Diazepam Mylan Generics

Patient Information Leaflet

Diazepam Mylan Generics 5 mg/ml oral drops, solution

diazepam
Generic Medicine
Please read all of this leaflet carefully before you take 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Diazepam Mylan Generics is and what it is used for
2. What you need to know before taking Diazepam Mylan Generics
3. How to take Diazepam Mylan Generics
4. Possible side effects
5. How to store Diazepam Mylan Generics
6. Contents of the pack and other information

1. What Diazepam Mylan Generics is and what it is used for

Diazepam Mylan Generics contains the active substance diazepam, which belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states that cause significant distress to the individual.
This medicine is indicated:

• in adults, and in children from the age of 2 years, for the treatment of anxiety, tension, and other anxiety-related disorders;
• in adults for the treatment of sleep disorders (insomnia). Diazepam Mylan Generics should be used only when the disorder is severe, disabling, and causes significant distress.

2. What you need to know before taking Diazepam Mylan Generics

Do not take Diazepam Mylan Generics

• if you are allergic to diazepam, to other similar medicines (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
• if you have severe breathing problems (respiratory failure);
• if you have severe liver problems (hepatic failure);
• if you have breathing difficulties during sleep (sleep apnoea).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam Mylan Generics.
Treatment must be carried out under medical supervision and should last as short a time as possible. Your doctor will determine the most appropriate dose and duration of treatment for you. Treatment should be limited in duration, and your doctor will explain how to gradually reduce the dose before stopping. When stopping Diazepam Mylan Generics, symptoms that led to treatment may reappear.

Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly or debilitated (see section 3 "How to take Diazepam Mylan Generics – Use in the elderly"). Your doctor may decide to reduce the dose;
• if you have reduced blood flow to the brain (arteriosclerosis);
• if you have heart or lung problems (cardiorespiratory failure). Your doctor may decide to reduce the dose;
• if you have previously abused alcohol or drugs;
• if you have liver or kidney problems (hepatic or renal failure).

Tolerance
If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence
When taking this medicine, there is a risk of dependence, meaning a need to continue taking the medicine. The risk increases with higher doses and longer treatment duration. The risk is greater if you have previously abused drugs or alcohol.
Withdrawal
If you abruptly stop taking Diazepam Mylan Generics, you may experience withdrawal symptoms such as headache, diarrhoea, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability. In severe cases, derealisation (feeling detached from the external world), depersonalisation (feeling detached from one's own body), hyperacusis (increased sensitivity to sound), numbness and tingling in the extremities, hypersensitivity to light, noise, and physical touch, or hallucinations (seeing or hearing things that are not there) may occur.
After stopping treatment, insomnia and anxiety may temporarily reappear and worsen. Additional disturbances such as mood changes, anxiety, restlessness, or sleep disorders may also occur.
Since the risk of withdrawal or rebound symptoms is higher after abrupt discontinuation of treatment, your doctor will explain how to gradually reduce the dose before stopping.
Amnesia
This medicine may cause you to forget events that occur while taking it (anterograde amnesia).
Behavioural reactions
If you experience any of the following behavioural disturbances, stop taking the medicine immediately and contact your doctor:

• restlessness
• agitation
• anxiety
• irritability
• aggressiveness
• delirium (misinterpretation of reality)
• anger
• nightmares
• hallucinations (seeing or hearing things that do not exist)
• psychosis (thought disturbances)
• behavioural changes

Children
Diazepam Mylan Generics should be used in children only when absolutely necessary, following medical evaluation, and treatment duration should be as short as possible.
Other medicines and Diazepam Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

• antipsychotics (clozapine and olanzapine) and antidepressants (fluvoxamine, fluoxetine), used to treat mental disorders;
• hypnotics, medicines used to promote sleep;
• anxiolytics/sedatives, used to treat anxiety;
• certain strong painkillers (narcotic analgesics such as morphine, pethidine, and methadone), used to relieve pain;
• antiepileptics (carbamazepine and phenytoin), used for epilepsy (a condition characterised by uncontrollable body movements and loss of consciousness);
• anaesthetics (ketamine), medicines that reduce pain sensitivity and cause sedation;
• antihistamines, used to treat allergies;
• antifungals (fluconazole, voriconazole, and itraconazole), medicines used to treat fungal infections;
• oral contraceptives, medicines used to prevent pregnancy;
• omeprazole, esomeprazole, cimetidine, and antacids, medicines for stomach disorders;
• disulfiram, used to treat alcohol dependence;
• isoniazid, an antibiotic used to treat tuberculosis;
• diltiazem, used to treat high blood pressure and certain heart conditions;
• idelalisib, a medicine used to treat leukaemias and lymphomas;
• modafinil and armodafinil, used for narcolepsy, a condition involving excessive sleepiness;
• rifampicin, an antibiotic;
• metoclopramide, a medicine used for nausea and vomiting;
• levodopa, used to treat Parkinson’s disease, a condition causing tremor, stiffness, and slowness of movement;
• theophylline, a medicine used to treat asthma, a condition characterised by bronchial constriction and inflammation;
• medicines containing caffeine.

Concomitant use of Diazepam Mylan Generics and opioids (strong analgesics, medicines for addiction therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening.
For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Diazepam Mylan Generics together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Diazepam Mylan Generics and alcohol
You must not consume alcohol during treatment with this medicine.
Diazepam Mylan Generics with food and drinks
Food reduces the absorption of Diazepam Mylan Generics.
Avoid drinking grapefruit juice during treatment with Diazepam Mylan Generics, as it may increase the medicine’s effects.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of Diazepam Mylan Generics has not been established.
Do not take Diazepam Mylan Generics during the first 3 months of pregnancy. An increased risk of congenital malformations has been reported with the use of benzodiazepines during the first trimester of pregnancy.
If your doctor considers it necessary for you to take Diazepam Mylan Generics in the later stages of pregnancy, fetal heart rate irregularities may occur. If administered during labour and delivery, your baby may experience low body temperature (hypothermia), poor sucking, loss of muscle tone (hypotonia), and breathing difficulties.
In addition, your newborn may show signs of dependence withdrawal at birth.
Breastfeeding
Do not take this medicine if you are breastfeeding, as diazepam passes into breast milk.
Driving and using machines
The use of Diazepam Mylan Generics affects your ability to drive and operate machinery, as it may cause sedation, amnesia (a memory disorder), impaired concentration, and altered muscle function. If your sleep duration is insufficient, or if you consume alcohol, the likelihood of impaired alertness may increase.
Diazepam Mylan Generics contains ethanol (alcohol), propylene glycol, and sodium
This medicine contains 96 mg of alcohol (ethanol) in 1 ml. The amount in 1 ml of this medicine is equivalent to less than 2.4 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 618 mg of propylene glycol per 1 ml. If the child is under 5 years of age, speak with your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol. If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment. If you have liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
This medicine contains less than 1 mmol (23 mg) of sodium per 10 mg, i.e., essentially 'sodium-free'.

3. How to take Diazepam Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Anxiety and Insomnia
Adults
The recommended dose is 2 mg (10 drops), two or three times a day, up to 5 mg (25 drops), one or two times a day.
The maximum dose is 10 mg per day. Do not exceed the maximum dose.
Elderly patients and debilitated patients
The recommended dose is 2 mg, twice a day.
Hospital treatment of anxiety states
The recommended dose is 10–20 mg, three times a day.
Anxiety
Children

Instructions for use
Take Diazepam Mylan Generics oral solution as follows:

• To open the bottle: press down on the cap and simultaneously unscrew it (Fig. 1).
• To dispense the drops, hold the bottle in an upright position with the opening facing downwards and let the drops fall into a glass (Fig. 2). The drops must be diluted with a small amount of water or another beverage.
• To close the bottle: screw the cap back on until it is tightly sealed (Fig. 3).

Fig. 1 Fig. 2 Fig. 3
Duration of treatment
Treatment for insomnia and anxiety should be as short as possible.
The duration of treatment, including a gradual withdrawal period, ranges from a few days to 4 weeks for insomnia and from a few days up to 8–12 weeks for anxiety.
In certain cases, after re-evaluating your health status, your doctor may decide to extend the duration of treatment beyond the periods indicated above.
Treatment is initiated with the lowest recommended dose.
Do not exceed the maximum dose.
Your doctor will determine the appropriate dose and will assess whether a dose reduction is necessary if you are elderly or debilitated.
At the beginning of treatment, you will be closely monitored by your doctor, who will prescribe the dose most suitable for your clinical condition.
If you take more Diazepam Mylan Generics than you should
If you have taken an excessive dose of Diazepam Mylan Generics or if you suspect that a child may have ingested this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose of Diazepam Mylan Generics can be life-threatening and may cause drowsiness, ataxia (reduced motor coordination and impaired gait), dysarthria (difficulty articulating words), and nystagmus (involuntary eye movements).
Mild cases are characterized by obtundation (reduced level of consciousness), mental confusion, and lethargy (deep sleep and reduced responsiveness to stimuli).
In more severe cases, symptoms include ataxia, hypotonia, hypotension, respiratory depression, coma, and death. Coma (loss of consciousness), if it occurs, usually lasts for a few hours but may be prolonged and cyclical, especially in elderly patients. Respiratory depressant effects associated with benzodiazepines are more severe in patients with pre-existing respiratory disorders.
Treatment
Your vital functions (heart rate, respiration, and brain activity) will be monitored and symptoms will be treated accordingly.
If you are conscious and the overdose occurred within the last hour, vomiting may be induced, or gastric lavage may be performed, activated charcoal may be administered, and, if necessary and under close monitoring, an antidote (a substance that counteracts the effects of the medicine) may be given.
In case of accidental ingestion or intake of an excessive dose of Diazepam Mylan Generics, contact your doctor immediately or go to the nearest hospital.
If you forget to take Diazepam Mylan Generics
Do not take a double dose to make up for the missed dose.
If you stop taking Diazepam Mylan Generics
Do not stop treatment with Diazepam Mylan Generics suddenly or without first discussing it with your doctor, as withdrawal symptoms or rebound phenomena may occur—namely, a worsening of the symptoms that led to starting treatment (see section "Warnings and precautions").
Treatment should be discontinued gradually. Please consult your doctor before stopping treatment with Diazepam Mylan Generics.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience:

• depression and mental disorders such as restlessness, agitation, irritability, disorientation, aggression, nervousness, hostility, anxiety, delirium (a false interpretation of reality), anger, nightmares, abnormal dreams, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), hyperactivity, inappropriate behaviour, and other behavioural side effects. If any of these side effects occur, inform your doctor immediately; he or she will explain how to discontinue treatment. These reactions occur more frequently in children and elderly patients.

In addition, the following may occur:

• ataxia (reduced motor coordination and gait)*,
• dysarthria (reduced ability to articulate words),
• difficulty speaking,
• headache*,
• tremors,
• dizziness,
• anterograde amnesia (difficulty in memorizing new information),
• confusion*,
• mood and emotional disturbances*,
• reduced alertness*,
• depression,
• changes in sexual desire,
• drowsiness, even during daytime*,
• falls and fractures,
• nausea,
• dry mouth,
• increased salivation,
• constipation,
• other stomach and intestinal disorders,
• diplopia (double vision)*,
• blurred vision,
• hypotension (low blood pressure),
• circulatory depression (a condition in which the heart does not effectively pump blood to various parts of the body),
• increased transaminases and alkaline phosphatase (blood tests indicating liver disturbances),
• urinary incontinence (involuntary loss of urine),
• urinary retention (inability to empty the bladder),
• skin reactions,
• vertigo*,
• heart failure (a condition in which the heart does not effectively pump blood to various parts of the body), cardiac arrest (cessation of heart activity),
• respiratory depression including respiratory failure (slow and ineffective breathing),
• jaundice (yellowing of the skin and whites of the eyes),
• fatigue*,
• muscle weakness*.

* These side effects may occur at the beginning of treatment and usually disappear with subsequent doses.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diazepam Mylan Generics

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 that month.
The stated expiry date applies to the product in its original, undamaged packaging,
stored correctly.
The product should be used within 3 months of first opening the bottle. Any excess product must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Diazepam Mylan Generics contains

• The active substance is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
• The other components are: ethanol 96%, glycerol, sodium saccharin, propylene glycol, soluble orange flavour, soluble lemon flavour, erythrosine (E 127), purified water.

Description of the appearance of Diazepam Mylan Generics and contents of the pack
Pack containing one 20 ml bottle of solution.
The bottle has a child-resistant closure to protect against tampering by children.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A., Vittor Pisani 20, 20124 Milan, Italy

Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29, 10090 S. Bernardo d'Ivrea (TO), Italy
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC), Italy