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OTC - Ameflu - Cough and cold preparations - New Ameflu Night Time

COMPOSITION: Each film coated tablet contains:

  • Active ingredients:

Acetaminophen….………..…..500 mg

Phenylephrine HCl………..…..10 mg

Dextromethorphan HBr………15 mg

Chlorpheniramine maleate……4 mg

  • Expicients: Maize starch, pregelatinized starch, povidone K30, sodium starch glycolate, talc, magnesium stearate, colloidal silicon dioxide, citric acid anhydrous, opadry II blue.

DESCRIPTION OF PRODUCT:

  • Blue, film-coated caplets, printed “New Ameflu Night Time” and lunate on both sides.

DESCRIPTION OF PACKAGING:

    –  Box of 1 blister x 10 film coated tablets.

    –  Box of 10 blisters x 10 film coated tablets.


WHAT IS THE MEDICINE USED FOR:

NEW AMEFLU NIGHT TIME is used for:

Temporarily relieves the common cold symptoms: aches and pains, headache, sore throat, nasal congestion (stuffy), cough, runny nose, sneezing and fever.


HOW MUCH AND HOW OFTEN SHOULD YOU USE THIS MEDICINE:

Administration: This medicine is used orally.

Dosage:

Adults and children from 12 years and older: Take 1 tablet every 4-6 hours, not to exceed 6 tablets in 24 hours.


WHEN SHOULD YOU NOT TAKE THIS MEDICINE:

Do not use this drug if you:

  • Known hypersensitivity to any ingredients of this product.
  • Receiving monoamine oxidase inhibitors.
  • Severe coronary artery disease and severe hypertension.
  • G6PD deficiency.
  • Severe hepatic failure.
  • Narrow-angle glaucoma.
  • Prostatic hypertrophy.
  • During acute asthmatic attacks.
  • Bladder neck obstruction.
  • Peptic ulcers, obstruction of pylorus duodenum.
  • Children under 6 years.

SIDE EFFECTS:

Acetaminophen:

Skin rash and other allergic reactions occur occasionally. The rash is usually erythematosus or urticarial, but sometimes it is more serious and may be accompanied by drug fever and mucosal lesions. If fever, bullae localize around the natural cavities, consider Steven-Johnson syndrome, the medicine should be discontinued immediately. Overdose of acetaminophen can lead to severe liver damage and sometimes acute tubular necrosis. Patients who show hypersensitivity reactions to the salicylates only rarely exhibit sensitivity to acetaminophen and related drugs. In few isolated cases, the use of acetaminophen has been associated with neutropenia, thrombocytopenia, and pancytopenia.

Uncommon, (more than 1 in 1000 people)

Skin: Rash.

Gastrointestinal: Nausea, vomitting.

Blood: Decreased neutrophils, decreased all blood cells, decreased white blood cells, anemia.

Kidney: Kidney diseases, kidney toxicity when abused for a long period of time.

Rare (less than 1 in 1000 people):

Skin: Stevens-Johnson syndrome, toxic epidermal necrosis, Lyell’s syndrome, acute generalized exanthematous pustulosis.

Others: Hypesensitivity reations.

Phenylephrine hydrochloride:

Common, (more than 1 in 100 people):

Central nervous system: Agitation, restlessness, anxiety, sleep problems, weakness, dizziness, chest pain, shakiness, abnormal sensation.

Cardiovascular: Hypertension.

Skin: Pale skin, cold feeling on skin, moving of body hair.

Uncommon, (more than 1 in 1000 people):

Cardiovascular: Hypertension and associated pulmonary edema, cardiac arrhythmias, bradycardia, peripheral vasoconstriction and reduced organ perfusion to these organs.

Respiratory: Respiratory failure.

Neurology: Excitation, hallucination, paranoid.

Eye: Release of pigment particles in the iris, blurring of the cornea.

Rare (less than 1 in 1000 people):

Cardiovascular: Myocarditis, bleeding under the pericardium.

Dextromethorphan hydrobromide:

Common, (more than 1 in 100 people):

Body: Fatigue, dizziness.

Cardiovascular: Tachycardia.

Gastrointestinal: Nausea.

Skin: Flushing.

Uncommon (more than 1 in 1000 people):

Skin: Hives

Rare (less than 1 in 1000 people):

Occasionally mild sleepiness, gastrointestinal disorder.

Chlorpheniramine maleate:

When used with therapeutic doses, the most common adverse effect is drowsiness, fatigue, dizziness, loss of coordination and mild anti-muscarinic effects. These adverse effects often go away after several days of treatment. Children (especially infants) and the elderly are very sensitive to muscarinic inhibitory effects.

Common (more than 1 in 100 people):

Neurology: Inhibition of the central nervous system: sleepiness, from mild to deep sleep, fatigue, dizziness, loss of co-ordination (sometimes paradoxical excitation, especially in young children, high doses in adults), headache, psychomotor disorder.

Anti-muscarinic effects: Dry mouth, thick phlegm, blurred vision, urinary retention, constipation, increase in gastric reflux.

Uncommon (more than 1 in 1000 people):

Gastrointestinal: Nausea, vomitting, diarrhea, epigastric pain.

Cardiovascular: Palpitations, arrhyrhmia.

Skin: Rash, hypersensitivity reactions (bronchospasm, angioedema and anaphylaxis reaction).

Rare (less than 1 in 1000 people):

Hematology: Agranulocytosis, thromocytopenia, hemolytic anemia, throbocytopenia.

Others: Seizures, sweating, myalgia, paresthesia, extrapyramydal effects, sleep disorders, depression, confusion, tinnitus, hypotension, allopecia.

In case of any unexpected reaction consult your doctor or pharmacist.


WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILST TAKING THIS MEDICINE:

Consult your doctor before using this drug if you are taking one of the following medicines or food:

  • Monoamine oxidase inhibitors (MAOIs) (certain drugs for depression, psychiatric or emotional conditions, or parkinson’s disease), or for 2 weeks after stopping the MAOI drug.
  • Anticonvulsants (phenytoin, barbiturate, carbamazepine), isoniazid.
  • Other sympathomimetic amines.
  • Beta-blocking drugs and antihypertensive drugs (including debrisoquine, guanethidine, reserpine, methyldopa).
  • Tricyclic antidepressants (e.g. amitriptyline, imipramine).
  • Ergot alkaloids (ergotamine and methylsergide).
  • Digoxin.
  • Atropine.
  • Ethanol or sedative drugs.
  • Phenytoin.

WHAT SHOULD YOU DO IF YOU MISS A DOSE:

If you 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.


HOW SHOULD YOU KEEP THIS MEDICINE:

Store at temperature from 15oC to 30oC, in a dry place, protect from light.


SIGNS AND SYMPTOMS OF OVERDOSE:

Symptoms of acetaminophen overdose: Nausea, vomiting and abdominal pain (normally settle within 24 hours of ingestion). After 24 hours symptoms may include right subcostal pain and tenderness, usually indicates development of hepatic necrosis. Liver damage is greatest 3-4 days after ingestion and may lead to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death.

Symptoms of phenylephrine HCl overdose: Hypertension, headache, convulsions, cerebral haemorrhage, palpitation, slow heart rate.

Symptoms of dextromethorphan HBr overdose: Nausea, vomiting, somnolence, blurred vision, nystagmus, urinary retention, euphoria, hallucination, ataxia, respiratory failure and convulsion.

Symptoms of chlorpheniramine maleate overdose: The estimated lethal dose of chlorpheniramine is 20 to 50 mg/kg body weight. The symptoms and signs of overdosage include sedation, paradoxical stimulation of CNS, toxic psychosis, epilepsy, apnoea, convulsion, anticholinergic effects, dystonic reactions, cardiac collapse and arrhythmia.


WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE:

Talk to your doctor or go to a hospital straight away.

Remember to take medicine that is left with you or medicine pack so the doctor knows what you have taken.


PRECAUTIONS THAT SHOULD BE TAKEN WHEN TAKING THIS MEDICINE:

  • Can cause rare but serious skin reactions, can cause death including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or Lyell Syndrome, acute generalized exanthematous pustulosis (AGEP).
  • Description of above syndromes:

+ Steven-Johnson syndrome (SJS): drug allergies can be bullous, bullae localize around the natural cavities: the face, nose, mouth, ears, genitals and anus. Also may include high fever, pneumonia, liver, kidney dysfunction. Diagnosis of Steven-Johnson syndrome (SJS) when at least two natural cavities injured.

+ Toxic epidermal necrolysis (TEN) is the most severe allergic reactions can include:

– The diversity in skin lesions: morbilliform erythema, scarlatinoid erythema, erythema or bullous erythema, the lesions rapidly spread throughout the body;

– Ophthalmic mucosa lesions: corneal inflammation, purulent conjunctivitis, corneal ulcer.

– Injury to gastrointestinal mucosa: stomatitis, erosive oral mucosa, ulceration of pharynx, throat, esophagus, stomach, intestines;

– Injury to the genital, urinary mucosa.

– There are also the serious systemic symptoms such as fever, gastrointestinal bleeding, pneumonia, glomerulonephritis, hepatitis,… high mortality rate: 15-30%.

+ Acute generalized exanthematous pustulosis (AGEP): small, sterile pustules, arising within large areas of erythema. Lesions usually appear in the folds like the underarms, groin and face, then can spread throughout the body. Usual systemic symptoms of fever, neutrophilia in blood test

  • When detecting first signs of skin rash or any other hypersensitivity reaction, patients should stop using the drug. Patients with history of severe skin reaction caused by acetaminophen, do not take again, inform the medical staff when having medical care.

Ask a doctor before use if you have:

  • Anemia
  • Alcohol dependency
  • Chronic malnutrition or dehydration
  • Myasthenia gravis
  • Chronic respiratory disease.
  • Are the elderly.
  • Liver disease, kidney disease, heart disease, high blood pressure, thyroid disease, diabetes.
  • Trouble urinating due to an enlarged prostate gland.
  • Persistent or chronic cough such as due to smoking, asthma, or emphysema.
  • Cough that occurs with too much phlegm (mucus).
  • A breathing problem such as emphysema or chronic bronchitis.
  • Glaucoma.

Be cautious when using this product:

  • Excitability may occur, especially in children.
  • Marked drowsiness may occur.
  • Alcohol, sedatives, and tranquilizers may increase the drowsiness effect.
  • Avoid alcoholic drinks.
  • Do not use with other products containing Acetaminophen.

Stop use and ask a doctor if:

  • Nervousness, dizziness, or sleeplessness occurs.
  • Pain, nasal congestion or cough gets worse or lasts more than 7 days.
  • Fever gets worse or lasts more than 3 days.
  • Redness or swelling is present.
  • New symptoms occur.
  • Cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Pregnancy: Only used for pregnant women if really necessary, with consideration about the harms caused by drugs, lower dose and for a short time. Not recommended for pregnant women last 3 months of pregnancy.

Breast-feeding: Must be very cautious when using the drug during breastfeeding, should considered between breast-feeding and taking this product, depending on the importance of medication for the mother.

Effects on ability to work: This product can cause irritability, drowsiness, fatigue, dizziness, nausea, loss of coordination, euphoria, hallucinations. Be careful when operating machinery, driving vehicles, who work at height and other cases.


WHEN SHOULD YOU CONSULT YOUR DOCTOR OR PHARMACIST:

In case of overdosage or adverse drug reactions.

When you are taking other drugs or foods.

For further information, consult your doctor or pharmacist.


SHELF-LIFE OF DRUG: 36 months from manufacturing date. Do not use after expiry date.

 

Manufacturer:

OPV PHARMACEUTICAL JOINT STOCK COMPANY

Lot 27, Road 3A, Bien Hoa Industrial Zone II, Dong Nai Province.

Tel : (061) 3992999    Fax: (061) 3835088