Active ingredient
- venlafaxine hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL30306/0218, PL30306/0216.
Venlafaxine Tablets 37.5mg & 75mg
PATIENT INFORMATION LEAFLET
Venlafaxine 37.5mg and 75mg tablets
Important things you need to know about venlafaxine
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.
In this leaflet:
1 What Venlafaxine tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 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 anxiety disorders in adults. 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 tablets are used to treat adults with depression. Treating depression properly is important. 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
Do not take Venlafaxine tablets if you
Take special care with Venlafaxine tablets if you
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 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 with your dental hygiene whilst taking these tablets.
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.
Some medicines may interact with Venlafaxine tablets and should be used with caution. 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, especially:
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:
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.
Taking Venlafaxine tablets with food and drink
Venlafaxine tablets should be taken with food (see section 3 ‘How to take’).
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 risks to your unborn child with your doctor.
Make sure your midwife and/or doctor know you are on Venlafaxine. 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.
As venlafaxine passes into breast milk, there is a risk of an effect on the baby. Therefore, you should discuss with your doctor, and decide whether you should stop breast-feeding or stop the therapy with Venlafaxine tablets.
Driving and using machines
Venlafaxine may cause confusion, dizziness and blurred vision. If you are affected, do not drive or use machinery.
Important information about some of the ingredients of Venlafaxine tablets
Venlafaxine tablets contains a sugar called lactose. If a doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The tablets also contain sunset yellow (E110) which may cause allergic reactions (see section 4 below).
Tests
Venlafaxine tablets can cause unwanted effects that you may not be aware of, such as rises in blood pressure, abnormal heart beat, slight changes in blood levels, liver enzymes or blood salt or cholesterol. In rare cases Venlafaxine can reduce the function of blood platelets leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests, particularly if you have been taking Venlafaxine tablets for a long time.
3 How to take
Always take Venlafaxine tablets exactly as your doctor has told you. If you are not sure check with your doctor or pharmacist.
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.
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 more than the prescribed amount of tablets, contact your doctor or pharmacist at once.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), dilated pupils, 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 in one day than the daily amount that has been prescribed for you.
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 is 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, 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:
Serious side effects
If you notice any of the following, seek urgent medical attention:
Tell your doctor or pharmacist if you notice any of the following side effects or notice any other effects not listed:
Very common (more than 1 in 10 users)
Common (less than 1 in 10 users)
Uncommon (less than 1 in 100 users)
Frequency not known
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
Keep out of the reach and sight of children.
Do not use Venlafaxine tablets after the expiry date, which is stated on the packaging.
There are no special storage instructions
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
6 Further information
What Venlafaxine tablets contain
What Venlafaxine tablets look like and contents of the pack
Venlafaxine tablets are orange, round biconvex, film-coated tablets with the following markings:
37.5mg – V2 75mg - V4 with a scoreline.
Venlafaxine tablets come in pack sizes of 56 tablets, packed into blister packs or plastic containers
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised December 2014
AAAH4697
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 385 200
+44 (0)1271 385 257
+44 (0)1271 346 106