DIAZEPAM BLUEFISH 5 mg TABLETS

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

Do not take Diazepam Bluefish

• If you are allergic to diazepam or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the benzodiazepine group.
• If you have breathing difficulties related to or not related to sleep for a long time.
• If you have a disease called "myasthenia gravis", which is characterized by muscle weakness and fatigue.
• If you have severe respiratory problems (severe respiratory failure).
• If you have severe liver problems (severe liver failure).
• If you are addicted to drugs or alcohol, you should not take Diazepam Bluefish, unless your doctor has formally indicated it to you.

This medicine 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 only treatment in patients with depression, alone or associated with anxiety. Your doctor will probably have prescribed another medicine for these cases.

Do not use this medicine 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 breathing difficulties
• If you have severe muscle weakness
• If you have other diseases
• If you have allergies
• If you have a history of drug or alcohol dependence
• If you are taking other medicines

Your doctor will decide whether it is convenient for you to take a lower dose of Diazepam Bluefish or not to take it at all.

If you are an epileptic and are undergoing long-term treatment with Diazepam Bluefish, it is not recommended to use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Diazepam Bluefish, as convulsions may occur.

Other medicines and Diazepam Bluefish

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take other medicines. This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

Therefore, you should not take Diazepam Bluefish with other medicines unless your doctor is informed and approves it beforehand. For example, tranquilizers, sleep inducers and similar medicines act on the brain and nerves and can enhance the effect of Diazepam Bluefish.

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

The concomitant use of Diazepam Bluefish and opioids (strong painkillers, substitution therapy medicines and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. Due to this, concomitant use should only be considered when there are no other treatment options.

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

Please inform your doctor about all the opioid medicines you are taking and follow their recommendations on dosage carefully. It may be useful to inform your friends or family so that they are aware of the signs and symptoms mentioned above. 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 you should avoid the use of 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 uninterrupted use of the medicine for a long time. To minimize the risk of dependence, the following precautions should be taken into account.

• The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients), and never advise them to other people.
• Do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.
• Consult your doctor regularly so that they can decide whether to continue treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

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

Benzodiazepines pass into breast milk, so you should consult your doctor about taking Diazepam Bluefish while breastfeeding.

Driving and using machines

Do not drive or operate tools or machines because this medicine 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 older people

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

Diazepam Bluefish contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Diazepam Bluefish

Always follow exactly the administration instructions of the medicine 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 medicine.

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 under alcohol withdrawal treatment:10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg 3 or 4 times a day, as needed.

Adjunctive treatment for muscle spasms:2 to 10 mg, 3 or 4 times a day.

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

Special dosages

Use in children:From 2 to 2.5 mg, 1 or 2 times a day, gradually increasing as needed and tolerated; as a general rule 0.1-0.3 mg/kg per day. Due to the variety of response of children to medicines that act on the CNS, treatment should be started with the lowest dose and increased as required. Do not use in children under 6 months of age.

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

Treatment should be started with the lowest dose. The maximum dose should not be exceeded.

If you think the action of Diazepam Bluefish is too strong or too weak, tell your doctor or pharmacist.

In elderly patients or those 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.

Rules for correct administration

Do not increase the doses prescribed by the 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 (without chewing) with a little water or a soft drink.

The tablets will be taken when they are most needed, usually in the afternoon or evening.

Never change the dose that has been prescribed for you without consulting your doctor first

Duration of treatment

The duration of treatment should be as short as possible and never more than 2-3 months. Consult your doctor regularly so that they can decide whether to continue treatment.

Do not prolong treatment for longer than recommended.

To avoid withdrawal symptoms, you should 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 taken an overdose of Diazepam Bluefish, call your doctor, pharmacist or the nearest hospital immediately.

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

If you forget to take Diazepam Bluefish

Do not take a double dose to make up for forgotten doses. On the contrary, you should continue with the normal dose.

If you stop taking Diazepam Bluefish

When stopping the administration, restlessness, anxiety, insomnia, lack of concentration, headache and hot flashes may appear. It is not recommended to interrupt the medication abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell 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 of the type of confusion, impaired alertness, loss of sensitivity, constipation, depression, double vision, ataxia, difficulty articulating words, digestive changes, changes in heart rhythm, headache, hypotension, circulatory changes, increased or decreased libido, nausea, dry mouth or hypersalivation, incontinence or urinary retention, skin rashes, stuttering, tremors, dizziness and blurred vision have been described. The most common skin reactions are rash, urticaria and pruritus.

Very rarely, increased transaminases and alkaline phosphatase, jaundice, as well as cardiac arrest have been reported.

An increased risk of falls and fractures has been observed in older patients and in patients who are taking other sedative medicines (including alcoholic beverages) at the same time.

It is known that when benzodiazepines are used, behavioral side effects such as restlessness, agitation, irritability, delirium, outbursts of anger, aggression, nightmares, hallucinations, psychosis or inappropriate behavior may occur. These reactions are more frequent in older people and in children. If you experience these effects, you should stop treatment and contact your doctor immediately.

On the other hand, the use of benzodiazepines can lead to dependence, mainly when the medicine is taken uninterrupted for a long time. It is not recommended to interrupt the medication abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

Anterograde amnesia (difficulty remembering recent events) may occur at normal doses, the risk increases when the dose is increased. Amnestic effects may be associated with behavioral changes.

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

Reporting of 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 Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diazepam Bluefish

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 carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Diazepam Bluefish

• The active substance is diazepam. Each tablet contains 5 mg of diazepam.
• The other ingredients are lactose monohydrate, pregelatinized starch (derived from corn starch) and magnesium stearate.

Appearance of the product and contents of the pack

White or almost white, round, flat, with "5" on one face and marked on the other face.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer:

SANTA S.A.

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

Brasov, jud. Brasov, cod 500419, Romania

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

Bluefish Pharma S.L.U

AP 36007, 2832094 Madrid,

Sucursal 36

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this prospectus: July 2018

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/