DIAZEPAM 5 mg /Ml Oral Drops, Solution

Содержание инструкции

1. DIAZEPAM ABC 5 mg/ml oral drops, solution
   1. What is Diazepam ABC and what is it 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

DIAZEPAM ABC 5 mg/ml oral drops, solution

Diazepam

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Diazepam ABC and what is it used for

Diazepam ABC contains the active ingredient diazepam which belongs to a group of anxiolytics
derived from benzodiazepines.
Diazepam ABC is indicated in adultsand in childrenfrom two years of age for the treatment of:

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

Diazepam ABC is indicated in adultsfor the treatment of:

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

2. What you need to 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 can cause weakness and fatigue (myasthenia gravis);
• if you suffer from severe breathing problems (severe respiratory failure);
• if you have severe liver problems (severe, acute or chronic hepatic insufficiency);
• if you suffer from a condition that causes frequent interruptions of breathing during sleep (sleep apnea syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before using Diazepam ABC.
Therapy should be carried out under the supervision of a doctor and its duration should be as
short as possible. The doctor will determine the dose and duration of treatment most suitable for you. The
treatment will be of limited duration and the doctor will explain how to gradually reduce the
dose until discontinuation. When Diazepam ABC is stopped, the symptoms that led to treatment may reappear. After a few weeks of therapy, the medicine may
partially lose its effectiveness in inducing sleep, this effect is called tolerance.
Talk to 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 diseases, such as those due to arteriosclerosis (due to reduced blood supply);
• you have heart and breathing problems (cardiorespiratory insufficiency). The use of benzodiazepines can cause physical and psychological dependence on these medicines. This risk increases with the dose and duration of treatment and is more frequent in patients with a history of drug or alcohol abuse. Once physical dependence has developed, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms, such as headache, diarrhea, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, derealization (feeling of detachment from the external world), depersonalization (feeling of detachment from one's own body), hyperacusis (increased hearing sensitivity), numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations (seeing or hearing things that do not exist) may occur. Once treatment is stopped, insomnia and anxiety may reappear temporarily and in an aggravated form. In addition, other disorders may also arise, such as mood changes, anxiety, restlessness or sleep disturbances. Because the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, the doctor will explain how to gradually reduce the dose until stopping. This medicine can make you forget things that happen from taking it (anterograde amnesia). If you experience the following adverse reactions, the medicine should be discontinued, therefore contact your doctor if you experience:
• restlessness;
• agitation;
• anxiety;
• irritability;
• aggressiveness;
• delirium (incorrect interpretation of reality);
• anger;
• nightmares;
• hallucinations (seeing or hearing things that do not exist);
• psychosis (thought disorders);
• behavioral changes.

Children
The doctor will assess the use of Diazepam ABC in children and will prescribe it only if absolutely
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 medicine.
Tell your doctor if you are being treated with:

• antipsychotics, such as clozapine and olanzapine, medicines for treating mental disorders;
• anxiolytics or sedatives, medicines that reduce anxiety or induce sedation;
• antidepressants, such as fluvoxamine, medicines for the treatment of depression;
• hypnotics, medicines that induce sleep;
• antiepileptics, such as carbamazepine and phenytoin, medicines for treating epilepsy (a disease characterized by uncontrolled body movements and loss of consciousness);
• narcotic analgesics (morphine, pethidine and methadone), medicines used to reduce pain;
• anesthetics, such as ketamine, medicines that induce a reduction in pain sensitivity and sedation;
• antihistamines, medicines for the treatment of allergies;
• antifungals (fluconazole, voriconazole and itraconazole) medicines used to treat infections caused by fungi;
• oral contraceptives, medicines used to prevent pregnancy;
• omeprazole, esomeprazole, cimetidine and antacids, medicines for treating stomach disorders;
• disulfiram, used for the treatment of alcohol dependence;
• isoniazid, an antibiotic used to treat tuberculosis;
• diltiazem, used to treat high blood pressure and some heart disorders;
• idelalisib, a medicine used for the therapy of leukemias and lymphomas;
• modafinil and armodafinil, used for narcolepsy, a form of excessive sleepiness;
• rifampicin, an antibiotic;
• metoclopramide, a medicine used for nausea and vomiting;
• levodopa, used to treat Parkinson's disease, a disease that causes tremor, rigidity and slowness of movement;
• theophylline, a medicine used to treat asthma, a disease characterized by constriction and inflammation of the bronchi;
• medicines containing caffeine.

The concomitant use of Diazepam ABC and opioids (potent painkillers, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, breathing difficulties (respiratory depression) and coma, and is potentially life-threatening. For
this reason, concomitant use should only be considered when other therapeutic options are not
possible.
However, if the doctor prescribes Diazepam ABC together with opioids, they must limit the
dose and duration of concomitant treatment.
Tell your doctor about all opioid-based medicines you are taking and carefully follow
their recommendations regarding the dose. It may be helpful to inform friends or family so
they are aware of the signs and symptoms above. If you experience these symptoms, contact your
doctor.

Diazepam ABC with alcohol
You should not drink alcohol during treatment with Diazepam ABC.

Diazepam ABC with food and drink
Food reduces the absorption of Diazepam ABC.
Avoid drinking grapefruit juice during treatment with Diazepam ABC as it may
increase the effects of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The safety of Diazepam ABC in pregnancy has not been established.

Do nottake Diazepam ABC in the first 3 months of pregnancy. An increased
risk of congenital malformations associated with the use of benzodiazepines during the first trimester
of pregnancy has been reported.
If this medicine is prescribed, irregularities in the fetal heart rate may occur
during the last period of pregnancy. In case of administration during labor 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 have withdrawal symptoms at birth.

Breastfeeding
Since Diazepam ABC passes into breast milk, it is recommended to discontinue
breastfeeding during treatment.

Driving and using machines
Diazepam ABC impairs the ability to drive vehicles and use machines, as it can induce
sedation, amnesia (a memory disorder), alteration of concentration and muscle function. If the duration of sleep is insufficient, or if alcohol is taken, the probability that
vigilance is altered may be increased.

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 dose equal to 25 drops. If the child
is less than 5 years old, talk to your doctor or pharmacist before giving 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. The doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.

3. How to take Diazepam ABC

Use this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Anxiety and insomnia
Adults
The recommended dose is from 2 mg (10 drops), two or three times a day 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 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
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, it is possible to increase the dose 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 on the cap and unscrew simultaneously (fig. 1);
• let the drops fall into a glass holding the bottle in a vertical position with the opening facing downwards. If the liquid does not come out, shake the bottle or turn it over several times (fig. 2);
• to close the bottle: screw the cap on tightly (fig. 3).

Fig. 1Fig. 2Fig. 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
The treatment of insomnia and anxiety should be as short as possible. The duration of
treatment, including a period of gradual withdrawal, ranges from a few days to 4 weeks
for insomnia and from a few days to 8-12 weeks for anxiety.
In certain cases, the doctor, after re-evaluating your health status, may decide to
extend the duration of treatment as indicated above.
Treatment is started with the lowest recommended dose. Do not exceed the maximum dose.
The doctor will establish the dose and assess the need for any dose reduction if you are
elderly or debilitated.
At the beginning of treatment you will be carefully monitored by the doctor who will prescribe the dose
most suitable for your clinical condition.

If you use more Diazepam ABC than you should
If you use an excessive dose of Diazepam ABC contact your doctor or go to hospital
immediately
An excessive dosage of Diazepam ABC is rarely life-threatening, but can cause
drowsiness, ataxia (reduced motor and gait coordination), dysarthria (reduced ability to
articulate words) and nystagmus (involuntary eye movements). Mild cases are characterized
by obtundation (reduction of the state of consciousness), mental confusion and lethargy (deep sleep
and reduced response to stimuli).
In more severe cases, ataxia, hypotension, hypotension, respiratory depression, coma and
death occur. The coma (loss of consciousness), if it occurs, usually lasts a few hours but can
last longer and be cyclic, especially in elderly patients. The depressive respiratory effects
associated with benzodiazepines are more severe in patients with respiratory diseases.

Treatment
Your vital functions (heart rate, breathing and brain activity) will be monitored and
the symptoms that have arisen will be treated.
If you are conscious, within one hour of taking it, vomiting will be induced by gastric lavage or activated charcoal will be administered and, if necessary, under close monitoring, an antidote
(a substance that counteracts the effects of the medicine).

In case of accidental ingestion/intake of an excessive dose of Diazepam ABC, inform
your doctor immediately or go to the nearest hospital.

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

If you stop taking Diazepam ABC

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

If you have any further questions on the use of this medicine, ask 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 immediatelyyour doctor who will explain how to stoptreatment. These effects occur more frequently in children and the elderly. In addition, the following may occur:
• ataxia (reduced motor and gait coordination)*,
• dysarthria (reduced ability to articulate words),
• difficulty expressing oneself verbally,
• headache (head pain)*,
• tremors,
• dizziness,
• anterograde amnesia (difficulty memorizing new information),
• confusion*,
• mood and emotional state disorders*,
• reduced alertness*,
• depression,
• changes in sexual desire,
• drowsiness, even during the day*,
• falls and fractures,
• nausea,
• dry mouth,
• increased saliva production,
• constipation,
• other stomach and intestinal disorders,
• diplopia (double vision)*,
• blurred vision
• hypotension (low blood pressure),
• circulatory depression (condition in which the heart does not pump blood effectively 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 (condition in which the heart does not pump blood effectively 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 therapy and usually disappear with

subsequent administrations.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after “Exp.”.
The expiry date refers to the last day of that month.
The product must be used within 3 months of first opening the bottle. Excess product must be discarded.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Diazepam ABC contains
The active ingredient is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
The other ingredients are: ethyl alcohol, glycerol, saccharin, propylene glycol, soluble orange essence, soluble lemon 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 Authorisation 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