Diazepam rectal gel 5mg / 2.5ml 

What is a Diazepam 5 mg / 2.5 ml rectal solution and what it is used
Characters diazepam 5 mg / 2.5 ml rectal solution contains the active substance diazepam. Diazepam belongs to a group of active substances called benzodiazepines. The drugs in this group have a calming effect, relieve tension and relax the muscles. Usually the effect began to show in a few minutes.

Characters diazepam 5 mg / 2.5 ml rectal solution used in the following cases:
during seizures, for example. case of high temperature or epilepsy;
for the initial treatment of acute severe anxiety, tension and agitation;
for muscle spasms in the jaw trismus (lockjaw);
as pretreatment before small operating or dental procedures especially in cases where the injection is difficult (eg. in children) or impossible, although we must make rapid therapeutic effect.

2. What you should know before using Diazepam 5 mg / 2.5 ml solution rectal
Do not use characters Diazepam 5 mg / 2.5 ml rectal solution:
if you are allergic (hypersensitive) to diazepam, other benzodiazepines or any of the other ingredients of characters Diazepam 5 mg / 2.5 ml rectal solution;
if the patient is in severe shock or unconsciousness;
if the patient has alcohol poisoning or poisoning with other sedatives and tranquilizers;
if the patient with myasthenia gravis (a disease causing rapid physical exhaustion and weakness of certain muscles);
if the patient has severe liver disease;
if the patient suffers from severely impaired respiratory function or respiratory disorders associated with sleep, which is characterized by a very loud snoring and breathing pauses (apnea syndrome during sleep);
if the patient has a disease known as severe chronic hypercapnia. In these cases, there are high levels of carbon dioxide in the blood, which is mostly due to poor pulmonary ventilation;
in preterm newborn infants during the first 30 days of life or in children under the age of one year.
Warnings and Precautions
Talk to your doctor before using Diazepam hero 5 mg / 2,5 ml solution rectal
Pay special attention to:
in young children;
if the patient has to take sedatives / tranquilizers;
if the patient is over 65 years of age or has a serious illness;
if the patient has a disease, which can cause poor blood supply to the brain, eg. arteriosclerosis or if brain damage;
if the patient suffers from a mental disorder. In patients with depression or aggressive patients under the effect of diazepam can be stimulated suicide;
if the patient has liver or kidney disease;
if the patient has a heart and / or lung failure or lung disease;
if the patient has a certain eye disease (narrow-angle glaucoma);
if the patient has ever had alcohol or drug dependence.
Consult your doctor before using Diazepam hero 5 mg / 2,5 ml rectal solution if the above applies to a patient who is to be applied Diazepam hero 5 mg / 2,5 ml rectal solution.

Unusual (paradoxical) reactions
Sometimes it is possible occurrence of such effects, especially in elderly or frail, and in children. Instead the occurrence of fatigue and relief stimulate adverse effects such as restlessness, agitation, irritability, aggression, delusions, intense anger, nightmares, hallucinations, psychoses, inappropriate behavior or other behavioral problems.
In the event of such reactions should discontinue treatment with Diazepam hero 5 mg / 2,5 ml mg rectal solution.

Gaps in memory
They occur most often several hours after administration of Diazepam hero 5 mg / 2,5 ml rectal solution and can be especially true for recent events (anterograde amnesia).
In case you need to use characters Diazepam 5 mg / 2,5 ml rectal solution for a long time, often repeatedly, or in high doses
Your doctor should examine liver function and blood count.

Repeated use for a few weeks
It is possible to reduce the effects of Diazepam hero 5 mg / 2,5 ml rectal solution (pazvitie tolerance).

At constant or regular use for a long time
Possible development of tolerance and dependence on diazepam. If the patient suddenly stop treatment may occur withdrawal symptoms (such as those in patients who are accustomed to the use of sleeping pills or alcohol). The risk of addiction to diazepam is small in short-term treatment, but it is possible occurrence of withdrawal symptoms, even in the short-term treatment with normal therapeutic doses.

Possible withdrawal symptoms
The following may occur: headache and muscle aches, strongly manifested anxiety and tension, restlessness, confusion and irritability. In severe cases, possible loss of sense of reality, numbness and tingling of extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

Other medicines and Diazepam 5 mg / 2,5 ml
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Simultaneous administration of Diazepam 5 mg / 2,5 ml solution rectal and other drugs is possible amplification or attenuation of their effects.
Drug interactions are possible, even if the characters Diazepam 5 mg / 2,5 ml rectal solution used the previous day.

Enhancing the effect of both drugs:
Drugs with sedative suppressive effect as sleeping pills and tranquilizers, antidepressants and antiepileptic drugs, some drugs used for mental illness, for example. clozapine, certain pain / anesthetics, some antiallergic drugs and medicines for colds. The concomitant use of these drugs Diazepam hero 5 mg / 2,5 ml rectal solution can arise severe fatigue, severe respiratory and cardiovascular problems;
In combination with characters Diazepam 5 mg / 2,5 ml rectal solution, some painkillers (opioid analgesics) may enhance feelings of euphoria, helping to possible development of psychological dependence;
Also, alcohol and Diazepam 5 mg / 2,5 ml rectal solution can mutually enhance their effects. Patients should avoid alcohol consumption during the use of characters Diazepam 5 mg / 2,5 ml rectal solution.
Bass effects and side effects of Diazepam 5 mg / 2,5 ml rectal solution:
Cimetidine and omeprazole used in the treatment of gastric and duodenal ulcers;
Disulfiram used to quit drinking;
Rifampicin and Isoniazid used for treatment of tuberculosis;
Birth control pills ("the Pill");
Theophylline, used in respiratory diseases;
Some antifungal drugs.
Use of Diazepam 5 mg / 2,5 ml rectal solution with food, drinks and alcohol
Food and non-alcoholic beverages not affect the hero of Diazepam 5 mg / 2,5 ml rectal solution.
Patients should avoid alcohol consumption throughout the treatment period as may otherwise arise pronounced decrease in blood pressure and breathing problems.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

Pregnancy
Characters diazepam 5 mg / 2,5 ml rectal solution should not be used during pregnancy unless under explicit instructions of the doctor.
For this reason, you should tell your doctor if you are planning to become pregnant, if you are pregnant or think you are pregnant.

Breastfeeding
During breastfeeding, you can use Diazepam 5 mg / 2,5 ml rectal solution only if your doctor specifically tells you to do this.
If you must use this medicine several times during lactation, you must first stop breastfeeding.
If you use Diazepam 5 mg / 2,5 ml solution for rectal or only a short time should not breast that day and the next 4 days.

Driving and using machines
Warning: This medicine may affect the ability to drive and reactivity. Please note that your concentration and reactivity will be disrupted after using Diazepam hero 5 mg / 2,5 ml rectal solution. Therefore you must refrain from performing hazardous activities such as driving or operating machinery for at least 24 hours after the last administration.

3. How to use characters Diazepam 5 mg / 2.5 ml solution rectal
Always use Diazepam hero 5 mg / 2,5 ml rectal solution exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Characters diazepam 5 mg / 2,5 ml rectal solution is not suitable for holding long-term treatment as possible development of tolerance and dependence. Characters diazepam 5 mg / 2,5 ml rectal solution is intended for rectal use; tubes with rectal solution was placed into the anus. You will find instructions for use of Diazepam hero 5 mg / 2,5 ml rectal solution on the back of this leaflet.

DOSAGE
For children weighing over 15 kg is available characters Diazepam 10 mg / 2,5 ml rectal solution.

Unless otherwise prescribed by a doctor, the usual dose is:
Children weighing less than 10 kg, under the age of 1 year:
Not recommended for medicinal use.

Children weighing less than 15 kg, aged between 1 and 3 years
Recommended dose of 5 mg diazepam = 1 tube hero Diazepam 5 mg / 2,5 ml rectal solution. In the event that seizure did not disappear within 10 minutes may further apply other tube.
In children under 3 years of age, rectal tip of the tube should be inserted only halfway.

Children weighing more than 15 kg, aged 3 years and older:
Recommended dose of 10 mg diazepam = 1 tube Diazepam hero 10 mg / 2,5 ml rectal solution. In the event that seizure did not disappear within 10 minutes may further apply other tube.

Adults (over 18 years):
A dose of 10-20 mg diazepam = 1 ~ 2 tubes hero Diazepam 10 mg / 2,5 ml rectal solution. In the event that seizure did not disappear within 10 minutes may further apply other tube.
Treatment can be repeated every 12 hours.

Elderly (over 65 years) or debilitated adults:
Recommended dose of 5 mg diazepam = 1 tube hero Diazepam 5 mg / 2,5 ml rectal solution. In the event that seizure did not disappear within 10 minutes may further be administered another dose.

Use in patients with impaired hepatic, renal or pulmonary function and cardiac failure:
Recommended dose of 5 mg diazepam = 1 tube hero Diazepam 5 mg / 2,5 ml rectal solution. In the event that seizure did not disappear within 10 minutes may further apply other tube.

METHOD OF ADMINISTRATION
Aluminum sachet containing individually packed tubes to be opened immediately prior to use.
Tear the foil package.
Rectal solution with an open cannula: Unscrew the closing cap.
Rectal solution with cap with spike: Unscrew the closing cap and drill membrane tube with barb.
1. Place the patient in the lateral position.
2. Bend the knee of the limb that is above and pull it slightly forward.
3. pull off the patient.
4. Dissolve slightly two seat halves.
5. Carefully insert the tip of the tube. In children under 3 years, the nozzle must be inserted only halfway.
6. Slowly squeeze the tube until it is empty.
7. Remove the squeezable tube. Do not release the seat until completely remove the tube.
8. Squeeze the two seat halves together for about 5 seconds, so as not to pour the liquid.
9. Note the time of application. Regularly check the patient.
    
If seizures can not be controlled or have used a large amount of characters required Diazepam 5 mg / 2,5 ml rectal solution, you should immediately contact a doctor or the emergency room of the nearest hospital.

If you use more than the amount of characters Diazepam 5 mg / 2,5 ml solution rectal
In the event that you accidentally put the large amount of characters Diazepam 5 mg / 2,5 ml rectal solution, you should immediately consult a doctor or hospital.
Symptoms of overdose may include: strong sediranost, fatigue, apathy, confusion, marked muscle weakness, deep sleep, and strong agitation in some cases.
In severe cases may occur stupor, unsteady gait (expressed problems with movement coordination) and muscle weakness, severe breathing problems, severe decrease in blood pressure, loss of consciousness and even coma, and very rarely fatal in many severe cases.
Until the arrival of the doctor should monitor breathing, pulse, blood pressure and body temperature.

If you stop using Diazepam 5 mg / 2,5 ml solution rectal
If you used Diazepam characters (0 mg / 2,5 ml solution rectal long time (eg. Once daily for one week) should not suddenly discontinue use of the drug. Otherwise, you might encounter withdrawal symptoms. Your doctor will tell you how to gradually reduce the dose if you wish to stop treatment with Diazepam hero 5 mg / 2,5 ml rectal solution.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Diazepam 5 mg / 2,5 ml rectal solution can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

Side effects may include:
Very common (occurring in more than 1 in 10 patients);
common (occurring in more than 1 in 100 but less than 1 in 10 patients);
Uncommon: (occurring in more than 1 in 1000, but less than 1 in 100 patients);
rare (occurring in more than 1 in 10 000, but less than 1 in 1000 patients);
very rare (occurring in less than 1 in 10,000 patients).
Research
Rare: changes in liver function tests.
Cardiac disorders
Rare: loss of consciousness, slowed heartbeat, collapse, low blood pressure.
Blood and lymphatic system
Rare: problems in hematopoiesis (low white and red blood cells).
Nervous system
Common: fatigue, drowsiness, trouble walking, shaking, dizziness, headache, slurred or slurred speech, increased daytime fatigue and malaise (like morning sickness after alcohol intoxication);
Rare: a sensation of tingling, numbness, burning or numbness of the hands or legs, problems with the sense of heat and cold, problems with motor coordination, dry mouth, increased salivation.
Eye disorders
Common: blurred vision;
Rare: Eye twitching, reduced clarity of vision, blurred vision.
Respiratory, thoracic and mediastinal disorders
Rare: respiratory problems, such as allergic asthma, bronchospasm and laryngeal, delayed or accelerated breathing, shortness of breath, asthma events, apnea.
Gastrointestinal disorders
Rare: vomiting, nausea, diarrhea or constipation.
Renal and urinary tract
Rare: involuntary leakage of urine (incontinence), urinary retention, impaired urination.
Skin and subcutaneous tissue disorders
Very rare: allergic skin reactions, eg. painful swelling of the face, lips, throat and / or tongue. In the event of any of these effects, immediately consult a doctor or hospital.
Other rare side effects include hives, bruising, redness or rash with or without itching.

Disorders of the musculoskeletal system and connective tissue
Common: muscle relaxation, muscle weakness.
Endocrine disorders
Rare: impotence, increased or decreased libido, reduced possibility of pregnancy, menstrual irregularities, reduced thyroid function.
Metabolism and nutrition
Rare: Increased appetite.
Social conditions
Common: dependence or abuse.
Hepatobiliary disorders
Rare: jaundice (yellowing of the eyes and / or skin).
Reproductive system and breast disorders
Rare: breast augmentation, mammary secretion.
Psychiatric disorders
Common: confusion, temporary memory loss, stupor, memory impairment and cognitive abilities, lethargy and apathy, but also completely opposite reactions (known as paradoxical) as acute hyperexcitability, rages, anxiety, hearing or seeing invalid things or persons (hallucinations), sleep disorders, insomnia, intense muscle cramps, tendency to aggression. In the event of such reactions should discontinue the drug. More likely occurrence of such effects in children and the elderly;
Rare: feeling sad, bad mood or lethargy.

5. How to store characters Diazepam 5 mg / 2,5 ml solution rectal
Do not store above 25 ° C.
Store in the original package.