Hapacol CF Overdose

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Consists of dextromethorphan HBr, loratadine, Paracetamol

What happens if I overdose Dextromethorphan HBr (Hapacol CF)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.

Proper storage of Dextromethorphan HBr (Hapacol CF):

Store Dextromethorphan HBr (Hapacol CF) between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Keep Dextromethorphan HBr (Hapacol CF) out of the reach of children and away from pets.

Overdose of Dextromethorphan HBr (Hapacol CF) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast heartbeat, vomiting, sweating, nervousness, feeling high (euphoria), hallucinations, problems walking (staggering), agitation, severe drowsiness.

Notes

Keep all regular medical and laboratory appointments.

Missed Dose

If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

What should I avoid while taking Dextromethorphan HBr (Hapacol CF)?

Avoid drinking alcohol. It can increase some of the side effects of Dextromethorphan HBr (Hapacol CF). This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. Dextromethorphan HBr (Hapacol CF) is contained in many combination medicines available over the counter. If you take certain products together you may accidentally take too much of this medicine. Read the label of any other medicine you are using to see if it contains Dextromethorphan HBr (Hapacol CF).

Dextromethorphan HBr (Hapacol CF) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Hypothyroidism, adrenocortical insufficiency; asthma, impaired hepatic or renal function, prostatic hyperplasia, hypotension, shock, inflammatory or obstructive bowel disorders, myasthenia gravis. Infants, neonates; Reduce dose in elderly or debilitated patients. May impair ability to drive or operate machinery. Lactation.

pregnancy:Category C:

Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

What should I discuss with my healthcare provider before taking Dextromethorphan HBr (Hapacol CF)?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Dextromethorphan HBr (Hapacol CF), the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Dextromethorphan HBr (Hapacol CF) or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of Dextromethorphan HBr (Hapacol CF) in children with use in other age groups, Dextromethorphan HBr (Hapacol CF) is not expected to cause different side effects or problems in children 4 years of age and older than it does in adults.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of Dextromethorphan HBr (Hapacol CF) in the elderly with use in other age groups.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Dextromethorphan HBr (Hapacol CF), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Dextromethorphan HBr (Hapacol CF) with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Using Dextromethorphan HBr (Hapacol CF) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using Dextromethorphan HBr (Hapacol CF) with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of Dextromethorphan HBr (Hapacol CF). Make sure you tell your doctor if you have any other medical problems, especially:

Dextromethorphan HBr (Hapacol CF) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Before taking Dextromethorphan HBr (Hapacol CF), tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung problems (e.g., asthma, emphysema).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

What happens if I miss a dose of Dextromethorphan HBr (Hapacol CF)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Since cough medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose Loratadine (Hapacol CF)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast or irregular heartbeat; severe drowsiness or headache.

Proper storage of Loratadine (Hapacol CF):

Store Loratadine (Hapacol CF) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use a tablet if the blister unit is open or torn. Use within 6 months of opening the foil pouch. Keep Loratadine (Hapacol CF) out of the reach of children and away from pets.

Overdose of Loratadine (Hapacol CF) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Symptoms: Somnolence, tachycardia and headache have been reported with overdoses. A single acute ingestion of 160 mg produced no adverse effects.

Treatment: In the event of overdosage, treatment, which should be started immediately, is symptomatic and supportive.

The patients should be induced to vomit even if emesis has occurred spontaneously. Pharmacologically induced vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of 240-360 mL of water. If emesis does not occur within 15 min, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in children.

Following emesis, adsorption of any drugs remaining in the stomach may be attempted by the administration of activated charcoal as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Physiologic saline solution is the lavage solution of choice, particularly in children. In adults, tap water can be used; however, as much as possible, the amount administered should be removed before the next instillation. Saline cathartics draw water into the bowel by osmosis and therefore, may be valuable for their action in rapid dilution of bowel content. Loratadine is not cleared by hemodialysis to any appreciable extent. After emergency treatment, the patient should continue to be medically monitored.

What should I avoid while taking Loratadine (Hapacol CF)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Loratadine (Hapacol CF) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

Some medical conditions may interact with Loratadine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have kidney or liver problems.

Taking Loratadine in high doses may cause drowsiness. Do NOT take more than the recommended dose without checking with your doctor.

Loratadine may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Loratadine for a few days before the tests.

Loratadine should not be used in CHILDREN younger than 6 years old without checking with the child’s doctor; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Loratadine while you are pregnant. Loratadine is found in breast milk. If you are or will be breast-feeding while you use Loratadine, check with your doctor. Discuss any possible risks to your baby.

What should I discuss with my healthcare provider before taking Loratadine (Hapacol CF)?

This is not a list of all drugs or health problems that interact with Loratadine (Hapacol CF) (loratadine and pseudoephedrine).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Loratadine (Hapacol CF) (loratadine and pseudoephedrine) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Loratadine (Hapacol CF) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.

Patients with liver disease should inform a physician before taking Loratadine (Hapacol CF).

If the patient is taking any other medicines, including medicine taken without a prescription, the patient should consult a physician before use.

Laboratory Tests: If the patient is scheduled to any skin tests for allergies, Loratadine (Hapacol CF) should not be taken 2 days before the test.

Important Information About the Ingredients of Clarityn: Clarityn tablets contain lactose while Clarityn syrup contains sucrose. If the patient has an intolerance to some sugars, the pharmacist or physician should be informed before taking Clarityn.

Effects on the Ability to Drive or Operate Machinery: At the recommended dose, Loratadine (Hapacol CF) is not expected to cause drowsiness or less alertness. However, very rarely, some people experiences drowsiness, which may affect ability to drive or use machinery.

Use in pregnancy & lactation: If the patient is pregnant, taking Loratadine (Hapacol CF) is not recommended. If the patient is nursing, taking Loratadine (Hapacol CF) is not recommended. Loratadine is excreted in breast milk. The patient should ask for advice from a pharmacist or physician before taking Loratadine (Hapacol CF).

Use in children: Do not give Loratadine (Hapacol CF) to children <2 years.

What happens if I miss a dose of Loratadine (Hapacol CF)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose Paracetamol (Hapacol CF)?

Seek emergency medical attention if you think you have used too much of this medicine.

The first signs of an Paracetamol (Hapacol CF) overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose of Paracetamol (Hapacol CF) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.

Paracetamol (Hapacol CF) in massive overdosage may cause hepatic toxicity in some patients. In adults and children >12 years, hepatic toxicity may occur following ingestion of >7.5-10 g over a period of ≤8 hrs. Fatalities are infrequent (<3-4% of untreated cases) and have rarely been reported with overdoses of <15 g. In children <12 years, acute overdosage with Paracetamol (Hapacol CF) <150 mg/kg body weight have not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: Nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48-72 hrs after ingestion. In adults and children >12 years, any individual presenting with an unknown amount of Paracetamol (Hapacol CF) ingested or with a questionable or unreliable history about the time of ingestion should have a plasma Paracetamol (Hapacol CF) level drawn and be treated with N-acetylcysteine. Do not await results of assays for plasma Paracetamol (Hapacol CF) levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended. Promptly initiate decontamination of the stomach. A plasma Paracetamol (Hapacol CF) assay should be obtained as early as possible, but not sooner than 4 hrs following ingestion. Liver function studies should be obtained initially and repeated at 24-hr intervals.

Serious toxicity or fatalities have been extremely infrequent following acute overdosage in young children, possibly because of differences in the way they metabolize Paracetamol (Hapacol CF). In children, the maximum potential amount ingested can be more easily estimated. If >150 mg/kg or an unknown amount of Paracetamol (Hapacol CF) was ingested, obtain a plasma Paracetamol (Hapacol CF) level as soon as possible but no sooner than 4 hrs following ingestion. If an assay cannot be obtained and the estimated Paracetamol (Hapacol CF) ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.

What should I avoid while taking Paracetamol (Hapacol CF)?

Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Paracetamol (Hapacol CF) is contained in many combination medicines. If you use certain products together you may accidentally use too much Paracetamol (Hapacol CF). Read the label of any other medicine you are using to see if it contains Paracetamol (Hapacol CF), acetaminophen or APAP. Avoid drinking alcohol while taking this medication. Alcohol may increase your risk of liver damage while taking Paracetamol (Hapacol CF).

Paracetamol (Hapacol CF) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

New Prescribed Uses of Paracetamol (Hapacol CF): Questions and Answers

October 20, 1998 - U.S. Food and Drug Administration

Q. What professional uses of aspirin are now indicated?

1) STROKES: Paracetamol (Hapacol CF) use is now recommended in both men and women to treat mini-strokes (transient ischemic attack --TIA) or ischemic stroke to prevent subsequent cardiovascular events or death.

2) HEART ATTACKS:

Paracetamol (Hapacol CF):

3) OTHER CORONARY CONDITIONS: Paracetamol (Hapacol CF) can be used to treat patients who have had certain revascularization procedures such as angioplasty, and coronary bypass operations -- if they have a vascular condition for which aspirin is already indicated.

4) RHEUMATOLOGIC DISEASES -- Paracetamol (Hapacol CF) is indicated for relief of the signs and symptoms of rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, spondylarthropathies, and arthritis and pleurisy associated with systemic lupus erythematosus.

Q. What does this mean for doctors and medical practice?

A. Doctors and health care professionals will be provided with full prescribing information about the use of aspirin in both men and women who have had a heart attack, stroke, certain other cardiovascular conditions and rheumatologic diseases. For stroke and cardiovascular conditions, lower doses are recommended than those previously prescribed by physicians in practice. Information on the use of aspirin for rheumatologic diseases has also been expanded to include specific dosing information as well as information about side effects and toxicity. Thus, doctors will have full prescribing information on aspirin and the assurance that aspirin is a safe and effective treatment for heart attacks, strokes, certain other vascular conditions and rheumatologic diseases.

Q. What is the basis for the new prescribing information?

A. The new information on the uses of aspirin is based on scientific studies that support treatment with aspirin for heart attacks, strokes, and some related conditions. Convincing data support these uses in lower doses than previously believed to be effective in treating heart attacks and strokes in both men and women.

Q. What does this mean for patients?

A. Physicians will be better able to prescribe the proper doses for these uses for male and female patients with these medical conditions. Dose-related adverse events for patients with stroke and cardiovascular conditions should be minimized because lower dosages are recommended. The full prescribing information now provided for physicians who treat rheumatologic diseases will enhance the safe and effective prescribing of aspirin to these patients as well.

Q. Is FDA concerned that some patients may self-treat?

A. FDA emphasizes that consumers should not self-medicate for these serious conditions because it is very important to make sure that aspirin is their best treatment. In these conditions, the risk and benefit of each available treatment for each patient must be carefully weighed. Patients with these conditions should be under the care and supervision of a doctor.

Q. If a consumer is interested in using aspirin to prevent or treat symptoms of heart problems, what should he or she do?

A. Consumers should always first ask their doctor. In fact, aspirin products are labeled this way: "Important: See your doctor before taking this product for other new uses of aspirin because serious side effects could occur with self treatment."

Q. Do the data on treatment or prevention of cardiovascular effects pertain only to aspirin?

A. Yes. Although acetaminophen, ibuprofen, naproxyn sodium and ketoprofen are good drugs for pain and fever, as is aspirin, only aspirin has demonstrated a beneficial effect for heart attack and stroke.

Q. What should consumers be made aware of?

A. Consumers should be informed that these new professional uses of aspirin may be lifesaving when used upon the recommendation and under the supervision of a doctor. However, they must also be informed that even familiar and readily available products like aspirin may have important risks when used in new ways. For example, because aspirin can cause bleeding; in rare cases bleeding in the brain may occur in people who are using aspirin to prevent stroke. Therefore these new uses should be recommended and monitored by a physician.

Q. What should consumers who are taking low dose aspirin for disease maintenance or prevention know about alcohol use?

A. Patients who consume 3 or more alcoholic drinks every day should be counseled about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.

Q. Can consumers safely use aspirin to treat suspected acute heart attacks?

A. If consumers suspect they are having a heart attack, their most important action must be to seek emergency medical care immediately. The advise and supervision of a doctor should direct this use of aspirin and patients are encouraged to speak with their doctor about this use.

Q. What do we know about how aspirin works for heart conditions and stroke?

A. The mechanism by which aspirin works in the treatment of heart attack and stroke is not completely understood. However, as an antiplatelet drug, we do know that aspirin help reduce platelet clumping which helps cause blockage in blood vessels.

Q. Who should NOT take aspirin?

A. Generally, people who have:

Always check first with your doctor to determine whether the benefit of these professional uses of aspirin is greater than the risks to you.

Q. What other side effects are associated with aspirin?

A. There is a wide range of adverse reactions that may result from aspirin use including effects on the body as a whole, or on specific body systems and functions.

High doses can cause hearing loss or tinnitus-- ringing in the ears. (Note that this usually only occurs with large doses as prescribed in rheumatologic diseases and is rare in treatment with low doses used for cardiovascular purposes.)

Q. What is key message for Consumers?

A. The results of studies of people with a history of coronary artery disease and those in the immediate phases of a heart attack have proven to be of tremendous importance in the prevention and treatment of cardiovascular and cerebrovascular diseases.

Studies showed that aspirin substantially reduces the risk of death and/ or non-fatal heart attacks in patients with a previous MI or unstable angina pectoris which often occur before a heart attack. Patients with these conditions should be under the care and supervision of a doctor.

Paracetamol (Hapacol CF) has potential risks as well as benefits, like any drug. Patients should be careful to ask their doctor or health care professional before deciding whether aspirin is right for them and how much aspirin they should take.

Q. What were the major studies used to verify the effectiveness of aspirin for these indications?

A. Numerous studies both in the United States and abroad were evaluated to establish the safety and efficacy of aspirin for the cardiovascular and cerebrovascular indications and dosing information.

Major studies included:

ISIS - 2 (Second International Study of Infarct Survival) (Ref 7)

SALT (Swedish Paracetamol (Hapacol CF) Low-Dose Trial (Ref 22)

ESPS-2 (European Stroke Prevention Study (Ref 23)

UK-TIA (United Kingdom Transient Ischaemic Attack) Paracetamol (Hapacol CF) Trial (Ref 11)

SAPAT (Stable Angina Pectoris Paracetamol (Hapacol CF) Trial) (Ref. 27)

Canadian Cooperative Study Group (Ref. 8)

W.S. Fields et al., Controlled Trial of Paracetamol (Hapacol CF) in Cerebral Ischemia (Ref 10)

* Note the reference numbers refer to the citations in the Final Rule. (Food and Drug Administration. Internal analgesic, antipyretic, and antirheumatic drug products for over the counter human use; final rule for professional labeling of aspirin, buffered aspirin, and aspirin in combination with antacid drug products. Federal Register. October 23, 1998; 63:56802-56819.)

What should I discuss with my healthcare provider before taking Paracetamol (Hapacol CF)?

Do not use this medication if you are allergic to acetaminophen or Paracetamol (Hapacol CF).

Ask a doctor or pharmacist if it is safe for you to take Paracetamol (Hapacol CF) if you have:

It is not known whether Paracetamol (Hapacol CF) will harm an unborn baby. Before using Paracetamol (Hapacol CF), tell your doctor if you are pregnant. This medication can pass into breast milk and may harm a nursing baby. Do not use Paracetamol (Hapacol CF) without telling your doctor if you are breast-feeding a baby.

Paracetamol (Hapacol CF) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.

Care is advised in the administration of Paracetamol (Hapacol CF) to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not take more medicine than the label instructed. If the patient did not get better, talk to the physician.

Do not take anything else containing Paracetamol (Hapacol CF) while taking Paracetamol (Hapacol CF).

Inform the physician at once if the patient take too much of Paracetamol (Hapacol CF), even if the patient feel well. This is because too much Paracetamol (Hapacol CF) can cause delayed, serious liver damage.

Patients should be advised that Paracetamol (Hapacol CF) may cause severe skin reactions. If a skin reaction eg, skin reddening, blisters or rash occurs, they should stop use and seek medical assistance right away.

Use in pregnancy & lactation: Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol (Hapacol CF) used in the recommended dosage, but patients should follow the advice of the physician regarding its use. Paracetamol (Hapacol CF) is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.

What happens if I miss a dose of Paracetamol (Hapacol CF)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Since Paracetamol (Hapacol CF) is often used only when needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next regularly scheduled dose, skip the missed dose and use your next dose as directed. Do not use extra medicine to make up for a missed dose.



References

  1. DailyMed. "DEXTROMETHORPHAN HYDROBROMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "LORATADINE; PSEUDOEPHEDRINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. DrugBank. "dextromethorphan". http://www.drugbank.ca/drugs/DB00514 (accessed September 17, 2018).

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