Why it's used

Aceclofenac/Paracetamol is used to relieve severe pain and swelling in joint stiffness, long-term inflamed joint, joint inflammation affecting the spine, pain or inflammation of ear, throat, or nose, dental pain, low back pain, and reproductive organs pain. This medicine works by blocking prostaglandin synthesis.
Nonsteroidal Anti-inflammatory Drugs
Aceclofenac+Paracetamol is a prescription medicine that belongs to a class of medicines called Nonsteroidal Anti-inflammatory Drugs. Nonsteroidal anti-inflammatory drugs, also called as NSAIDs, help reduce fever, decrease pain, and prevent clotting of blood. NSAIDs also reduce inflammation in the body when used in higher doses.

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How to use

Read the medicine guide provided by your pharmacist, your doctor, or the medicine company. If you have any questions related to Aceclofenac+Paracetamol, ask your doctor or pharmacist. Use Aceclofenac/Paracetamol as per the instructions provided by your doctor.
Aceclofenac+Paracetamol is eaten with or after food. Aceclofenac+Paracetamol tablets should be taken with a sufficient amount of liquid. Aceclofenac+Paracetamol is eaten Aceclofenac+Paracetamol tablet should be taken two times a day, one tablet in the morning and one tablet in the evening.

Typical Dosage

The typical dose of Aceclofenac+Paracetamol for adults is one dose of Aceclofenac+Paracetamol twice daily. The maximum dose for adult patients of Aceclofenac+Paracetamol is 4000 mg/ day per day.
This medicine is to be used for longer periods of time.
If you have issues with the health of your liver, The dose should be reduced in the patient with liver disease.
Taking a higher dose of this medicine may increase the risk of side-effects.

Use in Children

If you are giving Aceclofenac/Paracetamol to a child, be sure to use a product that is for use in children. Use the child's weight or age to find the right dose from the product package or medicine label. If there is no information specified, consult with your doctor and follow their recommendation on pediatric dosage.

Avoid Alcohol

Avoid consuming alcohol together with Aceclofenac+Paracetamol.
Medicines may be recommended for uses other than those listed in the medicine guide. You should not use Aceclofenac/Paracetamol for conditions or symptoms for which it was not prescribed. Do not give Aceclofenac/Paracetamol to other people, even if they have the same conditions or symptoms that you have. The use of this medicine without the advice of a doctor may cause harm.

Storage

Follow storage instructions on the product package if available. Store Aceclofenac/Paracetamol away from light. Store this medicine away from children and pets.

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How to take Aceclofenac+Paracetamol

Your dose may depend on several personal factors. You should consult with your doctor to find out the dose that is best for you. The dose of Aceclofenac+Paracetamol depends on the following factors:
  • the health of the patient's kidneys

Aceclofenac+Paracetamol Dosage

Dosage for painful & inflammatory conditions

Adult
  • Recommended: one dose twice daily

Forms

Film-coated bilayered tablet
Strength: 100/500 mg

Overdose

What to do if you overdose on Aceclofenac+Paracetamol?
In the case of Aceclofenac+Paracetamol overdose, activated charcoal is recommended to use and elimination of poisons from the stomach should be done possibly within the first one hour. Aceclofenac+Paracetamol elimination from the body should be done by inducing vomiting and excessive urine production. Use of oral methionine or intravenous N-acetylcysteine after up to at least 48 hours shows beneficial effects in case of overdose. Complete monitoring of liver and functioning of kidneys should be done in patients especially for the first four hours following the overdose. For convulsions, diazepam should be given through veins.
Symptoms of an overdose of Aceclofenac+Paracetamol
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Aceclofenac/Paracetamol, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Aceclofenac+Paracetamol

Before you use Aceclofenac+Paracetamol, tell your doctor of your medical and health history including the following:
  • allergic reaction
  • difficulty in breathing
  • hives
  • inflammation of the mucous membrane
  • stomach and intestinal disorders (perforation, bleeding, ulcer)
  • swelling of the lower layer of skin
Bronchial asthma leads to narrowing of the bronchi. Allergic reactions progress into difficulty in breathing, inflammation of the mucous membrane, swelling of the lower layer of skin, hives. Also, stomach and intestinal disorders lead to blood-related abnormalities and inflammation of the digestive tract.
Before you use Aceclofenac+Paracetamol, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Discuss with your doctor if you are allergic to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
The use of Aceclofenac/Paracetamol may change blood creatinine level. There is an increase in blood creatinine level.
The use of this medicine may change the blood urea level. There is an increase in blood urea level.
The use of Aceclofenac/Paracetamol may change liver enzyme. There is an increase in liver enzyme level.
The use of this medicine may change blood phosphatase level. There is an increase in blood phosphatase level.
The use of this medicine may change blood alkaline phosphatase level. There is an increase in blood alkaline phosphatase level.

Use when Pregnant

Aceclofenac+Paracetamol is not safe for use in women who are pregnant. If you are pregnant or planning to become pregnant, you should discuss the impact on the fetus with your doctor before you start using this medicine. There are known risk of Aceclofenac+Paracetamol causing blood vessel closure connected to the fetus and increased blood pressure in newborns. Using Aceclofenac+Paracetamol during the 28th week of pregnancy, cause decreased uterine contraction. Aceclofenac+Paracetamol can be used during the first 26 weeks of pregnancy or labor if its benefit to the mother justifies the risk to the baby. Aceclofenac+Paracetamol belongs to the NSAID class of medicines. NSAIDs should not be taken after 29 weeks of pregnancy as these medicines may cause serious harm to the unborn baby.

If Breastfeeding

Aceclofenac/Paracetamol is known to be safe for use in women who are breastfeeding. There are very limited studies available for Aceclofenac+Paracetamol in breastfeeding. Aceclofenac+Paracetamol has been shown to pass in breast milk. Therefore, it is not recommended during breastfeeding. But aceclofenac is used during breastfeeding if its possible benefit to the mother explains the possible risk to the baby.

Alcohol

Avoid drinking alcohol with Aceclofenac+Paracetamol. Consumption of alcohol may cause serious liver damage.

Dizziness

Aceclofenac+Paracetamol can make you feel sleepy. Be careful, especially while driving, while using heavy machinery, or when doing any activity that needs you to be completely alert. The consumption of alcohol with Aceclofenac+Paracetamol can worsen the sleepiness.

Increase in Risk

This medicine may cause stomach bleeding. Regular use of tobacco or alcohol may increase the risk. Discuss with your doctor if you smoke and drink alcohol regularly. This medicine may increase your sensitivity to sunlight and make you prone to sunburn. If this happens, limit your time outdoors to prevent sunburn. Use a sunscreen and cover your skin.

Side-effects in Older Patients

Older patients may have a higher incidence of side-effects when using Aceclofenac/Paracetamol. Elderly patients may see an increased risk of stomach bleeding, and rupturing of the wall of the stomach or intestine.

Side-effects in Children

Younger patients may have a higher incidence of side-effects with Aceclofenac/Paracetamol. Younger patients may see an increased risk of serious liver damage.

Long-term Use

There is a risk of heart attack for long term use of Aceclofenac+Paracetamol.

What precautions should be taken during Pregnancy and Nursing, and administering Aceclofenac+Paracetamol to Children or the Older Adults?

Pregnant Women

Contraindicated or Not Recommended
Warning: Aceclofenac+Paracetamol delays the start and increases the duration of labor with increased bleeding in both mother and baby. There are known risk of Aceclofenac+Paracetamol causing closure of the blood vessel connecting to the fetus and increased blood pressure in newborns. Therefore Aceclofenac+Paracetamol should not be used during the 28th week of pregnancy, causing decreased uterine contraction.

Breastfeeding

Contraindicated or Not Recommended
Warning: There is very limited data available for Aceclofenac+Paracetamolduring breastfeeding. Aceclofenac+Paracetamol has been shown to pass in breast milk. Therefore, it is not recommended in breastfeeding. But aceclofenac is used during breastfeeding if its possible benefit to the mother justifies the possible risk to the baby.

Younger Adults Population

Precaution
Warning: If more than 5 doses of Aceclofenac+Paracetamol per day is used in children it can cause serious liver damage.

Older Adults Population

Precaution
Warning: It is advised to take care while using Aceclofenac+Paracetamol alone or with other medicines in elderly patients with kidney, liver, heart disease or having other drugs. Aceclofenac+Paracetamol can cause increased side effects in elderly patients like stomach bleeding and rupturing of the wall of the stomach or intestine which may be dangerous.

Aceclofenac+Paracetamol Side-effects

The following side-effects may commonly occur when using Aceclofenac/Paracetamol. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Aceclofenac/Paracetamol. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Aceclofenac/Paracetamol may cause the following side-effects:
The following severe side-effects may also occur when using Aceclofenac/Paracetamol:
  • Immune system disorders
    Symptoms: severe allergic reactions
  • Symptoms: depression
  • Stomach and intestinal disorders
    Symptoms: inflammation of stomach, mouth ulcer, constipation, stomach ulcer, inflammation of the pancreas, inflammation of mucous membrane, stomach and intestinal bleeding, blood vomiting vomiting
  • Skin and subcutaneous tissue disorders
    Symptoms: red or purple spots on the skin swelling of the lower layer of the skin
  • Skin disorders
    Symptoms: severe skin reactions sensitivity to light
    Discontinuation should be done at the first appearance of skin rash, mucosal lesions, or any other sign of allergic reactions.
  • Blood and lymphatic system disorders
    Symptoms: decrease in granulocytes, low level of thrombocytes, low level of neutrophils a decrease in the number of red blood cells
  • Metabolism and nutrition disorders
    Symptoms: increased potassium level low blood glucose level
  • Nervous system disorders
    Symptoms: sleepiness blood clot in an artery
  • Liver disorder
    Symptoms: inflammation of the liver liver damage
    If an abnormality in liver function tests worsens or persists, liver disease signs develop or eosinophilia, the rash occurs, the patient should discontinue the drug. Monitoring of kidney and liver function should be done properly.
  • Kidney disorders
    Symptoms: kidney failure, kidney damage inflamed spaces between the kidney tubules
Your doctor has prescribed Aceclofenac/Paracetamol because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious side-effects. This page does not list all possible side-effects of Aceclofenac/Paracetamol.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Aceclofenac+Paracetamol by Severity and Frequency

Common Side-effects

Following are the common side-effects of this medicine:

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Severe Side-effects

Following are the severe side-effects of this medicine:

Side-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:

Mild Allergic Reactions

Following are the symptoms of mild allergic reactions to this medicine:
Discontinuation should be done at the first appearance of skin rash, mucosal lesions, or any other sign of allergic reactions.

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
  • bullous dermatitis
  • red or purple spots on the skin
  • severe skin reaction
  • swelling of the lower layer of skin
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Respiratory Disorders

Patients suffering from or with a history of inflammatory lung disease are at an increased risk when using this medicine. Aceclofenac+Paracetamol have been reported to accelerate spasm of a bronchial smooth muscle in such patients. The patient should be cautious when using Aceclofenac+Paracetamol in patients suffering from or with a history of inflammatory lung disease.

Liver Damage

Patient taking alcohol (more than 3 drinks) every day, an adult taking a dose of more than 4000 mg in 24 hours are at an increased risk. Also, a child taking > 5 doses in 24 hours and if taken with other drugs containing paracetamol are at a higher risk when using these medicines. If paracetamol is taken more than the recommended dose, it can cause liver damage. Due to large doses of paracetamol allergic reactions such as swelling of the face, throat, and mouth, breathing difficulty, a rash may happen.

Heart and Brain Disorders

Patients with heart disease (e.g. high blood pressure, high level of cholesterol, high sugar level, smoking) are at an increased risk while using this medicine. Use of Aceclofenac+Paracetamol (at high doses and in long term treatment) may lead to a small increased risk of blood clot disorders (e.g heart attack or stroke), fluid retention and swelling. Patients with uncontrolled high blood pressure, heart failure, established heart disease, peripheral arterial disease, or heart disease should be treated only after careful monitoring. The patient should be careful before starting long-term therapy in patients with risk factors for heart disease.

Stomach & Intestinal Disorders

Elderly patients, patients with a history of ulcer (especially hemorrhage or perforation) are at higher risk when using this medicine. There is a risk of stomach and intestine disorders, which can be fatal any time during treatment. Patients should be cautious when receiving Aceclofenac+Paracetamol in combination with oral corticosteroids, anticoagulants, antiplatelet agents, and SSRIs. Monitoring patients with stomach-intestinal disorders, colon inflammation, or blood disorders as it may get worse. Patients who are at increased risk should start their treatment on a low dose and with protective agents. Therapy with Aceclofenac+Paracetamol should be discontinued if stomach and intestine bleeding occurs.

Mixed Connective Tissue Disorders

Patients with mixed connective tissue disorders including systemic lupus erythematosus (SLE) are at an increased risk when using this medicine. These patients may have a risk of inflammation of the brain linings.

Skin Related Disorders

Patients who were using Aceclofenac+Paracetamol in the first month of treatment are at highest risk for these reactions. Serious skin reactions including redness and scaling of the skin have been reported rarely with the use of Aceclofenac+Paracetamol. There is a risk of severe liver damage when doses are higher than the recommended one. Discontinue the drug at the first sign of skin rash, mucosal lesions, or any allergic reaction. Perform liver function tests if liver damage is suspected.

Allergic Reactions

Allergic reactions may occur without exposure to the drug with any of the NSAIDs including Aceclofenac+Paracetamol.

Blood Disorders

Aceclofenac+Paracetamol use can block clumping of platelets.

Long-term Treatment

Patients with an abnormality of heart, liver or functioning of kidneys and elderly patients are at an increased risk while using this medicine. Precaution should be taken in patients who are at increased risk of suffering from conditions such as coagulation disorders, history of stomach ulcers. Also from inflammation of the digestive tract, pregnancy, and lactation, bleeding in the brain, skin or nerve problems having enzyme deficiency in the liver. Caution is also needed in patients on diuretic or at risk of decreased blood volume. Patients receiving prolonged therapy should be monitored regularly for liver function, functioning of kidneys tests, and blood counts.

Interactions with Aceclofenac+Paracetamol

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Aceclofenac/Paracetamol. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Quinolone Antibiotics

Your doctor's guidelines may need to be followed while taking this medicine along with quinolone antibiotics which are used to treat a variety of illnesses such as respiratory and urinary tract infections. The combined use of Aceclofenac+Paracetamol with quinolones may increase the risk of developing convulsions.

Amethopterin

Aceclofenac/Paracetamol interacts with amethopterin (methotrexate) which treats cancer, autoimmune diseases, and for medical abortions. The combined use of methotrexate and Aceclofenac+Paracetamol shows a decrease in the elimination of methotrexate. Precaution should be taken if Aceclofenac+Paracetamol and methotrexate are used within 24 hours of each other. As Aceclofenac+Paracetamol can increase blood levels which may result in increased harmful effects.

Steroids

There may be an interaction of Aceclofenac+Paracetamol with steroids (mifepristone, corticosteroids) which are used to treat a variety of inflammatory diseases and conditions. The combined use of mifepristone and Aceclofenac+Paracetamol can cause a reduction in the effect of mifepristone. Combined therapy of aceclofenac with corticosteroids can increase the risk of stomach bleeding. Aceclofenac+Paracetamol use should be avoided for 8-12 days after the use of mifepristone.

Cardiac Glycosides

Aceclofenac/Paracetamol may interact with cardiac glycosides which are used to treat heart disease. The combined use of Aceclofenac+Paracetamol with cardiac glycosides may worsen the risk of heart failure, reduce kidney efficiency, and increase blood glycoside level.

Nucleoside Reverse Transcriptase Inhibitors

Special instructions need to be followed while taking this medicine along with nucleoside reverse transcriptase inhibitors (zidovudine) which are used to treat HIV. The combined use of Aceclofenac+Paracetamol with zidovudine increases the risk of bleeding into the joints and collection of blood outside the blood vessels in HIV(+) patients having a blood clotting disorder.

Antidiabetic Agents

Your doctor's guidelines may need to be followed while taking this medicine along with antidiabetic agents which are used to control increased blood sugar level. The combined use of aceclofenac with oral antidiabetic agents can cause a decrease and increase in blood sugar level.

Anti-Hypertensives

Aceclofenac/Paracetamol interacts with anti-hypertensives which are used to treat high blood pressure of the body. The combined use of aceclofenac with anti-hypertensives drugs shows a reduction in the effect of anti-hypertensives.

Antiplatelet Agents and SSRIs

Special instructions need to be followed while taking this medicine along with Anti-platelet agents which are used to prevent the formation of blood clots and selective serotonin reuptake inhibitors which are used to treat the depressive disorder. The combined use of aceclofenac with anti-platelet agents and selective serotonin reuptake inhibitors shows an increase in the risk of stomach bleeding.

Diuretics

There may be an interaction of Aceclofenac+Paracetamol with diuretics (potassium-sparing diuretics) which are used to promote diuresis, the increased production of urine. The combined use of diuretics with Aceclofenac+Paracetamol reduces the diuretics effects. Also, diuretics increase the risk of kidney damage when used with Aceclofenac+Paracetamol. While using the Aceclofenac+Paracetamol with potassium-sparing diuretics, it is necessary to monitor blood potassium level in patients.

Other Nonsteroidal Anti-inflammatory Drugs

Aceclofenac/Paracetamol may interact with nonsteroidal anti-inflammatory drugs (aspirin, cyclooxygenase-2 selective inhibitors, ibuprofen) which are used to reduce pain, fever and prevent blood clots. The combined use of Aceclofenac+Paracetamol with other NSAIDs may increase the risk of side effects including stomach bleeding. Combined therapy with ibuprofen may increase the risk of bleeding into the joints and collection of blood outside the blood vessels in HIV(+) patients having a blood clotting disorder.

Immunosuppressants

Aceclofenac/Paracetamol may interact with immunosuppressants (ciclosporin) which are used to prevent organ refusal after a kidney, heart, or liver transplant. The combined use of aceclofenac with ciclosporin increase the risk of kidney damage.

Antibacterial Agents

Your doctor's guidelines may need to be followed while taking this medicine along with antibacterial agents (chloramphenicol, rifampicin, and St. John's wort extract) which are used to treat bacterial infections. The combined use of chloramphenicol and paracetamol may affect the absorption of chloramphenicol mainly in patients suffering from malnutrition. Use of paracetamol with enzyme producing agents like rifampicin and St. John's wort extract (hypericum) may cause a decrease in the level of paracetamol.

Uricosuric Drugs

Special instructions need to be followed while taking this medicine along with uricosuric drugs (probenecid), which are used to treat severe pain, redness, and tenderness in joints and excess of uric acid. The combined use of probenecid and paracetamol shows decrease metabolism of paracetamol which can influence the clearance of paracetamol.

Anticonvulsants

Aceclofenac/Paracetamol interacts with anticonvulsants (alcohol, barbiturates) which are used to treat epileptic seizures. The combined use of paracetamol and drugs which induce liver microsomal enzymes like anticonvulsants may increase the liver damage of paracetamol.

Antimanic Agents

There may be an interaction of Aceclofenac+Paracetamol with antimanic agents (lithium) which are used to treat manic-depressive illness. The combined use of lithium and Aceclofenac+Paracetamol shows a decrease in the elimination of lithium.

Antiepileptic Drugs

Aceclofenac/Paracetamol may interact with antiepileptic drugs (phenytoin, phenobarbital, carbamazepine) which are used to treat epilepsy. The combined use of paracetamol with enzyme producing agents such as antiepileptic drugs shows a reduction in absorption of paracetamol approx. 60 %.

Anti-Coagulants

There may be an interaction of Aceclofenac+Paracetamol with anticoagulants (warfarin and other coumarins) which are used to treat blood clots. The combined use of anticoagulants with paracetamol increases the effect of anticoagulants. Combined therapy of warfarin and other coumarins with prolonged regular use of paracetamol increases the risk of bleeding.

Interactions of Aceclofenac+Paracetamol by Severity

Serious

The following medicines may interact when taken together and can cause harmful effects in the body. Please consult with your doctor or pharmacist before taking these medicines together.

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Aceclofenac+Paracetamol be not used?

Drug Sensitivity

Aceclofenac+Paracetamol should not be used in the patients those who are sensitive to paracetamol, aceclofenac or any of the substance of the drug.

Stomach Disorders

Aceclofenac+Paracetamol should not be used in patients with current or previous history of repeated stomach ulcer or bleeding. Stomach ulcers can be possibly fatal.

Allergic Reactions

Aceclofenac+Paracetamol should not be used in the patients previously known to have allergic reactions in response to aspirin, ibuprofen, or other NSAIDs. These patients may have the following symptoms if they use this medicine:
  • lungs inflammation
  • inflammation in nose
  • swelling of the lower layer of skin
  • hives

Heart Disorders

Aceclofenac+Paracetamol should not be used in patients with serious heart failure, high blood pressure.

Liver and Kidney Disorders

Aceclofenac+Paracetamol should not be used in patients with liver or kidney failure.

Pregnancy

Aceclofenac+Paracetamol should not be used during pregnancy particularly in the 28 weeks of pregnancy unless there are not many reasons to doing so. It is preferred to use the lowest effective dose. There is an increased risk of improper blood circulation in the newborn. The frequent use of Aceclofenac+Paracetamol may reduce contraction in uterine muscles on using it in the last trimester of pregnancy.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Aceclofenac+Paracetamol is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Aceclofenac/Paracetamol .
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