Naltrexone Accord Healthcare

Patient Information Leaflet

Naltrexone Accord Healthcare 50 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine as 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, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Naltrexone Accord Healthcare is and what it is used for

The active substance, naltrexone hydrochloride, belongs to the category of other nervous system drugs;
medicines used in substance dependence disorders.
What Naltrexone Accord Healthcare is used for
Naltrexone hydrochloride is used in combination with other medicines or therapies to help individuals
dependent on opioid drugs (opiates) overcome their addiction.
Naltrexone works by blocking receptors in the brain in order to block the effects of opiates. Individuals
will no longer experience the euphoria they previously felt after taking opioids.
Naltrexone hydrochloride is used as part of a comprehensive treatment programme to help individuals
with alcohol dependence maintain abstinence (self-denial).
Naltrexone Accord Healthcare does not cause dependence.

2. What you need to know before taking Naltrexone Accord Healthcare

Do not take Naltrexone Accord Healthcare

• if you are allergic to naltrexone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems
• if you have severe liver problems
• if you have acute hepatitis
• if you are opioid-dependent
• if your urine tests positive for opioids
• if you experience withdrawal symptoms after an injection of naloxone
• if you are taking a medicine containing an opioid, for example certain cough medicines, certain medicines for the treatment of diarrhoea (such as kaolin and morphine), and analgesics (painkillers). Note: Naltrexone hydrochloride does not block the effects of non-opioid analgesics (such as ibuprofen, paracetamol, and acetylsalicylic acid).
• if you are taking methadone.

If you think any of the conditions listed above apply to you, do not take the tablets.
Consult your doctor first and follow their advice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Naltrexone Accord Healthcare

• Do not take opioids during treatment with Naltrexone Accord Healthcare. Although Naltrexone Accord Healthcare normally blocks some of the effects (e.g. psychoactive effects), if you take high doses of opioids, you may experience breathing difficulties and circulatory problems (opioid poisoning).
• You must not use Naltrexone Accord Healthcare if you are still opioid-dependent, as Naltrexone Accord Healthcare will cause severe withdrawal symptoms in this situation.
• You must inform any doctor treating you that you are taking Naltrexone Accord Healthcare. If an anaesthetic is required in an emergency, non-opioid anaesthetics should be used. If opioid-containing anaesthetics are needed, higher than usual doses may be required. You may also be more sensitive to side effects (breathing difficulties and circulatory problems).
• You must not attempt to overcome the blocking effect of Naltrexone Accord Healthcare by taking high doses of opioids. There is a risk that opioids may still be present in your body after the effects of Naltrexone Accord Healthcare have worn off. In this case, an overdose—an unintentional overdose with serious consequences—could occur.
• Naltrexone is eliminated from the body via the liver and kidneys. Liver problems are common in individuals dependent on opioids. Your doctor will perform liver function tests before and during treatment.

If any of the warnings listed above apply to you, or have applied in the past, consult your doctor.

Children and adolescents
Naltrexone must not be used in children and adolescents under 18 years of age due to lack of clinical data in this age group. Safe use in children has not been established.

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

Other medicines and Naltrexone Accord Healthcare
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines contain opioids and may not be effective while you are taking Naltrexone Accord Healthcare.
You should inform your doctor if you require cough syrups or medicines for diarrhoea or pain, as these may contain opioids.
If, despite the contraindication to concomitant use, opioid-containing medicines are required in an emergency, the appropriate dose needed to relieve pain may be higher than usual.
Close medical monitoring is absolutely necessary, as respiratory depression and other symptoms may be more pronounced and prolonged.

Naltrexone Accord Healthcare with food and drink
Taking food and drink does not affect treatment with Naltrexone Accord Healthcare.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The safety of using Naltrexone Accord Healthcare during pregnancy has not been established.
It is not known whether naltrexone is excreted in breast milk. Since the safety of naltrexone use in newborns and children has not been established, breastfeeding during treatment with Naltrexone Accord Healthcare is not recommended.

Driving and using machines
Naltrexone may impair mental and/or physical abilities required to perform potentially hazardous activities such as driving a car or operating machinery.

Naltrexone Accord Healthcare contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Naltrexone Accord Healthcare

Always take Naltrexone Accord Healthcare exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet daily, unless your doctor has prescribed a different dose.

• Naltrexone Accord Healthcare should be taken orally with a small amount of liquid.
• Before starting Naltrexone Accord Healthcare, you must not have taken any other opioids for at least 7–10 days. Your doctor may prescribe a test to confirm the absence of these medicines in your body before beginning treatment. In general, treatment starts with a dose of 1/2 tablet daily (25 mg), which is then increased to 1 tablet daily (50 mg).
• Naltrexone Accord Healthcare should only be used for the condition for which it was prescribed by your doctor.
• It is important that you carefully follow your doctor's instructions regarding dosage.
• It is important that you take Naltrexone Accord Healthcare for the duration prescribed by your doctor. Treatment may last three months or longer, depending on your doctor's judgment. Naltrexone Accord Healthcare should be combined with other forms of treatment. If you notice that the effect of Naltrexone Accord Healthcare is too strong or not strong enough, consult your doctor or pharmacist.

If you take more Naltrexone Accord Healthcare than you should
If you take more tablets than prescribed, inform your doctor immediately.
If you forget to take Naltrexone Accord Healthcare
You may still take Naltrexone Accord Healthcare when you remember.
Do not take a double dose to make up for a missed dose.
If you stop treatment with Naltrexone Accord Healthcare
If you intend to stop treatment before the end of the prescribed period, always discuss this with your doctor.
If you have any doubts about how to use 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.
Naltrexone Accord Healthcare may affect liver function. Your doctor may carry out blood tests before starting treatment and at various times during treatment to monitor your liver function.
If you notice any of the following side effects, stop taking Naltrexone Accord Healthcare and contact your doctor immediately:

• Abdominal pain lasting more than a few days
• Pale stools
• Dark urine
• Yellowing of the eyes, as these could be signs indicating that your liver is not working properly.

If you notice any of the following side effects, contact your doctor immediately:

• Swelling of the face, lips or throat
• Rash
• Breathing difficulties, as these could be signs of an allergic reaction.

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

• Sleep difficulties
• Anxiety or nervousness
• Cramps and abdominal pain
• Feeling unwell and/or sick
• Lack of energy or weakness
• Joint and/or muscle pain
• Headache
• Fast or irregular heartbeat
• Restlessness

Common (may affect up to 1 in 10 people)

• Irritability
• Mood swings
• Increased energy
• Feeling down
• Dizziness
• Chills
• Increased or excessive sweating
• Dizziness
• Increased tearing
• Increased heart rate
• Palpitations
• Changes in electrocardiogram (ECG) readings
• Chest pain
• Diarrhea
• Constipation
• Rash
• Urinary retention
• Delayed ejaculation
• Erectile dysfunction
• Loss of appetite
• Thirst
• Increased energy
• Trembling

Uncommon (may affect up to 1 in 100 people)

• Certain infections (e.g. oral herpes, athlete’s foot)
• Swollen/enlarged lymph nodes
• Hallucinations
• Confusional state
• Depression
• Paranoia
• Disorientation
• Nightmares
• Agitation
• Reduced libido
• Abnormal dreams
• Tremor
• Drowsiness
• Blurred vision
• Eye irritation
• Abnormal intolerance to visual perception of light
• Swelling of the eyes
• Eye pain
• Eye tension
• Ear discomfort
• Ear pain
• Ringing in the ears
• Vertigo
• Fluctuation in blood pressure
• Flushing
• Nasal congestion and discomfort
• Sneezing
• Increased sputum
• Sinus problems
• Voice disorders
• Shortness of breath / breathing difficulties
• Cough
• Yawning
• Runny nose
• Flatulence
• Haemorrhoids
• Ulcer
• Dry mouth
• Liver disorders (including liver inflammation)
• Increased liver enzymes
• Oily skin
• Itching
• Acne
• Hair loss
• Groin pain
• Increased urination
• Inflammation of the urinary bladder
• Increased appetite
• Weight loss
• Weight gain
• Fever
• Pain
• Cold hands or feet
• Feeling of warmth

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

• Suicidal thoughts
• Suicide attempt
• Bleeding disorder
• Speech disorder

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

• Euphoria
• Rash / rashes
• Damage to skeletal muscles

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Naltrexone Accord Healthcare

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after 'Exp.'. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Naltrexone Accord Healthcare contains
The active substance is naltrexone hydrochloride.
Each film-coated tablet contains 50 mg of naltrexone hydrochloride.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate.
Film coating: hypromellose (E464), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171).

Description of the appearance of Naltrexone Accord Healthcare and contents of the pack
Naltrexone Accord Healthcare is available as yellow, oval, biconvex film-coated tablets, with a score line on one side and smooth on the other.
The tablet can be divided into two equal halves.
Naltrexone Accord Healthcare is available in opaque white PVC/PE/Aclar-Al blisters and Al-Al blisters containing 7, 14, 28, 30, 50 and 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia, 32009,
Greece

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

| Country | Proposed Name | |-------------|-------------------| | Austria | Naltrexone Accord 50 mg Filmtabletten | | Belgium | Naltrexone Accord 50 mg comprimes pellicules / filmomhulde tabletten / Filmtabletten | | Bulgaria | Naltrexone Акорд 50 мг филмирани таблетки | | Cyprus | Naltrexone Accord 50 mg Film-coated Tablets | | Denmark | Naltrexon Accord 50 mg filmovertrukne tabletter | | Estonia | Naltrexone Accord 50 mg õhukese polümeerikattega tabletid | | Finland | Naltrexon Accord 50 mg kalvopäällysteinen tabletti / filmdragerade tabletter | | Germany | Naltrexonhydrochlorid Accord 50 mg Filmtabletten | | Ireland | Naltrexone Hydrochloride 50 mg Film-coated Tablets | | Italy | Naltrexone Accord Healthcare 50 mg compresse rivestite con film | | Latvia | Naltrexone Accord 50 mg apvalkotās tabletes | | Lithuania | Naltrexone Accord 50 mg plėvele dengtos tabletės | | Norway | Naltrexone Accord | | Poland | Naltex, 50 mg tabletki powlekane | | Portugal | Naltrexona Accord 50 mg comprimidos revestidos por película | | Spain | Naltrexone Hydrochloride Accord 50 mg comprimidos recubiertos con película EFG | | Sweden | Naltrexone Accord 50 mg filmdragerad tablet | | The Netherlands | Naltrexonhydrochloride Accord 50 mg filmomhulde tabletten |