Dolan FP/Dolan FP Forte

Each 5 mL (1 teaspoonful) suspension contains: Ibuprofen 100 or 200 mg.
Ibuprofen (Dolan FP) 100 mg/5 mL Suspension, and Ibuprofen (Dolan FP Forte) 200 mg/5 mL Suspension are orange-colored and orange-flavored suspensions using the TasteRite Technology. TasteRite technology is a unique taste-masking system developed specifically for liquid dosage forms. This technology significantly reduces the bitterness of the medicine so that children taste the flavor and not the medicine.

These products contain ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Like other NSAIDs, ibuprofen works by changing the body's chemical response to pain, swelling and fever resulting in relief of symptoms of inflammation (e.g., swelling, redness) and relief of pain and/or fever.

For Ibuprofen 100 mg/5 mL and 200 mg/5 mL Suspension: For the relief of mild to moderate aches and pains due to: Dental pain including teething pain, toothache; Headache including migraine, neuralgia (painful disorder of the nerves); Muscular aches including sprains and strains, minor arthritis pain, backache (including low back pain); Common cold, flu, or sore throat; Menstrual cramps (dysmenorrhea).
For the relief of other types of pain such as earache, or pain after vaccination or surgery.
For the relief of inflammation from arthritis, non-serious arthritic conditions, and juvenile rheumatoid arthritis.
For fever reduction.

Like other NSAIDs, the lowest effective dose should be used for the shortest possible time. After observing the response to initial therapy with this product, the dose and frequency should be adjusted to suit individual patient needs.
This medicine is given orally and may be taken with food or milk if stomach upset occurs.
Recommended oral dose in children: 5 to 10 mg/kg body weight per dose given every 6 to 8 hours, or, as directed by a doctor. (See table.)

Click on icon to see table/diagram/image

For patients with juvenile rheumatoid arthritis: The usual recommended dose is 7.5 to 12.5 mg/kg body weight per dose given every 6 hours. Consultation with a doctor is strongly recommended for patients with this condition.
Missed Dose: If the child missed a dose, take the next dose as soon as the patient remembers if still needed for pain and/or fever or inflammation. If it is almost time to take the next dose, wait until then to take the medicine and skip the missed dose.
Do not double the dose and do not exceed the maximum dose in 24 hours.

The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, fatigue (lethargy), and drowsiness. Other symptoms include headache, ringing in the ears (tinnitus), central nervous system depression, convulsions, low blood pressure, and irregular heartbeat. Excessive acidity of the blood (metabolic acidosis), coma, acute kidney failure, too much potassium in the blood (hyperkalemia), absence of spontaneous breathing (apnea), respiratory depression, and respiratory failure may rarely occur.
If more than the recommended dosage has been given, consult a doctor or contact a Poison Control Center right away.

Do not take this medicine if the child has or is: Allergic to ibuprofen, aspirin or any other NSAID, or to other ingredients in the product.
Currently taking aspirin or other NSAIDs.
Bronchospasm (constriction of air passages of the lungs), angioedema (rapid swelling that occurs in the tissue just below the surface of the skin), nasal polyps or allergic-type reactions after taking aspirin or other NSAIDs.
Suffering from stomach ulcers, bleeding or other stomach problems such as inflammatory bowel disease.
Severe heart or liver disease.
Severe kidney disease (creatinine clearance less than 30 mL/min).
Conditions involving an increased tendency for active bleeding.
Dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluids.
Systemic Lupus Erythematosus (SLE).
Dengue fever, since NSAIDs may increase the risk of bleeding.
To undergo heart surgery (right before or after).

Allergy Alert: Ibuprofen may cause a severe allergic reaction which may include: Hives (elevated, whitish or reddish patches on the skin with severe itching or pricking sensations); Shock (anaphylactic), a hypersensitivity reaction resulting to generalized skin lesions and itchiness, followed by vascular collapse and often accompanied by life-threatening respiratory distress; Facial swelling; Skin reddening; Asthma (wheezing); Skin rash or skin blisters.
Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the child is: Has/had stomach ulcers or bleeding problems; Is taking a blood thinning (anticoagulant) or steroid medicine; Is taking other medicines containing prescription or nonprescription NSAIDs (aspirin, ibuprofen or others); Has 3 or more alcoholic drinks everyday while using this product; Is taking more for a longer time than directed.
The risk of heart attack or stroke may increase if the child uses more than or longer than directed.
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.
Do not use after the expiry date on the label.
Consult a doctor: Ask a doctor before use if the child is: Having problems or serious side effects from taking pain relievers or fever reducers; Taking aspirin or other NSAIDs; Taking other medicines; Under a doctor's care for any serious condition.
Ask a doctor before use if: Stomach bleeding warning applies to the child; The child has heart problems, previous stroke or might be at risk of these conditions (e.g., high blood pressure, high cholesterol, diabetes, or if the patient is a smoker); The child has a history of stomach problems, such as heartburn, Crohn's disease (inflammation of the digestive system) or ulcerative colitis (ulcers in the lining of the rectum and colon); The child has blood clotting disorder (e.g., hemophilia); The child has liver or kidney problems; The child has asthma; The child is taking a diuretic; The child has a connective tissue disease (autoimmune diseases affecting connective tissue); The child is 12 to 18 years old, as there is a risk of renal impairment, especially if the child has not been drinking fluids or has lost fluids due to continuous vomiting or diarrhea.
Stop use and ask a doctor if: The child experiences any of the following signs of stomach bleeding: Feels faint; vomits blood or dark particles that look like coffee grounds; has bloody or black stools; has a stomach pain that does not get better.
An allergic reaction occurs.
New symptoms occur.
Symptoms do not get better.
Redness or swelling is present in the painful area.
The child does not get any relief within 24 hours of treatment.
Pain gets worse or lasts more than 3 days in children.

Undesirable effects from the use of ibuprofen are rare, but they may occur. Tell the doctor if the patient experiences any undesirable effect.
The most frequently reported undesirable effects (1 to 10%) of ibuprofen include constipation, decreased appetite, diarrhea, dizziness, dyspepsia, ear infection (otitis media), fever, fluid retention, fullness of the gastrointestinal tract (bloating or flatulence), headache, heartburn, indigestion, itching, mouth ulcers (stomatitis), nausea, nervousness, rash, ringing in the ears (tinnitus), sore throat (pharyngitis), stomach cramps or pain, swelling, vertigo, and vomiting.
Less common undesirable effects (<1% of patients) include: Blood: Bleeding episodes (e.g., nose bleed, heavy menstrual bleeding), blood does not clot properly, decrease in hemoglobin and hematocrit, low platelet count, low red or white blood cell count (i.e., agranulocytosis, aplastic anemia, hemolytic anemia, eosinophilia, granulocytopenia, leukopenia, neutropenia, pancytopenia).
Allergic Reactions: Autoimmune disorders (e.g., SLE, Henoch-Schönlein purpura), constriction of air passages of the lungs, dry mouth, gingival ulceration, hives, itching, rapid swelling beneath the skin (angioedema), serum sickness, stuffy nose (rhinitis), swelling of the face, tongue and voice box, syndrome of abdominal pain, fever, chills, nausea and vomiting, wheezing or difficulty in breathing, whole-body allergic reaction (anaphylaxis), worsening of asthma.
Metabolism and Nutrition: Benign enlargement of the male breasts, increased acid in blood and body tissues, low blood sugar, low sodium in the blood, menstrual delay.
Psychiatric: Anxiety, confusion, depression, drowsiness, hallucination, insomnia.
Nervous System: Dream abnormalities, inflammation of the brain lining (aseptic meningitis; symptoms include stiff neck, headache, feeling or being sick, fever or feeling disoriented), loss of sensation (paresthesia), muscle spasm, tingling of hands and feet.
Special Senses: Blurred and/or decreased visual sharpness (amblyopia), cataracts, decreased hearing, depressed vision in the visual field (scotoma) and/or changes in color vision, double vision (diplopia), impaired hearing, inflammation of the optic nerve, inflammation or infection of the membrane lining the eyelids (conjunctivitis), visual disturbance.
Cardiovascular: Cerebrovascular accident (stroke), chest pain, fluid retention, heart failure, increased blood pressure, irregular heartbeat, low blood pressure, palpitations, swelling of tissues usually in the lower limbs (edema).
Stomach/Gut: Inflammation of the stomach lining or pancreas, passing black or bloody stools, stomach ulceration and/or bleeding, temporary burning sensation in the mouth or throat, vomiting with blood (or liquid with what looks like coffee grounds), worsening inflammation of the intestine or colon (colitis, Crohn's disease).
Liver: Abnormal liver function tests, inflammation of the liver (hepatitis), liver disorders especially with long-term treatment, liver failure, yellowing of the skin or whites of the eyes (jaundice).
Skin: Blisters, hives, loss of hair, sensitivity to light or the sun; symptoms of serious allergies (e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis, and erythema multiforme) which include multiple skin lesions, itch, fever, and joint pains.
Kidneys: Acute pain on the side or back, blood in the urine, decreased creatinine clearance, excess serum proteins or urea in the urine, frequent urination, inflammation of the bladder (cystitis), kidney damage, kidney failure, swelling of the ankles.
Body as a Whole: Fatigue, general ill feeling (malaise), mood swings (emotional lability), tiredness.

Aspirin: Ibuprofen may interfere with the anti-platelet activity of aspirin, thus limiting aspirin's cardioprotective effect.
Other NSAIDs: Phenylbutazone, indomethacin, salicylates (e.g., aspirin), and other NSAIDs (e.g., mefenamic acid, naproxen, diclofenac, ketoprofen), including cyclooxygenase (COX)-2 inhibitors (e.g., celecoxib, etoricoxib), increase the risk of stomach and intestinal bleeding in patients receiving ibuprofen.
Aminoglycosides: NSAIDs, such as ibuprofen, increase aminoglycoside toxicity by decreasing the excretion of aminoglycoside antibiotics (e.g., amikacin, gentamicin, neomycin, tobramycin).
Antacids: The plasma levels of ibuprofen may be increased when taken together with antacids such as magnesium hydroxide.
Antihypertensives and Diuretics: NSAIDS may reduce the effect of these drugs (e.g., captopril, enalapril, losartan, telmisartan); diuretics (e.g., furosemide) may also cause acute reduction in kidney function of NSAIDs.
Blood Thinning Medicines (Anticoagulants): When taken with blood thinning (anticoagulant) medicines (e.g., warfarin, dicumarol) or together with thrombolytic agents (e.g., streptokinase), ibuprofen may cause stomach and intestinal bleeding.
Cardiac Glycosides: NSAIDs may worsen heart failure, reduce kidney function and increase blood levels of these medicines (e.g., digoxin).
Cholestyramine: May reduce the absorption of ibuprofen.
Ciclosporin and Tacrolimus: Increased risk of kidney damage.
Corticosteroids, Selective Serotonin-Reuptake Inhibitors (SSRIs), and Anti-platelet Agents: May increase the risk of stomach bleeding with ibuprofen.
Ginkgo Biloba: May enhance the risk of bleeding when given with ibuprofen.
Lithium and Methotrexate: Ibuprofen increases the amount of lithium and methotrexate in the blood, thus increasing the risk of toxicity.
Medicines Affecting Liver Enzymes: Medicines which hinder the enzymes responsible for the metabolism of ibuprofen may alter its safety and efficacy.
Medicines that Lower Blood Sugar (for Diabetes): Ibuprofen may increase plasma levels of medicines used to treat diabetes (sulfonylureas such as gliclazide, glipizide, glimepiride) and insulin by inhibiting their metabolism.
Probenecid: May reduce the metabolism and excretion of ibuprofen, thus increasing the risk of ibuprofen toxicity.
Quinolone Antibiotics: A possible increased risk of convulsions may occur with ibuprofen.
Zidovudine: An increased risk of blood problems such as bleeding into a joint (hemarthrosis) and bruising (hematoma) may result when given with ibuprofen.
Tell the doctor if the patient is taking other medicines, including vitamins, supplements, and herbal medicines.

Store at temperatures not exceeding 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

Non-Rx