Special Warning : אזהרת שימוש

Warnings
For Acetylsalicylic Acid
Acetylsalicylic acid may precipitate bronchospasm and induce asthmatic attacks in susceptible patients (see Contraindications).


Acetylsalicylic Acid, Paracetamol & Caffeine Caplets       14. 2. 2005, RH Reye Syndrome-Salicylate Association: The use of salicylates, in particular acetylsalicylic acid, in children and adolescents up to the age of 20, with viral febrile illness, especially influenza or chickenpox, may be associated with the development of Reye’s syndrome-a rare, acute, life- threatening condition, characterized by vomiting and lethargy that may progress to delirium and coma.
Chronic alcohol users (3 or more alcoholic drinks per day) should be warned that they may be at an increased risk of stomach bleeding from use of acetylsalicylic acid.
Acetylsalicylic acid should be used with caution in patients with asthma or allergic disorders. Continuous prolonged use of acetylsalicylic acid should be avoided in the elderly because of the risk of gastrointestinal bleeding

Hypersensitivity: Cross-sensitivity may exist between acetylsalicylic acid and other non-steroidal anti-inflammatory drugs which inhibit prostaglandin synthesis. This cross- sensitivity does not appear to occur with non-acetylated salicylates such as sodium salicylate, salicylamide or choline salicylate.
Acetylsalicylic acid hypersensitivity is more prevalent in patients with asthma, nasal polyps or chronic urticaria, swelling of face or lips.
Use in Surgery: Use of salicylates should be avoided, if possible, one week prior to surgery, to reduce the likelihood of post-operative bleeding.

For Caffeine
Consumption of large quantities of products containing caffeine may reactivate preexisting duodenal ulcers.

For Paracetamol
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. Patients should be advised not to take other paracetamol-containing products concurrently.

Use in Pregnancy
Safety of use in pregnancy has not been established.
The use of acetylsalicylic acid during pregnancy should be avoided since it may produce adverse reactions in the mother, such as anemia, antepartum or postpartum hemorrhage, prolonged gestation and prolonged labor.
Acetylsalicylic acid readily crosses the placenta. It may cause constriction of the ductus arteriosus and other untoward effects in the fetus.
The use of acetylsalicylic acid during the later stages of pregnancy has been associated with the following fetal adverse effects: low birth weight, increased incidence of intracranial hemorrhage in premature infants, still-births and neonatal death. In high dosage and continuous use, acetylsalicylic acid is a possible teratogen.

Use in Lactation
The safety of use in lactation has not been established. It is known that acetylsalicylic acid is excreted in breast milk. Paracetamol also appears in very low concentrations in breast milk. Therefore this product should not be used in nursing women unless, in the judgment of the physician, the potential benefits to the mother outweigh the possible hazards to the fetus.

Use in Pediatrics
This preparation is not recommended for use in children under 12 years of age.

Acetylsalicylic Acid, Paracetamol & Caffeine Caplets       14. 2. 2005, RH   Page 2 of 6 Use in Patients with Impaired Hepatic or Renal Function
Because of the paracetamol and acetylsalicylic acid components, this product should be administered with care to patients with impaired hepatic (especially in patients with collagen diseases-a warning related to acetylsalicylic acid) or renal function.

Adverse Reactions
Adverse Reactions in Connection with Acetylsalicylic Acid
Gastric irritation may occur.
Some patients may exhibit notable sensitivity to acetylsalicylic acid which may provoke various reactions including urticaria and other skin eruptions, angioneurotic edema, rhinitis, severe paroxysmal bronchospasm, dyspnea and tinnitus.
Acetylsalicylic acid increases bleeding time, decreases platelet adhesiveness and modifies fibrinolysis. In large doses, it may cause hypoprothrombinemia.

Adverse Reactions in Connection with Paracetamol
Adverse reactions of paracetamol are usually mild, though hematological reactions have been reported in rare cases.
Skin eruptions may occur as an allergic reaction.
Long term use and/or high dosage may cause liver and kidney damage.

Adverse Reactions in Connection with Caffeine
Caffeine may cause nausea, abdominal pain, diarrhea, insomnia, restlessness, nervousness, tinnitus, muscular tremor and palpitations.

Precautions
For Acetylsalicylic Acid
Acetylsalicylic acid should be used with great caution in patients prone to dyspepsia or known to have a lesion of the gastric mucosa.
Acetylsalicylic acid should be used with caution in the following situations:
• in dehydrated patients, particularly children
• in patients with coagulation or platelet function disorders.
• in patients with gout (see Drug Interactions and Diagnostic Interference) 
For Paracetamol
If a sensitivity reaction occurs, discontinue use.

For Acetylsalicylic Acid and Paracetamol
Paracetamol and aspirin may cause liver damage (additive effect with alcohol) and stomach bleeding

Effects on Driving