LUMINALE 200 mg /Ml Injectable Solution

Зміст інструкції

1. LUMINALE 200 mg/ml injectable solution for intramuscular use
   1. What is LUMINALE and what is it used for
   2. What you need to know before using LUMINALE
   3. How to use LUMINALE
   4. Possible side effects
   5. How to store LUMINALE
   6. Contents of the pack and other information
2. LUMINALE 100 mg tablets
   1. What is LUMINALE and what is it used for
   2. Cosa deve sapere prima di prendere LUMINALE
   3. How to take LUMINALE
   4. Possible side effects
   5. How to store LUMINALE
   6. Contents of the pack and other information
3. LUMINALE 15 mg tablets
   1. What is LUMINALE and what is it used for
   2. What you need to know before taking LUMINALE
   3. How to take LUMINALE
   4. Possible side effects
   5. How to store LUMINALE
   6. Contents of the pack and other information

LUMINALE 200 mg/ml injectable solution for intramuscular use

Phenobarbital

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What LUMINALE is and what it is used for
• 2. What you need to know before you use LUMINALE
• 3. How to use LUMINALE
• 4. Possible side effects
• 5. How to store LUMINALE
• 6. Contents of the pack and other information

1. What is LUMINALE and what is it used for

LUMINALE contains the active ingredient phenobarbital, a sedative belonging to the group of
antiepileptic, barbiturate hypnotic drugs.
LUMINALE is primarily indicated as a general sedative, with particular regard to epilepsy
and all conditions requiring long-term sedation.
LUMINALE is particularly useful in focal epilepsy and in status epilepticus.
It can be used as a hypnotic and in the detoxification of chronic barbiturism (disintoxication
from chronic barbiturate use, hypnotic-sedative substances).

2. What you need to know before using LUMINALE

Do not use LUMINALE

• if you are allergic to phenobarbital, barbiturates or any of the other ingredients of this medicine (listed in section 6).
• in case of porphyria
• if you suffer from kidney and liver failure
• if you suffer from heart problems (severe heart disease)
• if you experience acute alcohol, analgesic, or hypnotic intoxication.
• if you are taking daclatasivir, dasabuvir, paritaprevir, ombitasvir, ledipasvir, sofosbuvir (medicines used against HIV and hepatitis C virus) (see "Other medicines and LUMINALE").

Warnings and precautions
Consult your doctor or pharmacist before using LUMINALE.
A small number of patients treated with antiepileptic drugs like LUMINALE have
developed self-harming or suicidal thoughts. If these thoughts emerge at any time, contact your doctor immediately.
Phenobarbital can cause habituation. Continued therapy induces the formation of liver enzymes
that accelerate the metabolism of some drugs, such as anticoagulants, some
antibiotics, adrenal steroids (hormones produced by the adrenal glands, located above the kidneys)
etc.
Preparations based on Hypericum perforatum (also known as St. John's wort) should not
be taken at the same time as medicines containing phenobarbital due to the risk of a
decrease in plasma levels and a decrease in the therapeutic efficacy of phenobarbital (see
section “Other medicines and LUMINALE”).
Abrupt discontinuation of treatment in epileptic patients can induce a state of status epilepticus.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and
DRESS syndrome) have been reported with the use of Luminale, these initially appear as
round red spots or circular patches often accompanied by blisters on the central
trunk.
Further signs to note include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
The rash may progress with the development of widespread blisters or exfoliation of the skin.
DRESS syndrome is also accompanied by changes in the values ​​of some blood components (blood count), enlargement of the glands and changes in other internal organs, such as the
liver.
The highest risk of developing severe skin reactions occurs within the first 8 weeks of
treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS syndrome, with the use of phenobarbital-based medicines, Luminale should no longer be
reused.
If you develop a rash or these skin symptoms, stop taking Luminale,
urgently consult a doctor and inform them that you are taking this medicine.

Other medicines and LUMINALE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The effects of Luminale may be influenced by or influence the following medicines.
The association between Luminale and the following medicines is contraindicated:

• Daclatasivir, dasabuvir, paritaprevir, ombitasvir, ledipasvir, sofosbuvir (used against HIV and hepatitis C virus), due to the possible decrease in their effectiveness.

The association between Luminale and the following medicines is not recommended:
St. John's Wort (Hypericum perforatum): the effectiveness of phenobarbital may be reduced by
the simultaneous administration of preparations based on Hypericum perforatum. This is due to
the induction of enzymes responsible for drug metabolism by preparations based on
Hypericum perforatum, which therefore should not be administered concurrently with
phenobarbital. The induction effect can persist for at least 2 weeks after discontinuation of
treatment with Hypericum perforatum products. If a patient is taking
simultaneously Hypericum perforatum products, blood levels of phenobarbital
must be monitored and therapy with Hypericum perforatum products must be
interrupted. Blood levels of phenobarbital may increase with discontinuation of
Hypericum perforatum intake. The dosage of phenobarbital may require adjustment.
Estroprogestins and progestins (hormones used as contraceptives), as Luminale
decreases contraceptive efficacy. If you are taking Luminale, you should use a different method
of contraception, such as a barrier contraceptive method (mechanical contraceptive).
(see section “Pregnancy and breastfeeding”).

LUMINALE with alcohol
The effect of alcohol is potentiated and the consumption of alcoholic beverages should be limited.
The association between Luminale and the following medicines requires particular caution (in some cases the
doctor may modify the doses):

• Cyclosporine(used to prevent rejection in organ transplants), as Luminale decreases its action.
• Corticosteroids(glucocorticoid, mineralcorticoid hormones, used against inflammation, in some diseases such as Addison's disease and in transplants), as Luminale decreases their action.
• Levothyroxine(used for the thyroid), as the doctor may modify the dosage.
• Theophyllineand all derivatives of theophylline (used for asthma), as Luminale decreases its action.
• Folic acid(used for anemias), as it decreases the action of Luminale.
• Valproic acid(used for seizures), as it increases the action of Luminale. Luminale, in turn, decreases the action of valproic acid. See your doctor if you feel excessive calmness (sedation). Your doctor will have blood tests done to measure the concentrations of Luminale and valproic acid in the blood. See your doctor if you experience nausea, vomiting, agitation, confusion, seizures, drowsiness, muscle coordination disorders (symptoms of hyperammonemia).
• Warfarin/dicoumarol(oral anticoagulants, used to make the blood more fluid), as Luminale decreases their action.
• Imipramine antidepressants(used for depression), as they promote the onset of seizures (generalized convulsive crises).
• Chloramphenicol, dextropropoxyphene: these drugs can increase plasma levels of phenobarbital, with a possible increase in phenobarbital toxicity.
• Antacids: these drugs can determine a reduced intestinal absorption of phenobarbital, with reduced antiepileptic efficacy and possible worsening of seizures.
• Phenytoin(used for seizures), as Luminale can vary its amount in the blood.
• Carbamazepine(used for seizures), as Luminale decreases its presence in the blood.
• Benzodiazepines: phenobarbital can increase metabolism and decrease plasma concentrations of benzodiazepines: if necessary, adjust the dose of these drugs.
• Haloperidol and other neuroleptics: phenobarbital can increase metabolism and decrease plasma concentrations of haloperidol and other neuroleptics: if necessary, adjust the dose of these drugs.
• Griseofulvin: phenobarbital can increase metabolism and decrease plasma concentrations of griseofulvin, with consequent reduced antifungal activity.
• Paroxetine, reboxetine: phenobarbital can reduce plasma levels of these drugs

Other associations to be considered

• Anticancer drugs: phenobarbital can increase the metabolism of anticancer drugs and reduce their therapeutic efficacy.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The need for antiepileptic treatment should be reassessed when the patient plans a
pregnancy. Women of childbearing potential should be informed of the risks and benefits
related to the use of phenobarbital during pregnancy.
The risk of congenital defects is increased (2 or 3 times) in the offspring of mothers treated with an
antiepileptic drug; those most frequently reported are cleft lip, cardiovascular malformations and neural tube defects (part of the embryo from which the brain and
spinal cord develop).
Polytherapy (therapy with more drugs) with antiepileptic drugs may be associated with a higher
risk of congenital malformations compared to monotherapy. Therefore, it is important to practice
monotherapy whenever possible.
Abrupt discontinuation of antiepileptic therapy should not be practiced due to the danger of a resumption
of epileptic seizures which could have serious consequences for both mother and child.
Women of childbearing potential should use a consistently effective method of contraception
during the entire treatment with Luminale and also in the two months following the end of therapy with
Luminale. Phenobarbital can interact with estroprogestins and progestins (used as
contraceptives), with decreased contraceptive efficacy due to increased hepatic catabolism.
Therefore, a different method of contraception, in particular of a mechanical type, should be preferred.
If a woman is planning a pregnancy, she should consider switching to an appropriate
alternative treatment before conception. If a woman becomes pregnant, the risks and benefits of treatment with Luminale should be carefully evaluated for both the woman and the fetus and whether
treatment with Luminale can continue or needs to be replaced with appropriate alternative treatment.
If treatment with Luminale must continue, use the lowest effective dose of
Luminale.
Exposure to phenobarbital in utero can potentially determine cognitive and
neurological alterations in the child.
Folic acid supplementation during pregnancy can help reduce the risk of
the onset of neurological defects in the newborn.
Breastfeeding
Phenobarbital crosses the placental barrier and is therefore excreted in breast milk. Consequently,
there is a small risk of sedation in the newborn. Therefore, breastfeeding is not recommended.
Fertility
Phenobarbital increases the plasma concentration of the sex hormone-binding protein
(SHBG) in both sexes. This can lead to a reduction in plasma levels of biologically
active testosterone and estradiol, with resulting menstrual disorders, sexual problems and reduced
fertility.

Driving and using machines
This medicine alters the ability to drive vehicles or use machinery as it reduces
attention and lengthens reaction times, so avoid driving or using machinery during the
treatment
Luminale 200 mg/ml injectable solution for intramuscular use contains 700 mg of propylene
glycol per vial. If the child is less than 4 weeks of age, talk to your doctor or pharmacist
before administering this medicine, especially if they are taking other medicines
containing propylene glycol or alcohol. Luminale 200 mg/ml injectable solution for intramuscular use
also contains small amounts of ethanol (alcohol) less than 100 mg per vial.

3. How to use LUMINALE

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose in adults is one vial per day by
intramuscular route. Do not exceed 400 mg in 24 hours. In children, 10 mg for each year of age starting
from 1 year.
In the treatment of elderly patients, the dosage must be carefully established by the doctor who
will have to evaluate a possible reduction of the aforementioned dosages.

If you use more LUMINALE than you should
Treatment of acute barbiturate poisoning involves immediate gastric lavage, if the
patient's condition allows.
Removal of the drug already absorbed can be achieved with forced diuresis (use of
diuretics that increase urine production) and urine alkalinization (reduction
of acidity). In the most severe cases, hemodialysis (artificial blood purification) is useful and
mechanical control of breathing may be necessary. The administration of antibiotics
is necessary to prevent the onset of pulmonary complications.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
For congenital malformations, see section “Pregnancy”

Rare side effects (may affect more than 1 in 1,000 people)

• allergic dermatitis, erythema multiforme, severe adverse skin reactions (SCARs) such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
• toxic hepatitis
• leukopenia (reduction of white blood cells), agranulocytosis (severe reduction of white blood cells), thrombocytopenia (reduction of platelets, which are small cell fragments necessary for blood coagulation) and purpura (blood spots on the skin).
• excitement, agitation and delirium. In pediatric patients, manifestations of psychomotor hyperactivity (inattention and impulsivity) may occur

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

• drug reaction with eosinophilia and systemic symptoms (DRESS).

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• bone marrow aplasia
• hypoprothrombinemia (reduction of prothrombin necessary for blood coagulation) sensitive to vitamin K therapy may occur in newborns of mothers treated with phenobarbital.
• During chronic treatments, megaloblastic anemia (reduction and increase in volume of red blood cells) sensitive to folate treatment and osteomalacia (loss of calcium from bones) that responds to vitamin D treatment may occur.
• Sedation, ataxia (disorder of the coordination of voluntary movements, which are performed without measure and with errors of direction), nystagmus (rapid and involuntary oscillation of the eyes) and mental confusion may occur, especially in the elderly, following the administration of high doses.
• Cases of bone disease including osteopenia and osteoporosis (thinning of the bones due to loss of calcium and phosphates) and fractures (resulting from calcium loss) have been reported. Contact your doctor or pharmacist if you have been on an antiepileptic drug for a long time, or if you have a history of osteoporosis, or if you are taking steroids.
• Altered mood, attention impairment, confused state

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 this leaflet. You can also report side effects directly to
adverse-reactions
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store LUMINALE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp.
The expiry date refers to the product in intact packaging, correctly
stored.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LUMINALE contains

• The active ingredient is phenobarbital. 1 vial contains 200 mg of phenobarbital (equivalent to 219 mg of sodium phenobarbital).
• The other ingredients are: propylene glycol, ethanol, water for injections.

Description of the appearance of LUMINALE and contents of the pack
Pack of 10 vials

Marketing Authorisation Holder
SUBSTIPHARM 24 rue Erlanger, 75016 Paris - France

Distributor for sales
SUBSTIPHARM S.r.l. Via Felice Casati, 20 – 20124 Milano

Manufacturer
Famar Italia S.p.A. – Via Zambeletti, 25 – 20021 Baranzate (MI)

LUMINALE 100 mg tablets

Phenobarbital

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What LUMINALE is and what it is used for
• 2. What you need to know before you take LUMINALE
• 3. How to take LUMINALE
• 4. Possible side effects
• 5. How to store LUMINALE
• 6. Contents of the pack and other information

1. What is LUMINALE and what is it used for

LUMINALE contains the active ingredient phenobarbital, a sedative belonging to the group of
antiepileptic, barbiturate hypnotic drugs.
LUMINALE is primarily indicated as a general sedative, with particular regard to epilepsy
and all conditions requiring long-term sedation.
LUMINALE is particularly useful in focal epilepsy and in status epilepticus.
It can be used as a hypnotic and in the detoxification of chronic barbiturism (disintoxication
from chronic use of barbiturates, hypnotic-sedative substances).

2. Cosa deve sapere prima di prendere LUMINALE

Non prenda LUMINALE

• se è allergico al fenobarbitale, ai barbiturici o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6).
• in caso di porfiria
• se soffre di insufficienza renale ed epatica
• se soffre di problemi al cuore (cardiopatie gravi)
• se manifesta intossicazioni acute da alcool, da analgesici, da ipnotici.
• se prende daclatasivir, dasabuvir, paritaprevir, ombitasvir, ledipasvir, sofosbuvir (farmaci utilizzati contro il virus dell’HIV e il virus dell’epatite C) (vedere "Altri medicinali e Luminale").

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere LUMINALE.
Un piccolo numero di pazienti in trattamento con farmaci antiepilettici come LUMINALE ha
sviluppato pensieri autolesivi o di suicidio. In qualunque momento emergano pensieri di questo
genere contattate immediatamente il medico curante.
Il fenobarbitale può dare assuefazione. La terapia continuata induce la formazione di enzimi epatici
che accelerano il metabolismo di alcuni farmaci, ad esempio degli anticoagulanti, di alcuni
antibiotici, degli steroidi surrenali (ormoni formati dai surreni, ghiandole poste al di sopra dei reni)
ecc.
Preparazioni a base di Hypericum perforatum (detta anche erba di San Giovanni) non dovrebbero
essere assunte in contemporanea con medicinali contenenti fenobarbitale a causa del rischio di un
decremento dei livelli plasmatici e di diminuzione dell'efficacia terapeutica del fenobarbitale (vedere
paragrafo “Altri medicinali e LUMINALE”).
La brusca sospensione del trattamento in pazienti epilettici può indurre uno stato di male epilettico.
Eruzioni cutanee potenzialmente letali (sindrome di Stevens-Johnson, necrolisi epidermica tossica e
sindrome di DRESS) sono state segnalate con l’uso di Luminale, queste appaiono inizialmente come
macchie rosse rotonde o chiazze circolari che spesso si accompagnano a vesciche nella parte centrale
del tronco.
Ulteriori segni da notare comprendono ulcere nella bocca, gola, naso, genitali e congiuntivite (occhi
rossi e gonfi).
Queste eruzioni cutanee potenzialmente letali per la vita sono spesso accompagnate da sintomi simil-
influenzali. L’eruzione può progredire con lo sviluppo di vesciche diffuse o esfoliazione della pelle.
La sindrome di DRESS è anche accompagnata da alterazioni dei valori di alcuni componenti del
sangue (emocromo), ingrossamento delle ghiandole e alterazioni di altri organi interni, come per
esempio il fegato.
Il più alto rischio di comparsa di reazioni cutanee gravi si verifica nelle prime 8 settimane di
trattamento.
Se avete sviluppato la sindrome di Stevens-Johnson o la necrolisi epidermica tossic o la sindrome di
DRESS, con l’uso di medicinali a base di fenobarbitale, il Luminale non deve essere più riutilizzato.
Se si sviluppano un rash cutaneo o questi sintomi cutanei, interrompere l’assunzione di Luminale,
consultare con urgenza un medico e informarlo che si sta assumendo questo farmaco.
Fenobarbitale può essere associato a disturbi cognitivi ed effetti negativi in merito all’umore (ad
esempio sintomi depressivi) con impatto sul benessere e qualità di vita. Relativamente a tali
possibilità i pazienti devono essere monitorati.
I farmaci antiepilettici, tra cui il fenobarbitale, così come l’epilessia di per sé, possono determinare
disfunzioni degli ormoni sessuali. E’ necessario considerare gli effetti ormonali indotti dall’epilessia
o dai farmaci antiepilettici quando si intraprende una terapia antiepilettica, specialmente se si
prevede la necessità di un trattamento a lungo termine.

Altri medicinali e LUMINALE
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere
qualsiasi altro medicinale.
Gli effetti di Luminale possono essere influenzati o influenzare i seguenti medicinali.
L’associazione tra Luminale ed i seguenti medicinali è controindicata:

• Daclatasivir, dasabuvir, paritaprevir, ombitasvir, ledipasvir, sofosbuvir (utilizzati contro il virus dell’HIV e il virus dell’epatite C), a causa della possibile diminuzione della loro efficacia.

L’associazione tra Luminale ed i seguenti medicinali è sconsigliata:
Erba di San Giovanni (Hypericum perforatum): l'efficacia del fenobarbitale può essere ridotta dalla
somministrazione contemporanea di preparazioni a base di Hypericum perforatum. Ciò a seguito
dell'induzione degli enzimi responsabili del metabolismo dei farmaci da parte di preparazioni a base
di Hypericum perforatum che pertanto non dovrebbero essere somministrate in concomitanza con
fenobarbitale. L'effetto di induzione può persistere per almeno 2 settimane dopo l'interruzione del
trattamento con prodotti a base di Hypericum perforatum. Se un paziente sta assumendo
contemporaneamente prodotti a base di Hypericum perforatum i livelli ematici di fenobarbitale
devono essere controllati e la terapia con prodotti a base di Hypericum perforatum deve essere
interrotta. I livelli ematici di fenobarbitale potrebbero aumentare con l'interruzione dell'assunzione di
Hypericum perforatum. Il dosaggio di fenobarbitale potrebbe necessitare di un aggiustamento.
Estroprogestinici e progestinici (ormoni utilizzati come anticoncezionali), poiché Luminale
diminuisce l'efficacia contraccettiva. Se sta prendendo Luminale, deve utilizzare un diverso metodo
contraccettivo come ad esempio un metodo contraccettivo di barriera (contraccettivo meccanico)
(vedere paragrafo “Gravidanza e allattamento”).

LUMINALE con alcol
L’effetto dell’alcol è potenziato e l’assunzione di bevande alcoliche dovrebbe essere limitata.
L’associazione tra Luminale ed i seguenti medicinali richiede particolare cautela (in alcuni
casi il medico potrebbe modificare le dosi):

• Ciclosporina(utilizzata per impedire il rigetto nei trapianti d'organo), poiché Luminale diminuisce la sua azione.
• Corticosteroidi(ormoni gluco-steroidi, mineral-corticoidi, utilizzati contro le infiammazioni, in alcune malattie come il morbo di Addison e nei trapianti), poiché Luminale iminuisce la loro azione.
• Levotiroxina(utilizzata per la tiroide), poiché il medico potrebbe modificare la posologia.
• Teofillinae per tutti i derivati della teofillina (utilizzata per l'asma), poiché Luminale diminuisce la sua azione.
• Acido folico(utilizzato per le anemie), poiché diminuisce l'azione di Luminale.
• Acido valproico(utilizzato per le convulsioni), poiché aumenta l'azione di Luminale. Il Luminale, a sua volta, diminuisce l’azione dell’acido valproico. Si rivolga al suo medico se avverte un senso di calma eccessiva (sedazione). Il suo medico le farà fare degli esami del sangue per misurare le concentrazioni di Luminale e di acido valproico nel sangue. Si rivolga al suo medico se avverte nausea, vomito, agitazione, confusione, convulsioni, sonnolenza, disturbi della coordinazione muscolare (sintomi di iperammoniemia).
• Warfarin/dicumarolo(anticoagulanti orali, utilizzati per rendere il sangue più fluido), poiché Luminale diminuisce la loro azione.
• Antidepressivi imipraminici(utilizzati per la depressione), poiché favoriscono la comparsa di convulsioni (crisi convulsive generalizzate).
• Cloramfenicolo, destropropossifene: questi farmaci possono incrementare i livelli plasmatici di fenobarbitale, con conseguente possibile aumento della tossicità di fenobarbitale.
• Antiacidi: questi farmaci possono determinare un ridotto assorbimento intestinale di fenobarbitale, con efficacia antiepilettica ridotta e possibile peggioramento delle convulsioni.
• Fenitoina(utilizzata per le convulsioni), poiché Luminale può variare la sua quantità nel sangue.
• Carbamazepina(utilizzata per le convulsioni), poiché Luminale diminuisce la sua presenza nel sangue.
• Benzodiazepine: fenobarbitale può aumentare il metabolismo e diminuire le concentrazioni plasmatiche delle benzodiazepine: se necessario adeguare la dose di questi farmaci.
• Aloperidolo e altri neurolettici: fenobarbitale può aumentare il metabolismo e diminuire le concentrazioni plasmatiche dell’aloperidolo e altri neurolettici: se necessario adeguare la dose di questi farmaci.
• Griseofulvina: fenobarbitale può aumentare il metabolismo e diminuire le concentrazioni plasmatiche di griseofulvina, con conseguente ridotta attività antifungina.
• Paroxetina, reboxetina: fenobarbitale può ridurre i livelli plasmatici di questi farmaci

Altre associazioni da prendere in considerazione

• Farmaci anticancro: fenobarbitale può aumentare il metabolismo dei farmaci anticancro e ridurre la loro efficacia terapeutica.

Gravidanza, allattamento e fertilità
Gravidanza
Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza, o se sta allattando con
latte materno chieda consiglio al medico o al farmacista prima di prendere questo medicinale.
La necessità del trattamento antiepilettico deve essere rivalutata quando la paziente pianifica una
gravidanza. Le donne in età fertile devono essere informate dei rischi e dei benefici relativi all’uso di
fenobarbitale durante la gravidanza.
Il rischio di difetti congeniti è aumentato (di 2 o 3 volte) nella prole di madri trattate con un
antiepilettico; quelli più frequentemente riportati sono labbro leporino, malformazioni
cardiovascolari e difetti del tubo neurale (parte dell’embrione da cui si sviluppa il cervello ed il
midollo spinale).
La politerapia (terapia con più farmaci) con farmaci antiepilettici può essere associata con un rischio
più alto di malformazioni congenite rispetto alla monoterapia. Perciò è importante che si pratichi la
monoterapia ogni volta che sia possibile.
Non si deve praticare una brusca interruzione della terapia antiepilettica per il pericolo di una ripresa
di attacchi epilettici che potrebbe avere gravi conseguenze sia per la madre che per il bambino.
Le donne in età fertile devono usare in maniera continuativa un efficace metodo contraccettivo
durante l’intero trattamento con Luminale e anche nei due mesi successivi alla fine della terapia con
Luminale. Fenobarbitale può interagire con estroprogestinici e progestinici (utilizzati quali
anticoncezionali), con diminuzione dell’efficacia contraccettiva per aumentato catabolismo epatico.
Pertanto, si deve di preferenza utilizzare un diverso metodo contraccettivo, in particolare di tipo
meccanico.
Se una donna pianifica una gravidanza, deve prendere in considerazione di passare ad un appropriato
trattamento alternativo prima del concepimento. Se una donna rimane incinta, si devono valutare
attentamente rischi e benefici del trattamento con Luminale sia per la donna che per il feto e se il
trattamento con Luminale può continuare o è necessario sostituirlo con un trattamento alternativo
appropriato. Se il trattamento con Luminale deve proseguire, utilizzare la dose efficace più bassa di
Luminale.
L’esposizione al fenobarbitale in utero può potenzialmente determinare alterazioni cognitive e
neurologiche nel bambino.
La supplementazione con acido folico durante la gravidanza può aiutare a ridurre il rischio di
insorgenza di difetti neurologici nel neonato.
Allattamento
Fenobarbitale attraversa la barriera placentare ed è quindi escreto nel latte materno. Di conseguenza,
esiste un piccolo rischio di sedazione nel neonato. Pertanto, l’allattamento al seno è sconsigliato.
Fertilità
Fenobarbitale aumenta la concentrazione plasmatica della proteina legante gli ormoni sessuali
(SHBG) in entrambi i sessi. Ciò può determinare una riduzione dei livelli plasmatici biologicamente
attivi di testosterone ed estradiolo, con conseguenti disturbi mestruali, problemi sessuali e riduzione
della fertilità.

Guida di veicoli e utilizzo di macchinari
Questo medicinale altera la capacità di guidare veicoli o di usare macchinari in quanto riduce
l’attenzione e allunga il tempo dei riflessi, pertanto eviti di guidare o usare macchinari durante il
trattamento

3. How to take LUMINALE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
As a sedative, the recommended dose is from 50 to 100 mg (half/one tablet) per day. As an
anticonvulsant, the recommended dose in adults is from 100 to 300 mg (1-3 tablets) per day
in two - three times. In children, the doses should be reduced (from 100 to 20 mg) according to age and weight and the LUMINALE 15 mg tablets preparation is indicated.
In severe insomnia, the recommended dose is from 50 to 200 mg (from half to 2 tablets) in the evening,
one hour before bedtime. The tablets can be broken up in a little water or
possibly added to food.
In the treatment of elderly patients, the dosage must be carefully established by the doctor who
will have to evaluate a possible reduction of the dosages mentioned above.

If you take more LUMINALE than you should
Treatment of acute barbiturate poisoning involves immediate gastric lavage, if the
patient's conditions allow it.
Removal of the drug already absorbed can be obtained with forced diuresis (use of
diuretics that increase urine production) and urine alkalinization (reduction
of acidity). In the most severe cases, it is useful to resort to hemodialysis (artificial blood purification) and
it may be necessary to mechanically control breathing. The administration of antibiotics
is necessary to prevent the onset of pulmonary complications.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
For congenital malformations see section “Pregnancy”

Rare side effects (may affect more than 1 in 1,000 people)

• allergic dermatitis, erythema multiforme, severe adverse skin reactions (SCARs) such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
• toxic hepatitis
• leukopenia (decrease in white blood cells), agranulocytosis (severe decrease in white blood cells), thrombocytopenia (decrease in platelets, which are small cell fragments necessary for blood clotting) and purpura (blood spots on the skin).
• excitement, agitation and delirium. In pediatric patients, manifestations of psychomotor hyperactivity (inattention and impulsivity) may occur

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

• drug reaction with eosinophilia and systemic symptoms (DRESS).

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• bone marrow aplasia
• hypoprothrombinemia (reduction of prothrombin necessary for blood clotting) sensitive to vitamin K therapy may occur in newborns of mothers treated with phenobarbital.
• During chronic treatments, megaloblastic anemia (reduction and increase in volume of red blood cells) sensitive to folate treatment and osteomalacia (loss of calcium from bones) that responds to vitamin D treatment may occur.
• Sedation, ataxia (disorder of the coordination of voluntary movements, which are performed without measure and with errors of direction), nystagmus (rapid and involuntary oscillation of the eyes) and mental confusion may occur, especially in the elderly, following the administration of high doses.
• Cases of bone pathology including osteopenia and osteoporosis (thinning of the bones due to loss of calcium and phosphates) and fractures (resulting from calcium loss) have been reported. Contact your doctor or pharmacist if you have been on an antiepileptic drug for a long time, or if you have a history of osteoporosis, or if you are taking steroids.
• Altered mood, attention impairment, confused state

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to
adverse-reactions
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store LUMINALE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Scad.
The expiry date refers to the product in intact packaging, correctly
stored.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LUMINALE contains

• 1 tablet contains 100 mg of phenobarbital.
• The other ingredients are: talc, povidone, stearic acid, corn starch.

Description of the appearance of LUMINALE and contents of the pack
Pack of 20 tablets

Marketing Authorisation Holder
SUBSTIPHARM 24 rue Erlanger, 75016 Paris - France

Distributor for sale
SUBSTIPHARM S.r.l. Via Felice Casati, 20 – 20124 Milano

Manufacturers
Famar Italia S.p.A. – Via Zambeletti, 25 – 20021 Baranzate (MI)

LUMINALE 15 mg tablets

Phenobarbital

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What LUMINALE is and what it is used for
• 2. What you need to know before you take LUMINALE
• 3. How to take LUMINALE
• 4. Possible side effects
• 5. How to store LUMINALE
• 6. Contents of the pack and other information

1. What is LUMINALE and what is it used for

LUMINALE contains the active ingredient phenobarbital, a sedative belonging to the group of
antiepileptic, barbiturate hypnotics.
LUMINALE is primarily indicated as a general sedative, with particular regard
to epilepsy and all conditions requiring long-term sedation.
LUMINALE is particularly useful in focal epilepsy and in status epilepticus. However, the low
dosage of phenobarbital present in the preparation allows reaching adequate blood levels only
in children. LUMINALE can also be used as a hypnotic.

2. What you need to know before taking LUMINALE

Do not take LUMINALE

• if you are allergic to phenobarbital, barbiturates or any of the other ingredients of this medicine (listed in section 6).
• in case of porphyria
• if you suffer from kidney and liver failure
• if you suffer from heart problems (severe heart disease)
• if you experience acute alcohol, analgesic, hypnotic poisoning
• if you are taking daclatasivir, dasabuvir, paritaprevir, ombitasvir, ledipasvir, sofosbuvir (medicines used against HIV and hepatitis C virus) (see "Other medicines and LUMINALE").

Warnings and precautions
Consult your doctor or pharmacist before taking LUMINALE.
A small number of patients treated with antiepileptic drugs such as LUMINALE have
developed self-harming or suicidal thoughts. If thoughts of this kind emerge at any time, contact your doctor immediately.
Phenobarbital can cause habituation. Continued therapy induces the formation of liver enzymes
that accelerate the metabolism of some drugs, for example anticoagulants, some
antibiotics, adrenal steroids (hormones produced by the adrenal glands, located above the kidneys)
etc.
Preparations based on Hypericum perforatum (also known as St. John's wort) should not
be taken at the same time as medicines containing phenobarbital due to the risk of a
decrease in plasma levels and a decrease in the therapeutic efficacy of phenobarbital (see
paragraph “Other medicines and LUMINALE”).
Abrupt discontinuation of treatment in epileptic patients can induce a state of status epilepticus.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and
DRESS syndrome) have been reported with the use of LUMINALE, these initially appear
as round red spots or circular patches often accompanied by blisters on the central part of the trunk.
Further signs to note include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
The rash may progress with the development of widespread blisters or exfoliation of the skin.
DRESS syndrome is also accompanied by changes in the values of some blood components (blood count), enlargement of the glands and changes in other internal organs, such as the
liver.
The highest risk of developing severe skin reactions occurs in the first 8 weeks of
treatment.
If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome,
with the use of phenobarbital-based medicines, LUMINALE should no longer be
reused.
If you develop a skin rash or these skin symptoms, stop taking
LUMINALE, urgently consult a doctor and inform them that you are taking this medicine.

Other medicines and LUMINALE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The effects of Luminale may be affected by or affect the following medicines.
The association between Luminale and the following medicines is contraindicated:

• Daclatasivir, dasabuvir, paritaprevir, ombitasvir, ledipasvir, sofosbuvir (used against HIV and hepatitis C virus), due to the possible decrease in their efficacy.

The association between Luminale and the following medicines is not recommended:
St. John's Wort (Hypericum perforatum): the efficacy of phenobarbital may be reduced by
the simultaneous administration of preparations based on Hypericum perforatum. This is due to
the induction of enzymes responsible for drug metabolism by preparations based on
Hypericum perforatum, which therefore should not be administered concurrently with
phenobarbital. The induction effect can persist for at least 2 weeks after discontinuation of
treatment with Hypericum perforatum products. If a patient is taking
Hypericum perforatum products simultaneously, blood levels of phenobarbital
must be monitored and treatment with Hypericum perforatum products must be
interrupted. Blood levels of phenobarbital may increase with discontinuation of
Hypericum perforatum. The dosage of phenobarbital may need to be adjusted.
Estroprogestins and progestins (hormones used as contraceptives), as Luminale
decreases their contraceptive efficacy. If you are taking Luminale, you should use a different
method of contraception, such as a barrier contraceptive (mechanical contraceptive). (see paragraph “Pregnancy and breastfeeding”).

LUMINALE with alcohol
The effect of alcohol is potentiated and the consumption of alcoholic beverages should be limited.
The association between Luminale and the following medicines requires particular caution (in some
cases the doctor may modify the doses):

• Cyclosporine(used to prevent rejection in organ transplants), as Luminale decreases its action.
• Corticosteroids(glucocorticoid, mineralocorticoid hormones, used against inflammation, in some diseases such as Addison's disease and in transplants), as Luminale decreases their action.
• Levothyroxine(used for the thyroid), as the doctor may modify the dosage.
• Theophyllineand all derivatives of theophylline (used for asthma), as Luminale

decreases its action.

• Folic acid(used for anemia), as it decreases the action of Luminale.
• Valproic acid(used for seizures), as it increases the action of Luminale. Luminale, in turn, decreases the action of valproic acid. Contact your doctor if you feel excessive calmness (sedation). Your doctor will have blood tests done to measure the concentrations of Luminale and valproic acid in the blood. Contact your doctor if you experience nausea, vomiting, agitation, confusion, seizures, drowsiness, muscle coordination disorders (symptoms of hyperammonemia).
• Warfarin/dicoumarol(oral anticoagulants, used to make the blood more fluid), as Luminale decreases their action.
• Imipramine antidepressants(used for depression), as they promote the onset of seizures (generalized convulsive crises).
• Chloramphenicol, dextropropoxyphene: these drugs can increase plasma levels of phenobarbital, with a possible increase in phenobarbital toxicity.
• Antacids: these drugs can determine a reduced intestinal absorption of phenobarbital, with reduced antiepileptic efficacy and possible worsening of seizures.
• Phenytoin(used for seizures), as Luminale can vary its amount in the blood.
• Carbamazepine(used for seizures), as Luminale decreases its presence in the blood.
• Benzodiazepines: phenobarbital can increase metabolism and decrease plasma concentrations of benzodiazepines: if necessary, adjust the dose of these drugs.
• Haloperidol and other neuroleptics: phenobarbital can increase metabolism and decrease plasma concentrations of haloperidol and other neuroleptics: if necessary, adjust the dose of these drugs.
• Griseofulvin: phenobarbital can increase metabolism and decrease plasma concentrations of griseofulvin, with resulting reduced antifungal activity.
• Paroxetine, reboxetine: phenobarbital can reduce plasma levels of these drugs

Other associations to be considered

• Anticancer drugs: phenobarbital can increase the metabolism of anticancer drugs and reduce their therapeutic efficacy.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The need for antiepileptic treatment should be reassessed when the patient plans a
pregnancy. Women of childbearing age should be informed of the risks and benefits
related to the use of phenobarbital during pregnancy.
The risk of congenital defects is increased (by 2 or 3 times) in the offspring of mothers treated with an
antiepileptic drug; those most frequently reported are cleft lip, cardiovascular malformations and neural tube defects (part of the embryo from which the brain and
spinal cord develop).
Polytherapy (therapy with multiple drugs) with antiepileptic drugs may be associated with a higher
risk of congenital malformations compared to monotherapy. Therefore, it is important to practice
monotherapy whenever possible.
Abrupt discontinuation of antiepileptic therapy should not be practiced due to the danger of a resumption
of epileptic seizures which could have serious consequences for both mother and child.
Women of childbearing age should use a continuous effective method of contraception
during the entire treatment with Luminale and also in the two months following the end of therapy with
Luminale. Phenobarbital can interact with estroprogestins and progestins (used as
contraceptives), with decreased contraceptive efficacy due to increased hepatic catabolism.
Therefore, a different method of contraception, in particular of a mechanical type, should be preferred.
If a woman plans a pregnancy, she should consider switching to an appropriate
alternative treatment before conception. If a woman becomes pregnant, the risks and benefits of treatment with Luminale should be carefully evaluated for both the woman and the fetus and whether
treatment with Luminale can continue or needs to be replaced with an appropriate alternative
treatment. If treatment with Luminale must continue, use the lowest effective dose of
Luminale.
Exposure to phenobarbital in utero can potentially determine cognitive and
neurological alterations in the child.
Supplementation with folic acid during pregnancy can help reduce the risk of
the onset of neurological defects in the newborn.
Breastfeeding
Phenobarbital crosses the placental barrier and is therefore excreted in breast milk. Consequently,
there is a small risk of sedation in the newborn. Therefore, breastfeeding is not recommended.
Fertility
Phenobarbital increases the plasma concentration of the sex hormone binding protein
(SHBG) in both sexes. This can lead to a reduction in the plasma levels biologically
active of testosterone and estradiol, with resulting menstrual disorders, sexual problems and reduction
of fertility.

Driving and using machines
This medicine alters the ability to drive vehicles or use machines as it reduces
attention and lengthens reaction times, therefore avoid driving or using machines during
treatment.

3. How to take LUMINALE

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is 1 to 3 tablets 3 times a day.
In the treatment of elderly patients, the dosage must be carefully established by the doctor who
will have to evaluate a possible reduction of the above dosages.

If you take more LUMINALE than you should
Treatment of acute barbiturate poisoning involves immediate gastric lavage, if the
patient's conditions allow it.
Removal of the drug already absorbed can be obtained with forced diuresis (use of
diuretics that increase urine production) and alkalinization of the urine (reduction
of acidity). In the most severe cases, hemodialysis (artificial blood purification) is useful and
mechanical control of breathing may be necessary. The administration of antibiotics
is necessary to prevent the onset of pulmonary complications.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
For congenital malformations, see section “Pregnancy”

Rare side effects (may affect more than 1 in 1,000 people)

• allergic dermatitis, erythema multiforme, severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
• toxic hepatitis
• leukopenia (decreased white blood cells), agranulocytosis (severe decrease in white blood cells), thrombocytopenia (decreased platelets, which are small cell parts necessary for blood clotting) and purpura (blood spots on the skin).
• excitement, agitation and delirium. In pediatric patients, manifestations of psychomotor hyperactivity (inattention and impulsivity) may occur

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

• drug reaction with eosinophilia and systemic symptoms (DRESS).

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• bone marrow aplasia
• hypoprothrombinemia (reduction of prothrombin necessary for blood clotting) sensitive to vitamin K therapy may occur in newborns of mothers treated with phenobarbital. During chronic treatments, megaloblastic anemia (reduction and increase in volume of red blood cells) sensitive to folate treatment and osteomalacia (loss of calcium from bones) that responds to vitamin D treatment may occur.
• Sedation, ataxia (disorder of the coordination of voluntary movements, which are performed without measure and with errors of direction), nystagmus (rapid and involuntary oscillation of the eyes) and mental confusion may occur, especially in the elderly, following the administration of high doses.
• Cases of bone pathology including osteopenia and osteoporosis (thinning of the bones due to loss of calcium and phosphates) and fractures (resulting from calcium loss) have been reported. Contact your doctor or pharmacist if you have been taking an antiepileptic drug for a long time, or if you have a history of osteoporosis, or if you are taking steroids.
• Altered mood, attention impairment, confused state

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to
adverse-reactions .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store LUMINALE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Scad.
The expiry date refers to the product in intact packaging, correctly
stored.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LUMINALE contains

• The active ingredient is phenobarbital. 1 tablet contains 15 mg of phenobarbital. The other ingredients are: talc, povidone, stearic acid, corn starch.

Description of the appearance of LUMINALE and contents of the pack
Pack of 30 tablets

Marketing Authorisation Holder
SUBSTIPHARM 24 rue Erlanger, 75016 Paris - France

Distributor for sale
SUBSTIPHARM S.r.l. Via Felice Casati, 20 – 20124 Milano

Manufacturer
Famar Italia S.p.A. – Via Zambeletti, 25 – 20021 – Baranzate (MI)