• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Biquelle XL is and what it is used for
2. What you need to know before you take Biquelle XL
3. How to take Biquelle XL
4. Possible side effects
5. How to store Biquelle XL
6. Contents of the pack and other information

• 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:
  • some medicines for HIV
  • azole medicines (for fungal infections)
  • erythromycin or clarithromycin (for infections)
  • nefazodone (for depression)

Do not take Biquelle XL if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Biquelle XL.

Talk to your doctor before taking Biquelle XL if:

• You have depression or other conditions that are treated with antidepressants. The use of these medicines together with Biquelle XL can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Biquelle XL”).
• You, or someone in your family, have or have had any heart problems, for example heart rhythm problems, weakening of the heart muscle or inflammation of the heart, or if you are taking any medicines that may have an impact on the way your heart beats.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• You have problems with your liver.
• You have ever had a fit (seizure).
• You have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood sugar levels while you are taking Biquelle XL.
• You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (loss of brain function). If you are, Biquelle XL should not be taken because the group of medicines that Biquelle XL belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
• You are an elderly person with Parkinson’s disease/parkinsonism.
• You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
• You have or have had a condition where you stop breathing for short periods during your normal nightly sleep (called “sleep apnoea”) and are taking medicines that slow down the normal activity of the brain (“depressants”).
• You have or have had a condition where you can’t completely empty your bladder (urinary retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside your eye. These conditions are sometimes caused by medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat certain medical conditions.
• If you have a history of alcohol or drug abuse.

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

• A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or a severe sense of feeling sleepy. This could increase the risk of accidental injury (fall) in elderly patients.
• Fits (seizures).
• A long-lasting and painful erection (priapism).
• Have a fast and irregular heartbeat, even when you are at rest, palpitations, breathing problems, chest pain or unexplained tiredness. Your doctor will need to check your heart and if necessary, refer you to a cardiologist immediately.

These conditions can be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

• A fever, flu-like symptoms, sore throat, or any other infection, as this could be a result of a very low white blood cell count, which may require Biquelle XL to be stopped and/or treatment to be given.
• Constipation along with persistent abdominal pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.
• Thoughts of suicide and worsening of your depression
  If you are depressed you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer. These thoughts may also be increased if you suddenly stop taking your medication. You may be more likely to think like this if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.
  If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Severe cutaneous adverse reactions (SCARs) which can be life threatening or fatal have been reported very rarely with treatment of this medicine. These are commonly manifested by:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.
• Toxic Epidermal Necrolysis (TEN), a more severe form causing extensive peeling of the skin.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) consists of flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes).

Stop using Biquelle XL if you develop these symptoms and contact your doctor or seek medical attention immediately.

Weight gain has been seen in patients taking Biquelle XL. You and your doctor should check your weight regularly.

Biquelle XL is not for use in children and adolescents below 18 years of age.

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

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

• Some medicines for HIV.
• Azole medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

In particular, tell your doctor if you are taking any of the following medicines:

• Epilepsy medicines (like phenytoin or carbamazepine).
• High blood pressure medicines.
• Barbiturates (for difficulty sleeping).
• Thioridazine or Lithium (other anti-psychotic medicines).
• Medicines that have an impact on the way your heart beats, for example, medicines that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (medicines to treat infections).
• Medicines that can cause constipation.
• Medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat certain medical conditions.
• Anti-depressants. These medicines may interact with Biquelle XL and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). Contact your doctor when experiencing such symptoms.

Before you stop taking any of your medicines, please talk to your doctor first.

• Biquelle XL can be affected by food and you should therefore take your tablets at least one hour before a meal or at bedtime.
• Be careful how much alcohol you drink. This is because the combined effect of Biquelle XL and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking Biquelle XL. It can affect the way the medicine works.

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 Biquelle XL during pregnancy unless this has been discussed with your doctor. Biquelle XL should not be taken if you are breast-feeding.

The following symptoms, which can represent withdrawal, may occur in newborn babies of mothers that have used Biquelle XL in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

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

If you are having a urine drug screen, taking Biquelle XL may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.

Biquelle XL contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

If you are elderly your doctor may change your dose.

Biquelle XL should not be used by children and adolescents aged under 18 years.

If you take more Biquelle XL than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heartbeats. You may also experience other symptoms including dry mouth, constipation and blurred vision. Contact your doctor or nearest hospital straight away. Take the Biquelle XL tablets with you.

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

If you suddenly stop taking Biquelle XL, you may be unable to sleep (insomnia) or you may feel sick (nausea) or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability.

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

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

The following side effects have been seen more often in children and adolescents or have not been seen in adults:

Very Common side effects

(may affect more than 1 in 10 people):

• Increase in the amount of a hormone called prolactin, in the blood. Increases in the hormone prolactin could in rare cases lead to the following:
  • Boys and girls to have swelling of breasts and unexpectedly produce breast milk.
  • Girls to have no monthly period or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
• Increase in blood pressure.

Common side effects

(may affect up to 1 in 10 people):

• Feeling weak, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritated.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is quetiapine. Biquelle XL tablets contain 600mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:
  Tablet core: lactose anhydrous, 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.

• The 600mg prolonged-release tablets are white to off white, oval biconvex and engraved with ‘600’ on one side and 22.7mm in length, 10.2mm in width and 8.1mm in thickness.
• Biquelle XL prolonged-release tablets are available as PVC/PCTFE- Aluminium foil blisters packed in a cardboard box.

Pack sizes:

Biquelle XL 600mg: 10, 30, 50, 56, 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer:

or