Venlafaxine 37.5mg Tablets
Package leaflet: Information for the user
Venlafaxine 37.5 mg tablets Venlafaxine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 37.5 mg is and what it is used for
2. What you need to know before you take Venlafaxine 37.5 mg
3. How to take Venlafaxine 37.5 mg
4. Possible side effects
5. How to store Venlafaxine 37.5 mg
6. Contents of the pack and other information
1. What Venlafaxine 37.5 mg is and what it is used for
Venlafaxine 37.5 mg 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 37.5 mg 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. What you need to know before you take Venlafaxine 37.5 mg Do not take Venlafaxine 37.5 mg
• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If 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 37.5 mg, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine 37.5 mg before you take any MAOI (see also the sections “Serotonin syndrome” and “ Other medicines and Venlafaxine 37.5 mg”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine 37.5 mg
• If you use other medicines that taken together with Venlafaxine 37.5 mg could increase the risk of developing serotonin syndrome (see the section “Other medicines and Venlafaxine 37.5 mg").
• 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 been told you have an abnormal heart rhythm.
• 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 e.g., warfarin (used to prevent blood clots).
• 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 have diabetes.
Venlafaxine 37.5 mg 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.
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.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should take special care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venlafaxine 37.5 mg. Therefore, the dosage of your diabetes medicines may need to be adjusted.
Children and adolescents
Venlafaxine 37.5 mg 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 this medicine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed this medicine 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 37.5 mg. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of this medicine in this age group has not yet been demonstrated.
Drug-Laboratory Tests
when you are taking or have taken Venlafaxine 37.5 mg, urine Screening tests for phencyclidine (PCP) and amphetamine may show false-positive results. In this case, confirmatory tests may have to be performed.
Other medicines and Venlafaxine 37.5 mg
Tell your doctor or pharmacist if you are taking/using,have recently taken/used or might take/use any other medicines..
Your doctor should decide whether you can take Venlafaxine 37.5 mg 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 which are used to treat depression or Parkinson’s disease must not be taken with Venlafaxine 37.5 mg. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “What you need to know before you take Venlafaxine 37.5 mg”).
• 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:
• Triptans (used for migraine)
• Other medicines to treat depression, for instance SNRIs, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
• 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)
• 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, 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 immediately, or go to the casualty department at your nearest hospital if you think serotonin syndrome is happening to you.
You must tell your doctor if you are taking medicines that can affect your heart rhythm. Examples of these medicines include:
• Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat abnormal
heart rhythm)
• Antipsychotics such as thioridazine (See also Serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• Antihistamines (used to treat allergy)
The following medicines may also interact with Venlafaxine 37.5 mg 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)
• Indinavir (to treat HIV infection)
Tell your doctor if you are taking oral contraceptives.
Venlafaxine 37.5 mg with food, drink and alcohol
Venlafaxine 37.5 mg should be taken with food (see section 3 “How to take Venlafaxine 37.5 mg"). You should avoid alcohol while you are taking Venlafaxine 37.5 mg.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should use Venlafaxine 37.5 mg only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Venlafaxine 37.5 mg. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (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 37.5 mg 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 breastfeeding or stop the therapy with this medicine.
Driving and using machines
Do not drive or use any tools or machines until you know how Venlafaxine 37.5 mg affects you.
Venlafaxine 37.5 mg contains 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.
3. How to take Venlafaxine 37.5 mg
Always take this medicine exactly as your doctor has told you.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 37.5 mg at approximately the same time each day, in the morning and in the evening.
Venlafaxine 37.5 mg should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Venlafaxine 37.5 mg may need to be different.
Do not stop taking Venlafaxine 37.5 mg without talking to your doctor (see the section “If you stop taking Venlafaxine 37.5 mg").
If you take more Venlafaxine 37.5 mg than you should
Call your doctor or pharmacist immediately if you take more of this medicine than the amount 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 37.5 mg
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 37.5 mg that has been prescribed for you in one day.
If you stop taking Venlafaxine 37.5 mg
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 37.5 mg, he/she may ask you to reduce your dose slowly, before stopping treatment altogether. Side effects are known to occur when people stop using this medicine, especially when Venlafaxine 37.5 mg is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, lightheadedness, 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 37.5 mg 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, do not take more Venlafaxine 37.5 mg. 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, mouth, tongue, throat area, skin, hands, or feet.Together with shortness of breath and/or skin rashes this may be a serious allergic reaction.
• 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)
• Skin rash, which may lead to severe blistering and peeling of the skin
• 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 immediately about:
• 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)
• Vomiting blood, black (tarry) stools or blood in stools,which can be a sign of internal bleeding
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of inflammation of the liver (hepatitis)
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• Heart problems, such as abnormal, rapid or irregular heart beat, which could lead to fainting, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, abnormal muscle tone, involuntary movements of the muscles, face, jaw, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take Venlafaxine 37.5 mg, If you stop taking
Venlafaxine 37.5 mg")
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
• 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, “What you need to know before you take Venlafaxine 37.5 mg")
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
Other side effects
Very common: may affect more than 1 in 10 people
• Headache;
• Nausea; Dry mouth;
• Sweating (including night sweats)
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; increased muscle tonus;
• Visual disturbance including inability of the eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• 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; grinding of the teeth
• A sensation of an inability to sit or stand still; fainting; stiffness; spasms; impaired coordination and balance; altered taste sensation
• Feeling dizzy (particularly when standing up too quickly)
• Sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare: may affect up to 1 in 1,000 people _•_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
• Disorientation and confusion often accompanied by hallucination (delirium); aggression
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; 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)
• Slight changes in blood levels of liver enzymes
• Abnormal breast milk production
Venlafaxine 37.5 mg 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 37.5 mg 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 37.5 mg for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www .mhra.gov .uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine
5. How to store Venlafaxine 37.5 mg
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the packaging.
This medicinal product does not require any special storage conditions
Do not throw away any medicines via wastewater< 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 37.5 mg contains
The active substance is venlafaxine.
Each tablet contains 37.5 mg venlafaxine (as hydrochloride).
The other ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate (type A), magnesium stearate, yellow and brown iron oxide (E 172).
What Venlafaxine 37.5 mg looks like and contents of the pack
Beige-coloured, oval tablet.
Venlafaxine 37.5 mg is available in PVC/aluminium blister packs of 20, 28, 30, 50, 56, 60 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Str.3
89079 Ulm
Germany
Manufacturers
Combino Pharmaceuticals SL C / Fructuos Gelabert 6-8,
08970 - Saint Joan Despi, Barcelona, Spain
Combino Pharm Malta Ltd HF 60 HAL FAR Industrial Estate HAL FAR BBG07-Malta
Merckle GmbH Ludwig-Merckle-Strasse 3,
89143 Blaubeuren-Weiler, Germany
This leaflet was last revised in March 2016
PL 15773/0891