Buprenorphine Sandoz 1 mg Uses, Dosage, Side Effects, Precautions & Warnings

BUPRENORPHINE SANDOZ 1 mg sublingual tablets
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BUPRENORPHINE SANDOZ 1 mg sublingual tablets >> Generic drug of the Therapeutic class: Neurologypsychiatry
Active ingredients: Buprenorphine

what is Buprenorphine Sandoz 1 mg ?

This medication is exclusively reserved for the substitution treatment of major drug dependence on opiates, within the framework of medical and psycho-social monitoring, based on an agreement between the patient and his doctor.

what is Buprenorphine Sandoz 1 mg used for and indication?

This treatment is reserved for adults and children over 15 years who have volunteered to receive substitution treatment.

PRESENTATION (S) AVAILABLE FOR BUPRENORPHINE SANDOZ 1 MG

2 presentations are available for this medication:

  • PVC-Aluminum blister pack (s) of 7 tablet (s)
  • PVC-Aluminum blister pack (s) of 28 tablet (s)
FEATURE DESCRIPTION
Pharmaceutical class other central nervous system drugs
Active substance (s) buprenorphine hydrochloride
General medicine no
Pharmaceutical form compressed
Route (s) of administration sublingual
Social security reimbursement rate 65%
Laboratory (s) SANDOZ
Conditions of issue available by simple prescription

Buprenorphine Sandoz 1 mg Dosage

  • Administration in one dose per day.
  • The doses are individual. They are gradually adapted under medical supervision, according to the needs of each patient.
  • If you have the impression that the effect of BUPRENORPHINE SANDOZ 1 mg, sublingual tablet is too strong or too weak, consult your doctor or pharmacist.

Buprenorphine Sandoz 1 mg Contraindications

Do not take BUPRENORPHINE SANDOZ 1 mg sublingual tablet in the following cases:

  • known allergy to buprenorphine or to any other component of the product,
  • children under 15,
  • severe respiratory failure,
  • severe liver disease,
  • acute alcohol poisoning or alcohol withdrawal syndrome (delirium tremens),
  • in combination with methadone,
  • in combination with level III opioid analgesics.

How To Take Buprenorphine Sandoz ?

Method and route of administration

The sublingual route is the only effective and well-tolerated route for taking this drug.

Allow the tablets to melt under the tongue.

The tablets should not be swallowed.

Duration of treatment

The duration of treatment should be determined individually for each patient.

Stopping treatment, by gradually reducing the dosage, may be considered, with your consent, after your condition has stabilized sufficiently. The doses should be reduced in successive stages under the supervision of your doctor.

Do not change or stop treatment without the consent of your doctor.

The effectiveness of treatment depends on:

  • the dosage,
  • associated medico-psychological and socio-educational measures.

how does Buprenorphine Sandoz 1 mg work?

Pharmacotherapeutic group: drug used in opioid dependence, ATC code: N07BC01.

  • Buprenorphine is a morphine agonist-antagonist and binds to the µ and κ brain receptors. Its activity in opioid substitution treatment is attributed to its slowly reversible binding to µ receptors, which is said to minimize the need of drug addicts for a long period of time.
  • The partial agonist activity of buprenorphine gives the product a high therapeutic index by limiting its depressant effects, in particular on cardio-respiratory functions. The therapeutic margin of buprenorphine may be reduced in the event of combination with benzodiazepines or in situations of misuse of buprenorphine.

How To Store Buprenorphine Sandoz 1 mg ?

  • Keep this medication out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton. The expiration date refers to the last day of that month.
  • Store at a temperature not exceeding 25 ° C.
  • Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

Buprenorphine Sandoz 1 mg Side Effects

Like all medicines, BUPRENORPHINE SANDOZ 1 mg sublingual tablets can cause side effects, although not everybody gets them.

During a first administration, the occurrence of a withdrawal syndrome is possible.

The following side effects have been observed:

  • Common side effects (1% -10%)  : constipation, nausea, vomiting, insomnia, headache, malaise and dizziness, fatigue, drowsiness, drop in blood pressure when changing from lying or sitting to lying down or sitting down standing, sweating.
  • Rare side effects (0.01% -0.1%)  : respiratory failure, hallucinations, hepatitis (liver damage) with or without jaundice.

Intravenous misuse poses the risk of skin infection and severe acute hepatitis .

Other post-marketing adverse  reactions: hypersensitivity reactions (allergy), such as rash, pruritus (itching), bronchospasm (bronchial spasm), angioedema (swelling of the face and neck which may cause breathing difficulties) and anaphylactic shock (severe generalized allergic reaction).

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Buprenorphine Sandoz 1 mg Interactions

The combination with sedative drugs, anxiolytics, antidepressants and certain antihypertensives may increase the central effects of buprenorphine and requires appropriate medical supervision.

The combination of this product with benzodiazepines (drugs indicated in anxiety or insomnia) may be responsible for death from respiratory failure.

The combination of this drug with naltrexone can cause the onset of a withdrawal syndrome.

The concomitant use of certain medicines (ritonavir, nelfinavir, indinavir, ketoconazole or itraconazole) may lead to increased concentrations of buprenorphine in the blood. This requires close medical supervision and sometimes a reduction in the doses of BUPRENORPHINE SANDOZ by your doctor.

The intake of alcoholic beverages and drugs containing alcohol is strongly discouraged.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicine, even one obtained without a prescription.

Effects on ability to Drive and use machines

  • BUPRENORPHINE SANDOZ may cause drowsiness, dizziness or altered thinking. This can especially happen during the first weeks of treatment or when your dose is changed, but also when you drink alcohol or take other sedatives with BUPRENORPHINE SANDOZ. 
  • You should not drive, use any tools or machines, or engage in hazardous activities until you know how this medicine affects you.
  • Ask your doctor or pharmacist for advice.

Warnings and Precautions

Special warnings

This product can be the cause of fatal respiratory failure, especially when taken in combination with benzodiazepines (drugs indicated for anxiety or insomnia) and when used improperly.

Cases of severe acute hepatitis (severe liver damage) have been reported with the misuse of BUPRENORPHINE SANDOZ, especially by the intravenous route and in high doses. These attacks may be favored by certain conditions such as viral infections (chronic hepatitis C), alcoholism, anorexia, or by certain associated drugs (for example: antiretrovirals, aspirin, amiodarone, isoniazid, valproic acid). In the event of the appearance of significant fatigue, itching or jaundice, consult your doctor so that he determines the origin and decides to continue the treatment under supervision or to organize its discontinuation.

This product may cause withdrawal syndrome if administered less than 4 hours after taking a narcotic (morphine, heroin or related products).

This product may cause drowsiness which may be increased by products such as alcoholic beverages, tranquilizers, sedative drugs, sleeping pills.

Tell your doctor if you have:

  • recent head trauma
  • low blood pressure
  • in men: urinary disorders (in particular linked to an enlarged prostate).

This medicine may mask the pain signaling certain diseases. Remember to tell your doctor if you are taking this medicine.

This product may cause a drop in blood pressure when changing from lying down to standing.

This product may cause drug dependence.

Short-term prescription and dispensing are recommended, particularly at the start of treatment.

This medicine contains lactose. Its use is not recommended in patients with lactose intolerance (a rare hereditary disease).

Precautions for use

Tell your doctor if you have:

  • asthma or illness with respiratory failure,
  • kidney disease,
  • liver disease.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

  • Based on the available data and the maternal / fetal benefit, buprenorphine can be used during pregnancy. However, an adjustment of the daily dosage may be necessary in order to maintain the effectiveness of the treatment.
  • Chronic maternal intake of buprenorphine at any dose at the end of pregnancy may lead to withdrawal syndrome (squealing, poor food intake, abnormal sleep, irritability, tremor, hypertonia, myoclonus or convulsions) in the newborn. This syndrome is usually delayed for several hours to several days after birth. Respiratory disorders in newborns have also been reported. Therefore, if the mother is treated until the end of the pregnancy, monitoring should be considered at birth and for several days afterwards.

Feeding with milk

  • Very small amounts of buprenorphine and its metabolites pass into breast milk. These amounts are not sufficient to avoid withdrawal syndrome which may be delayed in breastfed infants. After an assessment of individual risk factors, breast-feeding may be considered in patients treated with buprenorphine.

Fertility

  • In a study conducted with pharmacological doses in mice, testicular atrophy with tubular calcification was demonstrated in treated animals.

What happens if I overdose from Buprenorphine Sandoz 1 mg ?

If you take more BUPRENORPHINE SANDOZ 1 mg sublingual tablet than you should:

  • An overdose of buprenorphine requires the patient to be placed under medical supervision and possibly emergency treatment in hospital. Immediately consult your doctor or pharmacist.

What should I do if I miss a dose?

If you forget to take BUPRENORPHINE SANDOZ 1 mg sublingual tablet:

  • If you forgot to take a dose, tell your doctor as soon as possible. Do not take a double dose to make up for the dose you forgot to take.

What happens if you stop taking Buprenorphine Sandoz 1 mg ?

If you stop taking BUPRENORPHINE SANDOZ 1 mg sublingual tablet:

  • Do not change the treatment in any way and do not stop the treatment without the consent of your doctor. Suddenly stopping treatment may lead to the onset of withdrawal symptoms.
  • If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is  Forms and Composition ?

Appearance and shape

  • Sublingual tablet.
  • Round, white, biconvex tablet debossed with “1” on one side, with an arrow debossed on the other side.
  • 7 tablets in blister packs (PVC / Aluminum).

Other shapes

  • BUPRENORPHINE SANDOZ zero point four (0.4) mg, sublingual tablet, box of seven (7)
  • BUPRENORPHINE SANDOZ two (2) mg, sublingual tablet, box of seven (7)
  • BUPRENORPHINE SANDOZ eight (8) mg, sublingual tablet, box of seven (7)
  • BUPRENORPHINE SANDOZ four (4) mg, sublingual tablet, box of seven (7)
  • BUPRENORPHINE SANDOZ six (6) mg, sublingual tablet, box of seven (7)

Composition

Active ingredient Sublingual tablet

Buprenorphine 1 mg ** per unit dose

Active ingredients: Buprenorphine

Excipients with known effects ? :

  • Lactose monohydrate

Other excipients:

  • Mannitol
  • Corn starch
  • Povidone K30
  • Citric acid anhydrous
  • Sodium citrate
  • Sodium stearyl fumarate

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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