Methadone hidrohloride Inn-farm

Leaflet accompanying the packaging: Information for the user

Methadone hydrochloride INN-FARM, 1 mg/ml, oral solution

Methadone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Methadone hydrochloride INN-FARM and what is it used for
• 2. Important information before taking Methadone hydrochloride INN-FARM
• 3. How to take Methadone hydrochloride INN-FARM
• 4. Possible side effects
• 5. How to store Methadone hydrochloride INN-FARM
• 6. Contents of the pack and other information

1. What is Methadone hydrochloride INN-FARM and what is it used for

The medicine contains methadone hydrochloride, which belongs to a group of medicines called opioid analgesics. It is used to treat opioid dependence. All patients taking Methadone hydrochloride INN-FARM must be routinely monitored for signs of misuse, abuse, and dependence.

2. Important information before taking Methadone hydrochloride INN-FARM

When not to take Methadone hydrochloride INN-FARM:

• if you are allergic to methadone or any of the other ingredients of this medicine (listed in section 6). An allergic reaction includes a rash, itching, or difficulty breathing;
• if you have an asthma attack (do not take this medicine during an asthma attack). If you are self-administering the medicine (self-administering), wait until the asthma attack has subsided and you have fully recovered;
• if you breathe very slowly or shallowly (respiratory depression);
• if you are addicted to alcohol;
• if you have recently had a head injury or have increased pressure in the brain;
• if you are taking monoamine oxidase inhibitors (MAOIs) used to treat depression or if you have taken MAOIs in the last two weeks (see "Methadone hydrochloride INN-FARM and other medicines");
• if you are not opioid-dependent;
• if you have heart problems (QT interval prolongation);
• if you have severe liver dysfunction;
• if you have a bowel disease called ulcerative colitis;
• if you have a ureteral spasm (causing back pain and urinary problems);
• if you have a bile duct spasm (causing pain on the right side under the ribs, usually after a meal);
• during childbirth.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before taking Methadone hydrochloride INN-FARM.

Warnings and precautions

Before taking this medicine, discuss it with your doctor or pharmacist if you have:

• severe breathing difficulties;
• a recent head injury;
• liver or kidney problems;
• epilepsy;
• inadequate pituitary function (hypopituitarism);
• reduced thyroid function (hypothyroidism);
• inadequate adrenal function;
• an adrenal tumor (pheochromocytoma);
• enlarged prostate;
• low blood pressure;
• shock (circulatory failure);
• a muscle disease called myasthenia;
• gastrointestinal problems;
• known risk factors for QT interval prolongation, namely:
• irregular heartbeat in the past;
• heart disease in the past;
• sudden death without a known cause in the family;
• low potassium, sodium, or magnesium levels;
• pregnancy or breastfeeding;
• extreme illness or old age. Sensitivity to the medicine may be greater in these cases.

If you experience any of the following symptoms while taking Methadone hydrochloride INN-FARM, consult your doctor or pharmacist: weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These symptoms may indicate that the adrenal glands are producing too little cortisol and hormone replacement may be necessary (see section 4). Long-term use may be associated with a decrease in sex hormone levels and an increase in prolactin levels. If you experience symptoms such as low libido, impotence, absence of menstruation, or infertility, contact your doctor. Sleep apnea Methadone hydrochloride INN-FARM may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. The doctor may consider reducing the dose. Tolerance, dependence, and addictive use This medicine contains methadone, which is an opioid medicine. Repeated use of opioids can lead to reduced efficacy of the medicine (the patient's body gets used to the effect of the medicine, which is called "tolerance"). Repeated use of Methadone hydrochloride INN-FARM can also lead to dependence, abuse, and addictive use, which can result in life-threatening overdose. Dependence or addictive use can make the patient feel like they have no control over the amount of medicine they take or how often they take it. The risk of developing dependence or abuse varies from patient to patient. A patient may be at greater risk of developing abuse or dependence on Methadone hydrochloride INN-FARM if:

• The patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• The patient smokes.
• The patient has ever had mood disorders (depression, anxiety disorders, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If you experience any of the following symptoms while taking Methadone hydrochloride INN-FARM, it may indicate that you have developed dependence or abuse:

• You feel the need to take the medicine for longer than your doctor recommended.
• You feel the need to take a higher dose than recommended.
• You use the medicine for reasons other than the one for which it was prescribed, such as "to calm down" or "to be able to sleep".
• You have repeatedly tried to stop or control the use of the medicine but failed.
• After stopping the medicine, you feel unwell and feel better after taking it again ("withdrawal symptoms").

If you experience any of these symptoms, talk to your doctor and discuss the best treatment option for you, including the right time to stop treatment and a safe way to stop treatment (see section 3, Stopping Methadone hydrochloride INN-FARM). If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before taking Methadone hydrochloride INN-FARM.

Methadone hydrochloride INN-FARM and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Methadone hydrochloride may affect the way other medicines work. Also, some medicines may affect the way methadone works. Do not take Methadone hydrochloride INN-FARM:

• at the same time or within 2 weeks of stopping monoamine oxidase inhibitors (MAOIs).

In particular, you should inform your doctor if you are taking any of the following medicines:

• other opioid painkillers;
• medicines that affect the mind (such as thioridazine, phenothiazine derivatives, haloperidol, and sertindole);
• medicines used to treat heart conditions, such as verapamil and quinidine;
• medicines used to treat depression (desipramine, nefazodone, fluvoxamine, fluoxetine, paroxetine, and sertraline);
• anti-inflammatory and immunosuppressive medicines (such as dexamethasone and cyclosporine);
• antiviral medicines, including some medicines used to treat HIV infection (nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, amprenavir, delavirdine, lopinavir/ritonavir, ritonavir/saquinavir, abacavir, didanosine, and stavudine);
• antibiotics (medicines used to treat bacterial infections), such as ciprofloxacin and macrolide antibiotics, e.g., clarithromycin, telithromycin, and erythromycin;
• medicines used to treat fungal infections, such as fluconazole, itraconazole, and ketoconazole;
• cimetidine, used to treat stomach ulcers;
• naloxone, used to reverse the effects of opioids;
• medicines used to counteract the effects of opioid medicines, such as naltrexone and buprenorphine;
• rifampicin, used to treat tuberculosis (TB);
• medicines used to treat epilepsy, such as phenytoin, carbamazepine, phenobarbital, and primidone;
• cannabidiol (a medicine used to treat seizure disorders);
• gabapentin and pregabalin (medicines used to treat epilepsy, nerve pain, or anxiety), may increase the risk of opioid overdose, respiratory depression (breathing difficulties), and may be life-threatening;
• medicines that cause urine acidification, such as ascorbic acid (vitamin C) and ammonium chloride;
• a medicine used to treat diarrhea (e.g., loperamide, diphenoxylate);
• a diuretic (e.g., spironolactone);
• a medicine that increases sleepiness;
• metamizole, a medicine used to treat pain and fever;
• preparations containing St. John's Wort, used to treat depression.

The risk of side effects increases when methadone and antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline) are used together. If you experience any of the following symptoms, contact your doctor:

• changes in mental state (e.g., agitation, hallucinations, coma)
• rapid heartbeat, unstable blood pressure, fever
• exaggerated reflexes, coordination disorders, muscle stiffness
• gastrointestinal disorders (e.g., nausea, vomiting, diarrhea) (see section 4).

Concomitant use of Methadone hydrochloride INN-FARM and sedative medicines, such as benzodiazepines or similar medicines, increases the risk of sleepiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not available. If your doctor prescribes Methadone hydrochloride INN-FARM with sedative medicines, the dose of the medicine and the duration of concomitant treatment should be limited by your doctor. You should inform your doctor about all sedative medicines you are taking and follow your doctor's instructions regarding the dose. It may be helpful to inform friends or relatives about the above symptoms and signs. If these symptoms occur, contact your doctor. Other medicines that may also affect the heart (e.g., sotalol, amiodarone, and flecainide). You should inform your doctor about all other medicines you are taking, as they may be dangerous if used with methadone. In such cases, your doctor may decide that, at the start of treatment, it is necessary to monitor heart activity using an electrocardiogram (ECG) to ensure that these effects do not occur. Methadone may also affect some blood and urine tests (including doping test results). You should inform your doctor if you are taking methadone before any tests are performed.

Using Methadone hydrochloride INN-FARM with food, drink, and alcohol

Methadone hydrochloride INN-FARM can be taken with or without food. You must not drink alcohol while taking Methadone hydrochloride INN-FARM. This is because methadone can cause sleepiness and drinking alcohol can increase sleepiness. You must not drink grapefruit juice while taking Methadone hydrochloride INN-FARM, as grapefruit juice can change the way methadone works.

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. When taking a pregnancy test, you should be aware that Methadone hydrochloride INN-FARM may affect the results. You must not take this medicine during childbirth. If you are breastfeeding or thinking of breastfeeding while taking methadone, consult your doctor, as the medicine may affect the baby. You should monitor the breastfed baby for unusual symptoms, such as increased sleepiness (more than usual), breathing difficulties, or floppiness. If you notice any of these symptoms, contact your doctor immediately.

Driving and using machines

Methadone can seriously affect your ability to drive and use machines while taking the medicine and afterwards. You may resume these activities only after your doctor's permission.

Methadone hydrochloride INN-FARM contains sorbitol.

This medicine contains 21 mg of sorbitol in 1 ml. Sorbitol is a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance - a rare genetic disorder that prevents the body from breaking down fructose - you should contact your doctor before taking the medicine. In some people, sorbitol may affect the amount of methadone absorbed from the swallowed dose. In these patients, switching from Methadone hydrochloride INN-FARM to other methadone products that do not contain sorbitol may cause changes in methadone blood levels and recurrence of withdrawal symptoms. In such cases, contact your doctor.

Methadone hydrochloride INN-FARM contains sodium benzoate.

This medicine contains 3 mg of sodium benzoate in 1 ml.

Methadone hydrochloride INN-FARM contains the colorant orange yellow S.

which may cause allergic reactions.

Methadone hydrochloride INN-FARM contains sodium.

This medicine contains 0.478 mg of sodium (a major component of common salt) in 1 ml. When taking the maximum daily dose (150 mg) of methadone, the amount of sodium is approximately 3.59% of the recommended maximum daily intake of sodium for an adult.

3. How to take Methadone hydrochloride INN-FARM

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Methadone hydrochloride INN-FARM should only be taken by mouth. Under no circumstances should this medicine be injected, as it may cause serious and permanent damage to the body and may be fatal. Your doctor will tell you how much Methadone hydrochloride INN-FARM to take and how often. It is important not to take more than the dose agreed with your doctor.

Adults

The usual starting dose is 10-30 mg per day. The dose will be slowly increased until the patient's withdrawal symptoms or intoxication symptoms disappear. The usual dose is 60-120 mg per day. Your doctor will decide what dose to use and when to reduce it.

The elderly

Your doctor may decide to reduce the dose and monitor your condition more closely.

Patients with kidney or liver disease

Your doctor may decide to reduce the dose and monitor your condition more closely. Patients with severe liver problems should not be given this medicine.

Use in children and adolescents

Methadone hydrochloride INN-FARM is not intended for use in children and adolescents.

Taking a higher dose of Methadone hydrochloride INN-FARM than recommended

If you take too much methadone, you may experience:

• breathing difficulties, slow or shallow breathing;
• extreme sleepiness, fainting, or coma;
• pinpoint pupils;
• muscle weakness;
• cold and clammy skin;
• low blood sugar;
• slow heartbeat, low blood pressure, heart attack, or shock;
• brain problems (known as toxic leukoencephalopathy);
• in severe cases, death may occur. If you have taken too much methadone, contact your doctor immediately, even if you feel well, as you may have methadone poisoning.

Missing a dose of Methadone hydrochloride INN-FARM

Do not take a missed dose. Wait until the next dose is due and take only that amount. Do not take a double dose to make up for a missed dose.

Stopping Methadone hydrochloride INN-FARM

Do not stop taking this medicine without your doctor's advice, as you may experience withdrawal symptoms (see section 4). Your doctor will tell you how to gradually reduce the dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Methadone hydrochloride INN-FARM can cause side effects, although not everybody gets them.

Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms:

• an allergic reaction, which may include: swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, or severe itching of the skin with a rash;
• serious heart problems. Symptoms may include changes in heartbeat, such as faster or slower heartbeat, breathing difficulties, and dizziness with slow and shallow breathing;
• slow and shallow breathing;
• increased pressure inside the skull, if you have had a head injury or brain disease in the past.

Continue taking the medicine but tell your doctor immediately if you experience any of the following side effects:

• asthma or worsening of asthma.

Other possible side effects:

Very common (may affect more than 1 in 10 people):

• nausea or vomiting.

Common (may affect up to 1 in 10 people):

• fluid retention;
• feeling of euphoria, seeing or hearing things that are not real (hallucinations), confusion;
• feeling of sleepiness (sedation);
• blurred vision, pinpoint pupils, dry eyes;
• feeling of dizziness or spinning;
• constipation;
• transient rash, sweating;
• feeling of tiredness, sleepiness,
• weight gain.

Uncommon (may affect up to 1 in 100 people)):

• feeling of dysphoria, agitation, confusion, difficulty sleeping, decreased sex drive;
• headache, fainting;
• low blood pressure, hot flashes;
• breathing difficulties (including coughing) due to fluid accumulation in the lungs, worsening of asthma, dryness in the nose;
• dry mouth, tongue inflammation;
• bile duct spasm (abdominal pain);
• itching, hives, rash, bruising;
• urinary retention (difficulty urinating), decreased urine production;
• decreased potency, menstrual disorders, milk production in the breasts;
• swelling of the legs, swelling;
• weakness;
• low body temperature.

Rare (may affect up to 1 in 1000 people):

• heart problems, slower heartbeat, feeling of palpitations;
• collapse, shock;
• respiratory arrest;
• slowdown of bowel movements (intestinal obstruction).

Side effects with unknown frequency:

• decreased platelet count, which increases the risk of bleeding or bruising;
• increased prolactin levels;
• inadequate adrenal function (with symptoms such as nausea or vomiting, loss of appetite, fatigue, weakness, dizziness, low blood pressure);
• loss of appetite;
• low potassium or magnesium levels in the blood;
• low blood sugar;
• serotonin syndrome (see section 2);
• nystagmus (involuntary eye movements);
• hearing loss;
• ureteral spasm (causing back pain and urinary problems);
• long-term use of methadone is associated with breast enlargement in men, impaired fertility, sexual dysfunction, and decreased sex hormone levels;
• the patient may develop dependence on Methadone hydrochloride INN-FARM (see section 2 "Warnings and precautions");
• sleep apnea.

Withdrawal symptoms can be observed after stopping opioid use. These include: body aches, diarrhea, gooseflesh, eating disorders, nervousness or restlessness, yawning, runny nose, shivering or tremors, colicky abdominal pain, nausea, sleep disturbances, increased sweating and yawning, weakness, and unexplained fever. In some people, the heart may beat slightly faster or stronger. With proper dose adjustment and gradual tapering of opioids, these symptoms are usually mild.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Methadone hydrochloride INN-FARM

Keep this medicine out of the sight and reach of children. This medicine should be stored in a safe place, out of the reach of other people. Taking this medicine by people it was not prescribed for may lead to serious harm and death. Do not use this medicine after the expiry date which is stated on the carton and bottle after "EXP". The expiry date refers to the last day of that month. Store in the original package to protect from light. After first opening, this medicine should be used within 90 days when stored in the original package to protect from light. This medicine does not require any special storage precautions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Methadone hydrochloride INN-FARM contains

• The active substance is methadone hydrochloride. 1 ml of oral solution contains 1 mg of methadone hydrochloride.
• The other ingredients are: sorbitol liquid, non-crystallizing (E420), glycerol (E422), sodium benzoate (E211), citric acid monohydrate (E330), brilliant blue FCF (E133), orange yellow S (E110), and purified water.

What Methadone hydrochloride INN-FARM looks like and contents of the pack

Methadone hydrochloride INN-FARM is a clear, green oral solution. Packaging of 100 ml: A cardboard box containing a glass bottle with 100 ml of oral solution with a child-resistant closure and a leaflet. Packaging of 1000 ml: A cardboard box containing a bottle with 1000 ml of oral solution with a child-resistant closure and a leaflet. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

INN-FARM d.o.o. Maleševa ulica 14 1000 Ljubljana Slovenia Tel.: +386 70 390 711 Fax: + 386 5191 116 e-mail: [email protected]

Importer

ALKALOID-INT d.o.o Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Croatia: Metadon Alkaloid 1 mg/ml oralna otopina Ireland: Methadone hydrochloride 1 mg/ml oral solution Malta: Methadone Alkaloid 1 mg/ml oral solution Poland: Methadone hydrochloride INN-FARM United Kingdom (Northern Ireland): Methadone Alkaloid 1 mg/ml oral solution Date of last revision of the leaflet:26.06.2023