Caspol Side effects

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Did you have any side effects with this medicine?

Consists of chlorpheniramine maleate, paracetamol, Phenylpropanolamine HCl, salicylamide

What are the possible side effects of Chlorpheniramine maleate (Caspol)?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side effects of Chlorpheniramine maleate (Caspol) in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Drowsiness, dizziness, headache, constipation, stomach upset, blurred vision, decreased coordination, or dry mouth/nose/throat may occur. These effects may decrease as your body adjusts to the medication. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. Chlorpheniramine can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.

If you are using a sustained-release product, an empty tablet shell may appear in your stool. This is harmless.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (e.g., hallucinations, irritability, nervousness, confusion), ringing in the ears, trouble urinating.

Tell your doctor right away if any of these rare but very serious side effects occur: easy bruising/bleeding, fast/irregular heartbeat, seizure.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

What is the most important information I should know about Chlorpheniramine maleate (Caspol)?

  • Chlorpheniramine maleate (Caspol) may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Chlorpheniramine maleate (Caspol). Using Chlorpheniramine maleate (Caspol) alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Do NOT exceed the recommended dose or take Chlorpheniramine maleate (Caspol) for longer than prescribed without checking with your doctor.
  • If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
  • Chlorpheniramine maleate (Caspol) may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Chlorpheniramine maleate (Caspol). Use a sunscreen or protective clothing if you must be outside for a prolonged period.
  • If you are scheduled for allergy skin testing, do not take Chlorpheniramine maleate (Caspol) for several days before the test because it may decrease your response to the skin tests.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Chlorpheniramine maleate (Caspol).
  • Use Chlorpheniramine maleate (Caspol) with caution in the ELDERLY because they may be more sensitive to its effects.
  • Caution is advised when using Chlorpheniramine maleate (Caspol) in CHILDREN because they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Chlorpheniramine maleate (Caspol), discuss with your doctor the benefits and risks of using Chlorpheniramine maleate (Caspol) during pregnancy. It is unknown if Chlorpheniramine maleate (Caspol) is excreted in breast milk. Do not breast-feed while taking Chlorpheniramine maleate (Caspol).

Chlorpheniramine maleate (Caspol) contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Hypersensitivity to antihistamines; narrow-angle glaucoma; stenosing peptic ulcer; symptomatic prostatic hypertrophy; asthmatic attack; bladder neck obstruction; pyloroduodenal obstruction; MAO therapy; use in newborn or premature infants and in breast-feeding mothers.

What are the possible side effects of Paracetamol (Caspol)?

Get emergency medical help if you have any signs of an allergic reaction to Paracetamol (Caspol): hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop using Paracetamol (Caspol) and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using acetaminophen and call your doctor at once if you have:

  • chest pain, trouble breathing; or

  • liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Paracetamol (Caspol) side effects may include:

  • vomiting;

  • constipation;

  • feeling agitated;

  • headache; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Paracetamol (Caspol) in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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The following serious adverse reactions are discussed elsewhere in the labeling:

  • Hepatic Injury
  • Serious Skin Reactions
  • Allergy and Hypersensitivity

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

Adult Population

A total of 1020 adult patients have received Paracetamol (Caspol) in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses. Most patients were treated with Paracetamol (Caspol) 1000 mg every 6 hours. A total of 13.1% (n=134) received Paracetamol (Caspol) 650 mg every 4 hours.

All adverse reactions that occurred in adult patients treated with either Paracetamol (Caspol) or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥ 3% and at a greater frequency than placebo are listed in Table 3. The most common adverse events in adult patients treated with Paracetamol (Caspol) (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.

Table 3. Treatment-Emergent Adverse Reactions Occurring ≥ 3% of Paracetamol (Caspol)-treated Patients and at a greater frequency than Placebo in Placebo-Controlled, Repeated Dose Studies

* Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of Paracetamol (Caspol) may mask fever.

System Organ Class – Preferred Term Paracetamol (Caspol)

(N=402)

n (%)

Placebo

(N=379)

n (%)

Gastrointestinal Disorders

Nausea

Vomiting

138 (34)

62 (15)

119 (31)

42 (11)

General Disorders and Administration Site Conditions

Pyrexia*

22 (5) 52 (14)
Nervous System Disorders

Headache

39 (10) 33 (9)
Psychiatric Disorders

Insomnia

30 (7) 21 (5)

Other Adverse Reactions Observed During Clinical Studies of Paracetamol (Caspol) in Adults

The following additional treatment-emergent adverse reactions were reported by adult subjects treated with Paracetamol (Caspol) in all clinical trials (n=1020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525).

Blood and lymphatic system disorders: anemia

General disorders and administration site conditions: fatigue, infusion site pain, edema peripheral

Investigations: aspartate aminotransferase increased, breath sounds abnormal

Metabolism and nutrition disorders: hypokalemia

Musculoskeletal and connective tissue disorders: muscle spasms, trismus

Psychiatric disorders: anxiety

Respiratory, thoracic and mediastinal disorders: dyspnea

Vascular disorders: hypertension, hypotension

Pediatric Population

A total of 355 pediatric patients (47 neonates, 64 infants, 171 children, and 73 adolescents) have received Paracetamol (Caspol) in active-controlled (n=250) and open-label clinical trials (n=225), including 59.7% (n=212) who received 5 or more doses and 43.1% (n=153) who received more than 10 doses. Pediatric patients received Paracetamol (Caspol) doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule. The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively.

The most common adverse events (incidence ≥ 5%) in pediatric patients treated with Paracetamol (Caspol) were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

Other Adverse Reactions Observed During Clinical Studies of Paracetamol (Caspol) in Pediatrics

The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with Paracetamol (Caspol) (n=355) that occurred with an incidence of at least 1%.

Blood and lymphatic system disorders: anemia

Cardiac disorders: tachycardia

Gastrointestinal disorders: abdominal pain, diarrhea

General disorders and administration site conditions: injection site pain, edema peripheral, pyrexia

Investigations: hepatic enzyme increase

Metabolism and nutrition disorders: hypoalbuminemia, hypokalemia, hypomagnesemia, hypophosphatemia, hypervolemia

Musculoskeletal and connective tissue disorders: muscle spasm, pain in extremity

Nervous system disorders: headache

Psychiatric disorders: insomnia

Renal and urinary disorders: oliguria

Respiratory, thoracic and mediastinal disorders: pulmonary edema, hypoxia, pleural effusion, stridor, wheezing

Skin and subcutaneous tissue disorders: periorbital edema, rash

Vascular disorders: hypertension, hypotension

What is the most important information I should know about Paracetamol (Caspol)?

There are many brands and forms of Paracetamol (Caspol) available and not all brands are listed on this leaflet.

Do not use more of this medication than is recommended. An overdose of Paracetamol (Caspol) can cause serious harm. The maximum amount of Paracetamol (Caspol) for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more Paracetamol (Caspol) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Caspol) and never use more than 2 grams (2000 mg) per day.

Do not use this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to use Paracetamol (Caspol).

Before using Paracetamol (Caspol), tell your doctor if you have liver disease or a history of alcoholism.

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

Paracetamol (Caspol) contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Paracetamol (Caspol) should not be used in patients who have previously exhibited hypersensitivity to aspirin and/or nonsteroidal antiinflammatory agents. Paracetamol (Caspol) should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).

What are the possible side effects of Phenylpropanolamine HCl (Caspol)?

If you experience any of the following serious side effects from this medication, stop taking Phenylpropanolamine HCl (Caspol) and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  • seizures;

  • unusual behavior or hallucinations; or

  • an irregular or fast heartbeat.

Other, less serious side effects may be more likely to occur. Continue to take Phenylpropanolamine HCl (Caspol) and talk to your doctor if you experience

  • dizziness, lightheadedness, or drowsiness;

  • headache;

  • insomnia;

  • anxiety;

  • tremor (shaking) or restlessness;

  • nausea or vomiting; or

  • sweating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Side effects of Phenylpropanolamine HCl (Caspol) in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Constipation.

Skin rash.

Codeine can cause drowsiness, although at the dose contained in this medicine this is very unlikely. However, if you do find this medicine makes you feel sleepy or dizzy you should not drive or operate machinery and avoid alcoholic drink.

The side effects listed above may not include all of the side effects reported by the medicines’s manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

What is the most important information I should know about Phenylpropanolamine HCl (Caspol)?

Phenylpropanolamine HCl (Caspol) has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain Phenylpropanolamine HCl (Caspol).

Do not take Phenylpropanolamine HCl (Caspol) for longer than 7 days if your condition does not improve or if your symptoms are accompanied by a high fever.

Do not take more of this medication than is recommended on the package or by your doctor.

Use caution when driving, operating machinery, or performing other hazardous activities. Phenylpropanolamine HCl (Caspol) may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Phenylpropanolamine HCl (Caspol) contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

Decreased kidney function.

Decreased liver function.

Children under 10 years of age, unless on the advice of a doctor.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Side effects of Salicylamide (Caspol) in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

CNS disturbances, GI disturbances, flushing, hyperventilation, sweating, dry mouth, rash and thrombocytopenic purpura. Tinnitus, ecchymosis, haemorrhagic lesions, leukopenia or thrombocytopenia in high doses.

Salicylamide (Caspol) contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

Severe renal or hepatic impairment.

References

  1. DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: 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. DTP/NCI. "salicylamide: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Chlorphenamine hydrogen maleate: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Caspol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Caspol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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