Package Insert: Information for the Patient

Deanxit Film-Coated Tablets

Flupentixol 0.5 mg (dihydrochloride) and melitracen 10 mg (hydrochloride)

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Deanxit and for what it is used

2. What you need to know before starting to take Deanxit

3. How to take Deanxit

4. Possible adverse effects

5. Storage of Deanxit

6. Contents of the package and additional information

Deanxit contains the active principles flupentixol and melitraceno.Deanxit belongs to a group of medications that alleviate symptoms of a depressed mood state.

The combination of the active principles forms a preparation with antidepressant, anxiolytic, and activating properties.

Deanxit is used to treat anxiety and depression in patients with or without psychosomatic symptoms.

Do not take Deanxit:

• If you are allergic to flupentixol, melitracen, or any of the other components of this medication (listed in section 6).
• If you have a decreased level of consciousness.
• If you have a blood disorder.
• If you have a rare adrenal gland disorder (pheochromocytoma).
• If you have recently had a heart attack (myocardial infarction).
• If you have heart rhythm disorders that can be seen on an electrocardiogram (ECG).
• If you are taking a medication known as monoamine oxidase inhibitors (MAOIs) at the same time.

MAOIs include medications such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, and moclobemide, and are used to treat depression and selegiline, which is used to treat Parkinson's disease.

Although you have stopped taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine for depression or selegiline for Parkinson's disease, you should wait 2 weeks before starting to take Deanxit.

You should have waited at least one day since you stopped taking moclobemide.

Deanxit tablets are not suitable for patients with severe depression, such as patients who need to be hospitalized or require electroconvulsive therapy (ECT), and are also not suitable for excitable or hyperactive patients.

Warnings and precautions:

Inform your doctor or pharmacist before starting to take Deanxit if you

• Have an organic brain syndrome (which may be a consequence of alcohol or organic solvent intoxication).
• Have a history of seizures.
• Have difficulty urinating.
• Have an overactive thyroid gland (hyperthyroidism).
• Have a liver or heart disorder.
• Are more excited or hyperactive than normal, as this medication may increase this sensation.
• Have hypokalemia or hypomagnesemia (too little potassium or magnesium in your blood or a genetic predisposition to either of these).
• Have a history of cardiovascular disorders.
• Have diabetes (you may need to adjust your antidiabetic treatment).
• Have glaucoma (increased intraocular pressure).
• Are about to undergo surgery, it is recommended to stop administering the product several days before the operation.
• Are taking medications known as selective serotonin reuptake inhibitors (SSRIs).
• If you or a family member has a history of blood clots, as certain medications in this group have been associated with the formation of blood clots.

Children and adolescents:

The use of Deanxit is not recommended in children and adolescents.

Older adults:

In older adults with dementia, a slight increase in the number of deaths in patients taking antipsychotics compared to patients not taking this medication has been observed.

Thoughts of suicide and worsening of depression or anxiety disorder:

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or committing suicide. These may increase when you first start taking antidepressants, as all these medications take time to start working, usually around two weeks, although in some cases it may take longer.

You would be more prone to having these thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• If you are a young adult.Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming yourself or committing suicide, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

Manic episodes:

Some patients with bipolar disorder may enter a manic phase. This is characterized by a rapid and profuse change in ideas, excessive joy, and excessive physical activity. In this case, it is essential to consult your doctor; it is likely that you will change your medication.

Use of Deanxit with other medications:

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Inform your doctor if you are taking any of the following medications:

• Adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (including some cold medications).
• Guanetidine and similar medications (used to lower blood pressure).
• Tricyclic antidepressants.
• Medications that change heart rhythm (quinidine, amiodarone, sotalol, dofetilide, thioridazine, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium).
• Medications that cause a disturbance in electrolyte balance (too little potassium or magnesium in your blood).
• Medications that increase the concentration of Deanxit in your blood.
• Medications that cause drowsiness (alcohol, barbiturates, and other sedative medications).
• Lithium (for the prevention and treatment of bipolar disorder).
• Levodopa (for the treatment of Parkinson's disease).

Use of Deanxit with food, drinks, and alcohol:

Deanxit may increase the sedative effects of alcohol, so you may feel more drowsy. It is not recommended to consume alcohol during treatment with Deanxit.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

If you are pregnant or think you may be pregnant, consult your doctor. Deanxit should not be used during pregnancy unless it is clearly necessary.

The following symptoms may appear in newborns of mothers who took Deanxit during the third trimester (last three months of pregnancy): tremor, rigidity, and/or muscle weakness, tendency to sleep, agitation, respiratory problems, and difficulty feeding.

If your baby shows any of these symptoms, you should contact your doctor.

Breastfeeding:

If you are breastfeeding, consult your doctor. You should not use Deanxit during breastfeeding, as small amounts of the medication may pass into breast milk.

Fertility:

Studies in animals have shown that Deanxit affects fertility. Please consult your doctor.

Driving and operating machinery:

Deanxit generally does not cause drowsiness; however, if you feel dizzy or sleepy when starting to take this medication, do not drive or operate tools or machines until the effects have disappeared.

Deanxit contains lactose:

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Deanxit contains sodium:

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

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

The recommended dose is:

Adults

Normally two tablets a day: 1 in the morning and 1 at noon.

Your doctor may increase the dose to 2 tablets in the morning and 1 at noon.

The maximum dose is 4 tablets a day.

Maintenance dose: usually 1 tablet in the morning.

Older adults (65 years or older)

1 tablet in the morning.

Your doctor may increase the dose to 1 tablet in the morning and 1 tablet at noon.

Maintenance dose: usually 1 tablet in the morning.

Deanxit can be taken with or without food.

Swallow the tablets with a glass of water. Do not chew them.

Treatment duration

Patients generally respond to Deanxit treatment quite quickly, although if you have taken the maximum dose for about a week and still do not feel better, it is possible that your doctor may decide to discontinue treatment.

Your doctor will indicate the duration of your treatment. Continue treatment according to your doctor's recommendations.

Do not modify the medication dosage without consulting your doctor.

If you take more Deanxit than you should

If you believe you or anyone else may have taken more Deanxit tablets,consult your doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.Do this even if there are no signs of discomfort or intoxication. Bring the Deanxit packaging with you if you visit a doctor or hospital.

The symptoms of overdose include drowsiness, irritability, excitement, hallucinations, dilated pupils, rapid heart rate,urinary difficulties, dry mucous membranes, constipation, convulsions, fever, unconsciousness, coma, difficulty breathing (blue skin discoloration), irregular heartbeats, cardiac problems that may cause difficulty breathing or swelling of the ankles, low blood pressure, metabolic acidosis, hypokalemia (low potassium levels that may cause muscle weakness, spasms, or abnormal heart rhythm).

If you forget to take Deanxit

If you forget to take a dose, take the next dose when it is due. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Deanxit

Do not stop taking Deanxit even if you start feeling better, unless your doctor has instructed you to do so.

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

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

If you experience any of the following symptoms, contact your doctor or go to the hospital immediately.

Very rare (may affect up to 1 in 10,000 people):

• Unusual movements of the mouth and tongue; this may be an early sign of a condition known as tardive dyskinesia.

• High fever, unusual muscle stiffness, and disturbances in consciousness, especially if accompanied by sweating and rapid heart rate; these symptoms may be signs of a rare condition called neuroleptic malignant syndrome, which has been reported with the use of different antipsychotics.

• Yellowing of the skin and white in the eyes, which may indicate that your liver is affected and a sign of a condition known as jaundice.

• Symptoms of infection such as sudden unexplained fever, sore throat, and mouth ulcers; these may be signs of a strongly reduced number of white blood cells and a condition known as agranulocytosis.

Frequency not known (the frequency cannot be estimated from the available data):

• Suicidal thoughts or suicidal behavior, see "Warnings and precautions" section.

• Blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness in the legs), which may move through the blood vessels to the lungs, causing chest pain and difficulty breathing.

The following side effects are more pronounced at the beginning of treatment and most of them usually disappear during continued treatment:

Frequent (may affect up to 1 in 10 people):

• Lack of sleep (insomnia), agitation

• Drowsiness, tremors, dizziness
• Difficulty focusing on objects close to the eye (accommodation disorder)
• Dry mouth
• Constipation
• Fatigue
• Abnormal heart rhythm on electrocardiogram (ECG)

Rarely (may affect up to 1 in 100 people)

• Nightmares, anxiety, confused state
• Fast heart rate (tachycardia), irregular heartbeat (arrhythmia)
• Abnormal liver function tests
• Rash, hair loss (alopecia)
• Muscle pain (myalgia)
• Feeling of weakness

Rare(may affect up to 1 in 1,000 people):

• Nausea
• Problems with digestion or discomfort in the upper part of the abdomen (dyspepsia)

Very rare (may affect up to 1 in 10,000 people):

• Low platelet count (thrombocytopenia), reduced white blood cell count (leucopenia)
• Brusque movements (dyskinesia), tremors, stiffness, and dragging (parkinsonism)
• Liver disease

Unknown (the frequency cannot be estimated from the available data)

• Drug withdrawal syndrome in newborns, see also "Pregnancy, lactation, and fertility" section.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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 label. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Keep in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of medications you no longer need. This will help protect the environment.

Composition of Deanxit

The active principles are flupentixol and melitracen.

Each Deanxit film-coated tablet contains flupentixol dihydrochloride, corresponding to 0.5 mg of flupentixol and melitracen hydrochloride, corresponding to 10 mg of melitracen.

The other components are: betadex, lactose monohydrate, cornstarch, hydroxypropylcellulose, microcrystalline cellulose, sodium croscarmellose, talc, hydrogenated vegetable oil, magnesium stearate.

Coating: poly(vinyl alcohol), macrogol 3350, talc, macrogol 6000

Colorants: titanium dioxide E171, erythrosine E127, indigo carmine E132.

Appearance of the product and content of the container

Deanxit film-coated tablets are pink, round, and biconvex.

Deanxit tablets are available in blister packs or plastic containers in the following container sizes:

30, 50, and 100 in blister packs

100 in plastic containers

Not all container sizes may be marketed

Holder of the marketing authorization and responsible for manufacturing

Holder:

Lundbeck España, S.A.

Av. Diagonal, 605.

E-08028 Barcelona.

Spain

Responsible for manufacturing:

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Last review date of this leaflet: March 2021

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