Venlafaxine 37.5 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Venlafaxine 37.5 mg Film-coated Tablets Venlafaxine 75 mg Film-coated Tablets
Important things you need to know about venlafaxine
• Venlafaxine is for depression
• Venlafaxine should not be given to anyone under 18 years of age- see Section 2 ‘Use in children and adolescents under 18 years of age’
• Venlafaxine may not work straight away. After you start treatment, you may feel worse before you feel better. It may take between two and four weeks before you start to feel better. Your doctor may ask to see you again a couple of weeks and after you start treatment and then regularly until you start to feel well again. Tell your doctor if you do not start to feel better - see Section 2 ‘You may feel worse before you feel better’.
• Some people who are depressed may think of harming or killing themselves. If you have these thoughts at any time, tell your doctor or go to a hospital straight away - see Section 2 ‘Thoughts of suicide and worsening of your depression or anxiety disorder’
• If you have taken too many tablets tell your doctor or go to a hospital straight away. Do this even if you feel well. This is because taking too much of this medicine can be dangerous
• Do not stop taking your tablets or change the amount you take without checking with your doctor first. Keep taking them even if you feel better. If you stop taking venlafaxine suddenly you may get withdrawal reactions - see Section 3 ‘If you stop taking venlafaxine tablets’
• Taking some other medicines with venlafaxine may cause problems. Tell your doctor if you are taking or have recently taken any other medicines - see Section 2 ‘Taking other medicines’
• Tell your doctor straight away if you feel restless and can’t keep still, feel ‘high’ or over-excited or have jerky muscle movements which you can’t control - see Section 4 ‘Possible side effects’
• If you have problems with your heart or have high blood pressure, talk to your doctor before taking venlafaxine - see Section 2 'Take special care with venlafaxine tablets’
• If you are pregnant, planning to become pregnant, or are breast-feeding, talk to your doctor before taking venlafaxine - see section 2 ‘Pregnancy and Breast-feeding’
There is more information on all of these points in the rest of this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
• What Venlafaxine Tablets are and what they are used for
• Before you take Venlafaxine Tablets
• How to take Venlafaxine Tablets
• Possible side effects
• How to store Venlafaxine Tablets
• Further information
1. WHAT VENLAFAXINE TABLETS ARE AND WHAT THEY ARE USED FOR
Venlafaxine is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions, such as anxiety disorders. 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 is a treatment for adults with depression. Treating depression properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
2. BEFORE YOU TAKE VENLAFAXINE TABLETS
Do not take Venlafaxine Tablets
• If you are allergic to venlafaxine or any of the other ingredients of Venlafaxine Tablets.
• If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with other medicines, including Venlafaxine Tablets, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine Tablets before you take any irreversible MAOI (see also the “Taking other medicines” section and the information in that section about 'Serotonin syndrome'.).
Take special care with Venlafaxine Tablets
• If you use other medicines that taken concomitantly with Venlafaxine Tablets could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
• 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.
• 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 your cholesterol levels 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 are diabetic.
Venlafaxine Tablets may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before taking Venlafaxine Tablets.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) 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.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
You may feel worse before you feel better
Venlafaxine may not work straight away. After you start treatment you may feel worse before you feel better. It may take between two and four weeks before you start to feel better. Your doctor may ask to see you again a couple of weeks after you start treatment and then regularly until you start to feel well again. Tell your doctor if you do not start to feel better.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.
Use in children and adolescents under 18 years of age
Venlafaxine Tablets should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Venlafaxine Tablets for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Venlafaxine Tablets for a patient under 18, and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Venlafaxine Tablets. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Venlafaxine Tablets in this age group has not yet been demonstrated.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Your doctor should decide whether you can take Venlafaxine Tablets with other medicines.
Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
• Monoamine oxidase inhibitors (MAOIs: see the section “Before you take Venlafaxine Tablets”).
Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines. Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Products containing St. John’s Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting. Get medical care right away if you think serotonin syndrome is happening to you.
The following medicines may also interact with Venlafaxine Tablets and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Taking Venlafaxine Tablets with food and drink
Venlafaxine Tablets should be taken with food (see section 3 “HOW TO TAKE VENLAFAXINE TABLETS”).
You should avoid alcohol while you are taking Venlafaxine Tablets.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Venlafaxine Tablets only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
If you are taking Venlafaxine Tablets during pregnancy, let your midwife and/or doctor know as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include not feeding properly and trouble with breathing. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.
Make sure your midwife and/or doctor know you are on Venlafaxine Tablets. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Venlafaxine Tablets.
Driving and using machines
Do not drive or use any tools or machines until you know how Venlafaxine affects you.
Important information about some of the ingredients of Venlafaxine Tablets
Venlafaxine Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Also contains Sunset Yellow (E110) which may cause allergic reactions.
3. HOW TO TAKE VENLAFAXINE TABLETS
Always take Venlafaxine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose is 75 mg per day in divided doses, two or three times a day. The dose can be raised by your doctor gradually and, if needed, even up to a maximum dose of 375 mg daily for depression.
Take Venlafaxine Tablets at approximately the same time each day, in the morning and in the evening.
Venlafaxine Tablets should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Venlafaxine Tablets may need to be different.
Do not stop taking Venlafaxine Tablets without talking to your doctor (see the section “If you stop taking Venlafaxine Tablets”).
If you take more Venlafaxine Tablets than you should
Call your doctor or pharmacist immediately if you take more than the amount of Venlafaxine Tablets prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Venlafaxine Tablets
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than the daily amount of Venlafaxine Tablets that has been prescribed for you in one day.
If you stop taking Venlafaxine Tablets
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Venlafaxine Tablets, he/she may ask you to reduce your dose slowly, before stopping treatment altogether.
Side effects are known to occur when people stop using Venlafaxine Tablets, especially when Venlafaxine Tablets are stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness and/or a “spinning” sensation, light-headedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely, electric shock sensations, weakness, sweating, seizures or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue Venlafaxine Tablets treatment.
If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Venlafaxine Tablets can cause side effects, although not everybody gets them.
Allergic reactions
If any of the following happen, do not take more Venlafaxine Tablets. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch) Serious side effects
If you notice any signs of the following, you may need urgent medical attention:
• Heart problems, such as fast or irregular heart rate, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria
• Treatment withdrawal (see the section “HOW TO TAKE VENLAFAXINE TABLETS, If you stop taking Venlafaxine Tablets”)
Complete side effect listing
Very common (Affects more than 1 user in 10)
• dry mouth, headache
• nausea
• sweating (including night sweats)
Common (Affects 1 to 10 users in 100)
• weight loss, increased cholesterol
• abnormal dreams; decreased libido; dizziness; increased muscle tonus; insomnia; nervousness; pins and needles; sedation; tremor; confusion; feeling separated (or detached) from yourself and reality
• blurred vision
• increase in blood pressure; flushing; palpitations
• Yawning
• appetite decreased; constipation; vomiting
• difficulties passing urine; increased frequency in urination
• abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding
• weakness (asthenia); chills
Uncommon (Affects 1 to 10 users in 1,000)
• bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding
• weight gain
• lack of feeling or emotion; hallucinations; involuntary movement of the muscles; agitation; impaired coordination and balance
• altered taste sensation; ringing in the ears (tinnitus)
• feeling dizzy (particularly when standing up too quickly), fainting,
• fast heartbeat
• grinding of the teeth; diarrhoea
• rash; abnormal hair loss
• inability to pass urine
• abnormal orgasm (females)
• sensitivity to sunlight
• serious allergic reaction which causes swelling of the face or throat (angioedema)
Rare (Affects 1 to 10 users in 10,000)_
• a sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling over-excited or euphoric
• loss of bladder control (urinary incontinence)
Not known (Frequency cannot be estimated from the available data)
• reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection
• slight changes in blood levels of liver enzymes; decrease in blood sodium levels; itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); confusion, excessive water intake (known as SIADH); abnormal breast milk production
• 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; disorientation and confusion often accompanied by hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of harming or killing yourself
• severe eye pain and decreased or blurred vision
• decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting
• coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)
• severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• a feeling of dizziness or “spinning” (vertigo)
• aggressive behaviour
Venlafaxine Tablets sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol. More rarely, Venlafaxine Tablets may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Venlafaxine Tablets for a long time.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE VENLAFAXINE TABLETS
Keep out of the reach and sight of children.
Do not use Venlafaxine Tablets after the expiry date, which is stated on the packaging.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Venlafaxine Tablets contain
The active substance is venlafaxine hydrochloride.
Each tablet contains 37.5 mg or 75mg of venlafaxine.
The other ingredients are lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, povidone K30, magnesium stearate, hypromellose 6cP, titanium dioxide (E171), macrogol/PEG 400, sunset yellow FCF lake (E110), Talc.
What Venlafaxine Tablets look like and contents of the pack
Venlafaxine 37.5 mg tablets are orange, round, biconvex, film-coated tablets, marked with V2.
Venlafaxine 75 mg tablets are orange, round, biconvex, film-coated tablets, marked with V4 with a scoreline.
Venlafaxine Tablets come in pack sizes of: 14, 28, 30, 42 and 56 film-coated tablets, packed into blister packs or plastic containers.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing,
London W5 5TL
Manufacturer:
Actavis hf, Reykjavikurvegur 78, 220 Hafnarfjordur, Iceland. This leaflet was last updated in January 2012