Luminal 200 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Luminal 200 mg/ml injectable solution

phenobarbital

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

1. What Luminal injectable solution is and what it is used for
2. What you need to know before using Luminal injectable solution
3. How to use Luminal injectable solution
4. Possible adverse effects
5. How to store Luminal injectable solution
6. Contents of the pack and other information

1. What Luminal injectable solution is and what it is used for

Luminal belongs to a group of medicines called antiepileptic barbiturates.

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

generalized tonic-clonic seizures and simple partial seizures.

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

2. What you need to know before using Luminal injectable solution

Do not use Luminal injectable solution:

• If you are allergic to phenobarbital, barbiturates, or any of the other components of this medicine (listed in section 6).
• If you have acute alcohol intoxication.
• If you have a respiratory disease where breathing difficulty or obstruction is evident.
• If you are simultaneously taking hypnotics or analgesics.
• If you have intoxication due to stimulants or sedative psychotropic drugs.
• 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 medicine:

• If long-term treatment (for 3 months) is required, as you may develop dependence syndrome.
• If you are taking vitamin D, as it may affect the metabolism of this vitamin.
• If you are elderly, since your biological functions may be reduced and dose adjustment may be necessary (see section “3. How to use Luminal injectable solution”).
• If your liver or kidneys do not function properly, your doctor must reduce the dose and perform frequent monitoring, as there is a risk of hepatic encephalopathy (see section “3. How to use Luminal injectable solution”).
• If you are an alcoholic, your doctor should reduce the dose.
• If administered to children, dose adjustment will be necessary (see section “3. How to use Luminal injectable solution”). If treatment is prolonged, consult your doctor. In this case, preventive treatment for rickets should be initiated.
• In some patients (elderly, children, etc.), excitement, restlessness, mental confusion, irritability, and hyperactivity in children may occur.
• A small number of patients treated with antiepileptic medicines such as Luminal have experienced thoughts of self-harm or suicide. If you have such thoughts at any time, contact your doctor immediately.
• If symptoms of allergic reaction or liver problems occur, treatment must be discontinued as directed by your doctor.
• Serious skin problems have been reported with the use of this medicine, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP):
  • These skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) initially appear as red spots or circular patches, often with a central blister.
  • Symptoms of SJS/TEN may include blistering, peeling, or bleeding of the skin anywhere on the body (including lips, eyes, mouth, nose, genitals, hands, or feet), with or without rash.
  • Other additional signs may include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).
  • These skin rashes are often accompanied by flu-like symptoms such as fever, chills, or muscle pain.
  • The period of highest risk for developing severe skin reactions is during the first weeks of treatment.
  • If you have previously developed Stevens-Johnson syndrome or toxic epidermal necrolysis while using Luminal, you must never use the medicine again.
  • If you develop rashes with signs of swelling and/or color change, or symptoms such as skin itching, stop using Luminal immediately, seek medical attention, and inform the doctor that you are using this medicine.
  • 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 elevated liver enzymes, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.
  • Symptoms of AGEP appear at the beginning of treatment and may include a red, scaly, widespread rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms), accompanied by blisters and fever.
  • If you develop severe skin reactions or any of the reactions mentioned above, contact your doctor or healthcare professional immediately.
• Inform your doctor if you notice an increase in seizure frequency or the appearance of new types of seizures at the beginning of treatment.
• Treatment must not be stopped abruptly, as this may trigger seizures.
• Alcohol must not be consumed with this medicine to avoid increasing the sedative effect.

Women of childbearing potential/Contraception

If you are a woman of childbearing potential and do not plan to become pregnant, you must use an effective method of birth control (contraception) throughout treatment with phenobarbital and for two months after stopping treatment. Phenobarbital may affect the effectiveness of hormonal contraceptives, such as the oral contraceptive pill, making them less effective in preventing pregnancy. Talk to your doctor, who will advise you on the most appropriate type of contraception while using phenobarbital.

If you are a woman of childbearing potential and plan to become pregnant, speak with your doctor before stopping contraception and before becoming pregnant about the possibility of switching to other suitable treatments to avoid fetal exposure to phenobarbital.

There is a risk of harm to the fetus if this medicine is used during pregnancy. Women of childbearing age must use effective contraceptive methods during treatment with this medicine (see “Pregnancy and breastfeeding”).

Other medicines and Luminal

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Luminal; in such cases, it may be necessary to adjust the dose or discontinue treatment.

• Alcoholic beverages or medicines containing alcohol,

• Antidepressants (for treatment of depression),

• Methadone,

• Other central nervous system depressants: morphine derivatives (analgesics, antitussives, and replacement therapies), benzodiazepines and other medicines for anxiety, sedative antidepressants, hypnotics, neuroleptics, sedating H1 antihistamines, central antihypertensives, baclofen, and thalidomide,

• Methotrexate (for treatment of arthritis),

• Oral contraceptives (see section “Women of childbearing potential/Contraception”)

• Do not use Luminal together with:

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

• Use with caution when combined with the following medicines:

• Ifosfamide (used in chemotherapy), if Luminal is used for epilepsy treatment,

• Oral anticoagulants (used to prevent or delay blood clotting),

• Antiproteases: antivirals such as amprenavir, indinavir, and nelfinavir,

• Cyclosporine, tacrolimus (immunosuppressants),

• Corticosteroids,

• Digitoxin (medicines acting on the cardiovascular system),

• Dihydropyridines (for treatment of high blood pressure),

• Disopyramide (for treatment of tachycardias),

• Doxycycline (for treatment of bacterial infections),

• Thyroid hormones (for treatment of hypothyroidism),

• Hydroquinidine, quinidine (for treatment of heart arrhythmias),

• Itraconazole (for treatment of fungal infections),

• Montelukast (preventive treatment for asthma),

• Theophylline and its derivatives such as aminophylline (used as diuretics, vasodilators, or anti-asthmatics),

• Zidovudine (for treatment of viral infections),

• Estrogens and progestogens (not used as contraceptives).

• The following combinations should be taken into consideration:

• Estrogen-progestogen and progestogen contraceptives, as their efficacy may be reduced; therefore, alternative contraceptive methods should be considered (see section “Women of childbearing potential/Contraception”),

• Ritonavir, simeprevir, dolutegravir (antiretrovirals, protease inhibitors), as they may reduce antiprotease efficacy,

• Anticancer medicines, as this may lead to reduced exposure to these cancer treatments,

• Lamotrigine (antiepileptic),

• Beta-blockers: alprenolol, metoprolol, and propranolol (used for vascular disorders, anxiety, extrapyramidal disorders, or tremors),

• Carbamazepine (antiepileptic),

• Procarbazine (used in chemotherapy),

• Amitriptyline/amitriptyline N-oxide (antidepressants),

• Apixaban, ticagrelor (antithrombotics), as their efficacy may be reduced.

• Effect of other medicines on Luminal:

• Folic acid derivatives (for treatment of certain vitamin deficiencies) reduce the efficacy of phenobarbital.

• Other interactions of medicines with Luminal:

• Valproic acid (for treatment of epilepsy and bipolar disorder),

• Phenytoin (antiepileptic).

Use of Luminal injectable solution with food, drinks, and alcohol

During treatment with this medicine, alcoholic beverages must not be consumed.

Pregnancy and breastfeeding

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

Neurodevelopmental disorders (developmental delays due to brain development disorders) have been reported in children exposed to phenobarbital during pregnancy. Studies on risk remain contradictory.

Pregnancy

Phenobarbital crosses the placenta.

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

Neurodevelopmental disorders (developmental delays due to brain development disorders) have been reported in children exposed to phenobarbital during pregnancy. Studies on risk remain contradictory.

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

You should not use phenobarbital during pregnancy unless no other treatment works.

Contact your doctor immediately if you are pregnant. Your doctor must explain the possible effects of phenobarbital treatment on your baby, and the risks and benefits must be carefully evaluated. Do not stop using phenobarbital without consulting your doctor first, as abrupt discontinuation may increase the risk of seizures, which could have harmful effects on both you and the fetus.

If you have used Luminal during the last trimester of pregnancy, appropriate monitoring should be performed to detect possible disorders in the newborn, such as seizures, excessive crying, muscle weakness, and sucking difficulties.

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

As a preventive measure, it is recommended to administer vitamin K1 orally to the mother before and at the time of delivery, and to provide appropriate supplements to the newborn.

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

Breastfeeding

If you are breastfeeding, administration of phenobarbital is not recommended, as it passes into breast milk and may affect the newborn.

Driving and use of machines

This medicine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction capacity. These effects, as well as the underlying illness, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special attention, until your doctor has assessed your response to this medicine.

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

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

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

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

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

This medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e., it is essentially “sodium-free”.

3. How to use Luminal injectable solution

Follow exactly the administration instructions for this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not stop treatment abruptly, as this could trigger convulsive seizures (see section "Warnings and precautions"); treatment should be discontinued gradually.

Adults

The recommended starting dose is 50–100 mg per day. This dose should be administered in two divided daily doses. It may be given either intramuscularly or, once diluted, slowly by intravenous route.

The dose should be progressively adjusted until the appropriate individual maintenance dose is reached.

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 two divided daily doses. Administer once diluted, slowly by intravenous route.

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

Patients with impaired liver or kidney function

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

Elderly patients

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

If you use more Luminal than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately. Telephone: 91 562 04 20.

After massive administration of the drug, symptoms such as nausea, vomiting, headache, obsession, mental confusion, and possibly coma accompanied by a characteristic neurovegetative state (with decreased respiratory rate (irregular bradypnea), obstruction of the trachea and bronchi, and decreased blood pressure) may occur.

The recommended treatment in such cases includes forced diuresis, alkalization, respiratory support, antibiotic treatment, potassium supplementation, and even hemodialysis or peritoneal dialysis if necessary.

If you forget to use Luminal injectable solution

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent adverse effects (may affect up to 1 in 10 patients):

• Disorder of the hand tendons (Dupuytren's contracture),
• Allergic dermatitis, particularly rashes associated with spots or redness, ending with peeling (scarlatiniform or morbilliform maculopapular rashes),
• Increased gamma-glutamyltransferase, transaminases, and alkaline phosphatase in blood,
• Nausea, vomiting,
• Somnolence (difficulty waking up, sometimes combined with speech difficulties),
• Disorders in thinking and memory,
• Memory impairment,
• Behavioral disorders (such as agitation or aggression).

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Changes in mood,
• Sleep disorders/insomnia,
• Problems with coordination and balance,
• Joint pain (arthralgia).

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Impaired attention.

Frequency not known (cannot be estimated from available data):

• 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 number and increased size of red blood cells) due to folic acid deficiency,
• Decreased neutrophil count in blood (neutropenia),
• Leukopenia and thrombocytopenia (blood cell disorders),
• Loss of memories (amnesia),
• Abnormal muscle movements such as tics, tremors (dyskinesia),
• Hepatitis,
• Bone disorders, including osteopenia and osteoporosis (bone demineralization) and fractures in patients undergoing prolonged treatment with phenobarbital. Consult your doctor or pharmacist if you are on long-term treatment with antiepileptic drugs, have a history of osteoporosis, or are taking steroids.
• Treatment must be discontinued if serious adverse reactions affecting liver function and/or skin occur, or if hypersensitivity reactions develop.
• Decreased thyroid hormones in serum.
• Fixed drug eruption,
• Exfoliative dermatitis,
• Dependence.

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

Possible severe skin reactions, including extremely rare cases such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and exfoliative dermatitis. 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. You may also experience flu-like symptoms such as fever, chills, or muscle pain.

Drug reaction with eosinophilia and systemic symptoms (DRESS): Signs and symptoms of DRESS may include flu-like symptoms and a generalized rash accompanied by high body temperature and swollen lymph nodes. Abnormal blood test results may include elevated liver enzymes, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

Caution should be exercised when replacing phenobarbital with another antiepileptic, such as phenytoin or carbamazepine, as this may rarely lead to a cross-reaction between phenobarbital and either of these two medicines.

Treatment must be discontinued if serious adverse reactions affecting liver function and/or skin occur, or if hypersensitivity reactions develop.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines:

www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Luminal injectable solution

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Instead, return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Luminal injectable solution

The active substance is phenobarbital.

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

Appearance of the medicinal product and contents of the pack

Class I glass ampoules.

Pack containing 10 ampoules.

Marketing Authorisation Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: March 2025

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