ספטמבר 2026

רופא/ה, רוקח/ת נכבד/ה,

ברצוננו להודיעך כי חלו מספר עדכונים בעלון לרופא עבור התכשירים הרפואיים:

Nurofen Quick 256 mg – 142-71-31929-00

Nurofen Quick 512 mg – 142-72-31944-00

מרכיב פעיל וכמותו:

Ibuprofen sodium dihydrate 256 mg (equivalent to 200 mg ibuprofen)

Ibuprofen sodium dihydrate 512 mg (equivalent to 400 mg ibuprofen)

התוויה:

For the symptomatic relief of mild to moderate pain, such as headache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, the pain of non-serious arthritis, migraine, cold and flu symptoms, sore throat and fever

בהודעה זו מצוינות התוספות המהותיות ועדכונים אשר מהווים החמרה בלבד. השינויים המודגשים ברקע צהוב מהווים החמרה.

בעלון לצרכן ובעלון לרופא ישנם שינויים נוספים שאינם מהווים החמרה, תוספת מידע וכן השמטת מידע.

העלונים נשלחו לצורך העלתם למאגר התרופות שבאתר משרד הבריאות וניתן לקבלם מודפסים על ידי פניה לבעל הרישום:

רקיט בנקיזר (ניר איסט) בע”מ, רחוב הנגר 6 הוד השרון, מיקוד 4527704.

טל’ 09-9611700.

בברכה,

שרית רוזן רוקחת ממונה

רקיט בנקיזר (ניר איסט) בע”מ

 

4.6 Fertility, Pregnancy and lactation

Pregnancy:

Ibuprofen should be avoided during the first and second trimesters of pregnancy. During the third trimester, the use of ibuprofen is contraindicated.

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryofoetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

 

4.8 Undesirable effects

System Organ Class Frequency Adverse Event
Blood and Lymphatic System Disorders Very rare Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis).First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Immune System Disorders Uncommon Urticaria and pruritus
Very rare Severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).
Not Known Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea.
Nervous System Disorders Uncommon Headache
Very rare Aseptic meningitis
Cardiac Disorders Not Known Cardiac failure and oedema
Not Known Kounis syndrome
Vascular Disorders Not Known Hypertension
Respiratory, Thoracic and Mediastinal Disorders Not Known Respiratory tract reactivity comprising asthma, bronchospasm or dyspnoea
Gastrointestinal Disorders Uncommon Abdominal pain, nausea, dyspepsia
Rare Diarrhoea, flatulence, constipation and vomiting
Very rare Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis.
Not Known Exacerbation of colitis and Crohn’s disease (section 4.4).
Hepatobiliary Disorders Very rare Liver disorders
Skin and Subcutaneous Tissue Disorders Uncommon Various skin rashes
Very rare Severe cutaneous adverse reactions (SCARs), Bullous reactions, including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
Acute generalised exanthematous pustulosis (AGEP)
Photosensitivity reactions

 לעלון לרופא לחצו כאן