APCLAVEN XL 150 MG PROLONGED-RELEASE CAPSULE - patient leaflet, side effects, dosage

Patient leaflet - APCLAVEN XL 150 MG PROLONGED-RELEASE CAPSULE

Read all of this leaflet carefully before you start taking this medicine.

1. Keep this leaflet. You may need to read it again.
2. If you have any further questions, ask your doctor or pharmacist.
3. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
4. 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.

In this leaflet

1. What Apclaven XL Capsules are and what they are used for
2. Before you take Apclaven XL Capsules
3. How to take Apclaven XL Capsules
4. Possible side effects
5. How to store Apclaven XL Capsules
6. Further information

1. WHAT APCLAVEN XL CAPSULES ARE AND WHAT THEY ARE USED FOR

Apclaven XL is an antidepressant and one of a group of medicines called serotonin noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression. It is thought that people who are depressed may have lower levels of serotonin and noradrenaline in their brain. Whilst it is not fully understood how antidepressants work, Apclaven XL prolonged release capsule may help to relieve the symptoms of depression by increasing the levels of these substances in the brain.

Apclaven XL capsule is a treatment for adults with depression. Apclaven XL capsule is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks). Treating depression or anxiety disorders 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. BEFORE YOU TAKE APCLAVEN XL CAPSULES

Do not take Apclaven XL

if you are allergic (hypersensitive) to venlafaxine or any of the other ingredients of Apclaven XL capsules.
if you are also taking or have taken any time 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 other medicines, including Apclaven XL can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Apclaven XL before you take any MAOI (see also the sections “Serotonin syndrome” and “Taking other medicines”).

Take special care with Apclaven XL

if you use other medicines that taken at the same time as apclaven xl could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”)
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

if your cholesterol levels get higher during treatment.
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.

Apclaven XL 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 Apclaven XL capsules.

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 adults (aged less than 25 years) 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 Apclaven XL. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene

Diabetes

Your blood glucose levels may be altered due to Apclaven XL. Therefore, the dosage of your diabetes medicines may need to be adjusted.

Use in children and adolescents under 18 years of age

Apclaven XL 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 Apclaven XL for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Apclaven XL 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 Apclaven XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Apclaven XL in this age group has not yet been demonstrated.

Taking Apclaven XL 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 Apclaven XL 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 (maois: see the section “before you take apclaven xl Capsules”).
serotonin syndrome: serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with Apclaven XL treatment, particularly when taken with other medicines. Examples of these medicines include:
- triptans (used for migraine)
- medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
- medicines containing linezolid, an antibiotic (used to treat infections)
- medicines containing moclobemide, a reversible 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)

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.

The following medicines may also interact with Apclaven XL 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)

Taking Apclaven XL with food and drink

Apclaven XL should be taken with food (see section “How to take Apclaven XL Capsules”).

You should avoid alcohol while you are taking Apclaven XL.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Apclaven XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.

If you are taking Apclaven XL during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include not feeding properly and trouble with 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.

Apclaven XL 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 Apclaven XL.

Driving and using machines

Do not drive or use any tools or machines until you know how Apclaven XL affects you.

Important information about some of the ingredients of Apclaven XL

sunset yellow as a colouring agent – is contained in the 75 mg and 150 mg strength capsules. It may cause an allergic reaction.
ponceau 4R red as a colouring agent – is contained in the 37.5 mg capsules. It may cause an allergic reaction.
sucrose – is contained in all strength capsules. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product

3. how to take apclaven xl capsules

Always take Apclaven XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual recommended starting dose for treatment of depression, generalised anxiety disorder and social anxiety disorder is 75 mg per 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. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then increase the dose gradually. The maximum dose for generalised anxiety disorder, social anxiety disorder and panic disorder is 225 mg/day.

Take Apclaven XL at approximately the same time each day, either in the morning or in the evening. Capsules must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.

Apclaven XL capsules should be taken with food.

If you have liver or kidney problems, talk to your doctor, since your dose of Apclaven XL may need to be different.

Do not stop taking Apclaven XL without talking to your doctor (see the section “If you stop taking Apclaven XL”).

If you take more Apclaven XL than you should

Call your doctor or pharmacist immediately if you take more than the amount of Apclaven XL prescribed by your doctor.

The symptoms of a possible overdose may include a rapid heartbeat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Apclaven XL

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 Apclaven XL that has been prescribed for you in one day.

If you stop taking Apclaven XL

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 Apclaven XL, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using Apclaven XL, especially when Apclaven XL 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 Apclaven XL 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, Apclaven XL 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 Apclaven XL. Inside Apclaven XL capsules are spheroids or small white balls that contain the Apclaven XL active ingredient. These spheroids are released from the capsule into your gastrointestinal tract. As the spheroids travel the length of your gastrointestinal tract, Apclaven XL 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 Apclaven XL has been absorbed

Allergic reactions

If any of the following happen, do not take more Apclaven XL. 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, throat, hands, or feet
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)

Serious side effects

If you notice any signs of the following, you may need urgent medical attention:

heart problems, such as fast or irregular heart rate, increased blood pressure
eye problems, such as blurred vision, dilated pupils
nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
psychiatric problems, such as hyperactivity and euphoria
treatment withdrawal (see the section “how to take apclaven xl capsules, if you stop taking Apclaven XL)

Other reported side effects

Very common (affects more than 1 in 10 users)

headache; dry mouth; sweating (including night sweats)
nausea

Common (affects 1 to 10 users in 100)

weight loss; appetite decreased; constipation; vomiting; increased cholesterol
feeling separated (or detached) from yourself and reality; nervousness; confusion; abnormal

dreams; insomnia

tremor; increased muscle tonus
pins and needles
increase in blood pressure; flushing, palpitations
increased frequency in urination; difficulties passing urine
decreased libido; abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence)

Menstrual irregularities such as increased bleeding or increased irregular bleeding

Weakness (asthenia); dizziness; sedation, chills

Blurred vision

Yawning

Uncommon (affects 1 to 10 users in 1,000)

bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding
grinding of the teeth; involuntary movement of the muscles
hallucinations
general swelling of the skin especially the face, mouth, tongue, throat area or hands and feet and/or a raised itchy rash (hives) may be present
sensitivity to sunlight; abnormal hair loss; rash
impaired coordination and balance; feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat
weight gain; diarrhoea
altered taste sensation
lack of feeling or emotion; agitation
ringing in the ears (tinnitus)
inability to pass urine;
abnormal orgasm (females)

Rare (affects 1 to 10 users in 10,000)

a sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling overexcited or euphoric.
inability to control urination

Frequency not known

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; slight changes in blood levels of liver enzymes; decrease in blood sodium levels;
itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis)
excessive water intake (known as siadh)
abnormal breast milk production
a high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome
euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonergic syndrome
disorientation and confusion often accompanied by hallucination (delirium)
stiffness, spasms and involuntary movements of the muscles
thoughts of harming or killing yourself
severe eye pain and decreased or blurred vision
decrease in blood pressure; abnormal, rapid or irregular heartbeat, which could lead to fainting
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)
skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this

may be a serious allergic reaction)

confusion
vertigo
aggression

Apclaven XL 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, Apclaven XL 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 Apclaven XL for a long time.

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.

5. how to store apclaven xl capsules

Keep out of the sight and reach of children.

Do not use Apclaven XL after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Store below 30°C and store in the original container to protect from moisture.

Do not use Apclaven XL after 100 days of opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

What Apclaven XL contains

The name of your medicine is Apclaven XL 37.5 mg or 75 mg or 150 mg Prolonged release capsule. It will be referred to as Apclaven XL capsules throughout this leaflet. Each prolonged release capsule contains either 37.5 mg or 75 mg or 150 mg venlafaxine hydrochloride as an active substance.

The other contents of the capsules are Sugar Spheres (contains sucrose), Ethyl cellulose (E462), hydroxypropylcellulose Hypromellose (E464), Talc (E553b) Dibutyl sebacate, Oleic acid, and Colloidal anhydrous silica.

The capsule shell contains: Gelatin, Sodium lauryl sulphate, Ponceau 4R red (E124), Quinoline yellow (E104) and Titanium dioxide (E171) for 37.5 mg, Sunset yellow (E110), Quinoline yellow (E104) and Titanium dioxide (E171) for 75 mg, Sunset yellow (E110), Quinoline yellow (E104), Patent blue (E131) and Titanium dioxide (E171) for 150 mg.

Remember : This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

What Apclaven XL looks like and contents of the pack

Apclaven XL Prolonged release capsule is available in three strengths

- 37.5 mg: White to off-white pellets filled in hard gelatin capsule shells „size 3" with orange cap

and clear transparent body

- 75 mg: White to off-white pellets filled in hard gelatin capsule shells „size 1" with yellow cap

and clear transparent body

- 150 mg: White to off-white pellets filled in hard gelatin capsule shells „size 0" with buff cap

Marketing Authorisation Holder:

Torrent Pharma (UK) Ltd.

Unit 4, Charlwood Court

County Oak Way

Crawley

West Sussex

RH11 7XA

United Kingdom.

Manufacturer:

APC Pharmaceuticals & Chemicals (Europe) Limited, 9th Floor, CP House, 97–107 Uxbridge Road, Ealing, London W5 5TL

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