Aflamil 100 mg film-coated tablets (aceclofenac) – pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis

Aflamil 100 mg film-coated tablets contain aceclofenac, a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic action. It is used for the symptomatic treatment of pain and inflammation in chronic rheumatic diseases of the joints and spine.

In Serbia a pack of 20 film-coated tablets of 100 mg (2 blisters of 10) is authorised. The medicine is prescription-only.

What is Aflamil (aceclofenac) used for and how is it taken correctly?

Key facts about the medicine

What is Aflamil used for?

According to the approved leaflet, Aflamil is used for the symptomatic treatment of pain and inflammation in:

• osteoarthritis (inflammation of bones and joints);
• rheumatoid arthritis (chronic inflammation of joints and connective tissue);
• ankylosing spondylitis (chronic inflammatory disease of the musculoskeletal system).

How is it used and dosed?

The film-coated tablets are for oral use; swallow them with enough liquid, with a meal or immediately after a meal.

• The maximum recommended daily dose is 200 mg, given as two separate 100 mg doses: one tablet in the morning and one in the evening.
• The duration of treatment is decided by the doctor; side effects can be minimised by using the lowest dose for the shortest possible time.
• During long-term treatment the doctor will regularly check blood counts and liver and kidney function.

Special patient groups

• Children: use is not recommended because of a lack of data on efficacy and safety.
• Elderly: no dose reduction is needed, but caution is required – older people have a higher risk of ulcers, bleeding and perforation in the digestive tract, which may occur without warning symptoms.
• Liver impairment: the recommended starting dose is one tablet (100 mg) daily; severe liver disease is a contraindication.
• Kidney impairment: in mild to moderate impairment no dose reduction is needed, with precautions; severe kidney disease is a contraindication.

Contraindications – when the medicine must not be used

Do not take Aflamil:

• if you are allergic to aceclofenac or any of the excipients;
• if you have had an asthma attack, narrowing of the airways, acute rhinitis, skin rash or other allergic reactions after acetylsalicylic acid or other NSAIDs;
• if you have active bleeding or a bleeding disorder;
• if you have previously had NSAID-related bleeding or perforation in the digestive tract, or have/have had a stomach ulcer or digestive tract bleeding;
• in established heart failure, ischaemic heart disease and/or cerebrovascular disease, or peripheral arterial disease;
• in severe kidney or liver disease;
• in the last trimester of pregnancy.

Precautions and warnings

• Talk to your doctor if you have digestive complaints, a history of ulcers, Crohn's disease or ulcerative colitis, a blood clotting disorder, heart disease, mild or moderate liver or kidney disease, a tendency to fluid retention, a history of cerebrovascular bleeding, recent surgery, porphyria, systemic lupus erythematosus or asthma.
• Increased cardiovascular risk: tell your doctor if you smoke or have diabetes, angina, blood clots, high blood pressure or raised cholesterol/triglycerides. Medicines like Aflamil may be associated with an increased risk of heart attack.
• Severe skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) occur very rarely, mostly in the first month of treatment – stop the medicine immediately at the first sign of rash or hypersensitivity.
• Do not take the medicine if you have chickenpox, as a serious skin and soft tissue infection may rarely occur.
• The medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is essentially „sodium-free“.

Interactions with other medicines, alcohol and food

Tell your doctor about all medicines you take, including non-prescription ones.

• Combinations not recommended: acetylsalicylic acid, corticosteroids and other NSAIDs (e.g. ibuprofen, naproxen); warfarin, heparin and other anticoagulants; lithium; digoxin; high-dose methotrexate; SSRI antidepressants.
• Caution or dose adjustment needed: medicines for high blood pressure and heart disease (ACE inhibitors, diuretics, beta-blockers, angiotensin II antagonists); low-dose methotrexate; ciclosporin and tacrolimus; zidovudine; medicines for diabetes; other NSAIDs and salicylates.
• There is also a risk of pharmacokinetic interactions with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole.
• Take the medicine with a meal or immediately after a meal.

Pregnancy and breastfeeding

Aflamil must not be taken in the last three months of pregnancy. In the first and second trimester it is not recommended unless the doctor considers it necessary – then at the lowest dose and for the shortest time. NSAIDs may make it harder to become pregnant; tell your doctor if you are planning a pregnancy.

It is not known whether aceclofenac passes into breast milk – if you are breastfeeding, ask your doctor before taking the medicine.

Driving and using machines

If you experience dizziness, vertigo or other central nervous system disturbances during treatment, do not drive or operate machinery.

Possible side effects

Most side effects are mild and disappear when treatment is stopped.

• Common (up to 1 in 10): dizziness, indigestion, abdominal pain, nausea, diarrhoea, increased liver enzymes.
• Uncommon (up to 1 in 100): flatulence, gastritis, constipation, vomiting, mouth inflammation with ulcers, itching, rash, skin inflammation, hives, increased blood urea and creatinine.
• Rare (up to 1 in 1,000): black stools, bloody diarrhoea, ulcers and bleeding in the digestive tract, high or worsened blood pressure, heart failure, difficulty breathing, anaemia, swelling of the face, tongue or throat, allergic reactions including anaphylactic shock, visual disturbances.
• Very rare (up to 1 in 10,000): blood count disorders, raised potassium, depression, abnormal dreams, insomnia, tingling, tremor, drowsiness, headache, taste disturbance, vertigo, ringing in the ears, palpitations, flushing and hot flushes, vasculitis, bronchospasm, pancreatitis, vomiting blood, stomach ulcer, bowel perforation, worsening of Crohn's disease and ulcerative colitis, liver damage, purpura, eczema, severe skin reactions, nephrotic syndrome, kidney failure, swelling, fatigue, leg cramps, weight gain.

Suspected side effects can be reported to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: symptoms are nausea, vomiting, stomach pain, dizziness, drowsiness and headache. Contact a doctor or emergency service immediately and take the leaflet with you.
• Missed dose: do not take a double dose; take the next dose at the usual time.
• Stopping treatment: the duration of treatment is decided by the doctor; do not stop on your own.

Related information

• How to recognise arthritis and how it is treated
• Which is the safest painkiller?

For additional care and support with joint and muscle pain, see also the Bones, joints and muscles category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Each film-coated tablet contains 100 mg aceclofenac.
• Excipients – core: glyceryl distearate; croscarmellose sodium; povidone K-30; microcrystalline cellulose. Coating (Sepifilm 752): macrogol stearate; titanium dioxide (E171); microcrystalline cellulose; hypromellose.
• White, round, biconvex film-coated tablets marked „A“; Alu-Alu blister of 10 tablets, carton with 2 blisters (20 tablets).
• Marketing authorisation holder: Predstavništvo Richter Gedeon Nyrt, Vladimira Popovića 6, Belgrade.
• Manufacturer: Gedeon Richter Plc, Gyömrői út 19-21, Budapest, Hungary, in cooperation with Almirall S.A., Barcelona, Spain.

Storage

• Store below 25 °C.
• Shelf life: 3 years; do not use after the expiry date on the pack.
• Keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Can I take Aflamil together with ibuprofen or aspirin?

This is not recommended. The leaflet states that aceclofenac should not be combined with acetylsalicylic acid, corticosteroids or other NSAIDs (e.g. ibuprofen, naproxen), as this increases the risk of side effects, especially in the digestive tract.

How many Aflamil tablets can I take per day?

The maximum recommended daily dose is 200 mg – one tablet in the morning and one in the evening. In liver impairment the recommended starting dose is one tablet daily.

Should Aflamil be taken before or after food?

Aflamil should be taken with a meal or immediately after a meal, with enough liquid.

Can I use Aflamil during pregnancy?

It is contraindicated in the last trimester. In the first and second trimester it is not recommended unless the doctor considers it necessary, and then at the lowest dose for the shortest time.

Sources

• ALIMS – Patient leaflet Aflamil® 100 mg film-coated tablets (approved September 2021, Serbian)
• ALIMS – Summary of Product Characteristics Aflamil® 100 mg film-coated tablets (authorisation 515-01-03765-20-001 of 10.09.2021, Serbian)
• ALIMS – List of new authorisations and renewals 01.09.–15.10.2021 (Aflamil 100 mg, 2 x 10 tablets)

Sources checked on: 23 October 2026.