Clonazepam XGX Pharma 1 mg/ml, concentrate for solution for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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.

1. What Clonazepam is and what it is used for
2. What you need to know before you use Clonazepam
3. How to use Clonazepam
4. Possible side effects
5. How to store Clonazepam
6. Contents of the pack and other information

• if you are allergic to clonazepam, any other benzodiazepine (such as diazepam or nitrazepam), or any of the other ingredients of this medicine (listed in section 6)
• if you have severe breathing problems since this medicine can make breathing difficulties worse
• if you have severe liver problems
• if you are addicted to medicines, drugs or alcohol
• in children under 12 years of age

Clonazepam should not be given to patients who are in coma.

Talk to the doctor or nurse before receiving Clonazepam if you:

• have ever had depression or tried to harm or kill yourself
• are pregnant, breast-feeding or think you may be pregnant (see Pregnancy and breast-feeding section)
• have ever had drug or alcohol problems or if you have consumed alcohol or drugs just before receiving this medicine
• have mild to moderate liver problems
• have a lung condition causing breathing problems as this medicine could make your breathing worse. Your dose will be adjusted in accordance with your respiratory condition
• feel weak, unstable, or shaky because this medicinal product affects the central nervous system (CNS)
• have a rare hereditary blood disorder called “porphyria”
• are older since you will have an increased risk of side effects
• have severe muscle weakness (myasthenia gravis)
• have withdrawal symptoms

Anterograde amnesia may occur with the use of benzodiazepines at therapeutic doses and the risk increases with higher doses.

During treatment with benzodiazepines, paradoxical reactions such as restlessness, agitation, irritability, aggression, anxiety, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behaviour, and other behavioural disorders have been reported. Paradoxical reactions may be a class effect of benzodiazepines. If this occurs during treatment with this medicine, gradual discontinuation of treatment should be considered. Paradoxical reactions are more common in children and the elderly.

This medicine must not be used in children under 12 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you have any doubt about whether any medicine you are taking may affect the use of Clonazepam, please speak to your doctor.

The effects of Clonazepam may be intensified by medicines such as:

• antiepileptic medicines for treating epilepsy e.g., phenytoin, phenobarbital, carbamazepine, lamotrigine and valproate
• St. John’s wort (used for mild depression and mild anxiety)
• medicines used to treat absence seizures (valproic acid)
• medicines that cause drowsiness and sleepiness (CNS depressants)
• opioids (strong pain killers, medicines for replacement therapy and some cough medicines) since it may increase the risk of severe side effects.

If Clonazepam is combined with one of these drugs, it is usually necessary to adjust the dosage to achieve the optimum effect of the medicines.

Do not drink alcohol during treatment with this medicine. This is because it may make you feel very sleepy and cause problems with your breathing.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask the doctor or pharmacist for advice before giving this medicine.

Pregnancy

Since ingredients of this medicine crosses the placenta there is a risk that the baby can be affected by this medicine. Therefore, this medicine should be used with caution during pregnancy.

Breast-feeding

Clonazepam passes into breast milk and there is a risk that the baby can be affected. Therefore, breast-feeding should be discontinued during the treatment with this medicine.

This medicine has an impact on the ability to drive, use machines or any activities that requires increased attention since it can slow down your reactions. Driving should therefore be avoided after receiving this medicine, especially during the first days after treatment before you know how the medicine affects you.

Benzyl alcohol

This medicine contains 31 mg benzyl alcohol in each ampoule. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant, breast-feeding or if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Ethanol

This medicine contains 158 mg of alcohol (ethanol) in each ampoule which is equivalent to 158 mg/ml. The amount in one dose of this medicine is equivalent to 4 ml beer or 2 ml wine.

The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents.

The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.

If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

If this medicine is given slowly over 2 hours, the effects of alcohol may be reduced.

Propylene glycol

This medicine contains 805 mg propylene glycol in each ampoule which is equivalent to 805 mg/ml.

If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

Since this medicine is given at the hospital, it is unlikely that the wrong dose will be given. However, if you get too much medicine, you may experience symptoms such as drowsiness, loss of coordination, difficulty with speech, involuntary eye movements, absence of reflexes, slowed breathing, low blood pressure, difficulty breathing or unconsciousness. Tell your doctor or nurse right away if you think you have been given too much.

If treatment with this medicine is stopped suddenly, there is a risk of provoking tonic clonic seizures, status epilepticus or withdrawal symptoms. Withdrawal symptoms include tremors, restlessness, sleep disturbances, anxiety, headache, difficulty concentrating, sweating, muscle and abdominal pains, confusion and in rare cases delirium and convulsions.

Treatment with this medicine should only be stopped in consultation with a doctor.

Rare (may affect up to 1 in 1 000 people):

• bleeding from the skin and mucous membranes and bruising due to low levels of platelets in the blood (thrombocytopenia)

Very rare (may affect less than 1 in 10 000 people):

• severe acute allergic reactions (anaphylactic reaction) with symptoms such as generalized itching and hives, swelling, wheezing and difficulty breathing, fainting, and/or other allergy symptoms.

Not known (cannot be estimated from the available data):

• epilepsy
• heart failure including cardiac arrest
• breathing difficulties
• vein inflammation or thrombosis

Common (may affect up to 1 in 10 people):

• impaired concentration
• sleepiness
• delayed response
• low level of muscle tone
• dizziness
• fatigue (tiredness, apathy)
• muscle weakness
• problems with coordination of movement and walking (ataxia)
• rapid involuntary movements of the eyes

Rare (may affect up to 1 in 1 000 people):

• sexual desire disorder
• headache
• nausea, upper abdominal pain
• nettle rash, itching, rash, transient hair loss, pigmentation changes
• inability to retain urine (incontinence)
• inability of a man to maintain an erection (erectile dysfunction)

Not known (cannot be estimated from the available data):

• hypersensitivity
• emotional disorders, mood changes, confusion, loss of direction, depression, paradoxical reactions to a medication (the inability to rest or relax, irritability, aggression, nervous excitement , nervousness, unfriendliness behaviour, anxiety, sleep disorders, delusion, anger, nightmares and abnormal dreams, perception of something not present (hallucination), condition of being abnormally or extremely active (hyperactivity), psychoses, inappropriate behaviour and other behavioural side effects)
• inability to transfer information from short-term memory to long-term memory and amnesia which may be associated with inappropriate behaviour
• addiction and withdrawal symptoms
• double vision
• difficulty speaking (organic speech disorder)
• risk of falls and fracture

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via system 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 provide more information on the safety of this medicine.

• The active substance is clonazepam.
  Each ml of Clonazepam (one ampoule) contains 1 mg of clonazepam.
• The other ingredients are anhydrous ethanol, benzyl alcohol, glacial acetic acid, propylene glycol.

A colourless or slightly yellowish-greenish solution (sterile concentrate).

10 ampoules of amber transparent borosilicate glass are packed in a carton box. Ampoules are packed in two plastic trays, before placement in the carton box.