Buprenorphine/Naloxone G.L. Pharma

Buprenorphine/Naloxone G.L. Pharma is used to treat opioid dependence as part of a complete treatment program.

Form
resoribletti
Strength
4 mg / 1 mg
Active Ingredient
Buprenorphine hydrochloride
Manufacturer
G.L. Pharma GmbH

How to Use

Dosage

The recommended starting dose for adults and adolescents over 15 is 1-2 Buprenorphine/Naloxone G.L. Pharma 2 mg/0.5 mg tablets. One or two additional 2 mg/0.5 mg tablets can be given on day 1 if needed.

Method

Take once a day by placing the tablets under your tongue. Keep them there until they are completely dissolved, which usually takes 5-10 minutes. Do not chew or swallow the tablets. Do not eat or drink before the tablets have fully dissolved.

Important

The maximum daily dose is 24 mg of buprenorphine.

Possible Side Effects

COMMON
  • Difficulty sleeping (insomnia)
  • Constipation
  • Nausea
  • Excessive sweating
  • Headache
  • Drug withdrawal syndrome
  • Weight loss
  • Swelling of hands and feet
  • Drowsiness
  • Anxiety
  • Nervousness
  • Tingling sensation
  • Depression
  • Decreased sex drive
  • Increased muscle tension
  • Abnormal thoughts
  • Watery eyes or other tear disorders
  • Blurred vision
  • Flushing
  • High blood pressure
  • Migraine
  • Runny nose
  • Sore throat and pain when swallowing
  • Increased cough
  • Stomach upset or discomfort
  • Diarrhoea
  • Abnormal liver function tests
  • Gas (flatulence)
  • Vomiting
  • Rash
  • Itching
  • Hives
  • Pain
  • Joint pain
  • Muscle pain
  • Leg cramps
  • Difficulty getting or keeping an erection
  • Abnormal urine
  • Abdominal pain
  • Back pain
  • Weakness
  • Infection
  • Chills
  • Chest pain
  • Fever
  • Flu-like symptoms
  • General discomfort
  • Accidents due to poor alertness or coordination
  • Fainting
  • Dizziness
RARE
  • Swollen glands (lymph nodes)
  • Restlessness
  • Tremor
  • Abnormal dreams
  • Excessive muscle activity
  • Feeling unreal (depersonalization)
  • Drug dependence
  • Memory loss
  • Loss of interest
  • Excessive euphoria
  • Seizures
  • Speech disorder
  • Small pupils
  • Difficulty urinating
  • Eye inflammation
  • Fast or slow heart rate
  • Low blood pressure
  • Palpitations (fast or irregular heartbeat)
  • Heart attack
  • Chest tightness
  • Shortness of breath
  • Worsening of asthma
  • Yawning
  • Pain and sores in mouth
  • Tongue discoloration
  • Acne
  • Skin lumps
  • Hair loss
  • Dry or flaky skin
  • Joint inflammation
  • Urinary tract infection
  • Blood in urine
  • Abnormal ejaculation
  • Vaginal or menstrual problems
  • Kidney stones
  • Protein in urine
  • Painful or difficult urination
  • Sensitivity to heat or cold
  • Heatstroke
  • Loss of appetite
  • Feelings of hostility
  • Sudden withdrawal syndrome (if taken too soon after illegal opioids)
  • Withdrawal syndrome in newborns
  • Slow or difficult breathing
  • Tooth decay
  • Liver damage, possibly with yellow skin or eyes
  • Hallucinations (seeing or hearing things that aren't there)
  • Swelling of the face and throat (life-threatening allergic reactions)
  • Drop in blood pressure when standing up from sitting or lying down

Important Warnings

  • Do not take if you are allergic to buprenorphine, naloxone, or any other ingredient in this medicine.
  • Do not take if you have severe breathing problems or severe liver problems.
  • Do not take if you are intoxicated by alcohol or experiencing alcohol withdrawal symptoms. Do not drink alcohol with this medicine.
  • Do not take if you are using naltrexone or nalmefene, as it can block the medicine's effects and cause severe withdrawal.
  • Never give this medicine to anyone else. Misuse, especially with other drugs or alcohol, can cause severe breathing problems and be fatal.
Show 6 more warnings
  • Do not stop taking this medicine suddenly without talking to your doctor, as it can cause strong withdrawal symptoms.
  • This medicine can make you drowsy, especially at the start of treatment or if taken with alcohol or other sedatives. Do not drive or operate machines until you know how it affects you.
  • If you are pregnant or breastfeeding, talk to your doctor. This medicine can cause withdrawal symptoms and breathing problems in newborns, and it passes into breast milk.
  • Tell your doctor if you are taking antidepressants, as combining them with this medicine can lead to a serious condition called serotonin syndrome.
  • Your doctor will do regular blood tests to check your liver. Tell your doctor if you have any liver problems before starting treatment.
  • This medicine is not for children under 15 years old.