Naltrexone Hydrochloride Tablets 50mg Taj Pharma

  1. Name of the medicinal product

Naltrexone Hydrochloride 50mg film-coated tablets

  1. Qualitative and quantitative composition

Each film-coated tablet contains
Naltrexone hydrochloride                             50.00mg
Excipient                                                        q.s

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film-coated tablet

  1. Clinical particulars

4.1 Therapeutic indications

For use as an additional therapy within a comprehensive treatment program including psychological guidance for detoxified patients who have been opioid-dependent (see section 4.2 and 4.4) & alcohol dependence to support abstinence.

4.2 Posology and method of administration

Use in adults

Naltrexone treatment should be initiated and supervised by suitable qualified physicians.

The initial dose of naltrexone hydrochloride should be 25mg (half a tablet) for opioid-dependent patient followed by the usual dose of one tablet per day (= 50mg naltrexone hydrochloride)

A missed dose can be managed by providing 1 tablet per day each day till the next regular dosage-administration.

Naltrexone administered to opioid-dependent persons can cause life-threatening withdrawal symptoms. Patients suspected of using or being addicted to opioids must undergo a naloxone provocation test (see section 4.4), unless it can be verified that the patient has not taken any opioids for 7-10 days (urine test) prior to the initiation of treatment with naltrexone.

As Naltrexone is an adjunctive therapy and the full recovery process in opioid-dependent patients is individually variable, no standard duration of treatment can be stated; an initial period of three months should be considered. However, prolonged administration may be necessary.

The recommended dose for alcohol dependence to support abstinence is 50mg per day (1 tablet). A dose of over 150mg on any single day is not recommended, since this can lead to a higher incidence of side effects.

As naltrexone hydrochloride is an adjunctive therapy and the full recovery process from alcohol dependence is individually variable, no standard duration of treatment can be stated; an initial period of three months should be considered. However, prolonged administration may be necessary

The dosage-regimen can be modified in order to improve compliance to a three-times-a-week dosing schedule as follows: administration of 2 tablets (=100mg naltrexone hydrochloride) on Monday and on Wednesday and 3 tablets (=150mg naltrexone hydrochloride) on Friday.

Paediatric population

Naltrexone should not be used in children and adolescents under 18 years of age, since clinical data in this age-group are lacking. Safe use in children has not been established.

Older people

There are insufficient data on the safety and efficacy of naltrexone for this indication in elderly patients.

4.3 Contraindications

  • Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
  • Severe renal impairment
  • Severe hepatic impairment
  • Acute hepatitis
  • Opioid addicted patients with a current abuse of opioids since an acute withdrawal syndrome may ensue.
  • Positive screening result for opioids or after failure of the naloxone provocation test.
  • for use in conjunction with an opioid – containing medication
  • in combination with methadone (see section 4.5).

4.4 Special warnings and precautions for use

In accordance to national guidance the therapy should be initiated and supervised by a physician experienced in treatment of opioid-addicted and alcohol-addicted patients

High dose opioid intake, concomitant with Naltrexone treatment, can lead to life-threatening opioid poisoning from respiratory and circulatory impairment.

Should naltrexone be used in opioid-dependent patients a withdrawal syndrome may occur rapidly: the first symptoms can occur within 5 minutes, the last after 48 hours. The treatment of withdrawal symptoms is symptomatic.

It is not uncommon for alcohol abusing individuals to show signs of impaired hepatic function. Abnormal hepatic function test parameters have been reported in obese and elderly patients receiving naltrexone in dosages higher than recommended (up to 300mg/day). Hepatic function controls should be made before and during treatment. Special attention should be paid to patients with hepatic enzyme levels in serum exceeding three times the normal value and patients with renal impairment.

Liver function test abnormalities have been reported in obese and elderly patients taking naltrexone who have no history of drug abuse. Liver function tests should be carried out both before and during treatment.

Patients must be warned against the concomitant use of opioids (e.g. opioids in cough medication, opioids in symptomatic medication for the treatment of common colds, or opioids contained in anti diarrhoeal agents, etc.) during naltrexone treatment (see section 4.3).

Naltrexone treatment must begin only when the opioid has been discontinued for a sufficiently long period (about 5 to 7 days for heroin and at least 10 days for methadone).

If the patient needs opioid treatment, e.g. opioid analgesia or anesthesia in emergency situations, the dose needed may be higher than normal. In these cases, the respiratory depression and circulatory effects will be more profound and longer lasting. Symptoms related to release of histamine (generalized erythema, diaphoresis, itching and other skin and mucocutaneous manifestations) can also be manifested more easily. The patient requires specific attention and care in these situations.

During treatment with naltrexone, painful conditions should be treated with non-opioid analgesia only.

Patients should be warned that large doses of opioids to overcome the blockade may after the cessation of the naltrexone result in an acute opioid overdose, with possible fatal outcome.

Patients might be more sensitive to opioid containing medicines after treatment with naltrexone.

Patients suspected of using or being addicted to opioids must undergo a naloxone provocation test, unless it can be verified that the patient has not taken any opioids for 7-10 days (urine test) prior to the initiation of treatment with naltrexone.

A withdrawal syndrome precipitated by naloxone will be of shorter duration than withdrawal precipitated by naltrexone.

The recommended procedure is as follows:

Intravenous provocation

  • Intravenous injection of 0.2mg naloxone
  • If after 30 seconds no adverse reactions occur, a further i.v. injection of 0.6mg naloxone may be administered.
  • The patient should be observed continuously for 30 minutes for any detectable sign of withdrawal symptoms.

If any symptoms of withdrawal occur naltrexone-therapy must not be undertaken. If the test-result is negative the treatment can be initiated. If any doubt exists that the patient is opioid-free, the challenge may be repeated with the dosage of 1.6mg. If no reaction occurs after this, 25mg of naltrexone hydrochloride can be administered to the patient.

A naloxone hydrochloride provocation test should not be made in patients with clinically prominent withdrawal symptoms nor in any case of a positive urine test for opioids.

Naltrexone is extensively metabolised by the liver and excreted predominantly in the urine. Therefore, caution should be observed in administering the medicinal product to patients with impaired hepatic or renal function. Liver function tests should be carried out both before and during treatment.

The risk of suicide is known to increase in substance abusers, with or without concomitant depression. Treatment with Naltrexone tablet does not eliminate this risk.

Lactose

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant administration of naltrexone with an opioid-containing medication should be avoided.

Presently, clinical experience and experimental data on the effect of naltrexone on the pharmacokinetics of other substances are limited. Concomitant treatment with naltrexone and other medicinal products should be conducted with caution and should be followed carefully.

No interaction studies have been performed.

In vitro studies have shown that neither naltrexone nor its main metabolite 6-ß-naltrexol is metabolised via human CYP450 enzymes. Therefore it is unlikely that the pharmacokinetics of naltrexone is affected by cytochrome P450 enzyme inhibiting drugs.

Association not recommended: opioid derivatives (analgesics, antitussives, substitution treatments), Central antihypertensives, (alpha-methyldopa).

Concomitant administration of naltrexone with an opioid-containing medication should be avoided.

Methadone in substitution treatment. There is a risk of onset of withdrawal syndrome.

Association to be taken into account: barbiturates; benzodiazepines, anxiolytics others than benzodiazepines (i.e meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, trimipramine), sedative antihistaminics H1, neuroleptics (droperidol).

Data from a safety and tolerability study of co-administration of naltrexone with acamprosate in non-treatment seeking, alcohol dependent individuals showed that naltrexone administration significantly increased acamprosate plasma level. Interaction with other psychopharmacological agents (e.g. disulfirame, amitryptiline, doxepine, lithium, clozapine, benzodiazepines) have not been investigated

Until now no interaction between cocaine and naltrexone hydrochloride has been described.

There are no known interactions between naltrexone and alcohol.

For interactions with opioid containing drugs please see section 4.4.

4.6 Fertility, pregnancy and lactation

Pregancy

There are no clinical data on naltrexone hydrochloride use in pregnancy. Data from animal studies have shown reproductive toxicity (see section 5.3.). The data are insufficient to establish clinical relevance. The potential risk for humans is unknown. Naltrexone should only be given to pregnant women when, in the judgement of the attending physician the potential benefits outweigh and the possible risk.

The use of naltrexone in pregnant alcoholic patients receiving long-term treatment with opiates or substitution treatment with opiates, or in pregnant patients who are opioid-dependent, creates a risk of acute withdrawal syndrome which could have serious consequences for the mother and the foetus (see section 4.4). Naltrexone administration must be suspended if opiate analgesics are prescribed (see section 4.5).

Lactation:

There are no clinical data on naltrexone HCl use in lactation. It is unknown whether naltrexone or 6-beta-naltrexol is excreted in human breast milk. During treatment breast feeding is not recommended.

4.7 Effects on ability to drive and use machines

Naltrexone may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving a car or operating machinery.

4.8 Undesirable effects

The following undesirable effects are ranked according to system organ class and to their frequency:

Very common (≥ 1/10)

Common (≥1/100 to < 1/10)

Uncommon (≥1/1,000 to < 1/100)

Rare (≥ 1/10,000 to < 1/1,000)

Very rare (< 1/10,000)

not known (cannot be estimated from the available data)

MedDRA system organ class
Infections and infestation
UncommonOral herpes
Tinea pedis
Blood and lymphatic system disorders
UncommonLymphadenopathy
RareIdiopathic thrombocytopenic purpura
Metabolism and nutrition disorders
CommonDecreased appetite
Psychiatric disorders:
Very commonNervousness
Anxiety
Insomnia
CommonAffective disorders
Despondency
Irritability
Mood swings
UncommonHallucination
Confusional state
Depression
Paranoia
Disorientation
Nightmare
Agitation
Libido disorder
Abnormal dreams
RareSuicidal ideation
Attempted suicide
Very rareEuphoria
Nervous system disorder
Very commonHeadache
Sleep disorders
Restlessness
CommonDizziness
Shivering
Vertigo
UncommonTremor
Somnolence
RareSpeech disorder
Eye disorders
CommonLacrimation increased
UncommonVision-blurred

Eye irritation

Photophobia
Eye swelling
Eye pain
Asthenopia
Ear and labyrinth disorders
UncommonEar discomfort
Ear pain
Tinnitus
Vertigo
Cardiac disorders
CommonTachycardia
Palpitations
Electrocardiogram change
Vascular disorders
UncommonBlood pressure fluctuation
Flushing
Respiratory, thoracic and mediastinal disorder
CommonChest pain
UncommonNasal congestion
Nasal discomfort
Rhinorrhea
Sneezing
Oropharyngeal pain
Sputum increased
sinus disorder
Dyspnoea
Dysphonia
Cough
Yawning
Gastrointestinal disorder
Very commonAbdominal pain
Abdominal cramps
Nausea or Inclination to vomit
Vomiting
CommonDiarrhoea
Constipation
UncommonFlatulence
Haemorrhoids
Ulcer
Dry mouth
Hepatobiliary disorders
UncommonLiver disorder
blood bilirubin increased
hepatitis
During treatment an increase of liver transaminases may occur. After discontinuation of Naltrexone the transaminases decreased to baseline within several weeks.
Skin and subcutaneous tissue disorder
CommonRash
UncommonSeborrhoea
Pruritus
Acne
Alopecia
Very rareExanthema
Musculoskeletal and connective tissue disorders :
Very commonArthralgia
Myalgia
UncommonGroin pain
Very RareRhabdomyolysis
Renal and urinary disorders
CommonUrine retention
UncommonPollakiuria
Dysuria
Reproductive system and breast disorders
CommonDelayed ejaculation
Erectile dysfunction
General disorder and administration site conditions
Very commonFeebleness
Asthenia
CommonLack of appetite
Thirst
Energy increased
Chills
Hyperhidrosis
UncommonIncreased appetite
weight loss
weight gain
Pyrexia
Pain
Peripheral coldness
Feeling hot

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system (To be completed nationally).

4.9 Overdose

Symptoms

  • There is limited clinical experience with naltrexone overdose in patients.
  • There was no evidence of toxicity in volunteers receiving 800mg/day for seven days.

Treatment

  • In case of overdose, patients should be monitored and treated symptomatically in a closely supervised environment.
  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: other nervous system drugs; drugs used in addictive disorders.

Naltrexone is a specific opioid antagonist with only minimal agonistic activity. It acts by stereospecific competition with receptors which are mainly located in the central and peripheral nervous system. Naltrexone competitively binds to these receptors and blocks the access for exogenously administered opioids.

Naltrexone treatment does not lead to physical or mental dependence. No tolerance for the opioid antagonising effect is seen.

Naltrexone Hydrochloride 50mg film-coated tablets reduces the risk of relapse and supports abstinence from opioids.

Naltrexone Hydrochloride 50mg film-coated tablets is a non-aversive therapy and does not cause reactions after opioid intake. Therefore it does not cause a disulfiram-type reaction.

The mechanism of action of naltrexone in alcoholism is not completely elucidated, however an interaction with the endogenous opioid system is suspected to play an important role. Alcohol consumption in humans has been hypothesised to be reinforcing through an alcohol-induced stimulation of the endogenous opioid system.

Naltrexone is not an aversive therapy and does not cause a disulfiram-like negative reaction when alcohol is ingested.

The prominent effect of naltrexone treatment of alcohol-addicted patients seems to be a reduction of the risk of a full relapse with uncontrolled binge-drinking after having consumed a limited amount of alcohol.

This gives the patient a “second chance” to escape the otherwise mutually reinforcing mechanisms of a full relapse with complete loss of control. Naltrexone also seems to have an effect on the primary craving as it is non-reinforcing on isolated consumption of limited amounts of alcohol.

5.2 Pharmacokinetic properties

Absorption

Naltrexone is rapidly and almost completely absorbed from the gastrointestinal tract after oral administration.

Biotransformation

It undergoes a liver first-pass effect and peak plasma concentration is reached within approximately one hour.

Naltrexone is hydroxylated in the liver basically to the main active metabolite 6-beta-naltrexol and, to a lesser extent, to 2-hydroxy-3-methoxy-6-beta-naltrexol.

The plasma-half-life of naltrexone is approximately 4 hours, the average blood level is 8.55mg/ml, and plasmaprotein-binding is 21%. The plasma-half-life of 6-beta-naltrexol is 13 hours.

Elimination

The medicinal product is excreted primarily renal. About 60% of the peroral dose is excreted within 48 hours as glucuronidised 6-beta-naltrexol and naltrexone.

5.3 Preclinical safety data

Preclinical data revealed no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. However, there is some evidence on hepatotoxicity with increasing dose, since reversible increases of liver enzymes has been found in humans with therapeutic and higher doses (see section 4.4 and 4.8).

Naltrexone (100mg/kg, approximately 140 times the human therapeutic dose) caused a significant increase in pseudo-pregnancy in the rat. A decrease in the pregnancy rate of mated female rats also occurred. The relevance of these observations to human fertility is not known.

Naltrexone has been shown to have an embryocidal effect in the rat and rabbit when given in doses approximately 140 times the human therapeutic dose. This effect was demonstrated in rats dosed with 100mg/kg of naltrexone prior to and throughout gestation, and rabbits treated with 60mg/kg of naltrexone during the period of organogenesis.

  1. Pharmaceutical particulars

6.1 List of excipients

Tablet core

Lactose monohydrate, Cellulose Microcrystalline

Crospovidone, Colloidal anhydrous silica

Magnesium stearate

Film Coating:

Hypromellose, Macrogol, Polysorbate 80, Iron Oxide Yellow

Iron oxide red, Titanium Dioxide

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions

6.5 Nature and contents of container

Naltrexone Hydrochloride 50mg film-coated tablets are packed in White opaque PVC/PE/Aclar – Alu Blister and Alu-Alu blister packs containing 7, 14, 28, 30, 50 and 56 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

  1. Manufactured in india by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

 

 

Naltrexone Hydrochloride Tablets 50mg Taj Pharma

 

Package leaflet: Information for the user  

Naltrexone Hydrochloride 50mg film-coated tablets Naltrexone Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Naltrexone Hydrochloride film-coated tablets is and what it is used for
  2. What you need to know before you take Naltrexone Hydrochloride film-coated tablets
  3. How to take Naltrexone Hydrochloride film-coated tablets
  4. Possible side effects
  5. How to store Naltrexone Hydrochloride film-coated tablets
  6. Contents of the pack and other information

 

  1. What Naltrexone Hydrochloride film-coated tablets is and what it is used for

The active ingredient, naltrexone hydrochloride, belongs to a group of medicines other nervous system drugs; drugs used in addictive disorders

  1. What you need to know before you take Naltrexone Hydrochloride film-coated tablets

What is Naltrexone Hydrochloride film-coated tablets used for Naltrexone hydrochloride is used in combination with other medicines or therapy to help those who are dependent on drugs such as heroin (opioids), overcome their addiction

It is indicated as supportive therapy in maintaining abstinence (self denial) in alcohol-dependent patients. Naltrexone acts by blocking receptors in the brain to block the action of opioids. Individuals will no longer experience the euphoria previously experienced after taking opioids.

Do not take Naltrexone Hydrochloride film-coated tablets

  • if you are allergic to naltrexone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • if you are dependent on opiates or are undergoing treatment involving abstinence (self denial), since abstinence syndrome or an exacerbation of abstinence syndrome can occur.
  • if you are continuously using a medicinal product containing an opioid, for example certain cough medicines, medicines to treat diarrhoea (such as kaolin and morphine) and analgesics (pain killers).
  • Note: Naltrexone hydrochloride does not have a blocking effect on analgesics which do not contain any opioids (such as ibuprofen, paracetamol and acetylsalicylic acid).
  • if you have an acute liver infection or if your liver function is poor.
  • if patients have withdrawal symptoms after naloxone hydrochloride administration.
  • if you take methadone.

 

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow his advice.

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Naltrexone Hydrochloride film-coated tablets

  • If you have liver or kidney diseases. Patients who have used Naltrexone  Hydrochloride  film-coated tablets can still have hypersensitivity reactions when taking medicines containing opiates,  even in  the  period  after use.
  • Before starting the treatment. Your doctor may carry out a blood test. Blood tests are also necessary  during treatment, because Naltrexone Hydrochloride film-coated tablets is processed by the liver and these tests show how well your liver is working.
  • If patient needs opioid treatment g. opioid analgesic or anaesthesia in emergency situation, opioid dose  is higher to achieve the therapeutic effect. In these cases respiratory depression and  circulatory effect  will  be more profound and longer lasting.
  • Naltrexone treatment must begin only when the opioid has been discontinued for a sufficiently long period (about 5 to 7 days for heroin and at least 10 days for methadone).
  • Liver function test abnormalities have been reported in obese and  elderly patients taking naltrexone who  have no history of drug abuse.
  • It is important to stop taking Naltrexone Hydrochloride film-coated tablets immediately and to tell your doctor in the event of the following symptoms: persistent abdominal pain, white  stools,  dark urine  or if  your eyes and/or skin turn yellow.

 

Consult your doctor if one of the above warnings applies to you, or has done so in the past.

Children and adolescents

Naltrexone should not be used in children and adolescents under 18 years of age, since clinical data in this age- group are lacking. Safe use in children has not been established.

Use in older people

There are insufficient data on the safety and efficacy of naltrexone for this indication in elderly patients.

 

Other medicines and Naltrexone Hydrochloride film-coated tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

  • Simultaneous use of Naltrexone Hydrochloride film-coated tablets and  medicines  containing  opiates must be avoided. If you try to overcome the blocking action  of Naltrexone  Hydrochloride  film-coated  tablets with large quantities of opioids, you will find yourself in great difficulties. Such action  can  lead  to  breathlessness, coma and can even be fatal.
  • Simultaneous use of Naltrexone Hydrochloride film-coated tablets and thioridazine can cause drowsiness. No other harmful affects due to interaction between Naltrexone Hydrochloride  film-coated  tablets and other medicines are known.
  • Medicines can have a reciprocal effect on one another.

 

Naltrexone Hydrochloride film-coated tablets with food and drink

Taking food and drink has no influence on your treatment with Naltrexone Hydrochloride film-coated tablets.

Pregnancy and breast-feeding

The safety of using Naltrexone  Hydrochloride  film-coated  tablets during pregnancy has not  been demonstrated. It is not known whether naltrexone is excreted in breast milk. Because the safety of using naltrexone in neonates and children has not been demonstrated, breast-feeding is not advised while using Naltrexone Hydrochloride film-coated tablets.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,  ask  your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Naltrexone may impair the mental and/or physical abilities required for performance  of potentially  hazardous tasks such as driving a car or operating machinery.

 

Naltrexone Hydrochloride film-coated tablets contains lactose monohydrate

This medicinal product contains 192.85mg of lactose. According to  dosage  recommendations  each  dose supplies up to 192.85mg of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

  1. How to take Naltrexone Hydrochloride film-coated tablets

 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or

pharmacist if you are not sure.

 

The recommended dose is 1 tablet per day unless a different dose has been prescribed by your doctor.

 

Naltrexone Hydrochloride film-coated tablets taken orally with small amount of liquid.

Before starting to take Naltrexone Hydrochloride film-coated tablets, you must not have used any other opiates for at least 7-10 days. Your doctor can use a test to establish whether you are clear of these drugs before you start the treatment. Generally speaking, treatment begins at a dose of 1/2 tablet per day (25mg),  later increased to 1 tablet per day (50mg).

Naltrexone Hydrochloride film-coated tablets must be used exclusively for the disorder for which  your doctor has prescribed this medicine.

It is important to follow your doctor’s instructions closely with respect to the dosage.

It is important that you take Naltrexone Hydrochloride film-coated  tablets for the period of time prescribed by your doctor. The treatment can last for three months or longer, according to the judgment of your doctor. Naltrexone Hydrochloride film-coated tablets should be combined with other forms of treatment.

 

If you notice that the effect of Naltrexone Hydrochloride film-coated tablets is too strong or not strong enough, consult your doctor or pharmacist.

 

If you take more Naltrexone Hydrochloride film-coated tablets than you should

If you have taken more than the prescribed number of tablets, you should inform your doctor immediately.

If you forget to take Naltrexone Hydrochloride film-coated tablets

You can still take the Naltrexone Hydrochloride film-coated tablets when you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Naltrexone Hydrochloride film-coated tablets

If you consider stopping before the end  of the agreed period of treatment, always discuss this with your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 

  1. Possible side effects

 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Naltrexone Hydrochloride film-coated tablets can affect your liver function. Your doctor may carry out blood test before you start treatment and at various times during treatment to monitor your liver function.

If you notice any of the following, stop taking Naltrexone Hydrochloride film-coated tablets and contact your doctor immediately:

  • Abdominal pain lasting more than a few days
  • White bowel movements
  • Dark urine
  • Yellowing of your eyes

As these may be signs that your liver isn’t working well.

If you notice any of the following, tell your doctor immediately:

  • Swelling of the face, lips, or tongue
  • Skin rash
  • Difficulty breathing

As these may be signs of an allergic reaction

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

  • Difficulty sleeping
  • Anxiety or nervousness
  • Abdominal cramps and pain
  • Feeling sick and/or being sick
  • Lack of energy or strength
  • Joint and/or muscle pain
  • Headaches
  • Fast or irregular heartbeat
  • Restlessness

 

Common (may affect up to 1 in 10 people)

  • Irritability
  • Mood swings
  • Increased energy
  • Despodency
  • Dizziness
  • Shivering
  • Increased or excessive sweating
  • Vertigo
  • Increased lacrimation
  • Increased heart beat
  • Palpitations
  • Change in ECG readings
  • Pain in the chest
  • Diarrhoea
  • Constipation
  • Rash
  • Urine retention
  • Delayed ejaculation
  • Erectile dysfunction
  • Lack of appetite
  • Thirst
  • Energy increased
  • Chills

Uncommon (may affect up to 1 in 100 people)

  • Some infections (e.g. Oral herpes, tinea pedis)
  • Swollen/enlarged lymph nodes
  • Hallucinations
  • Confusional state
  • Depression
  • Paranoia
  • Disorientation
  • Nightmare
  • Agitation
  • Reduced libido
  • Abnormal dreams
  • Tremor
  • Drowsiness
  • Blurred vision
  • Irritation in eye
  • Abnormal intolerance to visual perception of light
  • Swelling of eyes
  • Eye pain
  • Strain in eye
  • Ear discomfort
  • Ear pain
  • Ringing of ear
  • Vertigo
  • Blood pressure fluctuation
  • Flushing
  • Nasal congestion & discomfort
  • Sneezing
  • Sputum increased
  • Sinus problems
  • Voice disorders
  • Shortness of breath/difficulty in breathing
  • Cough
  • Yawning
  • Runny nose
  • Flatulence
  • Piles
  • Ulcer
  • Dry mouth
  • Liver disorders (including inflammation of liver)
  • Increase in liver enzymes
  • Greasy skin
  • Pruritus
  • Acne
  • Hair loss
  • Groin pain
  • Increased urination
  • Inflammation of urinary bladder
  • Increased appetite
  • Weight loss
  • Weight gain
  • Fever
  • Pain
  • Coldness in hands or feet
  • Feeling hot

 

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

  • Suicidal thoughts
  • Attempt to suicide
  • Bleeding disorder
  • Speech disorder

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

  • Euphoria
  • Skin rash/ eruptions
  • Skeletal muscle damage

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine

 

  1. How to store Naltrexone Hydrochloride film-coated tablets

 

  • 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 after ‘EXP’. The expiry date refers to the last day of that month.
  • This medicinal product does not require any special storage conditions.
  • Do not throw away any medicines via wastewater or household waste. Ask your  pharmacist  how  to throw away medicines you no longer use. These measures will help to protect the environment.

 

  1. Contents of the pack and other information

What Naltrexone Hydrochloride film-coated tablets contains

The active substance is Naltrexone hydrochloride.

 

Each film-coated tablet contains 50mg Naltrexone Hydrochloride.
The other ingredients are:

Core Tablet: lactose monohydrate, cellulose microcrystalline, crospovidone, colloidal anhydrous silica, magnesium stearate

Film-coating: Hypromellose, macrogol 400, polysorbate 80, iron oxide yellow, iron oxide red, titanium dioxide

What Naltrexone Hydrochloride film-coated tablets looks like and contents of the pack

Naltrexone Hydrochloride film-coated tablets are available as yellow coloured, oval, biconvex,  film  coated tablets with breakline on one side and plain on other side.

The tablet can be divided into equal halves.

Naltrexone Hydrochloride film-coated tablets are available in white opaque PVC/PE/Aclar-Alu blister and Alu – Alu blister packs containing 7, 14, 28, 30, 50 and 56 tablets.

Not all pack sizes may be marketed.

  1. Manufactured in india by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com