16.01.2020 Tarihli Asetil Salisilik Asit İçeren Tekli veya Kombine İlaçlar Hk_ ENG

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MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY Medicines and Medical Devices Agency of Turkey

Number : 62820468-000-E.12525 Subject : Medicines containing acetyl salicylic acid alone or in combination NORMAL

16.01.2020 DOSSIER Ref: Our decision for Associations, dated 04.04.2019, with No. E. 56366.

The section on “2-Products containing only Acetyl Salicylic Acid (75 mg, 80 mg, 81 mg, 100 mg, 150 mg, 300 mg)” in our association announcement regarding products containing acetyl salicylic acid alone or in combination” has been amended in line with the decision adopted by the “Clinical Evaluation Commission of Medicinal Products for Human Use” within our Agency and the updated association decision is provided below.
It has been decided to annul the following association decisions upon their re-evaluation by the “Clinical Evaluation Commission of Medicinal Products for Human Use”: • Association announcement dated 19.07.2007 on “Preparations Containing Combination of Acetyl Salicylic Acid and Ascorbic Acid”, • Association announcement dated 20.04.2009, on “Acetyl Salicylic Acid Preparations”, • Association announcement dated 06.02.2012, with No. 0012552 and job tacking No. 549646, on “Preparations Containing Acetyl Salicylic Acid”, • Association announcement dated 07.08.2014, with No. 95839 and job tacking No. 1391881, on “Preparations Containing Acetyl Salicylic Acid”, • Association announcement dated 30.09.2014, with No. 117489 and job tacking No. 1445084 on “Preparations Containing Acetyl Salicylic Acid”. • Furthermore, it is suitable for all preparations containing acetyl salicylic acid alone or in combination to be prescription medicines. 1-General Provisions: a- The upper limits on what may be contained in the indications specific to the active substance content of each medicinal product have been designated below. Registration applicants may declare one, some or all of these indications relating to the product referred in the circular in the indications section of the product; however, they should not add a new indication other than these. b- In case of statements indicating the “age limit for children/adults” in the indications of the products, it is mandatory for registration applicants to remove the statements on age from this section, add the following note instead of these and indicate in the relevant section what is required by this note. Note: Registration applicants may declare the upper age limit where desired provided that they do not go below the age limit indicated for children in their declarations on critical age groups.

2- The indications should be as follows for products containing only Acetylic salicylic acid (75 mg, 80 mg, 81 mg, 100 mg, 150 mg, 300 mg):

SUMMARY OF PRODUCT CHARACTERISTICS It may be used,

• As part of standard treatment in unstable angina pectoris,
• As part of standard treatment in acute myocardial infarction,
• In reinfarction prophylaxis,
• Following the operations and other interventions related with arterial blood vessels [Percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG)],
• In the prevention of transient ischemic attacks and cerebral infarction in risky patient groups,
• In Kawasaki disease; ○ For reducing inflammation in the febrile period, ○ As a prophylactic in the prevention of thrombocyte aggregation in coronary aneurysm.
• For the purpose of preventing cardiovascular events to all persons who fulfill the following conditions in people with no atherosclerotic cardiovascular disease: ○ Patients aged between 40-70 years, ○ With a 10-year cardiovascular event risk of more than 10% (SCORE risk calculation, etc.), ○ With a low bleeding potential.

PACKAGE LEAFLET

• As part of standard treatment in chest pain occurring at rest/not associated with movement (Unstable angina pectoris),
• As part of standard treatment in sudden heart attack (Acute myocardial infarction),
• In the protection against recurrence of heart attack (reinfarction),
• In the prevention of vascular occlusion and clots following cardiovascular surgeries,
• In the prevention of temporary paralyses and strokes in risky patient groups,
• In vasculitis frequently developing in young children under the age of five and characterized with fever, skin rash, strawberry tongue, red and cracked lips, redness in the palms of the hands and the soles of the feet (Kawasaki disease),
  ○ For reducing inflammation in the febrile period ○ In the prevention of blood clotting in of abnormal expansion (aneurism) in the walls of blood vessels feeding the heart.
• It may be used for the purpose of preventing cardiovascular events to all persons who fulfill all of the following conditions in people with no atherosclerotic cardiovascular disease: ○ Patients aged between 40-70 years, ○ With a 10-year cardiovascular event risk of more than 10% (SCORE risk calculation, etc.),

○ With a low bleeding potential.

3- The indications should be as follows for Acetyl salicylic acid 500 mg: “- In mild-moderate pains,

• Fever, See section 4.4. Special warnings and precautions for use for children and adolescents.)” 4-The indications for Acetyl salicylic acid + Ascorbic acid (Vitamin C) or citric acid should be as follows: (The upper limits for the active substance amount should be 500 mg for ASA + 250 mg for Vitamin C, respectively.) “It is indicated in pain and fever associated with cold and flu in adolescents aged 16 and above and adults.” 5- The indications for Acetyl salicylic acid + Pseudoephedrine should be as follows (The upper limits for the active substance amount should be 500 mg for ASA + 30 mg for Pseudoephedrine, respectively. All precautions relating to pseudoephedrine should be arranged in line with the Association announcement dated 15.03.2018, with No. E.50239 on “Medicines containing pseudoephedrine salts”:

“It is indicated in case of nasal congestion where fever is accompanied by pain and cold and flu accompanied with mild body pain in adolescents aged 16 and above and adults”.

SUMMARY OF PRODUCT CHARACTERISTICS The following statement should be included into the section 4.4. Special warnings and precautions for use: “It should be used with caution in patients aged above 60, with hypertension, hyperthyroidism, diabetes mellitus, cardiovascular disease, ischemic heart disease, glaucoma, kidney failure or prostate hypertrophy (hyperplasia). It should not be used for longer than five days.”

PACKAGE LEAFLET The statement mentioned in the section “USE … CAREFULLY in the following conditions” should be arranged as follows: “It should be used with caution in patients aged above 60, with hypertension, hyperthyroidism, diabetes, cardiovascular disease, ischemic heart disease (disease which develops due to malnutrition of heart muscle), glaucoma (elevation in intraocular pressure), kidney failure or prostate enlargement. It should not be used for longer than five days.” 6-The indications for Acetyl salicylic acid + Caffeine should be as follows: (The upper limits for the active substance amount should be 500 mg for ASA + 65 mg for Caffeine, respectively) “It is indicated for mild and moderate acute pain and febrile conditions in adolescents aged 16 and above and adults.” 7- The indications for Acetyl salicylic acid + Paracetamol + Caffeine should be as follows: [The total upper limit of both active substances in the combination of ASA + Paracetamol should not surpass 500 mg (their individual amount should not be less than 200 mg) + the upper limit of Caffeine should be 65

mg. In combination preparations containing paracetamol, the daily dose of paracetamol should not surpass 2 grams in those taking alcohol and 4 grams in those not taking alcohol.]

SUMMARY OF PRODUCT CHARACTERISTICS “It is indicated in mild and moderate pains such as headache, dental pain, acute migraine attacks, neuralgia, musculoskeletal system pains and dysmenorrhea and conditions accompanied with pain such as cold in adolescents aged 16 and above and adults. See section “4.4. Special warnings and precautions for use” of the product for children and adolescents.

PACKAGE LEAFLET “It is indicated in mild and moderate pains such as headache, dental pain, acute migraine attacks, neuralgia, musculoskeletal system pains and dysmenorrhea and conditions accompanied with pain such as cold in adolescents aged 16 and above and adults. See section “4.4. Special warnings and precautions for use” of the product for children and adolescents. 8- Only one of the following statements specific to the product should be written in addition to “It should not be used without the physician’s recommendation in children” in the part on children in the section 4.4. Special warnings and precautions for use in the SPC of the products:

• In combination products containing ASA: “Its use is not recommended under the age of 16 unless there is a specific indication.”
• In products containing only ASA: “Its use is not recommended under the age of 16 unless there is a specific indication (such as Kawasaki disease).” 9-All statements related with indications, posology, warnings-precautions within the scope of this announcement shall be adequately reflected in the Package Leaflet as well.
  I hereby submit for your information and kindly request that the SPC/PL applications in which abovementioned amendments are made are sent to the Pharmacological Evaluation Unit regarding until 31.01.2020 for review. Dr. Hakkı GÜRSÖZ President of the Agency

Distribution: Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers Association of Turkey Turkish Pharmaceutical Industry Association Association of Innovator Pharmaceutical Companies Self-Care Products Association