Patient Leaflet Updated 10-Feb-2021 | Chiesi Limited
Depefex 75mg & 150mg XL Capsules
INFORMATION FOR THE USER
Depefex® 75 mg XL Capsules
Depefex® 150 mg XL Capsules
SIX IMPORTANT THINGS YOU NEED TO KNOW ABOUT DEPEFEX
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Depefex is and what it is used for
2. What you need to know before you take Depefex
3. How to take Depefex
4. Possible side effects
5. How to store Depefex
6. Contents of the pack and other information
The name of this medicine is Depefex 75 mg XL Capsules and Depefex 150 mg XL Capsules. For convenience, this leaflet will call it Depefex
1. WHAT DEPEFEX IS AND WHAT IT IS USED FOR
Depefex belongs to a group of medicines called antidepressants. They are one of a group of medicines called a selective serotonin and noradrenaline reuptake inhibitor (SNRI). It is thought that people who are depressed 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.
Depefex are used for the treatment of depression. Your doctor may continue to give you Depefex when you are feeling better to stop your symptoms coming back or stop you becoming depressed in the future. Treating your depression properly is important to help you get better. If not treated your condition may not go away or may be more difficult to treat.
You may find it helpful to tell a friend or relative that you are depressed and ask them to read this leaflet as well. You might ask them to tell you if they are worried about any changes in your behaviour.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEPEFEX
DO NOT TAKE DEPEFEX IF:
If any of these apply to you, tell your doctor or pharmacist immediately, as the capsules may not be suitable for you.
USE IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE
Depefex should not normally be used in children and adolescents under the age of 18 years.
Take special care and tell your doctor or pharmacist before taking Depefex if:
Depefex 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 have any of the above, please talk with your doctor before taking Depefex.
Thoughts of harming yourself:
People who are depressed can sometimes have thoughts of harming or killing themselves. These may be increased when you first start taking antidepressants since these medicines take time to work, usually about two weeks but sometimes longer.
If you get these thoughts at any time, contact your doctor or go to the nearest hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the risk of caries (tooth decay). Therefore, you should take special care in your dental hygiene.
Medicines like Depefex (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
Taking Depefex with 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 Depefex 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.
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, mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. 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 right away 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:
The following medicines may also interact with Depefex and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
Taking Depefex with food, drink and alcohol
You should swallow each capsule whole with food and with a drink of water.
You should avoid drinking alcohol while you are taking the capsules. Alcohol may make your symptoms or side effects worse.
Pregnancy, breast-feeding and fertility
You must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, so that another medicine can be considered. You should use Depefex only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor know you are on Depefex. 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 hour after the baby is born. If this happens to your baby or if your baby is not feeding properly or has trouble breathing, you should contact your midwife and/or doctor immediately. If you take Depefex near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Depefex so they can advise you.
Breast-feeding is not recommended as venlafaxin in Depefex can pass into the breast milk, and there would be risk of an effect on the baby. Therefore, you should discuss this matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Depefex.
Driving and using machines
Possible side effects of Depefex are dizziness, confusion and eye sight changes such as blurred vision. If you get these or feel that your judgement, thinking or co-ordination is affected when you take Depefex do not drive or use machines.
Important information about some of the ingredients of Depefex
This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking the medicinal product.
3. HOW TO TAKE DEPEFEX
Always take Depefex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual starting dose is one 75 mg capsule a day. However, your doctor may start with a different dose, particularly if you are elderly or have liver or kidney problems. Your doctor may also change your dose during the course of your treatment. Your dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression.
You should swallow each capsule whole at approximately the same time each day, either in the morning or evening. Do not break open, crush or chew the capsules, or put them in water before swallowing.
Depefex should be taken with food. Do not stop taking Depefex without talking to your doctor (see the section “If you stop taking Depefex”).
If you take more Depefex than you should
Never take more capsules than your doctor tells you. If you accidentally take too many capsules contact your doctor or hospital immediately.
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 Depefex
If you forget to take a capsule, you can take it up to 12 hours after you usually take it, and then take your next capsule at the usual time. If the period after the missed dose is more than 12 hours, you should miss the dose altogether and just take your next capsule at the usual time.
Do not take a double dose to make up for a forgotten capsule.
If you stop taking Depefex
Do not stop taking your capsules or reduce the dose without the advice of your doctor, even if you feel better. If your doctor thinks you no longer need Depefex, your dose will be reduced gradually before stopping treatment altogether.
Side effects are known to occur when people stop using Depefex, especially when the capsules are stopped suddenly or the dose 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, weakness, sweating, fits/ seizures, or flu-like symptoms. These symptoms are generally non-serious and disappear within a few days.
Your doctor will advise you on how you should gradually stop Depefex and if you suffer any of these or other symptoms that are troublesome, return to your doctor for further advice.
If you require any further information on Depefex please consult your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Depefex can cause side effects, although not everybody gets them.
Do not be concerned if you see small white granules or balls in your stools after taking Depefex. Inside Depefex capsules are spheroids or small white balls that contain the venlafaxine active ingredient. These spheroids are released from the capsule into your gastrointestinal tract. As the spheroids travel the length of your gastrointestinal tract, venlafaxine is slowly released. The spheroid “shell” remains undissolved and is eliminated in your stools. Therefore, even though you may see spheroids in your stools, your dose of venlafaxine has been absorbed.
Although the frequency cannot be estimated from the available data 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 Depefex XL).
If any of the following happen, do not take more Depefex XL. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
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).
Frequency not known (cannot be estimated from the available data)
Other reported side effects
Very common (affects more than 1 person in 10 users):
Common (affects less than 1 person in 10 users):
Uncommon (affects less than 1 person in 100 users):
Rare (affects less than 1 person in 1000 users):
Very rare (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from the available data):
Depefex sometimes causes unwanted effects which you may not be aware of, such as increases in blood pressure or abnormal heart beat, or slight changes in blood levels of liver enzymes, sodium or rarely cholesterol (fats). More rarely, Depefex may reduce the function of platelets in your blood, leading to increased chance of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking the capsules for a long time.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of medicine.
5. HOW TO STORE DEPEFEX
Keep this medicine out of the sight and reach of children.
Do not use Depefex after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store Depefex above 25°C. Store in the original package in order to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your Pharmacist how to dispose of medicines no longer required.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Depefex Capsules contain
Each Capsule contains 75 mg or 150 mg of venlafaxine as venlafaxine hydrochloride. The other ingredients in the capsules are: stearic acid, ethylcellulose, talc, gelatin, sucrose and maize starch. The 75mg capsules also contain Titanium dioxide
What Depefex Capsules look like and contents of the pack
Depefex Capsules come in two strengths. Depefex 75 mg XL Capsules are white opaque capsules containing white or whitish pellets. Depefex 150 mg XL Capsules are natural transparent capsules containing white or whitish pellets. They come in packs containing 28 capsules.
Marketing Authorisation Holder and Manufacturer
This leaflet was last approved in 01/2021
“Is this leaflet hard to see or read? Telephone: 0161 488 5555 for help”
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG
0800 009 2329
+44 (0)1748 827 271