Luminalum Unia

Leaflet attached to the packaging: information for the user

Luminalum UNIA

100 mg, tablets

Phenobarbital

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have 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 their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Luminalum UNIA and what is it used for
• 2. Important information before taking Luminalum UNIA
• 3. How to take Luminalum UNIA
• 4. Possible side effects
• 5. How to store Luminalum UNIA
• 6. Contents of the packaging and other information

1. What is Luminalum UNIA and what is it used for

Luminalum UNIA contains the active substance phenobarbital, which has a sedative effect on the central nervous system. Depending on the dose, the medicine has a sedative, hypnotic, and antiepileptic effect.

Indications for use:

• epilepsy - partial and generalized tonic-clonic seizures.

2. Important information before taking Luminalum UNIA

When not to take Luminalum UNIA

• if the patient is allergic to phenobarbital or other barbituric acid derivatives or any of the other ingredients of this medicine (listed in section 6);
• if the patient has respiratory failure;
• if the patient has severe liver failure;
• if the patient is in hepatic coma;
• if the patient has porphyria (a disease characterized by abnormal heme production - a component of hemoglobin);
• if the patient has alcoholism;
• if the patient has been diagnosed with acute poisoning with substances that have a sedative effect on the central nervous system;
• if the patient is breastfeeding.

Warnings and precautions

Luminalum UNIA should be used with caution:

• if the patient has asthma or other diseases that cause shortness of breath, bronchial constriction, or respiratory failure, as phenobarbital may exacerbate shortness of breath;
• if the patient has depression with suicidal tendencies;
• if the patient abuses drugs;
• if the patient has cerebral circulation disorders;
• if the patient has severe anemia;
• if the patient has hyperkinesia (increased motor excitability);
• if the patient has hyperthyroidism;
• if the patient has acute or chronic pain (possibility of masking important symptoms);
• if the patient has diabetes;
• if the patient has adrenal insufficiency;
• if the patient is weakened, as during treatment, stimulation, depression, confusion, disorientation (see section 4: Possible side effects) may occur;
• if the patient has liver or kidney function disorders. In such a patient, the doctor may reduce the dose of the medicine.

During the use of the medicine, life-threatening skin reactions have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome), which initially appear as red spots or round rashes, often with blisters on the torso. Additionally, oral mucosal ulcers, throat, nose, genital, and conjunctival ulcers may occur (symptoms may also include red and swollen eyes). These potentially life-threatening skin symptoms are often accompanied by flu-like symptoms. Initially, a small rash can lead to extensive blisters or skin peeling. For this reason, during treatment, skin reactions should be monitored. If a rash or other skin reactions occur, the use of the medicine should be discontinued and a doctor should be consulted. The greatest risk of their occurrence exists in the first few weeks of treatment. If the patient develops Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome after taking a medicine containing phenobarbital, such a medicine should never be used again in this patient.

If the patient develops a rash or the above-mentioned skin symptoms, they should discontinue the use of phenobarbital and immediately consult a doctor and inform them about the use of this medicine.

In the case of long-term treatment in children, vitamin D prophylaxis (1200 to 2000 IU/day) or vitamin D should be initiated. The use of phenobarbital can lead to psychological and physical dependence. Sudden withdrawal of the medicine may cause withdrawal symptoms (see section: Discontinuation of Luminalum UNIA). Long-term use of phenobarbital may reduce its effectiveness. In children and the elderly (over 65 years), phenobarbital may cause paradoxical reactions (see section 4: Possible side effects). Phenobarbital affects the results of laboratory tests (see section: Luminalum UNIA and other medicines).

Luminalum UNIA 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 about medicines they plan to take. Luminalum UNIA weakens the effect of the following medicines:

• doxycycline(an antibiotic used to treat bacterial infections);
• metronidazole(a medicine used to treat infections caused by certain bacteria and protozoa);
• theophylline(a medicine used to treat asthma);
• quinidine(a medicine used to treat heart rhythm disorders);
• corticosteroids(also known as steroids, used to treat, among other things, rheumatic disease);
• cyclosporin(a medicine used in patients after organ transplantation);
• paracetamol(a medicine used to relieve pain and reduce fever);
• phenylbutazone(a medicine used to treat, among other things, ankylosing spondylitis and rheumatoid arthritis);
• griseofulvin(an antibiotic used to treat fungal infections);
• itraconazole(a medicine used to treat fungal infections);
• levothyroxine(a medicine used to treat hypothyroidism);
• oral anticoagulants(used to reduce blood clotting, e.g., warfarin);
• oral contraceptives containing estrogens(may require a change in birth control method);
• tricyclic antidepressants(used to treat depression);
• digoxin(a medicine used to treat heart failure and heart rhythm disorders);
• haloperidol(a medicine used to treat mental disorders, including schizophrenia).

When using Luminalum UNIA, special caution should be exercised if any of the following medicines are used at the same time:

• phenothiazine and thioxanthene derivatives(medicines used to treat mental disorders, including schizophrenia), as they increase the risk of seizures; therefore, the doctor should adjust the dose of phenobarbital;
• chlorpromazine(a psychotropic medicine used to treat schizophrenia), as Luminalum UNIA weakens its effect;
• primidone(a medicine used to treat epilepsy), as it may enhance the sedative effect of phenobarbital or increase the likelihood of side effects (e.g., may change the type of seizure). In the case of concurrent use of phenobarbital and primidone, it is necessary to reduce the dose of primidone;
• carbamazepine or valproic acid derivatives(medicines used to treat epilepsy); the doctor should monitor the levels of carbamazepine and valproic acid derivatives in the blood;
• valproic acid(a medicine used to treat epilepsy), as it enhances the effect of phenobarbital;
• phenytoin(a medicine used to treat epilepsy), as phenobarbital changes (increases or decreases) its level in the blood;
• hydantoin(a medicine used to treat epilepsy), as side effects may occur; therefore, the doctor should closely monitor its level in the blood;
• rifampicin(an antibiotic used to treat tuberculosis or other infections) - may decrease the level of phenobarbital in the blood; therefore, the doctor should adjust the dose of phenobarbital;
• MAO inhibitors(medicines used to treat depression), as they prolong the effect of phenobarbital;
• calcium channel blockers(medicines used to treat high blood pressure), as phenobarbital may enhance their blood pressure-lowering effect;
• guanethidine(a medicine used to treat high blood pressure), as phenobarbital may enhance the symptoms of orthostatic hypotension (dizziness or fainting when standing up from a sitting or lying position);
• vitamin D, as phenobarbital decreases its level in the blood, therefore, in patients taking phenobarbital for a long time, especially in children, vitamin D prophylaxis should be initiated, and vitamin D supplements (1200 to 2000 IU/day) or vitamin D should be used;
• long-term use of phenobarbital before the use of anesthetics(e.g., halothane, enflurane, methoxyflurane) may cause liver damage, and in the case of methoxyflurane, there is an additional risk of kidney damage;
• maprotiline(a medicine used to treat depression) - when used in high doses, it may reduce the antiepileptic effect of Luminalum UNIA;
• ketamine(a medicine used for preoperative anesthesia), especially when used in high doses, increases the risk of hypotension - significant decrease in blood pressure and (or) respiratory depression - slowing and shallowing of breathing, apnea, and death due to asphyxiation;
• carbonic anhydrase inhibitors(medicines used to treat glaucoma, e.g., acetazolamide) may cause osteopenia (decrease in bone mass). In case of osteopenia symptoms, the doctor should discontinue carbonic anhydrase inhibitors and apply appropriate treatment.

Phenobarbital enhances the effect of the following medicines:

• sleeping pills;
• sedatives;
• opioid analgesics (strong painkillers, e.g., morphine);
• antihistamines with sedative effect (medicines used to treat, among other things, allergies);
• methotrexate (a medicine used to treat certain cancers and rheumatoid arthritis).

Alcohol enhances the sedative effect of phenobarbital on the central nervous system.

Phenobarbital affects the results of some laboratory tests:

• may decrease the absorption of cyanocobalamin labeled with Co;
• may decrease the reaction to metyrapone (due to increased metabolism of metyrapone);
• may cause a false positive response to phentolamine;
• may decrease the level of bilirubin in the blood (as a result of the activation of glucuronyltransferase - an enzyme responsible for binding bilirubin).

Luminalum UNIA with alcohol

During the use of this medicine, you should not drink any alcoholic beverages. Alcohol enhances the effect of Luminalum UNIA.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. Pregnancy Phenobarbital taken during pregnancy may cause serious birth defects and may affect the development of the child. Birth defects reported in studies include cleft lip (cleft upper lip) and cleft palate (cleft upper palate) and heart defects. Other birth defects have also been reported, such as genital developmental disorders (hypospadias), smaller than normal head size, facial abnormalities, nail and finger abnormalities. If the patient takes phenobarbital during pregnancy, there is a higher risk than in other women of giving birth to a child with birth defects that require treatment. In the general population, the baseline risk of serious developmental disorders is 2-3%. In women taking phenobarbital, this risk is about 3 times higher. Newborns born to mothers taking phenobarbital during pregnancy may also be at increased risk of being smaller than expected. In children exposed to phenobarbital during pregnancy, developmental disorders (delays in development due to brain development disorders) have been reported. The results of studies on the risk of developmental disorders are conflicting. Phenobarbital should not be used during pregnancy unless other medicines do not work. In case of pregnancy, you should immediately consult a doctor. The doctor should discuss the possible effect of phenobarbital on the unborn child and carefully weigh the risks and benefits of treatment. You should not stop taking phenobarbital without consulting a doctor, as sudden withdrawal of the medicine may increase the risk of seizures, which can harm the patient and their unborn child. If a woman took phenobarbital in the third trimester of pregnancy, the pregnancy should be monitored to detect potential disorders in the newborn, such as seizures, excessive crying, muscle weakness, feeding disorders. Women of childbearing age, contraception Women of childbearing age should use effective contraception during treatment with phenobarbital and for 2 months after its completion. Phenobarbital may affect the effectiveness of hormonal contraceptives, such as birth control pills, and reduce their effectiveness in preventing pregnancy. You should consult a doctor who will discuss the most suitable type of contraception to use during treatment with phenobarbital. If the patient is a woman of childbearing age and plans to become pregnant, before stopping contraception and becoming pregnant, they should consult a doctor about changing to other appropriate treatment methods to avoid exposing the unborn child to phenobarbital. Phenobarbital used in the third trimester of pregnancy may cause physical dependence, withdrawal symptoms, and bleeding in the newborn. Luminalum UNIA should not be used during breastfeeding, as the medicine passes into breast milk.

Driving and using machines

Luminalum UNIA may cause drowsiness and prolonged reaction time, therefore, during treatment, you should not drive vehicles or operate machines.

Luminalum UNIA contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium in one tablet, which means that the medicine is considered "sodium-free".

3. How to take Luminalum UNIA

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist. Luminalum UNIA can be taken regardless of meals.

Recommended dosage

The dosage is determined by the doctor individually for each patient (to achieve a blood level in the range of 15 to 40 micrograms per mL). Adults usually take 60 mg to 200 mg (2 tablets) per day, in a single dose. The medicine should be taken at night.

Use in children and adolescents

Do not use in children and adolescents.

Taking a higher dose of Luminalum UNIA than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor. Symptoms of acute overdose:

• severe confusion (see section 4: Possible side effects);
• weakness or lack of reflexes;
• significant drowsiness;
• fever, decreased body temperature;
• breathing disorders;
• bradycardia (slow heart rate);
• slurred speech;
• staggering;
• abnormal eye movements;
• significant weakness.

Symptoms of severe overdose:

• Cheyne-Stokes respiration (irregular breathing - shallow, slow, and even apnea alternating with hyperpnea - very deep breathing);
• lack of reflexes;
• tachycardia (rapid heart rate);
• coma;
• it may lead to shock syndrome characterized by apnea, circulatory collapse, and cardiac arrest leading to death.

Symptoms of chronic overdose:

• severe confusion;
• constant irritability;
• disturbed assessment of the situation;
• sleep disorders.

Missing a dose of Luminalum UNIA

In case of missing a dose, you should take the medicine as soon as possible. If it is almost time for the next dose, you should skip the missed dose. The next dose should be taken at the usual time. You should not take a double dose to make up for the missed dose.

Discontinuation of Luminalum UNIA

The medicine should be discontinued gradually. Sudden discontinuation of Luminalum UNIA may cause withdrawal symptoms, such as:

• delirium (confusion);
• tremors, seizures;
• insomnia, nightmares;
• irritability;
• death.

In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms requiring immediate contact with a doctor:

Uncommon side effects(may occur in less than 1 in 100 patients):

• confusional states (disorders of consciousness and orientation in time, place, situation, or own person);
• depression (excessive sadness), especially in the elderly (over 65 years) or debilitated patients;
• paradoxical reactions (anxiety, agitation, aggressive behavior), especially in children, the elderly, or debilitated patients.

Rare side effects(may occur in less than 1 in 1,000 patients):

• agranulocytosis (significant decrease in the number of granulocytes - one type of white blood cell, causing increased susceptibility to infections);
• allergic reactions (rash or hives, swelling of the eyelids, face, or lips, wheezing or shortness of breath, especially in people with asthma, hives, or angioedema);
• exfoliative dermatitis (fever, red, thickened, or peeling skin);
• hallucinations;
• hypotension;
• megaloblastic anemia (characterized by weakness, easy fatigue, pallor of the skin and mucous membranes, headache, and dizziness);
• Stevens-Johnson syndrome (blisters on the skin and (or) mucous membranes, which, when ruptured, become painful ulcers (erosions); often accompanied by fever, muscle and joint pain);
• thrombocytopenia (decrease in platelet count - increased risk of bleeding and bruising).

Very rare side effects(may occur in less than 1 in 10,000 patients):

• potentially life-threatening skin rashes: Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 2).

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

• there have been reports of life-threatening skin rashes (drug reaction with eosinophilia and systemic symptoms) (see section 2).

Symptoms of side effects occurring during long-term use of phenobarbital:

• liver damage (jaundice of the white part of the eyes or skin);
• osteopenia (decrease in bone mass);
• rickets (a chronic disease caused by a deficiency of vitamin D, leading to bone deformities. Characterized by pain and tenderness of the bones, lack of appetite, muscle weakness, unexplained weight loss).

Symptoms requiring contact with a doctor only if they do not disappear or are troublesome:

Common side effects(may occur in less than 1 in 10 patients):

• balance disorders;
• dizziness or feeling of emptiness in the head;
• drowsiness;
• sensations similar to those after alcohol abuse.

Uncommon side effects(may occur in less than 1 in 100 patients):

• anxiety or nervousness;
• constipation;
• confusional states;
• headaches;
• irritability;
• nausea or vomiting;
• nightmares or sleep disorders.

Symptoms requiring contact with a doctor, occurring after discontinuation of phenobarbital treatment:

Moderate symptoms, occurring within 8 to 12 hours:

• anxiety;
• muscle tremors, tremors of the hands;
• weakness;
• dizziness;
• vision disorders;
• nausea, vomiting;
• sleep disorders, increased number of dreams or nightmares;
• orthostatic hypotension (dizziness or fainting when standing up from a sitting or lying position).

Severe symptoms, occurring within 16 hours and lasting up to 5 days:

• seizures;
• hallucinations.

There have been reports of bone disorders, including osteopenia, osteoporosis (bone "thinning"), and fractures. You should consult a doctor or pharmacist if you are taking long-term antiepileptic therapy, have osteoporosis, or are taking steroids.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luminalum UNIA

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Store in the original packaging. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Luminalum UNIA contains

• The active substance of the medicine is phenobarbital. Each tablet contains 100 mg of phenobarbital.
• The other ingredients are: lactose monohydrate; gelatin; magnesium stearate; talc; potato starch; sodium carboxymethyl starch.

What Luminalum UNIA looks like and what the packaging contains

The tablets are packaged in Al/PCW film blisters. The medicine packaging is 10 white, biconvex, uncoated tablets (1 blister) placed together with the patient information leaflet in a cardboard box.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne "UNIA" Spółdzielnia Pracy ul. Chłodna 56/60, 00-872 Warsaw tel.: 22 620 90 81 ext. 190, fax: 22 654 92 40 e-mail: unia@uniapharm.pl The content of the Luminalum UNIA leaflet is available in the Ulotka Audio system under the national, free phone number: 800 706 848.

Date of last revision of the leaflet: