Diazepam Stada 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Diazepam Stada 10 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Diazepam Stada is and what it is used for
- What you need to know before taking Diazepam Stada
- How to take Diazepam Stada
- Possible adverse effects
- How to store Diazepam Stada
- Contents of the pack and other information
1. What Diazepam Stada is and what it is used for
Diazepam Stada contains the active substance diazepam, which belongs to a group of medicines called benzodiazepines.
Diazepam has calming, sedative, muscle-relaxant, and anticonvulsant effects.
Doctors prescribe diazepam for patients who experience symptoms of anxiety, agitation, and psychological tension due to psychoneurotic conditions and transient situational disorders. Benzodiazepines are indicated only for the treatment of severe disorders that significantly limit a person's functioning or subject them to considerable stress.
It may also be helpful in relieving symptoms of acute agitation, tremor, and hallucinations in patients experiencing alcohol withdrawal syndrome.
Diazepam helps relieve muscle pain caused by muscle or joint spasms, inflammation, trauma, etc. It may also be used to treat spasms resulting from conditions such as cerebral palsy (a group of disorders affecting a person's ability to move, maintain balance, and posture), paraplegia (paralysis of the lower half of the body, affecting both legs), choreoathetosis (continuous, involuntary, slow, and irregular movements of fingers and hands), and generalized stiffness syndrome.
Diazepam may be used as an adjunctive treatment (a treatment given after the primary treatment to increase the likelihood of recovery) for seizure disorders (such as epilepsy, convulsions), but it has not been shown to be effective as a sole treatment. In such cases, your doctor will periodically evaluate whether the medicine remains beneficial for your condition.
2. What you need to know before taking Diazepam Stada
Do not take Diazepam Stada
- If you are allergic to diazepam or to any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to other medicines in the benzodiazepine group.
- If you have long-standing respiratory difficulties with or without sleep-related symptoms.
- If you have a condition called "myasthenia gravis", which is characterized by muscle weakness and fatigue.
- If you have severe respiratory problems (severe respiratory insufficiency).
- If you have severe liver problems (severe hepatic insufficiency).
If you suffer from drug or alcohol dependence, you should not take diazepam unless your doctor specifically instructs you to do so.
This medicine is not recommended for the primary treatment of psychotic disorders (severe mental disorders causing abnormal thoughts and perceptions), nor should it be used as the sole treatment in patients with depression, either alone or associated with anxiety. Your doctor will likely have prescribed another medication for these conditions.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Diazepam Stada.
- If you have liver or kidney disease
- If you have respiratory difficulties
- If you suffer from severe muscle weakness
- If you have other medical conditions
- If you have allergies
- If you have a history of drug or alcohol dependence
- If you are taking other medicines
Your doctor will decide whether you should take a lower dose of diazepam or should not take it at all.
If you have epilepsy and are on long-term diazepam treatment, the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of diazepam is not recommended, as seizures may occur.
Children
Do not use this medicine in children under 6 months of age.
Taking Diazepam Stada with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is extremely important because taking more than one medicine at the same time may increase or decrease their effects.
Therefore, you should not take diazepam with other medicines unless your doctor is aware and has approved it beforehand. For example, sedatives, sleep-inducing medicines, and similar drugs act on the brain and nerves and may enhance the effect of diazepam.
Cisapride, cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole temporarily increase the sedative effect of diazepam, thereby increasing the risk of drowsiness.
In addition, the metabolism of phenytoin may be affected if you are taking diazepam; therefore, if you are taking this medicine, your doctor will adjust the doses accordingly.
Concomitant use of diazepam and opioids (strong analgesics, medications for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes diazepam together with opioids, your doctor must limit the dose and duration of concomitant treatment.
Inform your doctor about all opioid medicines you are taking and strictly follow your doctor's advice regarding dosage. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.
If you need further information on this, consult your doctor or pharmacist.
Taking Diazepam Stada with food, drinks, and alcohol
Alcoholic beverages increase the sedative effects of diazepam; therefore, avoid consuming alcohol during treatment. If you need additional information, consult your doctor.
Risk of dependence
The use of benzodiazepines may lead to dependence. This mainly occurs after taking the medicine continuously for a long time. To minimize the risk of dependence, the following precautions should be observed:
- Benzodiazepines should only be taken under medical prescription (never because they worked for someone else), and you should never recommend them to others.
- Do not increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended duration.
- Consult your doctor regularly so they can decide whether you should continue treatment.
Pregnancy and breastfeeding
Before starting treatment, your doctor must know if you are pregnant, suspect you are pregnant, or plan to become pregnant. Your doctor will then decide whether or not you should take diazepam.
Benzodiazepines pass into breast milk; therefore, you should consult your doctor about whether or not to take diazepam while breastfeeding.
Driving and using machines
Do not drive or operate tools or machinery, as this medicine may cause sedation, amnesia, difficulty concentrating, and muscle weakness, which may negatively affect your ability to drive vehicles or operate machinery. This effect is increased if you have also consumed alcohol.
Use in elderly people
Elderly people may require lower doses of diazepam than younger patients. If you are elderly, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.
Diazepam Stada contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Diazepam Stada
Follow exactly the instructions for use provided 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 inform you of the duration of your treatment with diazepam.
Remember to take your medication.
Follow these instructions unless your doctor has given you different advice:
Use in adults
Anxiety symptoms: 2 to 10 mg, 2 to 4 times daily, depending on the severity of symptoms.
Symptomatic relief in acute alcohol withdrawal: 10 mg, 3 or 4 times during the first 24 hours, then reduced to 5 mg 3 or 4 times daily, as needed.
Adjuvant for relief of musculoskeletal spasm: 2 to 10 mg, 3 or 4 times daily.
Adjuvant in anticonvulsant therapy: 2 to 10 mg, 2 or 4 times daily.
Use in children
2 to 2.5 mg, 1 or 2 times daily, gradually increased according to need and tolerance; as a general rule, 0.1–0.3 mg/kg daily. Due to the variable response of children to drugs acting on the CNS, treatment should be initiated with the lowest dose and increased as required. Not to be used in children under 6 months of age.
Use in elderly patients or in the presence of debilitating diseases
2 to 2.5 mg, 1 or 2 times daily, then gradually increased as needed and tolerated.
Treatment should be initiated with the lowest dose. The maximum dose must not be exceeded.
If you feel that the effect of diazepam is too strong or too weak, inform your doctor or pharmacist.
In elderly patients or those with liver or kidney disorders, muscle weakness, in children, in debilitated patients or those with low serum albumin levels, your doctor will prescribe a lower dose.
Instructions for correct administration
Do not increase the doses prescribed by your doctor under any circumstances.
Each individual dose must not exceed the limits indicated, nor must the total daily dose, unless your doctor prescribes a higher dose.
Diazepam tablets should be taken without chewing, with a glass of water or a non-alcoholic drink.
The tablets should be taken at the times when they are most needed, usually in the afternoon or evening. Never change the prescribed dose on your own.
Duration of treatment
Treatment duration should be as short as possible and never longer than 2–3 months. Consult your doctor regularly to determine whether treatment should continue.
Do not extend the treatment beyond the recommended period.
To avoid withdrawal symptoms, diazepam should not be stopped abruptly, especially if it has been taken for a long time.
If you take more Diazepam Stada than you should
If you or someone else has taken an overdose of diazepam, contact your doctor, pharmacist or the nearest hospital immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Diazepam Stada
Do not take a double dose to make up for missed doses. Instead, continue with your normal dose.
If you stop taking Diazepam Stada
Upon discontinuation, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur. Abrupt interruption of the medication is generally not recommended; instead, the dose should be gradually reduced according to your doctor's instructions.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Most patients tolerate diazepam well, but the most frequent adverse effects, which occur especially at the beginning of treatment, are tiredness and drowsiness.
Occasionally, other adverse effects have been reported, such as confusion, impaired alertness, loss of sensation, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, gastrointestinal disturbances, changes in heart rate, headache, hypotension, circulatory disturbances, increased or decreased libido (sexual drive), nausea, dry mouth or hypersalivation (excessive salivary secretion), urinary incontinence or retention, skin rashes, stammering, tremor, dizziness, and blurred vision. The most common skin reactions are rash (skin inflammation), urticaria (reddish hives), and pruritus (skin tingling or irritation causing an urge to scratch the affected area).
Very rarely, increased transaminases and alkaline phosphatase, jaundice (yellowing of the skin and eyes), and cardiac arrest have been reported.
An increased risk of falls and fractures has been observed in elderly patients and in patients taking other sedative medicines simultaneously (including alcoholic beverages).
It is known that when benzodiazepines are used, adverse behavioral effects may occur, such as restlessness, agitation, irritability, delirium (incoherent thinking), rage attacks, aggression, nightmares, hallucinations, psychosis (loss of contact with reality), or inappropriate behavior. These reactions are more frequent in elderly patients and in children. If you experience these effects, you must stop treatment and contact your doctor immediately.
Furthermore, the use of benzodiazepines may lead to dependence, particularly when the medicine is taken continuously over a long period. Generally, it is not recommended to abruptly stop the medication, always following your doctor's instructions.
Anterograde amnesia (difficulty remembering recent events) may occur at normal doses, and the risk increases with higher doses. Amnesic effects may be associated with behavioral disturbances.
If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Diazepam Stada
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly discard medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Diazepam Stada
- The active substance is diazepam. Each tablet contains 10 mg of diazepam.
- The other components are lactose monohydrate, corn starch, and magnesium stearate.
Appearance of the product and contents of the pack
Diazepam Stada 10 mg tablets: round, flat, bevelled tablets, white or almost white, with the imprint E1 on one side.
Diazepam Stada 10 mg tablets are available in packs of 25 and 30 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio Stada, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. de Barcelona, 69
08970 Sant Joan Despí (Barcelona)
Spain
Date of the most recent review of this leaflet: July 2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/