البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
TETRAHYDROZOLINE HYDROCHLORIDE
J-C HEALTH CARE LTD
S01GA02
EYE DROPS, SOLUTION
TETRAHYDROZOLINE HYDROCHLORIDE 0.05 %
OCULAR
Not required
JANSSEN PHARMACEUTICA N.V.,BELGIUM
TETRYZOLINE
TETRYZOLINE
Relief from soreness, burning, itching, irritation redness due to congestion of the eyes.
2022-07-31
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed without a doctor’s prescription VISINE ® Original Eye Drops ACTIVE INGREDIENTS - Tetrahydrozoline HCl 0.05% Inactive and allergenic ingredients: see section 6 _“Further Information”_. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. THE MEDICINE IS INTENDED FOR ADULTS AND CHILDREN ABOVE THE AGE OF 6. FOR USE IN CHILDREN BELOW THIS AGE, REFER TO A DOCTOR. Use this medicine in accordance with the instructions in the dosage section in this leaflet. Consult the pharmacist if you need further information. Refer to the doctor if signs of the illness worsen or do not improve after 3 days. 1. WHAT IS THE MEDICINE INTENDED FOR? VISINE ORIGINAL EYE DROPS: For relief of burning, stinging, irritation and redness of the eyes. THERAPEUTIC GROUP: Sympathomimetic decongestants. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredients or to any of the additional ingredients contained in the medicine (see details in section 6 – “Further Information”). • You suffer from narrow-angle glaucoma. • Do not use this medicine in patients under the age of two years. ! SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH THE MEDICINE, TELL THE DOCTOR IF: o You are suffering from an infection, the presence of a foreign body, and mechanical or chemical injury of the eye. • Use the medicine only for mild irritation of the eyes. • Use of the medicine is not recommended in complex conditions of the eye, such as glaucoma. • Avoid contact of the medicine with the skin in cases of inflammation or injury, due to the presence of boric acid among the medicine’s ingredients. • Discontinue use and refer to a doctor if the signs of the illness (symptoms) do not improve within 3 days, or اقرأ الوثيقة كاملة
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Visine original eye drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN ACTIVE INGREDIENTS Tetryzoline Hydrochloride 0.05% w/v Excipients with known action: Visine original eye drops contains benzalkonium chloride and boric acid. 3. PHARMACEUTICAL FORM Ophthalmic solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief from soreness, burning, itching, irritation redness due to congestion of the eyes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children aged 6 years and older: Instil 1-2 drops of Visine original eye drops on each eye, 4 times per day at most. Children aged 6-12 years old : Use under the supervision of an adult. Children aged 2-6 years old: Use under the supervision of a healthcare professional. 4.3 CONTRAINDICATIONS • Known hypersensitivity to the active ingredient or to any of the excipients. • Narrow angle glaucoma. • Children under 2 years old. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Visine original eye drops must be used only for light ophthalmic irritations. In cases of infections, presence of foreign objects in the eyes and mechanical or chemical eye trauma, it is necessary to consult your doctor. The use of Visine original eye drops is not indicated for serious ophthalmic conditions, such as glaucoma. In addition, contact between Visine original eye drops and the skin must be avoided in presence of an inflammation or trauma, due to the boric acid contained. The use of the product must be stopped and the condition evaluated by a healthcare professional if no relief occurs within 72 hours or if the disturbance and hyperaemia persist or increase, or if pain develops in the eye, along with changes in vision. The long-term use and abuse of the product could lead to increase or reactive hyperaemia. When using the product, the pupils of the eyes may temporarily enlarge. 2 The use of the product may cause temporary mydriasis. The container nozzle must not come into contact with any surface to preve اقرأ الوثيقة كاملة