HYDROCORTISONE 10 MG

Israel - English - Ministry of Health

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Active ingredient:
HYDROCORTISONE
Available from:
REKAH PHARMACEUTICAL INDUSTRY
ATC code:
H02AB09
Pharmaceutical form:
TABLETS
Composition:
HYDROCORTISONE 10 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
REKAH PHARMACEUTICAL PROD.LTD
Therapeutic group:
HYDROCORTISONE
Therapeutic area:
HYDROCORTISONE
Therapeutic indications:
Anti inflammatory.
Authorization number:
135 35 22570 00
Authorization date:
2011-08-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

08-09-2016

Patient Information leaflet Patient Information leaflet - Hebrew

08-09-2016

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS (PREPARATIONS) – 1986

The dispersing of this medicine requires a doctor’s prescription.

Read this package insert carefully in its entirety before using this medicine

The format of this leaflet was determined by the Ministry

of Health and its content was checked and approved by it in - 08/2011

Hydrocortisone 10 mg

Tablets

COMPOSITION: Each tablet contains: Hydrocortisone 10 mg

Inactive ingredients: Aerosil, Pregelatinized starch, Talc, Magnesium stearate,

Lactose (each tablet contains 35.5mg of Lactose).

Therapeutic activity: A glucocorticosteroid preparation indicated for treatment and

relief of inflammations, swelling, itching, severe allergies, skin problems, asthma

and rheumatic diseases.

Therapeutic group: Glucocorticosteroid.

When should the preparation not be used?

Do not use this medicine if you are sensitive to any of its ingredients.

Do not use this medicine if you are about to receive any type of live attenuated

vaccination.

Do not use this medicine if you are suffering from systemic fungal infections.

This medicine contains Lactose. Do not use this medicine if you are sensitive to lactose.

Do not take this medicine without consulting a doctor before starting

treatment:

If you are pregnant or breastfeeding. If you are suffering, or have suffered in the

past, from impaired function of: the heart and/or vascular system (high blood

pressure, clots in the veins), the eyes (e.g. glaucoma), the liver, the kidney/urinary

tract, the digestive system (e.g. ulcer), the thyroid gland, ocular herpes, bone

diseases (osteoporosis), tuberculosis, fungal infections or any other infections

serious

injury,

diabetes, AIDS,

recent

operation,

chickenpox,

measles,

hypercholesterolemia, myasthenia gravis, psychosis and lupus.

How will this medicine affect your daily life?

Do not drink wine or alcoholic beverages while under treatment with this medicine.

Warnings: Do not use this medicine frequently, or for a long period, without

consulting a doctor. If you are sensitive to any type of food or medicine, inform

your doctor before commencing treatment with this medicine. Patient should be

monitored for blood pressure changes. Patient should be monitored for vision

changes (blurred vision, cataract). Inform your doctor if you have to undergo a

skin test or an operation. When used for a prolonged period this medicine may

retard growth in children and adolescents, therefore, the doctor’s instructions

should be carefully followed. It is important for patients who has not already had

these illnesses to avoid contact with someone who has chickenpox or measles.

Diabetic patients- this medicine can affect blood glucose levels- if there is a change

in glucose levels in the blood or urine, consult your doctor. Use of this medicine may

cause oropharnygeal candidiasis. While using this medicine for a prolonged period

with large doses- patient should undergo periodic urinary free cortisol test.

Drug interactions: If you are taking another drug concomitantly or if you have just

finished treatment with another medicine, inform the attending doctor, in order to

prevent hazards or lack of efficacy arising from drug interactions. This is especially

important for medicines belonging to the following groups: drugs affecting the

central nervous system (e.g. sedatives, hypnotics, drug for parkinsonism, epilepsy),

rifampin,

diuretics/potassium

supplements,

antiacids,

amphotericin

oral

antidiabetic agents or insulin, digoxin, ritodrine, mitotane, live attenuated vaccines,

anticoagulants,

sodium

containing

medications,

cyclosporine,

ketoconazole,

pyridostigmine, griseofulvin, clarithromycin, erythromycin, quinolone’s antibiotics

(Ciprofloxacin, Levofloxacin, Ofloxacin).

Side effects: In addition to the desired effect of the medicine, adverse reactions

may occur during the course of taking this medicine, for example: impaired skin

healing, depression, euphoria, increased appetite, gastrointestinal disturbances,

nervousness or restlessness, insomnia, dry mouth, diarrhoea, nausea, weakness,

rash. These side effects usually disappear within a short time following the period

of adaptation to the medicine.

Effects that require special attention:

Blurred vision, frequent urination, increased thirst (rare): continue treatment and

contact your doctor. Swelling of the legs or face (rare): stop treatment and contact

your doctor. Menstrual problems (rare): stop treatment and contact your doctor.

Dizziness, vomit with blood (rare): stop treatment and contact your doctor.

Signs of infection: sore throat, fever, sneezing or cough: contact your doctor as

soon as possible. Muscle cramps, muscle weakness, reddish-purple strips on the

skin, eye sensitivity to light, growth impairment in children, swollen legs, excessive

hair growth, acne, osteoporosis, cataract, glaucoma, hyperglycemia, pulmonary

tuberculosis, disturbed levels of water and\or salt content,contact the doctor.

In the event that you experience side effects not mentioned in this leaflet, or if there

is a change in your general health, consult your doctor immediately.

Dosage: Dosage is according to doctor’s instructions only.

Do not exceed the recommended dosage. If you forget to take this medicine at the

specified time, take the dose as soon as you remember, but never take a double

dose to compensate for a missed one!

Directions for use: Take the medicine with a meal. Take antacids between meals.

The tablet can be halved or crushed.

How can you contribute to the success of the treatment?

Even if there is an improvement in your health, do not discontinue use of this

medicine before consulting your doctor. If the doctor instructed you to discontinue

use, it should be done gradually.

AVOID POISONING! This medicine, and all other medicines, must be stored in a

safe place out of the reach of children and/or infants, to avoid poisoning. If you have

taken an overdose, or if a child has accidentally swallowed the medicine, proceed

immediately to a hospital emergency room and bring the package of the medicine

with you. Do not induce vomiting unless explicitly instructed to do so by a doctor!

This medicine has been prescribed for the treatment of your ailment; in another

patient it may cause harm. Do not give this medicine to your relatives, neighbours

or acquaintances. Do not take medicines in the dark! Check the label and the dose

each time you take your medicine. Wear glasses if you need them.

Storage: Store in a dry place below 25˚C.

Even if kept in their original container and stored as recommended, medicines may

be kept for a limited period only. Please note the expiry date of the medicine! In

case of doubt, consult the pharmacist who dispensed the medicine to you.

Licence Number: 135.35.22570.00

Manufacturer: Rekah Pharmaceutical Industry Ltd., 30 Hamelacha St., Holon, Israel.

رثخت دض ةيودا ،ةفعض

ُم

م ةيح تاحاقل ،ناتوتيم ،نيردوتير ،ينسكوجيد ،ينلوسنلاا وا مفلا قيرط ،ينبلوبسيرج ،ينماجيتسودويرب .لوزانوكوتيك ،نيروبسولكيس ،مويدوصلا يوتح ةيودا ،مدلا .ينسيمورتيرا ،ينسيمورتيرلاك .)ينسكولبوا ،ينسكولبوبل ،ينسكولفورفيست( تاينولونيوكلا ةليصف نم ةيويح تاداضم هلامعتسا ةرتف ءانثأ رهظت دقف ،ءاودلل ةبوغرلما ةيبطلا تاريثأتلا ىلا ةفاضإ :ةيبنالجا ضارعلأا تابارطضا ،ةيهشلا ةدايز ،ةوشنلا ،بائتكلاا ،دللجا ءافش يف صقانت :لثم ةيبنالجا ضارعلأا ضعب حفط ،فعض ،نايثغ ،لاهسا ،مفلا فافج ،قرلاا ،ةحارلا نادقف وا ةيبصع ،يمضهلا زاهلجا يف .رضحتسلما ىلع دوعتلا نم ةريصق ةرتف دعب ةداع ضارعلاا هذه يفتخت ،يدلج

:)ا

ردان( شطعلا ةدايز ،لوبتلا ةرثك ،ةيؤرلا شوشت :

ً

اصاخ

ً

امامتها يضتقت يتلا ضارعلأا .بيبطلل هجوتو جلاعلا يف رمتسا .بيبطلا ىلا هجوتو جلاعلا نع فقوت ٬)ا

ردان( ينقاسلا وا هجولا يف خافتنا .بيبطلا ىلا يهجوتو جلاعلا نع يفقوت ٬)ا

ردان( ةيرهشلا ةرودلا يف لكاشم .بيبطلا ىلا هجوتو جلاعلا نع فقوت :)ا

ردان( راود .بيبطلا ىلا هجوتو جلاعلا نع فقوت :)ا

ردان( مد عم ؤيقتلا تاجنشت .ةصرف برقا يف بيبطلا عجار ،لاعسلا وا شطعلا ،ىملحا ،قللحا يف ملا :ثولت تاملاع ،دلاولاا ىدل ومنلا ؤطابت ،ءوضلل يننيعلا ةيساسح ،دللجا ىلع يجسفنب-ءارمح طوطخ ،تلاضعلا قرزلا ،ينعلا ةسدع ماتعا ،ءاظعلا ةشاشه ،بابشلا بح ،رعشلا ونم ةدايز ،لجرلاا يف خافتنا وا/و لئاوسلا نزاوت بارطضا ،يوئرلا لسلا ،مدلا يف ركسلا ةبسن يف عافترا ،)اموكولاج( .بيبطلا ىلا هجوت ،مسلجا يف حلاملاا ماعلا كروعش ىلع رييغت يأ أرط اذا وأ ،ةرشنلا هذه يف ركذت مل ةيبناج ضارعأ كيدل ترهظ اذا امأ

لااح بيبطلا ةعجارم ذئدنع كيلع ،ءاودلا اذهل كلامعتسلا ةجيتن .طقف بيبطلا تاميلعت بسح :ةيئاودلا ةعرلجا بجيف ،ددلمحا تقولا يف ءاودلا لامعتسا تيسنو ثدح اذا .اهب ىصولما ةعرلجا زواتج عن

ُم

.لاوحلاا نم لاح يا يف ا

عم ينتعرج لامعتسا عن

ُم

ي نكلو !كركذت روف هلامعتسا تاداضم تارضحتسم لوانت بجي .ماعطلا عم ءاودلا اذه لوانت بجي :لامعتسلاا تاداشرا .صرقلا نحط/مسق نكي .تابجولا ينب ةضوملحا ؟جلاعلا حانج يف ةدعاسلما كنكيم فيك اذا .بيبطلا ةراشتسا نودب ءاودلا اذهب جلاعلا فاقيا عن

ُم

ي ةيحصلا كتلاح يف نستح ثدح اذا ىتح .يجيردت لكشب كلذب مايقلا بجيف جلاعلا فاقياب بيبطلا حصن لافطلأا يديأ لوانتم نع

اديعب قلغم ناكم يف ءاود لكو ءاودلا اذه ظفح بجي !ممستلا ي/بنتج . ممستلاب مهتباصا يدافتل كلذو ، عضرلا وأ/و ىلا هجوتلا كيلع ،ءاودلا اذه نم أطخ ة/لفطلا علب اذا وا ةيئاودلا ريداقلما لامعتسا يف تطرفا اذا . بيبطلا نم ةحيرص تاميلعت نودب ؤيقتلا ي/ببست لا .ءاودلا ةوبع

ابحطصم

لااح ىفشتسلما ،كبراقلا ءاودلا اذه طعت لا .ا

رضم نوكي دق رخآ ضيرم ىدل ،كضرم جلاعل ءاودلا اذه فص

ُم

ريداقلما نم دكأتلاو ءاودلا عباط صيخشت بجي !ةمتعلا يف ءاودلا ي/لوانتت لا .كفراعم وا كناريج . كلذ رملأا مزل اذا ةيبطلا تاراظنلا ي/عض . ءاود اهيف ني/لوانتت ةرم لك يف ةيئاودلا .ةيوئم ةجرد ٢٥لا تتح ةرارح ةجردبو فاج ناكم يف ظفحا :نيزختلا بجوبم اهظفح تمو ةيلصلاا اهتبلع يف تلظ ولو ىتح .طقف ةدودحم تارتفل ةلحاص ةيودلأا ىقبت كشلا ةلاح يف .ةوبعلا ىلع ةنودلما رضحتسلما ةيحلاص ءاهتنا خيرات ةظحلام ءاجرلا .نزلخا تاميلعت .ةوبعلا سفن يف ةفلتخم ةيودا نزخ زوجي لا .ءاودلا اذه كل فرص يذلا يلديصلا ةراشتسا كيلع ! 135.35.225700.00 :لجسلا مقر .ليئارسا ،نولوح ،30 اخلايماه عراش ، .ض.م ةيئاودلا ةعانصلل حكير :جتنلما

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