Diazepam CINFA 5 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
diazepam cinfa 5 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What diazepam cinfa is and what it is used for
- What you need to know before taking diazepam cinfa
- How to take diazepam cinfa
- Possible side effects
- How to store diazepam cinfa
- Contents of the pack and other information
1. What diazepam cinfa is and what it is used for
diazepam cinfa contains diazepam as the active substance, which belongs to a group of medicines called benzodiazepines.
Diazepam has tranquilizing, sedative, muscle-relaxant, and anticonvulsant effects.
Doctors prescribe diazepam for individuals experiencing symptoms of anxiety, agitation, and psychic tension caused by psychoneurotic conditions and transient situational disorders. Benzodiazepines are indicated only for the treatment of severe disorders that significantly impair a person's functioning or subject them to considerable stress.
It may also be useful in relieving symptoms of acute agitation, tremor, and hallucinations in patients experiencing alcohol withdrawal syndrome.
This medicine 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), athetosis (continuous, involuntary, slow, and writhing movements of fingers and hands), and generalized stiffness syndrome.
This medicine can be used as an adjunctive treatment (a treatment given following the primary treatment to increase the likelihood of recovery) for seizure disorders (such as epilepsy, convulsions), although it has not been shown to be effective as monotherapy. 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 cinfa
Do not take diazepam cinfa
- If you are allergic to diazepam or to any of the other components of this medicine (listed in section 6).
- If you are allergic (hypersensitive) to other medicines in the benzodiazepine group.
- If you have long-term breathing difficulties with or without sleep-related symptoms.
- If you have a disease 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 formally instructed by your doctor.
This medicine is not recommended for the primary treatment of psychotic disorders (severe mental disorders causing abnormal thoughts and perceptions), and should not be used as the sole treatment in patients with depression, either alone or associated with anxiety. Your doctor will likely have prescribed another medicine for these conditions.
Warnings and precautions
Consult your doctor or pharmacist before starting to take diazepam cinfa.
- If you have any heart, liver, or kidney disease.
- If you have breathing difficulties.
- If you suffer from severe muscle weakness.
- If you have other illnesses.
- If you have allergies.
- If you have a history of, or problems with, drug dependence or central nervous system depressants, including alcohol.
- 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.
In patients with depression, diazepam only acts on the anxious component, so it does not constitute treatment for depression itself and may eventually unmask certain signs of depression.
If you have epilepsy and are undergoing long-term treatment with diazepam, the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of diazepam is not recommended, as seizures may occur.
Your doctor will pay special attention due to the increased risk if you are elderly or severely debilitated.
Children
Do not use this medicine in children under 6 months of age.
The duration of treatment should be as short as possible.
Elderly patients
Elderly patients may require lower doses of diazepam than younger patients. The pharmacological effects of benzodiazepines in elderly patients appear to be greater than in younger populations.
If you are elderly, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.
Patients with hepatic impairment
The sedative effect of diazepam is increased in patients with alcoholic cirrhosis.
Other medicines and diazepam cinfa
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is extremely important because taking more than one medicine at the same time may increase or decrease their effects.
For example, tranquilizers, sleep-inducing medicines, and similar drugs act on the brain and nerves and may enhance the effect of diazepam.
Cimetidine, ketoconazole, fluconazole, voriconazole, fluvoxamine, fluoxetine, hormonal contraceptives, disulfiram, isoniazid, diltiazem, idelalisib, modafinil, armodafinilo, esomeprazole, and omeprazole temporarily increase the sedative effect of diazepam, increasing the risk of drowsiness. The same applies to grapefruit juice.
Conversely, medicines such as rifampicin and carbamazepine reduce the effects of diazepam.
Additionally, 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.
The sedative effect and cardiorespiratory depression may be increased when diazepam is combined with other central nervous system depressants, potentially leading to coma or death.
Xanthines such as theophylline and caffeine counteract the sedative effects of diazepam.
Therefore, you should not take diazepam with any other medicine unless approved by your doctor.
If you need further information on this, consult your doctor or pharmacist.
Taking diazepam cinfa with food, drinks, and alcohol
Alcoholic beverages increase the sedative effects of diazepam; therefore, avoid consuming alcoholic drinks during treatment. Consult your doctor if you need further information.
Diazepam should not be taken with grapefruit juice, as it may increase diazepam levels in your body.
Food and antacids may slow down, but do not reduce, the absorption of diazepam from the tablet; this may result in milder effects after a single dose, but does not affect treatment with multiple doses.
Prokinetic medicines (medicines to improve intestinal transit) increase the absorption of diazepam.
Risk of dependence
The use of benzodiazepines and benzodiazepine-like drugs may lead to physical and psychological dependence. This occurs mainly after prolonged, uninterrupted use of the medicine. 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 treatment should continue.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
If, due to strict medical necessity, you take diazepam before or during childbirth, the newborn may experience hypothermia (abnormally low body temperature), weakness, hypotension, and breathing difficulties. Cases of withdrawal syndrome in newborns have also been reported.
Benzodiazepines pass into breast milk, so you should consult your doctor about whether or not to take diazepam during breastfeeding.
Driving and using machines
Diazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or impair reaction ability. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.
diazepam cinfa contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult them before taking this medicine.
3. How to take diazepam cinfa
Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Depending on the nature of your condition, your age and weight, your doctor will prescribe the most appropriate dose and indicate the duration of your treatment with diazepam.
Remember to take your medicine.
Follow these instructions unless your doctor has given you different ones:
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.
Adjunctive treatment for relief of musculoskeletal spasm: 2 to 10 mg, 3 or 4 times daily.
Adjunctive treatment in anticonvulsant therapy: 2 to 10 mg, 2 or 4 times daily.
Dosing in special populations
Use in children: 2 to 2.5 mg, 1 or 2 times daily, gradually increased according to needs and tolerance; as a general rule, 0.1–0.3 mg/kg per day. Due to the variable response of children to drugs acting on the CNS, treatment should be initiated at 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 started 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, the 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 indicated limits, nor must the total daily dose, unless your doctor prescribes a higher dose.
Diazepam tablets should be taken without chewing, with a little water or a non-alcoholic drink.
The tablet may be divided into equal doses.
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
The duration of treatment should be as short as possible and never exceed 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, you must not stop taking diazepam abruptly, especially if you have been taking it for a long time.
If you take more diazepam cinfa than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and amount ingested.
If you forget to take diazepam cinfa
Do not take a double dose to make up for missed doses. Instead, continue with your normal dose.
If you stop treatment with diazepam cinfa
When stopping administration, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur. Abrupt discontinuation 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 will experience them.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Most patients tolerate diazepam well, but the most common adverse effects—particularly at the beginning of treatment—are fatigue, muscle weakness, and drowsiness.
Occasionally, other adverse effects have been reported, such as confusion, reduced alertness, loss of sensation, dizziness, affective disorders, emotional and mood disturbances, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating speech, gastrointestinal disturbances, changes in heart rhythm, headache, hypotension, circulatory disturbances, changes in libido (sexual desire), nausea, dry mouth or hypersalivation (excessive salivary secretion), urinary incontinence or urinary retention, skin rashes, stammering, tremor, vertigo, and blurred vision. The most frequent skin reactions are rash (skin inflammation), urticaria (red welts), and pruritus (tingling or irritating discomfort of the skin causing an urge to scratch the affected area).
Very rarely, elevated transaminases and alkaline phosphatase levels, 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).
Heart failure and respiratory depression, including respiratory failure, may occur.
It is known that when benzodiazepines are used, adverse behavioural effects may occur, such as restlessness, disorientation, agitation, irritability, delirium (incoherent thinking), rage attacks, aggressiveness, nervousness, hostility, anxiety, nightmares, abnormal dreams, hallucinations, psychosis (loss of contact with reality), hyperactivity, or inappropriate behaviour. These reactions are more frequent in elderly individuals and in children. If you experience any of these effects, you must stop treatment and contact your doctor immediately.
Furthermore, the use of benzodiazepines may lead to dependence, primarily when the medicine is taken continuously over a long period. Abrupt discontinuation of the medication is generally not recommended and should always follow 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 behavioural 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of diazepam cinfa
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 is 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 packaging and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of diazepam cinfa
- The active substance is diazepam. Each tablet contains 5 mg of diazepam.
- The other components are monohydrate lactose, corn starch, and magnesium stearate.
Appearance of the product and contents of the pack
Round, flat, bevelled tablets, white or almost white in colour, scored on one side and marked with the letter "E" on the other side.
Presented in PVC/aluminum blisters. Each package contains 30 or 40 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona) Spain
or
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent revision of this leaflet: November 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80698/P_80698.html
QR code linking to: https://cima.aemps.es/cima/dochtml/p/80698/P_80698.html