Primidonum
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.
Mizodin should be used with caution:
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).
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:
Mizodin reduces the effect of the following medicines. If you are taking any of these medicines, your doctor may need to increase the dose:
Do not drink any alcoholic beverages while taking this medicine.
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.
Mizodin may cause drowsiness and prolonged reaction time, so do not drive vehicles or operate machines during treatment.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".
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.
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:
Dose | Consecutive days of treatment |
125 mg (half a tablet) per day - in the evening | for the first 3 days |
125 mg twice a day | on the 4th, 5th, and 6th day |
125 mg three times a day | on the 7th, 8th, and 9th day |
Maintenance dose: 250 mg three times a day | from the 10th day |
Do not take more than 6 tablets (1500 mg) per day.
If you have taken a higher dose of the medicine than recommended, consult your doctor immediately.
Symptoms of overdose:
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.
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.
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):
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.
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.
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.
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.
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 Mizodin patient information leaflet is available in the Ulotka Audio system at the national, free phone number: 800 706 848.
Need help understanding this medicine or your symptoms? Online doctors can answer your questions and offer guidance.