Lomilan - instructions for use, doses, side effects, contraindications

1 ml of the suspension contains: active substance: loratadine - 1,000 mg; Excipients: polysorbate 80 - 1,000 mg; citric acid monohydrate - 1,550 mg; sodium citrate dihydrate - 0.600 mg; sodium benzoate 2.0 mg; avicel RC 591 FMC - 16,000 mg; white sugar crystalline - 300.0 mg; aroma of wild cherry - 2,500 mg; glycerol conc. - 70,000 mg; propylene glycol 50,000 mg; purified water - 690.313 mg.

Description:Homogeneous suspension from white to almost white. The smell is the aroma of cherry.

Pharmacotherapeutic group:Antiallergic - H1 histamine receptor blocker

ATX: & nbsp

R.06.A.X Other antihistamines for systemic use

R.06.A.X.13 Loratadin

Pharmacodynamics:

Loratadin refers to antihistaminic drugs of systemic action, blockers H₁-gistaminovyh receptors. It has antiallergic, antipruritic, antiexudative action. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasms of smooth muscles. The antiallergic effect develops 30 minutes after taking the drug, reaches a maximum after 8 to 12 hours and lasts for 24 hours. It has no effect on the central nervous system and is not addictive.

Pharmacokinetics:

Loratadine is rapidly and completely absorbed from the gastrointestinal tract. The presence of food slows down absorption. The maximum concentration in the blood serum is achieved within 1 h after administration. The connection with plasma proteins is more than 95%. Metabolised in the liver with the formation of an active metabolite of descabroxetoxyloratadine (DL).

Does not penetrate the blood-brain barrier. The half-life is about 8 hours, in elderly people and with chronic alcoholism the half-life increases. It is excreted with bile and kidneys.

With chronic renal failure and hemodialysis, the pharmacokinetics practically does not change.

Indications:

Prophylaxis and treatment of the following diseases:

- seasonal and year-round allergic rhinitis;

- allergic conjunctivitis;

- treatment of allergic skin diseases (including chronic idiopathic urticaria);

- pseudoallergic reactions;

- Allergic reactions to insect bites.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- pregnancy, lactation period;

- Children under 2 years;

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

Carefully:

Carefully should be used for liver failure, severe renal failure (CC <30 mL / min).

Pregnancy and lactation:

The safety of Lomilan® during pregnancy is not established, therefore the use of the drug during this period is contraindicated.

Lomilan® is secreted into breast milk, so if you need to use the drug during lactation, you should decide whether to stop breastfeeding.

Dosing and Administration:

Inside. Possible reception with food. Wash down with water, milk.

Children under 12 years of age are advised to take Lomilan® as a suspension.

Adults and children over 12 years of age. 2 dosage spoons (10 ml) of the suspension 1 once a day.

Children from 2 to 12 years:

with a body weight of more than 30 kg:

2 dosage spoons (10 ml) of the suspension once a day;

with a body weight of less than 30 kg:

1 dosage suspension of the suspension (5 ml) 1 time per day.

Patients with impaired liver function should be prescribed a reduced daily dose of Lomilan®:

adults and children with a body weight of more than 30 kg: 2 dosage spoons of the suspension (10 ml) every other day.

The duration of treatment depends on the duration of the manifestation of the symptoms of the disease. If the patient's condition does not improve within 3 days after the start of treatment, then loratadine not effective.

Elderly patients or patients with renal insufficiency do not need a dose adjustment.

Patients with severe renal insufficiency (CC <30ml / min):

In adults and children from the age of 6 with kidney failure (creatinine clearance <30 ml / min), the starting dose should be 10 mg (two dosage spoons) every other day; in children from 3 years old - the starting dose should be 5 mg (one dosage spoon) every other day.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their developmental frequency as follows: very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, < 1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the immune system

rarely: reactions hypersensitivity (including angioedema and anaphylactic reactions).

From the nervous system

often: headache, drowsiness, increased nervous excitability, increased fatigue; infrequently: insomnia; rarely: dizziness, convulsions.

From the side of the cardiovascular system

rarely: tachycardia, heart palpitations, syncope, arrhythmia.

From the gastrointestinal tract

infrequently: increased appetite; rarely: nausea, dry mouth, gastritis.

Co hand liver and bile ducts

rarely: function violation liver.

From the skin

rarely: allergic reactions (rash), alopecia.

In addition to the above reactions children may develop a sedative effect.

Undesirable effects from the central nervous system (headache (2.7%), nervousness (2.3%) and fatigue (1%)) were detected more often than with placebo ("pacifiers").

Overdose:

Symptoms: headache, drowsiness, palpitation, which can last a long time. There is no specific antidote.

When an overdose of the drug recommended gastric lavage and intake of adsorbents (Activated carbon). Lomilan® is not excreted by hemodialysis. To date, it is also not known whether Lomilan® is excreted by peritoneal dialysis. After conducting emergency therapy, it is necessary to conduct medical supervision of the patient.

Interaction:

Simultaneous application inducers of microsomal liver enzymes (phenytoin, ethanol, barbiturates, rifampicin, tricyclic antidepressants) decreases the effectiveness of loratadine.

Possible interaction of the drug with inhibitors of cytochrome isoenzymes, such as CYP3A4 or CYP2D6 (ketoconazole, quinidine, itraconazole, erythromycin, fluoxetine), increases the concentration of Lomilan® in the blood plasma, which can lead to increased side effects of the drug.

Special instructions:

The drug should be stopped at least two days before the skin allergic tests, because Lomilan^® can influence their results.

Special precautions for the destruction of unused medicinal product

There is no need for special precautions when destroying an unused Lomilan® preparation.

Effect on the ability to drive transp. cf. and fur:

Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Form release / dosage:

Suspension for oral administration, 5 mg / 5 ml.

Packaging:

Primary packaging

For 120 ml of the suspension in a dark glass bottle with a capacity of 125 ml with a ring label for 100 ml or without it,Sealed with a polyethylene screw cap with a first-break control ring and a low-density polyethylene liner inside.

Secondary packaging

One bottle together with a dosage spoon and instructions for medical use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N016160 / 01

Date of registration:28.12.2009 / 27.04.2017

Expiration Date:Unlimited

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

SANDOZ ILAC SANAYI VE TICARET, A.S. Turkey

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp02.04.2018

Illustrated instructions

Instructions

Lomilan® (Lomilan®)