ACTAFENAK

ACTAFENAK film-coated tablets were a prescription medicine containing diclofenac sodium, a non-steroidal anti-inflammatory drug. Diclofenac reduces pain, swelling, stiffness and other symptoms of inflammation.

Two packs were listed in historical Serbian medicine registers:

• ACTAFENAK 25 mg – 10 film-coated tablets;
• ACTAFENAK 50 mg – 10 film-coated tablets.

ACTAFENAK – former uses, administration and precautions

What was ACTAFENAK used for?

According to historical registers, ACTAFENAK was used to relieve pain and inflammation associated with:

• rheumatoid arthritis;
• osteoarthritis;
• ankylosing spondylitis;
• periarthritis, tendinitis, tenosynovitis and bursitis;
• acute gout;
• pain following sprains, dislocations, fractures and other injuries;
• selected postoperative pain and swelling;
• migraine attacks;
• other painful inflammatory musculoskeletal conditions, as assessed by a doctor.

Diclofenac relieves symptoms but does not cure the underlying chronic rheumatic or degenerative condition.

Dosage and administration

The exact ACTAFENAK dose was determined by a doctor according to the strength of the tablets, severity of pain, underlying condition, age, other illnesses and concurrent medicines.

Current instructions for oral diclofenac in adults commonly list a total dose of 75–150 mg daily in two or three divided doses, with a maximum of 150 mg per day. This is general safety information about diclofenac and is not a recommendation to use historical ACTAFENAK packs.

• Use the lowest effective dose for the shortest necessary period.
• Take the medicine exactly as prescribed.
• Do not increase the number of tablets when pain is not adequately controlled.
• Do not combine different strengths without clear medical instructions.
• Longer treatment may require monitoring of the gastrointestinal tract, blood pressure, kidneys, liver and cardiovascular risk.

Children and adolescents

Diclofenac dosing in younger patients depends on age, body weight, indication and pharmaceutical form. Current guidance for 50 mg diclofenac tablets does not recommend their use in children under 14 years of age.

The existence of a former 25 mg tablet does not mean that the product was suitable for every child. Treatment must be prescribed by a paediatrician or another doctor.

When must diclofenac not be used?

• allergy to diclofenac or another ingredient;
• previous asthma, swelling, hives or a serious allergic reaction caused by aspirin, ibuprofen or another NSAID;
• active or recurrent stomach or duodenal ulcer;
• previous gastrointestinal bleeding or perforation associated with NSAID treatment;
• severe liver or kidney impairment;
• severe heart failure;
• established ischaemic heart disease, peripheral arterial disease or cerebrovascular disease;
• the final three months of pregnancy.

Warnings and precautions

Before treatment, tell the doctor about:

• high blood pressure, high cholesterol or diabetes;
• heart disease, previous stroke or risk factors for blood clots;
• asthma, hay fever, chronic obstructive lung disease or nasal polyps;
• previous ulcer, inflammatory bowel disease, Crohn’s disease or ulcerative colitis;
• kidney or liver disease;
• a bleeding or clotting disorder;
• systemic lupus erythematosus or another connective-tissue disorder;
• planned surgery or dental treatment.

The risk of heart attack and stroke increases with higher doses and longer treatment. Diclofenac should therefore be used at the lowest effective dose for the shortest possible time.

Interactions with other medicines

Special care is required with:

• other pain and inflammation medicines, including ibuprofen, naproxen, aspirin and COX-2 inhibitors;
• anticoagulants and antiplatelet medicines, including warfarin and clopidogrel;
• corticosteroids;
• selective serotonin reuptake inhibitors;
• diuretics, ACE inhibitors, beta blockers and other blood-pressure medicines;
• lithium or digoxin;
• methotrexate;
• ciclosporin or tacrolimus;
• trimethoprim;
• quinolone antibiotics;
• medicines for diabetes;
• phenytoin;
• voriconazole or rifampicin;
• colestipol or cholestyramine.

Do not combine diclofenac with another NSAID without professional advice, even when the medicines have different brand names.

Pregnancy, breastfeeding and fertility

During the first six months of pregnancy, diclofenac should be used only when considered essential by a doctor, at the lowest dose and for the shortest time. From approximately week 20, prolonged use may affect the fetal kidneys and circulation and requires medical monitoring.

Diclofenac is contraindicated during the final three months of pregnancy. Current oral diclofenac guidance does not recommend breastfeeding during treatment.

Diclofenac may temporarily reduce female fertility and is not recommended for women trying to become pregnant without medical advice.

Driving and using machines

Do not drive or use machines if dizziness, drowsiness, fatigue, visual disturbance or another symptom affecting concentration occurs.

Possible side effects

Common adverse effects may include:

• abdominal pain or discomfort;
• heartburn, nausea and vomiting;
• diarrhoea, indigestion and wind;
• headache and dizziness;
• rash;
• increased liver enzymes.

Serious adverse effects may include:

• gastrointestinal ulceration, bleeding or perforation;
• heart attack or stroke;
• worsening heart failure and fluid retention;
• acute kidney injury;
• hepatitis, jaundice or serious liver injury;
• severe allergic reactions and bronchospasm;
• Stevens–Johnson syndrome, toxic epidermal necrolysis and other severe skin reactions;
• blood-cell abnormalities and bleeding disorders.

Overdose

Overdose may cause vomiting, abdominal pain, gastrointestinal bleeding, diarrhoea, dizziness, ringing in the ears, impaired consciousness and seizures. Severe poisoning may damage the kidneys or liver.

Contact a doctor or emergency service immediately after an excessive dose and take the medicine pack with you.

Missed dose

Take the missed dose when remembered unless the next dose is due soon. Do not take a double dose.

Composition and excipients

The active substance in the historical product was diclofenac sodium in a strength of 25 mg or 50 mg.

The exact original list of ACTAFENAK excipients has not been confirmed in the available public documentation. Excipients from another diclofenac product should not be copied because formulations may differ.

Storage

The historical register listed no special storage conditions and a shelf life of three years. All original packs from that period are now expired and must not be used.

• Do not dispose of old medicines in wastewater or household waste.
• Return expired or unused packs to a pharmacy for safe disposal.
• Keep medicines out of the sight and reach of children.

Frequently asked questions