Medication info

Donafen M Soft Capsules

OTC medicationSoft capsule경구
Ingredient · strength
Ibuprofen›200mg / 1 capsuleMagnesium Aluminometasilicate›100mg / 1 capsule
Manufacturer / importer
(주)서흥
Appearance
Red oval soft capsules containing white contents
Packaging
10 capsules/box [(10 capsules/PTP)*1]
Approval status
Active

MFDS item code 202201645 · Notified 2022.04.21

Summary

Main use
Relief of pain (e.g., headache, toothache) and fever
Who takes it
Adults · Children
Adult dose
Aged 15 years and above (adults): 1 to 2 capsules per dose, up to 3 times a day. Take with food and maintain an interval of at least 4 hours between doses.
Child dose
Children aged 7 to under 15 years: 1 capsule per dose, up to 3 times a day. Take with food and maintain an interval of at least 4 hours between doses.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Relief of pain (e.g., headache, toothache) and fever

  • Headache
  • toothache
  • post-extraction pain
  • sore throat
  • ear pain
  • joint pain
  • neuralgia
  • low back pain
  • muscle pain
  • shoulder pain
  • bruising
  • fracture pain
View approved original text

This medication is used to alleviate various types of pain, including headaches, toothaches, and post-extraction pain. It is also effective in reducing symptoms such as sore throat, ear pain, joint pain, neuralgia, low back pain, muscle pain, shoulder stiffness, bruising, fracture pain, sprain pain, menstrual pain, and trauma-related pain. Additionally, it helps reduce fever and symptoms such as chills.

How to take

Adult dose

Aged 15 years and above (adults): 1 to 2 capsules per dose, up to 3 times a day. Take with food and maintain an interval of at least 4 hours between doses.

Child dose

Children aged 7 to under 15 years: 1 capsule per dose, up to 3 times a day. Take with food and maintain an interval of at least 4 hours between doses.

Precautions

This medication should be consulted with a doctor or pharmacist before use by individuals who regularly consume more than three glasses of alcohol daily, as it may increase the risk of gastrointestinal bleeding. Caution is advised for individuals with cardiovascular diseases or risk factors, especially those with hypertension, heart failure, ischemic heart disease, peripheral artery disease, or cerebrovascular disease. High doses may increase the risk of thrombotic events, such as myocardial infarction or stroke. It should not be used by those with allergies to this medication or its components, those who have experienced asthma attacks, and infants under 3 months of age. It is also advisable to avoid co-administration with other antipyretic analgesics, cold medicines, and sedatives during treatment. Children suspected of having chickenpox or influenza, especially those under 15 years old, should consult a healthcare provider before use. Individuals with allergies, liver, kidney, thyroid conditions, diabetes, hypertension, the elderly, pregnant or breastfeeding women should also consult a healthcare professional before use. Care should be taken if gastrointestinal issues such as heartburn, stomach pain, ulcers, bleeding, or severe dehydration due to vomiting or diarrhea are present. This medication may reduce the efficacy of aspirin when taken together and increase the risk of gastrointestinal adverse reactions, so consultation with a professional is advised. If symptoms such as rash, itching, vomiting, stomach pain, dizziness, or swelling occur during treatment, discontinue use immediately and consult a healthcare provider. Severe allergic reactions or skin adverse reactions may occur, requiring immediate treatment. Adhere strictly to the prescribed dosage and avoid long-term use, as well as avoiding alcohol during treatment. After 20 weeks of pregnancy, there is a risk of fetal renal function impairment and oligohydramnios; therefore, it is recommended to use the minimum effective dose for the shortest duration and to consider ultrasound examinations if necessary. Store this medication out of reach of children in a tight container, avoiding direct sunlight and keeping it in a cool, dry place. Furthermore, it is important not to transfer it to other containers to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, cold sweat, pallor, difficulty breathing → severe allergic reaction. Severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes → severe skin adverse reactions. Asthma, shortness of breath or difficulty breathing → respiratory issues. Conis syndrome → severe edema or urination problems. Accompanied by elevated blood pressure (possible association with severe edema or urination problems).

Mild side effects

  • Nausea
  • vomiting
  • loss of appetite
  • constipation
  • stomach pain
  • abdominal discomfort
  • dizziness
  • swelling
  • rash
  • redness
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  • itching
  • joint pain
  • pruritus

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is essential to maintain a storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Red oval soft capsules containing white contents

Package unit

10 capsules/box [(10 capsules/PTP)*1]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.