APR ACLOMEE

INFORMATION FOR THE USER  

Aceclofenac 100mg + Paracetamol 325mg Tablets  

Read all of this information carefully before you start taking this medicine because it contains important information for you. 

• Keep this information. You may need to read it again. 
• If you have any further questions, ask your doctor, pharmacist or nurse. 
• This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.  

1. COMPOSITION: 

Each tablet contains: 

Aceclofenac – 100mg 

Paracetamol – 325mg  

For oral use only.  

2. DESCRIPTION: 

Aceclofenac is an analgesic, antipyretic & anti-inflammatory drug & belongs to a class of drugs called NSAID’s (Non-steroidal anti-inflammatory drug). Paracetamol is also an NSAID. 

Together both the drugs help to relieve inflammation, pain, swelling & related symptoms.  

3. PHARMACOLOGICAL ACTION: 

Aceclofenac is a non-steroidal agent with marked anti-inflammatory & analgesic properties. The mode of action is largely based on the inhibition of prostaglandin synthesis. It is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins. 

Paracetamol acts predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) & to a lesser extent, through a peripheral action by blocking pain-impulse generation. Peripheral action may also be due to inhibition of prostaglandin synthesis or inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation. 

4. CLINICAL PHARMACOKINETICS: 

Aceclofenac is rapidly & completely absorbed as unchanged drug. Peak plasma conc. is reached approx. 1.25-3 hrs following ingestion. It penetrates into the synovial fluid, where the conc. reach approx. 57% of those in plasma. The volume of distribution is approx. 25 L. The mean plasma elimination half-life is ~4 hrs. It is highly protein- bound (>99%). It circulates mainly as unchanged drug. 4′- hydroxyaceclofenac is the main metabolite detected in plasma. Approx. two-thirds of the dose is excreted via the urine, mainly as hydroxymetabolites. No changes in the pharmacokinetics have been detected in the elderly. 

Paracetamol is readily absorbed from the GI tract with peak plasma conc. occurring about 30 min-2 hrs after ingestion. It is metabolised in the liver & excreted in the urine mainly as the glucuronide & sulphate conjugates. >5% is excreted as unchanged. The elimination half-life varies from about 1-4 hrs. Plasma-protein binding is negligible at usual therapeutic conc. but increases with increasing conc. A minor hydroxylated metabolite produced in very small amounts by mixed-function oxidases in the liver & which is usually detoxified by conjugation with liver glutathione may accumulate following overdose & cause liver damage. 

5. INDICATIONS: 

Aceclofenac + Paracetamol tablets are indicated for the relief of pain & inflammation in: 

1. Osteoarthritis 
2. Rheumatoid arthritis 
3. Ankylosing spondylitis 
4. Moderate musculoskeletal pain 
5. Orthopaedic injuries 
6. Fractures 
7. Sports injuries

6. CONTRAINDICATIONS: 

Aceclofenac + Paracetamol tablets are contraindicated in the following cases:  

1. Hypersensitivity to Aceclofenac or Paracetamol or to any of the excipients in the tablets. 
2. Active, or history of recurrent peptic ulcer/haemorrhage (2 or more distinct episodes of proven ulceration or bleeding). 
3. Patients who have previously shown hypersensitivity reactions (eg. Asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. \
4. Hepatic failure & renal failure. 
5. Patients with established congestive heart failure (NYHA II-IV), ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. 
6. History of GI bleeding or perforation, related to previous NSAIDS therapy. 
7. Active bleedings or bleeding disorders. 

Note: 

1. Should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. In such cases the lowest effective dosage should be used. 
2. Not recommended for use in children.

7. WARNINGS AND PRECAUTIONS: 

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.  

The use of Aceclofenac with concomitant NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided.  

Elderly: Increased frequency of adverse reactions to NSAIDs especially GI bleeding & perforation.  

Respiratory disorders: Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.  

Cardiovascular, Renal & Hepatic Impairment: May cause a dose dependent reduction in prostaglandin formation & precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics or recovering from major surgery & the elderly. 

Renal: Patients with mild-moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function.  

Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), the medication should be discontinued. Close medical surveillance is necessary in patients suffering from mild-moderate impairment of hepatic function. Hepatitis may occur without prodromal symptoms. Use in patients with hepatic porphyria may trigger an attack.  

Cardiovascular & cerebrovascular effects: Appropriate monitoring is required for patients with a history of hypertension &/or mild to moderate congestive heart failure as fluid retention & oedema have been reported in association with NSAID therapy. Patients with congestive heart failure (NYHA-I) & patients with significant risk factors for CV events (e.g. hypertension) should only be treated after careful consideration. Should also be administered with caution & under close medical surveillance to patients with a history of cerebrovascular bleeding.  

Gastrointestinal bleeding, ulceration & perforation: GI bleeding, ulceration/perforation has been reported with all NSAIDs at any time during treatment, with/without warning symptoms or a previous history of serious GI events.  

SLE & mixed connective tissue disease: May cause an increased risk of aseptic meningitis. 

Dermatological: Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis, have been reported very rarely. Patients appear to be at highest risk for these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the 1st month of treatment. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.  

Hypersensitivity reactions: Allergic reactions, including anaphylactic /anaphylactoid reactions, can also occur.  

Haematological: May reversibly inhibit platelet aggregation.  

Long-term treatment: Patients should be monitored as a precautionary measure e.g. renal, hepatic function (elevation of liver enzymes may occur) & blood counts.  

8. ADVERSE EFFECTS: 

Gastrointestinal: Peptic ulcers, perforation or GI bleeding, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain. 

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs & may consist of: 

1. Non-specific allergic reactions & anaphylaxis. 
2. Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea. 
3. Assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema. 

Cardiovascular & cerebrovascular: Oedema, hypertension & cardiac failure have been reported. 

Aceclofenac is structurally related & metabolised to diclofenac for which a greater amount of clinical trial & epidemiological data consistently point towards an increased risk of general arterial thrombotic events (ex. myocardial infarction or stroke , particularly at high doses or in long treatment). Epidemiological data has also found an increased risk of acute coronary syndrome & myocardial infarction associated with the use of aceclofenac. 

Renal: Interstitial nephritis 

Neurological & special senses: Optic neuritis, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus), with symptoms such as stiff neck, headache, nausea, vomiting etc. 

Haematological: Agranulocytosis, aplastic anaemia  

Dermatological: Bullous reactions including Stevens Johnson Syndrome & Toxic Epidermal Necrolysis, Photosensitivity. 

If serious adverse reactions occur, treatment should be withdrawn. 

9. DRUG INTERACTIONS: 

Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of 2 or more NSAIDs (including aspirin) as this may increase the risk of adverse effects including GI bleeding.  

Anti-hypertensives: May reduce the effect of antihypertensives. The risk of acute renal insufficiency which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when ACE- inhibitors or angiotensin II receptor antagonists are combined with NSAIDs.  

Diuretics: May inhibit the activity of diuretics. Can increase the risk of nephrotoxicity of NSAIDs.  

Cardiac glycosides like digoxin: May exacerbate cardiac failure, reduce glomerular filtration rate & inhibit the renal clearance of glycosides, resulting in increased plasma glycoside levels. 

Lithium: Can inhibit renal clearance of lithium, resulting in increased serum conc. of lithium. The combination should be avoided unless frequent monitoring of lithium can be performed.  

Methotrexate: Renal function should be monitored.  

Mifepristone: Should not be used for 8-12 days after mifepristone administration as it can reduce the effect of mifepristone.  

Corticosteroids: Increased risk of GI ulceration or bleeding.  

Anti-coagulants: May enhance the effects of anti-coagulants (ex. Warfarin). Close monitoring of patients should be undertaken.  

Quinolone antibiotics: Can increase the risk of convulsions associated with quinolone antibiotics. 

Anti-platelet agents & selective serotonin reuptake inhibitors (SSRIs): Increased risk of GI bleeding.  

Ciclosporin, Tacrolimus: Administration together with ciclosporin/tacrolimus is thought to increase the risk of nephrotoxicity. 

Zidovudine: Increased risk of haematological toxicity when given with zidovudine.  

Antidiabetic agents: Isolated reports of hypoglycaemic & hyperglycaemic effects. 

Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Should not be taken within 1 hour if maximal analgesia is required. 

Metoclopramide & Domperidone: The absorption of paracetamol is increased by metoclopramide & domperidone. Concurrent use need not be avoided. 

Chloramphenicol: Increases plasma conc. of chloramphenicol. 

10. DOSAGE: 

Adults: The recommended dose is 2 tablets daily; 1 tablet in the morning & 1 in the evening. 

Paediatric population: No clinical data on the use in children; not recommended for use in children. 

Elderly: The elderly, who are more likely to be suffering from impaired renal, CV or hepatic function & receiving concomitant medication, are at increased risk of adverse reactions. The patient should be monitored regularly for GI bleeding. 

Pharmacokinetics are not altered in elderly patients; it is not necessary to modify the dose/dose frequency.  

Renal insufficiency: There is no evidence that the dosage of needs to be modified in patients with mild renal impairment.  

Hepatic insufficiency: should be reduced in patients with hepatic impairment. 

11. ADMINISTRATION: 

Aceclofenac + Paracetamol tablets are supplied for oral administration & should be swallowed whole with a sufficient quantity of liquid. Do not crush or chew the tablets. Never change the dose of your medicine without talking to your doctor first. Continue to take your tablets for as long as your doctor recommends. 

12. PRESENTATION: 

13. STORAGE: 

Store below 25°C in a cool & dry pace. Protect from direct sunlight. Keep away from the reach of children.  

14. MANUFACTURED BY:

15. MARKETED BY:

This leaflet was last revised on October 2020.