Ascophen ULTRA, 250 mg+65 mg+250 mg 20 pcs.

Special Instructions

General

This medication should not be taken concomitantly with medications containing ASA or paracetamol.

Similar to other migraine medications, caution should be exercised to rule out other potentially serious neurological disorders before starting treatment of suspected migraine in patients who have not previously been diagnosed with migraine, or in those patients in whom migraine presents with atypical symptoms.

If patients experience vomiting during >20% of migraine attacks or require bed rest during >50% of attacks, the drug should not be used.

If migraine after taking the first two tablets of the drug does not stop, it is necessary to seek medical attention.

The drug should not be used if during at least the last three months the patient had more than 10 headache attacks per month. In this case, the headache should be suspected due to excessive use of medication and the treatment should be cancelled.

In addition, patients should seek medical attention. Caution should be exercised in patients with risk factors for dehydration, such as vomiting, diarrhea, or before or after major surgery.

Because of its pharmacodynamic properties, the drug may mask signs and symptoms of infection.

Due to the content of acetylsalicylic acid in the drug

The drug should be used with caution in patients with gout, impaired renal or hepatic function, dehydration, uncontrolled arterial hypertension, deficiency of glucose-6-phosphate dehydrogenase and diabetes.

Due to inhibition of platelet aggregation by ASA the drug may lead to prolongation of bleeding time during and after surgical interventions (including minor ones, such as tooth extraction).

The drug should not be used simultaneously with anticoagulants and other drugs that disrupt blood clotting without physician’s supervision (see section “Interaction with other medicinal products”). Patients with blood clotting disorders should be closely monitored. Caution should be exercised in case of meto- or menorrhagia.

If a patient develops bleeding or gastrointestinal ulceration while taking the drug, it should be discontinued immediately. At any time of treatment with any NSAIDs, potentially fatal bleeding, ulceration and perforation of the GI tract may occur, with or without precursors and severe gastrointestinal complications in the history.

These complications tend to be more severe in older patients. Alcohol, glucocorticosteroids and NSAIDs may increase the risk of gastrointestinal bleeding (see section “Interaction with other medicinal products”).

The drug may contribute to the development of bronchospasm and exacerbation of bronchial asthma (including bronchial asthma due to intolerance to analgesics) or other hypersensitivity reactions. Risk factors include bronchial asthma, seasonal allergic rhinitis, nasal polyposis, chronic obstructive pulmonary disease, chronic respiratory tract infections (especially those associated with symptoms characteristic of allergic rhinitis).

These phenomena may also occur in patients with allergic reactions (e.g., skin, including itching and urticaria) to other substances. In such patients it is recommended to exercise special caution.

Children under 18 years of age should not be prescribed medicines containing acetylsalicylic acid as an antipyretic because they can increase the risk of Reye’s syndrome in case of viral infection. Symptoms of Reye syndrome are hyperpyrexia, prolonged vomiting, metabolic acidosis, nervous system and mental disorders, hepatomegaly and liver dysfunction, acute encephalopathy, respiratory disorders, seizures, coma.

ASK can distort the results of laboratory tests of thyroid function due to false positive low concentrations of levothyroxine (T4) and triiodothyronine (Tz) (see section “Interaction with other medicines”).

Due to the paracetamol content of the drug

Caution should be exercised when prescribing the drug to patients with impaired renal or hepatic function or alcohol dependence.

The risk of paracetamol poisoning is increased in patients taking other potentially hepatotoxic drugs or drugs that induce microsomal liver enzymes (such as rifampicin, isoniazid, chloramphenicol, sleeping pills and anticonvulsants, including phenobarbital, phenytoin and carbamazepine). Patients with alcoholism in anamnesis are in a special risk group for liver damage (see section “Interaction with other medicinal products”).

Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis may develop during drug administration, which may be fatal. Patients should be informed about the signs of serious skin reactions. The drug should be discontinued at the first manifestations of skin reactions or any other signs of hypersensitivity.

Due to the caffeine content of the drug

The drug should be used with caution in patients with gout, hyperthyroidism and arrhythmia.

When using the drug it is necessary to limit consumption of products containing caffeine, because the excessive intake of caffeine can lead to nervousness, irritability, insomnia and, in some cases, palpitations.

Influence on ability to drive vehicles and mechanisms

Studies on the effect on the ability to drive vehicles and operate mechanisms have not been conducted. In case of adverse reactions such as dizziness or somnolence, you should refrain from these activities and inform the physician.

Contraindications

• Hypersensitivity to the main or excipients of the drug;
• Errotic ulcers of the gastrointestinal tract (in the acute phase), gastrointestinal bleeding or perforation, peptic ulcer in the anamnesis;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and sinuses, and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including acetylsalicylic acid or other non-steroidal anti-inflammatory drugs).ч. history);
• hemophilia and other blood clotting disorders; hemorrhagic diathesis, hypoprothrombinemia;
• vitamin K deficiency;
• portal hypertension;
• chronic heart failure III-IV functional class by NYHA;
• arterial hypertension grade III;
• pregnancy;
• pregnancyperiod of breastfeeding;
• glaucoma;
• deficiency of glucose-6-phosphate dehydrogenase;
• surgical interventions with profuse bleeding;
• children under 15 years of age as an anesthetic, with febrile syndrome under 18 years of age;
• concurrent administration of methotrexate at a dose greater than 15 mg/week.

With caution

Mild to moderate renal or hepatic impairment, advanced age, gout, alcoholism, epilepsy and susceptibility to seizures, chronic heart failure NYHA functional class I-II, coronary heart disease, cerebrovascular disease, peripheral artery disease, smoking, chronic obstructive pulmonary disease, concomitant use of methotrexate at a dose less than 15 mg/week, concomitant therapy with anticoagulants, advanced age, concomitant use with nonsteroidal anti-inflammatory drugs, glucocorticosteroids, anticoagulants, antiaggregants, selective serotonin reuptake inhibitors.

Side effects

Many of the listed adverse reactions are clearly dose-dependent and vary from patient to patient. The frequency of adverse drug reactions is classified according to the recommendations of the World Health Organization: very common (>1/10), common (>1/100 to ≤1/10), infrequent (>1/1000 to ≤1/100), rare (>1/10000 to ≤1/1000), very rare (≤1/10000), frequency unknown (frequency of occurrence cannot be determined based on available data).

Infections and invasions:
rarely – pharyngitis.

Metabolic and nutritional disorders:
rarely – decreased appetite.

Mental disorders:
often – nervousness;
infrequently – insomnia;
rarely – anxiety, euphoric mood, inner tension.

Nervous system disorders:
often – dizziness;
infrequently – tremor, paresthesias, headache;
rarely – taste disorder, attention disorder, amnesia, impaired movement coordination, hyperesthesia, pain in the paranasal sinuses.

Visual organ disorders:
rarely – visual impairment.

Hearing organ disorders:
infrequent – tinnitus.

Cardiovascular system disorders:
infrequent – arrhythmia.

Vascular disorders:
rarely – hyperemia, peripheral circulation disorders.

Respiratory system disorders, thoracic and mediastinal organs:
rarely – nasal bleeding, hypoventilation, rhinorrhea.

Disorders of the digestive system:
frequently – nausea, abdominal discomfort;
infrequently – dry mouth, diarrhea, vomiting;
rarely – belching, flatulence, dysphagia, paresthesias in the mouth, increased salivation.

Skin and subcutaneous tissue disorders:
rarely – hyperhidrosis, itching, urticaria.

Musculoskeletal system disorders:
rarely – musculoskeletal stiffness, neck pain, back pain, muscle spasms.

General disorders:
infrequently – fatigue, increased excitability;
rarely – asthenia, heaviness in the chest.

Other:
infrequent – increased heart rate.

If you experience or worsen the side effects listed in the instructions, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Acetylsalicylic acid.

In mild intoxication – dizziness, tinnitus, deafness, increased sweating, nausea, vomiting, headache and confusion. Occurs at plasma concentrations of 150-300 µg/ml.

The treatment is dose reduction or discontinuation of therapy.

At concentrations above 300 µg/ml, more severe intoxication occurs, manifesting as hyperventilation, fever, anxiety, ketoacidosis, respiratory alkalosis, and metabolic acidosis. Central nervous system depression may lead to coma, and cardiovascular collapse and respiratory failure may also occur.

The highest risk of chronic intoxication is seen in children and the elderly when more than 100 mg/kg/day is taken for several days.

Treatment- If ingestion of more than 120 mg/kg of salicylates is suspected, activated charcoal is given repeatedly orally within the last hour.If more than 120 mg/kg of salicylates are taken, their plasma concentration should be determined, although it is impossible to predict its severity based on this indicator alone; clinical and biochemical parameters should also be considered.

If plasma concentrations exceed 500 µg/ml (350 µg/ml for children younger than 5 years), intravenous sodium bicarbonate effectively removes salicylates from plasma. If plasma concentrations exceed 700 µg/ml (lower concentrations in children and the elderly) or in severe metabolic acidosis, hemodialysis or hemoperfusion is the therapy of choice.

Paracetamol overdose. In overdose intoxication is possible, especially in elderly patients, children, patients with liver disease (caused by chronic alcoholism), in patients with nutritional disorders, as well as in patients taking microsomal liver enzyme inducers, in which lightning hepatitis, liver failure, cholestatic hepatitis, cytolytic hepatitis may develop, in the above cases – sometimes with fatal outcome.

The clinical picture of acute overdose develops within 24 hours after taking paracetamol. Symptoms: gastrointestinal disorders (nausea, vomiting, decreased appetite, abdominal discomfort and (or) abdominal pain), pale skin.

Hepatocyte cytolysis with complete and irreversible liver necrosis, liver failure, metabolic acidosis and encephalopathy occurs when administered to adults 7.5 g or more or children more than 140 mg/kg at one time, which may lead to coma and death.

12-48 hours after administration of paracetamol an increase in the activity of microsomal liver enzymes, lactate dehydrogenase, bilirubin concentration and prothrombin decrease is noted. Clinical symptoms of liver damage appear 2 days after overdose of the drug and reach their maximum on the 4th-6th day.

The treatment is immediate hospitalization. Determination of plasma paracetamol quantification before starting treatment as soon as possible after overdose.

The administration of SH-group donators and precursors of glutathione synthesis-methionine and acetylcysteine-is most effective in the first 8 hours. The need for additional therapeutic measures (further administration of methionine, intravenous (IV) administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Symptomatic treatment. Laboratory studies of the activity of microsomal liver enzymes should be performed at the beginning of treatment and then – every 24 hours. In most cases, microsomal liver enzyme activity normalizes within 1-2 weeks. In very severe cases, liver transplantation may be necessary.

Caffeine.Common symptoms are gastralgia, agitation, delirium, anxiety, nervousness, restlessness, insomnia, mental agitation, muscle twitching, confusion, seizures, dehydration, rapid urination, hyperthermia, headache, increased tactile or pain sensitivity, nausea and vomiting (sometimes with blood), tinnitus.

In severe overdose, hyperglycemia may occur. Cardiac disorders are manifested by tachycardia and arrhythmia.

The treatment is dose reduction or caffeine withdrawal.

Pregnancy use

The use of the drug is contraindicated during pregnancy and breastfeeding because the safety of this combination in pregnant and breastfeeding women has not been studied.

If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Similarities

Ascophen-P, Coffil-plus, Citramon Ultra, Citramon, Citramon P, Citramon-ExtraCap, Brustrio