VENLAFAXINE MEDI

SCHEDULING STATUS S5

PRODUCT NAME, STRENGTH AND PHARMACEUTICAL FORM

VENLAFAXINE 37,5 MEDI (EXTENDED RELEASE CAPSULE) – contains venlafaxine hydrochloride equivalent to 37,5 mg venlafaxine base.

VENLAFAXINE 75 MEDI (EXTENDED RELEASE CAPSULE) – contains venlafaxine hydrochloride equivalent to 75 mg venlafaxine base.

VENLAFAXINE 150 MEDI (EXTENDED RELEASE CAPSULE) – contains venlafaxine hydrochloride equivalent to 150 mg venlafaxine base.

WHAT VENLAFAXINE MEDI IS AND WHAT IT IS USED FOR

VENLAFAXINE MEDI is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicine is used to treat depression and anxiety disorders in adults. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain. VENLAFAXINE MEDI tablets are used to treat adults with depression. Treating depression properly is important. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENLAFAXINE MEDI Do not take VENLAFAXINE MEDI:

• If you are allergic to venlafaxine or to any of the other ingredients in VENLAFAXINE MEDI (listed in Section 6)
• If you are taking or have recently taken (within the last two weeks) another antidepressant medicine known as a monoamine oxidase inhibitor (MAOI)
• If you are under 18 years of age
• If you are pregnant or breastfeeding

Warnings and precautions

Take Special Care with VENLAFAXINE MEDI:

• When using other medicines that when taken concomitantly with venlafaxine tablets could increase the risk of developing serotonin syndrome or neuroleptic malignant syndrome (this is a reaction to antipsychotic medicines that is marked by fever, muscle stiffness, fast heartbeat, irregular breathing and altered mental state).
• If you are depressed or have anxiety, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, as these medicines will take some time to work. If you have thoughts of harming or killing yourself, contact your doctor or go to a hospital immediately.
• You may find it helpful to tell a relative or friend and have them read this leaflet.
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure or if you have high blood pressure which is not properly controlled.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding.
• If you have high cholesterol levels or they get higher.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.
• If you have diabetes, treatment with VENLAFAXINE MEDI may alter your sugar levels and therefore the dose of insulin or oral antidiabetic may need to be adjusted.
• If you have had serious problems with your heart rhythm.
• If you have moderate or severe heart failure.
• You may within the first few weeks of treatment with VENLAFAXINE MEDI experience unpleasant restlessness which is accompanied by inability to sit or stand still. Inform you doctor or health care provider as increasing the dose of VENLAFAXINE MEDI can be fatal.
• If you experience dry mouth when using VENLAFAXINE MEDI; this may increase the risk of caries and therefore it is important to maintain good oral hygiene.
• You may get a false positive urine test for phencyclidine (PCP) and amphetamine when taking VENLAFAXINE MEDI and several days after stopping therapy.

HOW TO TAKE VENLAFAXINE MEDI

Do not share medicines prescribed for you with any other person.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual recommended dose for VENLAFAXINE MEDI is 75 mg, given once daily. If required, your doctor may increase your dose to 150 mg, given once daily. If needed, the dose can be further increased up to 225 mg given once daily. Dose increases have to be done gradually and your doctor will explain how to do this.

It is recommended that VENLAFAXINE MEDI be taken with food. Each capsule should be swallowed whole with fluid. Do not divide, crush, chew or place the capsule in water. VENLAFAXINE MEDI should be administered once daily, at approximately the same time either in the morning or in the evening.

If you take more VENLAFAXINE MEDI than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you take too many capsules you must seek immediate medical attention, even if you feel well, because of the risk of serious side effects. Remember to take the packet with you, even if it is empty.

If you forget to take VENLAFAXINE MEDI

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

Do not be concerned if you forget to take a capsule. You can take it up to 12 hours after you usually take it; then take your next capsule at the usual time. If the period after the missed dose is more than 12 hours, you should miss the dose altogether and just take your next capsule at the usual time.

If you stop taking VENLAFAXINE MEDI

Do not stop taking VENLAFAXINE MEDI or change the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need VENLAFAXINE MEDI he/she will ask you to reduce your dose slowly before stopping treatment altogether. This should help reduce the chance of withdrawal symptoms. If VENLAFAXINE MEDI is stopped suddenly or the dose reduced too quickly, some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, feeling or being sick, diarrhoea, nervousness, agitation, confusion, tinnitus (ringing in the ears), tingling or rarely electric shock sensations, weakness, poor co-ordination, tremor, sweating or seizures.
If you experience any of these or other symptoms which are troublesome, return to your doctor for further advice.

Possible Side Effects

VENLAFAXINE MEDI can have side-effects.

Not all side effects reported for VENLAFAXINE MEDI are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VENLAFAXINE MEDI, please consult your doctor, pharmacist or other health care professional for advice.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Swollen face or tongue, or shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)

These are very serious side effects. If you have them, you may have had a serious reaction to

VENLAFAXINE MEDI. 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:

• Seizures, fits or convulsions
• Severe muscle tenderness, stiffness or weakness, especially if accompanied by dark urine (this can be caused by muscle breakdown leading to kidney problems – ‘rhabdomyolysis’)
• Black tarry stools (faeces), which can be a sign of internal bleeding
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• A high temperature with rigid muscles, confusion or agitation, and sweating or if you experience jerky muscle movements which you can’t control. These may be symptoms of serious conditions known as neuroleptic malignant syndrome
• Euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonergic syndrome
• Frequent or unusual bruising or bleeding, such as nose bleeds (this could indicate that VENLAFAXINE MEDI has had an effect on your blood, and this may need to be tested)
• Feeling ‘high’ or very over-excited (mania or hypomania)
• Rapid or irregular heartbeat, flushing or faintings.

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

Tell your doctor if you notice any of the following:

Frequent side effects:

• Feeling sick, vomiting, decreased appetite, constipation, abdominal pain.
• Headache, unusual tiredness or weakness, sweating (including night sweats), dizziness, dry mouth, difficulty sleeping or drowsiness, nervousness.
• Change in sexual function e.g. abnormal ejaculation in men, lack of orgasm
• Palpitations.
• Abnormal dreams.
• Tremor, stiff muscles.
• Strange feeling on the skin such as “pins and needles” or burning.
• Feeling the need to go to the toilet more often than usual.
• Reduced sex drive, impotence.
• Blurred vision or other changes in your vision, tinnitus (ringing in the ears).
• Yawning.
• Chest pain.
• Weight loss.
• Increased cholesterol levels in the blood (particularly with prolonged administration and possibly with higher doses).
• Increased blood pressure.
• Hot flashes/flushes.

Less frequent side effects:

• Weight gain.
• Muscle spasm.
• Hallucinations.
• Difficulty in urinating.
• Increased sensitivity of your skin to sunlight.
• Altered taste sensation.
• Feeling dizzy or unsteady on standing due to a fall in blood pressure (especially for elderly patients).
• Skin rash
• Apathy

Side effects that have an unknown frequency

• Thoughts of harming or killing yourself.
• Severe skin rash which may lead to blistering and peeling of the skin.
• Steven- Johnson syndrome a rare serious disorder of the skin and mucous membranes.
• Itching, a rash of round welts.
• Itchiness, yellow skin or eyes, dark urine or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis).
• Agitation, disorientation, confusion often accompanied by hallucination (delirium), feeling aggressive or having aggressive thoughts – this is more likely at the start of, and after stopping treatment.
• Feeling of restlessness or if you feel unable to sit or stand still.
• Rarely clumsiness or loss of balance, total or partial loss of sensation in part of the body.
• Depression, emotional lability, abnormal thinking.
• Sore muscles.
• Chills.
• Diarrhoea, indigestion, belching, gas.
• Menstrual disturbances in women.
• Loss of bladder control.
• Abnormal breast milk production.
• Appetite increase.
• Clenching or grinding of teeth.
• Decreased blood pressure.
• Abnormal liver function tests.
• Low levels of sodium in the blood.
• An increased number of white blood cells in the lungs (a breathing disorder called pulmonary eosinophilia).
• Sore throat, runny nose.
• A skin disorder characterised by bull’s-eye-shaped lesions.
• Abnormal hair loss.

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 or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse drug Reaction reporting Form”, found online under SAHPRA’s publications : https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VENLAFAXINE MEDI

HOW TO STORE VENLAFAXINE MEDI

KEEP OUT OF REACH OF CHILDREN

Any unused medicine or waste material should be returned to the pharmacy for destruction. Do not dispose of unused medicine in drains or sewerage systems (e.g toilets).

CONTENTS OF THE PACK AND OTHER INFORMATION

What VENLAFAXINE MEDI contains:

The active ingredient in VENLAFAXINE MEDI is venlafaxine

The other ingredients include: copovidone, colloidal silicon dioxide, ethyl cellulose microcrystalline cellulose, magnesium stearate, povidone, talc

What VENLAFAXINE MEDI looks like and contents of the pack:

VENLAFAXINE 37,5 MEDI:

Light grey opaque / peach opaque, size ‘3’ hard gelatin capsules having thick and thin radial circular band on the body in red ink and thick and thin radial circular band on the cap in red ink. The capsule is filled with 3 white to off-white, round, biconvex, film coated mini tablets of 12,5 mg each.

VENLAFAXINE 75 MEDI:

Peach opaque / peach opaque, size ‘1’ hard gelatin capsules having thick and thin radial circular band on the body in red ink and thick and thin radial circular band on the cap in red ink. The capsule is filled with 6 white to off-white, round, biconvex, film coated mini tablets of 12,5 mg each.

VENLAFAXINE 150 MEDI:

Dark orange / dark orange opaque, size ‘0’ hard gelatin capsules having thick and thin radial circular band on the body in white ink and thick and thin radial circular band on the cap in white ink. The capsule is filled with 12 white to off-white, round, biconvex, film coated mini tablets of 12,5 mg each.
VENLAFAXINE MEDI is packed in blister packs of unprinted aluminium foil and white opaque PVC/PVdC film. Such blisters are packed into a carton of 30 capsules, along with a package insert.

HOLDER OF CERTIFICATE OF REGISTRATION

Epiglo Pharmaceuticals (Pty) Ltd
Allandale Building First Floor
23 Magwa Crescent
Waterfall City
Gauteng
1685

THIS LEAFLET WAS REVISED IN

01/06/2021

REGISTRATION NUMBER

VENLAFAXINE 37,5 MEDI – 48/1.2/1328 VENLAFAXINE 75 MEDI – 48/1.2/1329 VENLAFAXINE 150 MEDI – 48/1.2/1330

Access to the corresponding Professional information.

A copy of the professional Information is contained in the packaging of VENLAFAXINE MEDI.