Package leaflet: Information for the user

Venlafaxine Alter 75 mg modified-release hard capsules, 150 mg modified-release hard capsules

Venlafaxine
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Venlafaxine Alter is and what it is used for

Venlafaxine Alter contains the active substance venlafaxine.
Venlafaxine Alter is an antidepressant belonging to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used for the treatment of 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 in which antidepressants work is not fully understood; however, they may help by increasing the levels of serotonin and noradrenaline in the brain.
Venlafaxine Alter 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 disorders 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 need to know before taking Venlafaxine Alter

Do not take Venlafaxine Alter

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 last 14 days, any of the medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Venlafaxine Alter may result in serious or even life-threatening side effects. In addition, you must

wait at least 7 days after stopping treatment with Venlafaxine Alter before starting any irreversible MAOI
(see also the section titled “Other medicines and Venlafaxine Alter”
and the information in that section regarding “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine Alter:

If you are taking other medicines that, when used together with Venlafaxine Alter, may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Alter”).
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 have a tendency to bruise easily or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots), or if you are pregnant (see section “Pregnancy and breastfeeding”).
If you have a history, or if someone in your family has had mania or bipolar disorder (feelings of over-excitement or euphoria).
If you have a history of aggressive behaviour. Venlafaxine Alter may cause feelings of restlessness or an inability to sit still during the first few weeks of treatment. If you experience these symptoms, inform your doctor.

Medicines such as Venlafaxine Alter (so-called selective serotonin reuptake inhibitors (SSRIs) and
serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4).
In some cases, these symptoms may persist after discontinuation of treatment.
Do not drink alcohol during treatment with Venlafaxine Alter, as this may cause extreme drowsiness and loss of consciousness. Concomitant use of alcohol and/or certain medicines may worsen symptoms of depression and other conditions, such as anxiety disorders.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide.
These thoughts may increase when you first start taking antidepressants, as it takes time for these medicines to take effect, usually about two weeks but sometimes longer.
You are more likely to have these thoughts:

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Clinical study data have shown an increased risk of suicidal behaviour in young people (under 25 years of age) with psychiatric disorders treated with an antidepressant.

If at any time you experience thoughts of harming yourself or suicide, contact your doctor or go to hospital immediately.
It may be helpful to inform a close relative or friend about your depression or anxiety disorder, and ask them to read this leaflet. You may also ask them to alert you if they notice worsening of your depression or anxiety, or changes in your behaviour.
Dry mouth
Dry mouth has been reported in 10% of patients treated with Venlafaxine Alter. This may increase the risk of oral deterioration (dental caries). Therefore, you should pay particular attention to your oral hygiene.
Diabetes
In patients with diabetes, treatment with SSRIs or venlafaxine may alter glycaemic control. Adjustment of insulin or oral antidiabetic dosage may be necessary.
Children and adolescents
Venlafaxine Alter is normally not recommended for use in children and adolescents under 18 years of age. It is important to know that patients under 18 years of age taking this class of medicines are at increased risk of developing adverse reactions, including suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger).
Nevertheless, your doctor may prescribe this medicine to 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, speak with your doctor. You must inform your doctor if any of the listed symptoms appear or worsen while a patient under 18 years of age is taking Venlafaxine Alter. In addition, the long-term effects of this medicine on growth, maturation, and cognitive and behavioural development in this age group have not been established.
Other medicines and Venlafaxine Alter
Tell 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 Alter with other medicines.
Do not start or stop 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 Alter. Inform your doctor if you have taken any of these medicines within the last 14 days. (MAOIs: see section “What you need to know before taking Venlafaxine Alter”)
Serotonin syndrome: A potentially life-threatening condition or reactions resembling Neuroleptic Malignant Syndrome (NMS) (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)
Other medicines for depression, e.g. SNRIs, SSRIs, tricyclics, or medicines containing lithium
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, meperidine, or pentazocine (used for acute pain)
Medicines containing dextromethorphan (used for cough)
Medicines containing methadone (used for 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 a disease with symptoms such as hearing, seeing, or perceiving things that do not exist, false beliefs, unjustified suspicion, unclear thinking, and antisocial state)

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 Neuroleptic Malignant Syndrome (NMS).
Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by blood test).
Contact your doctor immediately, or go to the nearest hospital emergency department if you think you may have serotonin syndrome.
You must inform your doctor if you are taking medicines that may affect 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 above: serotonin syndrome)
Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
Antihistamines (used to treat allergies)

The following medicines may also interfere with Venlafaxine Alter 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 Alter with food, drinks and alcohol
You should take Venlafaxine Alter with food (see section “How to take Venlafaxine Alter”).
Do not drink alcohol during treatment with Venlafaxine Alter. Concomitant use with alcohol may cause extreme drowsiness and loss of consciousness, and may worsen symptoms of depression and other conditions such as anxiety disorders.
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 use Venlafaxine Alter only after discussing with your doctor the potential benefits and potential risks to the fetus.
Ensure that your midwife and/or doctor know that you are being treated with Venlafaxine Alter. When taken during pregnancy, similar medicines (SSRIs) 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 discolouration of the baby. These symptoms usually occur within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
If you take this medicine during pregnancy, in addition to breathing problems, another symptom the baby may have at birth is difficulty feeding. If you are concerned because your baby shows these symptoms at birth, contact your doctor and/or midwife who will assist you.
If you take Venlafaxine Alter near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Venlafaxine Alter so they can advise you on what to do.
Venlafaxine Alter is excreted in breast milk. There is a risk of adverse effects on the infant. Therefore, you should discuss this with your doctor, who will decide whether you should discontinue breastfeeding or discontinue therapy with this medicine.
Driving and using machines
Do not drive and do not use tools or operate machinery until you know how this medicine affects you.

3. How to take Venlafaxine Alter

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg daily. Your doctor may gradually increase the dose, and if necessary, up to a maximum of 375 mg daily 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 daily.
Take Venlafaxine Alter at approximately the same time each day, in the morning or evening. The capsules must be swallowed whole with liquid and must not be opened, broken, chewed, or dissolved.
Venlafaxine Alter must be taken with food.
If you have liver or kidney problems, discuss this with your doctor, as a dose adjustment of this medicine may be necessary.
Do not stop treatment with this medicine without consulting your doctor (see section “If you stop taking Venlafaxine Alter”).

If you take more Venlafaxine Alter than you should
Contact your doctor or pharmacist immediately if you take more of this medicine than prescribed.
Overdose can be life-threatening, especially when taken concomitantly with alcohol and/or certain medicines (see “Other medicines and Venlafaxine Alter”).
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 Alter
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 the next dose at the usual time. Do not take a double dose to make up for the forgotten one. Do not take more than the prescribed daily dose of Venlafaxine Alter in a single day.

If you stop taking Venlafaxine Alter
Do not stop treatment or reduce the dose without first consulting your doctor, even if you feel better. If your doctor decides that you no longer need to continue taking Venlafaxine Alter, they may instruct you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects may occur when patients discontinue treatment with this medicine, especially if stopped abruptly or if the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, lightheadedness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, 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 Alter. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the side effects listed below, do not take any more Venlafaxine Alter. Contact your doctor immediately
or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

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

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

Chest tightness, wheezing, difficulty swallowing or breathing
Severe rash, itching, or hives (raised red or pale patches on the skin that often itch)
Signs and symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, 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 heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test)
Signs of infection such as high temperature, chills, shivering, headache, sweating, flu-like symptoms. This may be due to a blood disorder leading to an increased risk of infection
Severe skin rash, which may lead to severe blistering and peeling of the skin
Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis

Other side effects that you should report to your doctor may include (the frequencies of these side
effects are included in the list “Other possible side effects” below):

Cough, wheezing and shortness of breath which may be accompanied by high temperature
Black stools or blood in stools
Itching, yellowing of the skin or eyes, or dark urine, which may be signs of liver inflammation (hepatitis)
Heart problems, such as rapid 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 stiffness), seizures
Psychiatric problems, such as hyperactivity and unusual feelings of excitement
Withdrawal syndrome (see section “How to take Venlafaxine Alter, If you stop taking Venlafaxine Alter”)
Prolonged bleeding – if you cut or injure yourself, it may take longer than usual for the bleeding to stop

Other possible side effects
Very common (may affect more than 1 in 10 people)

Dizziness; headache; drowsiness
Insomnia
Nausea; dry mouth; constipation
Sweating (including night sweats)

Common (may affect up to 1 in 10 people)

Decreased appetite
Confusion; feeling detached (or independent) from oneself; inability to reach orgasm; decreased libido; agitation; nervousness; abnormal dreams
Tremor; a feeling of restlessness or inability to sit or stand still; tingling; altered taste sensation; increased muscle tone
Vision disturbances including blurred vision; dilated pupils; inability of the eye to automatically refocus from distant to near objects
Ringing in the ears (tinnitus)
Fast heartbeat; palpitations
Increased blood pressure; flushing
Shortness of breath; yawning
Vomiting; diarrhoea
Mild rash; itching
Increased frequency of urination; inability to urinate; difficulty urinating
Menstrual irregularities such as increased bleeding or increased and irregular 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 people)

Hyperactivity, racing thoughts and reduced need for sleep (mania)
Hallucinations; feeling detached (or independent) from reality; abnormal orgasm; lack of feelings or emotions; feeling overexcited; teeth grinding
Fainting; involuntary muscle movements; coordination and balance disorders
Dizziness (especially when standing up too quickly); decreased blood pressure
Vomiting blood, black tarry stools or blood in stools; which may be signs of internal bleeding
Sensitivity to sunlight; bruising; abnormal hair loss
Inability to urinate
Muscle stiffness, spasms and involuntary movements
Slight changes in blood levels of liver enzymes

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

Seizures
Cough; wheezing 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 levels of sodium in the blood
Severe eye pain and decreased or blurred vision
Abnormal, fast or irregular heartbeat, which may lead to fainting
Severe abdominal or back pain (which may indicate a serious problem with the liver, intestine, 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 people)

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

Frequency not known (cannot be estimated from the available data)

Suicidal thoughts and suicidal behaviour: cases of suicidal ideation and suicidal behaviour have been reported during treatment with venlafaxine or immediately after stopping venlafaxine treatment (see section 2 “What you need to know before taking Venlafaxine Alter”)
Aggressiveness
Vertigo
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see section 2, Pregnancy and breastfeeding, for further information. Occasionally, Venlafaxine Alter may cause side effects that are not yet known, such as increases in blood pressure or abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium or cholesterol. More rarely, Venlafaxine Alter may reduce platelet function in your blood, leading to an increased risk of bruising and bleeding. Therefore, your doctor may wish to carry out occasional blood tests, especially if you have been taking Venlafaxine Alter for a long time.

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

5. How to store Venlafaxine Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.
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. Package contents and other information

What Venlafaxine Alter contains

The active substance is venlafaxine.

Each modified-release capsule contains 75 mg or 150 mg of venlafaxine as venlafaxine hydrochloride.

The excipients are:
75 mg hard modified-release capsules:
Capsule contents: hypromellose, methacrylic acid-ammonium methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate
Coating: basic butyl methacrylate copolymer 12.5%
Capsule shell: gelatin, titanium dioxide (E171), iron oxide red (E172)
Printing ink: shellac, iron oxide black (E172), propylene glycol (E1520)

150 mg hard modified-release capsules:
Capsule contents: hypromellose, methacrylic acid-ammonium methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate
Coating: basic butyl methacrylate copolymer 12.5%
Capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127), indigo carmine (E132)
Printing ink: shellac, iron oxide black (E172), propylene glycol (E1520)

Description of the appearance of Venlafaxine Alter and pack contents

75 mg hard modified-release capsules: opaque beige – hard gelatin capsules (size 0) of opaque beige colour containing two round, biconvex, film-coated tablets, with the imprint "VEN" on the cap and "75" on the body.

150 mg hard modified-release capsules: opaque scarlet red – hard gelatin capsules (size 00) of opaque scarlet red colour containing three round, biconvex, film-coated tablets, with the imprint "VEN" on the cap and "150" on the body.

Pack sizes: 14, 28, 30 and 98 hard modified-release capsules of 75 mg
10, 28 and 98 hard modified-release capsules of 150 mg

Marketing Authorization Holder and Manufacturer

Laboratori Alter s.r.l.
Via Egadi 7
20144 Milan, Italy

Manufacturers
Pharmathen S.A.
6, Dervenakion str.
15351, Pallini Attikis
Greece
Pharmathen International SA
Sapes, Industrial Park, Block 5
69300, Rodopi
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Venlapete 75 mg, 150 mg depotkapsler, hårde
Italy: Venlafaxine Alter 75 mg, 150 mg hard modified-release capsules
Greece: Xadevil 75 mg, 150 mg σκληρά καψάκια παρατεταμένης αποδέσμευσης