What Tibinide is and what it is used for
Tibninide belongs to the group of antituberculosis drugs. The active substance in Tibinide is isoniazid, which is a bactericidal agent with an effect only on tubercle bacteria. Tibinide is most often used in combination with other drugs against tuberculosis.
What you need to know before taking Tibinide
Do not use Tibinide
- if you are allergic to isoniazid or any of the other ingredients of this medicine (listed in section 6).
- if you have liver disease or liver damage.
- if you have previously had a serious side effect in connection with treatment with isoniazid (fever, chills, arthritis ).
Warnings and precautions
Talk to your doctor before taking Tibinide if you have or have had any of the following:
- impaired renal function, the dose of Tibinide may need to be reduced.
- impaired liver function.
- epilepsy, the risk of suffering side effects such as convulsions is higher.
- diabetes mellitus, it may become more difficult to control your diabetes.
- psychosis, the risk of relapse increases with treatment with Tibinide.
Treatment with isoniazid can affect the liver. Contact your doctor in case of suspected liver damage. Early signs of liver damage are yellowing of the skin, itching, abdominal pain, nausea, dark-colored urine, and loss of appetite.
You should not consume alcohol while being treated with Tibinide.
Tibinide should not be used in people who weigh less than 45 kilograms.
If you are hypersensitive to ethionamide, pyrazinamide, and niacin ( nicotinic acid ), you may also be hypersensitive to isoniazid contained in Tibinide.
Other medicines and Tibinide
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are using any of the following medicines:
- Alfentanil is used by injection as a pain reliever before and after surgery.
- Antacids containing aluminum for heartburn and acid reflux, eg Novalucol, Novaluzid, Rennie.
- Anticoagulants, for example, warfarin.
- Benzodiazepines, such as diazepam , flurazepam, triazolam and midazolam, which have a sleep-inducing and sedative effect.
- Disulfiram such as included in Antabuse.
- Medicines against epilepsy eg ethosuximide, phenobarbital, phenytoin, carbamazepine.
- Haloperidol is used in psychosis.
- Ketoconazole, is used for fungal infections.
- Levodopa for Parkinson’s disease.
- Methotrexate, a cytotoxic drug.
- Paracetamol , for pain and fever.
- Prednisolone, is a cortisone preparation.
- Rifampicin, is an anti-tuberculosis drug.
- Sulfasalazine is used to treat rheumatism.
- Theophylline is used for asthma.
Other medicines can affect or be affected by the treatment with Tibinide. Treating doctors, therefore, need to be aware of other concomitant medications.
Tibinide with food, drink, and alcohol
Intake of alcohol should be avoided during treatment with Tibinide because the effect of isoniazid can be reduced and the risk of liver damage increased with simultaneous use.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
No known influence on the ability to drive and use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to take Tibinide
Always take this medicine as directed by your doctor. Consult a doctor or pharmacist if you are unsure.
The dose must be determined by a doctor.
Tibinide tablets should be swallowed whole with a glass of water or other drink.
The tablets are taken on an empty stomach, ie at least 1 hour before or 2 hours after a meal.
Use for children and adolescents
Tibinide tablets should not be used by people weighing less than 45 kg as the necessary dose adjustment is not possible.
If you have taken too much Tibinide
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, always contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Tibinide
If you forget to take a tablet, take it as soon as possible. If it is less than 6 hours until the next dose, skip the forgotten tablet and take the next tablet as planned.
If you stop taking Tibinide
Always take the tablets until the treatment is finished, even if you start to feel better.
Always consult a doctor before you stop taking Tibinide.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you experience any of the following symptoms:
- Inflammation of the pancreas, causes severe pain in the abdomen and back ( pancreatitis, has been reported – occurring in an unknown number of users).
- Severe widespread skin damage (sloughing of the epidermis and superficial mucous membranes) ( toxic epidermal necrolysis, TEN, may affect up to 1 in 1,000 users).
- Drug reactions causing skin rash, fever, inflammation of internal organs, altered blood count, and systemic disease (DRES’s syndrome, may affect up to 1 in 1,000 users).
- Yellowing of the skin or the whites of the eyes, darker urine and paler stools, tiredness, weakness, feeling unwell, loss of appetite, nausea, or vomiting caused by liver problems ( hepatitis, may affect up to 1 in 100 people).
- In rare cases, Tibinide can affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with a greatly worsened general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or difficulty urinating, you should see a doctor as soon as possible so that a lack of white blood cells can be ruled out via a blood test ( agranulocytosis ). It is important that you then information about your medication. The frequency is not known for this side effect.
- An extremely strong allergic reaction with a skin rash is usually in the form of blisters or sores in the mouth and eyes as well as other mucous membranes such as the genitals (Steven-Johnson syndrome). The frequency is not known for this side effect.
Other side effects that may occur:
Very common (affects more than 1 in 10 users):
- Numbness in the hands and feet, and nerve inflammation in the arms and legs which manifests itself as a burning sensation. Simultaneous treatment with pyridoxine reduces the risk of this side effect.
- Elevated liver enzymes.
Uncommon (affects less than 1 in 100 but more than 1 in 1000 users):
- Convulsions, brain disease.
- Memory disorders, psychosis.
Has been reported (occurring in an unknown number of users):
- Dizziness, headache, tremors, vertigo, increased reflexes.
- Confusion, disorientation, hallucinations.
- Nausea, vomiting, loss of appetite, dry mouth, belching, abdominal pain, constipation.
- Difficulty urinating, kidney damage.
- Increased blood sugar, disturbance of the acid/base balance in the blood, pellagra (a condition characterized by gastrointestinal discomfort, skin redness, nervous and mental disturbance).
- Allergic reactions in the form of severe skin reactions, itching, fever, altered blood count, hypersensitivity, swollen lymph nodes, rheumatic syndrome, and lupus-like syndrome.
- Inflammation in the blood vessels.
- Various forms of anemia reduced amount of blood platelets.
- Allergic pneumonia.
- Arthritis (joint inflammation).
- Damage to optic nerve one.
How to store Tibinide
Store out of the sight and reach of children.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is isoniazid 300 mg.
Other ingredients are microcrystalline cellulose, stearic acid, talc, and silicon dioxide.
Appearance and package sizes of the medicine
White, round, flat tablet with the score.
Packaging: 100 tablets in a plastic jar.
Marketing Authorisation Holder:
Meda AB
Box 906
170 09 Solna.
Telephone 08-630 19 00