PATIENT INFORMATION LEAFLET Page 1 of 6
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER 1 ethambutol hydrochloride Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for your child. - Keep this leaflet; you may need to read it again. - If you have any further questions, ask your health care provider. - This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child s. - If your child has any side effects, tell the health care provider. This includes any side effects not listed in this leaflet. See section 4 What is in this leaflet: 1. What Ethambutol hydrochloride 100 mg is and what it is used for 2. What you need to know before you give your child Ethambutol hydrochloride 100 mg 3. How to give Ethambutol hydrochloride 100 mg 4. Possible side effects 5. How to store Ethambutol hydrochloride 100 mg 6. Contents of the pack and other information 1. WHAT ETHAMBUTOL HYDROCHLORIDE 100 MG DISPERSIBLE TABLETS IS AND WHAT IT IS USED FOR Ethambutol hydrochloride 100 mg contain the active ingredient ethambutol. Ethambutol hydrochloride 100 mg are used for the initial treatment of tuberculosis (TB) in children weighing less than 20 kg. Although the product is intended for children, safety information on its use in adults is given. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE YOUR CHILD ETHAMBUTOL HYDROCHLORIDE 100 MG DISPERSIBLE TABLETS Do not use Ethambutol hydrochloride 100 mg if your child: is allergic (hypersensitive) to ethambutol, or to any of the other ingredients of this medicine (listed in section 6) Warnings and precautions Talk to your health care provider if your child has: problems with eyesight. Contact your health care provider at once if you or your child notice any problems with vision. Your health care provider will check your child s vision before treatment and also during treatment. kidney disease. Your healthcare provider may change the dose of this medicine if your child has kidney problems. 1 Trade names are not prequalified by WHO. This is the national medicines regulatory authority s responsibility. Throughout this WHOPAR the trade/proprietary name is given as an example only. Page 2 of 6
Taking other medicines Tell your health care provider if your child is taking, has recently taken or might take any other medicines. Your child should not take Ethambutol hydrochloride 100 mg at the same time as stomach medicines that contain aluminium hydroxide (used to relieve heartburn and indigestion), as this can make ethambutol less effective. Taking Ethambutol hydrochloride 100 mg with food and drink Your child can take Ethambutol hydrochloride 100 mg with food or between meals. Pregnancy If a woman becomes pregnant, or is planning to become pregnant, she must contact a health care provider to discuss the potential benefits and risks of the tuberculosis therapy for the mother and the child. Breast-feeding Ethambutol passes into breast milk. However, unwanted effects have not been reported in breastfeeding infants of mothers who are taking ethambutol. Driving and using machines Ethambutol may cause visual disturbances or tingling or numbness in the hands and feet. They can affect the ability to drive and to use machines. Ethambutol hydrochloride 100 mg contains aspartame This medicine contains 20 mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. 3. HOW TO GIVE Ethambutol hydrochloride 100 mg Ethambutol hydrochloride 100 mg should always be taken exactly as described by the health care provider. Check with your child s health care provider if you are not sure. The dose of Ethambutol hydrochloride 100 mg depends on the weight of your child. Recommended Dose based on weight of the children Child s weight Up to 4 kg Dose ½ tablet 2 once daily 4.5 to 7 kg 1 tablet once daily 8 to 14 kg 2 tablets once daily 15 to 20 kg 3 tablets once daily 2 Use the break-line to divide the tablet into two equal halves Place the correct dose of Ethambutol hydrochloride 100 mg in a cup and add about 50 ml water. When all the solid has broken down, give the mixture to the child and make sure that the child drinks it all. Then give the child some water to drink. Once the dose has been mixed with water your child should take it within 10 minutes. Page 3 of 6
You should give your child Ethambutol hydrochloride 100 mg at around the same time every day. Your child can take the medicine with food or between meals. If your child has a kidney disease, your child s health care provider may change the dose. Ethambutol hydrochloride 100 mg is not recommended for adults or children who weigh more than 20 kg. Ethambutol hydrochloride 100 mg is usually given for the first two months of tuberculosis treatment. Your child s health care provider will decide how long your child should take it. If your child takes too many Ethambutol hydrochloride 100 mg You should immediately contact a health care provider or the nearest hospital emergency department if your child has taken too many tablets. Remember to take the pack and any remaining tablets with you. If a dose of Ethambutol hydrochloride 100 mg is missed If a dose is missed, your child should be given a dose as soon as possible, unless the next scheduled dose is due within 6 hours. Skip the missed dose if it is almost time for the next regular dose. A dose should not be doubled to make up for a missed dose. If your child stops taking Ethambutol hydrochloride 100 mg Your child should keep taking the medicine for as long as the health care provider has ordered, even if feeling better. If the medicine is stopped too soon, the infection may not be completely cured. Treatment should not be stopped unless the health care provider says so. If you have any further questions on the use of this product, ask the health care provider. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ethambutol hydrochloride 100 mg can cause side effects, but not everybody gets them. When treating tuberculosis, it is not always possible to differentiate between unwanted from Ethambutol hydrochloride 100 mg and those caused by any other medicines your child may be taking at the same time. For this reason, it is important that you tell the health care provider of any change in your child s health. You should ask for medical help immediately if your child has: sudden problems with breathing, wheeziness, swelling of the face, eyes, lips or throat, flushed appearance or irregular heartbeat. These may be symptoms of a severe allergic reactions Speak with your health care provider straightaway if your child has: changes in vision, including blurred vision, eye pain or not being able to see colours properly (colour blindness); these effects can occur in up to 1 in 10 people The following side effects can also occur in patients treated with ethambutol: Very common side effects (may affect more than 1 in 10 people) high levels of uric acid in the blood (hyperuricaemia) which may lead to gout (pain or swelling of the joints) in some people Rare side effects (may affect up to 1 in 1000 people) tingling, pins-and-needles and numbness rash, itchiness, hives (red, itchy bumps on the skin) Page 4 of 6
Very rare side effects (may affect up to 1 in 10 000 people) burning pain, weakness affecting the hands and feet, dizziness, headache confusion, disorientation, hallucination (seeing or hearing things that are not there) liver problems (hepatic failure) kidney problems feeling ill, joint pains, fever lung damage causing breathing difficulty skin allergy to bright light, severe skin rashes with blistering and skin peeling Frequency of side effects not known tremor strange taste, nausea (feeling sick), vomiting, loss of appetite, gas (flatulence), belly pain, diarrhoea, upset stomach inflammation of the liver, jaundice, blood tests suggesting liver problems blood tests showing reduced blood platelets (which can cause bleeding and bruising) and some types of white blood cells If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your child s health care provider as soon as possible. 5. HOW TO STORE ETHAMBUTOL HYDROCHLORIDE 100 MG DISPERSIBLE TABLETS Keep out of the reach and sight of children. Strip pack: Do not store above 30 C in a dry place. Protect from light. Blister pack: Do not store above 30 C in a dry place. Protect from light. Avoid excursions over 30 C. Store tablets in blisters in the provided carton. Once mixed in water, the mixture should be taken within 10 minutes. Medicines should not be disposed of in wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ethambutol hydrochloride 100 mg contains The active ingredient of Ethambutol hydrochloride 100 mg is 100 mg of ethambutol hydrochloride. The other ingredients are: colloidal silicon dioxide, microcrystalline cellulose, corn starch, sodium starch glycolate, croscarmellose sodium, aspartame, povidone, low-substituted hydroxypropyl cellulose, purified talc, silicified microcrystalline cellulose, orange flavour FTP (containing propylene glycol) and magnesium stearate Page 5 of 6
What Ethambutol hydrochloride 100 mg looks like and contents of the pack Strip pack Plain Alu-Alu strip pack of 6 tablets. Such 10 strips are packed in a carton along with package leaflet. Blister pack Amber-coloured PVC/PE/PVdC-Alu blister of 10 tablets. Such 10 blisters are packed in a carton along with package leaflet. Supplier Macleods Pharmaceuticals Ltd 304 Atlanta Arcade Marol Church Road Andheri (East) Mumbai 400 059 India Tel: + 91 22 66762800 Fax: + 91 22 28216599 Email: exports@macleodspharma.com Manufacturer Macleods Pharmaceuticals Ltd Unit II Plot No 25 27, Survey No 366 Premier Industrial Estate Kachigam Daman 396 210 India Tel: +91 0260 2240125/2244337 This leaflet was last approved in July 2018. Detailed information on this medicine is available on the World Health Organization (WHO) web site: https://extranet.who.int/prequal/ Page 6 of 6