Patient Information Leaflet

Dintoina 100 mg coated tablets

sodium phenytoin
Please read all of this leaflet carefully before taking this medicine because 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 other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Dintoina is and what it is used for
What you need to know before taking Dintoina
How to take Dintoina
Possible side effects
How to store Dintoina
Contents of the pack and other information

1. What Dintoina is and what it is used for

Dintoina contains the active substance sodium phenytoin.
It belongs to a group of medicines called "antiepileptics", which are used to treat epilepsy.
Sodium phenytoin (a non-sedative antiepileptic) acts against seizures and has no calming (sedative) effect, thus allowing good mental and physical performance.
Dintoina is used for the treatment of:

primary generalized seizures, except for "absence seizures" (epilepsy with absence seizures)
partial epileptic seizures
facial nerve pain (trigeminal neuralgia)
certain heart rhythm disorders (cardiac arrhythmias).

2. What you need to know before taking Dintoina

Do not take Dintoina

if you are allergic to phenytoin or to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to other medicines with a chemical structure similar to phenytoin (hydantoin derivatives).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dintoina:

if you are elderly, have liver problems or suffer from serious illnesses, as your doctor will prescribe a dosage appropriate to your condition
if you have a hereditary disorder (an enzyme deficiency) that may alter your body's response to the drug
if you are taking preparations containing St. John’s wort (Hypericum perforatum), as these may reduce the effectiveness of Dintoina when taken concomitantly (see section “Other medicines and Dintoina”)
if you belong to the Thai or Chinese ethnic population and test positive for a genetic variant (HLA-B*1502), as there is an increased risk of developing severe skin-related adverse reactions
if you are of Taiwanese, Japanese, Malaysian or Thai descent and tests have shown that you carry the CYP2C9*3 genetic variant.

If Dintoina is used during pregnancy, there is a risk of harm to the unborn child. Women of childbearing potential must use effective contraceptive measures during treatment with Dintoina (see section “Pregnancy, breastfeeding and fertility”).
Contact your doctor immediately if, during treatment with Dintoina:

you have thoughts of suicide or of harming yourself (a small number of people treated with antiepileptic medicines such as Dintoina have experienced such thoughts)
you experience a slowing of the heartbeat (bradycardia), shortness of breath and loss of consciousness, as there is a risk of developing potentially life-threatening heart rhythm and conduction disturbances. These may all be symptoms of sudden and unexpected cardiac arrest (known as cardiac arrest)
you develop swelling of certain glands (lymph nodes), your doctor will prescribe another medicine for seizures
you develop a skin rash characterized by red spots and blisters (purpuric, exfoliative or bullous rash), your doctor will discontinue treatment. If the rash is mild (morbilliform or scarlatiniform), treatment may be resumed after the rash has completely disappeared. However, if the rash reappears upon resumption of treatment, you must stop taking the medicine
you develop confusion, delirium (misinterpretation of reality) or psychosis (behavioral changes causing difficulty in relating to others), as these may indicate excessive levels of phenytoin in the blood. It may be helpful to inform friends and family members so they are aware of what could occur during treatment
you experience bone fractures, osteoporosis (decalcification of bones) or other changes, including decreased levels of calcium, phosphorus and vitamin D. Consult your doctor or pharmacist if you are on long-term treatment with antiepileptic drugs and have a history of osteoporosis.

If you suffer from both “grand mal” (epilepsy with tonic-clonic seizures) and “petit mal” (epilepsy with absence seizures), your doctor will add a specific treatment for petit mal.
Potentially life-threatening skin rashes have been reported with the use of phenytoin. Contact your doctor immediately and inform them that you are taking this medicine if you experience the following reactions:

Stevens-Johnson syndrome and toxic epidermal necrolysis, which initially appear as round red spots or circular patches, often accompanied by blisters on the central trunk. Other signs to watch for include mouth, throat, nose, genital or eye ulcers (conjunctivitis with red and swollen eyes). These potentially fatal skin reactions are often accompanied by flu-like symptoms. These rashes may progress to widespread blistering or skin peeling. The highest risk of such skin reactions occurs during the first weeks of treatment. If you have previously developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking phenytoin, you must never restart treatment
DRESS syndrome, a drug allergy reaction that usually, but not exclusively, presents with fever, skin rash, enlarged lymph nodes and an increase in a type of white blood cells.

If you abruptly stop taking Dintoina, you may experience epileptic seizures.
The dose reduction, discontinuation or substitution of Dintoina must be done gradually, following your doctor’s instructions.
Children
Your doctor will monitor certain parameters and assess the need for vitamin D supplementation.
Other medicines and Dintoina
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
It is particularly important that your doctor knows if you are taking any of the following medicines:

cumarin, blood-thinning medicines (anticoagulants), cimetidine, chloramphenicol, disulfiram, phenylbutazone, sulfaphenazole and isoniazid, as these increase the activity and side effects of Dintoina
corticosteroids, as their blood concentration may be altered by Dintoina
oral contraceptives, as their effectiveness may be reduced by Dintoina
medicines acting on the nervous system (barbiturates), as these reduce the activity of Dintoina in a variable and unpredictable manner
medicines used to treat depression (tricyclic antidepressants), as high doses may increase the risk of seizures. If you are taking these medicines, your doctor will prescribe an appropriate dosage of Dintoina
theophylline and carbamazepine, as these may reduce the blood concentration of Dintoina
preparations containing St. John’s wort (Hypericum perforatum), as these may reduce the effect of Dintoina. The reduced effectiveness of Dintoina may persist for at least 2 weeks after stopping St. John’s wort treatment. If you are taking St. John’s wort preparations together with Dintoina, your doctor may prescribe blood tests, discontinue St. John’s wort therapy and possibly adjust your Dintoina dosage
anticoagulants, e.g. rivaroxaban, dabigatran, apixaban, edoxaban
lacosamide
ticagrelor
valproate.

Results of certain laboratory tests (such as the metyrapone test and iodine bound to proteins test) may be altered by Dintoina.
Pregnancy, breastfeeding and fertility
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 and fertility
If you are of childbearing age or could become pregnant, your doctor will prescribe this medicine only after careful assessment of the benefit-risk balance.
If you are planning a pregnancy, your doctor will reassess the need for antiepileptic treatment.
Dintoina may cause serious birth defects. If you take Dintoina during pregnancy, the risk of your baby having a birth defect is up to 3 times higher than in women who do not take antiepileptic medicines. Serious birth defects observed include abnormalities of growth, skull, face, nails, fingers, heart, spinal cord and spine. Some of these may occur together as part of the fetal hydantoin syndrome.
Neurological development problems (brain development) have been observed in children born to mothers who took phenytoin during pregnancy. Some studies have shown that phenytoin negatively affects neurological development in children exposed in utero to phenytoin, while other studies have not found such an effect. The possibility of an effect on neurological development cannot be ruled out.
This risk increases if more than one medicine is taken to control seizures. Therefore, it is important to take only one antiepileptic medicine whenever possible.
If you are a woman of childbearing age and are not planning a pregnancy, you must use an effective contraceptive method during treatment with Dintoina. Dintoina may affect how hormonal contraceptives work, such as the contraceptive pill (birth control), making them less effective in preventing pregnancy. Consult your doctor, who will advise you on the most appropriate type of contraception to use during Dintoina treatment.
If you are a woman of childbearing age and are planning a pregnancy, consult your doctor before stopping contraception and before attempting to become pregnant, to evaluate switching to other appropriate treatments, in order to avoid exposing the fetus to phenytoin.
If you are pregnant or think you might be, inform your doctor immediately. Do not stop taking the medicine until you have discussed it with your doctor.
Stopping treatment without medical advice could cause seizures, which may be dangerous for you and the fetus. Your doctor may decide to change your treatment.
Breastfeeding
Sodium phenytoin, the active ingredient in Dintoina, passes into breast milk.
If you are breastfeeding, your doctor will evaluate the benefits and risks for the infant.
Driving and using machines
Dintoina may affect reaction times. Take this into account if you need to drive vehicles of any kind or perform tasks requiring normal levels of alertness.
Dintoina contains sodium
This medicine contains 9 mg of sodium (a main component of table salt) per tablet.
This corresponds to 0.5% of the maximum daily dietary intake recommended for an adult.

3. How to take Dintoina

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the optimal dose for your individual case by periodically monitoring
drug levels in your blood, so that you receive the lowest effective dose. This will allow you to achieve
the maximum therapeutic effect with the minimum risk of side effects.
Once the effective dose has been established, it may take several days before the beneficial effect of
the medicine becomes apparent.
If you have previously been treated with other therapies, switching to Dintoina will be done
gradually over 6–7 days. Treatment with Dintoina must be taken daily and continuously.
Adults
The initial dose (if you have not previously received other treatments) is 1 Dintoina tablet (100 mg)
taken 3 times daily with meals and at least half a glass of water. Your doctor may adjust this dose
depending on your response to treatment.
In most adults, the satisfactory maintenance dose ranges between 3 and 4 tablets per day.
Your doctor may increase the dose up to a maximum of 6 tablets per day, if necessary.
Children
The initial dose is 5 mg per kilogram of body weight per day, divided into 2 or 3 equal subdoses,
without exceeding 300 mg daily. This dose may be adjusted by the doctor according to the child's response.
The recommended daily dose is usually between 4 and 8 mg per kilogram of body weight.
In children over 6 years of age, the minimum adult dose may be required. As a general guide:

Children over 6 years of age: 1/2–1 tablet at a time, up to 2–3 times daily, always taken with food and some water.
Children under 6 years of age: 1/2–1 tablet per day, crushed or mixed with sugar, jam, or honey, and divided into 2–3 doses taken after meals.

If you take more Dintoina than you should
In case of accidental ingestion/overdose of Dintoina, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include:

rhythmic, oscillating, involuntary eye movements (nystagmus)
tendency to loss of muscular coordination (ataxia)
drowsiness
headache (cephalalgia)
vomiting
speech disturbances
mental confusion or irreversible brain dysfunction (non-recoverable brain damage) and cerebellar atrophy (a disorder of the cerebellum causing balance problems and tremors)
dizziness
muscle twitching
slowed heart rate (bradycardia), disturbances in heart rhythm and conduction (arrhythmia), which may lead to sudden and unexpected cardiac arrest.

If you forget to take Dintoina
Do not take a double dose to make up for the missed dose.
If you stop taking Dintoina
Do not stop taking Dintoina abruptly, as this may cause epileptic seizures.
Discontinuation of treatment must be done gradually, following your doctor's instructions.
If you have any 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 everybody gets them.
The following side effects may occur:
Rare (may affect up to 1 in 1,000 people):

inflammation of the liver (hepatitis)
decrease in certain blood cells (agranulocytosis)
blood disorders (thrombocytopenia, leucopenia, pancytopenia). Your doctor will ask you to have blood tests
cases of increased size of blood cells (macrocytosis) or production of abnormally shaped blood cells (megaloblastic anaemia). In these cases, your doctor will prescribe folic acid.

Very rare (may affect up to 1 in 10,000 people):

potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Not known (frequency cannot be estimated from the available data):

gastrointestinal effects such as nausea, vomiting, heartburn (dyspepsia) and constipation. These effects can be avoided by taking the medicine during or immediately after meals
slowing of the heartbeat (bradycardia), disturbances in heart rhythm and conduction (arrhythmia), which may lead to sudden and unexpected cardiac arrest
skin rashes (morbilliform or scarlatiniform), red spots on the body (purpura), skin lesions with exfoliation, blistering dermatitis
reduction in the number of a specific type of red blood cells (red cell aplasia)
swelling of the gums, in case of prolonged treatment with Dintoina. This phenomenon can be prevented or significantly reduced by careful oral and dental hygiene (repeated several times a day)
movement disorders (dyskinesia, chorea, dystonia, tremors and asterixis)
agitation, delirium and cerebellar atrophy (a disorder of the cerebellum causing balance problems and tremors)
allergic reaction to the medicine, potentially severe (DRESS syndrome), characterised by skin rash, fever, swollen lymph nodes and an increase in a type of white blood cells
bone diseases, including thinning of the bones (osteopenia and osteoporosis), reduced bone density and fractures. Contact your doctor or pharmacist if you have been on long-term treatment with an antiepileptic medicine, or if you have a history of osteoporosis, or if you are taking medicines called steroids
low levels of calcium, phosphorus and vitamin D in the blood
abnormal thyroid function test results.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects may help provide more information on the safety of this medicine.

5. How to store Dintoina

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. 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 Dintoina contains

The active substance is sodium phenytoin. Each tablet contains 100 mg of sodium phenytoin.
The other components are maize starch, microcrystalline cellulose, talc, anhydrous colloidal silicon dioxide, stearic acid, sodium carboxymethylcellulose, sodium starch glycolate (type A). Coating: hydroxypropylcellulose, silicone emulsion.

Description of the appearance of Dintoina and package contents
Dintoina is available as coated tablets.
It is supplied in packs of 30 tablets in blister packs.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. – via Cavour, 70 – 27035 Mede (PV)