Diazepam ABC

Patient information leaflet

DIAZEPAM ABC 5 mg/ml oral drops, solution

Diazepam
Generic medicine
Please read this leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Diazepam ABC is and what it is used for

Diazepam ABC contains the active substance diazepam, which belongs to a group of anxiolytic agents known as benzodiazepine derivatives.
Diazepam ABC is indicated in adults and in children from the age of two years for the treatment of:

• Anxiety, tension, and other mental or physical symptoms associated with anxiety.

Diazepam ABC is indicated in adults for the treatment of:

• Insomnia (sleep disorders). Diazepam ABC should only be used when the condition is severe, disabling, and causes severe distress.

2. What you should know before taking Diazepam ABC

Do not take Diazepam ABC

• if you are allergic to diazepam, to medicines similar to Diazepam ABC (other benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a muscle disease that may cause weakness and fatigue (severe myasthenia gravis);
• if you have severe respiratory problems (severe respiratory insufficiency);
• if you have severe liver problems (severe acute or chronic hepatic insufficiency);
• if you suffer from a condition causing frequent interruptions in breathing during sleep (sleep apnoea syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before using Diazepam ABC.
Treatment must be carried out under medical supervision and should last for the shortest possible duration. 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 discontinuing Diazepam ABC, symptoms that led to treatment may reappear. After several weeks of treatment, the medicine may partially lose its effectiveness in inducing sleep; this effect is known as tolerance.
Contact your doctor if:

• you have previously abused alcohol or drugs;
• you are elderly;
• you are debilitated;
• you have liver or kidney problems;
• you have brain disorders, such as those due to arteriosclerosis (caused by reduced blood supply);
• you have heart or breathing problems (cardiorespiratory insufficiency).
  Benzodiazepines may lead to physical and psychological dependence. This risk increases with higher doses and longer treatment duration, and is more common in patients with a history of drug or alcohol abuse. Once physical dependence has developed, abruptly stopping treatment may lead to withdrawal symptoms such as headache, diarrhoea, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability. In severe cases, derealization (feeling detached from the external world), depersonalization (feeling detached from one's 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 real) may occur. After stopping treatment, insomnia and anxiety may temporarily reappear and worsen. Additional symptoms such as mood changes, anxiety, restlessness, or sleep disturbances may also occur. Because the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation, your doctor will explain how to gradually reduce the dose before stopping.
  This medicine may cause memory loss for events occurring after taking it (anterograde amnesia). If any of the following adverse reactions occur, the medicine should be discontinued; therefore, contact your doctor if you experience:
• restlessness;
• agitation;
• anxiety;
• irritability;
• aggression;
• delirium (misinterpretation of reality);
• anger;
• nightmares;
• hallucinations (seeing or hearing things that are not real);
• psychosis (thought disturbances);
• behavioural changes.

Children
Your doctor will evaluate whether Diazepam ABC is appropriate for the child and will prescribe it only if strictly necessary. The duration of treatment should be as short as possible.

Other medicines and Diazepam ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are being treated with:

• antipsychotics, such as clozapine and olanzapine, medicines used to treat mental disorders;
• anxiolytics or sedatives, medicines that reduce anxiety or induce sedation;
• antidepressants, such as fluvoxamine, medicines used to treat depression;
• hypnotics, medicines that induce sleep;
• antiepileptics, such as carbamazepine and phenytoin, medicines used to treat epilepsy (a condition characterized by uncontrolled body movements and loss of consciousness);
• narcotic analgesics (morphine, pethidine, and methadone), medicines used to relieve pain;
• anaesthetics, such as ketamine, medicines that reduce pain sensation and induce sedation;
• antihistamines, medicines 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 used to treat 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 to treat 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 characterized by bronchial constriction and inflammation;
• medicines containing caffeine.

Concomitant use of Diazepam ABC and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and may be potentially life-threatening. For this reason, concomitant use should be considered only when no other therapeutic options are available.
However, if your doctor prescribes Diazepam ABC together with opioids, the dose and duration of concomitant treatment should be limited.
Inform your doctor about all opioid-containing medicines you are taking and carefully follow their dosage recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms listed above. If you experience these symptoms, contact your doctor.

Diazepam ABC and alcohol
Do not consume alcohol during treatment with Diazepam ABC.

Diazepam ABC with food and beverages
Food reduces the absorption of Diazepam ABC.
Avoid consuming grapefruit juice during treatment with Diazepam ABC, as it may increase the medicine’s effects.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The safety of Diazepam ABC during pregnancy has not been established.
Do not take Diazepam ABC during the first 3 months of pregnancy. An increased risk of congenital malformations has been reported with benzodiazepine use during the first trimester of pregnancy.
If this medicine is prescribed during late pregnancy, fetal heart rate irregularities may occur. If administered during labour and delivery, the newborn may experience hypothermia (low body temperature), poor sucking, hypotonia (reduced muscle tone), and moderate respiratory depression (slow and ineffective breathing).
In addition, the newborn may experience withdrawal symptoms at birth.

Breastfeeding
Since Diazepam ABC passes into breast milk, breastfeeding should be discontinued during treatment.

Driving and using machines
Diazepam ABC impairs your ability to drive vehicles and operate machinery, as it may cause sedation, amnesia (a memory disorder), impaired concentration, and altered muscle function. If sleep duration is insufficient, or if alcohol is consumed, the likelihood of impaired alertness may increase.

Diazepam ABC contains ethanol (alcohol)
This medicine contains 100 ml of alcohol (ethanol) per 5 mg dose (25 drops). This amount is equivalent to less than 3 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

Diazepam ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose of 60 mg, i.e., essentially 'sodium-free'.

Diazepam ABC contains propylene glycol
This medicine contains 618 mg of propylene glycol per 25-drop dose. If the child is under 5 years of age, talk to 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 advised 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.

3. How to take Diazepam ABC

Use 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 daily.

Hospital treatment of anxiety states
The recommended dose is 10–20 mg, three times a day.

Anxiety
Children
From 2 to 12 years: the recommended dose is 1–2 mg (5–10 drops), three times a day.
The maximum daily dose is 6 mg. Do not exceed the maximum dose.

From 12 to 18 years: the recommended initial dose is 2 mg (10 drops), three times a day. If necessary and if tolerated, the dose may be increased up to a maximum of 10 mg per day. Do not exceed the maximum dose.

Method of administration
Take the drops of Diazepam ABC as follows:

• To open the bottle: press down on the cap and simultaneously unscrew it (Fig. 1);
• Let the drops fall into a glass, holding the bottle vertically with the opening facing downwards. If the liquid does not flow, shake or turn the bottle upside down several times (Fig. 2);
• To close the bottle: screw the cap back on until it is tightly sealed (Fig. 3).

Fig. 1 Fig. 2 Fig. 3
Dilute the drops of Diazepam ABC in water or another beverage. One drop of Diazepam ABC contains 0.2 mg of diazepam.

Duration of treatment
Treatment for insomnia and anxiety should be as short as possible. The duration of treatment, including a gradual withdrawal period, may vary 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 above-mentioned limits.

Treatment should be initiated with the lowest recommended dose. Do not exceed the maximum dose.
Your doctor will determine the appropriate dose and 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 ABC than you should
If you take an excessive dose of Diazepam ABC, contact your doctor or go to hospital immediately.
An overdose of Diazepam ABC is rarely life-threatening but may cause drowsiness, ataxia (reduced motor coordination and gait instability), dysarthria (impaired ability to articulate words), and nystagmus (involuntary eye movements). Mild cases are characterized by mental clouding (reduced level of consciousness), confusion, and lethargy (deep sleep and reduced responsiveness to stimuli).
In more severe cases, ataxia, hypotonia, hypotension, respiratory depression, coma, and death may occur. Coma (loss of consciousness), if it occurs, usually lasts a few hours but may persist longer and may be cyclical, especially in elderly patients. Respiratory depressant effects associated with benzodiazepines are more severe in patients with 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 one hour, vomiting may be induced, or gastric lavage or activated charcoal may be administered. If necessary, an antidote (a substance that counteracts the effects of the medicine) may be given under close medical supervision.

In case of accidental ingestion/overdose of an excessive amount of Diazepam ABC, contact your doctor immediately or go to the nearest hospital.

If you forget to take Diazepam ABC
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Diazepam ABC

• Do not stop treatment with Diazepam ABC abruptly, as withdrawal or rebound symptoms may occur—this means a worsening of the symptoms that led to starting treatment (see section “Warnings and precautions”).
• The dose of Diazepam ABC must be gradually reduced. Consult your doctor before stopping treatment with Diazepam ABC.

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.
If you experience:

• restlessness,
• agitation,
• irritability,
• disorientation,
• aggression,
• nervousness,
• hostility,
• anxiety,
• delirium (misinterpretation of reality),
• anger,
• nightmares,
• abnormal dreams,
• hallucinations (seeing or hearing things that do not exist),
• psychosis (thought disorders),
• hyperactivity,
• inappropriate behaviour,
• other behavioural side effects, inform your doctor immediately, who will explain how to discontinue treatment. These effects are more common 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 disorders),
• 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diazepam ABC

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
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 ABC contains
The active substance is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
The other components are: ethanol, glycerol, saccharin, propylene glycol, orange soluble essence, lemon soluble essence, erythrosine (E127), purified water.
Description of the appearance of Diazepam ABC and contents of the pack
Pack containing a bottle of 20 or 30 ml of solution.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin – Italy
Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO) – Italy