ACETISAL PH8 FILM TABLET

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

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

ACETISAL pH 8 – composition, former use and precautions

What was ACETISAL pH 8 used for?

According to the last approved leaflet, it was used in adults for anti-inflammatory treatment of:

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

The gastro-resistant coating delayed release of acetylsalicylic acid until the tablet had passed through the stomach. Because of this delayed release, the medicine was not suitable when rapid relief of headache, toothache or fever was required.

The gastro-resistant coating did not eliminate the systemic risk of gastrointestinal ulceration, bleeding, kidney injury or prolonged bleeding time.

Former medical dosage

The historical dosing instructions applied only to physician-supervised anti-inflammatory treatment:

• an initial total dose of 2.5–4 g of acetylsalicylic acid daily in divided doses;
• when necessary, 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.

Method of administration

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

Children and adolescents

ACETISAL pH 8 was not intended for people under 16 years of age except for specific indications determined by a specialist.

Use of acetylsalicylic acid in children and adolescents with viral infections is associated with a possible risk of Reye’s syndrome, a rare but very serious disorder affecting the liver and brain.

When must the medicine 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 increased tendency to bleed;
• serious 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.

Warnings and precautions

Special caution was required in people with:

• bronchial asthma, hay fever or nasal polyps;
• allergy to other painkillers or anti-inflammatory medicines;
• a previous ulcer or gastrointestinal bleeding;
• impaired liver or kidney function;
• gout or raised uric acid;
• G6PD deficiency;
• uncontrolled high blood pressure;
• planned surgery or dental extraction.

The effect of acetylsalicylic acid on platelets may continue for several days after the final dose and prolong bleeding during or after surgery and dental procedures.

Interactions with other medicines

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

• anticoagulants such as warfarin and heparin;
• antiplatelet medicines including 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 certain diuretics, 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 precautions were listed. Dizziness, hearing impairment, ringing in the ears or confusion may indicate excessive exposure and 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, nosebleeds, bleeding gums and easier bruising;
• headache, dizziness, ringing in the ears and hearing impairment;
• rash, itching, hives and other allergic 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.

Overdose

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

Acetylsalicylic-acid poisoning can be life-threatening. Emergency medical assistance is required after an excessive dose, even if symptoms have not yet developed.

Missed dose

A double dose was not taken to make up for a forgotten tablet. Further dosing depended on the physician’s prescribed regimen.

Excipients

The tablet core contained microcrystalline cellulose, maize starch, povidone K25, Cremophor RH 40, colloidal silica and stearic acid.

The gastro-resistant film contained macrogol 6000, titanium dioxide, talc, a methacrylic-acid and methacrylic-ester copolymer and Cremophor RH 40.

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