5 mg/ml rectal solution
What Stesolid Rectal Prefill is and what it is used for
Stolid 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. Stolid Rectal Prefill contains a solution of diazepam intended for administration in the rectum. The effect comes faster and is more pronounced than after the same dose in tablet form.
Stesolid Rectal Prefill is used when a quick effect of diazepam is desired, for example in the case of febrile convulsions, epilepsy, and the like, but also as a sedative and relaxant, among other things, just before unpleasant examinations, sampling, and operative interventions.
The diazepam contained in Stesolid 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 using Stesolid Rectal Prefill
Do not use Stesolid Rectal Prefill if you:
- are allergic to diazepam or other benzodiazepines or 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 using Stesolid Rectal Prefill if you:
- have suffered from alcoholism or drug abuse
- are older. Stesolid Rectal Prefill can confuse and affect 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 take Stesolid Rectal Prefill 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 you stop taking Stesolid Rectal Prefill ”.
Other medicines and Stesolid Rectal Prefill
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. Above all:
If the following medicines are taken in combination with Stesolid, 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 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 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 helpful 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 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 )
- 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 Rectal Prefill with food, drink, and alcohol
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 using this medicine.
If you take Stesolid Rectal Prefill 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.
Do not use Stesolid if you are breast-feeding
Driving ability and use of machinery
Stesolid Rectal Prefill 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.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Stesolid Rectal Prefill
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Dose and treatment time are determined by the doctor, who adjusts 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 Rectal Prefill and the dose may therefore need to be reduced. Your doctor decides which dosage of Stesolid Rectal Prefill 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 liver cirrhosis or impaired liver function, the dose must be lowered.
If you have used too much Stesolid Rectal Prefill
If you have taken 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 you have forgotten to use Stesolid Rectal Prefill
If you forget to take a dose, you should take it as soon as you realize that you previously forgot to take the medicine. If it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.
If you stop using Stesolid Rectal Prefill
- Do not stop treatment with the drug without consulting your doctor. Does one should be reduced gradually before stopping treatment completely. If you suddenly stop treatment with Stesolid, the risk of withdrawal symptoms increases.
With withdrawal symptoms, you may experience the following, among other things: headache, anxiety, panic, palpitations, sweating, tremors, stomach problems, irritation, aggression, sensory disturbances, muscle spasms, general malaise, loss of appetite, insomnia, mental side effects such as severe confusion, seizures. The probability of withdrawal and its severity depends on the duration of treatment, dosage strength, and degree of dependence.
- If you have epilepsy or have previously had seizures and discontinue treatment with Stesolid Rectal Prefill, 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 Rectal Prefill.
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 (for symptoms see “If you stop taking Stesolid Rectal Prefill” in section 3)
- Impaired coordination of muscle movements ( ataxia ) and other movement disorders, tremors
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 are 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 Rectal Prefill should be stored
Store at a maximum of 25 °C.
Use before the expiry date stated on the carton and label after EXP or 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
1 ml contains:
Active ingredient: diazepam 5 mg/ml.
Other ingredients: Glycofurol, ethanol 96%, water, sodium hydroxide, and hydrochloric acid (for the correct pH value ).
Appearance and package sizes of the medicine
Rectal syringes with attached rectal tips.
Instructions for use are included in the packaging.
Rectal solution 5 mg/ml:
Actavis Group PTC EHF.