Venlor XR 37,5 mg/75 mg/150 mg/225 mg/300 mg Tablets

VENLOR XR TABLET contains the active ingredient called venlafaxine hydrochloride. VENLOR XR TABLET belongs to a class of medicine known as Serotonin and Norepinephrine Reuptake Inhibitors (SNRI) and it is used in the treatment of depression, including depression associated with anxiety. It is also used to prevent episodes of depression from reoccurring.

Do NOT take VENLOR XR TABLET:

• if you are hypersensitive (allergic) to venlafaxine hydrochloride or any of the other ingredients of VENLOR XR TABLET (listed in section 6)
• if you are currently being treated with medicines which fall under a class called monoamine oxidase inhibitors (such as moclobemide)
• if you have stopped taking a medicine which falls under the class of monoamine oxidase inhibitors in less than 14 days
• if you are less than 18 years of age
• if you are pregnant or breastfeeding.

Warnings and precautions

Take special care with VENLOR XR TABLET:

• if you have been diagnosed with major depressive disorder
• if you have been diagnosed with an eye condition called glaucoma
• if you have a heart condition
• if you have high blood pressure
• if you have a history of seizures (fits)
• if you have a history or family history of a mood disorder
• if you have a history of excessive anger
• if you are elderly
• if you have a tendency to bleed or bruise easily
• if you have been diagnosed with high cholesterol
• if you are diabetic.

Tell your doctor:

• if you develop symptoms such as an increase in heart rate, an abnormal increase in body temperature, feeling anxious, seeing things that are not there (hallucinations), nausea, vomiting and diarrhoea.

Do not share medicines prescribed for you with any other person. Always take VENLOR XR TABLET exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is 75 mg taken once daily. Your dose may be increased based on individual need. The maximum dose is 375 mg. The dose must be taken at approximately the same time each day, either in the morning or in the evening. Your doctor will tell you how long your treatment with VENLOR XR TABLET will last. If you have the impression that the effect of VENLOR XR TABLET is too strong or too weak, tell your doctor or pharmacist.

If you take more VENLOR XR TABLET than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Overdose of VENLOR XR TABLET is common in combination with alcohol or other medicines. An overdose of VENLOR XR TABLET may result in increased side effects and even death.

If you forget to take VENLOR XR TABLET

Do not take a double dose to make up for forgotten individual doses.

VENLOR XR TABLET can have side effects. Not all side effects reported for VENLOR XR TABLET are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VENLOR XR TABLET, please consult your health care provider for advice.

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

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• any heart related side effects such as chest pain.

These are all very serious side effects. If you have them, you may have had a serious reaction to VENLOR XR TABLET. 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:

• chest tightness, wheezing, trouble swallowing or breathing,
• life threatening irregular heartbeat, rapid or slow heartbeat,
• signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of co-ordination, fast heartbeat, palpitations, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting,
• unexplained muscle pain, tenderness or weakness, abnormal muscle breakdown which can lead to kidney problems,
• less urine than is normal for you,
• Stevens-Johnson syndrome or other serious skin disorders (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters),
• serious illness with blistering of the skin,
• abnormal bleeding of skin, eye, or stomach,
• thinking of killing yourself (suicidal ideation) and suicidal behaviour,
• having hallucinations (strange visions or sounds),
• high blood pressure or low blood pressure (feeling dizzy when standing up),
• seizures, convulsions (fits), shivering,
• inflammation of the liver (hepatitis), with symptoms such as fatigue, loss of appetite and muscle or joint ache,
• memory loss, impaired concentration,
• rise in pressure in your eyes.

These are all serious side effects. You may need urgent medical attention.

Store at or below 25 °C. Store all medicines out of reach of children. Store in the original container. Do not use after the expiry date stated on the outer carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).