|The name of the preparation
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Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The drug is available without a prescription
What is Aspifox?
A preparation that inhibits platelet aggregation.
What does Aspifox contain and how does it work?
The active substance is a non-steroidal anti-inflammatory drug (NSAID) Acetylsalicylic acid
. Like other NSAIDs
, it has anti-inflammatory, analgesic, antipyretic and platelet aggregation inhibitors. The basis of the mechanism of action of acetylsalicylic acid is the inhibition of cyclooxygenases (both COX-1 and COX-2), enzymes involved in the synthesis of prostaglandins and thromboxane from lipids of cell membranes. Prostaglandins play a significant role in the development of inflammation, and thromboxane stimulates platelet aggregation and vasoconstriction (which may contribute to the formation of clots and congestion). Inhibition of increased prostaglandin synthesis underlies the analgesic and anti-inflammatory effects of acetylsalicylic acid, and the inhibition of thromboxane synthesis at the base of its antiaggregatory action.
Acetylsalicylic acid, used in low doses (usually 75-150 mg daily), inhibits platelet COX-1 activity. This leads to suppression of thromboxane synthesis, reduction of platelet aggregation ability and inhibition of vasodilator-dependent vasoconstriction. COX-1 activity is inhibited by acetylsalicylic acid irreversibly and persists throughout the life of the platelet, i.e. about 9 days. Analgesic and anti-inflammatory effects, dependent on inhibition of COX-2 induced inflammation, require higher doses of acetylsalicylic acid (usually 2-6 g per day).
The rate of absorption of acetylsalicylic acid from the gastrointestinal tract depends on the pharmaceutical form used. Acetylsalicylic acid found in enteric coated tablets is absorbed more slowly than from tablets disintegrating in the stomach. The release of the active substance from coated tablets takes place only in the small intestine, which contributes to the protection of the gastric mucosa against the irritating effect of acetylsalicylic acid.
When should I use Aspifox?
The indication for the use of the preparation is:
· Secondary prevention of myocardial infarction
· Prevention of cardiovascular diseases in people with stable angina
· Unstable angina pectoris (excluding acute phase)
· Prevention of vascular graft obstruction after cardiac surgery for coronary artery bypass grafts
Coronary angioplasty (except for acute phase)
· Secondary prevention in patients with temporary cerebral ischemia (TIA) and cerebrovascular ischemic events (CVA), with the exception of intracerebral bleeding.
The preparation is not recommended in conditions requiring urgent help. The use is limited to secondary prevention in chronic treatment.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used. You must not use the product if you are allergic (you are hypersensitive) to any of the ingredients or other inhibitors of prostaglandin synthesis.
The use of the preparation is contraindicated if you have ever had asthma attacks (so-calledaspirin-induced asthma) after taking salicylates or non-steroidal anti-inflammatory drugs (e.g., Ibuprofen
The use of the preparation is contraindicated in people:
· With active or recurrent gastric and / or duodenal ulcer disease, Gastrointestinal bleeding
or other bleeding (eg from cerebral vessels)
· With an increased risk of bleeding (haemorrhagic diathesis, hemophilia, thrombocytopenia or other problems with blood clotting)
· With severely impaired liver or kidney function
· Taking Methotrexate
in doses of 15 mg in a week or more in parallel
· In women in the third trimester of pregnancy (for 100 mg daily or more).
Do not use the preparation in children and adolescents up to 16 years of age, except when the doctor considers it necessary and in his opinion the expected benefits clearly outweigh the possible risks.
Take special care with Aspifox?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
The preparation is not recommended for use as a painkiller, anti-inflammatory or antipyretic.
The preparation is recommended for use in adults and adolescents after 16 years of age. Do not use the preparation in children and adolescents up to 16 years of age. Use of the preparation in children may be associated with the onset of Reye's syndrome, a severe condition leading to liver and brain damage, which is potentially life-threatening (see contraindications to the use of the preparation).
The preparation may cause prolongation of bleeding time, including during or after surgery (this also applies to minor surgical procedures, eg tooth extraction). You should consult a doctor because it is usually necessary to discontinue the preparation a few days before the planned surgery.
Do not use the product in case of heavy menstrual periods, as they may become worse.
Caution should be exercised if the preparation is used in people:
· After gastric ulcer and / or duodenal ulceration or bleeding occuring in the past (risk of ulcer recurrence and gastrointestinal bleeding)
· Using drugs that increase the risk of gastrointestinal ulceration (eg oral corticosteroid
s, selective SSRI serotonin reuptake inhibitors, deferasirox)
· With impaired renal function and in dehydrated patients (risk of worsening of renal function)
· With hepatic impairment (regular liver function tests recommended).
If you suspect or have been diagnosed with any of the above conditions, consult a physician before using the preparation.
It is not recommended to use the preparation and medicines that may increase the risk of bleeding, such as anticoagulants (eg Warfarin
), selective serotonin reuptake inhibitors or anti-inflammatories. If the doctor considers such combination treatment to be absolutely necessary, he will also recommend appropriate precautions.
In the event of any unusual bleeding, consult a physician immediately. If there is gastrointestinal bleeding or gastrointestinal ulceration, it will be necessary to discontinue the preparation.
The use of acetylsalicylic acid may result in bronchospasm causing difficulty in breathing, asthma attack or other hypersensitivity reactions. Increased risk includes patients with bronchial asthma, also if it has occurred in the past, patients with rhinitis, nasal polyps, chronic respiratory diseases, and people who have allergic reactions to any allergens (eg skin reactions, pruritus, urticaria).
Acetylsalicylic acid can rarely cause severe skin reactions, sometimes leading to death, such as Stevens and Johnson syndrome or toxic epidermal necrolysis. In the event of the first symptoms of skin lesions (rash, mucosal lesions) or any symptoms of hypersensitivity, the preparation should be discontinued immediately and a physician should be consulted.
Special care should be taken if the preparation is used by elderly people. In this age group, there is an increased risk of side effects, such as gastrointestinal bleeding or perforation, which can lead to death.If long-term use is required, patients of this age group should remain under medical supervision and regularly carry out the prescribed check-ups.
The use of anticoagulants, corticosteroids, anti-inflammatories, medicines used to treat chronic iron overload and selective serotonin reuptake inhibitors is not recommended. These medicines may increase the risk of bleeding and / or ulceration of the digestive tract. If you are using any of the medicines listed above, please consult your doctor before using the product. If the doctor considers such combination treatment to be absolutely necessary, care should be taken to check for side effects, including signs of bleeding or ulceration (see paragraph "Can I use other medicines in parallel?").
Acetylsalicylic acid, even when used in small doses, reduces the excretion of uric acid. In patients with reduced uric acid excretion, the preparation may cause gout attack.
The preparation used in doses greater than the recommended dose may increase the hypoglycaemic action of antidiabetic agents and increase the risk of hypoglycaemia.
Does this preparation affect the ability to drive vehicles?
There are no data on the effect of the preparation on the ability to drive and use machines / machines. Based on pharmacological data, the preparation is expected to have no such effect.
Dosage of Aspifox
The preparation is in the form of gastro-resistant tablets. It is intended for oral use. Use the preparation as recommended. Do not exceed the recommended doses, because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts about the use of the preparation, consult your doctor.
Usually 75-150 mg once daily.
Secondary prophylaxis in patients with transient cerebral ischemia (TIA) and cerebrovascular ischemic events (CVA), excluding intracerebral bleeding: 75-325 mg once daily.
Use with caution in the elderly. Persons in this group of patients should be subject to regular monitoring.
Do not use in children and adolescents up to 16 years of age unless the doctor considers the use of the preparation to be absolutely necessary and in his opinion the benefits of treatment outweigh the possible risks.
The preparation is intended for oral use. Can be taken with or without food. The tablets should be swallowed whole (do not break, chew, crumble because the tablet coating prevents irritation of the stomach lining), with a sufficient amount of liquid (1/2 glass of water).
Can Aspifox be used during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, consult a physician before using the product.
The use of acetylsalicylic acid in doses of 100 mg per day or more is contraindicated in women in the third trimester of pregnancy. Limited use of doses lower than 100 mg per day in the third trimester of pregnancy is allowed only on the order of a doctor and requires specialist monitoring.
The preparation should not be used in the first and second trimester of pregnancy, unless the doctor considers it absolutely necessary. The use of the preparation in the first and second trimester of pregnancy and in women planning pregnancy is allowed only on the order of the doctor, when it considers the use necessary after prior consideration whether the expected benefits to the mother outweigh the possible risk to the fetus (only short-term use of small doses). Only a doctor can assess the benefit / risk ratio in your case.
Before using the product during breastfeeding, consult a doctor (your doctor may allow short-term use of salicylates at low doses during this period). If you regularly take high doses of acetylsalicylic acid, breast-feeding should be stopped earlier.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Concomitant use of acetylsalicylic acid and methotrexate at doses of 15 mg per week or more is contra-indicated (possible increase in methotrexate concentration and increased bone marrow toxicity, sometimes severe intoxication leading to death).
Parallel administration of uricosuric drugs is not recommended, eg benzbromarone, probenecid (acetylsalicylic acid used together with drugs increasing the uric acid excretion, causes the weakening of the action of these drugs, in patients with reduced uric acid excretion the preparation may cause gout).
If you are taking any of the medicines listed below, consult your doctor before using the product, as you may need to change your dose or stop taking your medicine. Take particular care if you are using:
· Methotrexate at doses lower than 15 mg per week (possible increase in methotrexate concentration and increased bone marrow toxicity, if a physician recommends using acetylsalicylic acid in parallel, blood counts should be monitored once a week during the first weeks of treatment; renal and elderly patients require regular medical examinations and supervision)
· Anticoagulants such as warfarin, Heparin
(possible increased anticoagulant effect and prolonged bleeding time and increased risk of haemorrhage, anticoagulants are not recommended during the period of taking the preparation, however, if the doctor recommends their parallel use, bleeding time should be monitored)
· Thrombolytic drugs and platelet aggregation inhibitors such as ticlopidine, Clopidogrel
(possible worsening of their effect, prolonged bleeding time and increased risk of haemorrhage)
· Selective serotonin reuptake inhibitors (increased risk of gastrointestinal bleeding)
· Medicines used to treat chronic iron load (deferasirox)
· Antidiabetic medicines, e.g. insulin
, sulphonylureas (increased severity, risk of hypoglycaemia)
and lithium (risk of increased digoxin and lithium concentration in the blood, monitoring of digoxin and lithium in the blood plasma is recommended, especially when starting and ending treatment with acetylsalicylic acid)
· Diuretics (possible reduction of diuretic and antihypertensive effect, risk of acute renal failure
- hydration is recommended and monitoring of renal function at the beginning of treatment)
· Antihypertensive agents, including angiotensin converting enzyme inhibitors, angiotensin antagonists, and beta blockers (possible reduction of antihypertensive effect, risk of acute renal failure)
· Acetazolamide (carbonic anhydrase inhibitor, weak diuretic used sometimes in the treatment of e.g. glaucoma, toxic effects on the peripheral nervous system and severe acidosis)
· Corticosteroids used generally (use with acetylsalicylic acid increases the risk of ulceration and gastrointestinal bleeding)
· Other non-steroidal anti-inflammatory drugs (increased risk of side effects, especially gastrointestinal bleeding and kidney damage)
· Ibuprofen (possible reduction of platelet aggregation inhibiting the effects of acetylsalicylic acid in small doses)
· Cyclosporine or tacrolimus (increased risk of kidney damage, kidney function should be monitored)
· Phenytoin (possible increase in its effect)
· Valproic acid (possible increase in its toxicity).
Alcohol consumption increases the risk of gastrointestinal adverse reactions, including gastrointestinal bleeding.
What side effects can occur?
Like all medicines, Aspifox can also cause side effects, although it will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
The most common are indigestion and increased bleeding tendency. Rare (or unknown frequency): bleeding from the gastrointestinal tract (including tarry stools, bloody vomiting), gastrointestinal ulcer disease sometimes with bleeding and perforation, nausea, vomiting, liver dysfunction, renal dysfunction, thrombocytopenia, agranulocytosis, aplastic anemia , increased bleeding time and increased risk of bleeding (perioperative hemorrhage, haematomas, epistaxis, genital tract bleeding, bleeding from the gums, gastrointestinal haemorrhage, intracranial bleeding, heavy menstrual bleeding).In some cases, haemorrhage can be life-threatening; they can also lead to anemia (also as a result of occult gastrointestinal micro-bleeding) with appropriate symptoms, such as weakness, paleness, and reduced blood supply to organs and tissues. In addition, possible headache and dizziness, tinnitus, impaired hearing, hemorrhagic vasculitis, increased concentration of uric acid in the blood (hyperuricemia). Hypersensitivity reactions (rash, urticaria, pruritus) and Anaphylactic reactions
may occur, including life-threatening anaphylactic shock, angioneurotic edema
(swelling of the face, larynx, tongue, throat that may impede breathing), bronchospasm, asthma attack and severe skin reactions: necrosis toxic epidermis, Stevens and Johnson syndrome, erythema multiforme.
Other preparations on the Polish market containing acetylsalicylic acid
Abrea (enteric-coated tablets)
Acard (enteric-coated tablets)
Acard 150 mg (enteric-coated tablets)
Acard 300 mg (tablets)
Alepton (enteric-coated tablets)
Alka-Prim (effervescent tablets)
Alka-Seltzer (effervescent tablets)
Anacard medica protect (enteric-coated tablets)
Aspirin Cardio (coated tablets)
Aspirin Effect (granules)
Aspirin Pro (coated tablets)
Aspirin Ultra Fast (effervescent tablets)
Cardiopirin (enteric-coated tablets)
Encopirin (enteric-coated tablets)
Encopirin Cardio 81 (enteric-coated tablets)
Hascopiryn cardio (enteric-coated tablets)
Lecardi (gastro-resistant tablets)
Polocard (enteric-coated tablets)
Polopiryna Max (enteric-coated tablets)
Polopyrine S (tablets)
Proficar (enteric-coated tablets)
Pyramidon fast (oral powder)