Levamisole Hydrochloride Tablets USP 50mg
Levamisole Hydrochloride Tablets USP 100mg
Levamisole Hydrochloride Tablets USP 150mg
PATIENT INFORMATION LEAFLET
Read this entire leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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 pharmacist.
IN THIS LEAFLET:
1. What levamisole hydrochloride tablets are and what it is used for
2. Before you take levamisole hydrochloride tablets
3. How to use levamisole hydrochloride tablets
4. Possible side effects
5. How to store levamisole hydrochloride tablets
6. Further information
1. WHAT LEVAMISOLE HYDROCHLORIDE TABLETS are AND WHAT IT IS USED FOR
levamisole hydrochloride tablets contain Levamisole, which belongs to the group of immune-modulating agents. Immunomodulating agents like Levamisole change the activity of the immune system in the body. Levamisole hydrochloride tablets are used to treat Steroid Sensitive Nephrotic Syndrome (SSNS). It is used during and following therapy with prednisone or prednisolone.
2. BEFORE YOU TAKE LEVAMISOLE HYDROCHLORIDE TABLETS
Do not take levamisole hydrochloride tablets – If you are allergic (hypersensitive) to Levamisole or any of the other ingredients of the levamisole hydrochloride tablets tablet.
Take special care with LEVAMISOLE HYDROCHLORIDE TABLETS
– If you have a liver or kidney disease, please consult your doctor, who possibly adapts the dose accordingly. – If changes in the blood cells occur. Levamisole can induce changes in white blood cells. Therefore blood controls are required at regular intervals (e.g. every 3 weeks) during treatment. Treatment must be stopped immediately if significant changes in blood cells occur. Such changes in blood may be preceded by influenza-like symptoms, such as fever and shiverings. In such instances, you should immediately report these symptoms to your doctor. It should be noted that influenza-like symptoms might also occur without changes in the blood.
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including any medicines that have been obtained without a prescription. It is imperative that you tell your doctor – if you use anticoagulants (blood-thinners). – if you use medicines that contain Phenytoin (medicine prescribed for epilepsy). Levamisole may increase the blood level of Phenytoin. – if you use other medicines that affect the formation of blood cells (hematopoiesis).
Taking levamisole hydrochloride tablets with food and drink You should not drink any alcohol during treatment. Unpleasant side effects might emerge such as severe headaches, nausea, and vomiting.
There is no information available regarding the possible harmful effects of Levamisole during pregnancy. Do not take levamisole hydrochloride tablets while you are pregnant or if you intend to become pregnant. Ask your doctor for advice before taking any medicine.
Breast-feeding Do not take levamisole hydrochloride tablets when you are breastfeeding. Ask your doctor for advice before taking any medicine.
Driving or using machines You can drive and use tools or machines during treatment.
Important information regarding some of the ingredients of levamisole hydrochloride tablets
It contains lactose. If you have been informed by your doctor that you have an intolerance to some sugars, please ask your doctor before taking this medicinal product.
3. HOW TO USE LEVAMISOLE HYDROCHLORIDE TABLETS
Always take levamisole hydrochloride tablets exactly as your doctor told you. You should ask your doctor if you are not sure. The usual dose is 2.5 mg per kg body weight, to be taken every other day. The maximum dose is 150 mg, to be taken every other day. Ingest whole tablets. The tablet can be taken with some water or, if necessary, with custard or any appropriate liquid. Levamisole hydrochloride tablets treatment will be started during treatment with prednisone or prednisolone as soon as the urine is free of proteins for at least three days. The dosage and frequency of administration of prednisone/prednisolone will be cut down following a schedule provided by your doctor. Treatment will be continued for a period of at least 6 months. Treatment will be stopped if a relapse of SSNS occurs.
If you take more levamisole hydrochloride tablets than you should
In case of accidental intake by a child (in dosages higher than indicated), you should let the child vomit and contact your doctor immediately. Possible signs of an overdose: Extreme lethargy or sleepiness, confusion, dizziness, headaches and complaints of the intestines or stomach, such as diarrhoea, cramps, nausea and vomiting.
If you forget to take levamisole hydrochloride tablets
If you forget to take levamisole hydrochloride tablets at your usual time, you can safely take the dose later the same day. If the next day you realise that you forgot to take the dose from the previous day, do not take the dose that was missed. Simply continue with the regular next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking levamisole hydrochloride tablets
Do not stop taking levamisole hydrochloride tablets without first consulting your doctor. If you have any further questions on the use of this product, ask your doctor
4. POSSIBLE SIDE EFFECTS
Like all medicines, levamisole hydrochloride tablets can cause side effects, although not everybody gets them. Stop taking levamisole hydrochloride tablets and contact your doctor if you get the following side effects. – Changes in white blood cells (neutropenia). These changes might cause flu-like symptoms such as chills, fever, fatigue – Changes in blood platelets (thrombocytopenia). – Disorders of the brain and nerves (leukoencephalopathy). Symptoms of these disorders are confusion, loss of memory, unusual sleepiness, an unusual itching or tingling feeling that occurs without a clear reason, weakness of the muscle, seizures, coma or speech disturbances. – Hypersensitive reactions such as skin rash, itching, a swollen face or tightness of the chest.
5. HOW TO STORE
Keep out of reach and sight of children. Store in original package. Store below 25 ?C. Do not freeze. Do not use levamisole hydrochloride tablets after the expiry date stated on the carton and blister. After ?EXP? month (2 digits) and year (4 digits) are stated. The expiry date refers to the last day of that month. 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 to protect the environment.
6. FURTHER INFORMATION
What levamisole hydrochloride tablets 50, 100, 150 contains The active substance is Levamisole hydrochloride, equivalent to 50, 100 and 150 mg Levamisole respectively.
The other ingredients are Lactose monohydrate, Maize starch, Sodium starch glycollate, Hydroxypropyl cellulose, Microcrystalline cellulose, Sodium stearyl fumarate, Hydroxypropylmethylcellulose, Talc, Polyethylene glycol, Saccharin sodium and Titanium dioxide.
What levamisole hydrochloride tablets look like and the contents of the pack An levamisole hydrochloride tablets tablet is a white, round, film-coated tablet without inscriptions. Ten tablets are packed in an aluminium/PVC blister. A carton contains 5 blisters of 10 tablets.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)