Loxonin S is a Japanese antipyretic analgesic (Class 1 OTC drug) by Daiichi Sankyo Healthcare for headache, menstrual pain and other pain, and for fever.
Each tablet contains loxoprofen sodium hydrate 68.1 mg (60 mg as anhydrate); it contains no sedative-hypnotic ingredient.
Form: very pale red uncoated tablets.

Indications

Relief of headache, menstrual pain (period pain), toothache, pain after tooth extraction, sore throat, lower back pain, joint pain, neuralgia, muscle pain, stiff-shoulder pain, earache, bruise pain, fracture pain, sprain pain and pain from injuries.
Relief of fever with chills.

Ingredients & form

Very pale red uncoated tablet. Each tablet contains:
- Loxoprofen sodium hydrate 68.1 mg (60 mg as anhydrate)
Additives: hydroxypropyl cellulose, magnesium stearate, lactose hydrate, iron sesquioxide.
Red specks from the additives may be seen on the tablet.

Dosage

Take the following dose with water or warm water.
Adults (15 years and over): 1 tablet per dose, up to twice a day. Take it when symptoms appear, avoiding an empty stomach where possible. If symptoms appear again, a third dose may be taken. Leave at least 4 hours between doses.
Children under 15: do not use.
Precautions related to dosage:
(1) Strictly follow the dosage and administration.
(2) Take the tablet out by pressing it firmly through the foil of the blister sheet; swallowing it with the blister sheet can pierce the oesophageal mucosa or cause other accidents.
A doctor's instructions prevail.

Warnings

Do not use (not following this may worsen current symptoms or make side effects more likely):
1. Do not take this product if you:
- have ever had an allergic reaction to this product or any of its ingredients;
- have ever had asthma after taking this product, other antipyretic analgesics or cold medicines;
- are a child under 15 years of age;
- are being treated at a medical institution for gastric/duodenal ulcer, liver disease, kidney disease or heart disease;
- have been told by a doctor that you have a blood disorder such as a low red blood cell count (anaemia), a low platelet count (blood does not clot easily, bleeding easily) or a low white blood cell count;
- are pregnant and within 12 weeks of the expected delivery date.
2. While taking this product, do not take any of the following: other antipyretic analgesics, cold medicines, sedatives.
3. Do not drink alcohol before or after taking it.
4. Do not take it continuously for a long time (if pain or other symptoms keep recurring after 3–5 days of use, stop and see a doctor).
Consult a doctor, dentist or pharmacist before use if you:
- are under the care of a doctor or dentist;
- are pregnant or think you may be pregnant;
- are breast-feeding;
- are elderly;
- have ever had an allergic reaction to a medicine or other substance;
- have been diagnosed with bronchial asthma, ulcerative colitis, Crohn's disease, systemic lupus erythematosus or mixed connective tissue disease;
- have had gastric/duodenal ulcer, liver disease, kidney disease or a blood disorder.
Stop use at once and consult a doctor, dentist or pharmacist, taking this leaflet with you, if after taking it (possible side effects):
- after taking an antipyretic analgesic like this one, an excessive drop in body temperature, collapse (weakness) or cold hands and feet appear;
- a peptic ulcer or swelling (oedema) appears; rarely, serious gastrointestinal bleeding (vomiting blood, nausea/vomiting, abdominal pain, black tarry stools, bloody stools), gastrointestinal perforation (a hole in the digestive tract: nausea/vomiting, severe abdominal pain) or narrowing/obstruction of the small or large intestine (nausea/vomiting, abdominal pain, abdominal bloating) may occur — in that case see a doctor immediately;
- skin: rash/redness, itching;
- digestive system: abdominal pain, stomach discomfort, loss of appetite, nausea/vomiting, bloating, heartburn, mouth ulcers (stomatitis), indigestion;
- circulation: raised blood pressure, palpitations;
- nervous system: drowsiness, numbness, dizziness, headache;
- other: chest pain, fatigue, facial flushing, fever, anaemia, blood in the urine.
Rarely the following serious symptoms may occur — in that case see a doctor immediately:
- shock (anaphylaxis): soon after taking it, itching of the skin, hives, hoarseness, sneezing, itchy throat, breathing difficulty, palpitations, clouding of consciousness;
- blood disorders: sore throat, fever, general malaise, whitish inside of the face or eyelids, bleeding easily (bleeding gums, nosebleeds), bruises (that do not fade when pressed);
- mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis, erythema multiforme, acute generalised exanthematous pustulosis: high fever, red eyes, eye discharge, sore lips, sore throat, widespread rash/redness, blisters on reddened skin, small pustules on reddened skin, general malaise, loss of appetite, persisting or rapidly worsening;
- kidney damage: fever, rash, reduced urine volume, swelling of the whole body, general malaise, joint pain, diarrhoea;
- congestive heart failure: general malaise, palpitations, shortness of breath, chest discomfort, chest pain, dizziness, fainting;
- myocardial infarction: tightening chest pain, breathing difficulty, cold sweat;
- cerebrovascular disorder: sudden loss or clouding of consciousness, difficulty moving the arm and leg on one side, headache, vomiting, dizziness, slurred speech or difficulty finding words;
- interstitial pneumonia: breathlessness or breathing difficulty on climbing stairs or slight exertion, dry cough, fever, appearing suddenly or persisting;
- liver dysfunction: fever, itching, rash, jaundice (yellowing of the skin and whites of the eyes), dark brown urine, general malaise, loss of appetite;
- rhabdomyolysis: pain, numbness, weakness or stiffness of the muscles of the limbs, shoulders or lower back, general malaise, reddish-brown urine;
- aseptic meningitis: severe headache with stiff neck, fever, nausea/vomiting (reported especially in people treated for systemic lupus erythematosus or mixed connective tissue disease);
- asthma: wheezing or whistling when breathing, breathing difficulty.
If dry mouth, constipation or diarrhoea continue or get worse after taking it, stop use and consult a doctor or pharmacist, taking this leaflet with you.
If symptoms do not improve after 1–2 doses (another disease may be the cause), stop use and consult a doctor, dentist or pharmacist, taking this leaflet with you.

Storage

(1) Store in a cool place with little humidity, away from direct sunlight.
(2) Keep out of the reach of children.
(3) Do not transfer to another container (this may cause misuse or change the quality).
(4) Do not use after the expiry date shown.