50 mg film-coated tablets
naltrexone hydrochloride
What Naltrexone Vitaflo is and what it is used for
Naltrexone Vitaflo is used as adjunctive therapy in alcohol dependence. The treatment is part of a comprehensive treatment program that also includes psychological help to support abstinence in alcohol dependence.
Naltrexone Vitaflo reduces alcohol intake as the craving for alcohol decreases. More patients can abstain from alcohol and avoid relapse.
Naltrexone Vitaflo is not addictive.
Naltrexone hydrochloride contained in Naltrexone Vitaflo may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 you use Naltrexone Vitaflo
Do not use Naltrexone Vitaflo
- if you are allergic to naltrexone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you are using opiates (including medicines containing opioids )
- whether opiates have been detected in urine samples
- if you get withdrawal symptoms after naloxone injection
- if you have severe liver problems
- if you have severe kidney problems
Warnings and cautions
Your treatment should be started by a doctor with special knowledge of alcohol dependence.
- You must tell every doctor who treats you that you are using Naltrexone Vitaflo.
- You should not use Naltrexone Vitaflo if you are still addicted to opiates as treatment with naltrexone causes severe withdrawal symptoms in these cases.
- Naltrexone Vitaflo is excreted from the body via the liver and kidneys. Your doctor will check your liver function before starting treatment and during treatment.
- If blood tests are to be taken, tell your doctor that you are using Naltrexone Vitaflo as it may affect liver function tests.
- Anesthetics without opioid properties should be used in cases where you need anesthesia in emergency care.
- Tell your doctor if you become pregnant.
Other medicines and Naltrexone Vitaflo
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor if you need cough medicine, medicines for diarrhea or pain, as these medicines may contain opiates, and use in combination with an opioid-containing medicine should be avoided.
If drugs containing opiates need to be used in emergencies despite the use of combination drugs, the dose required for pain relief may be higher than normal. In these cases, close medical supervision is required as respiratory depression and other symptoms may become more severe and persist longer.
as respiratory depression and other symptoms may become more severe and persist for longer.
Pregnancy and breastfeeding
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 Vitaflo can be used during pregnancy and breastfeeding concerning the risk to both mother and baby.
Driving and using machines
Naltrexone Vitaflo can cause dizziness and lack of energy and thus affect the mental and physical ability needed for particularly risky tasks such as driving a car and operating machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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 Vitaflo contains lactose
Naltrexone Vitaflo 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 Vitaflo
Adults:
Always take Naltrexone Vitaflo tablets exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 tablet daily.
Processing time:
Your doctor will decide how long you should be treated. The normal treatment time is 3 months. In some cases, long-term treatment is necessary.
Children and youth:
Do not use by children or adolescents under 18 years.
Use in the elderly:
There are insufficient data on the efficacy and safety of treatment in the elderly in this area of use.
If you use more Naltrexone Vitaflo 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, hospital for risk assessment and advice.
In case of overdose, the symptoms resulting from the overdose should be treated. The effects of an overdose are not known.
Possible side effects
Like all medicines, Naltrexone Vitaflo can cause side effects, although not everybody gets them.
The following side effects may occur:
Very common (may affect more than 1 user in 10):
Anxiety, insomnia, headache, restlessness, nervousness, abdominal pain, nausea, vomiting, pain in muscles and joints, weakness.
Common (may affect up to 1 in 10 people):
Decreased appetite, palpitations, increased heart rate, ECG abnormalities, thirst, dizziness, increased tear production, chest pain, diarrhea, constipation, skin rash, delayed ejaculation, erectile dysfunction, increased energy, irritation, increased sweating, mental changes.
Uncommon (may affect up to 1 in 100 people):
Mouth herpes, athlete’s foot, enlarged lymph nodes, hallucinations, confusion, depression, persecution mania, disorientation, nightmares, agitation, sexual dysfunction, abnormal dreams, tremors, drowsiness, visual disturbances, eye irritation and swelling of the eyes, photosensitivity or irritability, changes in blood pressure, hot flashes, nasal congestion, nasal discomfort, runny nose, sneezing, mouth, and throat diseases, increased mucus production, sinus problems, voice disorders, cough, shortness of breath, yawning, gas formation, hemorrhoids, stomach ulcers, dry mouth, hepatitis, hepatitis ( inflammation the liver), seborrhea (mild inflammation of the skin, “scaly”), acne, hair loss, itching, groin pain, abnormally frequent urination, painful urination, tinnitus, dizziness, earache, ear discomfort, increased appetite, weight loss, weight gain, fever, pain, cold feelings in arms and legs.
Rare (may affect up to 1 in 1,000 people):
Decreased platelet count, suicidal ideation, suicide attempt.
Very rare (may affect up to 1 in 10,000 people):
Degradation of muscle tissue.
How to store Nalterxone Vitaflo
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 carton and blister. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Moisture sensitive.
Do not use Naltrexone Vitaflo if the tablets are broken or if chips have come off, consult your 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
One tablet contains 50 mg of the active substance naltrexone hydrochloride.
Other ingredients:
Lactose monohydrate, cellulose powder, microcrystalline cellulose, silica ( colloidal, anhydrous), crospovidone, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 4000, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172).
What the medicine looks like and contents of the pack
The Naltrexone Vitaflo tablet is beige and capsule-shaped with a notch on both sides. The tablet can be divided into two equal parts.
Naltrexone Vitaflo 50 mg film-coated tablets are supplied in blister packs of 7, 14, 28, 30, or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
AOP Orphan Pharmaceuticals AG
Vienna, Austria
Manufacturer:
Haupt Pharma, Wolfratshausen, Germany
Laboratories BTT, Erstein, France
Amomed Pharma GmbH, 1150 Vienna, Austria
This medicinal product is authorized under the European Economic Area under the names:
| Finland: | Naltrexone Vitaflo 50 mg tablets |
| France: | Naltrexone Mylan 50 mg, compressed skimmed pill |
| Ireland: | Ethyl 50 mg film-coated tablets |
| Netherlands: | Naltrexone hydrochloride 50 PCH, film-coated tablets 50 mg |
| Sweden: | Naltrexone Vitaflo 50mg film-coated tablets |