Overview
Zerodol TH 4 is a combination tablet made by Ipca Laboratories Ltd. Each tablet contains aceclofenac 100mg and thiocolchicoside 4mg. It is used for the treatment of pain due to muscle spasm.
- Aceclofenac 100mg — anti-inflammatory painkiller (NSAID)
- Thiocolchicoside 4mg — muscle relaxant
- Thiocolchicoside: maximum 7 days in a row
- Not for pregnancy, breastfeeding or under 16s
Uses
Zerodol TH 4 is used for pain due to muscle spasm. According to each ingredient’s official product information:
- Aceclofenac relieves pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
- Thiocolchicoside is a muscle relaxant used in adults and adolescents from 16 years as an add-on treatment for painful muscle contractions in acute conditions of the spine.
See also Zerodol 100mg and Alcinac MR, or browse arthritis and pain relievers.
How it works
- Aceclofenac blocks the cyclo-oxygenase (COX) enzyme, which reduces the body’s production of prostaglandins — chemicals involved in pain, swelling and inflammation.
- Thiocolchicoside is a muscle relaxant that eases painful muscle contractions.
Dosage
Take Zerodol TH 4 exactly as your doctor prescribes. Important limits from each ingredient’s official label:
- Thiocolchicoside: the maximum dose by mouth is 16mg a day, and treatment is limited to 7 days in a row. Do not take more, or for longer.
- Aceclofenac: the usual adult dose is 200mg a day (each tablet has 100mg, so 200mg is the amount in 2 tablets). Use the lowest effective dose for the shortest time needed.
- Aceclofenac is preferably taken with or after food.
- Liver problems: the aceclofenac dose should be reduced; ask your doctor.
- Children and adolescents under 16: must not use it.
Safety warning
- Do not take Zerodol TH 4 if you are pregnant, breastfeeding, or a woman who could become pregnant and is not using contraception.
- Chromosome damage risk (thiocolchicoside): in laboratory studies, a breakdown product of thiocolchicoside caused an abnormal number of chromosomes in dividing cells at levels close to those seen with normal doses. This is a risk factor for birth defects, miscarriage, reduced male fertility and possibly cancer. That is why the dose and the 7-day limit must not be exceeded.
- Do not take it if you: are allergic to any of its ingredients; 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; or have active bleeding or a bleeding disorder.
- Stomach bleeding (aceclofenac): can happen at any time, with or without warning, and can be fatal. 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 small increase in the risk of heart attack or stroke.
- Skin: very rare but serious skin reactions have been reported with NSAIDs. Stop at the first sign of a rash, mouth sores or an allergic reaction.
- May cause dizziness or drowsiness — if affected, do not drive or use machines.
Side effects
Common side effects of aceclofenac (up to 1 in 10 people) include:
- Indigestion (dyspepsia)
- Stomach pain
- Nausea
- Diarrhea
- Dizziness
- Raised liver enzymes
Less common or rare effects include vomiting, gas, constipation, mouth ulcers, itching, rash, swelling (edema), high blood pressure, stomach ulcer or bleeding, black stools, liver problems or jaundice, kidney problems, low blood counts and severe skin reactions. Get medical help straight away for any serious symptom.
Interactions
- Other NSAIDs, including aspirin, ibuprofen, naproxen and COX-2 inhibitors: avoid — more stomach side effects and bleeding.
- Blood thinners such as warfarin: their effect may be increased; close monitoring is needed.
- Corticosteroids, antiplatelet medicines and SSRI antidepressants: higher risk of stomach ulcers or bleeding.
- Blood pressure medicines (ACE inhibitors, ARBs) and diuretics: their effect may be reduced and the risk of kidney problems goes up.
- 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.
- Mifepristone: NSAIDs should not be used for 8–12 days after it.
Tell your doctor about all the medicines, vitamins and herbal supplements you take.
Pregnancy & breastfeeding
Zerodol TH 4 must not be used at any time during pregnancy or while breastfeeding. Thiocolchicoside caused birth defects in animal studies and passes into breast milk. Women who could become pregnant must use effective contraception while taking it. Thiocolchicoside may also affect fertility, and aceclofenac may reduce female fertility.
Storage
Store below 30°C (86°F). Keep out of the reach of children.
Pack sizes & prices
| Pack | Price per tablet | Pack price |
|---|---|---|
| 60 Tablets | $1.88 | $112.80 |
| 90 Tablets | $1.81 | $162.90 |
| 120 Tablets | $1.75 | $210.00 |
| 180 Tablets | $1.64 | $295.20 |
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FAQs
What is in Zerodol TH 4?
Each tablet contains aceclofenac 100mg and thiocolchicoside 4mg. It is made by Ipca Laboratories.
How long can I take Zerodol TH 4?
Thiocolchicoside taken by mouth is limited to 7 days in a row. Long-term use, and doses above the maximum, should be avoided because a breakdown product of thiocolchicoside can damage chromosomes in dividing cells.
Can women take Zerodol TH 4?
Thiocolchicoside must not be used during pregnancy, while breastfeeding, or by women who could become pregnant and are not using contraception. Talk to your doctor about effective contraception before use.
How many tablets can I take a day?
Take it exactly as your doctor prescribes. The official labels give a maximum of 16mg of thiocolchicoside a day and a usual adult aceclofenac dose of 200mg a day — with 100mg aceclofenac per tablet, that is the amount in 2 tablets.
Can teenagers take it?
No. Thiocolchicoside should not be used in children or adolescents under 16, and aceclofenac is not recommended for children.
Can I take it with ibuprofen or aspirin?
No. Aceclofenac is an NSAID, and taking it with other NSAIDs such as ibuprofen, naproxen or aspirin raises the risk of stomach bleeding and other side effects.
Sources: aceclofenac — UK Summary of Product Characteristics for Preservex 100 mg tablets on the electronic medicines compendium (emc); thiocolchicoside — European Medicines Agency, thiocolchicoside referral: approved product information (2013). This page is for information only and does not replace advice from your doctor or pharmacist.
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