Prospectus: information for the user
Diazepam 5mg tablets EFG
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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 and should not be given to others, even if they have the same symptoms, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist, even if it is for side effects not listed in this leaflet. See section 4.
Contents of the leaflet:
1 What diazepam is and what it is used for
2. What you need to know before you start taking Diazepam
3. How to take Diazepam tablets
4. Possible side side effects
5. Storage of Diazepam
6. Container contents and additional information
1. What Diazepam is and what it is used for
Diazepam contains the active substance diazepam, which belongs to the group of medicines called benzodiazepines.
Diazepam has tranquilizers, sedatives, muscle relaxants and anticonvulsants.
Doctors prescribe Diazepam to people who exhibit symptoms of anxiety, agitation and psychic stress produced by psychoneurotic states and transient situational disorders. Benzodiazepines are only indicated for the treatment of an intense disorder, which limits its activity or puts it in a situation of significant stress.
It may also be useful for the relief of symptoms of acute agitation, tremor and hallucinations in patients with alcohol withdrawal syndrome.
Diazepam contributes to the relief of muscle pain caused by spasms or inflammation of muscles or joints, trauma, etc. It can also be used to combat spasms caused by diseases such as cerebral palsy (a group of disorders that affect a person's ability to move, maintain balance and posture) and paraplegia (paralysis of the lower half of the body, affecting both legs ), As well as in athetosis (continuous, involuntary, slow and extravagant movements of the fingers and hands) and generalized stiffness syndrome.
Diazepam may be used as adjunctive therapy (treatment given after the main treatment to increase the chances of a cure) of seizure disorders (such as epilepsy, seizures) but has not been shown to be a single treatment. In these cases your doctor will periodically evaluate the usefulness of the drug for you.
2. What you need to know before you start taking diazepam 5mg
Do not take Diazepam
• If you have an allergy to diazepam or any of the other ingredients of this medicine (listed in section 6).
If you are allergic to other drugs in the benzodiazepine group.
If you have had breathing difficulties related or not with sleep for some time.
If you have a condition called "myasthenia gravis", which is characterized by weakness and muscle fatigue.
If you have severe respiratory problems (severe respiratory failure).
If you have severe liver problems (severe liver failure).
If you are dependent on drugs or alcohol, you should not take Diazepam 5mg or DIAZEPAM 10MG, unless your doctor tells you to do so.
This medication is not recommended for the primary treatment of psychotic disorders (severe mental disorders that cause abnormal thinking and perceptions), nor should it be used as the only treatment in patients with depression, alone or associated with anxiety. Your doctor will probably have prescribed another medication for these cases. This medication is often used for the diazepam high that many users enjoy. This though can lead to addiction and dependence.
Warnings and Precautions
Consult your doctor or pharmacist before you start taking Diazepam.
If you have liver or kidney disease
If you have breathing difficulties
If you suffer from severe muscle weakness
If you have other diseases
If you have allergies
If you have drug or alcohol dependency problems
If you are taking other medicines
Your doctor will decide whether to take a lower dose of Diazepam or not to take it at all.
If you are epileptic and are on long-term treatment with Diazepam, the use of the Anexate benzodiazepine antagonist (flumazenil) is not recommended to reverse the effect of Diazepam , as seizures may occur.
Do not use this medication in children younger than 6 months of age.
Taking Diazepam with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken or might need to take other medicines. This is extremely important because the simultaneous use of more than one drug may increase or decrease it's effectiveness.
Pregnancy and lactation
Before starting treatment, your doctor should know if you are or suspect you are pregnant or if you want to be pregnant. The doctor will then decide whether or not to take Diazepam.
Benzodiazepines pass into breast milk, so consult your doctor if you take Diazepam while you are breast-feeding.
Driving and using machines
Do not drive or operate tools or machines because this medicine can cause sedation, amnesia, difficulty concentrating, and muscle weakness, which can negatively affect the ability to drive or operate machinery. This effect is increased if you have also ingested alcohol.
Use in the elderly
Elderly people may need lower doses of Diazepam than younger patients. If you are elderly, your doctor may prescribe a lower dose and check your response to treatment. Please follow your doctor's instructions carefully.
Diazepam contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, check with your doctor before taking this medicine.
3. How to take Diazepam
Follow exactly the directions on the medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Depending on the nature of your illness, your age and weight, your doctor will prescribe the most appropriate dose and tell you the duration of your treatment with Diazepam.
Remember to take your medicine.
Follow these instructions unless your doctor has given you other indications:
Use in adults
Anxiety symptoms: 2 to 10 mg, 2 to 4 times a day, depending on the severity of the symptoms.
Symptomatic relief in acute alcohol withdrawal: 10 mg, 3 or 4 times during the first
24 hours, reducing to 5 mg 3 or 4 times a day, as needed.
Coadjuvant for the relief of musculoskeletal spasm: 2 to 10 mg, 3 or 4 times a day.
Coadjuvant in anticonvulsive therapy: 2 to 10 mg, 2 or 4 times a day.
Use in children
From 2 to 2.5 mg, 1 or 2 times a day, gradually increasing according to needs and tolerance; As a general rule 0.1-0.3 mg / kg per day. Because of the variety of response of children to drugs acting on the CNS, treatment with the lowest dose should be initiated and increased as required. Do not use in children younger than 6 months of age.
Use in the elderly or in the presence of debilitating diseases
From 2 to 2.5 mg, 1 or 2 times a day, then increasing gradually, according to need and tolerance.
Treatment should be started at the lowest dose. Do not exceed the maximum dose.
If you think Diazepam is too strong or weak, tell your doctor or pharmacist.
In elderly patients or patients suffering from liver or kidney disorders, or muscle weakness, in children, in debilitated patients or those with a low serum albumin level, the doctor will prescribe a lower dose.
Rules for proper administration
Do not increase at all the doses prescribed by the doctor.
Each individual dose should not exceed the indicated limits and the total daily dose either, unless your doctor prescribes a higher dose.
Diazepam tablets should be taken without chewing, with a little water or a non-alcoholic beverage.
The tablets will be taken at the times that are most necessary, usually in the evening or at night. Never change your prescribed dose yourself.
The duration of treatment should be as short as possible and never exceed 2-3 months. Consult your doctor regularly to decide whether to continue treatment.
Do not prolong the treatment longer than recommended.
To avoid withdrawal symptoms, you should not stop taking Diazepam abruptly, especially if you have been taking it for a long time.
If you take more Diazepam than you should
If you or someone else has ingested an overdose of Diazepam call your doctor, pharmacist or the nearest hospital immediately.
In case of overdose or accidental ingestion consult your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone: 91 562 04 20 indicating the medicine and the amount used.
If you forget to take Diazepam
Do not take a double dose to make up for a forgotten dose. On the contrary, you should continue with the normal dose.
If you stop taking Diazepam
Restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes may occur upon cessation of administration. In general, it is not recommended to abruptly stop the medication but to gradually reduce the dose, according to the doctor's instructions.