Rivotril belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system).

Rivotril is used to relieve anxiety. However, benzodiazepines should not be used to relieve nervousness or tension caused by the stress of everyday life.

Rivotril is used in the treatment of other conditions, also. Diazepam is used to help relax muscles or relieve muscle spasm. Diazepam injection is used before some medical procedures to relieve anxiety and to reduce memory of the procedure. The benzodiazepines may also be used for other conditions as determined by your doctor.

Rivotril may be habit-forming (causing mental or physical dependence), especially when taken for a long time or in high doses.

Special precautions

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Rivotril , the following should be considered:

Allergies� tell your doctor if you have ever had any unusual or allergic reaction to Rivotril . Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Rivotril may contain lactose, parabens, or soybean oil.

Pregnancy� Rivotril has been reported to increase the chance of birth defects when used during the first 3 months of pregnancy. Although similar problems have not been reported with the other benzodiazepines, the chance always exists since all of the benzodiazepines are related.

Benzodiazepines given just before or during labor may cause weakness in the newborn infant. When diazepam is given in high doses (especially by injection) within 15 hours before delivery, it may cause breathing problems, muscle weakness, difficulty in feeding, and body temperature problems in the newborn infant.

Breast-feeding� Rivotril is used to relieve anxiety. may pass into the breast milk and cause drowsiness, difficulty in feeding, and weight loss in nursing babies of mothers taking these medicines.

Children� Most of the side effects of these medicines are more likely to occur in children, especially the very young. These patients are usually more sensitive than adults to the effects of benzodiazepines.

Older adults� Most of the side effects of these medicines are more likely to occur in the elderly, who are usually more sensitive to the effects of benzodiazepines.

Taking benzodiazepines for trouble in sleeping may cause more daytime drowsiness in elderly patients than in younger adults. In addition, falls and related injuries are more likely to occur in elderly patients taking benzodiazepines.

Other medicines� although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.

Other medical problems� the presence of other medical problems may affect the use of benzodiazepines. Make sure you tell your doctor if you have any other medical problems, especially:

•  Alcohol abuse (or history of) or

•  Drug abuse or dependence (or history of)�Dependence on benzodiazepines may be more likely to develop

•  Brain disease�CNS depression and other side effects of benzodiazepines may be more likely to occur

•  Difficulty in swallowing (in children) or

•  Emphysema, asthma, bronchitis, or other chronic lung disease or

•  Hyperactivity or

•  Mental depression or

•  Mental illness (severe) or

•  Myasthenia gravis or

•  Porphyria or

•  Sleep apnea (temporary stopping of breathing during sleep)�Benzodiazepines may make these conditions worse

•  Epilepsy or history of seizures�Although some benzodiazepines are used in treating epilepsy, starting or suddenly stopping treatment with these medicines may increase seizures

•  Glaucoma, acute narrow angle�Benzodiazepines should NOT be used if you have this condition.

•  Glaucoma, open angle�Benzodiazepines can be used but your doctor should be monitoring your condition carefully.

•  Kidney or liver disease�Higher blood levels of benzodiazepines may result, increasing the chance that side effects will occur

Side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

•  Less common

• Anxiety;  confusion (may be more common in the elderly);  fast, pounding, or irregular heartbeat ;  lack of memory of events taking place after benzodiazepine is taken (may be more common with triazolam);  mental depression 

•  Rare

• Abnormal thinking, including disorientation, delusions (holding false beliefs that cannot be changed by facts), or loss of sense of reality ;  agitation;  behavior changes, including aggressive behavior, bizarre behavior, decreased inhibition, or outbursts of anger;  convulsions (seizures);  hallucinations (seeing, hearing, or feeling things that are not there);  hypotension (low blood pressure);  muscle weakness;  skin rash or itching ;  sore throat, fever, and chills;  trouble in sleeping;  ulcers or sores in mouth or throat (continuing);  uncontrolled movements of body, including the eyes;  unusual bleeding or bruising ;  unusual excitement, nervousness, or irritability ;  unusual tiredness or weakness (severe);  yellow eyes or skin 

•  Symptoms of overdose

• Confusion (continuing);  convulsions (seizures);  drowsiness (severe) or coma;  shakiness;  slow heartbeat;  slow reflexes;  slurred speech (continuing) ;  staggering;  troubled breathing ;  weakness (severe) 

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the benzodiazepines are similar, so any of the above side effects may occur with any of these medicines.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication.

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