Luminal 100 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Luminal 100 mg tablets

phenobarbital

Read the entire leaflet carefully before you start taking 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, ask 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 may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if these are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Luminal tablets are and what they are used for
2. What you need to know before taking Luminal tablets
3. How to take Luminal tablets
4. Possible adverse effects
5. How to store Luminal tablets
6. Contents of the pack and other information

1. What Luminal tablets are and what they are 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.

2. What you need to know before taking Luminal tablets

Do not take Luminal tablets:

• If you are allergic to phenobarbital, barbiturates, or any of the other ingredients 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 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, as your biological functions may be reduced and a dose reduction may be necessary (see section “3. How to take Luminal”).
• If your liver or kidneys do not function properly, your doctor must reduce the dose and perform frequent monitoring, due to the risk of hepatic encephalopathy (see section “3. How to take Luminal”).
• 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 take Luminal”). If treatment is prolonged, consult your doctor. In such cases, preventive treatment for rickets should be initiated.
• In some patients (elderly patients, 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 had thoughts of harming themselves or of suicide. If you experience 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 lesions, 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 serious skin reactions is during the first weeks of treatment.
  • If you have previously developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Luminal, you must never use this medicine again.
  • If you develop rashes with signs of swelling and/or color change, or symptoms such as skin itching, stop taking Luminal immediately, seek medical attention, and inform the doctor that you are taking this medicine.
  • Signs and symptoms of DRESS may include flu-like symptoms and a widespread rash with high body temperature, 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.
  • Symptoms of AGEP appear at the beginning of treatment and may include a widespread red, scaly rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms), blisters, and fever.
  • If you develop serious skin reactions or any of the reactions mentioned above, contact your doctor or healthcare professional immediately.
• Inform your doctor if, at the beginning of treatment, you notice an increase in seizure frequency or the appearance of new types of seizures.
• Treatment must not be stopped abruptly, as this may trigger seizures.
• Do not consume alcohol with this medicine, as it may increase the sedative effect.

Women of childbearing potential / Contraception

If you are a woman of childbearing potential and are not planning 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 contraceptive pill, making them less effective in preventing pregnancy. Speak with your doctor, who will advise you on the most appropriate type of contraception while taking phenobarbital.

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

There is a risk of fetal harm 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 (used to treat depression).

• Methadone.

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

• Methotrexate (used to treat arthritis).

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

• Do not take 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 taking the following medicines:

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

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

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

• Cyclosporine, tacrolimus (immunosuppressants).

• Corticosteroids.

• Digitoxin (medicines acting on the cardiovascular system).

• Dihydropyridines (used to treat high blood pressure).

• Disopyramide (used to treat tachycardia).

• Doxycycline (used to treat bacterial infections).

• Thyroid hormones (used to treat hypothyroidism).

• Hydroquinidine, quinidine (used to treat heart arrhythmias).

• Itraconazole (used to treat fungal infections).

• Montelukast (used for preventive asthma treatment).

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

• Zidovudine (used to treat viral infections).

• Estrogens and progestogens (not used as contraceptives).

• Consideration should be given to combining with the following medicines:

• Estrogen-progestogen and progestogen contraceptives, as their effectiveness 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 to treat vascular disorders, anxiety, extrapyramidal disorders, or tremors).

• Carbamazepine (antiepileptic).

• Procarbazine (used in chemotherapy).

• Amitriptyline/amitriptyline N-oxide (antidepressants).

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

• Effect of other medicines on Luminal:

• Folic acid derivatives (used to treat certain vitamin deficiencies) reduce the efficacy of phenobarbital.

• Other drug interactions with Luminal:

• Valproic acid (used to treat epilepsy and bipolar disorder).

• Phenytoin (antiepileptic).

Use of Luminal tablets 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 may 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 the risk remain contradictory.

Pregnancy

Phenobarbital crosses the placenta.

If taken 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 an increased 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 the risk remain contradictory.

If you take 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 taking 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 taking phenobarbital without first consulting your doctor, as abrupt discontinuation may increase the risk of seizures, which could have harmful effects on both you and the fetus.

If you have taken Luminal during the last trimester of pregnancy, appropriate monitoring should be carried out 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 within 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.

Breastfeeding

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

Driving and using machines

This medicine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, 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 sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Luminal tablets

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The tablets should be taken without chewing, with a sufficient amount of lukewarm liquid.

Adults

The recommended starting dose is 50–100 mg per day. This dose should be administered in two divided daily doses.

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 recommended starting and maintenance doses are 3 to 5 mg per kg of body weight per day, which may be administered in two doses.

If treatment is prolonged, your doctor may recommend preventive treatment 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 take 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.

Within the first hour after massive ingestion, nausea, vomiting, headache, obsession, mental confusion, and possibly coma accompanied by a characteristic neurovegetative state (with reduced respiratory rate (irregular bradypnea), obstruction of the trachea and bronchi, and decreased blood pressure) may appear.

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 take Luminal tablets

Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

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

These adverse effects can be classified according to their frequency of occurrence as:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

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

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

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

• Hand tendon disorders (Dupuytren's contracture),
• Allergic dermatitis, particularly rash associated with red spots, ending in skin peeling (scarlatiniform or morbilliform maculopapular eruptions),
• Increased gamma-glutamyl transferase, transaminases, and alkaline phosphatase in blood,
• Nausea, vomiting,
• Somnolence (difficulty waking up, sometimes associated with speech problems),
• Disturbances in thinking and memory,
• Memory impairment,
• Behavioral disturbances (such as agitation or aggression).

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

• Mood changes,
• 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,
• Reduction in 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 receiving long-term phenobarbital treatment. Consult your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids,
• Treatment should 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 stopped abruptly, 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 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 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 cells (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 should 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 can 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 tablets

Keep this medicine out of the 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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Luminal tablets

The active substance is phenobarbital.

The other excipients are: maize starch, talc, sodium carboxymethyl starch from potato (Type A) and magnesium stearate.

Appearance of the product and contents of the pack

PVC/Aluminum blister containing 50 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

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

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