Reminil

Reminil – the drug with antikholinesterazny action promoting improvement of cognitive function at dementia of altsgeymerovsky type.

Form of release and structure

Dosage forms of release of Reminil:

• Tablets, film coated: biconvex, round, on one party an engraving of "JANSSEN": on 4 mg – almost white or white color, an engraving on other party - "G4"; on 8 mg – pink color, an engraving on other party – G8; on 12 mg – orange-brown color, an engraving on other party - "G12" (on 14 pieces in blisters, on 1, 2 or 4 blisters in a cardboard pack);
• Capsules of the prolonged action: firm gelatinous, with the opaque case; capsules contain granules of almost white or white color; on 8 mg – the size No. 4, a lid of white color with a symbol of G8; on 16 mg – the size No. 2, a lid of light pink color with a G16 symbol; on 24 mg – the size No. 1, a lid of pinkish-brown color with a G24 symbol (on 300 pieces in polyethylene bottles, on 1 bottle in a cardboard pack; on 7 pieces in blisters, on 1 or 4 blisters (on 8 mg), or on 4, 8 or 12 blisters (on 16 mg), or on 2, 4, 8 or 12 blisters (on 24 mg) in a cardboard pack).

Structure of 1 tablet, film coated:

• Active agent: Galantaminum – 4, 8 or 12 mg (Galantaminum hydrobromide – 5,127/10,254/15,38 mg);
• Auxiliary components: microcrystallic cellulose, monohydrate of lactose (premix in the ratio 25% and 75% respectively), magnesium stearate, кросповидон, anhydrous colloid silicon dioxide;
• Cover: gipromelloza of 2910 (viscosity 5 мПа×с), propylene glycol, titanium dioxide (E171), talc; in addition: on 4 mg – iron oxide yellow (E172); on 8 mg – iron oxide red (E172); on 12 mg – iron oxide red (E172), orange-yellow S (E110) dye.

Structure of 1 capsule of the prolonged action:

• Active agent: Galantaminum – 8, 16 or 24 mg (in the form of hydrobromide);
• Auxiliary components: ethyl cellulose 20 мПа×с, macrogoal 400, sugar spheres (corn starch, sukroz), gipromelloza 2910 5 мПа×с, diethyl phthalate;
• Cover: gelatin, titanium dioxide; in addition: on 16 mg – red iron oxide; on 24 mg – red and yellow iron oxide.

Indications to use

Reminil appoint for treatment of dementia of altsgeymerovsky type of moderate or easy degree, including the states connected with chronic disturbances of cerebral circulation.

Contraindications

Absolute:

• Heavy functional disturbances of kidneys (at clearance of creatinine <9 ml/min.);
• Heavy abnormal liver functions (for capsules) or the expressed abnormal liver functions (> 9 points on a scale of Chayld-Pyyu) (for tablets);
• Hypersensitivity to drug components.

Relative (Reminil in the form of capsules it is necessary to appoint with care in the presence of the following diseases / states):

• Bronchial asthma, chronic obstructive pulmonary disease;
• General anesthesia;
• The period after the postponed operational intervention on bodies of digestive tract and a bladder;
• Unstable stenocardia, bradycardia, sick sinus syndrome, AV blockade;
• Obstructions of digestive tract, peptic ulcer of a stomach and duodenum;
• The combined use with the drugs promoting delay of heart rate (beta adrenoblockers, digoxin);
• Obstruction of urinary tract;
• Epilepsy.

At pregnancy Reminil appoint only after advantage ratio assessment with risk for health of mother and the child. Women during a lactation at purpose of drug are recommended to interrupt breastfeeding.

Reminil it is not recommended to children to appoint (the safety profile for this age group of patients is not studied).

Route of administration and dosage

Tablets
Reminil accept inside.

Frequency rate of reception – 2 times a day, is more preferable – along with meal of morning and in the evening.

The daily dose makes: initial (accept for 4 weeks) – 8 mg, supporting (accept for 4 weeks) – 16 mg (after comprehensive assessment of a clinical situation, in particular, of portability and the reached effect, its increase to 24 mg is possible).

At clearance of creatinine> 9 ml/min. it is not necessary to adjust Reminil's dose.

The initial dose at moderate functional disturbances of a liver makes 4 mg in 1 reception (in the morning). In a week increase in frequency rate of reception up to 2 times a day is possible (duration not less than 4 weeks).

At the combined reception with strong inhibitors of isoenzymes of CYP3A4 or CYP2D6 there can be a need for reduction of a dose of drug.

Capsules
Reminil accept inside, once a day, more preferably – in the morning along with food.

Initial daily dose – 8 mg.

Upon transition from Reminil's reception in tablets, the capsule should be accepted the next morning. The daily dose at the same time should not change.

During therapy it is necessary to accept enough liquid.

The initial supporting daily dose – 16 mg. It is accepted for not less than 4 weeks. Increase in a dose up to 24 mg perhaps after comprehensive assessment of a clinical picture, in particular, portability and therapeutic effect.

After sudden cancellation of treatment symptoms usually do not become aggravated. After a break of reception of Reminil for several days, reception is resumed from an initial dose then it is increased according to stated above to the scheme.

At damages of a liver of a moderate and heavy current the initial dose of 8 mg for a week is appointed every other day then frequency rate of reception is increased to 1 time a day a course by not less than 4 weeks. Such patients should not exceed a daily dose more than 16 mg.

At the combined reception with strong inhibitors of isoenzymes of CYP3A4 or CYP2D6 there can be a need for reduction of a dose of drug.

Side effects

Tablets

• Central nervous system: often – sleeplessness or drowsiness, dizziness, weakness, a headache, sudden falling, confusion of consciousness; seldom – faints, a tremor;
• Alimentary system: often – vomiting, anorexia, nausea, pains in a stomach, dyspepsia (anorexia, nausea and vomiting were more often noted at women);
• Others: often – infections of urinary tract, decrease in body weight, rhinitis, injuries; seldom – heavy bradycardia.

Capsules
Most often during Reminil's reception development of nausea and vomiting was observed. As a rule, these disturbances arise at selection of a dose. Their duration made not less than 7 days, generally they had periodic character. The most effective in such cases is purpose of antiemetic medicines and ensuring sufficient consumption of liquid.

Besides, during therapy the following side reactions can be observed (> 1/10 – very often,> 1/100, <1/10 – it is frequent,> 1/1000 and <1/100 – infrequently,> 1/10 000 and <1/1000 – it is rare, <1/10 000 – it is very rare):

• Cardiovascular system: often – bradycardia; infrequently – a cardiopalmus, AV blockade of the first degree, inflows, supraventricular premature ventricular contraction, a lowering of arterial pressure;
• Nervous system: often – a faint, dizziness, block, a tremor, a headache, drowsiness; infrequently – a hypersomnia, a food faddism, paresthesia;
• Immune system: infrequently – hypersensitivity;
• Alimentary system: very often – vomiting, nausea; often – dyspepsia, diarrhea, gastrointestinal discomfort, pains in a stomach;
• Skeletal and muscular system and connecting fabric: often – muscular spasms; infrequently – muscular weakness;
• Liver and biliary tract: very seldom – hepatitis;
• Mentality: often – hallucinations, a depression (it is very rare with a suicide); infrequently – hallucinations acoustical and visual;
• Metabolism and food: often – anorexia, appetite reduction; infrequently – dehydration (including, in some cases, serious which can lead to a renal failure);
• Organ of sight and hearing: infrequently – the obscured sight; very seldom – a sonitus;
• Skin and hypodermic fabrics: often – the strengthened sweating;
• Laboratory indicators: often – decrease in body weight; very seldom – increase in activity of liver enzymes;
• General disturbances: often – weakness, exhaustion.

Very seldom in placebo - controlled clinical trials development of the following undesirable phenomena was noted: rhinitis, a hamaturia, anemia, infections of urinary tract, increase in arterial pressure (relationship of cause and effect with performing therapy is not proved).

Special instructions

During therapy it is necessary to monitor change of weight of patients as decrease in body weight can be a symptom of Alzheimer's disease or be the result of Reminil's reception.

The majority of side reactions develop against the background of gradual increase in a dose of Reminil.

Drug is not intended for patients with weak cognitive disturbances, i.e. for patients with the isolated memory disturbances which are exceeding the expected level for their education and age but not meeting criteria of Alzheimer's disease.

It is necessary to consider that Reminil's reception can negatively affect ability to manage motor transport and to work with mechanisms.

Medicinal interaction

At the combined use of Reminil with some medicinal means / substances the following effects can be observed:

• CYP2D6 isoenzyme inhibitors (флувоксамин, amitriptyline, fluoxetine, quinidine, пароксетин): decrease in clearance of Galantaminum;
• Anticholinergic drugs: antagonism development;
• Other cholinomimetics: strengthening of their action (the combination is not recommended);
• Peripheral muscle relaxants of the depolarizing type (when carrying out an anesthesia): strengthening of neuromuscular blockade;
• The drugs reducing heart rate (for example, beta adrenoblockers and digoxin): strengthening of their action;
• Strong inhibitors of isoenzymes of CYP2D6 and CYP3A4: increase in frequency of development of undesirable reactions (mainly, vomitings and nausea) (decrease in a maintenance dose of Reminil can be required).

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 15-30 °C.

Period of validity – 2 years.