Venlafaxine 37.5 Mg Tablets
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Venlafaxine 37.5 mg Tablets Venlafaxine 75 mg Tablets
Venlafaxine Hydrochloride
Important things you need to know about Venlafaxine
• Venlafaxine is used to treat depression
• Venlafaxine should not be given to anyone under 18 years of age-see in 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 to four weeks before you start feeling better. Tell your doctor if you do not 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 in section 2 'Thoughts of suicide and worsening of your depression or anxiety disorder'
• If you have taken too many tablets it is important to seek immediate medical attention, even if you feel well, because of the risk of serious side effects.
• 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 in 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 in 'Other medicines and Venlafaxine Tablets'
• 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 in section 2 'What you need to know before you take 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 this entire 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, See section 4.
What is in this leaflet:
1. What Venlafaxine Tablets are and what they are used for
2. What you need to know before you take Venlafaxine Tablets
3. How to take Venlafaxine Tablets
4. Possible side effects
5. How to store Venlafaxine Tablets
6. Contents of the pack and other information_
1. What Venlafaxine Tablets are and what they are used for
Venlafaxine Tablets contain Venlafaxine Hydrochloride as the active ingredient. Venlafaxine belongs to the class of medicines called "antidepressants" which are used to relieve the symptoms of depressive illness and any associated anxiety. People who are depressed may have lower levels than usual of substances called "serotonin" and "noradrenaline" in their brain. While it is not fully understood how anti-depressants work, Venlafaxine may help by increasing the levels of these substances in your brain.
2. What you need to know before you take Venlafaxine Tablets Do not take Venlafaxine tablets if
• you are allergic to venlafaxine or any of the other ingredients of this medicine (see section 6)
• you are also taking, or have taken 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 Venlafaxine can cause serious or even life- threatening side effects. Also you must wait at least one week after you stop taking Venlafaxine tablets before you can take an MAOI.
Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine if you:
• use other medicines that taken together with Venlafaxine could increase the risk of developing serotonin syndrome (see the section "Other medicines and Venlafaxine tablets").
• have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• have a history of high blood pressure.
• have a history of heart problems.
• have a history of fits (seizures).
• have a history of low sodium levels in your blood (hyponatraemia).
• 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 e.g. warfarin (used to prevent blood clots).
• have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• have a history of aggressive behaviour.
Venlafaxine may cause a sensation of restlessness or an inability to sit or stand still during the first few weeks of treatment. You should tell your doctor if this happens to you. If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
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 first starting 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 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.
Dry mouth
Dry mouth is reported in 1 in 10 patients treated with Venlafaxine. This may increase the risk of tooth decay (dental caries). Therefore, you should take special care with your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venlafaxine. Therefore, the dosage of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Venlafaxine 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 for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Venlafaxine 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. Also, the long-term safety concerning growth, maturation and development of the brain in this age group have not yet been demonstrated.
Other medicines and Venlafaxine Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Venlafaxine can affect the way some other medicines work. Also, some other medicines can affect the way Venlafaxine works.
Do not start or stop taking any medicines, before checking with your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson's disease must not be taken with Venlafaxine. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see section 2).
• Serotonin syndrome:
A potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions (see the section "Possible Side Effects"), may occur with venlafaxine treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Medicines for migraine such as sumatriptan (triptans)
• Medicines for depression such as SNRI, SSRIs, tricyclics, or medicines containing lithium
• Antibiotics, such as linezolid, used to treat infections
• Medicines used to treat depression such as moclobemide (called reversible MAOIs)
• Medicines to help with weight loss such as sibutramine
• Medicines containing dextromethorphan (used to treat coughing)
• Medicines containing methadone (used to treat opioid drug addiction or severe pain)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
• 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)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming withdrawn)
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, nausea, coma, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Get medical care straight away if you think this is happening to you. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Venlafaxine.
The following medicines may also interact with Venlafaxine and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
• Ketoconazole (to treat fungal infections)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems) Venlafaxine Tablets with food and drink
• Take Venlafaxine with food (see section 3)
• You should avoid alcohol while you are taking Venlafaxine Tablets.
Pregnancy
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Venlafaxine only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
If you are taking this medicine and you find out that you are pregnant, 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.
If you are taking this medicine during pregnancy, other symptoms your baby might have when it is born is not feeding properly, in addition to having trouble 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.
Breast-feeding
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 this medicine.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
Make sure your judgement or coordination is not affected before you drive or use machinery.
VENLAFAXINE HYDROCHLORIDE SAME SIZE ARTWORK 480 mm x 140 mm
Do not drive or use any tools or machines until you know how this medicine affects you. Venlafaxine Tablets contain Lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking these tablets.
| 3. How to take Venlafaxine Tablets |
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults aged 18 years and over
The usual recommended starting dose is 75mg per day in divided doses, two or three times a day. If needed, your doctor may increase the dose gradually up to a maximum of 375mg daily.
If you have liver or kidney problems, talk to your doctor, as your dose may need to be different.
Take Venlafaxine tablets at approximately the same time each day, in the morning and in the evening, with food. Tablets must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Do not stop taking Venlafaxine tablets without talking to your doctor (see section 'If you stop taking Venlafaxine Tablets')
If you take more Venlafaxine Tablets than you should
If you take too many tablets 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.
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 a double dose to makeup for a forgotten dose If you stop taking Venlafaxine Tablets
Do not stop taking your tablets or change the dose without the advice of your doctor even if you feel better. If your doctor thinks thatyou no longer need Venlafaxine Tablets 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 Tablets are stopped suddenly or the dose is 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, sweating, seizures, or flu-like symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
| 4. Possible side effects |
Like all medicines, this medicine may cause side effects, although not everybody gets
them.
Stop taking Venlafaxine and see a doctor or go to a hospital straight away if:
• You get unexplained muscle pain, tenderness or weakness called "rhabdomyolysis"
• You get swelling of your hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (utricaria). You may be having an allergic reaction to Venlafaxine
• You get blistering or peeling of skin around your lips, eyes, mouth, nose and genitals, with flu-like symptoms and fever. These could be signs of an illness called "Stevens-Johnson syndrome"
Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test)
Tell your doctor straight away if
• You notice yellowing of your skin or eyes and your urine becomes darker in colour. You may also have a high temperature, feel tired, lose your appetite, have stomach pain or feel sick. These could be signs of a liver problem, such asjaundice or hepatitis
• You notice blood in your vomit or pass black tarry stools
• You have nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
• You have heart problems, such as fast or irregular heartbeat, increased blood pressure
• You feel 'high' or over-excited, see or hear things which are not there (hallucinations) and have difficulty concentrating or staying still (mania, hypomania or delirium)
• You have painful eyes with blurred vision and dilated pupils
• You have withdrawal effects (see ‘If you stop taking Venlafaxine Tablets')
• You have prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
If any of the following side effects gets serious or lasts longer than a few days, tell
your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)
• Nausea, dizziness
• Headache, sweating, dry mouth
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion;feeling separated (or detached) from yourself; lack of orgasm; decreased libido; nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing;
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or emotion; feeling over-excited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired coordination and balance; altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when standing up too quickly)
• Shortness of breath
• Inability to pass urine;
• Weight gain; weight loss
Rare: may affect up to 1 in 1,000 people
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
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
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2)
SAME SIZE ARTWORK 480 mmx140mm
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• 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)
• Abnormal breast milk production Blood tests
The following side effects also affect blood. They are only found in blood test results:
• Increase in blood cholesterol levels
• Changes to some of the cells or other parts of your blood
• Slight changes in blood levels or liver enzymes
• Increase in blood pressure or abnormal heart beat
• Reduced platelet count in your blood which leads to increased risk of bruising and bleeding
Your doctor may wish to do blood tests occasionally, particularly if you have been taking Venlafaxine for a long time.
Reporting of side effects
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. You can also report side effects directly via the Yellow Card Scheme atwww.mhra.gov.uk/yellowcard. By reporting side effects, you
can help provide more information on the safety of this medicine._
I 5. How to store Venlafaxine Tablets I
• Keep out of the sight and reach of children.
• Do not store above 25°C. Store in the original package.
• Do not put the tablets into another container, they might get mixed up. Do not remove the tablets from the blister pack or open the blister pack until you are ready to take the medicine.
• Do not use these Tablets after the "Expiry Date" which is stated on the carton or blister. The expiry date refers to the last day of that month.
• Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
| 6. Contents of the pack and other information |
What Venlafaxine Tablets contain
Each tablet contains Venlafaxine Hydrochloride Ph.Eur equivalent to Venlafaxine 37.5 mg or 75 mg as the active ingredient.
The other ingredients are lactose, microcrystalline cellulose, sodium starch glycollate, pregelatinised starch, magnesium stearate, yellow iron oxide (El 72) and red iron oxide (El 72).
What Venlafaxine Tablets look like and contents of the pack
Venlafaxine Tablets 75 mg are Peach colour, circular, flat bevelled edged uncoated tablets having embossed '75' on one side and 'BL' on other side.
Venlafaxine Tablets 37.5 mg are Peach colour, circular, flat bevelled edged uncoated tablets having embossed '37.5' on one side and 'BL' on other side.
Venlafaxine Tablets 75 mg and 37.5 mg are packed in blister pack of 28 and 56 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP41 EG, UK
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Venlafaxine 37.5 mg Tablets: PL 17907/0250
Venlafaxine 75 mg Tablets: PL 17907/0251
This leaflet was last revised in July 2014
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.
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