Exsira 50 mg Tablets

EXSIRA tablets are indicated for the treatment of major depressive disorder (MDD).

Do not use EXSIRA if:

• You are allergic to desvenlafaxine succinate or to any of the other ingredients of the EXSIRA formulation.
• You should not take EXSIRA together with other so-called MAO inhibitors (MAOI), a special group of anti-depressants. If you have been taking an MAOI then you should only start taking EXSIRA when there has been an interval of at least 14 days since you stopped taking the MAOI. If you stop taking EXSIRA you should wait at least 7 days before taking an MAOI. Serious reactions may occur, such as tremor, muscle twitching, sweating, nausea, vomiting, flushing (redness in the face), dizziness, elevated body temperature, seizures and death.
• You are less than 18 years of age.
• If you are pregnant or breastfeeding.

Take special care with EXSIRA if:

• Especially at the start of treatment and when the dose is altered, the doctor will observe whether there is deterioration in your symptoms.
• It has not been determined whether EXSIRA is safe and effective in children under the age of 18 years. There have been reports of hostile behaviour, suicidal tendencies and self-harm when medicines from the same group of medicines to which EXSIRA also belongs is used in children under 18 years of age.
• Mania has been reported in patients using EXSIRA. Therefore, EXSIRA should be used with caution, especially if you have a history or family history of mania.
• Serotonin syndrome, which is a potentially life-threatening medicine reaction that causes the body to have too much serotonin (a chemical produced by nerve cells) may occur. Symptoms may include: agitation, hallucinations, coma, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, loss of coordination, nausea, vomiting, diarrhoea. Serotonin syndrome most often occurs when two medicines that affect the body's level of serotonin are taken together at the same time. The medicines cause too much serotonin to be released or to remain in the brain area. Examples of medicines that cause this reaction when used together with EXSIRA are: triptans (migraine medicines) and antidepressant medicines such as selective serotonin reuptake inhibitors (SSRIs), selective serotonin/norepinephrine reuptake inhibitors (SSNRIs) and monoamine oxidase inhibitors (MAOIs). Tell your doctor if you think you are using any of these medications.
• Mydriasis (dilation of pupils) can occur when using EXSIRA. Therefore, patients with high internal pressure in the eyes or those with a high risk of narrow angle glaucoma (damage to the nerve of the eye) should be carefully monitored.

The following are precautions for use of EXSIRA to be discussed with your doctor if you have or have had any of the following:

• Your blood pressure can rise during treatment with EXSIRA, especially if you are taking high doses. It is therefore advisable to check your blood pressure at regular intervals.
• If you are elderly, your blood pressure may drop on standing up, causing you to feel dizzy or faint.
• If you have recently suffered a heart attack or suffer from a heart disease which has not been stabilised, special care is advised and the necessary dose for you should be especially carefully adjusted.
• Because high cholesterol levels can occur under long-term treatment with EXSIRA, cholesterol examinations should be taken into consideration.
• Please inform your doctor if you suffer or have previously suffered from seizures (especially epilepsy) because EXSIRA should then only be used with care.
• Withdrawal symptoms can occur after treatment with EXSIRA depending on the dose which has been taken and the duration of treatment, especially if the treatment is ended suddenly. It is recommended to end treatment by reducing the dose in steps.
• It is possible that there is increased risk of skin or mucous membrane bleeding during treatment with EXSIRA. Please inform your doctor if you know that you suffer from blood clotting disorders.
• Low sodium blood levels (hyponatraemia) and/or the so-called “syndrome of inappropriate ADH secretion” (SIADH) can occur under treatment with EXSIRA. When hyponatraemia is severe or acute in onset, symptoms of cerebral oedema occur (irritability, confusion, seizures and coma). Usually, patients are affected who have reduced quantities of circulating blood or whose bodies contain too little water, such as elderly patients or patients who are being treated with diuretics. Therefore special care is advised in dealing with these patients.
• Greater sensitivity to EXSIRA in older patients cannot be ruled out.

Taking EXSIRA with food and drink: You may take your daily dose of EXSIRA with or without food. You should avoid drinking alcohol while you are using EXSIRA.

Pregnancy and breastfeeding: If you are pregnant or breastfeeding your baby while taking EXSIRA, please consult your doctor, pharmacist or other healthcare professional for advice. You must not use EXSIRA if you are pregnant or breastfeeding. It has not been proven that EXSIRA is safe to use during pregnancy. If you are pregnant, or are planning to become pregnant, talk to your doctor before receiving EXSIRA. EXSIRA passes into breast milk in humans. Ask your doctor for advice before breastfeeding your baby.

Driving and using machinery: EXSIRA may lower the ability to react quickly and appropriately enough to unexpected or sudden events. Especially at the start of treatment and also if treatment is ended suddenly, you should allow for limitations in your capacity for judgement and reaction. Do not drive a car or other vehicle, do not operate any dangerous electrical tools or machines until you are sure that EXSIRA does not impair your reaction capacity. Especially bear in mind that alcohol and other sedatives can additionally impair your reaction capacity.

Using other medicines with EXSIRA: If you are taking medicines on a regular basis, including complementary or traditional medicines, the use of EXSIRA with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional for advice. Always tell your doctor if you are taking any other medicines, including medicines you buy without a prescription.

Always take EXSIRA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

EXSIRA should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved. The recommended dose for EXSIRA is 50 mg once daily, with or without food. Your doctor may increase the dose slowly at an interval of not less than 7 days, up to a maximum daily dose of 100 mg.

Children: Safety and effectiveness in children under 18 years of age has not been established.

Patients with kidney problems: Care should be taken when treating patients with severe renal impairment and end stage renal disease with EXSIRA. You should inform your doctor if you have or have had renal disease. Depending on the condition of your kidneys, your doctor may reduce the dose to avoid potential side effects. The reduction in kidney function should also be taken into consideration when you are elderly.

Patients with impaired liver function: No dosage adjustment is necessary for patients with liver impairment.

If you take more EXSIRA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you missed a dose of EXSIRA: If you are concerned that you may have missed a dose, talk to your doctor or nurse immediately. Do not take a double dose to make up for forgotten individual doses.

Effects when treatment with EXSIRA is stopped: If your doctor decides treatment with EXSIRA should be stopped, it will be done by gradually reducing the dose rather than abruptly stopping treatment so that the occurrence of withdrawal symptoms is minimised.

Switching from other antidepressants: If you are already using an antidepressant medicine prescribed by your doctor, you may experience side effects when discontinuing it in order to switch to EXSIRA. Your doctor may gradually reduce the dose of your current antidepressant medication to help to reduce these side effects.

EXSIRA can have side effects. Not all side effects reported for EXSIRA are included in this leaflet. Should your general health worsen while taking EXSIRA, please consult your doctor, pharmacist or other health care professional for advice.

Frequent side effects are:

• Increased and/or irregular heartbeat, increased blood pressure
• Tinnitus (ringing or buzzing in ears)
• Blurred vision, mydriasis (dilation of pupils)
• Nausea, dry mouth, constipation, diarrhoea, vomiting
• Fatigue, chills, lack of energy, feeling jittery, irritability
• Weight gain, weight loss
• Decreased appetite
• Stiffness of the muscles and bones
• Dizziness, headache, sleepiness/sedation, tremor, paraesthesia (‘pins and needles’), taste loss, disturbance in attention
• Insomnia (sleeplessness), anxiety, abnormal dreams, nervousness, decreased sex drive, inability to orgasm
• Erectile dysfunction or failure, delayed ejaculation (male)
• Yawning
• Excessive sweating, rash
• Hot flush

Less common side effects are:

• Allergic reaction
• Increased cholesterol, abnormal liver function tests, increased blood prolactin (prolactin is a hormone released by the pituitary gland that stimulates breast development and milk production)
• Low levels of sodium in the blood
• Syncope (fainting), convulsion, dystonia (sustained muscle contractions cause twisting and repetitive movements or abnormal postures)
• Withdrawal syndrome, abnormal orgasm, depersonalisation (feeling disconnected or detached from one’s body and thoughts)
• Hypomania (feeling overexcited, euphoric or overly irritable), hallucinations
• Difficulty starting or maintaining a urine stream, proteinuria
• Abnormal ejaculation (males), abnormal sexual function
• Epistaxis (nosebleeds)
• Alopecia (hair loss)
• Photosensitivity (sun allergy)
• Angioedema (swelling of the body usually due to an allergic reaction)
• Stevens-Johnson syndrome (an extremely serious allergic skin reaction)
• Orthostatic hypotension (drop in blood pressure when standing up), especially in the elderly
• Cold hands and feet

Store at or below 25 °C. Store all medicines out of reach of children. Keep well closed. Do not remove blister card from the carton until required for use. Protect from light and moisture. Do not store in the bathroom. Do not use after the expiry stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems e.g. the toilet.