Enodama 50mg Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Enodama 50mg, 125mg and 250mg 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

• if you are allergic to primidone, phenobarbital or any of the other ingredients of this medicine (listed in section 6)
• If you have porphyria (a rare inherited disorder of metabolism) or anyone in your family has it.

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 have ever had respiratory, kidneys or liver problems;
• if you are pregnant or are trying to become pregnant (see beneath for further information).

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) 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 or toxic epidermal necrolysis 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, 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:

• Other medicines used to treat epilepsy and other types of seizures (such as phenytoin, felbamate, valproic acid, carbamazepine, perampanel, lamotrigine, oxcarbazepine, stiripentol, tiagabine, zonisamide)
• Anticoagulants to prevent blood clots (such as acenocoumarol, fluindione, phenindione, warfarin)
• Barbiturates or benzodiazepines (such as sleeping tablets)
• Medicines used to treat severe pain, cough, or as a substitute for morphine addiction (such as methadone, oxycodone or fentanyl)
• Antibiotics (such as metronidazole, doxycycline, telithromycine)
• Asthma medicines (such as theophylline, montelukast)
• Hormone containing medicines (such as the oral contraceptive pill, estroprogestatives, progestatives, ulipristal)
• Thyroid hormones
• Medicines used to treat high blood pressure or heart conditions (such as beta-blockers, nimodipine)
• Cyclosporine (used to prevent rejection of an organ transplant and also for other diseases of the body’s immune system)
• Medicines used to treat mental health problems or depression (such as lurasidone, tricyclic antidepressants, lamotrigine, mianserin, quetiapine, sertraline)
• Steroid-containing medicines
• Medicines used to treat cancer (such as cyclophosphamide, etoposide, abiraterone, axitinib, eribuline, ifosfamide, bosutinib, crizotinib, dabrafenib, dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, pazopanib, ruxolitinib, sorafenib, sunitinib, vandetanib, regorafenib, vemurafenib, vismodegib, cabozantinib, ceritinib, ibrutinib, olaparib, ponatinib, carbazitaxel, docetaxel, irinotecan, procarbazine)
• St-John’s wort
• Medicines containing morphine or similar medicines called opiates
• Bedaquiline, delamanid (used to treat tuberculosis)
• Quinine (used to treat malaria)
• Medicines used to treat viral infections such as HIV infection or hepatitis C (such as boceprevir, cobicistat, daclatasvir, dasabuvir, dolutegravir, lopinavir, maraviroc, nelfinavir, ombitasvir+paritaprevir, rilpivirine, ritonavir, simeprevir, sofosbuvir, telaprevir)
• Anti-fungal medicines (voriconazole, albendazole, itraconazole, posaconazole)
• Anticoagulants (such as apixaban, dabigatran, rivaroxaban or ticagrelor)
• Folates (vitamin B9)
• Medicines used to reduce immunity (immune-suppressants, such as cyclosporine, tacrolimus, sirolimus, everolimus)
• Deferasirox (iron-chelator)
• Medicine used to treat cystic fibrosis (ivacaftor)
• Medicines used to treat a heart disease, high blood pressure or to regulate cardiac rhythms (such as class IA antiarythmics, calcium antagonists, bosentan, dronedarone, ivabradine, macitentan, nimodipine, propafenone, ranolazine or betablockers (metoprolol, propranolol)
• Antiparasite agent (albendazole, praziquantel).

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.

The use of primidone in pregnancy is associated with an increased risk of abnormalities in babies. Enodama is likely to cause malformations in the unborn child (especially cleft lip and palate, cardiovascular malformations and abnormality of the penis in male babies) when administered during pregnancy. Therefore, you must tell your doctor if you are pregnant, or trying to become pregnant.

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,

• During pregnancy: your doctor will adjust your dose to get the minimum effective dose for you.
• Before delivery: you will need to take vitamin K to prevent the bleeding this medicine may cause during the first 24 hours of your baby's life.
• After childbirth: an injection of vitamin K may also be prescribed to your baby, at birth, to avoid any bleeding.

Do not interrupt your treatment suddenly; this could lead to the recurrence of seizures, which would have serious consequences for you and your child.

It is recommended that you use effective contraception during treatment. Enodama can make the contraceptive pill ineffective and you should use another effective method of contraception - ask your doctor for advice regarding effective contraception.

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.

Breast-feeding is not recommended as Enodama 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.

At first, your dose may be as little as 125mg. 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

Your starting dose may be 50mg. 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 750mg.

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 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 50mg or 125mg or 250mg of primidone.

The other ingredients are carmellose calcium, magnesium stearate, povidone and stearic acid.

50mg: White to off-white, circular, biconvex, uncoated tablet debossed with 'I' on one side and plain on other side.

125mg: White to off-white, circular, biconvex, uncoated tablet debossed with 'TL' on one side and plain on other side.

250mg: 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.