ACETISAL pH8

ACETISAL pH 8, 500 mg gastro-resistant tablets were a prescription medicine containing acetylsalicylic acid. The product was intended for anti-inflammatory treatment of rheumatic and musculoskeletal disorders in adults.

Each gastro-resistant tablet contained 500 mg of acetylsalicylic acid. The former Serbian pack contained 20 tablets in two blisters of 10 tablets.

ACETISAL pH 8 – former uses, administration and precautions

What was ACETISAL pH 8 used for?

According to the leaflet approved for this pack, the medicine was used in adults for anti-inflammatory treatment of:

• osteoarthritis;
• rheumatoid arthritis;
• spondylitis;
• bursitis;
• other rheumatic disorders;
• certain musculoskeletal disorders.

The gastro-resistant coating delayed the release of acetylsalicylic acid until after the tablet had passed through the stomach. It did not eliminate systemic risks such as gastrointestinal ulceration, bleeding or prolonged bleeding time.

Former medical dosage

The dosing information in the historical leaflet applied to physician-supervised anti-inflammatory treatment:

• an initial total dose of 2.5–4 g of acetylsalicylic acid daily in divided doses;
• when required, the physician could gradually increase the daily dose by 500 mg;
• for rheumatoid arthritis, the leaflet listed 80 mg/kg body weight daily in divided doses.

These doses are not instructions for self-treatment. High-dose acetylsalicylic acid carries significant risks of bleeding, salicylate toxicity, kidney injury and other serious adverse effects.

Method of administration

• The tablet was taken after food with enough liquid.
• It had to be swallowed whole and not broken, crushed or chewed.
• The prescribed total daily dose was not to be exceeded.
• The duration of treatment and all dose changes were determined by a physician.

Children and adolescents

The medicine was not used in children or adolescents under 16 years, except for specific specialist indications such as prevention of thrombosis during certain cardiac surgical procedures.

Use of acetylsalicylic acid in younger people with viral infections is associated with the risk of Reye’s syndrome, a rare but very serious condition.

When must it not be used?

• allergy to acetylsalicylic acid, salicylates or another ingredient;
• previous asthma, bronchospasm, hives, rhinitis or angioedema caused by salicylates or another NSAID;
• active or recurrent stomach or duodenal ulcer;
• bleeding disorders or an abnormally increased tendency to bleed;
• severe liver or kidney impairment;
• serious unstable heart failure;
• concurrent methotrexate at 15 mg per week or more;
• the final trimester of pregnancy;
• age under 16 years, unless specifically prescribed by a specialist.

Special caution was required

• in asthma, hay fever, nasal polyps or chronic respiratory infections;
• in allergy to other painkillers or anti-inflammatory medicines;
• after a previous gastrointestinal ulcer or bleeding episode;
• in impaired liver or kidney function;
• in gout, as low-dose aspirin may reduce uric acid excretion;
• in severe G6PD deficiency because of the risk of haemolysis;
• in uncontrolled high blood pressure;
• before surgery or dental extraction;
• in older people receiving prolonged treatment.

Interactions with other medicines

Acetylsalicylic acid may increase the effects or adverse-event risk of:

• anticoagulants such as warfarin and heparin;
• antiplatelet medicines such as clopidogrel and ticlopidine;
• other non-steroidal anti-inflammatory medicines;
• corticosteroids;
• selective serotonin reuptake inhibitors;
• methotrexate;
• valproic acid;
• digoxin, lithium and barbiturates;
• certain blood-glucose-lowering medicines;
• sulfonamides and co-trimoxazole.

It may reduce the effects of diuretics, certain ACE inhibitors and uricosuric medicines. Alcohol further increases the risk of gastrointestinal irritation and bleeding.

Pregnancy and breastfeeding

During the first six months of pregnancy, the medicine could be used only when a physician considered it necessary. It was contraindicated during the final three months of pregnancy.

Use during breastfeeding was not recommended because small amounts of salicylates and their metabolites pass into breast milk.

Driving and using machines

No special driving precautions were listed. However, dizziness, hearing impairment or confusion require stopping the activity and obtaining medical advice.

Possible side effects

• heartburn, nausea, vomiting and abdominal pain;
• gastrointestinal ulceration, bleeding and, very rarely, perforation;
• prolonged bleeding time, nosebleeds, bleeding gums and easier bruising;
• rare serious gastrointestinal or intracranial bleeding;
• headache, dizziness, ringing in the ears and hearing impairment;
• rash, itching, hives and other hypersensitivity reactions;
• bronchospasm, breathing difficulty, angioedema and anaphylaxis;
• kidney injury and acute kidney failure;
• haemolysis or haemolytic anaemia in severe G6PD deficiency;
• increased liver enzyme levels.

Possible overdose symptoms

Ringing in the ears, impaired hearing, dizziness, headache, nausea, vomiting, rapid or deep breathing, sweating and confusion may indicate salicylate toxicity.

Acetylsalicylic-acid poisoning can be life-threatening. Contact emergency medical services immediately after an excessive dose, even if no symptoms have developed.

Missed dose

A double dose was not taken to make up for a forgotten tablet. Further dosing was determined according to the physician’s instructions.

Storage

• Store below 25 °C.
• Keep in the original package to protect from light and moisture.
• Keep out of the sight and reach of children.
• Do not use after the expiry date.
• Return old and unused packs to a pharmacy for safe disposal.

Frequently asked questions