Diazepam Qualigen 10 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Diazepam Qualigen 10 mg Tablets EFG
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Leaflet Contents:
- What Diazepam Qualigen is and what it is used for
- What you need to know before taking Diazepam Qualigen
- How to take Diazepam Qualigen
- Possible side effects
- How to store Diazepam Qualigen
- Contents of the pack and other information
1. What Diazepam Qualigen is and what it is used for
Diazepam Qualigen 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 patients who have symptoms of anxiety, agitation, and psychological tension caused by psychoneurotic conditions and transient situational disorders. Benzodiazepines are only indicated for the treatment of severe disorders that significantly limit your activity or subject you to considerable stress.
It may also be useful 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 or 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), as well as in athetosis (continuous, involuntary, slow, and writhing movements of fingers and hands) and generalized stiffness syndrome.
Diazepam may be used as an adjunctive treatment (a treatment given following the primary treatment to increase the likelihood of recovery) for convulsive disorders (such as epilepsy, seizures), although it has not been shown to be effective as a sole treatment. In such cases, your doctor will periodically assess the usefulness of the medicine for your condition.
2. What you need to know before starting to take Diazepam Qualigen
Do not take Diazepam Qualigen
- If you are allergic to diazepam or to any of the other ingredients 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 Qualigen unless your doctor has specifically instructed 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, whether alone or associated with anxiety. Your doctor will likely have prescribed another medication for these conditions.
Do not use this medicine in children under 6 months of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Diazepam Qualigen.
- 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 Qualigen or not take it at all.
In patients with depression, Diazepam Qualigen acts on the anxiety component and therefore does not constitute treatment for depression itself and may eventually unmask some symptoms of depression.
If you have epilepsy and are undergoing long-term treatment with Diazepam Qualigen, the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Diazepam Qualigen 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
The duration of treatment should be as short as possible.
Elderly patients
Elderly patients may require lower doses of Diazepam Qualigen 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 Qualigen
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 its effect.
For example, tranquilizers, sleep-inducing medicines, and similar drugs act on the brain and nerves and may enhance the effect of Diazepam Qualigen.
Cisapride, cimetidine, ketoconazole, fluconazole, voriconazole, fluvoxamine, fluoxetine, hormonal contraceptives, disulfiram, isoniazid, diltiazem, idelalisib, modafinil, armodafinil, esomeprazole, and omeprazole temporarily increase the sedative effect of Diazepam Qualigen, increasing the risk of drowsiness. The same applies to grapefruit juice.
Conversely, medicines such as rifampicin and carbamazepine reduce the effects of diazepam.
In addition, the metabolism of phenytoin may be affected if you are taking Diazepam Qualigen; 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 Qualigen is combined with other central nervous system depressants, possibly leading to coma or death.
Xanthines such as theophylline and caffeine counteract the sedative effects of Diazepam Qualigen.
Therefore, you should not use Diazepam Qualigen with any other medicine unless your doctor has specifically allowed it.
If you need more information about this, consult your doctor or pharmacist.
Taking Diazepam Qualigen with food, drinks, and alcohol
Alcoholic beverages increase the sedative effects of Diazepam Qualigen; 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 lead to 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 when the medicine is taken continuously over a long period. 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 another patient), 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
Consult your doctor or pharmacist before using any medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
If Diazepam Qualigen is taken before or during delivery due to strict medical necessity, 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; therefore, you should consult your doctor about whether or not to take Diazepam Qualigen during 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. Your doctor must decide when you can resume these activities. This effect is increased if you have also consumed alcohol.
Diazepam Qualigen 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 Qualigen
Follow exactly the instructions for use of this medicine as given by your doctor. 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 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.
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.
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 with the lowest dose and increased as required. Not to be used in children under 6 months of age.
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 possible 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, muscular weakness, children, 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 in any case.
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 little 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
The duration of treatment 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 prolong the treatment beyond the recommended period.
To avoid withdrawal symptoms, diazepam must not be stopped abruptly, especially if it has been taken for a long time.
If you take more Diazepam Qualigen than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Diazepam Qualigen
Do not take a double dose to make up for missed doses. Instead, continue with your normal dose.
If you stop taking Diazepam Qualigen
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 may produce 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 effect not listed in this leaflet, inform your doctor or pharmacist.
Most patients tolerate Diazepam Qualigen well, but the most common adverse effects, which occur especially at the beginning of treatment, are fatigue, muscle weakness, and drowsiness.
Occasionally, other adverse effects have been reported, such as confusion, decreased level of alertness, numbness, 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 rate, 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, raised itchy patches), and pruritus (tingling or irritating discomfort of the skin 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 concurrently taking other sedative medicines (including alcoholic beverages).
Heart failure and respiratory depression, including respiratory failure, may occur.
It is known that when benzodiazepines are used, adverse behavioral 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 behavior. These reactions are more frequent in elderly patients and in children. If you experience any of these effects, you must stop treatment and contact your doctor immediately.
In addition, the use of benzodiazepines may lead to dependence, particularly 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 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Diazepam Qualigen
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.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Diazepam Qualigen
-
The active substance is diazepam. Each tablet contains 10 mg of diazepam.
-
The other components are monohydrate lactose, corn starch, and magnesium stearate (E-572).
Appearance of the product and contents of the pack
Diazepam Qualigen 10 mg tablets: round, flat, bevelled tablets, white or almost white, with the imprint E1 on one side.
Diazepam Qualigen 10 mg tablets are available in packs containing 25 and 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder :
Neuraxpharm Spain, S.L.U.
Avda. Barcelona 69
08970 Sant Joan Despí
Barcelona – Spain
Manufacturer :
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona) - Spain
Date of the most recent revision of this leaflet: February 2024
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/