Bupyra XL Extended-Release Tablets

BUPYRA XL 150 contains 150 mg bupropion hydrochloride per extended release tablet. BUPYRA XL 300 contains 300 mg bupropion hydrochloride per extended release tablet. BUPYRA XL is a medicine prescribed by your doctor to treat your depression. It is thought to interact with chemicals in the brain called noradrenaline and dopamine, which are linked with depression.

Do not take BUPYRA XL:

• if you are hypersensitive (allergic) to bupropion hydrochloride or any of the other ingredients of BUPYRA XL
• if you are younger than 18 years of age
• if you have been diagnosed with epilepsy or have a history of seizures
• if you have a brain tumour
• if you are taking any other medicines which contain bupropion
• if you are usually a heavy drinker or taking any sedatives and recently stopped or plan to suddenly stop drinking or taking sedatives
• if you have an eating disorder, or used to (for example, bulimia or anorexia nervosa)
• if you are taking or have been taking other medicines for depression called monoamine oxidase inhibitors (MAOIs) in the last 14 days
• if you have severe liver problems
• if you are a female who has the potential to become pregnant and are not using any contraception.

Warnings and precautions:

Take special care with BUPYRA XL:

• if you have had a serious head injury or a history of head trauma
• if you have had a brain tumour
• if you have diabetes for which you use insulin or tablets
• if you are a heavy drinker or if you are using any sleeping pills (see also Do not take BUPYRA XL)
• BUPYRA XL has been shown to have an increased risk to cause fits (seizures). This side effect is more likely to occur in people from the groups listed above. If you have a fit during treatment you should stop taking BUPYRA XL. Do not take any more and see your doctor.
• if you have heart problems
• if you have a condition called Brugada syndrome (a rare hereditary syndrome that affects the heart rhythm) or if cardiac arrest or sudden death occurred in your family
• if you have severe liver problems
• if you have kidney problems
• if you are taking other medicines for depression, the use of these medicines together with BUPYRA XL can lead to serotonin syndrome, a potentially life-threatening condition (see Other medicines and BUPYRA XL in this section).

Thoughts of suicide and worsening of your depression:

If you are depressed, you can sometimes have thoughts of harming or killing yourself. These symptoms may worsen when BUPYRA XL treatment is started, since it takes time to work, or when your dosage is increased or decreased. You may be more likely to think like this:

• If you have previously had thoughts about killing or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

If you have a bipolar disorder (extreme mood swings), as BUPYRA XL could bring on an episode of this illness.

Do not share medicines prescribed for you with any other person. Always take BUPYRA XL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is 150 mg taken as a single daily dose. Your doctor may increase your dose to 300 mg every day if your depression does not improve after several weeks. Take your dose of BUPYRA XL tablets in the morning. Do not take BUPYRA XL more than once each day. The tablet is covered by a shell that slowly releases medicine inside your body. You may notice something in your stool that looks like a tablet. This is the empty shell passing from your body. You should swallow the tablet whole. The tablets should not be cut, crushed or chewed.

Your doctor will tell you how long your treatment with BUPYRA XL will last. It may take weeks or months of treatment for you to see any improvement in your symptoms and your symptoms might even worsen when BUPYRA XL is started. Do not stop treatment early.

If you have the impression that the effect of BUPYRA XL is too strong or too weak, tell your doctor or pharmacist.

If you take more BUPYRA XL than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison control centre. If you forget to take a dose of BUPYRA XL: Do not take a double dose to make up for forgotten individual doses. At least 24 hours should pass between each dose.

BUPYRA XL can have side effects. Not all side effects reported for BUPYRA XL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BUPYRA XL, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking BUPYRA XL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing and anaphylactic shock.
• Red skin or rash (like nettle rash), blisters or itchy lumps (hives) on the skin. Some skin rashes may need hospital treatment, especially if you also have a sore mouth or sore eyes. Pains in muscles or joints and fever have also been reported in association with rash and other symptoms suggestive of delayed hypersensitivity.
• Unusual wheezing or difficulty in breathing.
• Lupus skin rash or worsening of lupus symptoms (frequency not known - frequency cannot be estimated from the available data in people taking BUPYRA XL). Lupus is an immune system disorder affecting the skin and other organs. If you experience lupus flares, skin rash or lesions (particularly on sun-exposed areas) while taking BUPYRA XL, contact your doctor straight away, as it might be necessary to stop the treatment.
• Fainting.
• Yellowing of the skin and eyes, also called jaundice. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BUPYRA XL. 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 any of the following:

Less frequent:

• fast, strong and irregular heartbeat
• flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters that may affect the mouth and other parts of the body and can be life-threatening. These are all very serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• eating disorder (anorexia)
• difficulty in sleeping
• feeling agitated
• feelings of worry
• headache
• shakiness
• dizziness
• taste disturbance
• visual disturbances
• ringing in the ears (tinnitus)
• increase in blood pressure sometimes severe, flushing
• dry mouth
• feeling sick, vomiting
• stomach upset, stomach pain
• constipation
• sweating
• fever
• chest pain
• lack of energy

Less frequent side effects:

• weight loss
• blood glucose disturbances
• depression
• feeling confused
• unfriendliness
• feeling irritable
• restlessness
• seeing or hearing things that are not there (hallucinations)

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. BUPYRA XL 150: Store at or below 30 °C. BUPYRA XL 300: Store at or below 25 °C. Store in the original container in order to protect from moisture and light. Keep the bottle tightly closed. Shelf life: BUPYRA XL 150: Unopened: 2 years. After first opening: 2 months. BUPYRA XL 300: 3 years. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).