Noptiquel XR 400 mg Prolonged-Release Tablets

NOPTIQUEL XR belongs to a group of medicines called antipsychotics. NOPTIQUEL XR can be used to treat several illnesses, such as schizophrenia, bipolar disorder and major depression. Ask your doctor if you are unsure why NOPTIQUEL XR has been prescribed for you.

Do not take NOPTIQUEL XR:

• if you are hypersensitive (allergic) to quetiapine or any of the other ingredients of NOPTIQUEL XR (listed in section 6);
• if you are elderly (above 65 years) and you have dementia (memory disorders, personality changes, and impaired reasoning) with changes in behaviour;
• if you are taking any of the following medicines:
• some medicines for HIV infection (examples are indinavir, nelfinavir, ritonavir);
• azole type of antifungal medicines (examples are ketoconazole, fluconazole, itraconazole);
• antibiotics for infections (examples are erythromycin or clarithromycin);
• nefazodone (for depression).

Warnings and precautions

Special care should be taken with NOPTIQUEL XR if you -

• have Alzheimer’s disease or dementia (loss of brain function). The group of medicines that NOPTIQUEL XR tablets belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia;
• have problems swallowing;
• have bowel obstruction or constipation;
• have been diagnosed with diabetes or have a family history of diabetes, as NOPTIQUEL XR may cause high blood sugar and diabetes mellitus (see section 4 – Possible side effects);
• have high blood cholesterol (fats in your blood), as NOPTIQUEL XR may also increase your blood fats;
• have low levels of white blood cells or neutropenia (an abnormally low level of neutrophils, a type of white blood cell). NOPTIQUEL XR may further decrease white blood cells. (White blood cells help the body to fight infection, therefore a low count will make you more susceptible to disease);
• have been diagnosed with heart rhythm disorders or heart failure (see section 4);
• have low blood pressure, as NOPTIQUEL XR may further reduce your blood pressure and may cause you to become dizzy and to fall;
• recently had a stroke or a heart attack;
• have a history of blood clots in your veins (or if someone else in your family has been diagnosed with thrombosis), as medicines like NOPTIQUEL XR have been associated with the formation of blood clots;
• have, or previously had, thoughts of harming or killing yourself at any time. Contact your doctor, or go to a hospital straight away if this is the case;
• have ever had a seizure (fit);
• have a history of sleep apnoea (temporary stopping of breathing);
• have a history of alcohol or substance abuse;
• take medicines such as carbamazepine, phenytoin or any of the medicines listed under “Other medicines and NOPTIQUEL XR”;
• have urinary retention;
• have an enlarged prostate;
• have narrow angle glaucoma or increased eye pressure;
• have a liver problem.

Tell your doctor if you develop the following disorders during treatment (see full list under section 4 (Possible side effects)):

• Weight gain, urinate frequently and feel thirsty. These could be signs that you have high blood sugar or diabetes mellitus. You and your doctor should check your weight regularly.
• Increased blood cholesterol (determined by blood tests).
• Pancreatitis (inflammation of the pancreas): some signs may be abdominal pain that radiates to your back, nausea and vomiting. See section 4.
• Problems with body temperature control: if you feel colder or warmer than usual or have an abnormal level of thyroid hormone in the blood.
• 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 NOPTIQUEL XR to be stopped and/or treatment to be given.
• Sleepiness and sedation.
• Feeling dizzy when getting up, as your blood pressure may be very low and you may fall.
• Fever, muscular rigidity and an altered mental status. These signs may point to neuroleptic malignant syndrome (NMS), which is a relatively rare but potentially fatal complication of the use of neuroleptic medicines such as NOPTIQUEL XR.
• Withdrawal symptoms: You may have withdrawal symptoms if you suddenly stop taking NOPTIQUEL XR. You should follow your doctor’s instructions. Withdrawal symptoms are listed under “If you stop taking NOPTIQUEL XR”.

Do not share medicines prescribed for you with any other person. Always take NOPTIQUEL XR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take your tablets once a day and swallow whole with a drink of water. Do not chew or crush the tablets. You may take NOPTIQUEL XR with or without food. The usual maintenance (daily) dose depends on your illness and needs but usually between 50 mg and 800 mg. Your doctor will decide on your starting dose, and which maintenance dose is suitable for you.

If you have liver problems your doctor may change your dose. If you are elderly, your doctor may change your dose. Your doctor will tell you how long your treatment with NOPTIQUEL XR will last. Do not stop taking NOPTIQUEL XR even if you are feeling better, unless your doctor tells you to stop. Do not drink grapefruit juice while you are taking NOPTIQUEL XR. It can affect the way the medicine works.

If you have the impression that NOPTIQUEL XR is too strong or too weak, you should talk to your doctor or pharmacist.

Use in children:

NOPTIQUEL XR should not be used by children and adolescents aged under 18 years.

If you take more NOPTIQUEL XR than you should

If you take more NOPTIQUEL XR than prescribed by your doctor, you may feel drowsy, sleepy, dizzy and experience abnormal heartbeats. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

If you forget to take NOPTIQUEL XR

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 forgotten individual doses.

If you stop taking NOPTIQUEL XR

If you suddenly stop taking NOPTIQUEL XR, you may have withdrawal symptoms. Some of these symptoms are feeling sick (nausea), trouble sleeping (insomnia), being sick (vomiting), headache, diarrhoea, dizziness or irritability. Your doctor may suggest that you reduce the dose gradually before stopping treatment.

NOPTIQUEL XR can have side effects. Not all side effects reported for NOPTIQUEL XR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NOPTIQUEL XR, please consult your healthcare provider for advice. If any of the following happens, stop taking NOPTIQUEL XR and contact your doctor immediately or go to the department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
• Severe skin reactions with swelling below the skin, red welts, burning, painful, itchy skin areas, rash, fever, blistering and peeling.
• Swelling, pain and redness in the leg (blood clots in the veins).
• Chest pain and difficulty in breathing (if a blood clot travels through the blood vessels to the lungs).
• Stroke (sudden numbness or weakness in the face, arm or leg, confusion, trouble seeing, dizziness).
• Severe abdominal pain, radiating to your back (pancreatitis).
• Painful and/or prolonged erection (priapism). These are all very serious side effects. If you have them, you may have had a serious reaction to NOPTIQUEL XR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately, or go to the casualty department at your nearest hospital if you notice the following:

• Wheezing and breathlessness, night sweats, skin rashes (blood tests may show excessive amounts of certain white blood cells (eosinophilia)).
• A low blood platelet count – you may get bruised easier and excessively, get purple spots in skin, have prolonged bleeding from cuts, spontaneous bleeding from nose or gums (thrombocytopenia).
• Sore throat, chills, fever and infections – you may have a severe reduction in the number of white blood cells. Your doctor will order blood tests and treat you suitably.
• Weight gain.
• Thinking about suicide.
• Tremor, twisting and repetitive movements or abnormal body posture, slurred speech, restlessness and stiff muscles.
• Fits (seizures), involuntary and abnormal movements, especially of the tongue, mouth and jaw, facial grimacing, rapid eye blinking and uncontrollable movements of arms, legs, fingers and toes.
• Fever, muscular rigidity, change in mental status and a malfunction of the autonomic nervous system (the nerves that control involuntary bodily functions may be damaged).
• Abdominal pain with inability to pass a stool (obstruction).
• Jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems).
• Inflammation of the liver (hepatitis). Signs may be nausea, vomiting, loss of appetite, abdominal pain, dark urine, light coloured stools and tiredness.
• Muscle pains, weakness, vomiting, and confusion (rhabdomyolysis).
• Inability to urinate.
• Unusual tiredness or weakness. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Urine infections (frequent urination with burning, chills).
• Increased appetite, weight gain.
• Abnormal dreams; nightmares.
• Sleepiness.
• Headache.
• Having problems to speak properly.
• Dizziness, low blood pressure when standing (orthostatic hypotension, which may result in dizziness or feeling faint). This could increase the risk of accidental injury (fall), especially in elderly patients.
• Quick heartbeat.
• Difficult breathing.
• Constipation, dry mouth, indigestion, vomiting.
• Withdrawal (discontinuation) symptoms (see “Warnings and precautions”).
• Swelling of legs and feet.
• Fever, decreased strength and energy, irritability.

Less frequent side effects:

• Weight gain, fatigue (underactive thyroid gland).
• High blood sugar, worsening of pre-existing diabetes.
• Sleepwalking, sleep talking.
• Sleep related eating disorder.
• Restless legs.
• Stiff, jerky movements and smacking of lips.
• Shaking, usually starting in a limb, often your hand or fingers.
• Fainting.
• Blurred or abnormal vision.
• Irregular heartbeat.
• Runny nose.
• Trouble with swallowing.
• Skin rash (allergic skin reaction).
• Swelling of breasts and unexpected secretion of milk.
• Sexual dysfunction.
• Menstrual disorder.
• Feeling cold.

Laboratory tests may show:

• Eosinophilia - an increase in one type of white blood cells, which is sometimes seen in allergic reactions.
• Decrease in the amount of white blood cells. These changes will normally disappear when stopping the treatment of NOPTIQUEL XR.
• Thrombocytopenia - a decrease in platelets, which are cells that help you stop bleeding if you get a cut.
• Increase in the amount of liver enzymes. These changes will normally disappear when continuing the treatment of NOPTIQUEL XR.
• Changes in the amount of fatty substances (lipid levels such as triglycerides and cholesterol) in the blood.
• Increase in the amount of “creatine phosphokinase” - a substance in the muscles.
• Increase in the amount of sugar (glucose) in the blood.
• Increase in the amount of hormone prolactin in the blood. Rarely this may lead to:
• men and women to have swelling of breasts and unexpectedly produce breastmilk.
• women to have no monthly period or irregular periods.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the SAHPRA website: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NOPTIQUEL XR.

Store all medicines out of reach of children. Store in the original packaging, at or below 30 °C. Keep the blisters in the carton until required for use. Keep the bottles tightly closed. Do not use NOPTIQUEL XR after the expiry date printed on the label, container or blister. Do not store your medicine in the bathroom. Return any expired or unused medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).