Luminalum

Leaflet attached to the packaging: patient information

Luminalum, 100 mg, tablets

Phenobarbital

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Luminalum and what is it used for
• 2. Important information before using Luminalum
• 3. How to use Luminalum
• 4. Possible side effects
• 5. How to store Luminalum
• 6. Package contents and other information

1. What is Luminalum and what is it used for

Luminalum contains the active substance phenobarbital.
Luminalum has a sedative effect and, in higher doses, a hypnotic and anticonvulsant effect, inhibits the production of thyroid-stimulating hormone, and reduces smooth muscle tension.
Luminalum is used to treat:

• generalized tonic-clonic seizures,
• simple partial seizures, particularly in cases of drug-resistant epilepsy.

2. Important information before using Luminalum

When not to use Luminalum

This medicine should not be used in the following cases:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has porphyria (a disease characterized by abnormal heme production);
• if the patient is pregnant or breastfeeding;
• if the patient has alcoholism;
• if the patient has respiratory failure;
• if the patient has acute poisoning with centrally acting depressants (such as sedatives, hypnotics, some antiepileptic drugs, analgesics, and drugs used in psychiatric disorders);
• if the patient has severe liver failure or hepatic coma.

Warnings and precautions

Before starting treatment with Luminalum, the patient should discuss it with their doctor or pharmacist.
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Phenobarbital may cause:

• psychological and physical dependence, especially after long-term use of high doses. Sudden withdrawal of the medicine may then cause withdrawal symptoms;
• skin reactions:
• life-threatening skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with the use of Luminalum;
• patients should be informed about the subjective and objective symptoms associated with skin reactions. The highest risk of SJS or TEN occurs during the first few weeks of treatment;
• if symptoms of SJS or TEN appear (e.g., progressive rash often with blisters or mucosal ulcers), the use of Luminalum should be discontinued;
• the best results in reducing the risk of SJS or TEN are achieved with early diagnosis and immediate discontinuation of any suspected drug. Early withdrawal of the drug is associated with a better prognosis;
• if a patient develops SJS or TEN while using Luminalum, this medicine should not be used again in that patient;
• paradoxical reactions:
• in patients with acute pain, paradoxical reactions such as excitement, depression, anxiety, and confusion may occur;
• behavioral disorders:
• the use of the medicine may cause changes in the patient's behavior, including suicidal thoughts and tendencies. Therefore, patients should be monitored to detect the emergence of suicidal thoughts and tendencies. The treating doctor will inform the patient (and their caregiver) about the need for immediate medical consultation in case of suicidal thoughts or tendencies.

Patients with renal impairment:

• in patients with renal impairment, long-term treatment with phenobarbital should be avoided. In the case of short-term treatment, the doctor will prescribe significantly reduced doses of the medicine.

Patients with liver impairment:

• in patients with liver impairment, the medicine should be used with extreme caution. The doctor will prescribe a significantly reduced initial dose of the medicine.

Elderly patients:

• in elderly patients, the medicine should be used with extreme caution. They may be more sensitive to the effects of phenobarbital due to age-related changes in liver metabolism. The doctor will consider reducing the dose.

The medicine should be used with caution in patients with asthma, other diseases characterized by shortness of breath or narrowing of the airways.
Care should be taken in patients who have been diagnosed with depression with suicidal tendencies, drug abuse, cerebral circulation disorders, severe anemia, hyperkinesis (increased motor excitability), hyperthyroidism, acute or chronic pain (due to the possibility of masking diagnostically significant symptoms), diabetes, hypothyroidism.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

Children and adolescents

For safety reasons, Luminalum should not be used in children.
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Luminalum and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Luminalum interacts with many other medicines. This is particularly true for:

• anticoagulants,
• anti-inflammatory drugs,
• certain antibiotics and antimicrobial agents,
• sedatives and hypnotics,
• antidepressants, antipsychotics, and anti-Parkinson's disease drugs,
• drugs used in adrenal insufficiency,
• drugs used in heart diseases,
• contraceptives (the effectiveness of these drugs may be reduced),
• drugs used in cancer,
• anesthetics,
• anticonvulsants,
• drugs used in hypertension and glaucoma,
• drugs with analgesic and anti-inflammatory effects,
• drugs that lower body temperature,
• drugs used in folate deficiency,
• drugs used in hypothyroidism,
• drugs used in asthma,
• the drug used in the treatment of asthma (montelukast),

Using Luminalum with food, drink, and alcohol

Food does not affect the efficacy of the medicine. Luminalum can be taken with or without food.
During treatment with the medicine, it is contraindicated to drink alcohol. Concurrent use of phenobarbital with alcohol may enhance the depressant effect on the central nervous system, increasing or prolonging the effect of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Luminalum is contraindicated in pregnancy. The active substance of this medicine, phenobarbital, may cause fetal damage if administered during pregnancy.
After oral administration, phenobarbital easily crosses the placental barrier and is distributed in the tissues of the fetus, reaching the highest concentration in the placenta, liver, and brain of the fetus. It has been shown that the risk of congenital malformations during the administration of antiepileptic drugs to pregnant women is 2-3 times higher than in the general population. The most common developmental abnormalities are craniofacial defects, cleft palate, and cardiovascular defects.
Animal studies have not shown teratogenic effects of phenobarbital.
Sudden discontinuation of phenobarbital should not be done.
In the event that a woman took this medicine during pregnancy, during the last month of pregnancy, the mother and newborn should prophylactically take vitamin K. In newborns whose mothers took phenobarbital during pregnancy, withdrawal symptoms such as seizures or excessive excitement may develop, which may appear up to 14 days after birth, as well as abnormal movements, difficulty sucking, and disorders of calcium-phosphorus metabolism and bone mineralization.
Breastfeeding
Phenobarbital passes into breast milk and may have a depressant effect on the central nervous system of the infant.

Driving and operating machinery

• Do not drive vehicles or operate machinery during treatment, as the medicine causes impaired psychophysical fitness, including reduced concentration and reaction time.

Do not operate machinery or use tools.

• Do not engage in activities that require attention and vigilance.

Luminalum contains lactose

Luminalum contains the excipient lactose in an amount of 34 mg per tablet. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to use Luminalum

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor.
Recommended dose:
adults - orally 50 mg to 250 mg per day, in a single dose or divided doses.
Dosage should be adjusted individually for each patient.
The tablet can be divided into equal doses.
Method of administration
Swallow the tablet with water.
Luminalum can be taken with or without food.

Using a higher dose of Luminalum than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
In case of acute overdose, symptoms such as increased drowsiness, coma, respiratory disorders, loss of reflexes, pupil constriction, oliguria, tachycardia, decreased blood pressure, and decreased body temperature may occur. Shock (apnea, significant decrease in blood pressure, respiratory arrest, and death) may also occur.
If any of these symptoms occur, the patient should immediately stop taking the medicine and seek medical help or go to the nearest hospital.

Missing a dose of Luminalum

Do not take a double dose to make up for a missed dose.
Take the missed dose as soon as possible, unless it is close to the time of the next dose. In this case, skip the missed dose and continue treatment according to the recommended dosing schedule.

Discontinuing Luminalum

Phenobarbital may cause psychological and physical dependence. Sudden withdrawal of the medicine may cause withdrawal symptoms.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Luminalum can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows:
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• very common: (may occur in more than 1 in 10 people);
• common: (may occur in 1 to 10 people in 100);
• uncommon: (may occur in 1 to 10 people in 1,000);
• rare: (may occur in 1 to 10 people in 10,000);
• very rare: (may occur in less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

Within each frequency group, the undesirable effects are presented in order of decreasing severity.

• Nervous system disorders - common: drowsiness, excitement, disorientation, hyperkinesia (increased motor excitability), depression, ataxia (difficulty with coordination and balance), nightmares, nervousness, hallucinations, insomnia, anxiety, headaches, and dizziness.
• Respiratory, thoracic, and mediastinal disorders - rare: hyperventilation, apnea, interstitial lung disease.
• Cardiac disorders - rare: bradycardia (slow heart rate).
• Vascular disorders - rare: hypotension, syncope.
• Gastrointestinal disorders - rare: nausea, vomiting, constipation.
• Immune system disorders - frequency not known: hypersensitivity reactions: fever, rash, lymphadenopathy, eosinophilia, facial edema, angioedema, blood and liver disorders, general organ damage.
• Hepatobiliary disorders - very rare: hepatitis and liver function disorders, liver damage. In elderly patients, reduced liver function is an indication for dose reduction. If latent or overt porphyria or liver function impairment occurs, the use of the medicine should be limited to situations where the benefit-risk balance justifies it. The occurrence of intolerance reactions, including liver function disorders, is an indication for discontinuation of treatment. However, it is essential to distinguish between hypersensitivity reactions to antiepileptic drugs and symptoms of liver damage and transient increases in aminotransferases and (or) alkaline phosphatase, which do not require discontinuation of treatment.
• Blood and lymphatic system disorders - rare: megaloblastic anemia, agranulocytosis, thrombocytopenia.
• Musculoskeletal and connective tissue disorders:
• rare: osteopenia, rickets; in patients treated long-term with phenobarbital, decreased bone mineral density, osteopenia, and osteoporosis, as well as bone fractures, have been reported. The mechanism of bone metabolism disorders has not been identified;
• frequency not known: joint pain, Dupuytren's contracture.
• Psychiatric disorders:
• rare: withdrawal symptoms - sleep disorders, tremors, vision disturbances, nausea, vomiting, anxiety, nightmares, weakness, orthostatic hypotension, dizziness, seizures, hallucinations;
• frequency not known: personality disorders; excitement, depression, confusion in elderly patients.
• Renal and urinary disorders - rare: decreased renal function in elderly patients. This is an indication for dose reduction.
• Skin and subcutaneous tissue disorders:
• very rare: acute skin reactions (SCARs): Stevens-Johnson syndrome (SJS); toxic epidermal necrolysis (TEN); exfoliative dermatitis;
• frequency not known: erythematous or bullous rash, Lyell's syndrome.

If skin reactions occur, barbiturates should be discontinued.
Luminalum may cause psychological and physical dependence, especially after long-term use of high doses. Symptoms of sudden withdrawal of the product may be severe and even life-threatening.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Luminalum

Store in a temperature below 25°C, in the original packaging.
In the case of a bottle, to protect against moisture, store the container tightly closed.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.
Do not use this medicine if signs of deterioration are visible, such as discoloration of the tablets.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Luminalum contains

• The active substance of the medicine is phenobarbital. Each tablet contains 100 mg of phenobarbital.
• The excipients are: lactose, potato starch, talc, stearic acid, sodium carboxymethylcellulose type A, purified water.

What Luminalum looks like and what the package contains

Luminalum is a white, divisible tablet.
The immediate packaging is a polypropylene bottle, closed with a cap or a blister pack of PVC/PVDC/Aluminum. The immediate packaging is placed in the outer packaging, which is a cardboard box containing the patient leaflet. The package contains 10 tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel. 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl
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Date of last revision of the leaflet:

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