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SAPOFEN PLUS 100/15MG/5ML
SUSPENSION
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1.3.3.2 English leaflet
®
Sapofen Plus Tablets & Suspension
For cold and flu
COMPOSITION:
Tablets :
Each tablet contains 200 mg Ibuprofen B.P. and 30 mg Pseudoephedrine hydrochloride.
Suspension :
Each 5 ml contains 100 mg Ibuprofen B.P. and 15 mg Pseudoephedrine hydrochloride.
ACTION:
Sapofen Plus contains the following active ingredients:
Ibuprofen - a non-steroidal anti-inflammatory substance that is used to relieve pain, and reduce
fever.
Pseudoephedrine hydrochloride - a systemic nasal decongestant.
INDICATIONS:
Sapofen Plus is a specially formulated combination of Ibuprofen and Pseudoephedrine
hydrochloride providing fast and effective relief of all major cold and flu symptoms: Ibuprofen
to relieve aches and pains, headache and feverishness and to ease sore throats, plus the
clinically proven decongestant, Pseudoephedrine hydrochloride to clear blocked nose and nasal
sinuses.
CONTRAINDICATIONS:
—
Sapofen Plus should not be used if the patient has ever had an allergic reaction to any
other pain reliever/fever reducer.
—
Right before or after heart surgery.
—
In a patient who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain
drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2
weeks after stopping the MAOI drug.
WARNINGS:
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to
aspirin. Symptoms may include:
Hives, facial swelling, asthma (wheezing) shock, skin reddening, rash blisters.
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug
(NSAID), which may cause stomach bleeding.
SPIMACO
SAPOFEN PLUS 100/15MG/5ML
SUSPENSION
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The chance is higher if the patient: 60 years or older, has had stomach ulcers or bleeding
problems, takes a blood thinning (anticoagulant) or steroid drug, takes other drugs containing
prescription or nonprescription or takes more or for a longer time than directed.
Sore throat warning: In case of Sapofen plus suspension, severe or persistent sore throat or
sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.
Consult doctor promptly. In case of treating children with sore throat; do not use more than 2
days or administer to children under 3 years of age unless directed by doctor.
PRECAUTIONS:
doctor should be consulted before use if: stomach bleeding warning applies to the patient,
patient has a history of stomach problems, has lost a lot of fluid due to vomiting or diarrhea,
has high blood pressure, heart disease, liver cirrhosis, kidney disease, thyroid disease, diabetes
or asthma, is taking a diuretic.
Doctor or pharmacist should be asked before use if the patient is taking any other product that
contains pseudoephedrine or any other nasal decongestant, taking aspirin for heart attack or
stroke, because ibuprofen may decrease this benefit of aspirin.
When using this product:
—
Take with food or milk if stomach upset occurs.
—
The risk of heart attack or stroke may increase if you use more than directed or for
longer than directed.
—
If symptoms continue or get worse, redness or swelling is present in the painful area,
patient gets nervous, or dizzy, any new symptom appear, or if patient experiences any of the
following signs of stomach bleeding: feels faint vomits blood has bloody or black stools, has
stomach pain that does not get better then patient must stop use and ask a doctor.
—
Pediatric patients : If the child does not get any relief within first day (24 hours) of
treatment , fever or pain or nasal congestion gets worse or lasts more than 3 days then patient
must stop use and ask a doctor.
—
Adult patients: If fever gets worse or lasts more than 3 days nasal congestion lasts for
more than 7 days then patient must stop use and ask a doctor.
If pregnant or breast-feeding, ask doctor or pharmacist before use. It is especially important
not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so
by a doctor because it may cause problems in the unborn child or complications during
delivery.
UNDESIRABLE EFFECTS:
Side effects generally are very rare with Sapofen Plus. However, patients may develop GI
disturbances, skin rash, headache, nervousness and tinnitus.
SPIMACO
SAPOFEN PLUS 100/15MG/5ML
SUSPENSION
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In case of overdose, get medical help or go to the hospital right away.
DOSAGE:
Sapofen Plus tablets:
Adults and Children over 12 years: 1 to 2 tablets every four to six hours. Do not exceed 6
tablets per day. Tablet form is not suitable for children under 12 years of age.
Sapofen plus Suspension:
Do not give more than directed.
Shake well before using.
Find right dose on chart below. If possible, use weight to dose; otherwise use age. Do not use
in children below 2 years.
If needed, repeat dose every 6 hours.
Do not use more than 4 times a day.
DOSING CHART:
Weight (Kg)
Age (yr)
Dose
11-21
2-5
5 ml (1 teaspoon)
22-43
6 - 11
10 ml (2 teaspoons)
STORAGE:
Store below 30°C.
Availability:
Tablets: Sapofen Plus is available as tablets that contain Ibuprofen 200 mg and
Pseudoephedrine hydrochloride 30 mg/tablet.
Suspension: Sapofen Plus is available in bottles that contain Ibuprofen 100 mg and
Pseudoephedrine hydrochloride 15 mg/5 ml.
SPIMACO