5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg or 75 mg oral solution in single- dose levometadone
hydrochloride containers
What Levopidone is and what it is used for
Levopidone contains the active substance levomethadone hydrochloride. It belongs to a group of drugs that affect the nervous system.
Levopidone is used to treat adults who are addicted to substances called opioids or narcotic painkillers, e.g. heroin and morphine. It acts as a substitute for these addictive substances. The treatment must be combined with medical, psychological, and social follow-up.
Levometadone hydrochloride contained in Levopidone may also be approved for the treatment of other conditions not mentioned in this product information. 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 take Levopidone
Do not use Levopidone
You must always take Levopidone exactly as your doctor has told you. Levomethadone (Levopidone) is stronger than methadone. To avoid overdose, you must use Levopidone according to your doctor’s prescription (see also section 3 “How to take Levopidone”).
Levopidone should only be taken orally. Under no circumstances may you inject the medicine. Injection of the drug can cause serious and permanent damage to your body, which can be fatal.
Do not take Levopidone
- if you are allergic to levometadone or any of the other ingredients of this medicine (listed in section 6)
- if you are taking medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors ( MAOIs ) or have taken such medicines in the last two weeks (see section ‘Other medicines and Levopidone’)
- if you have severe breathing problems or lung problems
- if you are addicted to substances other than opioids .
No other drug for the treatment of addiction may be used during treatment with Levopidone, except for drugs used for the treatment of overdose (see section “Other drugs and Levopidone”).
Do not take Levopidone if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Levopidone.
Warnings and cautions
Talk to your doctor or pharmacist before using Levopidone:
- if you have acute asthma attacks
- if you have impaired lung capacity due to any lung disease or have difficulty breathing. Your doctor will need to evaluate your treatment carefully.
- if you have low levels of potassium in your body ( hypokalaemia )
- if you have kidney problems (including kidney stones and gallstones )
- if you have liver problems
- if you have an underactive thyroid gland ( hypothyroidism )
- if you have an enlarged prostate or narrowing of the urethra (may make it difficult to urinate)
- if you have suffered a head injury and the pressure in your brain is higher than it should be (check this with your doctor). You may have a severe headache.
- if you have stomach pain, diarrhea or constipation
- if you have certain changes in your heart rhythm or other serious heart disease. Levopidone can affect the electrical signals that control the contractions of the heart, especially at high doses . Therefore, tell your doctor if you have a history of heart problems.
- if you are taking strong painkillers ( opioids ) (see section “Other medicines and Levopidone”)
- if you are taking medicines that relax and help you sleep ( barbiturates and benzodiazepines ) (see section “Other medicines and Levopidone”).
If any of the above conditions apply to you, talk to your doctor.
Prolonged use of opioid drugs can lead to decreased levels of sex hormones and increased levels of the hormone et prolactin. Contact a doctor if you experience symptoms such as decreased sex drive, impotence, or missed periods.
Talk to your doctor or pharmacist if you get any of the following symptoms while taking Levopidone:
- weakness, fatigue, loss of appetite, nausea, vomiting or low blood pressure .
This may be a symptom that the adrenal glands are producing too little of the hormone et cortisol, and you may need to take hormone supplements.
Keep this medicine out of the sight and reach of children
Children are more sensitive to levomethadone than adults. Therefore, poisoning can occur at very low doses. To prevent children from accidentally ingesting levomethadone when using it at home, keep it in a safe place out of the reach of children.
Children and young people
Children and adolescents under 18 years of age should not take this medicine.
Other medicines and Levopidone
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines must not be used during treatment with Levopidone:
- medicines used to treat depression or Parkinson’s disease called monoamine oxidase inhibitors ( MAOIs ), especially if you have been taking them for the last two weeks (see also section ‘Do not take Levopidone’).
- other drugs for the treatment of addiction, e.g. methadone , naltrexone, buprenorphine and naloxone (except for the treatment of overdose).
Tell your doctor if you are taking any of the following medicines:
- any medicine that affects your mental state, e.g. risperidone , thioridazine, perfenazine, phenothiazines, haloperidol and sertindole (used to treat eg psychosis ) and atomoxetine (used to treat ADHD )
- strong painkillers ( opioids ) such as morphine and pentazocine
- drugs for heart disease, e.g. verapamil, quinidine , propafenone , flecainide , metoprolol , sotalol, amiodarone
- antidepressants, e.g. clomipramine, nortriptyline, desipramine, nefazodone, fluoxetine , fluvoxamine, paroxetine and sertraline
- tamoxifen for the treatment of cancer
- drugs that suppress inflammation and drugs that inhibit the function of the immune system, e.g. dexamethasone and cyclosporine
- antiviral drugs, including certain anti- HIV drugs , e.g. amprenavir, nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, lopinavir, saquvinavir, abacavir, delavirdine, didanosine and stavudine
- antibiotics Macrolide (drugs for bacterial infections), e.g. clarithromycin, telithromycin and erythromycin
- medicines for fungal infections, e.g. ketoconazole , itraconazole and fluconazole
- rifampicin for tuberculosis
- antiepileptic drugs , e.g. phenytoin , phenobarbital and carbamazepine
- products that make the urine more acidic, e.g. ammonium chloride and vitamin C tablets
- medicines for diarrhea, e.g. loperamide and diphenoxylate
- medicines called anticholinergics, as these medicines can cause constipation or blockage of the bowel if taken with Levopidone
- diuretics , e.g. spironolactone
- medicines or products containing cannabinoids
- (traditional) herbal medicines containing St. John’s wort
- medicines that make you relax and help you sleep ( barbiturates and benzodiazepines )
The risk of side effects is increased if you use levomethadone at the same time as antidepressants (eg citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, and nortriptyline).
Contact a doctor if you get symptoms such as:
- effects on mental health (eg agitation , hallucinations or coma )
- fast heartbeat, unstable blood pressure or fever
- excessive reflexes, impaired coordination, muscle stiffness
- gastrointestinal symptoms (eg nausea, vomiting or diarrhea)
Concomitant use of Levopidone and sedatives or medicines for sleep disorders such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Levopidone at the same time as sedatives, the dose and treatment time should be limited by your doctor.
Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Levopidone with drink and alcohol
Do not drink alcohol while using Levopidone, as it can cause serious side effects. Do not drink grapefruit juice while using Levopidone, as it may alter the effect of the medicine.
Pregnancy and breastfeeding
Levopidone may affect the fetus. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Talk to your doctor if you are breastfeeding or planning to breastfeed while taking levomethadone as it may affect your baby. Monitor your child for abnormal signs and symptoms such as increased drowsiness (more than usual), difficulty breathing, or muscle weakness; if your doctor decides that you can breastfeed during treatment. Contact a doctor immediately if you notice any of these symptoms.
Driving and using machines
Do not drive or use any tools or machines during treatment with Levopidone. You may feel sleepy and less alert while taking the medicine and for some time after you stop taking it. It is individual when you can drive a car or use machines and the doctor decides if it is appropriate.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Levopidone contains methyl parahydroxybenzoate (E 218)
May cause an allergic reaction (possibly delayed).
How to take Levopidone
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor:
- dose one is individually tailored for you
- dose one is based on how soon you get withdrawal symptoms
- Levomethadone (Levopidone) is stronger than methadone and the dosage is therefore different. To avoid overdose, it is very important that you use Levopidone according to your doctor’s prescription .o Do not take more or less of the medicine than you have been told to do.o Do not take the medicine more often or less often than you have been told to do.
You will start treatment with a starting dose that is gradually increased for a few weeks. After this starting period, dose one is stabilized and the maintenance dose is adjusted depending on how you respond to the treatment.
Dose one is usually taken once daily.
Talk to your doctor if you have difficulty concentrating, feel drowsy or elated, or dizzy when you get up. Your doctor may need to reduce your dose.
Elderly people and very sick people
Dose one may need to be reduced if you are over 65 or have very poor health. In such cases, your doctor may want to monitor you particularly closely.
Kidney and liver problems
Dose one may need to be reduced if you have kidney problems or severe, long-term liver problems. In such cases, your doctor may want to monitor you particularly closely.
How the medicine is taken
- Levopidone should only be taken orally. Under no circumstances may you inject the medicine. Injection of the drug can cause serious and permanent damage to your body, which can be life-threatening.
- The drug is ready to use and the oral solution is provided in single dose containers .
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Very common: may affect more than 1 user in 10
- nausea, vomiting.
Common: may affect up to 1 in 10 users
- accumulation of water in the body
- exhilaration ( euphoria )
- that you see or hear things that are not real (hallucinations)
- drowsiness
- dimsyn
- pin pupils
- constipation
- rash
- sweating
- fatigue
- weight gain.
Uncommon: may affect up to 1 in 100 people
- loss of appetite
- Depression
- concern
- difficulty sleeping
- confusion regarding time and place
- decreased sex drive
- headache
- fainting
- flushing
- low blood pressure
- accumulation of water in the lungs
- breathing difficulties (even with cough)
- dry mouth
- inflammation of the tongue
- bile duct cramps (causes stomach pain)
- itching
- hives
- sharp accumulation of water in the body ( edema )
- difficulty urinating
- difficulty getting or maintaining an erection
- menstrual disorders
- swollen legs
- weakness.
Rare: may affect up to 1 in 1,000 users
- slower pulse
- that you feel how the heart beats (palpitations)
- heart problems (especially at high doses ).
Has been reported: occurs in an unknown number of users
- lack of potassium or magnesium in the blood
- decreased platelet count
- low blood sugar level.
Some of the side effects may get worse over time. However, constipation and increased sweating are unlikely to improve. Talk to your doctor or pharmacist about treatment that can alleviate these side effects.
How to store Levopidone
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
- Do not freeze.
- 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.
Contents of the package and other information
Content declaration
- The active substance is levomethadone hydrochloride.One dose of oral solution contains 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg or 75 mg levomethadone hydrochloride .
- The other ingredients are methyl parahydroxybenzoate (E 218), betaine hydrochloride, glycerol , purified water.
What the medicine looks like and contents of the pack
Levopidone is a clear and colorless oral solution in single-dose containers. It is supplied in 50 ml brown glass bottles with a safety seal and a child-resistant plastic screw cap.
Pack sizes: 1, 3, or 7 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
dne pharma as
Karihaugveien 22
NO-1086 Oslo
Norway
Manufacturer
Pharma Production AS
Karihaugveien 22
NO-1086 Oslo
Norway