
Symptoms of intoxication
Headache, vomiting, hypotension, dizziness, ataxia, impaired consciousness, metabolic
acidosis, crystals in the urine. Sulthiame has a low toxicity. Overdoses of 4 to 5 g
sulthiame have been survived. The intake of about 20 g sulthiame by adults with the
intention of committing suicide was fatal in one case. In another case, a restitutio ad
integrum was achieved.
Treatment of intoxications
A specific antidote is not known. The standard measures (gastric lavage and active
charcoal) for minimising absorption and for maintaining vital functions should be taken.
Sodium bicarbonate can be infused to treat acidosis. Alkalising diuretic therapy is
recommended for preventing renal damage and crystalluria.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiepileptics
ATC code: N03AX03
Sulthiame belongs to the group of carbonic anhydrase inhibitors and displays an
anticonvulsant effect in the electroconvulsion test (rat and mouse) and in the convulsion
test with pentamethylene tetrazole (mouse).
5.2 Pharmacokinetic properties
Sulthiame pharmacokinetics were not systematically investigated in different age
categories in children and adolescents.
After oral administration, sulthiame is rapidly and completely absorbed, predominantly
from the upper section of the small intestine. Peak plasma concentrations are measured
after 1 - 5 hours.
About 29% of the active substance is bound to plasma proteins.
80 to 90% is eliminated with the urine and 10 to 20% with the faeces after biliary
secretion. Within 24 hours, 32% of the administered dose is excreted unchanged via the
5.3 Preclinical safety data
See section 4.9.
Long-term investigations on various animal species (rat, dog) have revealed no evidence
of dose-dependent toxic changes. With high doses, renal damage has been observed due
to crystallisation of the substance.
Carcinogenic and mutagenic potential
In three different in vivo and in vitro experimental models, no mutagenic potential of
sulthiame has been revealed. Long-term carcinogenicity studies have not been
Reproductive toxic properties of sulthiame are not sufficiently investigated. In an
embryotoxicity study on rats, embryotoxic effects have been revealed at the lowest
investigated dose (30 mg/kg/day). Studies on fertility disorders and effects on peri- and
postnatal development of the off-spring are lacking.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize Starch, Lactose monohydrate, Talc, colloidal anhydrous Silica, Gelatin,
Magnesium stearate, Hypromellose, Macrogol 4000, Titanium dioxide.
One tablet contains 50.0 mg lactose monohydrate.
6.3 Shelf life
The medicinal product should not be used after the expiry date (see folding box).
6.4 Special precautions for storage
Keep the container tightly closed.
Store below 25˚c
Use this medicine within 12 weeks after first opening
6.5 Nature and contents of container
Folding boxes containing 200 film-coated tablets in brown glass bottles with a child-proof
Folding boxes containing 200 film-coated tablets in polyethylene containers with a child-
proof polypropylene screw cap.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
DESITIN ARZNEIMITTEL GMBH
Weg beim Jäger 214
22335 Hamburg, Germany
8. LICENSE HOLDER
Megapharm Ltd. Hod Hasharon P.O.Box 519 4510501
9. MARKETING AUTHORISATION NUMBER
The format of this leaflet was determined by the ministry of health and its content was
checked and approved January 2016
OSP SPC 012016 P.1