Leaflet: information for the user

Diazepam Bluefish 5 mg tablets EFG

diazepam

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist or nurse.

- This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Diazepam Bluefish

3. How to take Diazepam Bluefish

4. Possible side effects

5. Storage of Diazepam Bluefish

6. Contents of the pack and additional information

Diazepam Bluefish contains as its active ingredient diazepam, which belongs to a group of medications known as benzodiazepines.

Diazepam has tranquilizing, sedating, muscle relaxing, and anticonvulsant effects.

Doctors prescribe Diazepam Bluefish for people who exhibit symptoms of anxiety, agitation, and mental tension caused by psychoneurotic states and transient situational disorders. Benzodiazepines are only indicated for the treatment of intense disorders that limit activity or subject the individual to significant stress.

It may also be useful for relieving symptoms of acute agitation, tremors, and hallucinations in patients with alcohol withdrawal syndrome.

Diazepam Bluefish contributes to the relief of muscle pain caused by spasms or inflammation of muscles or joints, trauma, etc. It may also be used to combat spasms originating from diseases such as cerebral palsy (a group of disorders that affect a person's ability to move, maintain balance, and posture) and paraplegia (paralysis of the lower half of the body, affecting both legs), as well as in ataxia (slow, involuntary, and continuous movements of fingers and hands) and in generalized rigidity syndrome.

Diazepam Bluefish may be used as an adjunctive treatment (treatment administered after the primary treatment to increase the chances of a cure) for convulsive disorders (such as epilepsy, seizures), but it has not been proven useful as a single treatment. In these cases, your doctor will periodically evaluate the usefulness of the medication for your case.

Do not take Diazepam Bluefish

- If you are allergic to diazepam or any of the other components of this medication (listed in section 6).

- If you are allergic to other medications in the benzodiazepine group.

- If you have respiratory difficultiesrelated or not to sleepfor a long time.

- If you have a disease called “myasthenia gravis”, characterized by muscle weakness and fatigue.

- If you have severe respiratory problems (Severe respiratory insufficiency).

- If you have severe liver problems (Severe hepatic insufficiency).

- If you suffer from drug or alcohol dependence, do not take Diazepam Bluefish, unless your doctor has formally indicated it.

This medication is not recommended for the primary treatment of psychotic disorders (severe mental disorders that cause abnormal ideas and perceptions), nor should it be used as the sole treatment for patients with depression, alone or associated with anxiety. Your doctor has probably prescribed another medication for these cases.

Do not use this medication in children under 6 months of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diazepam Bluefish.

• If you have any liver or kidney disease
• If you have respiratory difficulties
• If you suffer from severe muscle weakness
• If you have other diseases
• If you have allergies
• If you have drug or alcohol dependence problems
• If you are taking other medications

Your doctor will decide whether you should take a lower dose of Diazepam Bluefish or not take it at all.

If you are epileptic and following a long-term treatment with Diazepam Bluefish, do not use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Diazepam Bluefish, as this may cause seizures.

Other medications and Diazepam Bluefish

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take other medications. This is extremely important because the simultaneous use of multiple medications may increase or decrease their effect.

Therefore, do not take Diazepam Bluefish with other medications unless your doctor is informed and approves it in advance. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and may enhance the effect of Diazepam Bluefish.

Cisapride, cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole temporarily increase the sedative effect of Diazepam Bluefish, increasing the risk of drowsiness. Similarly, the metabolism of phenytoin may be affected if you are taking Diazepam Bluefish, so if you are taking this medication, your doctor will adjust the doses accordingly.

The concomitant use of Diazepam Bluefish and opioids (strong analgesics, substitution therapy medications, and some cough medications) increases the risk of drowsiness, respiratory depression, coma, and may pose a life-threatening risk. Therefore, concomitant use should be considered only when there are no other treatment options.

However, if your doctor prescribes Diazepam Bluefish along with opioids, they should limit the dose and duration of concomitant treatment.

Please inform your doctor of all opioid medications you are taking and follow their recommendations on dosage. It may be helpful to inform your friends or family members of the signs and symptoms mentioned earlier. Contact your doctor if you experience any of these symptoms.

If you need more information about this, consult your doctor or pharmacist.

Taking Diazepam Bluefish with food, drinks, and alcohol

Alcoholic beverages increase the sedative effects of Diazepam Bluefish, so avoid using alcoholic beverages during treatment. If you need additional information, consult your doctor.

Risk of dependence

The use of benzodiazepines can lead to dependence. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, the following precautions should be taken.

•The use of benzodiazepines should only be under medical prescription (never because they have worked in other patients), and never advise others.

•Do not increase the prescribed doses or prolong the treatment longer than recommended.

•Consult your doctor regularly to decide whether to continue treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, suspect you may be pregnant, or planning to become pregnant, consult your doctor or pharmacist before taking this medication.

Before starting treatment, your doctor should know if you are or suspect you are pregnant, or if you want to become pregnant. The doctor will then decide whether it is convenient or not to take Diazepam Bluefish.

Benzodiazepines pass into breast milk, so you should consult your doctor about taking or not taking Diazepam Bluefish while breastfeeding.

Driving and operating machinery

Do not drive or operate tools or machinery because this medication can cause sedation, amnesia, difficulty concentrating, and muscle weakness, which can negatively affect your ability to drive vehicles or operate machinery. This effect is increased if you have also consumed alcohol.

Use in elderly people

Elderly people may need lower doses of Diazepam Bluefish than young patients. If you are elderly, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.

Diazepam Bluefish contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult them before taking this medication.

Always follow exactly the medication administration instructions indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Depending on the nature of your illness, your age and weight, your doctor will prescribe the most suitable dose and indicate the duration of your treatment with Diazepam Bluefish. Remember to take your medication.

Follow these instructions unless your doctor has given you different instructions:

Adults.

Anxiety symptoms:2 to 10 mg, 2 to 4 times a day, depending on the severity of the symptoms.

Relief of symptoms in patients undergoing alcohol detoxification treatment:10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg 3 or 4 times a day, as needed.

Adjuvant for relief of muscle-skeletal spasm:2 to 10 mg, 3 or 4 times a day.

Adjuvant in anticonvulsant therapy: 2 to 10 mg, 2 or 4 times a day.

Special dosages

Use in children:2 to 2.5 mg, 1 or 2 times a day, increasing gradually as needed and tolerated; as a general rule, 0.1-0.3 mg/kg per day. Due to the variety of responses of children to medications acting on the CNS, treatment should begin with the lowest dose and increase as needed. Do not use in children under 6 months of age.

Use in elderly individuals or in the presence of debilitating diseases:2 to 2.5 mg, 1 or 2 times a day, increasing gradually as needed and tolerated.

Treatment should begin with the lowest dose. Do not exceed the maximum dose.

If you estimate that the action of Diazepam Bluefish is too strong or too weak, inform your doctor or pharmacist.

In patients with liver or kidney disorders, or muscle weakness, in children, in debilitated patients, or those with low serum albumin levels, the doctor will prescribe a lower dose.

Guidelines for correct administration

Do not increase the doses prescribed by your doctor.

Each individual dose and the total daily dose should not exceed the indicated limits unless your doctor has prescribed a higher dose.

Diazepam Bluefish tablets should be taken whole (not chewed) with a little water or a soft drink.

Diazepam Bluefish tablets should be taken when needed, usually in the afternoon or evening.

Never change the dose prescribed without consulting your doctor first.

Treatment duration

The treatment duration should be as short as possible and never exceed 2-3 months. Consult your doctor regularly to decide if treatment should continue.

Do not prolong treatment beyond the recommended duration.

To avoid withdrawal symptoms, do not stop taking Diazepam Bluefish abruptly, especially if you have been taking it for a long time.

If you take more Diazepam Bluefish than you should

If you or someone else has ingested an overdose of Diazepam Bluefish, callimmediatelyyour doctor, pharmacist, or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone: 91 562 04 20 indicating the medication and the amount used.

If you forgot to take Diazepam Bluefish

Do not take a double dose to compensate for the missed doses. Instead, continue with the normal dose.

If you interrupt treatment with Diazepam Bluefish

Stopping administration may cause restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes. It is generally not recommended to stop medication abruptly, but rather to gradually reduce the dose, as instructed by your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Most patients tolerate Diazepam Bluefish well, but the most common side effects, which occur especially at the beginning of treatment, are fatigue and drowsiness.

Occasionally, other side effects such as confusion, decreased alertness, numbness, constipation, depression, double vision, ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, digestive disturbances, heart rhythm alterations, headache, hypotension, circulatory disturbances, increased or decreased libido (sexual appetite), nausea, dry mouth or hypersalivation (excessive salivation), incontinence or urinary retention, skin eruptions, stuttering, tremor, vertigo, and blurred vision have been described. The most common skin reactions are inflammation (skin inflammation), urticaria (red itchy patches), and pruritus (uncomfortable skin itching that causes the desire to scratch the affected area).

Very rarely, an increase in transaminases and alkaline phosphatase, jaundice (yellowish discoloration of the skin and eyes), and cardiac arrest have been reported.

An increased risk of falls and fractures has been observed in elderly patients and in patients taking other sedatives (including alcoholic beverages) at the same time.

It is known that when benzodiazepines are used, side effects on behavior such as restlessness, agitation, irritability, delirium (incoherent ideas), outbursts of anger, aggression, nightmares, hallucinations, psychosis (loss of contact with reality), or inappropriate behavior can occur. These reactions are more common in the elderly and in children. If you experience these side effects, you should discontinue treatment and contact your doctor immediately.

On the other hand, the use of benzodiazepines can lead to dependence, mainly when the medication is taken continuously for a long time. It is generally not recommended to abruptly discontinue medication, always following the doctor's instructions.

Amnesia (difficulty remembering recent events) can appear at normal doses, and the risk increases with increased doses. Amnestic effects can be associated with behavioral alterations.

If you observe any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Diazepam Bluefish

•The active ingredient is diazepam. Each tablet contains 5 mg of diazepam.

•The other components are lactose monohydrate, pregelatinized starch (from cornstarch) and magnesium stearate.

Appearance of the product and content of the container

White or off-white, round, flat, with "5" on one side and marked on the other side.

Diazepam Bluefish 5 mg tablets are packaged in Al/PVC blisters and in white HDPE bottles

Al/PVC Blister: 30, 40 and 100 tablets

HDPE Bottle: 30, 40 and 100 tablets

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Responsible manufacturer:

SANTA S.A.

Str.Panselelor nr.25,nr. 27, nr. 29

Brasov, Brasov county, postal code 500419, Romania

You can requestmore information about this medication by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U

AP 36007, 2832094 Madrid,

Sucursal 36

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: July 2018

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/