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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Ethionamide is used in combination with other antituberculosis agents for the treatment of all forms of tuberculosis caused by Mycobacterium tuberculosis.
Ethionamide is used as a second line antimycobacterial drug when resistance to or toxicity from first-line drugs has been developed.


a.Do not take Ethionamide Tablets 250 mg:
- if you are hypersensitive (allergic) to ethionamide or any of the other ingredients of Ethionamide Tablets (see section 6, What Ethionamide Tablets contains), -
if you have severe liver disease.
b.Take special care with Ethionamide Tablets 250 mg:
Take Ethionamide Tablets always together with other antituberculosis drugs, that your doctor or health care provider prescribes for you.
If you develop clinical symptoms suggesting injury to the liver, such as loss of appetite, nausea, jaundice (yellow skin and white eyes), dark urine, discoloured stools, pain and tenderness in the upper right abdomen, tell your doctor immediately. .
If you experience rash or fever (possible signs of an allergic reaction), tell your doctor or health care provider immediately.
Your doctor or health care provider will regularly monitor your blood sugar, your thyroid function and your visual acuity throughout treatment with ethionamide because ethionamide may lead to alterations (see “Undesirable effects”).

Your doctor may prescribe a certain vitamin, called pyridoxine, for you to be taken concomitantly with ethionamide. This medicine may reduce the risk of developing nerve damage.
It is important that your doctor or health care provider knows about all your symptoms even when you think they are not related to tuberculosis infection.
c.Taking other medicines
Please tell your doctor, health care provider or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. These may affect the action of Ethionamide Tablets, or Ethionamide Tablets may affect their action. Ethionamide may interact with isoniazid and rifampicin and may make side effects worse: Ethionamide Tablets should not be taken with large amounts of alcohol.
d.Taking Ethionamide Tablets with food and drink
Ethionamide Tablets may be taken with or without food. Taking it with food may reduce gastrointestinal side effects.
e. Pregnancy and breast-feeding
You should avoid becoming pregnant while on treatment with Ethionamide Tablets. If you become pregnant, or are planning to become pregnant, you should contact your doctor or health care provider to discuss the potential benefits and risks of tuberculosis therapy for you and your child.
It is not known whether ethionamide is excreted into human milk. If continuation of breast-feeding during ethionamide treatment is deemed necessary, your baby should be closely monitored for side effects of ethionamide.
f. Driving and using machines Ethionamide
may cause side effects such as drowsiness or headache, which can impair your ability to drive and to use machines.


Always take Ethionamide Tablets exactly as your doctor or health care provider told you. You should check with your doctor, health care provider or pharmacist if you are not sure.
Your doctor will assign the dose of Ethionamide Tablets appropriate for you. The following information includes only the average doses of this medicine. If your prescribed dose is different, do not change it unless your doctor or health care provider tells you to do so.
For adults, the usual daily dose is two to four tablets (500 mg to 1 g daily), depending on body weight and tolerance. The daily dose can be taken either on a single occasion or split up in two doses over the day to improve tolerability. Ethionamide Tablets may be taken with or without food. Intake with food may improve gastrointestinal tolerance.
Children: For children, the dose must be determined by the doctor who prescribes the drug. Doses of 10-20 mg/kg of body weight per day have been recommended. The dose can be taken either on a single occasion or split up in two doses over the day to improve tolerability. If you have severe liver disease you should not take ethionamide. No dose adjustment is necessary if you have kidney disease.

a.If you take more Ethionamide Tablets 250 mg than you should
If you have taken too many tablets or if someone literally swallowed some, there is no immediate danger. However, you should contact your doctor, health care provider or the nearest hospital emergency department for further advice.
b.If you forget to take Ethionamide Tablets 250 mg
If you accidentally miss a dose and notice within 6 hours take the missed dose as soon as possible. Take the next regular dose as scheduled. If you notice later, then simply take your normal dose when the next one is due. Do not take a double dose to make up for forgotten individual doses.
c.If you stop taking Ethionamide Tablets 250 mg
Keep taking the medicine for as long as your doctor has told you, even if you are feeling better. If you stop the medicine too soon, your infection may not be completely cured.
You should not stop treatment unless your doctor or health care provider tells you to.
If you have any further questions about the use of this product, ask your doctor, health care provider, or pharmacist.


Like all medicines, Ethionamide Tablets can cause side effects, although not everyone gets them. When treating tuberculosis, it is not always possible to differentiate between unwanted effects caused by Ethionamide Tablets, or those caused by any other medicines you may be taking at the same time. For this reason, it is important that you inform your doctor or health care provider of any change in your health.
The most commonly reported side effects (greater than 1 in 10 patients treated) are stomach discomfort, abdominal pain, loss of appetite, vomiting, diarrhea, and nausea. The frequency depends on the dose and duration of treatment. Moreover, increased serum transaminases have been very commonly reported.
Other common side effects (greater than 1 in every 100 patients treated) are headache, dizziness, drowsiness, general weakness, feeling of pins and needles (paraesthesia), inflammation of the liver (hepatitis) and yellowing of the skin.
The following side effects have been reported in patients treated with ethionamide. However, frequency estimates for these effects are not available:
Decrease of platelets (blood cells important for blood clotting), metallic taste and sulfurous belching, increased salivation, taste disorders, a so called Pellagra-like syndrome (a condition presenting with diarrhea, skin inflammation and impaired brain function, caused by a lack of Niacin, a certain vitamin), thyroid underfunction, raised sugar in the blood, psychotic reactions (hallucinations, abnormal thinking, personality changes), low blood pressure (especially after standing up), altered brain function and/or structure (encephalopathy), tingling in the limbs, altered sense of smell, rash (red, raised or itchy), urticaria, acne, sensitivity to light (photosensitivity), inflammation of mucous lining (cheeks, gums, tongue, lips, throat), hair loss, red or purple discolouration on the skin (purpurea), breast enlargement in male patients, menstrual disturbance impotence, visual disturbance (blurred or double vision, complete or partial loss of vision), damage to the ear (eg dizziness, hearing loss, tinnitus), rash and fever.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or health care provider or pharmacist as soon as possible.


Keep out of the reach and sight of children.
Store below 300C, protect from light.
Do not use Ethionamide Tablets after the expiry date which is stated on the <label, carton, jar> after the expiry date. The expiry date refers to the last day of that month.
Do not use Ethionamide Tablets if you notice discolouration or swelling of the tablets.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.


Ethionamide Tablets 250 mg are yellow, circular, deep biconvex, film coated tablets having plain surface on both sides.


Ethionamide Tablets 250 mg are available in Strip packs of 10 tablets, container pack of 100 tablets.

Macleods Pharmaceuticals Ltd
Plot No. 25-27,
Sr. No. 366,
PremierInd. Estate,
Kachigam, Daman (U,T),
India
Tel: +91-0260 2244337
Fax: +91-0260 2241565


This leaflet was last approved in March 2015 ,Version no;1
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

Ethionamide is used in combination with other anti-tuberculosis agents to treat all forms of tuberculosis caused by Mycobacterium tuberculosis.

Ethionamide is used as a second-line antibacterial drug when resistance or toxicity develops with first-line drugs.

a.      Do not take ethionamide 250 mg tablets:

- If you are hypersensitive (allergic) to ethionamide or any of the other ingredients of ethionamide tablets (see section 6, What ethionamide tablets contain).

- If you have acute liver disease.

 

B- Exercise caution when taking ethionamide 250 mg tablets:

Always take ethionamide tablets with other anti-tuberculosis medications, as prescribed by your doctor or healthcare provider.

If you develop clinical symptoms that suggest liver injury, such as loss of appetite, nausea, jaundice (yellowing of the skin and whites of the eyes), dark urine, discolored stools, and pain and tenderness in the upper right abdomen, tell your doctor immediately.

If you develop a rash or fever (possible signs of an allergic reaction), tell your doctor or healthcare provider immediately.

Your doctor or healthcare provider will monitor your blood sugar, thyroid function, and visual acuity during treatment with ethionamide because ethionamide may cause changes (see "Unwanted Effects").

Your doctor may prescribe a certain vitamin, called pyridoxine, to be taken in conjunction with ethionamide, as this medication may reduce the risk of nerve damage.

It is important that your doctor or healthcare provider knows all the symptoms you are experiencing, even when you think they are not related to a tuberculosis infection.

c) Taking other medications

Please tell your doctor, healthcare provider, or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as these medicines may affect how ethionamide tablets work, or vice versa. Ethionamide may interact with isoniazid and rifampicin and may worsen side effects.

Ethionamide tablets should not be taken with large amounts of alcohol.

D- Take ethionamide tablets with food and drink

Ethionamide tablets can be taken with or without food. Taking the medication with food may reduce gastrointestinal side effects.

e- Pregnancy and breastfeeding

Pregnancy should be avoided while taking ethionamide tablets. If you become pregnant or plan to become pregnant, you should contact your doctor or healthcare provider to discuss the potential benefits and risks of TB treatment for you and your baby.

It is unknown whether ethionamide is excreted in breast milk. If breastfeeding is necessary during ethionamide treatment, your baby should be closely monitored for side effects of ethionamide.

Driving and using machines

Ethionamide may cause side effects such as drowsiness or headaches, which can impair your ability to drive and use machines.

Always take ethionamide tablets exactly as your doctor or healthcare provider tells you.

You should consult your doctor, healthcare provider, or pharmacist if you are unsure.

 

Your doctor will determine the appropriate dose of ethionamide tablets for you. The following information includes only the average doses of this medication. If your prescribed dose is different, do not change it unless instructed to do so by your doctor or healthcare provider.

 

For adults, the usual daily dose is 2 to 4 tablets (500 mg to 1 gram daily). Depending on body weight and tolerance, the daily dose can be taken as a single dose or divided into two doses throughout the day to improve tolerance. Ethionamide tablets can be taken with or without food. Taking the medication with food may improve gastrointestinal tolerance.

 

Children: For children, the dosage must be determined by the prescribing physician. A daily dose of 10-20 mg/kg of body weight is recommended. This dose can be taken as a single dose or divided into two doses throughout the day to improve tolerability. If you have severe liver disease, you should not take ethionamide.

It is not necessary to adjust the dose if you have kidney disease.

a)    If you take more ethionamide 250 mg tablets than you should

If you take too many tablets or if someone accidentally swallows some, there is no immediate danger; however, you should contact your doctor, healthcare provider, or the nearest hospital emergency department for further advice.

 

b) If you forget to take ethionamide 250 mg tablets

If you accidentally miss a dose and notice within 6 hours, take the missed dose as soon as possible and take your next regular dose as scheduled. If you notice later, simply take your regular dose when it is due for your next dose. Do not take a double dose to make up for missed doses.

 

C- If you stop taking ethionamide 250 mg tablets

Continue taking the medication for the full duration prescribed by your doctor, even if you feel well. Stopping the medication too soon may prevent the infection from being completely cured. Do not stop treatment unless instructed to do so by your doctor or healthcare provider.

If you have any further questions about the use of this product, ask your doctor, healthcare provider, or pharmacist.

Like all medicines, ethionamide tablets can cause side effects, although not everyone experiences them. When treating tuberculosis, it is not always possible to distinguish between unwanted effects caused by ethionamide tablets and those caused by any other medicines you may be taking at the same time. For this reason, it is important to inform your doctor or healthcare provider of any changes in your health.

 

The most commonly reported side effects (affecting more than 1 in 10 treated patients) are stomach discomfort, abdominal pain, loss of appetite, vomiting, diarrhea, and nausea. Frequency depends on the dose and duration of treatment. Furthermore, elevated blood transaminases have been reported very frequently.

 

Other common side effects (more than 1 in 100 treated patients) are headache, dizziness, drowsiness, general weakness, tingling or pins-and-needles sensation (numbness), hepatitis, and yellowing of the skin.

 

The following side effects have been reported in patients treated with ethionamide; however, estimates of the frequency of these effects are not available:

Low platelet count (blood cells important for blood clotting), metallic taste in the mouth and sulfurous belching, increased salivation, taste disturbances, a so-called pellagra-like syndrome (a condition characterized by diarrhea, dermatitis, and impaired brain function due to a deficiency of niacin, a specific vitamin), hypothyroidism, hyperglycemia, psychotic reactions (hallucinations, abnormal thinking, personality changes), low blood pressure (especially after standing), changes in brain function and/or structure (encephalopathy), tingling in the extremities, changes in sense of smell, skin rash (red, raised, or itchy), urticaria, acne, photosensitivity (sensitivity to light), inflammation of the mucous membranes (cheeks, gums, tongue, lips, throat), hair loss, skin discoloration to red or purple (purpura), breast enlargement in male patients, menstrual irregularities, impotence, and visual disturbances (blurred or double vision, and complete vision loss). Or partial vision loss), ear damage (such as dizziness, hearing loss, tinnitus), skin rash and fever.

 

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, please tell your doctor, healthcare provider or pharmacist as soon as possible.

Keep out of reach and sight of children.

Store below 30°C and away from light.

Do not use ethionamide tablets after the expiry date stated on the label, carton, or jar. The expiry date refers to the last day of that month.

Do not use ethionamide tablets if you notice a change in color or swelling of the tablets.

Medications should not be disposed of in wastewater or household waste. Ask your pharmacist.

Regarding how to dispose of medicines that are no longer required, these measures will help protect the environment.

What       do ethionamide 250 mg tablets look like and what are the contents of the pack? 

Ethionamide 250 mg tablets are yellow, round, deep biconvex tablets, film-coated and with a clear surface on both sides.

Ethionamide 250 mg tablets are available in strip packs of 10 tablets, and packs of 100 tablets.

Not all package sizes may be marketed.

 

What do ethionamide 250 mg tablets look like and what are the contents of the pack? 

Ethionamide 250 mg tablets are yellow, round, deep biconvex tablets, film-coated and with a clear surface on both sides.

Ethionamide 250 mg tablets are available in strip packs of 10 tablets, and packs of 100 tablets.

Not all package sizes may be marketed.

McLeods Pharmaceuticals Limited

Piece number 25-27

Street No. 366

Premier Industrial for Marketing and Real Estate Investment

Kachigam, Daman (U, T),

India.

Phone: +91-0260 2244337

Fax: +91-0260 2241565

ج. تمت الموافقة على هذه النشرة آخر مرة في شهر مارس عام 2015، نموذج رقم
 لم يتم إدخال بيانات نشرة الممارس الصحي لهذا الدواء حتى الآن

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