Overview
Zerodol CR 200mg is a controlled-release tablet that contains aceclofenac 200mg. It is made by Ipca Laboratories Ltd. Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) that relieves pain and inflammation. Aceclofenac is not approved by the US FDA; it is approved in other countries.
- Aceclofenac 200mg controlled-release per tablet
- Relieves pain and inflammation in arthritis
- Adult dose: 200mg a day (one tablet), with or after food
- Swallow whole — do not crush or chew
Uses
According to the official product information, aceclofenac 200mg controlled-release tablets are used for the relief of pain and inflammation in:
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
Also available: Zerodol 100mg (taken twice a day). See more pain relievers.
How it works
Aceclofenac is a non-steroidal agent with anti-inflammatory and pain-relieving properties. It works mainly by blocking the cyclo-oxygenase (COX) enzyme, which reduces the body’s production of prostaglandins — chemicals involved in pain, swelling and inflammation.
Dosage
Take Zerodol CR exactly as your doctor prescribes. The doses in the official product information are:
- Adults: the recommended dose is 200mg a day — one Zerodol CR 200mg tablet.
- Take it preferably with or after food. Swallow the tablet whole with enough liquid.
- Use the lowest effective dose for the shortest time needed to control symptoms.
- Liver problems: the dose should be reduced; the suggested starting dose is 100mg a day (so this 200mg tablet is not the starting strength).
- Mild kidney problems: no dose change is needed, but care is advised.
- Older people: no dose change, but they are more likely to have serious side effects and should be checked regularly for stomach bleeding.
- Children: not recommended.
Safety warning
- Do not take aceclofenac if you: are allergic to it; have an active or repeated stomach ulcer or bleeding; have had stomach bleeding or a perforation from an NSAID; have had asthma, runny nose, swelling or hives after aspirin, ibuprofen or other NSAIDs; have liver or kidney failure; have heart failure, heart disease, poor circulation in the legs, or stroke/mini-stroke; have active bleeding or a bleeding disorder; or are in the last 3 months of pregnancy.
- Stomach bleeding: bleeding, ulcers or perforation can happen at any time, with or without warning, and can be fatal. The risk is higher with higher doses, older age and a past ulcer. Stop and get help if you have black stools or vomit blood.
- Heart and blood vessels: aceclofenac is broken down to diclofenac, which is linked to a higher risk of heart attack or stroke, especially at high doses or with long use. It can also cause fluid retention and swelling. Use with care if you have high blood pressure or heart risk factors such as high cholesterol, diabetes or smoking.
- Kidneys and liver: NSAIDs can worsen kidney function and may affect the liver. Long-term use needs regular kidney, liver and blood tests.
- Skin: very rare but serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, mostly in the first month. Stop at the first sign of a rash, mouth sores or an allergic reaction.
- Asthma: NSAIDs can trigger breathing problems in people with asthma.
- Lupus (SLE) or mixed connective tissue disease: higher risk of aseptic meningitis.
- Avoid during chickenpox (risk of serious skin infections).
- Contains lactose — not for people with rare inherited galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- May cause dizziness, drowsiness, tiredness or vision problems — if affected, do not drive or use machines.
Side effects
Common side effects (up to 1 in 10 people) include:
- Indigestion (dyspepsia)
- Stomach pain
- Nausea
- Diarrhea
- Dizziness
- Raised liver enzymes
Less common or rare effects include gas, constipation, vomiting, mouth ulcers, gastritis, itching, rash, hives, headache, sleepiness, ringing in the ears, high blood pressure, swelling (edema), stomach bleeding, black stools, heart failure, palpitations, shortness of breath, anemia, liver injury or jaundice, kidney problems and severe skin reactions. Get medical help straight away for any serious symptom.
Interactions
- Other NSAIDs, including aspirin and COX-2 inhibitors: avoid — more side effects and stomach bleeding.
- Corticosteroids, antiplatelet medicines and SSRI antidepressants: higher risk of stomach ulcers or bleeding.
- Blood thinners such as warfarin: their effect may be increased; close monitoring is needed.
- Blood pressure medicines (ACE inhibitors, ARBs) and diuretics: their effect may be reduced and the risk of kidney problems goes up, especially in older or dehydrated people. With potassium-sparing diuretics, potassium should be checked.
- Lithium, digoxin and methotrexate: their levels or toxicity may increase.
- Cyclosporine and tacrolimus: higher risk of kidney damage.
- Quinolone antibiotics: possible higher risk of seizures.
- Zidovudine: higher risk of blood toxicity.
- Mifepristone: NSAIDs should not be used for 8–12 days after it.
- Diabetes medicines: rare reports of high or low blood sugar; the dose may need adjusting.
Tell your doctor about all the medicines, vitamins and herbal supplements you take.
Pregnancy & breastfeeding
Do not use aceclofenac in the last 3 months (third trimester) of pregnancy. In the first 6 months it should only be used if clearly needed, at the lowest dose for the shortest time. There is no information on whether aceclofenac passes into breast milk, so it should be avoided while breastfeeding unless the benefit clearly outweighs the risk. Aceclofenac may reduce female fertility and is not recommended for women trying to become pregnant.
Storage
Store below 30°C (86°F), protected from light and moisture. Keep out of the reach of children.
Pack sizes & prices
| Pack | Price per tablet | Pack price |
|---|---|---|
| 90 Tablets | $0.89 | $80.10 |
| 180 Tablets | $0.84 | $151.20 |
| 240 Tablets | $0.79 | $189.60 |
| 360 Tablets | $0.70 | $252.00 |
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FAQs
What does CR mean in Zerodol CR 200mg?
CR means controlled release. The tablet contains the full 200mg daily dose of aceclofenac and must be swallowed whole, not crushed or chewed.
How do I take Zerodol CR 200mg?
The recommended adult dose is 200mg a day, which is one Zerodol CR 200mg tablet. Take it preferably with or after food, swallowed whole with enough liquid. Use the lowest dose that works for the shortest time needed.
What is the difference between Zerodol CR 200mg and Zerodol 100mg?
Both contain aceclofenac and give the same 200mg daily dose for adults. Zerodol 100mg is taken as one tablet twice a day; Zerodol CR 200mg is a controlled-release tablet that holds the whole 200mg daily dose.
Is aceclofenac approved in the US?
No. Aceclofenac is not approved by the US FDA. It is approved in other countries, and this page uses the official product information from the Tanzania medicines regulator (TMDA).
Can I take it with ibuprofen or aspirin?
No. Taking two or more NSAIDs together, including aspirin, ibuprofen and COX-2 inhibitors, should be avoided because it raises the risk of stomach bleeding and other side effects.
Can I take aceclofenac during pregnancy?
It must not be used in the last 3 months of pregnancy. Earlier in pregnancy it should only be used if clearly needed, at the lowest dose for the shortest time. Ask your doctor first.
Can children take Zerodol CR 200mg?
No. Aceclofenac is not recommended for children because there are no clinical data in this age group.
Source: Summary of Product Characteristics for Aceclofenac Controlled Release Tablets 200 mg (Accecpan, Panacea Biotec), approved by the Tanzania Medicines and Medical Devices Authority (TMDA) (authorized 10/2021). Aceclofenac is not approved by the US FDA. This page is for information only and does not replace advice from your doctor or pharmacist.
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