Neofen 200mg #20 Tab (Ibuprofen)
non-steroidal
anti-inflammatory mean
ATС Code: M01E01
Drug form: Coated tablets.
Composition:
Active substance: Ibuprofen – 0.2 g
Aiding substances: Ascorbic
acid, starch, calcium or magnesium stearate,
talcum,
magnesium carbonate, polyvinylpyrrolidone, sacharosa, aerosyl, titanium
dioxide, E133.
Pharmacological operation: Ibuprofen is a non-steroidal
anti-inflammatory mean, which is characterised with analgesic and antipyretic
action.
Mechanism of preparations’
pharmacological action is determined by the selective competitive inhibition of enzyme cyclooxygenase (mostly in peripheral tissues) and
prostaglandins’ synthesis, represses thrombocyte
aggregation.
Anti-inflammatory action
is determined by reduction of blood vessels’ permeability, by improvement of
microcirculation and by reduction of inflammatory mediators migration from the
cells.
Reduction intensity of
inflammatory processes and decrease of
bradykinin formation stipulates preparation’s
analgesic action. Reduction of
thermoregulation center’s
excitability causes antipyretic action.
Pharmacokinetics: Ibuprofen is absorbed from the gastrointestinal
tract (80% of
intaken dose) . Maximal concentration in the blood plasma is
reached during 0.5-1 hour. 99% of Ibuprofen relates
to blood plasma proteins. Biological activity is connected with S-enantiomers. After
absorbtion 60% of pharmacologically inactive R-forms are transformed into
active S-forms. Preparation is quickly and completely secreted from organism by
way of 3 main metabolites (mainly by kidney, partly by bile).
Indication:
·
Headace, tooth ache;
·
Algodismenorrhea;
·
Diseases with fever (in combined
therapy);
·
Inflammatory- infectious diseases
of throat, ear and nose;
·
Pain in post-traumatic period
(arthralgia, mialgia, neuralgia);
·
Diseases of joints and muscle
(different genesis of osteoarthritis, among them rheumatoid arthritis,
osteoarthrosis, alkylosing spondilitis, bursit, tendenit, tendovaginit,
radiculit, soft tissue’s and skeletal system’s traumatic inflame).
Contra-indication:
·
Additional sensitivity towards Ibuprofen and other non-steroidal anti-inflammatory
means;
·
Gastric and duodenal ulcer in acute condition;
·
Expressed disorder of
kidney and liver function;
·
Pregnancy and lactation period;
·
Children till 12 year.
Caution:
Neofen is carefully
prescribed in patients with chronic heart insufficiency. During the treatment
period it’s inevitable to check function
of kidney and liver, blood production. In case of gastropathy symptoms occure EGD
and haemoglobin checking is recommended.
The preparation is
carefully prescribed:
·
Hyperbilirubinemia;
·
Liver cirrhose;
·
Gastric and duodenal ulcer in anamnesis, gastritis, colitis,
enterocolitis;
·
Pregnancy and lactation period;
·
Children till 12 year.
Administration and dosage rule: Taken perorally, afrer meal.
Dose is determined
individually according to the disease’s nosology and clinical form.
In adults: for moderate pain syndrom - 1 tablet (0.2g) 3-4 times a day.
For quick effect dose should be increased till 2 tablet (0.4hg) 3 times a day.
After medical effect is reached dose is
reducesd till 0.6-0.8g.
For rheumatoid arthritis –
4 tablet (0.8g) 3 times a day.
For trauma of soft tissue,
tension – 2-3 tablet 4 times a day.
For mild algodismenorrhea: 2 tablet (0.4g) 3-4
tablet a day.
For osteoarthritis,
phsorias arthritis and alkylosing spondilitis – 2-3 tablet (0.4-0.6g) 3-4 times
a day.
Children up to 12 years: Daily dose is 0.2g/kg, devided for
several intake. For juvenile rheumatoid arthritis – 0.03-0.04g/kg a day,
devided for several intake.
For lowering 39.20C
and more temperature – 0.01g/kg a day, for lowering less then 39.20C
– 0.005g/kg a day.
Overdosage: Overdose symptoms:
dizziness, head ache, nausea, vomiting, pains in stomach, headache, pressure
fall and breathing difficulties may acur.
In case of overdose
gastric lavage is recommended. It is necessary to have symptomatic treatment
according to the doctor’s prescription.
Side effects: Usually, Neofen is carried easily. Advantage
of this preparation compared with aspirin is it’s mild irritation effect. But
there may be ocured following side effects:
- From the side of digestion
system: feeling
of discomfort or pain in epigastrium, nausea, vomiting, diarrhea, gastrointestinal tract erosive-ulcerous
damages, bleeding;
- From the side of central nervous
system: headache, dizziness, sleep disorder;
- Allergic reactions: rash on the skin;
In case of long term usage
of the preparation disorder of kidneys function may ocured, rarely –
bronchospasm.
In case of detecting side
effect it is necessary to reduce dose or
stop treatment.
Interaction with other medicinal agents: Preparation
is carefully prescribed in combination with
indirect coagulant and thiazide diuretics.
Using
the preparation with anticoagulant and glucocortikosteroid risk of bleeding from
digestion system is increased.
Usage
with acetilsalicilic acid decreases Neofen’s effectiveness and increases its
toxicity, which is connected with destruction of Ibuprofen and protein complex
and then its metabolizing with toxic hydroxyl derivatives.
Using
Neofen with peroral antidiabetic preparation from urea-ammonia group enhances its hypoglicemic effect.
Neofen
reduces effect of diuretic and
antihypertenzic means, using with potassium maintaining diuretic means hyperkaliemia may be ocured.
Coffeine
increases Neofen’s analgesic effect.
Neofen
increases ethanol’s toxicity.
Cherry
juice, sugar syrup increases the rate of preparation’s absorbtion.
Pregnancy and lactation period: Usage the
preparation is contraindicated during pregnancy and lactation period. During
usage the preparation lactation should be stopped.
Influence of vehicle and mechanisms
management:
During
treatment by the preparation patients should abstain from management of motor
transport and mechanisms which demands concentration of attention.
Package: 10 tablets on blister,
2 blisters in the box.
Issue: III group
of a pharmaceutical product - issued without a doctor's
prescription.
Validity: 3 years.
Storage conditions: Store on
15-25ºC temperature in a dark, dry place and keep away from children.
In
case of visual defects and expiry of validity date, the preparation can not be
used.
