Diazepam Ratiopharm Italia

Package leaflet: Information for the patient

Diazepam ratiopharm Italia 5 mg/ml oral drops, solution

Equivalent 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Diazepam ratiopharm Italia is and what it is used for

Diazepam ratiopharm Italia contains diazepam, a substance that belongs to a group of
medicines called benzodiazepines, used to relieve severe emotional and
psychological distress that causes significant discomfort and sometimes limits normal daily activities.
This medicine is therefore indicated for the treatment of:

• anxiety, tension, and other physical or mental disorders associated with anxiety in adults and children from two years of age;
• sleep disorders (insomnia) in adults.

2. What you should know before taking Diazepam ratiopharm Italia

Do not take Diazepam ratiopharm Italia

• if you are allergic to the active substance, to other medicines of a similar type (other benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease causing muscle weakness and fatigue (Myasthenia gravis);
• if you have severe breathing problems (severe respiratory insufficiency);
• if you have severe liver problems (severe acute or chronic hepatic insufficiency);
• if you have breathing difficulties during sleep (sleep apnoea);
• during the first 3 months of pregnancy;
• during breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam ratiopharm Italia.
Avoid taking this medicine if you are taking medicines that depress the central nervous system (medicines with a calming effect on the brain), unless absolutely necessary (your doctor will advise you when it may be taken), because taking these medicines together could cause excessive calming effects (deep sedation), difficulty breathing (respiratory depression), and impaired heart function (cardiovascular depression).
Pay special attention and consult your doctor before taking Diazepam ratiopharm Italia:

• if you are elderly or debilitated; this medicine may reduce muscle tone, increasing the risk of falls and resulting fractures;
• if you have reduced blood flow to the brain (e.g. due to arteriosclerosis);
• if you have heart or lung problems (chronic cardiorespiratory or respiratory insufficiency).

Your doctor may decide to reduce the dose.

• if you have previously abused alcohol or drugs;
• if you have liver or kidney problems.

Additionally, you must immediately inform your doctor, who will explain how to stop treatment, if you experience behavioural disturbances such as restlessness, agitation, irritability, aggression, anxiety, delirium, anger, nightmares, hallucinations, or psychosis. These reactions are more frequent in children and the elderly (see section “Possible side effects”).
Duration of treatment
Treatment duration should be as short as possible and must not exceed 4 weeks for insomnia treatment and 8–12 weeks for anxiety treatment, including a gradual withdrawal period.
The treatment period may be extended following careful reassessment of your health status by your doctor.
Tolerance
If, after a few weeks of treatment with this medicine, you feel the medicine no longer has an effect on your symptoms, consult your doctor.
Dependence and withdrawal
During treatment with benzodiazepines such as diazepam, there may be a risk of developing dependence, i.e. an uncontrollable need to continue taking the medicine. This risk increases with higher doses and longer treatment duration. This phenomenon is more likely if you have previously abused drugs or alcohol.
If you develop dependence, you must avoid stopping treatment abruptly, because withdrawal symptoms may occur:

• headache, muscle pain, diarrhoea;
• extreme anxiety, tension, restlessness, confusion, and irritability. In severe cases of withdrawal, derealisation (feeling that things are unreal), depersonalisation (feeling detached from the surrounding environment), intolerance to sound (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that do not exist), or seizures (neurological disturbances causing sudden, uncontrollable movements) may also occur.

Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine (such as diazepam) to a short-acting one. Therefore, switching from one benzodiazepine to another is not recommended. Your doctor will advise you on the most appropriate treatment for your case.
It is important to know that after stopping treatment with this medicine, the same symptoms for which you were being treated may reappear, sometimes even more intensely than before (rebound symptoms).
Since withdrawal or rebound symptoms are more likely when treatment is stopped abruptly, it is recommended to gradually reduce the dose until treatment is discontinued in order to minimise the occurrence of such symptoms (mood changes and sleep disturbances).
Amnesia
Benzodiazepines may cause anterograde amnesia (memory loss that does not affect past memories but greatly impairs the ability to memorise new information), sometimes associated with behavioural disturbances.
This phenomenon occurs more frequently with higher doses, several hours after taking the medicine. Therefore, to reduce the risk, ensure you can sleep uninterrupted for 7–8 hours after taking Diazepam ratiopharm Italia.
Children
The use of benzodiazepines in children is not recommended unless the doctor considers it strictly necessary. In such cases, treatment duration should be as short as possible.
Other medicines and Diazepam ratiopharm Italia
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 any of the following categories of medicines:

• antipsychotics (neuroleptics) and antidepressants used to treat mental disorders;
• hypnotics used to promote sleep;
• anxiolytics/sedatives used to treat anxiety;
• certain strong painkillers (narcotic analgesics) that may cause excessive well-being when taken with Diazepam ratiopharm Italia. This may increase your need to continue taking these medicines (dependence);
• medicines used in the treatment of alcohol or drug dependence;
• antiepileptics used for epilepsy;
• anaesthetics used during surgical procedures;
• antihistamines with sedative effects used to treat allergies;
• medicines capable of inhibiting certain liver enzymes (especially cytochrome P450); your doctor will inform you if any of these are included among the medicines you are taking;
• corticosteroids that regulate immune-mediated inflammation;
• oral contraceptives;
• antifungals used to treat fungal infections;
• calcium antagonists, medicines used for certain heart problems and high blood pressure;
• medicines used to treat stomach disorders;
• prokinetics used for nausea and vomiting;
• medicines used to treat tuberculosis;
• medicines used in the treatment of certain blood cancers;
• medicines used to treat excessive daytime sleepiness (narcolepsy);
• medicines containing alcohol;
• medicines used to treat Parkinson’s disease.

In particular, inform your doctor if you are taking:
theophylline, caffeine, desmethyldiazepam, temazepam, oxazepam, cimetidine, fluvoxamine, fluoxetine, omeprazole, rifampicin, phenytoin, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir, saquinavir, fluconazole, itraconazole, voriconazole, isoniazid, disulfiram, cisapride, valproic acid, carbamazepine, diltiazem, idelalisib, modafinil, armodafinil, metoclopramide, morphine, pethidine, levodopa, clozapine, olanzapine, methadone, ketamine, levopromazine.
Concomitant use of Diazepam ratiopharm Italia 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. Therefore, concomitant use should only be considered when no alternative therapies are available. However, if your doctor prescribes Diazepam ratiopharm Italia together with opioids, the dose and duration of concomitant treatment must be determined by your doctor. Inform your doctor about all opioid medicines you are taking and follow your doctor’s advice 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 these symptoms.
Diazepam ratiopharm Italia with food, drinks, and alcohol
Food reduces the absorption of diazepam, delaying its effects.
DO NOT consume alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine.
DO NOT overconsume grapefruit juice during treatment with this medicine, as it may increase the medicine’s effect.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Diazepam ratiopharm Italia 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 strictly necessary, you may take Diazepam ratiopharm Italia in the later stages of pregnancy or during labour. In this case, your baby may show irregular heartbeat, low body temperature (hypothermia), poor sucking, muscle weakness (hypotonia), and breathing difficulties at birth.
In addition, your baby may show signs of physical dependence and withdrawal symptoms at birth.
Breastfeeding
If you are taking this medicine, stop breastfeeding, as diazepam passes into breast milk.
Driving and using machines
Diazepam ratiopharm Italia may significantly impair your ability to drive and use machinery, as amnesia, sedation, impaired concentration, and muscle weakness may occur during treatment. Furthermore, if you have not rested sufficiently, the risk of impaired attention is greater.
Finally, remember that consuming alcohol during treatment with this medicine enhances the sedative effect of diazepam, causing pronounced drowsiness and further reduced attention.
Diazepam ratiopharm Italia contains:

• ethanol (alcohol) This medicine contains 188 mg of alcohol (ethanol) in a maximum daily dose of 10 mg (10 mg corresponds to 2 mL or 50 drops). The amount in 2 mL of this medicine is equivalent to less than 5 mL of beer or 2 mL of wine. The small amount of alcohol in this medicine will not produce significant effects. High-dose intake (60 mg - 300 drops - hospital use only) This medicine contains 1126.08 mg of alcohol (ethanol) per 12 mL dose (300 drops). The amount in 300 drops of this medicine is equivalent to less than 29 mL of beer or 12 mL of wine. The amount of alcohol in this medicine does not appear to have significant effects in adults and adolescents, and its effects in children are not clearly evident. Some effects may occur in young children, for example, drowsiness. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant, talk to your doctor or pharmacist before taking this medicine. If you have alcohol dependence, talk to your doctor before taking this medicine.
• propylene glycol This medicine contains 618 mg of propylene glycol in 1 mL (1 mL corresponds to 25 drops).

High-dose intake (60 mg - 300 drops - hospital use only)
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 have kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.

• sodium This medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e. it is essentially “sodium-free”.

3. How to take Diazepam ratiopharm Italia

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor tells you to do so.
Your doctor will determine the correct dose for you based on your health condition, starting with the lowest dose suitable for your case.
During treatment, your doctor may adjust the dosage: always follow the prescribed dosage carefully. Do not exceed the maximum dose.
For the treatment of insomnia, take Diazepam ratiopharm Italia just before going to bed.

Anxiety and insomnia
Adult patients
The recommended dose may range from 2 mg (10 drops) 2–3 times daily, to 5 mg (25 drops) 1–2 times daily. The maximum dose is 10 mg per day. Do not exceed the maximum dose.
Special patient groups
If you belong to one of the patient groups listed below, your doctor may decide to monitor you closely, especially at the beginning of treatment, in order to identify the lowest effective dose for your case and to avoid the occurrence of adverse effects.
Elderly patients or those with liver or kidney problems or debilitated patients
The recommended dose is 2 mg (10 drops), twice daily.
Hospital treatment of anxiety states
The recommended dose is 10–20 mg, three times daily.
Use in children and adolescents
This medicine should not be given to children without careful assessment of the actual need for treatment; treatment duration should be as short as possible and under close medical supervision.
Anxiety
The initial dose and any subsequent increases will be determined by the doctor based on the child's weight and age.
from 2 to 12 years: the recommended dose is 1–2 mg (5–10 drops), three times daily.
from 12 to 18 years: the recommended initial dose is 2 mg (10 drops), three times daily, increasing if necessary and if tolerated, up to a maximum of 10 mg (50 drops) per day.
Do not exceed the maximum dose.
If the required dose is difficult to achieve with the drop formulation, your doctor will advise you on other diazepam formulations available on the market that may be more suitable for your case.

Duration of treatment
Anxiety, tension, and other anxiety-related disorders
Treatment duration should be as short as possible and generally should not exceed 8–12 weeks, including a period of gradual withdrawal.
In certain cases, your doctor may decide to extend the treatment after re-evaluating your health condition.
Insomnia
Treatment duration should be as short as possible and generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual withdrawal. In certain cases, your doctor may decide to extend the treatment after re-evaluating your health condition.
For the treatment of insomnia, the medicine should be taken just before going to bed.

Method of administration
Each drop (corresponding to approximately 0.04 ml) of Diazepam ratiopharm Italia contains 0.2 mg of diazepam. The drops should be diluted with a small amount of water or another beverage (the drops should not be taken together with alcoholic drinks. See section “Other medicines and Diazepam ratiopharm Italia”).

How to use the dropper bottle: to dispense the correct dose of medicine, the bottle must be held in a vertical position with the opening facing downwards. If the liquid does not flow, shake the bottle or turn it upside down several times and repeat the dispensing procedure as indicated above.

If you take more Diazepam ratiopharm Italia than you should
In case of accidental ingestion/overdose of this medicine, consult your doctor immediately or go immediately to the nearest hospital.
An excessive dose of diazepam is rarely life-threatening but may cause areflexia (absence of reflexes), apnea (absence of breathing), central nervous system depression with drowsiness, ataxia (reduced motor coordination and gait), 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 response to stimuli).
In more severe cases, ataxia, hypotonia (muscle weakness), hypotension (low blood pressure), 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.
Within one hour of ingestion, vomiting will be induced, if necessary by gastric lavage, or activated charcoal will be administered, and if needed, under strict monitoring, an antidote (a substance that counteracts the effects of the medicine) will be given.

If you forget to take Diazepam ratiopharm Italia
Do not take a double dose to make up for the forgotten dose.

If you stop taking Diazepam ratiopharm Italia

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

If you have any doubts about how to use 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 any of the following symptoms; the doctor will advise you on how to discontinue treatment:
depression and mental disorders such as restlessness, agitation, irritability, disorientation, aggression, delirium, nervousness, hostility, anxiety, rage, 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), behavioural changes, hyperactivity. These reactions can be severe and are more frequent in children and elderly patients.

To help you recognize some of these side effects, it may be helpful to inform a relative or close friend that you are taking this medicine and ask them to read this leaflet. You may ask them to notify you if they notice any changes in your behaviour.

The following side effects may occur at the beginning of treatment and usually resolve while continuing therapy:

• drowsiness (including during daytime), reduced alertness, confusion;
• mood and emotional disturbances;
• headache, dizziness;
• fatigue, muscle weakness, difficulty in controlling movements (ataxia);
• double vision.

Occasionally, the following side effects have also been reported:

• gastrointestinal disturbances;
• changes in sexual desire;
• skin reactions.

Other side effects include:

• depression;
• speech disorders (dysarthria or slurred speech);
• tremors;
• vision problems (blurred vision);
• fainting (syncope);
• vertigo;
• heart problems (heart failure including cardiac arrest, cardiovascular insufficiency);
• decreased heart rate (bradycardia);
• low blood pressure (hypotension);
• breathing difficulties (cardiorespiratory depression including respiratory failure);
• nausea;
• dry mouth;
• hypersalivation (particularly in children);
• constipation;
• increased appetite;
• yellowish discoloration of the skin and whites of the eyes (jaundice);
• skin irritations such as allergic dermatitis (itching, redness or skin rashes);
• incontinence;
• breast enlargement in men (gynecomastia);
• painful menstruation (dysmenorrhea);
• difficulty emptying the bladder (urinary retention);
• changes in heart rate;
• increased levels of liver enzymes known as transaminases;
• increased blood levels of an enzyme called alkaline phosphatase;
• increased risk of falls leading to fractures (especially in elderly patients);
• memory loss (anterograde amnesia), sometimes associated with behavioural changes (see section “Warnings and precautions”);
• physical and psychological dependence, leading to a need for excessive and uncontrolled use of the medicine (abuse) (see section “Warnings and precautions”);
• withdrawal or rebound symptoms upon discontinuation of treatment (anxiety, panic reactions, palpitations, excessive sweating, tremor, gastrointestinal disturbances, irritability, sensory disturbances, muscle spasms, malaise, reduced appetite, psychotic disorder, delirium, and epileptic seizures) (see section “Warnings and precautions”).

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 national reporting system at the following 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 ratiopharm Italia

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
The product should be used within 3 months of first opening the bottle. Any excess product must be discarded.
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.
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 ratiopharm Italia contains

• The active substance is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
• The other components are: ethanol 96 percent, glycerol, sodium saccharin, propylene glycol (E1520), orange soluble essence, lemon soluble essence, erythrosine, and purified water.

Description of the appearance of Diazepam ratiopharm Italia and the contents of the pack
Diazepam ratiopharm Italia is presented in a box containing a 20 ml dropper bottle of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 - 10015 Ivrea (TO) - Italy