Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
M01AE51
CAPSULES LIQUID FILLED
IBUPROFEN 200 MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG
PER OS
Not required
FAREVA RICHMOND INC, USA
IBUPROFEN, COMBINATIONS
IBUPROFEN, COMBINATIONS
Temporarily relieves symptoms associated with the common cold, or flu: in the presence of fever or pain with associated congestion.
2021-10-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor's prescription ADVIL COLD & SINUS 200 MG/30 MG LIQUI-GEL CAPSULES ACTIVE INGREDIENTS: Each Liqui-Gel capsule contains: Ibuprofen 200 mg (present as the free acid and potassium salt) Pseudoephedrine HCl 30 mg For the list of inactive ingredients and allergens in the medicine see section 2, subsection “Important information about some of the ingredients of the medicine” and section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. Take the preparation according to the instructions in the dosage section of this leaflet. Consult the pharmacist if you need more information. Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve after 10 days. 1. WHAT IS THE MEDICINE INTENDED FOR? For the temporary relief of symptoms associated with common cold or flu in the presence of fever or pain accompanied by nasal congestion. THERAPEUTIC CLASS: Ibuprofen belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). Pseudoephedrine belongs to the class of vasoconstrictors (blood vessel constrictors), and acts on the nasal blood vessels to relieve nasal congestion. 2. BEFORE USING THE MEDICINE X DO NOT USE ADVIL COLD & SINUS IF: • You are sensitive (allergic) to ibuprofen or pseudoephedrine, or to any of the other ingredients the medicine contains, as detailed in section 6, or if you have had an allergic reaction to a similar medicine in the past, such as aspirin/acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). Signs of an allergic reaction include skin rash, hives, itching, breathing difficulties, chest pressure, swelling of the mouth, face, lips or tongue. • You are under 12 years old. • You are pregnant or breastfeeding. • You have a stomach ulcer Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ADVIL COLD & SINUS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES MG/CAPSULE Ibuprofen 200 Pseudoephedrine Hydrochloride 30 Excipients with known effect: Sorbitol (E 420), soy lecithin blend, potassium. This medicine contains 17.8 mg of potassium in each capsule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Liquid filled capsules. A clear, light orange to light yellow with a slight orange hue, oval softgel filled with clear liquid, printed "Advil C&S" with black ink, compiled in a blister. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of symptoms associated with common cold or flu symptoms in the presence of fever or pain with associated congestion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short-term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). This combination product should be used where both, the decongestant action of pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory action of ibuprofen are required. If one symptom (either nasal congestion or headache and/or fever) predominates, single-agent therapy is preferable. Posology Adults, older people and adolescents over 12 years of age: Take 1 capsule every 4-6 hours to a maximum of 6 capsules in any 24 hour period. In case of more intense symptoms, 2 capsules (400 mg ibuprofen/60 mg pseudoephedrine hydrochloride) may be taken at a time. The dose can be repeated, if necessary, at six-hour intervals without exceeding a maximum daily dose of 6 capsules (1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride). Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Maximum duration of treatment is 10 days. Paediatric population _ _ Advil Cold & Sinus is contraindicated in children under the age of 1 Lugege kogu dokumenti