DIAZEPAM 2 mg Coated Tablet

Зміст інструкції

1. Diazepam EG STADA 2 mg tablets, 5 mg tablets, 10 mg tablets
   1. What is Diazepam EG STADA and what is it used for
   2. What you need to know before taking Diazepam EG STADA
   3. How to take Diazepam EG STADA
   4. Possible side effects
   5. How to store Diazepam EG STADA
   6. Package contents and other information

Diazepam EG STADA 2 mg tablets, 5 mg tablets, 10 mg tablets

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may 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 EG STADA is and what it is used for
• 2. What you need to know before you take Diazepam EG STADA
• 3. How to take Diazepam EG STADA
• 4. Possible side effects
• 5. How to store Diazepam EG STADA
• 6. Contents of the pack and other information

1. What is Diazepam EG STADA and what is it used for

Diazepam EG STADA contains the active ingredient diazepam, which belongs to a group of medicines
called benzodiazepines.
Diazepam EG STADA is used for the treatment of the following conditions:
In adults:

• symptoms of anxiety
• alcohol withdrawal symptoms

In adults and children over 6 years of age

• spasms or muscle pain caused by inflammation of the muscles and joints or trauma, including spasms caused by conditions such as cerebral palsy (a group of disorders that affect the ability to move, maintain balance and posture) and paraplegia (paralysis of the lower half of the body, affecting both legs), as well as athetosis (continuous, involuntary, slow movements and unusual sensation in fingers and hands) and stiff-person syndrome.

2. What you need to know before taking Diazepam EG STADA

DO NOT take Diazepam EG STADA if

• you are allergic to diazepam or any of the other ingredients of this medicine (listed in section 6);
• you suffer from a condition called myasthenia gravis which causes muscle weakness and fatigue;
• you have acute respiratory problems (slow and/or shallow breathing);
• you suffer from sleep apnea (a sleep disorder in which abnormal pauses in breathing occur during sleep);
• you suffer from severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam EG STADA if

• you have problems with your liver, heart or kidneys;
• you have a history of alcohol or drug abuse;
• you suffer from muscle weakness;
• you have respiratory problems;
• you have mental problems. Benzodiazepines are not recommended as a first-line treatment for psychosis (mental conditions). These medicines should not be used to treat depression or anxiety associated with depression as symptoms may worsen;
• you suffer from epilepsy or have a history of seizures.

Consult your doctor if

• after a few weeks you notice that the tablets are no longer working as well as when you started treatment. Tolerance to benzodiazepines can develop;
• you experience undesirable effects or changes in behaviour (see section 4).

There is a risk that you may develop dependence during the intake of this medicine.

Children and adolescents
Do not administer this medicine to children under 6 years of age unless after
consulting and under the strict supervision of a specialist (paediatrician, neurologist, psychiatrist,
anaesthesiologist or intensive care physician) who will determine the dose.
Children are more sensitive to the effects of benzodiazepines on the central nervous system,
as their body is not fully developed and able to metabolise this
medicine. For this reason, a greater amount of active substance may remain in
their body.

Other medicines and Diazepam EG STADA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Some other medicines can also affect the mechanism of action of
Diazepam EG STADA. Especially:

• antidepressants (e.g. fluvoxamine, fluoxetine);
• antipsychoticssuch as clozapine (for the treatment of mental problems);
• muscle relaxants(e.g. suxamethonium, tubocurarine);
• barbiturates such as phenobarbital(for treating epilepsy and mental disorders);
• other central nervous system depressors(buprenorphine, narcotic analgesics, opioids and derivatives used to treat cough, baclofen, thalidomide, pizotifen, central-acting antihypertensives). Taking these medicines and diazepam may affect your mental state, make you very sleepy and suppress breathing and blood pressure;
• disulfiram(for treating alcohol dependence). Taking this medicine and diazepam can cause a lot of drowsiness and make the elimination of diazepam from the body slower than usual;
• medicines for epilepsy,e.g. phenytoin and carbamazepine, as they may reduce the effect of diazepam. Diazepam may also have an influence on how phenytoin works;
• theophylline(for treating asthma and other respiratory disorders), as it may weaken the effect of diazepam;
• cimetidine, omeprazole or esomeprazole(medicines that reduce stomach acidity), as these may slow down the elimination of diazepam from the body compared to usual;
• rifampicin(an antibiotic) as it may speed up the removal of diazepam from the body compared to usual. The effect of diazepam may be weakened;
• atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir or saquinavir(antivirals), fluconazole, itraconazole, ketoconazole or voriconazole(antifungal medicines) as these may slow down the elimination of diazepam from the body compared to usual and therefore increase the risk of side effects;
• isoniazid(for the treatment of tuberculosis), as it may slow down the removal of diazepam from the body compared to usual;
• oral contraceptives, as they may slow down the elimination of diazepam from the body and increase its effect. When diazepam and oral contraceptives are taken simultaneously, breakthrough bleeding may occur, but contraceptive protection is not reduced;
• cisapride(used to treat stomach problems), as it may slow down the removal of diazepam from the body compared to usual;
• corticosteroids(medicines used to treat inflammation in the body) as they may weaken the effect of diazepam;
• levodopa(for the treatment of Parkinson's disease). Diazepam may reduce the effect of levodopa;
• valproic acid(for the treatment of epilepsy and mental disorders) as it may slow down the removal of diazepam from the body and increase its effect. Valproic acid taken with diazepam increases the risk of psychosis (mental conditions);
• ketamine(an anaesthetic) as diazepam increases the effect of ketamine.

Opioids
The simultaneous use of Diazepam EG STADA 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 may be life-threatening. Therefore, consider the concomitant use only when other therapeutic options are not possible.
If, however, your doctor prescribes Diazepam EG STADA together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Tell your doctor which opioids you are taking and strictly adhere to their prescription.
It may be helpful for friends or relatives to be aware of the signs and symptoms mentioned above. See a doctor if the above symptoms should occur.

Use of Diazepam EG STADA with food, drinks and alcohol
Do not drink alcoholduring treatment with diazepam. Alcohol can increase the sedative effects of
Diazepam EG STADA.
Grapefruit juice may increase the effect of diazepam.

Pregnancy, breastfeeding and fertility
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.
If you are pregnant, planning a pregnancy or breastfeeding, you should not take Diazepam EG STADA.
This medicine may have effects on your baby.

Driving and operating machinery
Talk to your doctor before driving vehicles or using machinery as Diazepam EG
STADA may impair your ability to react. These effects are increased by alcohol
use and lack of sleep.

Diazepam EG STADA contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Diazepam EG STADA

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

Dosage
The doctor will decide the appropriate dose for you and for how long you should take the tablets. Treatment should normally not exceed 4 weeks. If necessary, the doctor may increase the duration of treatment.

Use in adults
Recommended dose:

• Symptoms of anxiety or from 2 mg to 5 mg of diazepam two or three times a day. The dose may be increased to a maximum of 30 mg per day divided into 2 or 4 doses.
• Alcohol withdrawal syndrome or from 5 mg to 20 mg of diazepam repeatable once after 2-4 hours if necessary, or 10 mg of diazepam three or four times during the first day of treatment. After the first day, the dose is generally reduced to 5 mg of diazepam three or four times a day as needed. In more severe cases, the doctor may resort to alternative dosage regimens and hospital treatment may be necessary.
• Muscle spasms or up to 15 mg of diazepam per day divided into 2-4 doses.
• Muscle spasms in cerebral palsy or up to a maximum of 60 mg per day divided into 3 or 4 doses.

Use in children and adolescents
Children over 6 years of age and adolescents (over 20 kg)
The pediatrician will decide how much Diazepam EG STADA should be administered and how often.
The usual dose is 0.1-0.3 mg/kg of body weight per day divided into 2-4 doses.
Children under 6 years of age
The administration of Diazepam EG STADA is not recommended for children under 6 years of age
due to possible swallowing difficulties. More suitable pharmaceutical forms may be available for younger children.
Do not give this medicine to children under 6 years of age unless after consulting and
under the strict supervision of a specialist (pediatrician, neurologist, psychiatrist, anesthesiologist or intensive care physician) who will determine the dose.

Use in elderly patients
The doctor will decide how much Diazepam EG STADA should be administered and how often.
The dose will be lower than that usually prescribed for other adults. Treatment should be
started with the lowest possible dose (from 2 to 2.5 mg, once or twice a day) and should be
gradually increased if necessary and if tolerated.

Use in patients with kidney impairment
No dosage adjustment is normally required. However, patients with renal insufficiency should take diazepam with caution.
The use of benzodiazepines with active metabolites such as diazepam should be avoided in patients with
end-stage renal disease.

Use in patients with liver impairment
The doctor will decide how much Diazepam EG STADA should be administered and how often.
The dose will be lower than that usually prescribed for other adults.
Patients with severe liver disorders should not be treated with Diazepam EG STADA (see also “DO NOT take Diazepam EG STADA if”).

Use in overweight patients
If you are overweight, it may take longer for the medicine to take effect. In addition, the
effects of Diazepam EG STADA may take longer to wear off, including possible side effects.

Method of administration
The tablet can be divided into equal parts.

If you take more Diazepam EG STADA than you should

• if you have taken too many tablets (more than prescribed), or think a child has swallowed any, contact the nearest hospital emergency room or immediately inform your doctor or pharmacist;
• the signs of an overdose include loss of coordination of muscle movements, severe difficulty breathing (apnea), low blood pressure (hypotension), heart and lung problems (cardiorespiratory depression) and coma (unresponsive state of unconsciousness).

Duration of treatment
The duration of treatment should be as short as possible. In general, treatment should not
exceed 8-12 weeks.

If you forget to take Diazepam EG STADA
Do not take a double dose to make up for a missed dose. If you forget to take a
tablet, take it as soon as you remember. If you are about to take the next dose, skip the missed dose.

If you stop taking Diazepam EG STADA

• do not stop treatment without first talking to your doctor. If you stop treatment with Diazepam EG STADA, withdrawal symptoms may appear suddenly, including sleep disturbances, headache, muscle pain, tension, confusion, irritability or aggression, mood changes and hypersensitivity to light, noise and physical contact. Less common withdrawal symptoms include seeing or hearing things that are not there (hallucinations) and loss of reality perception (derealization).
• You should gradually reduce the number or dosage of tablets you take before stopping them completely. The doctor will tell you how to do it.

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.

Some side effects can be serious and require immediate medical attention:
Allergic reactions
If you develop an allergic reaction, consult a doctor immediately.The side effects
are as follows:

• sudden swelling of the throat, face and lips which can lead to difficulty in breathing and swallowing;
• sudden swelling of hands, feet and ankles, skin rash or itching.

Effects of a behavioral type

Consult your doctorif you experience any of the following side effects:

• aggression, irritability, nervousness, agitation, anxiety, delusional ideas, anger;
• difficulty sleeping, nightmares and vivid dreams. Your doctor may ask you to stop treatment.

For possible withdrawal symptoms, see "If you stop taking Diazepam EG STADA”
in section 3.
They are likely to be more frequent in children and the elderly.
Elderly patients
The risk of falls and subsequent fractures is higher in elderly patients treated with
benzodiazepines.

Other side effects:
The following side effects may occur at the beginning of treatment with Diazepam EG
STADA:

• drowsiness, fatigue, dizziness and mild mental confusion;
• muscle weakness, loss of muscle movement coordination (ataxia) and other movement disorders. Your doctor may suggest a reduction in the dose of Diazepam EG STADA and then increase it slowly.

During treatment, the following side effects may occur:
Psychiatric and nervous system disorders

• difficulty concentrating, reduced alertness, confusion and disorientation, agitation;
• memory loss;
• headache;
• depression;
• difficulty speaking;
• loss of coordination, including instability when walking;
• altered sexual desire (libido).

Effects on liver and blood (very rare)

• changes in the values of some liver enzymes detected by blood tests;
• yellowing of the skin and eyes (jaundice);
• blood problems. The signs may consist of fatigue, easy bruising, shortness of breath and nosebleeds. Your doctor may prescribe blood tests from time to time.

Effects on heart, circulation and blood vessels

• heart problems such as slowed heartbeat (bradycardia), heart failure and cardiac arrest;
• low blood pressure (hypotension). Dizziness or mild confusion may occur while standing up;
• circulatory problems (circulatory depression).

Effects on stomach and intestines (sporadic)

• nausea;
• constipation;
• stomach pain;
• dry mouth and increased salivation.

Effects on lungs and kidneys

• respiratory depression;
• inability to urinate (urinary retention), loss of bladder control (urinary leakage).

Effects on eyes, skin and hair

• double vision;
• blurred vision;
• vertigo with signs such as dizziness or a spinning sensation;
• the most common reactions are skin rash, urticaria, itching and erythematous rash.

If any of these side effects get worse, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after the inscription Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Package contents and other information

What Diazepam EG STADA contains

• The active ingredient is diazepam. Each tablet contains 2 mg of diazepam. Each tablet contains 5 mg of diazepam. Each tablet contains 10 mg of diazepam.
• The other ingredients are lactose monohydrate, pregelatinized corn starch and magnesium stearate.

Description of the appearance of Diazepam EG STADA and package contents
Tablets of variable color between white and off-white, flat, round (diameter 8.0 mm), with “2”
imprinted on one side and with a fracture line on the other side.
Tablets of variable color between white and off-white, flat, round (diameter 8.0 mm), with “5”
imprinted on one side and with a fracture line on the other side.
Tablets of variable color between white and off-white, flat, round (diameter 8.0 mm), with “10”
imprinted on one side and with a fracture line on the other side.
The tablet can be divided into equal parts.
They are inserted into a carton with the label text printed on it.
Diazepam EG STADA is packaged in Al/PVC blisters or in white HDPE bottles with a
they are inserted into a carton with the label text printed on it.
Diazepam EG STADA is packaged in Al/PVC blisters or in white HDPE bottles with a
they are inserted into a carton with the label text printed on it.
Package sizes:
20, 20x1, 25, 25x1, 30, 30x1, 50, 50x1, 60,60x1, 90, 90x1, 100 and 100x1 tablets in blisters.
20, 20x1, 25, 25x1, 30, 30x1, 50, 50x1, 60, 60x1, 90, 90x1, 100 and 100x1 tablets in blisters or 20
tablets in bottles.
20, 20x1, 25, 25x1, 30, 30x1, 50, 50x1, 60, 60x1, 90, 90x1, 100 and 100x1 tablets in blisters or 20
tablets in bottles.
Not all package sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6 - 20136 Milan

Manufacturers
S.C. Santa S.A., Carpatilor Street no. 60 Objective no. 47, 48, 58, 133 Brasov 500269 - Romania
Stada Arzneimittel AG, Stadastrasse 2-18 Bad Vilbel 61118 - Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
NL Diazepam STADA 2 mg tablets
Diazepam STADA 5 mg tablets
Diazepam STADA 10 mg tablets
BE Diazepam Eurogenerics 2 mg tablets
Diazepam Eurogenerics 5 mg tablets
Diazepam Eurogenerics 10 mg tablets
CZ Diazepam STADA
IT Diazepam EG STADA
LU Diazepam Eurogenerics 2 mg comprimés
Diazepam Eurogenerics 5 mg comprimés
Diazepam Eurogenerics 10 mg comprimés
PL Diazepam STADA