50 mg & 150 mg & 200 mg & 300 mg & 400 mg prolonged-release tablet 
quetiapine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Biquetan is and what it is used for 
2. What you need to know before you use Biquetan 
3. How to use Biquetan 
4. Possible side effects 
5. How to store Biquetan 
6. Contents of the packaging and other information 

1. What Biquetan is and what it is used for

Biquetane contains a substance called quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. Biquetane can be used to treat a number of diseases, such as:

  • Bipolar depression and depressive episodes in actual depression: when you may feel depressed or depressed, heavy with guilt, lack of energy, have a poor appetite, or sleep problems.
  • Mania: when you may feel very upset, elated, upset, enthusiastic, hyperactive, or have a bad judgment with elements of aggressive and fragmented behavior.
  • Schizophrenia: when you may see, hear or feel things that do not exist, believe in things that are not real, or feel unusually suspicious, anxious, confused, tense, or depressed.

When Biquetan is taken to treat depressive episodes in case of major depression, it is taken in addition to other medications used to treat this disease.

Your doctor may want you to continue taking Biquetan even when you feel better.

The quetiapine contained in Biquetan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Biquetan

Do not use Biquetan

  • if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
  • if you are taking any of the following medicines:
    • certain medicines for HIV
    • azoles (medicines for fungal infections)
    • erythromycin and clarithromycin (medicines for infections )
    • nefazodone (antidepressant).

If you are not sure, talk to your doctor or pharmacist before taking Biquetan.

Warnings and cautions

Talk to your doctor or pharmacist before taking Biquetan:

  • if you or someone in your family has or has had a heart problem, such as heart rhythm disorders, weak heart muscle, or inflammation of the heart, or if you are taking any medicines that may affect your heartbeat
  • if you have low blood pressure
  • if you have had a stroke, especially if you are older
  • if you have liver problems
  • if you have ever had a seizure ( epilepsy )
  • if you have diabetes or are at risk of getting diabetes. If you have it, your doctor may need to measure your blood sugar level when you use Biquetan
  • if you know you have had low white blood cell counts in the past (which may or may not have been caused by other medicines)
  • if you are older and suffer from dementia (a loss of brain function). If this is true for you, do not take Biquetan, as the group of medicines to which Biquetan belongs may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
  • if you are older and suffering from Parkinson’s disease/parkinsonism
  • if you or someone in your family has had a blood clot, as similar medicines have been linked to the formation of blood clots
  • if you have or have had a condition where you stop breathing for short periods during your normal night’s sleep (called “sleep apnea”) and take medicines that reduce the normal activity of the brain (“sedatives”)
  • if you have or have had a condition where you cannot empty the bladder completely ( urinary retention ), have an enlarged prostate, a blockage in the intestines, or increased pressure inside the eye. These conditions are sometimes caused by drugs (called “anticholinergics”) that affect the way nerve cells work to treat certain conditions.
  • if you have or have had problems with alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following after taking Biquetan:

  • a combination of fever, severe muscle stiffness, sweating, or decreased consciousness (a condition called neuroleptic malignant syndrome). You may need immediate medical attention
  • to uncontrollable movements, especially on the face or tongue
  • dizziness or troublesome drowsiness. In older patients, this could increase the risk of accidental injuries (by falling)
  • seizures
  • prolonged and painful erection (priapism).

Such conditions can be caused by this type of drug.

Talk to a doctor as soon as possible if you get:

  • fever, flu-like symptoms , sore throat, or any other infection, as this could be due to a very low number of white blood cells, which may require treatment with Biquetan to be discontinued and/or treatment for infection to be given.
  • constipation along with persistent pain in the abdomen or constipation that does not respond to treatment, as this can lead to a more severe blockage of the intestine.

Suicidal thoughts and worsening depression

You who are depressed can sometimes have thoughts of wanting to hurt yourself or commit suicide. These symptoms may worsen when you start treatment, as it takes time for a drug of this type to take effect, usually about 2 weeks, but sometimes longer.

Thoughts of this type can also increase if you suddenly stop taking your medicine. These thoughts can be common if you are a young adult. Clinical studies have shown that young adults (younger than 25 years) with depression have an increased risk of suicidal thoughts and/or thoughts of self-harm.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide. It can be helpful to tell a relative or close friend that you are depressed. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think the depression is getting worse or if they think your behavior is changing.

Drug-induced skin rash with eosinophilia and systemic symptoms (DRESS).

Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities ( eosinophilia ), enlarged lymph nodes, and involvement of other body organs (drug-induced skin rash with eosinophilia and systemic symptoms, also known as DRESS, or drug hypersensitivity syndrome). Stop using Biquetan if you get these symptoms and contact your doctor or see a doctor immediately.

Weight gain

It has been seen that some patients who take Biquetan gain weight. You and your doctor should check your weight regularly.

Children and young people

Biquetan should not be used by children and adolescents under 18 years of age.

Other medicines and Biquetane

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

Do not take Biquetan if you are taking any of the following medicines:

  • certain medicines for HIV
  • azoles (medicines for fungal infections)
  • erythromycin or clarithromycin (medicines for infections )
  • nefazodone (antidepressant).

Tell your doctor if you are taking any of the following medicines:

  • epilepsy drugs (such as phenytoin or carbamazepine)
  • medicines for high blood pressure
  • barbiturates (medicines for sleep disorders)
  • thioridazine or lithium (other antipsychotics)
  • drugs that affect the heartbeat, such as drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium ) such as diuretics ( diuretics ) or certain antibiotics (medicines for infections )
  • medicines that can cause constipation
  • drugs (called “anticholinergics”) that affect the way nerve cells work to treat certain conditions.

Talk to your doctor before stopping any of these medicines.

Biquette with food, drink, and alcohol

  • Biquetane can be affected by food and you should therefore take your tablets at least 1 hour before a meal or before bedtime.
  • You should be careful about how much alcohol you drink as the combination of Biquetan and alcohol can make you sleepy.
  • Do not drink grapefruit juice while taking Biquetan. It may affect the way the medicine works.

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 or pharmacist for advice before taking this medicine.

You should not take Biquetan during pregnancy unless you have discussed it with your doctor. You should not take Biquetan if you are breast-feeding.

The following symptoms, which correspond to problems that may occur when you stop taking the medicine, may occur in newborns of mothers who have taken Biquetan during the last trimester (the last three months of pregnancy): tremors, muscle stiffness, and/or muscle weakness, drowsiness, anxiety, breathing problems and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor.

Driving and using machines

Your tablets can make you sleepy. Do not drive or use any tools or machines until you know how the tablets affect you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Biquetane contains lactose

Biquetane 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.

Effects on drug tests in urine

If you provide a urine sample for a drug test, the use of Biquetan may cause you to test positive for methadone or certain antidepressants called tricyclic antidepressants(TCAs). This can happen when certain test methods are used, even though you may not be taking methadone or TCA, in which case a more specific test may be performed.

3. How to use Biquetan

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

Your doctor will decide on your starting dose. The maintenance dose (the daily dose one) depends on your illness and your needs but is normally between 150 mg and 800 mg.

  • You should take the tablets once a day.
  • Do not divide, chew, or crush the tablets.
  • Swallow the tablets whole with a glass of water.
  • Take the tablets without food (at least 1 hour before a meal or at night – your doctor will tell you which time is best).
  • Do not drink grapefruit juice while taking Biquetan. It may affect the way the medicine works.
  • Do not stop taking your tablets even if you feel better unless your doctor tells you to.

Liver problem

If you have liver problems, your doctor may change your dose.

Older

If you are older, your doctor may change your dose.

Use for children and adolescents

Biquetan should not be used by children and adolescents under 18 years of age.

If you forget to use Biquetane

If you forget to take a tablet, take it as soon as you remember. If it’s soon time for the next tablet, wait until then. Do not take a double dose to make up for a forgotten dose.

If you stop using Biquetan

If you suddenly stop taking Biquetan, you may have difficulty sleeping, feel nauseous or experience headaches, diarrhea, vomiting, dizziness, or feel irritable. 

Your doctor may suggest that you reduce the dose gradually before stopping your treatment.

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.

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

  • dizziness (may lead to falls), headache, dry mouth
  • drowsiness (may disappear with time when taking Biquetan) (may lead to falls)
  • withdrawal symptoms (symptoms that occur when you stop taking Biquetan) include difficulty falling asleep (insomnia), malaise (nausea), headache, diarrhea, vomiting, dizziness, and irritability. It is advisable to stop taking the medicine gradually over a period of at least 1-2 weeks.
  • weight gain
  • abnormal muscle movements, e.g. difficult to begin movements, tremors, a feeling of restlessness, or muscle stiffness without pain
  • altered levels of certain fats ( triglycerides and total cholesterol ).

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

  • fast heartbeat
  • the feeling of heart-pounding, rushing or skipping heartbeat
  • constipation, upset stomach (digestive problems)
  • impotence
  • swelling in arms or legs
  • drop in blood pressure when you get up. It may make you feel dizzy or faint (may lead to falls)
  • increased blood sugar content
  • dimsyn
  • strange dreams and nightmares
  • increased feelings of hunger
  • feeling of irritation
  • speech and language disorders
  • suicidal thoughts and worsening of your depression
  • shortness of breath
  • vomiting (mainly in the elderly)
  • fever
  • altered levels of thyroid hormones in the blood
  • reduced level of certain types of blood s
  • increased content of liver enzymes measured in blood samples
  • increased levels of the hormone et prolactin in the blood. An increase in the hormone et prolactin may in rare cases lead to the following:
    • Men and women can get a swelling of the breasts and unexpected production of breast milk.
    • in women, menstruation may cease or become irregular.

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

  • epilepsy or seizures
  • allergic reactions that may include raised lumps or streaks, skin swelling, and swelling around the mouth
  • the feeling of discomfort in the legs (also called restless legs syndrome)
  • difficulty swallowing
  • involuntary movements, especially of the face and tongue
  • sexual dysfunction
  • diabetes
  • change in the electrical activity of the heart that can be seen on the ECG ( QTprolongation)
  • a slower-than-normal heart rate may occur at the beginning of treatment and may be associated with low blood pressure and fainting
  • difficulty urinating
  • fainting (may lead to falls)
  • nasal congestion
  • reduced levels of red blood cells
  • lowered sodium levels in the blood
  • worsening diabetes.

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

  • a combination of fever, sweating, muscle stiffness, drowsiness, or fainting (a condition called ‘malignant neuroleptic syndrome’)
  • yellow skin and eyes (jaundice)
  • liver inflammation ( hepatitis )
  • a persistent and painful erection (priapism)
  • swelling of the breasts and unexpected production of breast milk ( galactorrhea )
  • menstrual disorder
  • blood clots in the veins, especially in the legs (with symptoms such as swelling, pain, and redness ) which can be passed on in the blood vessels to the lungs and cause chest pain and difficulty breathing. If you get symptoms similar to these, see a doctor immediately.
  • that you walk, talk, eat or have other activities while you sleep
  • decreased body temperature ( hypothermia )
  • pancreatitis
  • a condition (so-called “metabolic syndrome”) where you may have a combination of at least 3 of the following signs: an increase in abdominal fat, a decrease in “good cholesterol” ( HDL-C ), an increase in a type of fat in the blood called triglycerides, high blood pressure and an increase in blood sugar
  • a combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count, a condition called agranulocytosis
  • blockage of the intestine
  • increased levels of creatine phosphokinase in the blood (a substance that comes from the muscles).

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

  • severe rash, blisters, or red spots on the skin
  • severe allergic reaction ( anaphylactic reaction ) which may cause difficulty breathing or shock
  • rapid swelling of the skin, usually around the eyes, lips, and neck ( angioedema )
  • a serious disease with blistering of the skin, mouth, eyes, and genitals ( Stevens-Johnson syndrome )
  • disturbed secretion of a hormone that regulates urine volume
  • degradation of muscle fibers and muscle pain ( rhabdomyolysis ).

Has been reported (occurs in an unknown number of users):

  • rash with irregular red spots (erythema multiforme)
  • severe, sudden allergic reaction with symptoms such as fever, blisters, and peeling of the skin ( toxic epidermal necrolysis )
  • Discontinuation of the drug may occur in newborns of mothers who have used quetiapine during pregnancy
  • Stroke.

Biquetane belongs to a type of medicine that can cause heart rhythm disorders. Such disorders can be serious and, in severe cases, fatal.

Some side effects are only visible if you take a blood sample. This includes altered levels of certain fats ( triglycerides and total cholesterol ) or sugar in the blood, altered levels of thyroid hormones in the blood, elevated levels of liver enzymes, decrease in the number of certain types of blood cells, decreased levels of red blood cells, elevated levels of creatine phosphokinase (a substance in the muscles) in the blood, lowered sodium levels in the blood and elevated levels in the blood of the hormone et prolactin. An increase in the hormone et prolactin can in rare cases lead to:

  • Men and women can get a swelling of the breasts and unexpected production of breast milk.
  • in women, menstruation may cease or become irregular.

Your doctor may ask you to have blood tests regularly.

Additional side effects in children and adolescents

The same side effects that can occur in adults can also occur in children and adolescents.

The following side effects may be more common in children and adolescents or may not occur at all in adults:

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

  • the increased amount of the hormone et prolactin in the blood. Increased amounts of the hormone et prolactin can in rare cases lead to the following:
    • the breasts can swell in both boys and girls and unexpectedly form breast milk
    • menstruation may cease or become irregular in girls
  • increased appetite
  • vomiting
  • abnormal muscle movements. These include difficulty starting muscle movements, tremors, restlessness, or muscle stiffness without pain
  • increased blood pressure.

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

  • weakness, fainting (may lead to falls)
  • nasal congestion
  • that you feel annoyed.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Biquetan

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 expiration date is the last day of the specified month.

No 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 (s) is quetiapine. Biquetane tablets contain 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).

Other ingredients are:

Tablet core: anhydrous lactose, methacrylic acid – ethyl acrylate copolymer (1: 1), type A crystalline maltose, magnesium stearate, and talc.

Tablet coating: methacrylic acid – ethyl acrylate copolymer (1: 1), type A, triethyl citrate.

What the medicine looks like and the contents of the pack

50 mg prolonged-release tablets are white to off-white, round biconvex, debossed with “50” on one side, 7.1 mm in diameter and 3.2 mm in thickness.

150 mg prolonged-release tablets are white to off-white, oblong biconvex, debossed with “150” on one side, 13.6 mm in diameter, and 6.6 mm in thickness.

200 mg prolonged-release tablets are white to off-white, oblong-biconvex, debossed with “200” on one side, 15.2 mm in diameter and 7.7 mm in thickness.

300 mg prolonged-release tablets are white to off-white, oblong, biconvex, debossed with “300” on one side, 18.2 mm in diameter, and 8.2 mm in thickness.

400 mg prolonged-release tablets are white to off-white, oval biconvex, debossed with “400” on one side, 20.7 mm in diameter, and 10.2 mm in thickness.

Biquetan prolonged-release tablets are available as PVC / PCTFE-aluminum blisters packed in a carton.

Biquetane 50 mg: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 tablets.

Biquetane 150 mg, 200 mg, 300 mg, 400 mg: 10, 20, 30, 60, 90, 100, 120, 180 or 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

Bad Vilbel

Germany

Other manufacturers

Pharmathen International SA

Sapes Industrial Park Block 5

69300 Rodopi

Greece

Pharmathen SA

6, Dervenakion str.

153 51 Pallini, Attiki

Greece

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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