Do not take Vefamyl
- 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 Vefamyl, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Vefamyl before you take any MAOI (see also the section “Other medicines and Vefamyl” and the information in that section about “Serotonin Syndrome”).
Warnings and precautions
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Talk to your doctor or pharmacist before taking Vefamyl:
- If you use other medicines that taken together with Vefamyl could increase the risk of developing serotonin syndrome (see the section “Other medicines and Vefamyl”)
- 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 e.g. warfarin (used to prevent blood clots)
- 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.
Vefamyl 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 any of these conditions apply to you, please talk with your doctor before taking Vefamyl.
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 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 Vefamyl. Therefore, the dosage of your diabetes medicines may need to be adjusted.
Children and adolescents
Vefamyl should normally not be used in children and adolescents under the age of 18 years. Also, you should know that patients under the age of 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 Vefamyl for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Vefamyl for a patient under 18, and you want to discuss this, please go back to your doctor. You
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should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Vefamyl. Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of Vefamyl in this age group have not yet been demonstrated.
Other medicines and Vefamyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor should decide whether you can take Vefamyl 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 Vefamyl. 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 Vefamyl”).
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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 (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)
- 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 heartbeat, 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 heartbeat, 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.
The following medicines may also interact with Vefamyl 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)
Vefamyl with food, drink and alcohol
Venlafaxine should be taken with food (see section 3 “How to take Vefamyl”).
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You should avoid alcohol while you are taking Vefamyl.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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.
Make sure your midwife and/or doctor knows you are on Vefamyl. 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.
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 breastfeeding or stop the therapy with Vefamyl.
Driving and using machines
Do not drive or use any tools or machines until you know how Vefamyl affects you.