0.5 mg, 1 mg and 5 mg film-coated tablets
flupentixol

1. What Fluanxol is and what it is used for

Fluanxol contains the active substance flupentixol. Fluanxol belongs to a group of medicines called antipsychotics (also called neuroleptics ). These drugs affect the nerve pathways in specific parts of the brain and help correct chemical imbalances in the brain, which can cause the symptoms of your disease. Fluanxol is used in schizophrenia and other psychotic conditions.

Flupentixol contained in Fluanxol may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Fluanxol

Do not use Fluanxol

  • if you are allergic to flupentixol or any of the other ingredients of this medicine (listed in section 6).
  • in case of severe disturbances in the blood circulation.
  • in case of decreased level of consciousness e.g. in case of poisoning with alcohol, sleeping pills, or strong painkillers (morphine or equivalent).
  • in certain forms of blood diseases.
  • in pheochromocytoma (a rare benign tumor of the adrenal glands).

Warnings and cautions

Talk to your doctor or pharmacist before using Fluanxol if you:

  • has impaired liver function.
  • previously suffered from seizures and seizures.
  • has a brain injury caused by e.g. poisoning with alcohol or solvents.
  • have risk factors for stroke (eg smoking, high blood pressure ).
  • previously had low levels of white blood cells.
  • have previously suffered from cardiovascular disease or changes in heart rhythm.
  • use other antipsychotic drugs.
  • feel more upset or active than normal, as the drug may reinforce these feelings.
  • or someone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.

A dry mouth can cause tooth and oral mucosal damage during long-term treatment. Thoroughly clean your teeth with flour toothpaste twice a day.

Children and young people

Fluanxol is not recommended for this patient group.

Other medicines and Fluanxol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Be especially careful to tell your doctor about the following medications :

  • Antidepressant drugs (eg fluoxetine paroxetine, venlafaxine ).
  • Lithium (mood-stabilizing drug).
  • Drugs that lower blood pressure et.
  • Barbiturates and similar medicines (medicines that make you sleepy).
  • Medicines for epilepsy.
  • Levodopa and similar medicines (used to treat Parkinson’s disease ).
  • Metoclopramide (used to treat gastrointestinal diseases).
  • Piperazine (used in infections caused by roundworms and roundworms).
  • Drugs that are diuretic, e.g. thiazide diuretics (affects the salt and fluid balance, which may cause too little potassium or magnesium in the blood).
  • Drugs that affect the heart rhythm (eg quinidine, cisapride, certain antibiotics (moxifloxacin and erythromycin), malaria (mefloquine), methadone ).
  • Other antipsychotic drugs.
  • Codeine (painkiller).
  • Medicines are used to stop the production of breast milk (bromocriptine, cabergoline).

Fluanxol with food, drink, and alcohol

Fluanxol can be taken with or without food.

You should not drink alcohol during the treatment period as the sedative effect may be enhanced.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Fluanxol should not be used during pregnancy unless clearly necessary.

The following symptoms may occur in newborns of mothers who have used Fluanxol during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, anxiety, difficulty breathing, and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor.

Fluanxole passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if you use Fluanxol more than temporarily during breastfeeding.

Fluanxole may affect fertility. Please ask your doctor for advice.

Driving and using machines

Fluanxol may impair the reactivity of some people, which you should keep in mind at times when increased attention is required, e.g. while driving and precision work.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Fluanxol contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The 5 mg tablets also contain para-orange (E110) which may cause allergic reactions.

3. How to use Fluanxol

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults

You must adhere to the dosage that your doctor has indicated on the label from the pharmacy as it is tailored to your needs. Treatment is usually started with 1 mg 3 times daily. The dosage is then gradually changed to usually 4-6 mg daily. In some cases, significantly higher or lower doses may be necessary and the dosage may vary greatly depending on the disease state. The last daily dose should not be taken after 4 pm, as the preparation may cause sleep disturbances.

Elderly patients

Elderly patients should be given the dose at the low end of the dosing interval.

Use for children

Fluanxol is not recommended for use in children.

The tablets are swallowed with a glass of water.

If you use more Fluanxol then you should 

If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Do this even if you / the child does not notice any symptoms. In case of overdose, the side effects may be more pronounced. There may be impaired consciousness, difficulty breathing, palpitations, and seizures.

If you stop using Fluanxol

The duration of treatment is determined in consultation with your doctor. Do not stop treatment without consulting your doctor. When you stop taking Fluanxol, and especially if it happens quickly, you may experience so-called withdrawal symptoms. Symptoms of this can include nausea, vomiting, decreased appetite, diarrhea, runny nose, sweating, muscle pain, abnormal sensations such as tingling and ant crawling, insomnia, restlessness, anxiety, and worry.

If you have any further questions on the use of this product, ask 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 or nearest hospital immediately if you experience any of the following side effects during treatment :

Uncommon (may affect up to 1 in 100 people) :

  • Unusual movements of mouth and tongue; maybe an early sign of a condition known as tardive dyskinesia.

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

  • Fluanxol can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

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

  • High fever, unusual muscle stiffness, and effect on your level of consciousness, especially at the same time as sweating and palpitations. These symptoms may be signs of a rare condition called neuroleptic malignant syndrome that has been reported with the use of various antipsychotics.
  • Yellowing of the skin and whites of the eyes can mean that your liver is affected and be a sign of a condition called jaundice.
  • Blood clots, especially in the legs (symptoms are swelling, pain, and redness on the legs), can be transported to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.

The following side effects are most characteristic at the beginning of treatment and most of them disappear during further treatment:

Very common (may affect more than 1 user in 10) :

  • Drowsiness ( somnolence ), inability to sit or stand still ( akathisia ), involuntary movements (hyperkinesia), slow or reduced movements ( hypokinesia ).
  • Dry mouth.

Common (may affect more than 1 user in 10) :

  • Palpitations ( tachycardia ), the feeling of fast, powerful, or irregular heartbeat ( palpitation ).
  • Tremor, twisting or repetitive movements, or abnormal posture due to persistent muscle tension ( dystonia ), dizziness, headache.
  • Difficulty focusing on objects close to the eye (accommodation disorders), visual disturbances.
  • Difficulty breathing or painful breathing ( dyspnoea ).
  • Increased saliva production (saliva hypersecretion), constipation, vomiting, indigestion or problems centered on the upper abdomen ( dyspepsia ), diarrhea.
  • Problems with urination (urinary disorders), inability to urinate ( urinary retention ).
  • Increased sweating ( hyperhidrosis ), itching ( pruritus ).
  • Muscle pain ( myalgia ).
  • Increased appetite, increased weight.
  • Fatigue, weakness ( asthenia ).
  • Insomnia ( insomnia ), depression, nervousness, agitation, decreased libido (decreased libido ).

Uncommon (may affect up to 1 in 100 people) :

  • Jerky movements ( dyskinesia ), parkinsonism, speech difficulties, seizures.
  • Circulating eye movements (oculogyration).
  • Stomach pain, nausea, flatulence.
  • Rash, skin reactions due to photosensitivity (photosensitization), eczema, or inflammation of the skin ( dermatitis ).
  • Muscle stiffness.
  • Decreased appetite.
  • Low blood pressure ( hypotension ), hot flashes.
  • Abnormal liver function test.
  • Sexual disorders (missed ejaculation, erection problems).
  • Confusion state.

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

  • Low platelet count ( thrombocytopenia ), low / decreased white blood cell count ( neutropenia, leukopenia ).
  • Increased prolactin levels in the blood ( hyperprolactinemia ).
  • High blood sugar (hyperglycemia), affected glucose tolerance.
  • Hypersensitivity (hypersensitivity), acute systemic and severe allergic reaction ( anaphylactic reaction ).
  • Breast development in men ( gynecomastia ), excessive milk production ( galactorrhea ), missed periods ( amenorrhea ).

As with other medicines that work in a similar way to flupentixol (the active substance of fluanxol), rare cases of the following side effects have been reported:

  • QT prolongation (slow heart rate and ECG changes).
  • Irregular heart rhythm (ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia).
  • Torsades de Pointes (a special kind of irregular heartbeat).
  • Cardiac arrest

In rare cases, irregular heart rhythms ( arrhythmias ) have resulted in sudden death.

In elderly people with dementia who are treated with antipsychotic drugs, a small increase in the number of deaths has been reported compared with those who do not receive such treatment.

5. How to store Fluanxol

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 EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is flupentixol (as flupentixol dihydrochloride). Each film-coated tablet contains flupentixol dihydrochloride equivalent to 0.5 mg, 1 mg, and 5 mg flupentixol respectively.

The other ingredients are betadex, lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, croscarmellose sodium, talc, hydrogenated vegetable oil (cottonseed oil), magnesium stearate.

Coating and dyes (0.5 mg and 1 mg): Polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172).

Coating and dyes (5 mg): Polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), para-orange aluminum lacquer (E110).

What the medicine looks like and the contents of the pack

Fluanxol is available as film-coated tablets 0.5 mg, 1 mg, and 5 mg.

The tablets have the following appearance:

0.5 mg tablets: Round, slightly biconvex, yellow film-coated tablets marked with FD, 6.5 mm in diameter.

Tablets 1 mg: Oval, slightly biconvex, yellow film-coated tablets marked with FF, 8 x 5.5 mm.

Tablets 5 mg: Oval, slightly biconvex, ocher-yellow film-coated tablets marked with FK, 8 x 11.8 mm.

Fluanxol film-coated tablets are available as a bottle containing 100 tablets and a carton containing blisters of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

H. Lundbeck A / S

Ottiliavej 9

2500 Valby

Denmark

Agent

H. Lundbeck AB

Slagthuset

211 20 Malmö

Tel: 040-699 82 00

Muhammad Nadeem

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