5 mg/ml solution for injection, emulsion
What Stesolid Novum is and what it is used for
Stesolid Novum belongs to a drug group called benzodiazepines . It works by enhancing the effect of a depressant substance ( GABA ) in the brain. As a result, it acts as a tension reliever, sedative, muscle relaxant, and antispasmodic.
Stesolid Novum injection liquid is used when a very quick effect of diazepam is desired, for example in epilepsy, convulsions, acute anxiety, and restlessness and as a sedative (calming) agent before, for example, examinations and operations.
The diazepam contained in Stesolid Novum may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you receive Stesolid Novum
You should not receive Stesolid Novum if you:
- are allergic to diazepam or other benzodiazepines, peanuts or soy, or to any of the other ingredients of this medicine (listed in section 6).
- have a disease called myasthenia gravis, which causes the muscles to weaken and tire quickly.
- suffer from sleep apnea (a sleep disorder that involves abnormal pauses in breathing during sleep).
- have serious liver disease.
- have acute respiratory depression (slow and/or shallow breathing).
Warnings and precautions
Talk to your doctor or pharmacist before receiving Stesolid Novum if you:
- have suffered from alcoholism or drug abuse
- are older. Stesolid Novum can confuse and affect the muscles, which can lead to falls and fall injuries.
- have breathing problems
- suffering from depression
- have suicidal thoughts
- have epilepsy or have previously had seizures
Other important aspects
- Mental side effects – contact your doctor if you experience side effects such as agitation, restlessness, aggressiveness, nightmares, or hallucinations. Such side effects occur more often in children or the elderly. See section 4 “Possible side effects”.
- Memory loss – during treatment you may experience memory loss, which occurs more often during treatment with high doses of Stesolid. Symptoms often occur several hours after taking the drug, so make sure you can get an uninterrupted 7-8 hour period of sleep to reduce the risks.
- Dependence – with treatment with this medicine there is a risk of dependence. The risk increases with dose and duration of treatment and also in patients who previously had alcohol and drug problems. You should therefore receive Stesolid Novum for as short a time as possible.
- Tolerance – if after a few weeks you notice that the effect of the medicine is not as strong as at the beginning of the treatment, you should talk to your doctor.
- Withdrawal – withdrawal symptoms such as a relapse in sleep problems and anxiety can occur even at normal doses during a short treatment period, and to reduce the risk of withdrawal symptoms, the treatment must be gradually tapered. See section 3, “If your treatment with Stesolid Novum is interrupted”.
Other medicines and Stesolid Novum
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
If the following medicines are taken in combination with Stesolid Novum, they can affect your mental health, make you very drowsy and worsen your breathing and blood pressure:
- antidepressants (eg fluvoxamine, fluoxetine )
- antipsychotics such as clozapine (for treating mental health problems)
- antihistamines (for treating allergies )
- sedative (used for calming effect)
- sleeping pills (for sleeping problems)
- muscle relaxants (eg suxamethone, tubocurarine)
- some strong painkillers such as morphine ( opioids )
- phenobarbital (to treat epilepsy or mental disorders)
Simultaneous use of Stesolid Novum and opioid medicines (strong painkillers, medicines for the treatment of opioid dependence, and certain cough medicines) increases the risk of drowsiness, breathing difficulties ( respiratory depression ), coma, and can be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
If the doctor prescribes Stesolid Novum at the same time as opioid drugs, the dose and duration of treatment must be limited by the doctor.
Tell your doctor if you are taking any opioid medication and follow your doctor’s dosage recommendations carefully. It may be good to inform friends or relatives to be aware of the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Stesolid Novum can affect or be affected by certain medicines that contain the following active substances:
- disulfiram (for the treatment of alcohol dependence)
- medicines against epilepsy such as phenytoin and carbamazepine
- theophylline (for treating asthma and other breathing problems)
- cimetidine, omeprazole, or esomeprazole (medicines that reduce stomach acid)
- rifampicin ( antituberculosis antibiotic )
- ciprofloxacin ( antibiotic against, among other things, urinary tract infection)
- atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir or saquinavir (antiviral medicines)
- fluconazole , itraconazole, ketoconazole or voriconazole (medicines for fungal infections)
- isoniazid (for the treatment of tuberculosis )
- oral contraceptives ( birth control pills ), as they can make diazepam leave the body more slowly and increase its effect. Breakthrough bleeding can occur during simultaneous treatment with diazepam and oral contraceptives, but the preventive effect remains.
- corticosteroids (anti-inflammatory drugs)
- levodopa (for the treatment of Parkinson’s disease )
- valproic acid (for the treatment of epilepsy and mental disorders)
- ketamine (an anesthetic)
Stesolid Novum with food, drink, and alcohol
Do not drink alcohol during treatment with Stesolid Novum. Alcohol can affect the effect of Stesolid Novum, which can lead to impaired breathing, unconsciousness, and failing heart function and blood circulation.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this medicine.
If you receive Stesolid Novum late in pregnancy or during delivery, the baby may have a low body temperature, and suffer from muscle weakness and breathing difficulties. If the medicine is taken regularly during the latter part of the pregnancy, the child may develop abstinence.
Your doctor will decide whether the benefit of the treatment outweighs the risk to the unborn child and whether the medicine is suitable for you.
You should not receive Stesolid Novum if you are breastfeeding.
Driving ability and use of machinery
Stesolid Novum can make you feel sleepy and can affect your ability to concentrate. It can also affect the muscles. These side effects may persist for several days even after treatment with diazepam has ended. You should not drive a car or use tools or machines if you experience such side effects.
Stesolid Novum contains soybean oil and sodium
Stesolid Novum contains soybean oil
Stesolid Novum contains soybean oil. If you are allergic to peanuts or soya, you should not receive this medicine.
Stesolid Novum contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, i.e. is next to “sodium-free”.
How to get Stesolid Novum
You should always receive this medicine as directed by your doctor. Consult a doctor if you are unsure.
Dose and treatment time are determined by the doctor, who adapts it individually for you.
If you are older or frail, there is a greater risk that you are sensitive to the side effects of Stesolid Novum and the dose may therefore need to be reduced. Your doctor decides which dosage of Stesolid Novum is right for you and how often you should dose.
Impaired kidney function
Dose in normally does not need to be adjusted.
Impaired liver function
If you have received too much Stesolid Novum
If you have received too large a dose, or if you think a child has swallowed the liquid, you should immediately contact the nearest doctor or hospital for an assessment of the risk and advice.
Signs of overdose include impaired coordination, sleep-like drowsiness, fatigue, confusion, slurred speech, muscle weakness, and low blood pressure. Severe overdose can lead to coma (unconsciousness that cannot be lifted), cardiac arrest, and severe breathing difficulties.
If your treatment with Stesolid Novum is interrupted
Treatment with Stesolid Novum can lead to psychological or physical dependence. When physical dependence has developed, sudden discontinuation of treatment can lead to withdrawal. The probability of withdrawal and its severity depends on the duration of treatment, dose, and degree of dependence.
Treatment with the medicine must not be interrupted without first consulting your doctor. The dose should be reduced gradually before the treatment is stopped completely. If treatment with Stesolid Novum is stopped suddenly, the risk of withdrawal increases.
In case of abstinence, you may experience the following withdrawal symptoms, among other things:
- Headache, muscle pain, severe anxiety, tension, restlessness, palpitations, sweating, tremors, stomach problems, irritation, aggression, sensory disturbances, muscle spasms, general malaise, loss of appetite, insomnia, mental side effects such as severe confusion, irritability, and seizures.
- Recurrence of sleep problems and anxiety; a transient syndrome in which the symptoms that led to the initiation of treatment with Stesolid Novum return in an intensified form. This can be accompanied by mood swings, anxiety, sleep disturbances, and nervousness.
- If you have epilepsy or have previously had seizures and discontinue treatment with Stesolid Novum, there is a risk of convulsions or prolonged epileptic seizures. There is also a risk of seizures if you have alcohol or drug problems and suddenly stop treatment with Stesolid Novum.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately or go to the nearest emergency department if any of the following occur:
Uncommon (may affect up to 1 in 100 users):
- Respiratory depression (very slow and/or shallow breathing)
Rare (may affect up to 1 in 1,000 users):
- Respiratory arrest (respiratory arrest)
Very rare (may affect up to 1 in 10,000 users):
- Anaphylactic reaction (severe allergic reaction ) with symptoms such as sudden wheezing, swelling of the lips, tongue, and throat or the rest of the body, rash, fainting, or difficulty swallowing.
Other side effects:
Very common (may affect more than 1 in 10 users):
Common (may affect up to 1 in 10 users):
- Withdrawal symptoms – withdrawal (for symptoms see “ If your treatment with Stesolid Novum is stopped “ in section 3)
- Impaired coordination of muscle movements ( ataxia ) and other movement disorders, tremors
- Local reactions at the injection site such as pain and thrombophlebitis ( inflammation and blood clots in the vein wall).
Uncommon (may affect up to 1 in 100 users):
- Muscle weakness ( Myasthenia gravis )
- Memory loss
- Concentration difficulties
- Balance disorders
- Slurred speech
- Stomach and intestinal problems such as nausea, vomiting, constipation, diarrhea
- Increased saliva production
- Allergic skin reactions in the form of itching, redness, and swelling as well as rashes.
Rare (may affect up to 1 in 1,000 users):
- Mental side effects such as excitement, agitation, restlessness, irritation, aggressiveness, memory loss, delusions, tantrums, psychoses, nightmares, inappropriate behavior, or hallucinations. Can become serious. Children and the elderly are at higher risk of being affected. Talk to your doctor if this happens.
- Decreased alertness
- The feeling of emotional emptiness
- Heart problems such as slow heart rhythm ( bradycardia ), heart failure, and cardiac arrest.
- Low blood pressure, fainting
- The increased amount of mucus in the airways
- Dry mouth
- Increased appetite
- Jaundice (yellowing of the skin and whites of the eyes)
- Changes in liver enzymes shown in blood test results
- Inability to empty the bladder, poor bladder control ( urine leakage)
- Enlargement of mammary glands in men
- Impotence, altered sex drive
Very rare (may affect up to 1 in 10,000 users):
- Low white blood cell count ( leukopenia )
- High levels of certain enzymes in the blood ( transaminases )
Has been reported (occurring in an unknown number of users):
- Blurred vision, double vision, and involuntary eye movements (these side effects disappear after the end of treatment with diazepam )
How Stesolid Novum should be stored
Store at a maximum of 25 °C. Do not freeze.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Keep this medicine out of the sight and reach of children.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is diazepam 5 mg/ml
- Other ingredients are soybean oil, monoglyceride acetylate, egg phospholipid, glycerol, sodium hydroxide, and water for injections.
Appearance and package sizes of the medicine
Milk white emulsion.
Solution for injection, emulsion 5 mg/ml:
Marketing Authorisation Holder
Actavis Group PTC EHF.
Actavis Group PTC EHF
Reykjavík Curvegur 76-78