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v S i e r s y i b in, r l o l l o s n s. e k 6) s r r o of n to r to a h t e e e t t e e t i l i a t. s s n d e s y y e it e e r e s s e r l ) r , f , . , , t . , , , l Driving and using machines Phenytoin Injection may cause dizziness or drowsiness. If you experience these symptoms, do not drive or use any tools or machinery. Ask your doctor for advice before taking any medicine. Phenytoin Injection contains ethanol and sodium This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodium- free’. This medicinal product contains 10 % vol ethanol (alcohol), i.e. up to 395.75 mg per dose, equivalent to 7.9ml beer, 3.2ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. 3. HOW PHENYTOIN INJECTION IS GIVEN TO YOU Phenytoin Injection is given by a doctor or nurse. It may be given as an injection slowly into a muscle or a large vein. Alternatively, it may be diluted and given as a drip or infusion into one of your large veins (intravenously). When given as an intravenous infusion, Phenytoin Injection must be diluted with normal saline. Intramuscular or intravenous Phenytoin Injection should not be added to dextrose or dextrose-containing solutions as this could interfere with the dose of this medicine. The correct dose will be calculated by your doctor according to your body weight and will be written as the equivalent dose of phenytoin sodium (PE). The dose will be as mg per dose if given as an injection or mg per ml of solution if given as an infusion (drip). A repeat injection may be given after 30 minutes if necessary. During your treatment your doctor may monitor your blood levels of phenytoin by taking regular blood samples. Sometimes it is necessary to give Phenytoin Injection into your muscle if you cannot continue to take it by mouth. This is not normally continued for longer than one week. When switching from oral Phenytoin to intramuscular injection, the dose needs to be increased by approximately 50%. When switching back to oral Phenytoin, the dose should be reduced to half the original oral dose for the same period of time that the intramuscular injection was given. This is because phenytoin continues to be released from your muscles for some time after the injections have been given. The recommended dose is as follows: Adults Severe epileptic seizure or fits (Status Epilepticus) A dose of 10 to 15 mg per kg of body weight is given intravenously at a rate not exceeding 50 mg per minute in adults. This is followed by more Phenytoin Injection given every 6 to 8 hours either by injection or by mouth. If Phenytoin Injection does not stop your seizures, other treatments will be tried. Neurosurgery A dose of 100 to 200 mg may be given into your muscle (intramuscularly) approximately every 4 hours during surgery and for two to three days afterwards to prevent seizures. This dosage may then be reduced to a maintenance dose of 300 mg daily and adjusted according to your blood levels. Elderly Lower or less frequent dosing may be needed in some elderly patients due to decreased clearance of Phenytoin Injection. Your doctor may not need to change your dose, but side effects can occur more often in the elderly. Kidney or liver problems Make sure your doctor knows if you have liver or kidney problems as you may need your dose adjusted. Use in children and adolescents No dosage adjustment is required, but children tend to breakdown the medicine faster than adults and this may mean that your doctor has to change the number or timing of the Phenytoin Injection doses. Use in neonates (Very young babies) The starting dose is usually 15 to 20 mg per kg of baby weight. Intravenous Phenytoin Injection should not be given to neonates at a rate faster than 1 to 3 mg per kg body weight per minute. Intravenous Phenytoin Injection is more reliably absorbed than oral Phenytoin in very young babies. If you think you have been given more Phenytoin Injection than you should have Tell your doctor immediately. Phenytoin Injection is dangerous in overdose. The initial signs are nystagmus (condition of involuntary eye movement), diplopia (double vision), ataxia (the loss of full control of bodily movements) and dysarthria (motor speech disorder). Other signs are tremor, hyperflexia (muscle spasms), lethargy, nausea, vomiting. The patient may become comatose and hypotensive. Death is due to respiratory and circulatory depression. If you think you have missed a dose of Phenytoin Injection If you think that you may have missed a dose, tell your doctor immediately. If you have any further questions on the use of this medicine, ask your doctor or nurse. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side-effects, although not everybody gets them. Important: If you experience any of the following serious side effects contact your doctor immediately. • sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body). There is a higher incidence of this in black patients • if you experience skin discolouration, swelling and pain where the injection was given which then starts to spread down your arm to your hands and fingers. This may mean you have a condition known as Purple Glove Syndrome. In most cases this will improve on its own but in some cases it can be serious and require urgent medical treatment • if you develop potentially life-threatening skin rashes that causes blistering (this can affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome or toxic epidermal necrolysis (TEN). These have been reported very rarely • if you notice bruising, fever, you are looking pale or you have a severe sore throat. These may be the first signs of an abnormality of the blood, including decrease in the number of red blood cells, white cells or platelets. Your doctor may take regular blood samples to test for these effects • skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine), you may also experience pain and inflammation of the joints, these may be signs of a hypersensitivity reaction (e.g. drug reaction or rash with Eosinophilia and Systemic Symptoms (DRESS)) or be related to a condition called systemic lupus erythematosus (SLE) • if you experience confusion or have a severe mental illness, as this may be a sign that you have high amounts of phenytoin in your blood. On rare occasions, when the amount of the phenytoin in the blood remains high, irreversible brain injury has occurred. Your doctor may test your blood to see how much phenytoin is in the blood and may change your dose. Other side effects that may occur are as below: Not known: frequency cannot be estimated from the available data • effects on your nervous system: unusual eye movements, unsteadiness, difficulty in controlling movements, shaking, abnormal or uncoordinated movements, slurred speech, confusion, pins and needles or numbness, drowsiness, dizziness, vertigo, sleeplessness, nervousness, twitching muscles, headaches and change in taste • effects on your skin: skin rash including measles-like rash which is usually mild • effects on your stomach and intestines: feeling sick, being sick and constipation • effects on your blood and lymph system: swelling of the lymph glands • effects on your liver and kidney: inflammation of the kidneys and liver, liver damage or liver failure which can lead to death (seen as yellowing of the skin and whites of the eye), abnormal liver function • effects on your reproductive system and breasts: changes in the shape of the penis, painful erection • effects on your hands, face and body: changes in the hands with difficulty in straightening the fingers, changes in facial features, enlarged lips or gums, increased or abnormal body or facial hair • effects on medical tests: abnormal thyroid function tests • effects on your respiratory system: problems breathing including complete stopping of breathing, inflammation of the lining of the lung • effects on your immune system: problems with the body’s defense against infection, inflammation of the wall of the arteries • effect on your heart and circulation: low blood pressure, enlargement of blood vessels. Your blood pressure may also be lowered and experience heart rhythm problems when Phenytoin Injection is injected into your vein too quickly • effects on your bones: there have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor if you are on long-term antiepileptic medication, have a history of osteoporosis or take steroids • effects on injection site: Intramuscular phenytoin administration may cause pain, tenderness, dying or sloughing of skin cells and formation of an infection at the injection site. Please see your doctor if you notice any of these side effects and they cause you concern or if you notice any side effects not listed in this leaflet. Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 to provide more information on the safety of this medicine. 5. HOW TO STORE PHENYTOIN INJECTION Keep this medicine out of the sight and reach of children. This medicine should not be used after the expiry date which is stated on the ampoule (a small bottle) label and carton, after EXP. The expiry date refers to the last day of that month. The ampoules should be protected from light and stored at a temperature not greater than 30°C. If only part of the contents of an ampoule is used, the remaining solution should be discarded. Solutions in which a haziness or precipitate develops should not be used. The solution should not be mixed with any other drugs. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Phenytoin Injection contains The active substance is phenytoin sodium. Each 1ml of this solution contains 50mg of phenytoin sodium. The other ingredients are propylene glycol BP, ethanol BP and sodium hydroxide BP (as a 10% w/v solution) in water for injections BP. What Phenytoin Injection looks like and contents of pack Phenytoin Injection is a clear, colourless, particle-free solution. Each carton contains ten 5ml ampoules of Phenytoin Injection. Marketing Authorisation Holder Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK. Manufacturer Delpharm Tours, Rue Paul Langevin, BP 90241, 37172 Chambray-lès-Tours Cedex. This leaflet was last revised in December 2018. LF-116503-01

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