Lepheton ethylmorphine hydrochloride, ephedrine hydrochloride oral solution
What Lephetone Is And What Lepheton Used For
Lephetone contains ethylmorphine, which has an antitussive and mild sedative effect, and ephedrine, which has a mucosal decongestant and bronchodilator effect.
Lephetone is used for the short-term treatment of whooping cough.
What You Need To Know Before You Use Lepheton
Do Not Use Lepheton
- If you are allergic to ethylmorphine, ephedrine or any of the other ingredients of this medicine (listed in section 6),
- To children and adolescents (0-18 years) who have obstructive sleep apnea syndrome or are undergoing or are planning to undergo removal of tonsils or polyps,
- If you know that you very quickly convert ethyl morphine to morphine.
Warnings And Cautions
Talk to your doctor or pharmacist before using Lepheton
- If you have cardiovascular disease,
- If you have an overactive thyroid gland ( hyperthyroidism ),
- If you have an enlarged prostate,
- If you have diabetes,
- If you have glaucoma,
- If you have asthma. Ethylmorphine can worsen breathing problems.
Due to its content of ephedrine, lephetone may increase blood pressure, which is why patients with high blood pressure should consult a doctor before starting treatment with lephetone.
There is a certain risk of developing addiction in high doses and long-term use.
As dry mouth occurs, careful oral hygiene (brushing with fluoride toothpaste twice a day) during the use of Lepheton is important.
Ethyl morphine is converted to morphine in the liver by an enzyme. It is morphine that gives the cough suppressant effect. The ability to convert ethylmorphine differs between different people, and one can be affected differently. Some people have an increased risk of serious side effects because a large amount of morphine can be formed quickly in the liver. Get any of the following side effects. You must stop taking this medicine and contact a doctor immediately:
- Slow or shallow breathing
- Confusion
- Drowsiness
- Small pupils
- Nausea
- Vomiting
- Constipation
- Loss of appetite
If you have previously reacted strongly to medicines containing ethylmorphine of codeine, you should tell your doctor before starting treatment.
Children
Lephetone should not be used in children under 2 years of age.
Use in children with respiratory problems. Ethylmorphine is not recommended for children with respiratory problems that may occur in, for example, neuromuscular diseases, severe heart and respiratory conditions, or severe infections of the upper respiratory tract or lungs, as the symptoms of morphine poisoning may be more severe in these children.
Other Medicines And Lephetone
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Lepheton and certain medicines increase the risk of fatigue, impaired breathing ( respiratory depression ), and unconsciousness and can be life-threatening. Examples of these drugs are:
- Strong painkillers (opioid drugs)
- Sedatives and hypnotics (eg benzodiazepines and certain antihistamines )
- Anaesthetics for anaesthesia before e.g. an operation
- Certain medicines for mental illness (phenothiazines)
- Muscle relaxants
- Some medicines used to prevent blood clots (eg clopidogrel, prasugrel, ticagrelor) may have a delayed or reduced effect when taken with opium.
Due to this, concomitant use of Lepheton and the above medicines should only be considered by your doctor when other treatment options are not possible. If your doctor prescribes Lepheton at the same time as any of the above medicines, your dose and treatment time should be limited by your doctor. Tell your doctor if you are taking any of the above medicines, and follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about being aware of the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.
The treatment effect can also be affected if Lepheton is taken at the same time as certain other medicines, such as:
- Certain antidepressants (moclobemide, selegelin),
- Dexamethasone (an asthma medicine ),
- Certain other medicines may affect or be affected by treatment with Lepheton,
- Other preparations, including dietary supplements containing ephedrine, should not be used during treatment with Lepheton.
Lepheton With Alcohol
Alcohol consumption should be avoided during treatment with Lepheton.
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 taking this medicine.
Lephetone should not be used during pregnancy. Ephedrine and ethyl morphine passes into breast milk. Lephetone should not be used during breastfeeding.
Driving And Using Machines
During treatment with Lepheton, dizziness may occur. Reactivity can also be reduced. This should be considered when sharper attention is required, e.g. while driving.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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.
Lephetone Contains sorbitol, Sodium And Macrogol Glycerol Hydroxystearate.
This medicine contains 560 mg sorbitol per ml. Sorbitol is a source of fructose. If you (or your child) do not tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents fructose from being broken down, consult a doctor before using this medicine. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
This medicine contains less than 1 mmol (23 mg) sodium per ml, essentially ‘sodium-free’.
Lephetone contains macrogol glycerol hydroxy stearate, which may cause stomach upset and diarrhoea.
How To Use Lepheton
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Do not exceed the dose specified by your doctor.
- Overdose increases the risk of fatigue, impaired breathing ( respiratory depression ), and unconsciousness. Overdose can be life-threatening.
- Not for long-term treatment.
- Dose one is determined by the doctor, who adjusts it individually for you.
- The recommended dose for adults is 20 ml 3 times daily.
- The recommended dose for children 11-12 years (30-40 kg) is 10 ml 3 times daily.
- The recommended dose for children 6-10 years (20-30 kg) is 7.5 ml 3 times daily.
- The recommended dose for children 3-5 years (15-20 kg) is 5 ml 3 times daily.
- The recommended dose for children 2 years (13-15 kg) is 2.5 ml 3 times daily.
Small doses (2.5–5 ml) should be given with a dosing syringe to obtain an exact dosage. Use a 5 ml dosing syringe with a graduation of 0.5 ml.
NOTE: dosing syringe is not included in the package but is available from the pharmacy.
How to measure and give a dose with a dosing syringe
- Unscrew the cap from the bottle.
- Attach the syringe adapter to the neck of the bottle and make sure it is firmly seated.
- Make sure that the plunger on the dosing syringe is depressed. Then push the tip of the dosing syringe into the hole on the syringe adapter.
- Turn the bottle upside down. Slowly pull the plunger out of the syringe to the number of ml to be given.
- Turn the bottle right again and remove the dosing syringe from the bottle.
- Insert the dosing syringe into the baby’s mouth, point the dosing syringe at the inside of the cheek, and slowly push the plunger in until the baby has swallowed everything.
- Remove the adapter and put the cap back on the bottle.
- Clean the dosing syringe and adapter with water after use.
- In diabetics, there is some risk of temporarily rising blood sugar levels, but it is uncommon to take this medicine.
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the bottle after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Possible Lepheton Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- Difficulty urinating
- Especially in older men with an enlarged prostate
- Dizziness
- Headache
- Nausea
- Constipation
Uncommon (may affect up to 1 in 100 people):
- Sweating
- Palpitations
- Tremors
- Anxiety
- Insomnia
- Dry mouth
Rare (may affect up to 1 in 1,000 people):
- Muscle weakness
- Bile problems
- Hallucinations
- Hives
Contents Of The Pack And Other Information
Content Declaration
- The active substances are ethylmorphine hydrochloride 0.82 mg/ml and ephedrine hydrochloride 2.05 mg/ml.
- The other ingredients are macrogol glycerol hydroxy stearate, citric acid, sodium citrate, sorbic acid ( preservative E 200), and purified water. Sweetening: sorbitol 560 mg/ml, saccharin sodium 0.30 mg/ml. Flavours: anise oil, honey aroma, orange aroma.
What The Medicine Looks Like And Contents Of The Pack
- Colourless to slightly yellow, viscous solution.
- Pack sizes: 250 ml, 500 ml, and 1000 ml in a brown glass bottle with a child-resistant lid in white plastic.
Marketing Authorisation Holder
Meda AB
Box 906
170 09 Solna
Manufacturer
Unimedic AB
Box 91
864 21 Matfors