LUMINAL 200 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the Patient

Luminal 200 mg/ml Solution for Injection

Phenobarbital

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Luminal Solution for Injection and what is it used for
2. What you need to know before taking Luminal Solution for Injection
3. How to take Luminal Solution for Injection
4. Possible side effects
5. Storage of Luminal Solution for Injection
6. Contents of the pack and further information

1. What is Luminal Solution for Injection and what is it used for

Luminal belongs to a group of medications called barbiturate antiepileptics.

This medication is indicated for the treatment of the following types of epilepsy:

Generalized tonic-clonic seizures and simple partial seizures.

This medication is used in cases of severe illness or when oral treatment is contraindicated.

2. What you need to know before taking Luminal Solution for Injection

Do not use Luminal Solution for Injection:

• If you are allergic to phenobarbital, barbiturates, or any of the other components of this medication (listed in section 6).
• If you have acute alcohol intoxication.
• If you have respiratory disease with evident breathing difficulties or obstruction.
• If you are taking sedatives or analgesics simultaneously.
• If you have intoxication with stimulants or sedative psychopharmaceuticals.
• If you have porphyria, liver or kidney function disorders, or severe heart damage.
• If you are taking atazanavir, saquinavir, daclatasvir, dasabuvir, dolutegravir, paritaprevir, ombitasvir, ledipasvir, simeprevir, or sofosbuvir.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication:

• If you require prolonged treatment (for 3 months), as you may develop a dependence syndrome,
• If you are taking vitamin D, as it may affect the metabolism of this vitamin,
• If you are an elderly person, as your biological functions are decreased and the dose may need to be reduced (see section "3. How to use Luminal Solution for Injection"),
• If your liver or kidneys are not functioning properly, your doctor should reduce the dose and perform frequent checks, as there is a risk of hepatic encephalopathy (see section "3. How to use Luminal Solution for Injection"),
• If you are an alcoholic, your doctor should reduce the dose,
• If it is administered to children, as the dose will need to be adjusted (see section "3. How to use Luminal Solution for Injection"). If treatment is prolonged, consult your doctor. In this case, preventive treatment for rickets should be initiated,
• In some patients (elderly, children...), excitement, restlessness, mental confusion, as well as irritability and hyperactivity in children, may appear,
• A small number of people treated with antiepileptic medications like Luminal have had thoughts of self-harm or suicide. If you have these thoughts at any time, contact your doctor immediately,
• If allergic reaction symptoms or liver problems appear, treatment should be discontinued, according to your doctor's instructions,
• Severe skin problems such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of this medication:
• • These skin eruptions (Stevens-Johnson syndrome and toxic epidermal necrolysis) initially appear as red, circular spots or patches, often with a central blister.
  • Symptoms of SJS/TEN may include blisters, peeling, or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands, or feet) with or without a rash.
  • Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen, red eyes).
  • These skin eruptions are often accompanied by flu-like symptoms such as fever, chills, or muscle pain.
  • The period of highest risk for the onset of severe skin reactions is during the first weeks of treatment.
  • If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Luminal, you should not use the medication again at any time.
  • If you develop a rash with signs of swelling and/or color change or symptoms such as skin itching, stop using Luminal, go to a doctor immediately, and inform them that you are using this medication.
  • The signs and symptoms of DRESS may include flu-like symptoms and a widespread rash with high body temperature and enlarged lymph nodes. Abnormal blood test results may include increased liver enzyme levels and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
  • The symptoms of AGEP appear at the start of treatment and may include a red, scaly, and widespread rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms) and blisters accompanied by fever.
  • If you develop severe skin reactions or any of the reactions mentioned above, contact your doctor or healthcare professional immediately.
• Tell your doctor if you notice that at the start of your treatment, the frequency of seizures increases or new types of convulsive seizures appear.
• Do not stop treatment abruptly, as it may cause convulsive seizures
• Do not drink alcohol with this medication to avoid increasing the sedative effect.

Woman of childbearing potential/Contraception

If you are a woman of childbearing potential and are not planning to become pregnant, you should use an effective method of birth control (contraception) during the entire treatment with phenobarbital and up to two months after the end of treatment. Phenobarbital may affect the functioning of hormonal contraceptives, such as birth control pills, and make them less effective in preventing pregnancy. Talk to your doctor, who will indicate the most suitable contraceptive for you while using phenobarbital.

If you are a woman of childbearing potential and are planning to become pregnant, talk to your doctor before stopping contraception and before becoming pregnant about the possibility of switching to other suitable treatments to avoid exposing the fetus to phenobarbital.

There is a risk of harm to the fetus if this medication is used during pregnancy. Women of childbearing potential must use effective contraceptive methods during treatment with this medication (see "Pregnancy and Breastfeeding").

Other medications and Luminal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Certain medications may interact with Luminal, and in these cases, it may be necessary to change the dose or discontinue treatment.

• Alcoholic beverages or medications containing alcohol,
• Antidepressants (treatment of depression),
• Methadone,
• Other central nervous system depressant medications: morphine derivatives (analgesics, antitussives, and replacement therapies), benzodiazepines, and other medications for treating anxiety, sedative antidepressants, hypnotics, neuroleptics, antihistamines H1 sedatives, central antihypertensives, baclofen, and thalidomide,
• Methotrexate (treatment of arthritis).
• Oral contraceptives (see section "Woman of childbearing potential/Contraception")

• Do not useLuminal with:

• Atazanavir, saquinavir (protease inhibitor used to treat HIV infection), daclatasvir, dasabuvir, dolutegravir, paritaprevir, ombitasvir, ledipasvir, simeprevir, sofosbuvir (medications used to treat hepatitis C in adults).

• You shouldbe cautiouswith combinations of the following medications:

• Ifosfamide (used in chemotherapy), if Luminal is used as treatment for epilepsy,
• Oral anticoagulants (used to prevent or delay blood coagulation),

• Protease inhibitors: antivirals such as amprenavir, indinavir, and nelfinavir,

• Cyclosporine, tacrolimus (reduce immune response),
• Corticosteroids,
• Digitoxin (medications that act on the cardiovascular system),
• Dihydropyridines (treatment of high blood pressure),
• Disopyramide (medication for treating tachycardias),
• Doxycycline (treatment of bacterial infections),
• Thyroid hormones (treatment of hypothyroidism),
• Hydroquinidine, quinidine (treatment of heart arrhythmias),
• Itraconazole (treatment of fungal infections),
• Montelukast (preventive treatment for asthma),
• Theophylline and its derivatives such as aminophylline (used as diuretics, vasodilators, or anti-asthmatics),
• Zidovudine (treatment of viral infections),
• Estrogens and progestogens (not used as contraceptives).

• You shouldconsidercombinations with the following medications:

• Estrogen-progestogen and progestogen-only contraceptives, as they may decrease the effectiveness of the contraceptive, and alternative contraceptive methods should be considered (see section "Woman of childbearing potential/Contraception"),
• Ritonavir, simeprevir, dolutegravir, as antiretrovirals of the protease inhibitor group, as they may decrease the effectiveness of the antiprotease,
• Anticancer medications, as they may lead to a risk of lower exposure to these medications for cancer treatment,
• Lamotrigine (antiepileptic),

• Medications such as beta-blockers: alprenolol, metoprolol, and propranolol (used for treating vascular disorders, anxiety, extrapyramidal disorders, or tremors),
• Carbamazepine (antiepileptic),
• Procarbazine (used in chemotherapy),
• Amitriptyline/amitriptyline oxide (antidepressants),
• Apixaban, ticagrelor (antithrombotics), as they may decrease the effectiveness.

• Effect of other medications on Luminal:

• Folic acid derivatives (treatment of certain vitamin deficiencies) decrease the effectiveness of phenobarbital.

• Other medication interactions with Luminal:

• Valproic acid (treatment of epilepsy and bipolar disorder),
• Phenytoin (antiepileptic).

Using Luminal Solution for Injection with food, drinks, and alcohol

During treatment with this medication, you should not consume alcoholic beverages.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Neurodevelopmental disorders (delays in development due to brain development disorders) have been reported among children exposed to phenobarbital during pregnancy. The risk studies are still contradictory.

Pregnancy

Phenobarbital crosses the placenta.

If used during pregnancy, phenobarbital may cause severe birth defects and affect the child's development as they grow. The reported birth defects include cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) and cardiac anomalies. Other congenital anomalies have also been reported, such as hypospadias (a malformation of the penis), a smaller-than-normal head size, and facial, nail, and finger anomalies. Babies born to mothers who use phenobarbital during pregnancy may also have a higher risk of being smaller than expected.

Neurodevelopmental disorders (delays in development due to brain development disorders) have been reported among children exposed to phenobarbital during pregnancy. The risk studies are still contradictory.

If you use phenobarbital during pregnancy, you have a higher risk than other women of having a child with birth defects that require medical treatment. In the general population, the basic risk of major malformations is 2-3%. This risk increases approximately 3 times in women who use Luminal.

You should not use phenobarbital if you are pregnant, unless no other treatment works.

Talk to your doctor immediately if you are pregnant. Your doctor should explain the possible effects of treatment with phenobarbital on your baby and the risks and benefits should be carefully evaluated. Do not stop using phenobarbital until you have consulted your doctor, as abrupt discontinuation of the medication may increase the risk of developing convulsions, which can have harmful effects on you and the fetus.

If you have used Luminal during the last trimester of pregnancy, adequate follow-up should be performed to detect possible disorders in the newborn, such as convulsions, excessive crying, muscle weakness, and sucking disorders.

Luminal may cause, in some cases, bleeding in newborns within the first 24 hours of life, if the mother is being treated with this medication.

As a preventive treatment, it is recommended to administer vitamin K1 orally to the mother before and at the time of birth, and adequate supplements to the newborn.

A dependence syndrome, a withdrawal syndrome (with convulsions, hyperreactivity), and rarely, a moderate withdrawal syndrome (with abnormal movements, sucking problems, and bone mineralization problems) may also occur.

Breastfeeding

If you are breastfeeding, it is not recommended to administer phenobarbital, as it passes into breast milk, which may have repercussions on the newborn.

Driving and using machines

This medication may cause symptoms such as drowsiness, dizziness, or vision changes, and may decrease your reaction ability. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor evaluates your response to this medication.

Luminal contains propylene glycol (E-1520), ethanol, and sodium

This medication contains 700 mg of propylene glycol (E-1520) per ml.

Concomitant administration with any substrate for alcohol dehydrogenase, such as ethanol, may cause severe adverse reactions in children under 5 years of age.

This medication contains 83 mg of alcohol (ethanol) per ml (0.83% p/v). The amount in 1 ml of this medication is equivalent to less than 3 ml of beer or 1 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

This medication contains less than 1 mmol of sodium (23 mg) per ml, which is essentially "sodium-free".

3. How to use Luminal Solution for Injection

Follow the administration instructions for this medication exactly as stated in this package leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Do not stop treatment abruptly, as it may cause convulsive seizures (see section "Warnings and Precautions"), and it is recommended to do so gradually.

Adults

The recommended starting dose is 50-100 mg per day. This dose should be administered divided into 2 daily doses. It can be administered intramuscularly or slowly intravenously after dilution.

The dose will be progressively adjusted to the individual maintenance dose.

The recommended maintenance dose is 50-250 mg per day.

Use in children

The starting and maintenance doses are 3 to 5 mg per kg of body weight per day, which can be administered in 2 daily doses. Administer slowly intravenously after dilution.

If treatment is prolonged, your doctor may recommend preventive treatment for rickets.

Patients with liver or kidney function disorders

If your liver or kidneys are not functioning properly, your doctor should evaluate the benefits and risks of administering this medication and adjust the dose according to your situation.

Elderly patients

Your doctor will adjust the dose, and clinical and plasma level monitoring will be necessary.

If you use more Luminal than you should

In case of overdose or accidental use, consult your doctor, pharmacist, or call the Toxicology Information Service immediately. Phone: 91 562 04 20.

After massive administration of the medication, nausea, vomiting, headache, obsession, mental confusion, and possibly coma accompanied by a characteristic neurovegetative state (with irregular bradypnea, tracheobronchial obstruction, and decreased blood pressure) may appear.

The indicated treatment in this case is forced diuresis, alkalization, respiratory assistance, antibiotic treatment, potassium intake, and even hemodialysis or peritoneal dialysis if necessary.

If you forget to use Luminal Solution for Injection

Inform your doctor or pharmacist if you think you have forgotten a dose.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Frequent Adverse Effects(may affect up to 1 in 10 patients):

• Alteration in hand tendons (Dupuytren's contractures),
• Allergic dermatitis, particularly eruptions associated with spots or redness, ending with desquamation (maculopapular eruptions, scarlatiniform or morbilliform),
• Increased gamma-glutamyltransferase, transaminases, and alkaline phosphatase in blood,
• Nausea, vomiting
• Somnolence (difficulty waking up, sometimes accompanied by speech problems)
• Disorders of thought and memory,
• Memory impairment,
• Behavioral disorders (such as agitation or aggression).

Infrequent Adverse Effects(may affect up to 1 in 100 patients):

• Mood changes,
• Sleep disorders/insomnia,
• Coordination and balance problems,
• Joint pain (arthralgia).

Rare Adverse Effects(may affect up to 1 in 1,000 patients):

• Attention alteration.

Unknown Frequency(cannot be estimated from available data)

• A condition in which the number of red blood cells, white blood cells, and platelets in the blood is lower than normal (pancytopenia),
• Aplastic anemia,
• Agranulocytosis,
• Anemia (reduction in the number and increase in the size of red blood cells) due to folic acid deficiency,
• Decrease in neutrophil count in blood (neutropenia),
• Leukopenia and thrombocytopenia (blood cell disorders),
• Loss of memories (amnesia),
• Abnormal muscle movement, such as tics, tremors (dyskinesia),
• Hepatitis,
• Bone disorders, including osteopenia and osteoporosis (bone decalcification) and fractures in patients with prolonged treatment with phenobarbital. Consult your doctor or pharmacist if you are undergoing prolonged treatment with antiepileptics, have a history of osteoporosis, or take steroids.
• Treatment should be discontinued if severe adverse reactions occur that affect liver function and/or skin or hypersensitivity reactions occur.
• Decreased serum thyroid hormones.
• Fixed eruption,
• Exfoliative dermatitis,
• Dependence.

If treatment is prolonged, you may develop psychological or physical dependence. Therefore, if your treatment is suddenly stopped, you may experience headache, muscle pain, anxiety, tension, restlessness, confusion, and irritability. In severe cases, other symptoms such as depersonalization, increased auditory sensitivity, tingling, and cramps in the limbs, intolerance to light, sounds, and physical contact, hallucinations, or convulsions may appear.

Possible severe skin reactions, including extremely rare cases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and exfoliative dermatitis. The symptoms of SSJ/TEN may include blisters, desquamation, or bleeding in any part of the skin (including lips, eyes, mouth, nose, genitals, hands, or feet) with or without eruption. You may also have symptoms similar to those of the flu, such as fever, chills, or muscle pain.

Drug reaction with eosinophilia and systemic symptoms (DRESS): the signs and symptoms of DRESS may include flu-like symptoms and a generalized rash with high body temperature and enlarged lymph nodes. Abnormal blood test results may include elevated liver enzyme levels and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

At the start of treatment, the symptoms of DRESS may include a red, scaly, and generalized rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms) and blisters accompanied by fever.

Caution should be exercised when substituting phenobarbital with another antiepileptic, such as phenytoin or carbamazepine, as they may rarely give rise to a cross-reaction between phenobarbital and either of the two medications.

Treatment should be discontinued if severe adverse reactions occur that affect liver function and/or skin or hypersensitivity reactions occur.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines:

www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Luminal Injectable Solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Luminal Injectable Solution

The active ingredient is phenobarbital.

The other excipients are: propylene glycol (E-1520), ethanol, sodium hydroxide, and water for injectable preparations.

Appearance of the Product and Package Contents

Class I glass ampoules.

Package containing 10 ampoules.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Prospectus: March 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/