Package leaflet: Information for the patient

Diazepam Alter 5 mg/ml oral drops, solution

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

Contents of this leaflet:

What Diazepam Alter is and what it is used for
What you need to know before taking Diazepam Alter
How to take Diazepam Alter
Possible side effects
How to store Diazepam Alter
Contents of the pack and other information

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

Diazepam Alter 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:

for the treatment of anxiety, tension, and other anxiety-related disorders;
for the treatment of sleep disorders (insomnia).

2. What you should know before taking Diazepam Alter

Do not take Diazepam Alter

if you are allergic to the active substance, 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 insufficiency);
if you have breathing difficulties during sleep (sleep apnoea).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam Alter.
Avoid taking this medicine if you have alcohol or drug dependence involving central nervous system depressants, unless absolutely necessary.
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 Alter – 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 insufficiency). Your doctor may decide to reduce the dose;
if you have previously abused alcohol or drugs.

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: There is a risk of dependence when taking this medicine, meaning a need to continue taking it. The risk increases with higher doses and longer treatment duration. The risk is greater if you have previously abused drugs or alcohol.
Withdrawal: When you stop taking Diazepam Alter, you may experience withdrawal or rebound symptoms, even if you have taken the medicine at the recommended doses and for a short period of time (see section “If you stop treatment with Diazepam Alter”). To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
Duration of treatment: Treatment duration should be as short as possible and must not exceed four weeks for insomnia and 8–12 weeks for anxiety, including a gradual discontinuation period.
Amnesia: When using benzodiazepines, you may experience episodes of amnesia. To reduce the risk of amnesia (memory loss), ensure uninterrupted sleep of 7–8 hours.
Behavioural reactions: If you experience behavioural disturbances such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, or psychosis, inform your doctor, who will advise you to stop taking the medicine. These reactions are more common in children and the elderly.
Benzodiazepines must not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.
If you are scheduled for a procedure requiring anaesthetics, inform the hospital or doctor that you are taking Diazepam Alter.
For athletes: The use of medicines containing ethanol may result in a positive anti-doping test, depending on the blood alcohol concentration limits set by certain sports federations.
Children
Diazepam Alter should be used in children only when absolutely necessary, and treatment duration should be as short as possible.

Other medicines and Diazepam Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay special attention and inform your doctor if you are taking the following medicines:

antipsychotics and antidepressants, used to treat mental disorders;
hypnotics, medicines used to promote sleep;
anxiolytics/sedatives, used to treat anxiety;
certain strong painkillers, which may cause increased feelings of well-being when taken with Diazepam Alter. This may increase your desire to continue taking these medicines (dependence);
antiepileptics, used for epilepsy;
anaesthetics, used during surgical procedures;
sedating antihistamines, used to treat allergies.

The concomitant use of Diazepam Alter and opioids (strong analgesics, medicines for addiction treatment, 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 Alter 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 carefully follow the doctor’s dosage recommendations. 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 Alter with food, drinks and alcohol
Avoid alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine. This negatively affects your ability to drive vehicles or operate machinery.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Diazepam Alter during the first 3 months of pregnancy.
If your doctor considers it necessary for you to take Diazepam Alter in the later stages of pregnancy or during labour, your baby may experience low body temperature, reduced muscle tone, and breathing difficulties.
If Diazepam Alter has been taken regularly during the later stages of pregnancy, your baby may develop physical dependence and experience withdrawal symptoms.
Avoid taking this medicine while breastfeeding, as diazepam passes into breast milk.

Driving and using machines
The use of Diazepam Alter may affect your ability to drive vehicles or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are increased if you have not slept enough or have consumed alcohol. If this occurs, avoid driving or operating machinery.

Diazepam Alter contains ethanol (alcohol) and propylene glycol
This medicine contains 10 vol % ethanol (alcohol), e.g. up to 200 mg per 10 mg dose (50 drops), equivalent to 5 ml of beer or 2 ml of wine per dose.
It may be harmful for alcoholics.
This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
This medicine contains 618 mg of propylene glycol per 1 ml of solution (5 mg of diazepam).

3. How to take Diazepam Alter

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.
The recommended dose in adults ranges from 2 mg (10 drops) two to three times daily to 5 mg (25 drops) one to two
times daily.
Anxiety, tension and other disorders associated with anxiety
The duration of treatment should be as short as possible. Your doctor will regularly reassess your
condition and the need to continue treatment. Generally, treatment duration should not
exceed 8–12 weeks, including a period of gradual withdrawal.
In certain cases, your doctor may decide to extend treatment after evaluating your
health status.
Insomnia
The duration of treatment should be as short as possible. Generally, it 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 treatment after evaluating your
health status.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be
exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment and may reduce the
dose or frequency of administration if necessary.
Use in children
This medicine should be used in children only when absolutely necessary.
Children under 3 years of age: the recommended dose is 1–6 mg (5–30 drops) per day.
Children aged 4 to 14 years: the recommended dose is 4–12 mg (20–60 drops) per day.
Use in the elderly
In elderly and debilitated patients, a reduced dose should be administered.
The recommended dose is 2 mg (10 drops) twice daily.
The drops should be diluted with a small amount of water or another beverage. If you are taking this medicine for
the treatment of insomnia, take it just before going to bed.
Your doctor will determine the correct dose for you.
Instructions for using the dropper bottle: to deliver the correct dose of medicine, the
bottle must be held in an upright position with the opening facing downwards. If the liquid does not flow, gently shake the
bottle or invert it several times and repeat the dispensing procedure as described above.
If you take more Diazepam Alter than you should
If you (or someone else) have taken an excessive dose of Diazepam Alter or if you suspect that a child may
have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency
department.
An overdose may cause profound depression of the central nervous system, with symptoms such as drowsiness,
confusion, muscle problems (ataxia, hypotonia), low blood pressure, breathing difficulties, coma, or death.
If you forget to take Diazepam Alter
If you forget to take a dose of the medicine, 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 Alter
Do not stop treatment with Diazepam Alter suddenly or without first discussing it with your
doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will gradually reduce your dose to minimize
withdrawal symptoms, such as:

headache, muscle pain, tension;
severe anxiety, confusion, restlessness, irritability;
in severe cases of withdrawal, derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sound (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise and physical touch, hallucinations (seeing or hearing things that are not real), or epileptic seizures.

Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may
reappear more intensely than before (rebound insomnia and anxiety). The risk of developing these
symptoms is greater if you stop taking Diazepam Alter suddenly. You may also
experience mood changes, anxiety, restlessness, and sleep disturbances.
If you have any questions 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:

depression and mental disorders such as restlessness, agitation, irritability, aggression, delirium, rage, nightmares, 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. If any of these side effects occur, treatment must be discontinued. These reactions are more frequent in children and elderly patients.

Contact your doctor if you experience any of the following side effects:

drowsiness, even during daytime, reduced alertness, confusion;
reduced emotional responsiveness;
headache, dizziness;
fatigue, muscle weakness, difficulty in controlling movements (ataxia);
double vision;
stomach and intestinal disturbances;
changes in sexual desire;
skin reactions;
memory loss (amnesia) (see section Warnings and precautions).

The use of benzodiazepines (even at therapeutic doses) may lead to physical dependence: stopping treatment may result in withdrawal or rebound symptoms (see sections “Warnings and precautions” and “If you stop taking Diazepam Alter”).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "Exp.".
The expiry date refers to the last day of that month.
Use the medicine within 3 months after first opening the bottle. Discard any excess medicine.
Do not dispose of medicines 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 Alter 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, soluble orange essence, soluble lemon essence, erythrosine (E127), purified water.

Description of the appearance of Diazepam Alter and contents of the pack
Packaging containing one 20 ml bottle of solution.
Marketing Authorization Holder and Manufacturer
Laboratori Alter S.r.l. - Via Egadi, 7 – 20144 Milan
Manufacturer
ICE S.p.A. - Canton Moretti, 29 - 10090 S. Bernardo d'Ivrea (TO)
January 2026