ANTAXONE 100 mg /20 Ml Оральный Раствор

Содержание инструкции

1. ANTAXONE 50 mg hard capsules, 50 mg/10 ml oral solution, 100 mg/20 ml oral solution
   1. What is ANTAXONE and what is it used for
   2. What you need to know before taking ANTAXONE
   3. How to take ANTAXONE
   4. Possible side effects
   5. How to store ANTAXONE
   6. Contents of the pack and other information

ANTAXONE 50 mg hard capsules, 50 mg/10 ml oral solution, 100 mg/20 ml oral solution

Naltrexone hydrochloride

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ANTAXONE is and what it is used for
• 2. What you need to know before you take ANTAXONE
• 3. How to take ANTAXONE
• 4. Possible side effects
• 5. How to store ANTAXONE
• 6. Contents of the pack and other information

1. What is ANTAXONE and what is it used for

ANTAXONE contains the active ingredient naltrexone hydrochloride, which belongs to a group of medicines
called opioid antagonists, which are used in addiction disorders (such as heroin) to block
the activity of drugs derived from opium, such as heroin.
ANTAXONE is indicated for the treatment of opioid dependence, in people who intend to undertake
a detoxification path and who have not taken opioid substances for at least 7-10 days.

2. What you need to know before taking ANTAXONE

Do not take ANTAXONE

• if you are allergic to naltrexone hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you are taking medicines containing opioids (see the section “Other medicines and ANTAXONE”);
• if you suffer from a dependence or are in opioid withdrawal;
• if urine tests or the naloxone test show that you have taken opioids (see the section “How to take ANTAXONE”);
• if you have severe liver problems (acute hepatitis, liver failure);
• if you have severe kidney problems (severe renal insufficiency);
• if you are pregnant or breastfeeding (see the section “Pregnancy and breastfeeding”);
• if the person who is going to take this medicine is under 18 years of age (See the section “Children and adolescents”);
• if you are taking methadone (see section “Other medicines and ANTAXONE”. Warnings and precautionsTalk to your doctor before taking ANTAXONE.

During therapy with this medicine, you must be constantly monitored by a doctor specializing in the
treatment of opioid dependence. The doctor may provide you with a card to show if you need
medical care or emergency treatment.
Take this medicine with great cautionand tell your doctor:

• if you have liver or kidney problems (impaired renal or hepatic function);
• if you have recently taken opioid substances;
• if you are being treated with medicines belonging to the opioid group, used for example for cough, colds and diarrhoea;
• if you are being treated with any other medicine listed in the section “Other medicines and ANTAXONE”.

Before starting treatment with ANTAXONE, the doctor will check:

• the function of your liver. If the doctor considers it appropriate to start therapy with this medicine, you must undergo tests and examinations monthly, for the first 6 months, to verify the functioning of the liver; the doctor will assess the frequency of tests and examinations for the subsequent period;
• that you have not taken opioid substances for at least 5-7 days for heroin and at least 10 days for methadone (naloxone test). If you have recently taken opioid substances, the use of ANTAXONE may cause withdrawal syndrome, which manifests after 5 minutes of taking the medicine and can last up to 2 days, with symptoms such as:
• confusion;
• drowsiness;
• hallucinations;
• diarrhoea;
• vomiting.

If such symptoms should occur, the doctor will provide treatment which includes
administration of fluids intravenously and appropriate therapy based on your condition.

WARNING:do not take heroin or other opioid substances during treatment with ANTAXONE, even
at low doses, because they do not have euphoric effects and can cause severe poisoning with symptoms such as:
respiratory arrest (respiratory depression), sudden loss of heart and blood vessel function (cardiovascular collapse) and death. However, if it is necessary to take such substances to control
pain, the doctor must establish the dose to be taken based on the patient's needs.
Doses of ANTAXONE higher than those prescribed by the doctor can cause serious liver damage (hepatocellular lesions).
This medicine does not reduce the risk of suicide in people who use drugs and who may be
depressed.

Children and adolescents
The use of ANTAXONE is contraindicated in children and adolescents due to the lack of data on the
safety and efficacy of this medicine, therefore ANTAXONE should not be used in children and
adolescents under 18 years of age (see section “Do not take ANTAXONE”).

Elderly
There is no data on the efficacy and safety of ANTAXONE use in the elderly.

Other medicines and ANTAXONE
Tell your doctor if you are taking, have recently taken or might take any other medicine.
ANTAXONE must not be administered with certain medicines, so tell your doctor if you are
taking:

• medicines used for cough, colds and diarrhoea (belonging to the opioid group) (see the section “Do not take ANTAXONE”);
• medicines used to reduce pain (opioid-derived analgesics);
• medicines used to counteract the effects of acute opioid poisoning and for the treatment of drug dependence (opioid antagonists);
• medicines used for high blood pressure (central antihypertensives, alpha-methyldopa);
• methadone in substitution therapy, due to the risk of withdrawal syndrome (see the section “Do not take ANTAXONE”).

Use caution and tell your doctor if you are taking medicines used:

• for the treatment of anxiety, to induce sedation and sleep (barbiturates, benzodiazepines, meprobamate);
• for depression (amitriptyline, dosulepine, mianserin, trimipramine);
• for allergies (H1 antihistamines);
• to relieve excessive muscle tension (baclofen);
• for the treatment of leprosy and some types of tumors (thalidomide);
• for the treatment of mental disorders (thioridazine), because if taken together with ANTAXONE, it can cause drowsiness and muscle weakness (asthenia);
• for the treatment of psychiatric problems (droperidol). In alcohol-dependent subjects who are not seeking treatment, the administration with ANTAXONE significantly increases the plasma level of acamprosate.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, take ANTAXONE only if absolutely necessary and under the direct supervision of
your doctor. Do not breastfeed while taking this medicine.

Driving and operating machinery
This medicine can alter your ability to drive and operate machinery. Therefore, avoid driving
vehicles or using machinery while taking ANTAXONE.

ANTAXONE capsules contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with intolerance to
certain sugars, contact him before taking this medicine.

ANTAXONE oral solution contains:

• parahydroxybenzoates which may cause allergic reactions (including delayed reactions).
• sorbitol (7 g for each container of Antaxone 100 mg/20 ml and 3.5 g for each container of Antaxone 50 mg/10 ml). Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize fructose, talk to your doctor before taking this medicine. It may cause gastrointestinal problems and have a mild laxative effect.
• 12.4 mg of alcohol (ethanol) in every 10 ml (0.01% w/v). The amount in a dose of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not produce significant effects.
• Glucose. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take ANTAXONE

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor.
Treatment with ANTAXONE must always begin in specialized clinics for the treatment of drug dependence
(drug addiction) and then continue under strict medical supervision of the centers.
Before taking ANTAXONE, you must not have taken opioids for at least 7-10 days; your doctor may
prescribe some tests (urine analysis, naloxone test) to verify the absence of these substances
in the body (see the paragraph “What you need to know before taking ANTAXONE”).
The recommended dose, at the beginning of treatment, is 20-25 mg of ANTAXONE.
If, after one hour, withdrawal symptoms do not appear, the doctor may decide to proceed with maintenance therapy,
which provides for one of the following solutions:

• 50 mg per day;
• 50 mg per day from Monday to Friday and 100 mg on Saturday;
• 100 mg on alternate days;
• 150 mg every 3 days;
• 100 mg on Monday, 100 mg on Wednesday and 150 mg on Friday. It is recommended not to exceed the recommended dose of 150 mg per day because a higher incidence of undesirable effects has been observed.

The oral solution is indicated for those people who, in the past, have taken the drug in capsule or
tablet form.

If you take more ANTAXONE than you should
In case of ingestion/taking an excessive amount of this medicine, immediately contact your
doctor or the nearest hospital.

If you forget to take ANTAXONE
If you forget to take ANTAXONE, do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using opioid substances before taking this medicine because ANTAXONE may
worsen withdrawal symptoms.
The following side effects may occur:

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

• sleep disturbance, anxiety, nervousness, headache, restlessness;
• abdominal pain, nausea and vomiting;
• muscle pain (myalgia) and joint pain (arthralgia);
• weakness (asthenia). Common(may affect up to 1 in 10 people)
• loss of appetite;
• irritability, behavioral disturbances (affective disorders);
• dizziness;
• increased tearing;
• increased awareness of heartbeats (palpitation), increased heart rate (tachycardia) and heart problems (ECG changes);
• chest pain;
• diarrhea, constipation;
• skin irritation (erythema);
• sexual and fertility problems in men (erectile dysfunction, delayed ejaculation);
• thirst, fatigue, chills, increased energy and sweating (hyperhidrosis). Uncommon(may affect up to 1 in 100 people)
• enlargement of the lymph nodes (lymphadenopathy);
• increased appetite;
• sexual desire disorders (increased libido, decreased libido), depression, paranoia, agitation, confused state, disorientation, hallucinations, nightmares and abnormal dreams;
• tremors, drowsiness;
• blurred vision, sensitivity to light (photophobia), irritation, swelling, pain and tension in the eyes;
• discomfort and pain in the ears, perception of sounds in the ear (tinnitus), vertigo;
• inflammation of the veins (phlebitis), hot flushes, facial redness (flushing), changes in blood pressure (blood pressure fluctuations);
• mucus buildup (congestion) and nasal discomfort, increased mucus production, runny nose (rhinorrhea), sneezing, nasal disorders (sinus pain), nosebleeds (epistaxis), difficulty breathing (dyspnea), sore throat and pharynx, loss of voice (dysphonia), cough, yawning;
• flatulence, hemorrhoids, dry mouth, perforation of the stomach and intestines (ulcer);
• problems and inflammation of the liver (abnormal liver function tests, increased bilirubin in the blood, increased liver transaminases, hepatitis);
• itching, increased sebum production (seborrhea), acne, hair loss (alopecia);
• muscle and bone pain, especially in the arms and legs, muscle contractions, groin pain;
• frequent urination in small amounts (pollakiuria), problems with urination (urinary disorders);
• oral herpes, fungal skin infection of the foot (tinea pedis);
• swollen glands, general pain, skin swelling due to fluid accumulation, fever, feeling of cold in the arms and legs, feeling of warmth, weight gain or loss;
• increased blood pressure, heart problems (abnormal electrocardiogram).

Rare(may affect up to 1 in 1,000 people)

• disease characterized by a reduction in the number of platelets in the blood and skin redness with bleeding (idiopathic thrombocytopenic purpura);
• ideas and attempts of suicide;
• painful and prolonged erection (priapism);
• withdrawal syndrome.

Very rare(may affect up to 1 in 10,000 people)

• allergic reactions (hypersensitivity);
• serious muscle damage (rhabdomyolysis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store ANTAXONE

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 pack after “Exp.”.
The expiry date refers to the last day of that month and the product in intact packaging and
correctly stored.
Store the capsules at a temperature below 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ANTAXONE 50 mg hard capsules contain

• The active ingredient is naltrexone hydrochloride. One capsule contains 50 mg of naltrexone hydrochloride.
• The other ingredients are: lactose, magnesium stearate, gelatin, titanium dioxide (E171), indigotine (E132). What ANTAXONE 50 mg/10 ml oral solution contains
• The active ingredient is naltrexone hydrochloride. One container contains 50 mg of naltrexone hydrochloride.
• The other ingredients are: sorbitol 70%, bitter flavour 1631 (containing: ethanol, sorbitol and glucose), saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water. What ANTAXONE 100 mg/20 ml oral solution contains
• The active ingredient is naltrexone hydrochloride. One container contains 100 mg of naltrexone hydrochloride.
• The other ingredients are: sorbitol 70%, bitter flavour 1631 (containing: ethanol, sorbitol and glucose), saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water. Description of the appearance of ANTAXONE and contents of the pack50 mg hard capsules: pack of 14 capsules. 50 mg/10 ml oral solution: pack of 10 single-dose containers of 50 mg. 100 mg/20 ml oral solution: pack of 5 single-dose containers of 100 mg.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
ZAMBON ITALIA s.r.l.
Via Lillo del Duca 10
20091 Bresso (MI)
Italy

Manufacturer
ZAMBON S.p.A.
Via della Chimica 9
Vicenza
Italy