MIZODIN 250 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Mizodin
3. 250 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Mizodin and what is it used for
   1. Indications:
5. Important information before taking Mizodin
   1. When not to take Mizodin
   2. Warnings and precautions
   3. If the patient develops a rash or the above-mentioned skin symptoms, they should stop taking primidone and immediately consult a doctor and inform them about taking this medicine.
   4. Mizodin and other medicines
   5. Mizodin and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Mizodin contains sodium
6. How to take Mizodin
   1. Recommended dosage
   2. Taking a higher dose of Mizodin than recommended
   3. Missing a dose of Mizodin
   4. Stopping Mizodin
7. Possible side effects
   1. Reporting side effects
8. How to store Mizodin
9. Contents of the pack and other information
   1. What Mizodin contains
   2. What Mizodin looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Mizodin

250 mg, tablets

Primidonum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Mizodin and what is it used for

Mizodin contains the active substance primidone, which is a barbiturate derivative. The medicine has anticonvulsant properties. It is well absorbed from the gastrointestinal tract. The maximum concentration in the blood occurs about 3 hours after oral administration.

Indications:

• treatment of generalized tonic-clonic seizures (grand mal), nocturnal myoclonic seizures, complex partial seizures (psychomotor), and simple partial seizures. Mizodin can be used as monotherapy or in combination with other anticonvulsant medicines.

2. Important information before taking Mizodin

When not to take Mizodin

• if the patient is allergic to primidone, barbiturates, 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 - a component of hemoglobin).

Warnings and precautions

Mizodin should be used with caution:

• if the patient has kidney and/or liver function disorders - due to the risk of accumulation of barbiturate metabolites in the body;
• if the patient has hyperkinesia (increased motor excitability), as primidone exacerbates its symptoms;
• if the patient has respiratory diseases (e.g., asthma, pulmonary emphysema), as it may cause respiratory depression - slowing and shallowing of breathing, apnea, and death due to suffocation;
• in children, elderly patients (over 65 years old), and weakened patients, as it may cause paradoxical reactions (see section 4: Possible side effects). During primidone treatment, life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome) may occur, which initially had the form of reddish spots resembling targets or circular spots, often with central blisters, located on the torso. Additional objective symptoms to pay attention to include oral, throat, nose, and genital ulcers, as well as conjunctivitis (red and swollen eyes). Along with life-threatening skin rashes, flu-like symptoms often occur. The rash may transform into extensive areas covered with blisters or peeling skin. The greatest risk of severe skin reactions occurs in the first few weeks of treatment. If a patient has experienced Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome while taking primidone or another medicine containing phenobarbital, they should never restart treatment with these medicines.

If the patient develops a rash or the above-mentioned skin symptoms, they should stop taking primidone and immediately consult a doctor and inform them about taking this medicine.

Long-termuse of primidone may reduce its effectiveness (development of tolerance).
Long-term use of primidone may lead to physical and psychological dependence.
Sudden withdrawal of the medicine may cause withdrawal symptoms (see section: Stopping Mizodin).
Mizodin may cause orthostatic hypotension (dizziness or fainting when standing up from a sitting or lying position), so caution should be exercised when standing up.
During primidone treatment, megaloblastic anemia may develop (see section 4: Possible side effects). If it occurs, the doctor may recommend stopping Mizodin.
Primidone affects some laboratory test results (see section: Mizodin and other medicines).
During long-term use of Mizodin, the doctor should order blood tests (every 6 months, morphology, and biochemical blood composition, as well as determination of folic acid, phenobarbital, and primidone levels).

Mizodin and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Mizodin enhances the effect of medicines that suppress the central nervous system, such as:

• sleeping pills and sedatives;
• antihistamines with a sedative effect (used to treat allergies);
• opioid analgesics (strong painkillers, such as morphine).

Mizodin reduces the effect of the following medicines. If you are taking any of these medicines, your doctor may need to increase the dose:

• corticosteroids (steroids used to treat rheumatic diseases);
• anticoagulants (used to reduce blood clotting);
• corticotropin (adrenocorticotropic hormone - ACTH);
• cyclosporine (a medicine used in patients after organ transplantation);
• dacarbazine (a cytostatic used to treat melanoma);
• doxycycline (an antibiotic used to treat bacterial infections);
• metronidazole (a medicine used to treat infections caused by certain bacteria and protozoa);
• oral contraceptives containing estrogens (a change in the method of preventing pregnancy may be necessary). When taking Mizodin, be especially careful if you are also taking any of the following medicines:
• monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression, such as furazolidone, procarbazine, and selegiline), as they may prolong the effect of primidone;
• tricyclic antidepressants (medicines used to treat depression), as they may reduce the effect of primidone;
• other anticonvulsant medicines (e.g., carbamazepine, valproic acid derivatives), as they may change the type of seizure, so monitoring of their blood levels and possible adjustment of the primidone dose by the doctor is necessary. Carbamazepine reduces, and valproic acid derivatives enhance the effect of primidone;
• phenobarbital (a medicine used to treat epilepsy) may change the type of seizure and enhance the sedative effect of phenobarbital and Mizodin;
• St. John's Wort (Hypericum perforatum - an ingredient in herbal medicines used to treat digestive disorders and depression) may reduce the effect of Mizodin;
• carbonic anhydrase inhibitors (medicines used to treat glaucoma), may cause a decrease in bone mass;
• long-term use of primidone before the use of anesthetics (halothane, enflurane, and methoxyflurane) increases the risk of liver and kidney damage. During long-term use of Mizodin, the doctor may order the administration of vitamin D and folic acid (to supplement their deficiencies caused by Mizodin). Primidone affects the results of some laboratory tests:
• reduces the absorption of labeled cyanocobalamin Co;
• the reaction to metyrapone may decrease (due to increased metyrapone metabolism);
• may cause a false-positive reaction to phentolamine, so the medicine should be discontinued 24 to 72 hours before the test;
• may decrease the bilirubin level in the blood (as a result of the activation of glucuronyltransferase - an enzyme that binds bilirubin).

Mizodin and alcohol

Do not drink any alcoholic beverages while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Primidone taken during pregnancy may cause severe birth defects and may affect the development of the fetus. Birth defects reported in studies include cleft lip (cleft upper lip) and cleft palate (cleft upper palate), as well as heart defects. Other birth defects, such as genital abnormalities (hypospadias), smaller than normal head size, facial abnormalities, nail and finger abnormalities, have also been reported. If you take primidone 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 abnormalities is 2-3%. In women taking primidone, this risk is about three times higher.
Newborns born to mothers taking primidone during pregnancy may also be at increased risk of being smaller than expected.
In children exposed to primidone 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.
Primidone should not be taken during pregnancy unless other medicines do not work.
In case of pregnancy, consult your doctor immediately. The doctor should discuss the possible effects of primidone on the unborn child and carefully weigh the risks and benefits of treatment. Do not stop taking primidone until you have discussed it with your doctor, as sudden withdrawal of the medicine may increase the risk of seizures, which can harm you and your unborn child.
If a woman took primidone in the third trimester of pregnancy, the pregnancy should be monitored to detect potential disorders in the newborn, such as seizures, excessive crying, weakness, feeding disorders.
Women of childbearing age, contraception
Women of childbearing age should use effective contraception during primidone treatment and for two months after its completion. Primidone may affect the effectiveness of hormonal contraceptives, such as birth control pills, and reduce their effectiveness in preventing pregnancy. Consult your doctor, who will discuss the most suitable type of contraception to use while taking primidone.
If you are a woman of childbearing age and plan to become pregnant, before stopping contraception and becoming pregnant, consult your doctor about changing to other appropriate treatment methods to avoid exposing the unborn child to primidone.
During long-term use of Mizodin, the level of folic acid in the serum decreases. During pregnancy, the need for folic acid increases. In pregnant women, the doctor may order the administration of folic acid and vitamin B (to supplement their deficiencies caused by Mizodin).
Primidone taken in late pregnancy may cause dependence and withdrawal symptoms in the newborn, as well as bleeding.
Primidone taken during childbirth may cause respiratory disorders in the newborn.
Mizodin should not be taken during breastfeeding, as the medicine passes into breast milk and may cause excessive sleepiness in the child.

Driving and using machines

Mizodin may cause drowsiness and prolonged reaction time, so do not drive vehicles or operate machines during treatment.

Mizodin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Mizodin

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The dose is determined by the doctor individually for each patient.

Recommended dosage

Adults and children over 9 years old:
3 tablets (750 mg) to 6 tablets (1500 mg) per day.
If the doctor does not recommend otherwise, take the medicine according to the following scheme:

Do not take more than 6 tablets (1500 mg) per day.

Taking a higher dose of Mizodin than recommended

If you have taken a higher dose of the medicine than recommended, consult your doctor immediately.
Symptoms of overdose:

• disorientation (disturbances in time, place, situation, or self-orientation);
• double vision, nystagmus (eye tremors);
• breathing difficulties;
• symptoms similar to alcohol intoxication;
• coma;
• respiratory center paralysis;
• presence of primidone and PEMA (phenylethylmalonic acid amide) crystals in the urine - shown in laboratory tests.

Missing a dose of Mizodin

If you miss a dose, take the medicine as soon as possible. If it is almost time for the next dose, skip the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

Stopping Mizodin

Sudden withdrawal of Mizodin may cause withdrawal symptoms. Therefore, any changes or discontinuation of the medicine should be done gradually and under medical supervision.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mizodin can cause side effects, although not everybody gets them.
Side effects usually occur at the beginning of treatment.
Common side effects(may occur in up to 1 in 10 patients):

• drowsiness;
• apathy (passivity, loss of interest);
• ataxia (difficulty maintaining balance, unsteady gait);
• vision disturbances, nystagmus;
• nausea. Uncommon side effects(may occur in up to 1 in 100 patients):
• headache, dizziness;
• vomiting;
• allergic reactions manifesting as skin rashes (similar to measles or scarlet fever);
• paradoxical reactions (anxiety, agitation, aggressive behavior), especially in children and elderly patients (over 65 years old). Rare side effects(may occur in up to 1 in 1,000 patients):
• personality changes with psychotic reactions;
• megaloblastic anemia (manifested by weakness, easy fatigue, pale skin and mucous membranes, headache, and dizziness, loss of taste, tongue burning, diarrhea, or constipation);
• changes in blood count (revealed in laboratory tests);
• abnormal liver function test results: gamma-glutamyltransferase and alkaline phosphatase (revealed in blood tests);
• joint pain;
• bone demineralization (reduction of calcium in bones leading to their deformation);
• Dupuytren's contracture (contracture in the joints of the fingers);
• exfoliative dermatitis (manifested by itching, redness spreading to all parts of the body, and peeling of the skin);
• Stevens-Johnson syndrome (appearance of blisters on the skin and/or mucous membranes, which after rupture form painful ulcers; often accompanied by fever, muscle and joint pain);
• toxic epidermal necrolysis (Lyell's syndrome - peeling of large areas of skin and its necrosis);
• systemic lupus erythematosus (a chronic disease caused by immune system disorders, affecting many organs). Frequency not known(cannot be estimated from available data):
• life-threatening skin rashes (drug reaction with eosinophilia and systemic symptoms) (see section 2). If skin and/or mucous membrane changes occur, consult your doctor immediately.

There have been reports of bone disorders, including osteopenia, osteoporosis (bone "thinning"), and fractures. Consult your doctor or pharmacist if you are taking long-term anticonvulsant therapy, have osteoporosis, or are taking steroids.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Mizodin

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

6. Contents of the pack and other information

What Mizodin contains

• The active substance of the medicine is primidone. Each tablet contains 250 mg of primidone.
• The other ingredients are: magnesium stearate, gelatin, rice starch, potato starch, sodium carboxymethyl starch.

What Mizodin looks like and what the pack contains

Mizodin is a round, white, biconvex tablet with a dividing line on one side and the inscription "Mizodin" on the other side.
The tablets are packaged in Al/PCW foil blisters of 20 pieces each.
The medicine pack is 60 tablets (3 blisters) 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: [email protected]
The content of the Mizodin patient information leaflet is available in the Ulotka Audio system at the national, free phone number: 800 706 848.

Date of last revision of the leaflet: