Venlafaxine Doc Generici: detailed information

PATIENT LEAFLET: INFORMATION FOR THE USER

VENLAFAXINE DOC Generici 37.5 mg prolonged-release hard capsules, 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules

Equivalent medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What VENLAFAXINE DOC Generici is and what it is used for
What you need to know before taking VENLAFAXINE DOC Generici
How to take VENLAFAXINE DOC Generici
Possible side effects
How to store VENLAFAXINE DOC Generici
Contents of the pack and other information

1. WHAT VENLAFAXINE DOC GENERICS IS AND WHAT IT IS USED FOR

VENLAFAXINE DOC GENERICS is an antidepressant belonging to a group of medicines
called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of
medicines is used to treat depression and other conditions, such as anxiety disorders. It is believed that people who are depressed and/or anxious have lower levels of
serotonin and noradrenaline in the brain. The exact way antidepressants work is not fully understood; however, they may help by increasing the levels of serotonin and noradrenaline in the
brain.
VENLAFAXINE DOC GENERICS is a treatment for adults with depression. It is also a
treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear of or tendency to avoid social situations), and panic disorder (panic attacks). Appropriate treatment of depression or anxiety disorder is important to help you feel better. If left untreated, your condition may not improve and may become more severe and more difficult to treat.

2. WHAT YOU SHOULD KNOW BEFORE TAKING VENLAFAXINE DOC Generics

Do not take VENLAFAXINE DOC Generics

if you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
if you are currently taking or have taken within the past 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 VENLAFAXINE DOC Generics may cause serious or even life-threatening side effects. In addition, you must wait at least 7 days after stopping treatment with VENLAFAXINE DOC Generics before starting any irreversible MAOI (also see sections “Serotonin syndrome” and “Other medicines and VENLAFAXINE DOC Generics”).

Warnings and precautions
Medicines such as VENLAFAXINE DOC Generics (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Talk to your doctor or pharmacist before taking VENLAFAXINE DOC Generics:

If you are taking other medicines that, when taken together with VENLAFAXINE DOC Generics, may increase the risk of developing serotonin syndrome (see section “Other medicines and VENLAFAXINE DOC Generics”).
If you have eye problems, such as certain types of glaucoma (increased pressure inside the eye).
If you have a history of high blood pressure.
If you have a history of heart problems.
If you have been told you have an abnormal heart rhythm.
If you have a history of seizures.
If you have a history of low sodium levels in your blood (hyponatraemia).
If you tend to bruise easily or have a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, for example warfarin (used to prevent blood clots).
If you have a history of, or if anyone in your family has had, mania or bipolar disorder (feelings of over-excitement or euphoria).
If you have a history of aggressive behaviour.

VENLAFAXINE DOC Generics may cause a feeling of restlessness or inability to sit still during the first few weeks of treatment. If you experience these symptoms, inform your doctor.
If you have any of these conditions, talk to your doctor before using VENLAFAXINE DOC Generics.
Suicidal thoughts and worsening of your depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of harming yourself or of suicide. These thoughts may increase when you first start taking antidepressants, because it takes time before medicines like these begin to work—usually about two weeks, but sometimes longer.
You are more likely to have such thoughts:

If you have previously had thoughts of suicide or of harming yourself.
If you are young. Clinical studies have shown an increased risk of suicidal behaviour in young people (under 25 years) with psychiatric disorders who were treated with an antidepressant.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go immediately to the nearest hospital.
It may help to tell a close relative or friend that you are depressed or suffering from an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Dry mouth
Dry mouth occurs in 10% of patients treated with venlafaxine. This may increase the risk of dental caries (tooth decay). Therefore, you should pay particular attention to your oral hygiene.
Diabetes
Blood glucose levels may be altered due to VENLAFAXINE DOC Generics. Therefore, dosage adjustments of diabetes medications may be necessary.
Children and adolescents
VENLAFAXINE DOC Generics should normally not be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age have a higher risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking this class of medicines. Nevertheless, your doctor may prescribe VENLAFAXINE DOC Generics for patients under 18 years of age if they consider it to be in the patient’s best interest.
If your doctor has prescribed this medicine for a patient under 18 years of age and you wish to discuss it, talk to your doctor. You must inform your doctor if any of the listed symptoms appear or worsen when a patient under 18 years of age is taking VENLAFAXINE DOC Generics. In addition, the long-term effects of VENLAFAXINE DOC Generics on growth, maturation, and cognitive and behavioural development in this age group have not been established.
Other medicines and VENLAFAXINE DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will decide whether you can use VENLAFAXINE DOC Generics with other medicines.
Do not start or stop treatment with any other medicines, including over-the-counter medicines and herbal preparations, without first consulting your doctor or pharmacist.

Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease must not be taken with VENLAFAXINE DOC Generics. Inform your doctor if you have taken these medicines within the last 14 days (MAOIs: see section “What you should know before taking VENLAFAXINE DOC Generics”).
Serotonin syndrome: A potentially life-threatening condition, Malignant Neuroleptic Syndrome (MNS), (see section “Possible side effects”) may occur during treatment with venlafaxine, especially when taken with other medicines. Examples of such medicines include:
triptans (used for migraine)
medicines for the treatment of depression, for example SNRIs, SSRIs, tricyclics, or medicines containing lithium
medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
medicines containing linezolid, an antibiotic (used to treat infections)
medicines containing moclobemide, an MAOI (used to treat depression)
medicines containing sibutramine (used for weight loss)
medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
medicines containing dextromethorphan (used to treat cough)
medicines containing methadone (used to treat opioid dependence or acute pain)
medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
herbal preparations containing St. John’s wort (also known as Hypericum perforatum, a herbal remedy used to treat mild depression)
products containing tryptophan (used for sleep disorders and depression)
antipsychotics (used to treat disorders characterised by hearing, seeing, or feeling things that do not exist, false beliefs, unjustified suspicion, confused thinking, and social withdrawal).

Signs and symptoms of serotonin syndrome may include a combination of: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid fluctuations in blood pressure, hyperactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome may resemble Malignant Neuroleptic Syndrome (MNS). Signs and symptoms of MNS may include a combination of fever, rapid breathing, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by blood tests).
Contact your doctor immediately or go immediately to the nearest emergency department if
you think you may have serotonin syndrome.
Talk to your doctor if you are taking medicines that may affect your heart rhythm.
Examples of such medicines include:

antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythm)
antipsychotics such as thioridazine (see also serotonin syndrome above)
antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
antihistamines (used to treat allergies)

The following medicines may also interact with VENLAFAXINE DOC Generics and should be used with caution. It is particularly important that you inform your doctor or pharmacist if you are taking medicines containing:

ketoconazole (an antifungal medicine)
haloperidol or risperidone (for the treatment of psychiatric disorders)
metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

VENLAFAXINE DOC Generics with food, drinks and alcohol
You must take VENLAFAXINE DOC Generics with food (see section “How to take VENLAFAXINE DOC Generics”).
You must not consume alcohol while taking VENLAFAXINE DOC Generics.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You should take VENLAFAXINE DOC Generics only after discussing with your doctor the potential benefits and risks for the foetus.
Ensure that your midwife and/or doctor are informed that you are being treated with VENLAFAXINE DOC Generics.
Medicines similar to this one (SSRIs), if taken during pregnancy, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and a bluish skin colouration in the newborn. These symptoms usually appear within the first 24 hours after birth. Inform your midwife and/or doctor immediately if your baby shows these symptoms.
If you take this medicine during pregnancy, your baby may experience, in addition to breathing problems, other symptoms at birth if not adequately fed. If your baby shows these symptoms at birth and you are concerned, consult your doctor and/or midwife, who will be able to advise you.
VENLAFAXINE DOC Generics is excreted in breast milk. There is a risk of effects on the infant. Therefore, you must discuss this with your doctor, who will decide whether you should discontinue breastfeeding or stop treatment with this medicine.
Driving and using machines
Do not drive and do not use tools or machinery until you know how VENLAFAXINE DOC Generics affects you.

3. HOW TO TAKE VENLAFAXINE DOC Generici

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day.
Your doctor may gradually increase the dose, and if necessary, up to a maximum of 375 mg per day for depression.
If you are being treated for panic disorder, your doctor will start with a low dose (37.5 mg) and then gradually increase it.
The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg per day.
Take VENLAFAXINE DOC Generici approximately at the same time each day, in the morning and evening.
The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.
You must take VENLAFAXINE DOC Generici with food.
If you have liver or kidney problems, discuss this with your doctor, as a dose adjustment of VENLAFAXINE DOC Generici may be necessary.
Do not stop treatment with this medicine without consulting your doctor (see the section “If you stop taking VENLAFAXINE DOC Generici”).

If you take more VENLAFAXINE DOC Generici than you should
Contact your doctor or pharmacist immediately if you take more VENLAFAXINE DOC Generici than prescribed.
Symptoms of a possible overdose may include rapid heartbeat, changes in consciousness (ranging from drowsiness to coma), blurred vision, seizures, and vomiting.

If you forget to take VENLAFAXINE DOC Generici
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next scheduled dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the prescribed daily amount of VENLAFAXINE DOC Generici in one day.

If you stop taking VENLAFAXINE DOC Generici
Do not stop treatment or reduce the dose without consulting your doctor, even if you feel better.
If your doctor decides that you no longer need VENLAFAXINE DOC Generici, they may instruct you to gradually reduce the dose before stopping treatment completely. It is known that undesirable effects may occur when patients discontinue treatment with VENLAFAXINE DOC Generici, especially if treatment is stopped abruptly or if the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, a sensation of light-headedness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus (ringing in the ears), tingling sensations, or rarely electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how to gradually discontinue treatment with VENLAFAXINE DOC Generici. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following effects, do not take any more VENLAFAXINE DOC Generics. Contact your doctor immediately or go to the nearest hospital emergency department.

Uncommon (may affect up to 1 in 100 patients)

Swelling of the face, mouth, tongue, throat, hands, feet and/or itchy skin rash (urticaria), difficulty swallowing and breathing

Rare (may affect up to 1 in 1,000 patients)

Chest tightness, wheezing, difficulty swallowing or breathing
Severe skin rash, itching or hives (raised red or pale patches of skin that often itch)
Signs and symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid fluctuations in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting
In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid breathing, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by blood tests).
Signs of infection, such as high fever, chills, tremors, headache, sweating, flu-like symptoms. This may be caused by blood disorders leading to an increased risk of infection.
Skin rash, which may involve severe blistering and peeling of the skin
Unexplained muscle pain, tenderness or weakness. These may be signs of rhabdomyolysis.

Other adverse reactions that you must immediately report to your doctor are (the frequency of these adverse effects is listed below in the section “Other possible adverse reactions”):

Cough, wheezing, shortness of breath, which may be accompanied by high fever.
Black, tarry stools or blood in the stool.
Itching, yellowing of the skin or eyes, or dark urine, which may be symptoms of liver inflammation (hepatitis).
Heart problems such as rapid or irregular heartbeat, increased blood pressure.
Heart problems, such as fast or irregular heartbeat, increased blood pressure.
Eye problems, such as blurred vision, dilated pupils.
Nervous system problems, such as dizziness, tingling, movement disorders (muscle spasms or rigidity, seizures).
Psychiatric problems, such as hyperactivity or unusual sensation of over-excitement.
Withdrawal syndrome (see section “How to take VENLAFAXINE DOC Generics; If you stop taking VENLAFAXINE DOC Generics”).
Prolonged bleeding – if you cut or injure yourself, it may take longer than usual for the bleeding to stop.

Do not be concerned if you notice small granules or white beads in your stool after taking this medicine. Inside the VENLAFAXINE DOC Generics capsules are spheroids (small white beads) that contain the active substance (venlafaxine). These spheroids are released from the capsule in your stomach. As they travel through the gastrointestinal tract, they slowly release venlafaxine. The "shell" of the spheroids does not dissolve and is eliminated in the stool. Therefore, even if you see spheroids in your stool, the dose of medicine has been absorbed.

Other possible adverse reactions

Very common (may affect more than 1 in 10 patients)

Dizziness, headache, drowsiness, insomnia
Nausea, dry mouth, constipation
Sweating (including night sweats)

Common (may affect up to 1 in 10 patients)

Decreased appetite
Confusion, dizziness, feeling detached from oneself; absence of orgasm, decreased libido; agitation, nervousness; abnormal dreams
Tremor, sensation of restlessness or inability to sit still; tingling, altered taste sensation, increased muscle tone
Visual disturbances including blurred vision, dilated pupils, inability of the eyes to automatically focus from near to far
Ringing in the ears (tinnitus)
Rapid heartbeat, palpitations
Increased blood pressure, hot flushes
Shortness of breath, yawning
Vomiting, diarrhea
Mild skin rash, itching
Increased frequency of urination, inability to urinate, difficulty passing urine
Menstrual irregularities such as increased bleeding or increased irregularity of bleeding, abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
Weakness (asthenia); fatigue, chills
Weight gain, weight loss
Increased cholesterol

Uncommon (may affect up to 1 in 100 patients)

Hyperactivity, accelerated thinking and reduced need for sleep (mania)
Hallucinations, feeling detached from reality, abnormal orgasm, absence of feelings or emotions, sensation of over-excitement, bruxism (teeth grinding)
Fainting, involuntary muscle movements, impaired coordination and balance, sensation of dizziness (especially when standing up too quickly), decreased blood pressure
Vomiting blood, black tarry stools or blood in the stool, which may indicate internal bleeding
Sensitivity to sunlight, bruising, abnormal hair loss
Urinary incontinence
Muscle stiffness, spasms and involuntary movements
Slight changes in blood levels of liver enzymes

Rare (may affect up to 1 in 1,000 patients)

Seizures
Cough, breathlessness and shortness of breath, which may be accompanied by high temperature
Disorientation and confusion, often accompanied by hallucinations (delirium)
Excessive water intake (known as SIADH)
Decreased blood levels of sodium
Severe eye pain and reduced or blurred vision
Abnormal, rapid or irregular heartbeat, which may lead to fainting
Severe abdominal or back pain (which may indicate a serious problem with the intestine, liver or pancreas)
Itching, yellowing of the skin or eyes, dark urine, or flu-like symptoms, which are signs of liver inflammation (hepatitis)

Very rare (may affect up to 1 in 10,000 patients)

Prolonged bleeding, which may be a sign of reduced platelet count in the blood, leading to an increased risk of bruising or bleeding
Abnormal production of breast milk
Unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, or unexpected appearance of bruises or broken blood vessels (broken veins)

Frequency not known (cannot be estimated from available data)

Suicidal thoughts and behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or immediately after discontinuation of treatment (see section 2 WHAT YOU SHOULD KNOW BEFORE TAKING VENLAFAXINE DOC Generics)
Aggression
Dizziness

Sometimes VENLAFAXINE DOC Generics causes adverse reactions that you may not be aware of, such as increases in blood pressure or abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium or cholesterol. More rarely, VENLAFAXINE DOC Generics may reduce the function of platelets in your blood, resulting in an increased risk of bruising and bleeding. Therefore, your doctor may wish to perform occasional blood tests, especially if you have been taking VENLAFAXINE DOC Generics for a long time.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VENLAFAXINE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What VENLAFAXINE DOC Generici contains
The active substance is venlafaxine. Each prolonged-release hard capsule contains 37.5 mg, 75 mg or 150 mg of venlafaxine as venlafaxine hydrochloride.
The other components are:
37.5 mg prolonged-release hard capsules:
Capsule contents: hypromellose, methacrylic acid ammonium copolymer (type B), sodium lauryl sulfate, magnesium stearate; Coating: basic butyl methacrylate copolymer 12.5%; Capsule shell: gelatin, titanium dioxide (E 171); Ink: shellac, iron oxide black (E 172), propylene glycol (E1520).
75 mg prolonged-release hard capsules:
Capsule contents: hypromellose, methacrylic acid ammonium copolymer (type B), sodium lauryl sulfate, magnesium stearate; Coating: basic butyl methacrylate copolymer 12.5%; Capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172); Ink: shellac, iron oxide black (E 172), propylene glycol (E 1520).
150 mg prolonged-release hard capsules:
Capsule contents: hypromellose, methacrylic acid ammonium copolymer (type B), sodium lauryl sulfate, magnesium stearate; Coating: basic butyl methacrylate copolymer 12.5%; Capsule shell: gelatin, titanium dioxide (E 171), erythrosine (E127), indigo carmine I (E 132); Ink: shellac, iron oxide black (E 172); propylene glycol (E 1520).

Description of the appearance of VENLAFAXINE DOC Generici and the contents of the pack
37.5 mg prolonged-release hard capsules: opaque white – hard gelatin capsules (size 0), opaque white in colour, containing one round, biconvex, film-coated tablet, with the imprint VEN on the cap and 37.5 on the body.
75 mg prolonged-release hard capsules: opaque peach-coloured – hard gelatin capsules (size 0), opaque peach in colour, containing two round, biconvex, film-coated tablets, with the imprint VEN on the cap and 75 on the body.
150 mg prolonged-release hard capsules: opaque red – hard gelatin capsules (size 00), opaque red in colour, containing three round, biconvex, film-coated tablets, with the imprint VEN on the cap and 150 on the body.

Pack sizes:
37.5 mg: 10, 20, 28, 30, 98 and 100 capsules
75 mg: 14, 28, 30, 56, 98 and 100 capsules
150 mg: 10, 28, 30, 56, 98 and 100 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati, 40
20121 Milano
Italy

Manufacturers
Pharmathen S.A.
6 Dervenakion str.,
153 51 Pallini, Attiki
Greece
Pharmathen International S.A.
Sapes Industrial Park
Block 5
69300 Rodopi
Greece
Apotex Nederland B.V.
Bio Science Park
Archimedesweg 2
2333 CN Leiden
The Netherlands
LAMP S. Prospero SPA
Via della Pace 25A
41030 S. Prospero S/S (MO)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
BE: Venlafaxine Apotex 37.5 mg, 75 mg, 150 mg harde capsules met verlengde afgifte, hard
CZ: APO-VENLAFAXIN PROLONG 75 mg, 150 mg Tobolka s řízeným uvolňováním
NL: Venlafaxine Apotex XR 37.5 mg, 75 mg, 150 mg retard Katwijk, capsules met verlengde afgifte, hard
PL: Lafactin 37.5 mg, 75 mg, 150 mg Kapsułki o przedłużonym uwalnianiu
UK: Venaxx XL 75 mg, 150 mg prolonged-release capsules