Consumer medicine information

Venlafaxine SR SCP

Venlafaxine Hydrochloride Modified Release Capsules

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Venlafaxine SR SCP modified release capsules. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist or asking questions.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Venlafaxine SR SCP against the expected benefits it will have for you.

If you have any questions about Venlafaxine SR SCP, ask your doctor or pharmacist.

Keep this leaflet with your Venlafaxine SR SCP modified release capsules. You may need to read it again.

What Venlafaxine SR SCP is for

The name of your medicine is Venlafaxine SR SCP. It contains the active ingredient called venlafaxine hydrochloride.

Venlafaxine SR SCP modified release capsules are used in the treatment and prevention of relapse of depression and panic attacks and in the treatment of anxiety, including avoidance or fear of social situations.

Depression can affect your whole body and may cause emotional and physical symptoms such as feeling low in spirit, being unable to enjoy life, poor appetite or overeating, disturbed sleep, loss of sex drive, lack of energy and feeling guilty over nothing.

Excessive anxiety is a condition in which you feel constantly and uncontrollably worried and distressed. It may also make you feel irritable, and cause difficulty in thinking and sleeping. Other common symptoms associated with anxiety may include a dry mouth, a lump in the throat, cold clammy hands, diarrhoea and nausea.

Depression and anxiety are treatable illnesses. Anxiety or tension associated with the normal stress of everyday life usually does not require treatment with medicines.

Venlafaxine SR SCP modified release capsules belong to a class of medications for depression and anxiety, called Serotonin-Noradrenaline Reuptake Inhibitors (SNRIs).

Serotonin and noradrenaline are chemical messengers that allow certain nerves in the brain to work. Venlafaxine SR SCP modified release capsules increase the level of these two messengers. Experts think this is how it helps to restore your feeling of wellness.

Venlafaxine SR SCP is not addictive.

Your doctor may have prescribed Venlafaxine SR SCP modified release capsules for another purpose. Ask your doctor if you have any questions about why Venlafaxine SR SCP modified release capsules has been prescribed for you.

Before you take Venlafaxine SR SCP

When you must not take Venlafaxine SR SCP

Do not take Venlafaxine SR SCP if you are taking other medications for depression known as monoamine oxidase inhibitors, even if you have stopped taking them now, but have taken them within the last 14 days.

Do not take Venlafaxine SR SCP if you are allergic to it or to any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction include:

Skin rash
Itching or hives on the skin
Swelling of the face, lips, tongue or other parts of the body
Shortness of breath, wheezing or troubled breathing.

Do not give Venlafaxine SR SCP to children or adolescents under 18 years of age. The safety and effectiveness of Venlafaxine SR SCP in this age group have not been established.

Do not use Venlafaxine SR SCP after the expiry date (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well as it should.

Do not use Venlafaxine SR SCP if the packaging is torn or shows signs of tampering.

Before you start to take Venlafaxine SR SCP

Tell your doctor or pharmacist if you have allergies to the active ingredient or any of the other ingredients listed at the end of this leaflet.

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Venlafaxine SR SCP is not recommended for use during pregnancy. Your doctor will discuss the risks and benefits of using Venlafaxine SR SCP if you are pregnant. One of these risks is that newborn babies whose mothers have been taking Venlafaxine SR SCP may have several problems including breathing difficulties, seizures and lack of oxygen in their blood.

Tell your doctor or pharmacist if you are breast-feeding or planning to breast-feed. Venlafaxine SR SCP passes into breast milk and there is a possibility that the breast-feed baby may be affected. For this reason, the use of Venlafaxine SR SCP is not recommended in breast-feeding women.

Tell your doctor if you have, or have had, any medical conditions, especially the following:

A history of fits (seizures or convulsions)
A personal history or family history of bipolar disorder
A history of aggression
Blood pressure problems
Glaucoma (increased pressure in the eye)
A tendency to bleed more than normal
Raised cholesterol levels
Problems with your kidneys or liver
Problems with your heart
Your doctor may wish to do some heart tests such as an electrocardiogram (ECG) or blood tests during treatment with Venlafaxine SR SCP.
Any other medical conditions.

Tell your doctor if you plan to have surgery.

If you have not told your doctor about any of the above, tell them before you take Venlafaxine SR SCP.

Taking other medicines

Tell your doctor or pharmacist if you take any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop, such as St Johns Wort or tryptophan supplements.

Do not start to take any other medicine while you are taking Venlafaxine SR SCP, unless it is prescribed or approved by your doctor.

Some medicines may interfere with Venlafaxine SR SCP or Venlafaxine SR SCP may interfere with these medicines. These include:

Medications for depression known as monoamine oxidase inhibitors (such as phenelzine and tranylcypromine), even if you have stopped taking them now, but have taken them within the last 14 days. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Any other medications for depression, anxiety, obsessive-compulsive disorder or premenstrual dysphoric disorder, including St John’s Wort
Haloperidol, risperidone, lithium or clozapine (used to treat mental disorders)
Tramadol (a pain killer)
Cimetidine (used to treat reflux and stomach ulcers)
Triptans (used to treat migraine)
Amiodarone or quinidine (used to treat irregular heart beats)
Your doctor may wish to do some heart tests such as an electrocardiogram (ECG) or blood tests if you are using either of these medicines whilst taking Venlafaxine SR SCP.
Warfarin (used to prevent blood clotting)
Indinavir (an antiviral)
Erythromycin and linezolid (used to treat infections)
Ketoconazole or fluconazole (used as antifungal medicines)
Medications for weight loss, including sibutramine
Metoprolol (used to treat high blood pressure or angina).

You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Venlafaxine SR SCP.

How to take Venlafaxine SR SCP

Swallow the modified release capsules whole with a glass of water or other non-alcoholic liquid. Do not divide, crush, chew or place the modified release capsules in water.

How much to take

The usual starting dose is 75 mg taken once daily. For panic attacks, treatment is usually started with a dose of 37.5 mg once daily for the first 4 to 7 days. After that time the dose should be increased to 75 mg once daily. If necessary, after two weeks, your doctor may increase your dose.

Do not change your dose unless your doctor tells you to.

If you have kidney or liver problems, you may need a lower dose of Venlafaxine SR SCP. If you have heart problems and your doctor wishes to increase your dose of Venlafaxine SR SCP, your doctor may first do some blood tests or heart tests such as an electrocardiogram (ECG).

When to take it

Venlafaxine SR SCP should be taken once daily with food, at approximately the same time each day.

This could be either in the morning or in the evening.

Avoid drinking alcohol while you are using Venlafaxine SR SCP.

How long to take Venlafaxine SR SCP

Although you may begin to feel better after two weeks, it may take several weeks before you feel much better. It is important to give Venlafaxine SR SCP time to work.

Even when you feel well again, you may need to keep taking Venlafaxine SR SCP for several months to make sure the benefits last. Discuss this with your doctor and don’t stop taking Venlafaxine SR SCP until gaining your doctor’s agreement.

If you forget to take Venlafaxine SR SCP

If it is less than 12 hours until your next dose, skip the dose you missed and then take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking as you would normally.

Do not take a double dose to make up for the dose you missed. Contact your doctor if you have missed more than two doses in a row.

Always finish the modified release capsules you are taking in the current pack before you start a new pack.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

It is important that you do not take more Venlafaxine SR SCP modified release capsules than your doctor has prescribed. If you do take more than you have been prescribed, contact your doctor immediately for advice.

If anyone accidentally swallows any Venlafaxine SR SCP modified release capsules, call your nearest Poisons Information Centre for advice (tel: 13 11 26), or go to Accident and Emergency at your nearest hospital. Keep the telephone number for these places handy whilst taking any medications.

If you take too many Venlafaxine SR SCP modified release capsules you may:

Feel sleepy
Vomit
Have an increased heart rate or changes in heart rhythm
Have a seizure (fits)
Have breathing difficulties
Become unconscious
Have dilated pupils.

While you are taking Venlafaxine SR SCP

Things you must do

Visit your doctor regularly for a check up. Always discuss any questions you have about Venlafaxine SR SCP modified release capsules with your doctor.

Take Venlafaxine SR SCP modified release capsules as your doctor has prescribed.

Keep enough Venlafaxine SR SCP modified release capsules to last weekends and holidays. You need a prescription from your doctor to get more Venlafaxine SR SCP modified release capsules.

Watch carefully for signs that your depression or anxiety is getting worse, especially in the first few weeks of treatment or if your dose has changed.

Sometimes people with depression can experience a worsening of their depressive symptoms. This can happen even when taking an antidepressant.

Information from clinical trials has suggested that children, adolescents, and young adults (18-24 years), particularly those with depression, may be at increased risk of suicidal behaviour (including suicide attempts) if treated with venlafaxine, especially during initial treatment.

Tell your doctor immediately if you experience any of the following symptoms, especially if they are severe, you have not had these symptoms before or they happen very suddenly.

Anxiety or agitation
Panic attacks
Difficulty sleeping
Irritability
Aggressiveness
Hostility or impulsiveness
Restlessness
Overactivity or uninhibited behaviour
Other unusual changes in behaviour
Thoughts of suicide.

Tell your doctor immediately if you have any thoughts about suicide or doing harm to yourself.

Warning signs of suicide
All thoughts or talk about suicide or violence are serious. If you or someone you know is showing the following warning signs, either contact your doctor or a mental health advisor right away or go to the nearest hospital for treatment:

Thoughts or talk about death or suicide
Thoughts or talk about self-harm or doing harm to others
Any recent attempts of self-harm
An increase in aggressive behaviour, irritability or agitation.

Things to be careful of

Venlafaxine SR SCP modified release capsules may make you feel drowsy. Be careful driving or operating dangerous machinery until you know how it affects you.

Things you must not do

Do not suddenly stop taking Venlafaxine SR SCP modified release capsules if you have been taking it for some time.

Check with your doctor for the best way to slowly reduce the amount of Venlafaxine SR SCP you are taking before stopping completely.

Side effects from stopping treatment with Venlafaxine SR SCP may include:

Headache
Nausea and vomiting
Dizziness
Insomnia
Nervousness
Anxiety
Confusion and agitation
Diarrhoea
Sweating
Loss of appetite
Impaired coordination and balance
Tingling or numbness of the hands and feet.

Slowly reducing the amount of Venlafaxine SR SCP being taken reduces the possibility of these effects occurring.

Some of these symptoms may impair driving, or the operation of dangerous machinery. These activities should be avoided if you experience these symptoms.

Do not give this medicine to anyone else even if they have the same condition as you.

Side effects

All medicines can have side effects. Sometimes they are serious; often they are not.

Tell your doctor if you develop any of the following side effects or if they become troublesome.

Stomach, bowel or urinary tract problems such as:

Nausea or vomiting
Loss of appetite
Diarrhoea
Constipation
Difficulty passing urine.

Changes in your behaviour such as:

Difficulty sleeping or abnormal dreams
Sexual function problems such as delayed ejaculation, problems with erection, decreased sex drive or difficulties achieving orgasm
Nervousness
Teeth grinding
Muscle tremors, spasms, twitching, jerky movements or sustained muscle contractions
Impaired coordination and balance
Abnormal facial movements such as tongue thrusting, repetitive chewing, jaw swinging, or grimacing
A feeling of apathy or not caring about things
Hallucinations
Agitation
Confusion
Unusually overactive.

Difficulty thinking or working because of:

Yawning
Feeling sedated or drowsy
Dizziness
Changes in muscle tone
Muscle weakness or fatigue
Restlessness or difficulty sitting still
Headache
Rapid heart beat
Problems with breathing
Heavy menstrual periods.

Changes in your appearance such as:

Sweating (including night sweats)
Hot flushes
Rash
Hair loss
Itchiness
Weight loss or weight gain
Flow of milk in women who are not breast-feeding
Bleeding or bruising more easily than normal.

In some people, Venlafaxine SR SCP may lead to changes in the way your blood clots.

Changes in your sight, hearing, taste or touch such as:

Blurred vision
Dilated pupils
Visual disturbances
Sensitivity to sunlight
Ringing in the ears
Dry mouth
Numbness or pins and needles.

Other changes you may not be aware of:

Increased blood pressure
Increase in blood cholesterol levels.

Tell your doctor immediately, or go to your nearest hospital if you notice any of the following:

Fits or seizures, which may be accompanied by a sudden fever
Signs of allergy such as rash or hives, swelling of the face, lips or tongue, wheezing or difficulty breathing
Symptoms of sudden fever with sweating, rapid heart beat and muscle stiffness, which may lead to loss of consciousness
Palpitations, fainting, shortness of breath or chest pain
Dark, red or cola coloured urine, muscle weakness and tenderness, stiffness or aching
Stomach pain, yellowing of the skin, nausea, fever, clammy skin and sweating
Yellowing of the skin or eyeballs, fever, fatigue, loss of appetite, dark coloured urine or light coloured bowel movements
Symptoms of a high fever, agitation, confusion, trembling and abrupt contractions of muscles
Signs of an infection such as severe chills, fever, sore throat and mouth ulcers.

These symptoms are usually rare but may be serious and need urgent medical attention.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

After using Venlafaxine SR SCP

Storage

Keep your Venlafaxine SR SCP modified release capsules in their blister pack until it is time to take them. The modified release capsules may not last as well if you take them out of the blister pack.

Keep Venlafaxine SR SCP modified release capsules in a cool dry place where the temperature stays below 25°C.

Do not store Venlafaxine SR SCP modified release capsules or any other medicine in the bathroom or near a sink. Do not leave Venlafaxine SR SCP modified release capsules in the car or on windowsills. Heat and dampness can destroy some medicines.

Keep Venlafaxine SR SCP modified release capsules and all medication where young children cannot reach it. A locked cupboard, at least one-and-a-half metres above the ground, is a good place to store medicines.

Disposal

Return any unused medicine to your pharmacist.

Product description

What Venlafaxine SR SCP looks like

There are three strengths of Venlafaxine SR SCP modified release capsules, containing 37.5 mg, 75 mg or 150 mg of venlafaxine in a modified release formulation, which allows for once-a-day dosing. The modified release capsules have the following appearance:

37.5 mg, grey cap/peach body with thick and thin radial circular bands on the cap and body in red ink.
75 mg, peach cap and body with thick and thin radial circular bands on the cap and body in red ink.
150 mg, dark orange cap and body with thick and thin radial circular bands on the cap and body in white ink.

Venlafaxine SR SCP 37.5 mg, 75 mg and 150 mg are available in blister packs containing 28 modified release capsules.

Ingredients

Venlafaxine SR SCP modified release capsules contain venlafaxine hydrochloride as the active ingredient.

Venlafaxine SR SCP 37.5 mg, 75 mg and 150 mg modified release capsules contain the following inactive ingredients:

Cellulose – microcrystalline
Povidone
Talc, purified
Silica – colloidal anhydrous
Magnesium stearate
Ethyl cellulose
Copovidone
Gelatin
Titanium dioxide.

In addition to these:

Venlafaxine SR SCP 37.5 mg modified release capsules also contain black iron oxide E172, red iron oxide E172, yellow iron oxide E172 and SB-1033 red ink;
Venlafaxine SR SCP 75 mg modified release capsules also contain black iron oxide E172, red iron oxide E172 and SB-1033 red ink;
Venlafaxine SR SCP 150 mg modified release capsules also contain Brilliant Blue FCF E 133, Allura Red AC E 129, Sunset Yellow FCF E 110 and SB-0007P white ink.

Venlafaxine SR SCP does not contain gluten, sucrose, tartrazine or any other azo dyes.

Sponsor

SC Pharma Pty Ltd
56 Illabunda Drive
Malua Bay NSW 2536

ACN 132 282 707

Date of Information:
May 2010

Australian Registration Numbers:
VENLAFAXINE SR SCP 37.5 mg: AUST R 160296
VENLAFAXINE SR SCP 75 mg: AUST R 160297
VENLAFAXINE SR SCP 150 mg: AUST R 160298

Published by MIMS May 2015