50 mg film-coated tablets
naltrexone hydrochloride
What Naltrexone POA Pharma is and what it is used for
Naltrexone POA Pharma 50 mg film-coated tablets are used as adjunctive therapy in alcohol withdrawal. The treatment is part of a comprehensive treatment program for alcohol dependence to counteract withdrawal syndrome.
Naltrexone POA Pharma 50 mg film-coated tablets significantly reduce alcohol intake as the craving for alcohol decreases. More patients can abstain from alcohol and avoid relapse.
Naltrexone POA Pharma 50 mg film-coated tablets are not addictive.
Naltrexone hydrochloride contained in Naltrexone POA Pharma 50 mg film-coated tablets may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Naltrexone POA Pharma
Do not use Naltrexone POA Pharma
- if you are allergic to naltrexone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you are taking or have taken any opioid-containing medicines (eg morphine used to treat severe pain after surgery or for cancer)
- if you are opioid addicted (with failed withdrawal)
- if you have severe liver disease or acute hepatitis (hepatitis)
- if you have severe kidney disease.
- together with methadone (see section “Other medicines and Naltrexone POA Pharma below)
Warnings and cautions
Talk to your doctor or pharmacist before taking Naltrexone POA Pharma 50 mg film-coated tablets.
- Your treatment should be started by a doctor who has experience in the treatment of alcohol dependence.
- You must inform every doctor treating you that you are using Naltrexone POA Pharma 50 mg film-coated tablets (see sections “Concomitant treatment with Naltrexone POA Pharma 50 mg film-coated tablets and opioids” and “Other medicines and Naltrexone POA Pharma 50 mg film-coated tablets” below ).
- Tell your doctor if you have any liver or kidney disease. Liver function tests should be performed before and during treatment.
- Tell your doctor if you become pregnant.
- If blood tests are to be taken, tell your doctor that you are using Naltrexone POA Pharma 50 mg film-coated tablets as it may affect the results of liver function tests
Concomitant treatment with Naltrexone POA Pharma and opioids:
- During treatment with Naltrexone POA Pharma 50 mg film-coated tablets, pain conditions should not be treated with opioids .
- After treatment with Naltrexone POA Pharma 50 mg film-coated tablets, you may become more sensitive to opioid -containing medicines .
Treatment with Naltrexone POA Pharma in patients with additional opioid dependence:
- Do not take opioids after using Naltrexone POA Pharma 50 mg film-coated tablets. Treatment with naltrexone should be started only when opioid has been discontinued for a sufficiently long period (approximately 5 to 7 days for heroin and at least 10 days for methadone ).
- Although Naltrexone POA Pharma 50 mg film-coated tablets inhibit the opioid effect, opioids may still be present in your body after the effect of Naltrexone POA Pharma 50 mg film-coated tablets has diminished. Accidental overdose can have serious or life-threatening consequences ( circulatory failure , respiratory depression ). Naltrexone POA Pharma 50 mg film-coated tablets may cause life-threatening withdrawal symptoms in opioid-dependent patients.
Other medicines and Naltrexone POA Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Drugs containing opioids should be avoided during treatment with Naltrexone POA Pharma 50 mg film-coated tablets as the effect may be weaker.
Tell your doctor if you use
- opioid-containing medicines for cough, diarrhea or pain. The doctor will then prescribe drugs that do not contain opioids . Generally opioid-containing drugs should be avoided.
- methadone as a substitution treatment for drug abuse
- medicines for high blood pressure (alpha-methyldopa)
- sedatives and sleeping pills ( barbiturates , benzodiazepines, anxiolytics , hypnotics
- certain antidepressants (amitriptyline, doxepine, mianserin, trimipramine)
- sedative antihistamine er
- neuroleptics (droperidol)
If painkillers containing opioids need to be used in emergencies, the analgesic dose may be higher than normal. In these cases, careful monitoring by an experienced physician is required as respiratory depression and other symptoms may become more severe and persist longer.
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 before taking this medicine.
Your doctor will decide if Naltrexone POA Pharma 50 mg film-coated tablets can be used during pregnancy and breastfeeding about the risk to both mother and baby.
Driving and using machines
Naltrexone POA Pharma 50 mg film-coated tablets may cause side effects (such as reduced mental and/or physical ability) which may affect the ability to drive and drive.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Naltrexone POA Pharma contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Naltrexone POA Pharma
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults
1 tablet per day unless your doctor prescribes another dose.
Use for the elderly
There are insufficient data on the safety and efficacy of Naltrexone POA Pharma 50 mg film-coated tablets in the elderly.
Use in patients with liver or kidney disease
Tell your doctor if you have any liver or kidney disease. Your doctor will decide if the dosage of one of the Naltrexone POA Pharma 50 mg film-coated tablets needs to be adjusted or the treatment stopped.
Treatment time
Your doctor will decide how long you should be treated with Naltrexone POA Pharma 50 mg film-coated tablets. The treatment period is usually at least 3 months. In some cases, longer treatment times are necessary.
Method of administration
Naltrexone POA Pharma 50 mg film-coated tablets should be taken with a small amount of liquid.
Use for children and adolescents
Naltrexone POA Pharma 50 mg film-coated tablets should not be used in children and adolescents under 18 years of age.
If you use more Naltrexone POA Pharma than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Side effects other than those listed below are not known.
If you forget to use Naltrexone POA Pharma
Do not take a double dose to make up for a forgotten tablet.
If you stop using Naltrexone POA Pharma
Do not stop treatment without consulting a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Serious side effects:
If you get any of the following, stop taking Naltrexone POA Pharma film-coated tablets and contact a doctor immediately.
Rare:
- suicidal thoughts, suicide attempts.
Very rare:
- unexplained muscle pain, muscle cramps or muscle weakness. In rare cases, these muscle problems can become serious with e.g. degradation of muscle tissue causing kidney damage and in very rare cases death.
Other side effects:
Very common (affects more than 1 patient in 10):
- headache, restlessness
- sleep disorders, nervousness, anxiety
- abdominal pain, abdominal cramps, nausea
- vomiting tendency
- pain in muscles and joints
- powerlessness
Common (affects 1 to 10 users in 100):
- decreased appetite
- increased energy, despair, irritability, mood swings, affective disorders
- fraud, dizziness
- increased tear secretion
- increased heart rate , palpitation , ECG changes
- pains in the chest
- diarrhea, constipation
- rash
- urinary retention
- delayed ejaculation, decreased potency
- thirst, chills, increased sweating
Uncommon (affects 1 to 10 users in 1,000):
- cold sores, athlete’s foot
- lymphadenopathy (pathological change of lymph nodes )
- hallucinations, confusion, depression, paranoia , disorientation, nightmares, agitation , libido disorder, abnormal dreams
- trembling, fatigue
- blurred vision, eye irritation, photosensitivity, eye swelling, eye pain, eye fatigue
- earache, earache, tinnitus , dizziness
- fluctuations in blood pressure, feeling hot and redness on the face and neck ( flush )
- nasal congestion and runny nose, runny nose, sneezing, pain in the mouth and throat, increased salivation, trouble with the sinuses, shortness of breath, hoarseness, cough, yawning
- gas formation, hemorrhoids , stomach ulcers , dry mouth
- effects on liver function, increased bilirubin in the blood, hepatitis (after treatment, liver function returns to normal within a few weeks)
- dandruff (seborrhea), itching , acne , hair loss
- groin pain, increased urination frequency, awkward or painful urination
- increased appetite, weight loss, weight gain, fever, pain, peripheral cold, feeling hot
Rare (affects 1 to 10 users in 10,000):
- decreased number of platelets with increased risk of bleeding as a result
- speech disorders
Very rare (affects less than 1 in 10,000 people):
- euphoria
- red rash (exanthema)
How to store Naltrexone POA Pharma
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the blister and the carton.
If you notice any defects in the tablets such as chips or broken tablets, you should consult your doctor or pharmacist before using the tablets.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is naltrexone hydrochloride.
One tablet contains 50 mg of naltrexone hydrochloride (equivalent to 45.18 mg of naltrexone).
The other ingredients are
Tablet core:
Lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate.
Tablet coating:
Hypromellose (E464), macrogol 400, polysorbate 80 (E 433), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
What the medicine looks like and contents of the pack
Yellow, 6×13 mm oval, biconvex film-coated tablet with a scoreline on one side and smooth on the other side.
The tablet can be divided into two equal doses.
Naltrexone POA Pharma 50 mg film-coated tablets are available in packs of 7, 14, 28, 30, 50, and 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer:
Laboratori Fundació Dau
C / C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona
Spain