Caution: The following texts are translated from the Japanese original. We cannot take responsibility for ambiguity in the translation.

Designated Category 2 OTC medicine

ルミフェン LUMIFEN

Product features

● A non-steroidal anti-inflammatory analgesic formulated with alminoprofen.
● Relieves inflammation and works to alleviate symptoms such as arthralgia and reduce fever.

Indication

(1) Relief of joint pain, lumbago, pain due to stiff shoulders, sore throat (throat pain),headache, toothache, pain after tooth extraction, earache, neuralgia, muscular pain, contusion pain, bone fracture pain, pain associated with sprain (sprain pain), painful menses (menstrual pain), and traumatic pain
(2) Relief of fever at the time of chills (feeling cold due to fever) and fever

Dosage and administration

When symptoms appear, take the following single dose. Avoid taking on an empty stomach as much as possible. Always leave at least 4 hours between doses.

<Age: single dose: number of daily doses>
Adults (over 15): 1tablet: 2x as the limit (however, can be consumed for the third time if symptoms reoccur)
Under 15 years old: Do not take

Precautions of Dosage and Administration

(1)Strictly follow the prescribed dosage and administration.
(2) How to Dispense Tablets
Using a finger, push the convex portion of the PTP sheet containing tablets to break the aluminum foil on the back.
 (Can lead to unforeseen consequences such as piercing the esophageal mucosa if mistakenly swallowed)"

Ingredient and amount

In 1tablet
Aluminoprofen :200mg:Relieves inflammation and works to alleviate symptoms such as joint pain and
reduce fever.

Precautions

■When not to use the product
(If you do not follow these instructions, the current symptoms may worsen or adverse reactions/incidents are more likely to occur.)
1.This product should not be taken by the following persons.
(1)Those who have experienced allergic symptoms to this medication or any of its ingredients
(2)Patients who have experienced asthma from taking this drug, other antipyretic analgesics, cold remedies.
(3)Children under 15 years old.
(4) Those who have been diagnosed with the following.
 gastric/duodenal ulcer
(5) Pregnant women who are expected to given birth within 12 weeks.
2.This drug should not be taken together with the following drugs:
Other antipyretics/analgesics, cold medicine, sedatives
3.Do not operate vehicles or machinery if you experience drowsiness, dizziness, and temporary loss of vision after takin this medication.
4.Do not drink alcohol before/after taking this medicine
 (Generally, alcohol accelerates absorption of medication and speeds up metabolism, and since this increases the occurrence of side effects and toxicity, it may result in severe liver damage.)
5.Do not take this medicine for a long time

■Consultation
1.The following persons should contact a physician, dentist, pharmacist, or registered salesperson for a consultation before administration.
(1)Patients undergoing medical treatment from a physician or dentist.
(2)Pregnant women or women suspected of being pregnant.
(3)Nursing women.
(4)The elderly
(5)Patients who have experienced allergic symptoms associated with drugs, etc.
(6) Those who have been diagnosed with the following.
  blood disease, liver disease, kidney disease, heart disease, bronchial asthma, ulcerative colitis, crohn's disease
(7)Patients who experienced any of the following diseases.
gastric/duodenal ulcer, blood disease, liver disease, kidney disease
2.Symptoms such as excessive body temperature drop, lethargy (loss of strength), and cold limbs (cold hands and legs) may appear after taking antipyretic analgesics such as this medication. In such cases, discontinue use and consult a doctor, pharmacist, or registered seller with this document.
3.If the following symptoms are observed after taking this drug, these may be adverse reactions, so immediately discontinue the use of this drug, and show this document to your physician, pharmacist, or registered salesperson for a consultation.


Skin:rash/redness,itching,
Gastrointestinal system:stomachache,abdominal pain, stomach/ abdominal discomfort, nausea and vomiting,stomach heaviness, loss of appetite, stomatitis, dry mouth
Neuropsychiatric system:drowsiness, numbness in mouth, finger numbness, hoarse voice, disorientation, headache, dizziness
Cardiovascular system:palpitations
Respiratory system: shortness of breath
Other:edema, fever, nose bleeds, taste disorder, hair loss, transient vision loss

The following serious symptoms may occur in rare cases. In such cases, immediately seek medical aid:
<Symptom name: Symptoms>
Shock (anaphylaxis): Symptoms, such as itching of skin, urticaria, hoarseness, sneezing, itchy throat, breathing difficulties, palpitations, and clouding of consciousness may occur immediately after take.
Oculomucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis: Hyperthermia, ocular hyperaemia, eye discharge, lip erosion, pain throat, widespread skin rash/redness, etc. may persist or suddenly worsen.
Hepatic function failure: Symptoms, such as fever, itching, rash, jaundice (yellowing of skin and white of eyes), brown urine, general malaise, loss of appetite, etc. may occur.
Erythroderma (exfoliative dermatitis): Rash/redness and itching appear on skin all over the body, accompanied by high fever.
Hemorrhagic shock: Pulse increases, pallid complexion, cold limbs, and cold sweats occur.
Blood disorder (aplastic anemia, agranulocytosis): Sore throat, fever, overall lethargy, whiteness on the face and under the eyelids, tendency to bleed (gum bleeding, nosebleeds, etc.), blue bruises (color does not go away when pushed) and other may occur.
Blood disorder (hemolytic anemia): Worsening complexion, easily fatigued, lethargy, heart palpitations, and shortness of breath may occur.
Kidney disorders: Symptoms, such as fever, rash, reduced urinary volume, general oedema, general malaise, arthralgia (painful joints) and diarrhea, etc. may occur.
Interstitial pneumonia: Shortness and/or difficulties of breath when go upstairs or overwork, sudden dry cough and/or fever and its continuance
Congestive heart failure:Overall lethargy, heart palpitations, shortness of breath, chest discomfort, chest pain, dizziness, fainting and other may occur.
Aseptic meningitis: Symptoms, such as severe headache with a tight sensation along the neck, fever and feeling nausea/vomiting, etc. may occur. (these symptoms are frequently reported particularly in patients under treatment for systemic lupus erythematosus or mixed connective tissue disease. )
Asthma: Symptoms, such as wheezing or hissing when breathing, and difficult breathing, etc. may occur.

4.The following symptoms may be observed after taking this drug. If these symptoms persist or worsen , discontinue the use of this drug, and show this document to your physician, pharmacist, or registered salesperson for a consultation.
constipation, diarrhea
5.When symptoms do not improve even after taking the medicine 1 to 2 times, stop taking this medicine and consult a physician, dentist, pharmacist or registered salesperson, being sure to take this instruction leaflet with you. (another illness may also be considered).

Additive

Lactose, corn starch, hydroxypropyl cellulose, talc, Mg stearate, hypromellose, macrogol, sucrose, Ca carbonate, povidone, titanium oxide, carnauba wax

Precautions for storage and handling

(1)Store in a cool, low humidity place away from direct sunlight.
(2)Keep out of reach of children.
(3)Do not transfer the medicine to a different container. (It may lead to misuse or alter the quality of the drug. )
(4)Do not take the product after its expiration date.

Disclaimer on Multilingual Product Information

・This product is a pharmaceutical product approved under a Japanese law, the Law for Ensuring the Quality, Efficacy and Safety of Drugs and Medical Devices, with a view to its sale and use in Japan.

・Multilingual product information is a translation of the product labeling written in Japanese and provided for your information only. It does not warrant that its contents and the product itself conforms to laws and regulations in countries other than Japan.

・Multilingual product information is a tentative translation by Our Company, and may be modified or altered without notice.

・Our Company assumes no responsibility for any occurred problem attributable to the contents of the multilingual product information.