Bluefish Pharmaceuticals

Reason of change Revised text received on 20.06.16

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Reviewed & Approved by	PDC	QA	RA	Remarks Font Size - Heading 15, 12 pts. Rest all 9 pts. Date: 20.06.2016
Revision History	R1 - Initial Mock-up Artwork (AM-16-042) - 10.05.16

PACKAGE LEAFLET: INFORMATION FOR THE USER

Venlablue XL 37.5 mg, prolonged-release capsules, hard Venlablue XL 75 mg, prolonged-release capsules, hard Venlablue XL 150 mg, prolonged-release capsules, hard

Venlafaxine

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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.

1.    What Venlablue XL is and what it is used for

2.    Before you take Venlablue XL

3.    How to take Venlablue XL

4.    Possible side effects

5.    How to store Venlablue XL

6.    Further information

1. WHAT VENLABLUE XL IS AND WHAT IT IS USED FOR

Venlablue XL 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.

Venlablue XL is a treatment for adults with depression. Venlablue XL is also a treatment for adults with social anxiety disorder (fear or avoidance of social situations). 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.

Do not take Venlablue XL

-    if you are allergic to venlafaxine or any of the other ingredients of Venlablue XL

-    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 Venlablue XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlablue XL before you take any MAOI (see also the sections “Serotonin syndrome” and “Taking other medicines”).

Take special care with Venlablue XL

•    If you use other medicines that taken concomitantly with Venlablue 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.

• 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.

Venlablue 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 Venlablue XL.

venlafaxine 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 Venlablue 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 Venlablue XL with food and drink

Venlablue XL should be taken with food (See section 3).

You should avoid alcohol while you are taking Venlablue XL.

Pregnancy and breast-feeding

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

If you are taking Venlablue XL during pregnancy, your baby might present difficulties in feeding properly when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include 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.

Venlablue 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 Venlablue XL.

Make sure your midwife and/or doctor knows you are on Venlablue XL. When taking 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.

Driving and using machines

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

Important information about some of the ingredients of Venlablue XL

Venlablue XL 150 mg contains the colouring agents allura red and sunset yellow which may cause allergic reactions.

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

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 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 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 caries. Therefore, you should take special care in your dental hygiene.

Use in children and adolescents under 18 years of age

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

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 Venlablue 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 Venlablue XL”).

•    Serotonin syndrome:

•    Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with

The usual recommended starting dose for treatment of depression 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. The maximum dose for social anxiety disorder is 225 mg/day.

Take Venlablue 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. Chewing, crushing or dissolving the content of the capsule may damage the film coating that modifies the release of the drug.

Venlablue XL should be taken with food.

Do not be concerned if you see small white granules or balls in your stools after taking Venlablue XL. Inside Venlablue XL 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.

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

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

If you take more Venlablue XL than you should

Call your doctor or pharmacist immediately if you take more than the amount of Venlablue 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 Venlablue 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 Venlablue XL that has been prescribed for you in one day.

If you stop taking Venlablue XL

Do not stop taking your treament or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Venlablue XL he/she will ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur whe people stop using Venlablue XL, especially when Venlablue XL is 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, 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 Venlablue 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.

sodium or cholesterol. More rarely, Venlablue 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 Venlablue 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.

Like all medicines, Venlablue XL can cause side effects, although not everybody gets them.

Allergic reactions

If any of the following happen, do not take more Venlablue 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 Venlablue XL, if you stop taking Venlablue XL”).

Complete side effect listing

The frequency (likelihood of occurring) of side effects is classified as follows:

•    Blood and lymphatic system disorders

Uncommon: bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding 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

•    Immune system disorders

Uncommon: Photosensitivity reaction Not known: Anaphylaxis

•    Metabolism and nutrition disorders

Common: weight loss; increased cholesterol Uncommon: weight gain

Not known: 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); confusion, excessive water intake (known as SIADH); abnormal breast milk production

•    Nervous system disorders

Very common: dry mouth; headache

Common: abnormal dreams; decreased libido; dizziness; increased muscle tonus; insomnia; nervousness; pins and needles; sedation; tremor; confusion; feeling separated (or detached) from yourself and reality.

Uncommon: lack of feeling or emotion; hallucinations; involuntary movement of the muscles; agitation; impaired coordination and balance.

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

Not known: 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

•    Eye disorders

Common: blurred vision

Not known: severe eye pain and decreased or blurred vision

•    Ear and labyrinth disorders

Uncommon: ringing in the ears (tinnitus)

•    Cardiac disorder

Common: increase in blood pressure; flushing; palpitations Uncommon: feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat Not known: decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting

•    Respiratory, thoracic and mediastinal disoreder

Common: yawning

Not known: 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)

•    Gastrointestinal disorders

Very common: nausea

Common: appetite decreased; constipation; vomiting Uncommon: grinding of the teeth; diarrhoea, altered taste sensation

Not known: severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)

•    Skin and subcutaneous tissue disorders

Very common: sweating (including night sweats)

Common: chills

Uncommon: rash; abnormal hair loss

Not known: skin rash, which may lead to severe blistering

and peeling of the skin; itching; mild rash

•    Musculoskeletal and connective tissue disorders

Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

•    Renal and urinary disorders

Common: difficulties passing urine; increased frequency in urination

Uncommon: inability to pass urine

•    Reproductive system and breast disorder

Common: abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding

Uncommon: abnormal orgasm (females)

•    General disorders and administration site conditions

Common: weakness (asthenia)

Uncommon: sensitivity to sunlight

Not known: swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)

Keep out of the reach and sight of children.

Do not use Venlablue XL 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 above 30°C.

Do not use Venlablue XL if you notice that the capsules are sticky.

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 to protect the environment.

What Venlablue XL contains

The active substance is venlafaxine.

Each capsule contains: Venlafaxine hydrochloride, corresponding to 37,5 mg Venlafaxine.

Each capsule contains: Venlafaxine hydrochloride, corresponding to 75 mg Venlafaxine.

Each capsule contains: Venlafaxine hydrochloride, corresponding to 150 mg Venlafaxine.

The other ingredients are Tablet core:

microcrystalline cellulose, povidone, talc, silica, colloidal anhydrous, magnesium stearate

Tablet film coat:

ethyl cellulose, copovidone

37.5    mg Capsule:

black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin

Printing Inks:

Shellac, red iron oxide

75 mg:

Capsule:

black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin

Printing Inks:

Shellac, red iron oxide

150 mg:

Capsule:

allura red (E129), sunset yellow FCF (E110), brilliant blue FCF (E133), titanium dioxide (E171), gelatin

Printing Inks:

Shellac, titanium dioxide

What Venlablue XL looks like and contents of the pack

Prolonged release capsule, hard

37.5    mg: Light grey opaque / peach opaque, size ‘3’ hard gelatin capsules having thick and thin radial circular band on the body in red ink and thick and thin radial circular band on the cap in red ink. The capsule is filled with 3 white to off-white, round, biconvex, film coated mini tablets of 12.5 mg each.

75 mg: Peach opaque / peach opaque, size ‘1’ hard gelatin capsules having thick and thin radial circular band on the body in red ink and thick and thin radial circular band on the cap in red ink. The capsule is filled with 6 white to off-white, round, biconvex, film coated mini tablets of 12.5 mg each.

150 mg: Dark orange / dark orange opaque, size ‘0’ hard gelatin capsules having thick and thin radial circular band on the body in white ink and thick and thin radial circular band on the cap in white ink. The capsule is filled with 12 white to off-white, round, biconvex, film coated mini tablets of 12.5 mg each.

Blister packs of PVC/Aclar film and aluminium foil; 10, 14, 28, 30, 50 & 100 capsules

Blister packs of PVC/PVdC film and aluminium foil; 10, 14, 28, 30, 50 & 100 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm, Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gavlegatan 22

113 30 Stockholm, Sweden

This medicinal product is authorised in the Member States of the EEA under the following names:

Name of the

Member State Name of the medicinal product

Austria    Venlafaxin Bluefish 75 mg/150 mg

Hartkapseln, retardiert

Czech Republic Venlafaxine Bluefish 75 mg/150 mg Tvrda tobolka s prodlouzenym uvolnovamm Denmark    Venlafaxin Bluefish XR 75 mg/150 mg

Finland    Venlafaxine Bluefish 75 mg/150 mg

depotkapseli, kova Venlafaxine Bluefish 75 mg/150 mg depotkapsel, hard

France    Venlafaxine Bluefish LP 37.5 mg/75 mg/

150 mg gelules a liberation prolongee Germany    Venlafaxin Bluefish 75/150 mg

Hartkapseln, retardiert

Greece    Venlafaxine    Bluefish XR 75 mg/150 mg

KayorAsg napaxsxapsvqg anoSsapswqg Hungary    Venlafaxine    Bluefish XR 75 mg/150 mg

Nyujtott hatoanyagleadasu kapszulak Ireland    Venlablue XL 75 mg/150 mg

prolonged-release capsules, hard Italy    Venlafaxina ABC 75 mg/150 mg Capsule a

rilascio prolungato

Netherlands Venlafaxine Bluefish XR 37.5 mg/75 mg/ 150 mg Capsules met verlengde afgifte Norway    Venlafaxine    Bluefish XR

Poland    Venlafaxine    Bluefish XL

Portugal    Venlafaxina    Bluefish XR

Slovakia    Venlafaxine    Bluefish XR 75 mg/150 mg

tvrde kapsuly s predlzenym uvol’novamm Spain    Venlafaxina Bluefish 75 mg/150 mg

Capsulas de liberacion prolongada Sweden    Venlafaxine Bluefish 37.5 mg/75 mg/

150 mg depotkaplar, harda

United Kingdom Venlablue XL 37.5mg/75 mg/150 mg (RMS)    prolonged-release capsules, hard

This leaflet was last approved in 06/2016

Venlablue 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,