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The product code(s) for this leaflet is: PL 14040/0037.
Enodama 50mg, 125mg & 250mg
Enodama 50 mg, 125 mg and 250 mg Tablets
primidone
The name of your medicine is Enodama 50 mg, 125 mg and 250 mg Tablets but it will be referred to as Enodama throughout this leaflet.
1. What Enodama is and what it is used for
2. What you need to know before you take Enodama
3. How to take Enodama
4. Possible side effects
5. How to store Enodama
6. Contents of the pack and other information
Enodama belongs to a group of medicines used to treat seizures.
Enodama is used for the treatment of certain types of epilepsy, seizures (fits) or shaking attacks (essential tremor).
Do not take Enodama if any of the above apply to you. If you are not sure, talk to your doctor before taking Enodama.
This medication is not effective in certain forms of epilepsy. Your doctor will assess the need to prescribe you this medicine depending on the form of epilepsy you are suffering from.
Consult your doctor immediately if the frequency of your seizures increases or if seizures of a different type appear.
Talk to your doctor or pharmacist before taking Enodama
If you go into hospital, tell the medical staff that you are taking Enodama.
Your doctor may prescribe you Vitamin D supplementation (in case of long-term treatment).
A small number of people being treated with anti-epileptics such as Enodama have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome) have been reported with the use of Enodama, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome with the use of Enodama or any other medicine containing phenobarbital, you must not be re-started on these medicines at any time.
If you develop a rash or these skin symptoms, stop taking Enodama and seek immediate advice from a doctor and tell him that you are taking this medicine.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because some medicines may affect the way Enodama works, or Enodama may affect the way other medicines work.
In particular, tell your doctor if you are taking any of the following:
If you are not sure, talk to your doctor or pharmacist before using Enodama.
Alcohol can react with Enodama. Ask your doctor for advice if you want to drink alcohol.
Pregnancy
If taken during pregnancy, primidone which is extensively metabolised to phenobarbital can cause serious birth defects and can affect the way in which the child develops as it grows. Birth defects which have been reported in studies include cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth) and heart abnormalities. Other birth defects have also been reported, such as malformation of the penis (hypospadias), smaller than normal head size, facial, nail and finger abnormalities. If you take phenobarbital during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment. In the general population, the baseline risk of major malformations is 2-3%. This risk is increased by about 3 times in women taking phenobarbital (main metabolite of primidone).
Enodama should not be used during pregnancy unless nothing else works for you.
Talk to your doctor immediately if you are pregnant. Your doctor should discuss the possible effects of phenobarbital tablets on the unborn child and the risks and benefits of treatment should be considered carefully.
If you have taken Enodama during the last third of the pregnancy, appropriate monitoring should be conducted to detect potential disorders in the newborn, such as seizures, excessive crying, muscle weakness, sucking disorders.
Your doctor will talk to you about potential benefit of continuation of the treatment or whether another medication maybe more suitable for you. If you continue treatment,
Do not stop taking Enodama until you have discussed this with your doctor, as stopping the medication abruptly may increase the risk of developing seizures, which may have harmful effects on you and the unborn child.
Woman of child-bearing potential/Contraception
If you are a woman of childbearing age you should use effective contraception during treatment with Enodama and for two months after treatment. Enodama may affect how hormonal contraceptives, such as the contraceptive pill, work and make them less effective at preventing pregnancy. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while you are taking Enodama.
If you are a woman of childbearing age and are planning a pregnancy, talk to your doctor before you stop contraception and before you become pregnant about switching to other suitable treatments in order to avoid exposing the unborn baby to phenobarbital (primidone is extensively metabolized to phenobarbital).
Effects in the new born
The new born child may develop withdrawal symptoms if the mother has taken primidone in the late stages of pregnancy. Blood clotting problems have occurred occasionally in children born to women who were previously taking anticonvulsant drugs.
Babies born to mothers using Enodama during pregnancy may also be at increased risk of being smaller than expected.
Neurodevelopmental disorders (delays in development due to disorders in brain development) have been reported among children exposed to phenobarbital (main primidone metabolite) during pregnancy. Studies on the risk of neurodevelopmental disorders remain contradictory.
Breastfeeding
Breast-feeding is not recommended as primidone is found in breast milk and can make the baby sleepy. Contact your doctor if you are breastfeeding or want to breastfeed.
Enodama can make you feel sleepy. If so, do not drive or operate machinery.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dosage will be determined by your doctor and adjusted gradually on individual basis.
Enodama is normally taken twice a day. Try to take your tablets at the same time each day.
Swallow the tablets whole with a drink of water.
The score line included for the 250 mg strength is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses.
Epilepsy
At first, your dose may be as little as 125 mg. This will be adjusted by your doctor until your condition is controlled. Typical maintenance doses are as follows:
Age group Daily dose (milligrams)
Adults and children over 9 years 750 to 1500
Children 6 to 9 years 750 to 1000
Children 2 to 5 years 500 to 750
Children up to 2 years 250 to 500
Shaking attacks (Essential tremor)
Your starting dose may be 50 mg. This will be adjusted by your doctor until your condition is controlled. The highest dose tolerated for shaking attacks (essential tremor) is up to a maximum of 750 mg.
Elderly / Patients with renal or liver disease
Lower doses may be prescribed. Please check with your doctor.
Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left over medicine with you, as well as the container and label, so that the medical staff knows what you have taken.
If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten tablet.
Do not stop taking your Enodama, even if you are feeling well, unless your doctor tells you to. You may have become dependent on Enodama, and therefore you could get a withdrawal reaction if you stop treatment too quickly. Enodama treatment should be reduced gradually to prevent this.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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
Not known: frequency cannot be estimated from the available data
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Each tablet contains either 50 mg or 125 mg or 250 mg of primidone.
The other ingredients are carmellose calcium, magnesium stearate, povidone and stearic acid.
50 mg: White to off-white, circular, biconvex, uncoated tablet debossed with 'I' on one side and plain on other side.
125 mg: White to off-white, circular, biconvex, uncoated tablet debossed with 'TL' on one side and plain on other side.
250 mg: White to off-white, circular, biconvex, uncoated tablet debossed with 'TL' on one side and break line on other side.
Enodama is supplied in HDPE bottles containing 100 tablets, fitted with a child resistant white plastic cap consists of polypropylene inner, polypropylene outer with white colorant and liner.
This leaflet was last revised in 11/2024.