Eptadone 10 mg Oral Solution

Eptadone contains a medicine called methadone hydrochloride. This belongs to a group of medicines called narcotic analgesics. Eptadone is used in the treatment of opioid drug addiction.

Do not take Eptadone:

• if you are hypersensitive (allergic) to methadone or any of the other ingredients of Eptadone (listed in section 6);
• if you have any breathing difficulties or during an asthma attack;
• if you are dependent on alcohol or any other medicines;
• if you have or have recently had a head injury;
• if you are taking monoamine oxidase inhibitors (MAOI’s) which are medicines used to treat depression or if you have taken a MAOI medicine in the past two weeks (see ‘other medicines and Eptadone’);
• if you are in labour;
• if you have liver failure;
• if you have ulcerative colitis (inflammatory bowel disease);
• if you have biliary and renal tract spasm;
• if you have a risk of temporarily paralysation of the muscle contractions, which move food through the intestines;
• if you have a hormone-secreting tumour of the adrenal glands.

Eptadone should not be given to children.

Warnings and precautions

Tell your doctor or healthcare provider before you take Eptadone:

• if you have any breathing problems or lung conditions;
• if you have liver or kidney problems;
• if you have underactive thyroid (hypothyroidism);
• if you have an enlarged prostate gland (prostatic hypertrophy);
• if you are an elderly or very ill person. You may be sensitive to the medicine and it may cause low blood pressure and fainting.

Take special care with Eptadone:

• if you have any heart condition as this can be intensified with the use of Eptadone;
• if you have low potassium blood levels or other electrolyte imbalance;
• if you have problems with your adrenal glands (adrenocortical insufficiency);
• if you have low blood sugar levels;
• if you are currently taking any medicine that make you sleepy and relaxed;
• if you have convulsive disorders (seizures);
• if you have bowel problems;
• if you have myasthenia gravis (weakness and rapid fatigue of the muscles).

Tolerance, dependence, and addiction

Eptadone contains methadone which is an opioid medicine. Repeated use of opioids can result in the medicine being less effective (you become accustomed to it, known as tolerance). Repeated use of Eptadone can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on Eptadone if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Eptadone, it could be a sign that you have become dependent or addicted.

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Eptadone).

Withdrawal

This medicine should not be stopped suddenly, but gradually, as sudden stoppage could lead to withdrawal symptoms. Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Sleep-related breathing disorders

Eptadone can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Children

Do not give Eptadone to children as it may cause breathing difficulty.

Do not share medicines prescribed for you with any other person. Always take Eptadone exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Eptadone is to be taken by mouth. Eptadone is normally administered once daily. The correct dosage should be extracted from the bottle by using a dispenser, measuring cylinder or syringe. Treatment with Eptadone assumes that you are taking part in a programme including medicine-assisted rehabilitation for narcotics abuse, approved by a relevant authority. The dose will be determined by your doctor and is tailored for each individual patient.

Adults

The usual dose for addiction is initially 20 mg once daily. Your doctor will increase the dose over three weeks until you feel well and do not have withdrawal symptoms. The final dose is usually between 60 mg and 120 mg in 24 hours.

Special population

If you are elderly or very ill, you should be careful when taking repeated doses. If you suffer from impaired liver function, hypothyroidism or prostatic hypertrophy, your doctor may prescribe a lower initial dose.

Children

Eptadone must not be used in children.

Your doctor will tell you how long your treatment with Eptadone will last. If you have the impression that the effect of Eptadone is too strong or too weak, tell your doctor or pharmacist.

If you take more Eptadone than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Signs of severe overdosage include:

• apnoea (breathing stop and starts repeatedly);
• heart problems or heart stops beating;
• a brain disorder (known as toxic leukoencephalopathy);
• death may occur.

Signs of or taking too much Eptadone:

• inability to breath properly;
• extreme drowsiness that can leads to unconsciousness or coma;
• constriction of the pupils – pupils become smaller;
• muscle slack (which is represented by the delay between muscular contraction and recoil of the series);
• cold and clammy skin;
• slow heart rate;
• low blood pressure;
• low blood sugar.

If you forget to take Eptadone

Do not take / receive a double dose to make up for forgotten individual doses.

Eptadone can have side effects. Not all side effects reported for Eptadone are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Eptadone, please consult your healthcare provider for advice. If any of the following happens, stop taking Eptadone and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Severe itching of your skin with raised lumps.

These are all very serious side effects. If you have them, you may have had a serious reaction to Eptadone. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• changes in the way your heart beats, for example if you notice it beating faster;
• breathing difficulties and worsening of existing asthma;
• if your breathing becomes slow and shallow;
• confusion and disorientation;
• sleep disturbances;
• feeling elated (very happy); feeling down (dysphoria);
• agitation (annoyance);
• blurred vision, small pupils, dry eyes, visual disturbances;
• seeing or hearing things that are not there (hallucinations);
• breast growth and production of breast milk.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• nausea (feeling sick);
• vomiting;
• constipation;
• sweating;
• dizziness;
• drowsiness;
• feeling weak, tired;
• weight gain;
• fluid retention (swollen ankles, feet or legs);
• headaches;
• reduced sexual urge.

Less frequent side effects:

• fainting or passing out;
• dry mouth and nose;
• low blood pressure;
• itching skin;
• problems passing urine;
• inflammation of the tongue;
• facial flushing;
• low body heat (hypothermia);
• painful periods or lack of periods;
• underactive thyroid gland;
• biliary dyskinesia (a functional gallbladder disorder);
• you can become dependent of Eptadone (for more information see section 2 Warnings and precautions).

Side effects with unknown frequencies:

• reversible thrombocytopenia (low number of platelets in the blood) in opioid dependent patients with chronic hepatitis (inflammation of the liver).
• increased prolactin levels;
• decreased activity of the adrenal glands;
• hypogonadism (body's sex glands produce little or no hormones);
• anorexia (eating disorder causing people to obsess about weight and what they eat);
• low blood levels of potassium;
• low blood levels of magnesium;
• low blood sugar;
• increased intracranial pressure;
• nystagmus (involuntary rhythmic side-to-side, up and down or circular motion of the eyes), strabismus (eyes that look in different directions from each other), vision loss;
• sleep apnoea (breathing pauses during sleep).

You may develop tolerance to the effects Eptadone; this means you may notice that your medicine is less effective at relieving your symptoms. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of Eptadone.

Store all medicines out of reach of children. Store Eptadone in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them. Store at or below 25 °C. Store in the original packaging to protect from light. Keep the container tightly closed.

Do not use after the expiry date stated on the label / carton / bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).