Epanutin® Ready-Mixed    ™4]

Parenteral 250mg/5ml Solution for Injection or Infusion

(phenytoin sodium)

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    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.

-    You may have been given Epanutin Ready-Mixed as a single dose to control seizures in an emergency (status epilepticus). In this case, you will only be able to read this leaflet after you have had the product given to you. Your doctor will have considered the important safety information in this leaflet, but your urgent need for treatment may have been more important than some of the normal cautions. Check them now, especially if you are going to continue to be given Epanutin Ready-Mixed (or any other form of phenytoin)

This medicine is available using the above name but will be referred to as Epanutin Ready-Mixed throughout the leaflet.

What is in this leaflet:

1.    What Epanutin Ready-Mixed is and what it is used for

2.    What you need to know before you are given Epanutin Ready-Mixed

3.    How Epanutin Ready-Mixed is given

4.    Possible side effects

5.    How to store Epanutin Ready-Mixed

6.    Contents of the pack and other information

1.    WHAT EPANUTIN READY-MIXED IS AND WHAT IT IS USED FOR

This medicine is a solution for injection or infusion containing phenytoin, which belongs to a group of medicines called antiepileptic drugs.

Epanutin Ready-Mixed can be used to treat severe epileptic seizures or fits (status epilepticus). It can also be used to control or prevent seizures during or after brain surgery and/or severe head injury. Epanutin Ready-Mixed is also used to control or prevent seizures for short periods of time when antiepileptic drugs cannot be taken by mouth.

Epanutin Ready-Mixed can also be used to treat specific heart rhythm problems (cardiac arrhythmias) when these are caused by the drug digoxin, or when these do not respond well to treatment with other medicines, or when other treatments cannot be used.

You should consult your doctor if you are unsure why you have been given Epanutin Ready-Mixed, if you do not feel better or if you feel worse.

2.    WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN EPANUTIN READY-MIXED

Do not take Epanutin Ready-Mixed

-    If you are allergic (hypersensitive) to phenytoin, or any of the other ingredients of this medicine (listed in section 6).

-    If you are allergic to other medicines for epilepsy.

-    If you suffer from certain conditions that affect the heart rhythm for example a decreased heart rate (sinus bradycardia), heart block (sinoatrial block or A-V block) or Adams-Stoke Syndrome.

-    If you are taking medicines for HIV infection such as delavridine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Epanutin Ready-Mixed if you suffer from or have suffered in the past from any of the following conditions:

-    Low blood pressure or heart failure

-    Liver disease where the dosage may need to be adjusted

-    Diabetes

-    Porphyria (an inherited disease that affects haemoglobin biosynthesis)

-    Heart rhythm problems (Epanutin Ready-Mixed can treat some rhythm problems, but can make others worse)

-    Alcohol dependence.

A small number of people being treated with antiepileptics such as phenytoin sodium 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 Epanutin, 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 Epanutin, you must not be re-started on Epanutin at any time.

If you develop a rash or these skin symptoms, stop taking Epanutin, seek urgent advice from a doctor and tell him that you are taking this medicine. Consult your doctor before discontinuing Epanutin. If you suddenly stop taking this medicine you may have a seizure.

If you are taking phenytoin at the same time as you receive radiation therapy to your head and the dose of another medication called corticosteroids is reduced, you may more likely to develop a severe skin rash called erythema multiform or one that causes blistering called Stevens Johnson Syndrome or Toxic Epidermal Necrosis (see Possible Side Effects in section 4).

Other medicines and Epanutin Ready-Mixed

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Some medicines can affect the way Epanutin Ready-Mixed works, or Epanutin Ready-Mixed itself can reduce the effectiveness of other medicines taken at the same time. These include:

-    Medicines used for heart and circulation problems (e.g. dicoumarol, amiodarone, reserpine, digitoxin, digoxin, mexiletine, nisoldipine, furosemide, quinidine, warfarin and calcium channel blockers including diltiazem and nifedipine)

-    Medicines used for epilepsy (e.g. carbamazepine, lamotrigine, phenobarbital, sodium valproate, valproic acid, oxcarbazepine, topiramate, succinimides including ethosuximide, and vigabatrin)

-    Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole, miconazole).

-    Medicines used for tuberculosis and other infections

(e.g. chloramphenicol, isoniazid, rifampicin, sulfonamides, sulfadiazine, sulfamethizole, sulfamethoxazole-trimethoprim, sulfaphenazole, sulfisoxazole, doxycycline, ciprofloxacin)

-    Medicines used for stomach ulcers (e.g. omeprazole, sucralfate and the medicines known as H2 antagonists including cimetidine, ranitidine, famotidine and some antacids)

-    Medicines used for asthma and bronchitis (e.g. theophylline)

-    Medicines used for pain and inflammation (e.g. phenylbutazone, salicylates including aspirin and steroids)

-    Medicines used for sleeplessness, depression and psychiatric disorders (e.g. chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, quetiapine, trazodone, tricyclic antidepressants, fluvoxamine, sertraline and viloxazine)

-    Medicines used for diabetes (e.g. tolbutamide)

-    Some hormone replacement therapies (oestrogens), oral contraceptives (the birth control pill)

-    Medicines used for organ and tissue transplants, to prevent rejection (e.g. ciclosporin, tacrolimus)

-    Medicines used for cancer (e.g. antineoplastic agents including teniposide, fluorouracil, capecitabine, bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate)

-    Medicines used to lower high blood cholesterol and triglycerides (e.g. atorvastatin, fluvastatin, simvastatin)

-    Medicines used in the treatment of HIV infection (e.g. delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)

-    Medicines used to expel parasitic worms from the body (e.g. albendazole, praziquantel)

-    Muscle relaxants used for surgery (neuromuscular blockers), some anaesthetic medicines (halothane) and methadone

-    Some products available without a prescription (folic acid, vitamin D).

Your doctor may need to test the amount of phenytoin in your blood to help decide if any of these drugs are affecting your treatment.

The herbal preparation St John's wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St John's wort, consult your doctor before stopping the St John's wort preparation.

Epanutin Ready-Mixed may also interfere with certain laboratory tests that you may be given.

Epanutin Ready-Mixed with drinking alcohol

Drinking a lot of alcohol can also affect the concentration of phenytoin in your blood.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before you are given Epanutin.

You should not breast-feed if you are being given Epanutin Ready-Mixed.

Driving and using machines

Epanutin Ready-Mixed may cause dizziness or drowsiness. If you experience these symptoms, do not drive or use any tools or machinery and contact your doctor.

Epanutin Ready-Mixed contains ethanol and sodium

This medicinal product contains 8.8% ethanol (alcohol), i.e. up to 440.4 mg per 5 ml ampoule, equivalent to 8.8 ml beer, 3.7 ml wine per dose. It may be harmful if you suffer from alcoholism. It should be taken into account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease.

This medicine contains up to 1.1 mmol sodium (24.6 mg) per 5 ml ampoule. This should be considered if you are on a sodium-controlled diet.

3. HOW EPANUTIN READY-MIXED IS GIVEN

You will be in hospital when you are given Epanutin Ready-Mixed.

Epanutin Ready-Mixed will be either injected into one of your large veins (intravenously) or into your muscle (intramuscularly). When given intravenously, Epanutin Ready-Mixed must be diluted.

The dose and concentration of the solution of Epanutin Ready-Mixed you are given will be decided by your doctor 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).

Sometimes it is necessary to give Epanutin Ready-Mixed 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 Epanutin to intramuscular injection, the dose needs to be increased by approximately 50%. When switching back to oral Epanutin, 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 sometime after the injections have been given.

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 Epanutin given every 6 to 8 hours either by injection or by mouth.

If Epanutin does not stop your seizures, other treatments will be tried.

Cardiac arrhythmias (variations to normal heartbeat)

A dose of 3.5 to 5 mg per kg of body weight is given intravenously, at a rate not exceeding 50 mg per minute. This may be repeated a second time.

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.

Older people

Your doctor will not need to change your dose, but side effects may occur more often in older people.

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 Epanutin doses.

Neonates (Very young babies)

The starting dose is usually 15 to 20 mg per kg of baby weight. Intravenous Epanutin Ready-Mixed should not be given to neonates at a rate faster than 1 to 3 mg per kg body weight per minute.

Intravenous Epanutin is more reliably absorbed than oral Epanutin in very young babies.

If you are given more Epanutin Ready-Mixed than you should

Epanutin is dangerous in overdose. If you think you have been given too much Epanutin Ready-Mixed, contact your doctor immediately.

If you have any further questions on the use of this medicine, ask your

doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects although not

everybody gets them.

Tell your doctor immediately if you experience any of the following

symptoms after being given this medicine.

-    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 decreases 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.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by Actavis Italy S.p.A, Nerviano, Italy.

Procured from within the EU by Product Licence holder:

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 05.09.16[4]

Epanutin is a trademark of Parke, Davis & Company LLC.

Phenytoin Sodium Pfizer Ready-Mixed Parenteral 250mg/5ml Solution for Injection or Infusion

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you are given this medicine

because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    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.

-    You may have been given Phenytoin Sodium Ready-Mixed as a single dose to control seizures in an emergency (status epilepticus). In this case, you will only be able to read this leaflet after you have had the product given to you. Your doctor will have considered the important safety information in this leaflet, but your urgent need for treatment may have been more important than some of the normal cautions. Check them now, especially if you are going to continue to be given Phenytoin Sodium Ready-Mixed (or any other form of phenytoin)

This medicine is available using the above name but will be referred to as

Phenytoin Sodium Ready-Mixed throughout the leaflet.

What is in this leaflet:

1.    What Phenytoin Sodium Ready-Mixed is and what it is used for

2.    What you need to know before you are given Phenytoin Sodium Ready- Mixed

3.    How Phenytoin Sodium Ready-Mixed is given

4.    Possible side effects

5.    How to store Phenytoin Sodium Ready-Mixed

6.    Contents of the pack and other information

1. WHAT PHENYTOIN SODIUM READY-MIXED IS AND WHAT IT IS USED FOR

This medicine is a solution for injection or infusion containing phenytoin,

which belongs to a group of medicines called antiepileptic drugs.

Phenytoin Sodium Ready-Mixed can be used to treat severe epileptic seizures or fits (status epilepticus). It can also be used to control or prevent seizures during or after brain surgery and/or severe head injury. Phenytoin Sodium Ready-Mixed is also used to control or prevent seizures for short periods of time when antiepileptic drugs cannot be taken by mouth.

Phenytoin Sodium Ready-Mixed can also be used to treat specific heart rhythm problems (cardiac arrhythmias) when these are caused by the drug digoxin, or when these do not respond well to treatment with other medicines, or when other treatments cannot be used.

You should consult your doctor if you are unsure why you have been given Phenytoin Sodium Ready-Mixed, if you do not feel better or if you feel worse.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHENYTOIN SODIUM READY-MIXED Do not take Phenytoin Sodium Ready-Mixed

-    If you are allergic (hypersensitive) to phenytoin, or any of the other ingredients of this medicine (listed in section 6).

-    If you are allergic to other medicines for epilepsy.

-    If you suffer from certain conditions that affect the heart rhythm for example a decreased heart rate (sinus bradycardia), heart block (sinoatrial block or A-V block) or Adams-Stoke Syndrome.

-    If you are taking medicines for HIV infection such as delavridine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Phenytoin Sodium Ready-Mixed if you suffer from or have suffered in the past from any of the following conditions:

-    Low blood pressure or heart failure

-    Liver disease where the dosage may need to be adjusted

-    Diabetes

-    Porphyria (an inherited disease that affects haemoglobin biosynthesis)

-    Heart rhythm problems (Phenytoin Sodium Ready-Mixed can treat some rhythm problems, but can make others worse)

-    Alcohol dependence.

A small number of people being treated with antiepileptics such as phenytoin sodium 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 Phenytoin Sodium, 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 Phenytoin Sodium, you must not be re-started on Phenytoin Sodium at any time.

If you develop a rash or these skin symptoms, stop taking Phenytoin Sodium, seek urgent advice from a doctor and tell him that you are taking this medicine. Consult your doctor before discontinuing Phenytoin Sodium. If you suddenly stop taking this medicine you may have a seizure.

If you are taking phenytoin at the same time as you receive radiation therapy to your head and the dose of another medication called corticosteroids is reduced, you may more likely to develop a severe skin rash called erythema multiform or one that causes blistering called Stevens Johnson Syndrome or Toxic Epidermal Necrosis (see Possible Side Effects in section 4).

Other medicines and Phenytoin Sodium Ready-Mixed

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Some medicines can affect the way Phenytoin Sodium Ready-Mixed works, or Phenytoin Sodium Ready-Mixed itself can reduce the effectiveness of other medicines taken at the same time. These include:

-    Medicines used for heart and circulation problems (e.g. dicoumarol, amiodarone, reserpine, digitoxin, digoxin, mexiletine, nisoldipine, furosemide, quinidine, warfarin and calcium channel blockers including diltiazem and nifedipine)

-    Medicines used for epilepsy (e.g. carbamazepine, lamotrigine, phenobarbital, sodium valproate, valproic acid, oxcarbazepine, topiramate, succinimides including ethosuximide, and vigabatrin)

-    Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole, miconazole).

-    Medicines used for tuberculosis and other infections

(e.g. chloramphenicol, isoniazid, rifampicin, sulfonamides, sulfadiazine, sulfamethizole, sulfamethoxazole-trimethoprim, sulfaphenazole, sulfisoxazole, doxycycline, ciprofloxacin)

-    Medicines used for stomach ulcers (e.g. omeprazole, sucralfate and the medicines known as H2 antagonists including cimetidine, ranitidine, famotidine and some antacids)

-    Medicines used for asthma and bronchitis (e.g. theophylline)

-    Medicines used for pain and inflammation (e.g. phenylbutazone, salicylates including aspirin and steroids)

-    Medicines used for sleeplessness, depression and psychiatric disorders (e.g. chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, quetiapine, trazodone, tricyclic antidepressants, fluvoxamine, sertraline and viloxazine)

-    Medicines used for diabetes (e.g. tolbutamide)

-    Some hormone replacement therapies (oestrogens), oral contraceptives (the birth control pill)

-    Medicines used for organ and tissue transplants, to prevent rejection (e.g. ciclosporin, tacrolimus)

-    Medicines used for cancer (e.g. antineoplastic agents including teniposide, fluorouracil, capecitabine, bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate)

-    Medicines used to lower high blood cholesterol and triglycerides (e.g. atorvastatin, fluvastatin, simvastatin)

-    Medicines used in the treatment of HIV infection (e.g. delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)

-    Medicines used to expel parasitic worms from the body (e.g. albendazole, praziquantel)

-    Muscle relaxants used for surgery (neuromuscular blockers), some anaesthetic medicines (halothane) and methadone

-    Some products available without a prescription (folic acid, vitamin D).

Your doctor may need to test the amount of phenytoin in your blood to help

decide if any of these drugs are affecting your treatment.

The herbal preparation St John's wort (Hypericum perforatum) should not

be taken at the same time as this medicine. If you already take St John's

wort, consult your doctor before stopping the St John's wort preparation.

Phenytoin Sodium Ready-Mixed may also interfere with certain laboratory tests that you may be given.

Phenytoin Sodium Ready-Mixed with drinking alcohol

Drinking a lot of alcohol can also affect the concentration of phenytoin in your blood.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before you are given Phenytoin Sodium.

You should not breast-feed if you are being given Phenytoin Sodium Ready-Mixed.

Driving and using machines

Phenytoin Sodium Ready-Mixed may cause dizziness or drowsiness. If you experience these symptoms, do not drive or use any tools or machinery and contact your doctor.

Phenytoin Sodium Ready-Mixed contains ethanol and sodium

This medicinal product contains 8.8% ethanol (alcohol), i.e. up to 440.4 mg per 5 ml ampoule, equivalent to 8.8 ml beer, 3.7 ml wine per dose. It may be harmful if you suffer from alcoholism. It should be taken into account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease.

This medicine contains up to 1.1 mmol sodium (24.6 mg) per 5 ml ampoule. This should be considered if you are on a sodium-controlled diet.

3. HOW PHENYTOIN SODIUM READY-MIXED IS GIVEN

You will be in hospital when you are given Phenytoin Sodium Ready-Mixed.

Phenytoin Sodium Ready-Mixed will be either injected into one of your large veins (intravenously) or into your muscle (intramuscularly). When given intravenously, Phenytoin Sodium Ready-Mixed must be diluted.

The dose and concentration of the solution of Phenytoin Sodium Ready-Mixed you are given will be decided by your doctor 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).

Sometimes it is necessary to give Phenytoin Sodium Ready-Mixed 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 Sodium to intramuscular injection, the dose needs to be increased by approximately 50%. When switching back to oral Phenytoin Sodium, 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 sometime after the injections have been given.

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 Sodium given every 6 to 8 hours either by injection or by mouth.

If Phenytoin Sodium does not stop your seizures, other treatments will be tried.

Cardiac arrhythmias (variations to normal heartbeat)

A dose of 3.5 to 5 mg per kg of body weight is given intravenously, at a rate not exceeding 50 mg per minute. This may be repeated a second time.

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.

Older people

Your doctor will not need to change your dose, but side effects may occur more often in older people.

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 Sodium doses.

Neonates (Very young babies)

The starting dose is usually 15 to 20 mg per kg of baby weight. Intravenous Phenytoin Sodium Ready-Mixed should not be given to neonates at a rate faster than 1 to 3 mg per kg body weight per minute.

Intravenous Phenytoin Sodium is more reliably absorbed than oral Phenytoin Sodium in very young babies.

If you are given more Phenytoin Sodium Ready-Mixed than you should

Phenytoin Sodium is dangerous in overdose. If you think you have been given too much Phenytoin Sodium Ready-Mixed, contact your doctor immediately.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects although not everybody gets them.

Tell your doctor immediately if you experience any of the following symptoms after being given this medicine.

-    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 decreases 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.

What Phenytoin Sodium Ready-Mixed looks like and contents of the pack

Phenytoin Sodium Ready-Mixed is a clear, colourless, sterile solution for injection in transparent glass ampoules .

Phenytoin Sodium Ready-Mixed is available in packs containing 5 and 10 ampoules.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by Actavis Italy S.p.A., Nerviano, Italy.

Procured from within the EU by Product Licence holder:

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 05.09.16[4]

Other side effects that may occur are:

-    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. Page 5 of 7

-    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).

-    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: Increased levels of blood sugar, or decreased levels of blood calcium, phosphates, folic acid and vitamin D.

-    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 defence against infection, inflammation of the wall of the arteries and immunoglobin abnormalities.

-    Effect on your heart and circulation: low blood pressure, enlargement of blood vessels. Your blood pressure may also be lowered and experience heart problems when Phenytoin Sodium 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 or pharmacist 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, dying or sloughing of skin cells, and formation of an infection at the injection site.

Reporting of side effects

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PHENYTOIN SODIUM READY-MIXED

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original package.

Do not use after the expiry date. This date is printed on your pack. The Expiry date refers to last day of that month.

If the solution shows any signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Phenytoin Sodium Ready-Mixed 250 mg/5 ml Solution for injection or infusion contains

The active ingredient is phenytoin sodium.

Each 5 ml ampoule contains 250 mg of the active ingredient phenytoin sodium i.e. 50 mg/ml.

The other ingredients are propylene glycol, ethanol 96%, sodium hydroxide, water for injection and nitrogen (inert gas).