ZAREDROP 75 mg /Ml Roztwór Doustny

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1. Zaredrop 75 mg/ml oral solution
   1. What Zaredrop is and what it is used for
   2. What you need to know before taking Zaredrop
   3. How to take Zaredrop
   4. Possible side effects
   5. How to store Zaredrop
   6. Contents of the pack and other information

Zaredrop 75 mg/ml oral solution

Venlafaxine hydrochloride

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 pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Zaredrop is and what it is used for
• 2. What you need to know before you take Zaredrop
• 3. How to take Zaredrop
• 4. Possible side effects
• 5. How to store Zaredrop
• 6. Contents of the pack and other information

1. What Zaredrop is and what it is used for

Zaredrop is an antidepressant that belongs to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRI). These drugs are used for the treatment of depression and other conditions, such as anxiety disorders. It is believed that individuals suffering from depression and/or anxiety have lower levels of serotonin and norepinephrine in the brain. The mechanism of action of antidepressants is not yet fully understood, but these drugs may be helpful by increasing the levels of serotonin and norepinephrine in the brain.
Zaredrop is a treatment for adults suffering from depression. Adequate treatment of depression is important to help you feel better. If left untreated, your illness may not resolve and can become more serious and more difficult to treat.

2. What you need to know before taking Zaredrop

Do not take Zaredrop

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have taken in the last 14 days medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used in the treatment of depression or Parkinson's disease. The concomitant use of irreversible MAOIs and other drugs, including Zaredrop, can cause serious side effects, which may be potentially fatal. Also, you will need to wait at least 7 days after you have stopped taking Zaredrop before starting to use any MAOI (also see the section entitled “Serotonin syndrome” and “Other medicines and Zaredrop”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zaredrop

• If you are using other medicines that, if taken with Zaredrop, could increase the risk of serotonin syndrome (see the section entitled “Other medicines and Zaredrop”).
• If you are using other medicines that, if taken with Zaredrop, could alter your heart rhythm (see the section entitled “Other medicines and Zaredrop”).
• If you have eye problems, such as certain forms 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 that you have an abnormal heart rhythm
• If you have a history of seizures (convulsions).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you are prone to bruising or bleeding easily (history of bleeding disorders) or if you are taking other medicines that could increase the risk of bleeding, e.g. warfarin (used to prevent blood clots) or if you are pregnant (see "Pregnancy, breastfeeding and fertility”).
• If your cholesterol levels are increasing.
• If you are taking medicines indicated for weight loss (including fenfluramine).
• If you or a family member has had or has episodes of mania or bipolar disorder (feeling of overexcitement or euphoria).
• If you have a history of aggressive behavior.
• If your doctor has told you that you have an intolerance to certain sugars, contact them before using this medicine, as your blood glucose levels may be altered by Zaredrop. Therefore, it may be necessary to adjust the dosage of your diabetes medicines. Zaredrop can cause a feeling of restlessness or inability to stand or sit during the first weeks of treatment. If this happens to you, tell your doctor. If any of these conditions apply to you, we advise you to talk to your doctor before taking Zaredrop.

Medicines such as Zaredrop (so-called selective serotonin reuptake inhibitors -
noradrenaline (SNRIs)) can cause symptoms of sexual dysfunction (see section 4). In
some cases, persistence of these symptoms has been observed after discontinuation of treatment.
Do not drink alcohol during treatment with Zaredrop as this may cause extreme fatigue and
loss of consciousness. Concomitant use with alcohol and/or certain medicines may worsen the
symptoms of depression and other conditions, such as anxiety disorders.
Suicidal thoughts and worsening of depression or anxiety disorder.
If you feel depressed and/or suffer from anxiety disorders, you may sometimes think about harming yourself or committing suicide.
These thoughts may increase when you start treatment with antidepressants, as these
drugs need time to show their effect, usually about two weeks, sometimes longer. These thoughts may also occur when the dose is reduced or during
discontinuation of treatment with Zaredrop.
You may experience these thoughts:

• If you have thought about killing yourself or harming yourself in the past.
• If you are a young adult. Information collected in clinical studies has shown an increased risk of suicidal behavior in young adults (under 25 years of age) with psychiatric illnesses treated with antidepressants. If at any time you think you want to harm yourself or commit suicide, tell your doctor or go to the hospital immediately. It may be comforting to confide in a relative or friend that you are depressed or have disorders

believe that your depression or anxiety is getting worse or if they are concerned about changes in
your behavior.
Dry mouth
This effect has been reported in 10% of patients treated with venlafaxine. This symptom
may increase the risk of tooth decay. For this reason, careful oral hygiene is required.
Diabetes
Your blood glucose levels may be altered by the use of Zaredrop. Therefore, the
dosage of your diabetes medicines may require adjustment.
Children and adolescents
Zaredrop is generally not to be used in children and adolescents under 18
years of age. In addition, it should be known that patients under 18 years of age have a higher risk of
adverse effects, such as suicide attempts, suicidal thoughts and hostility (mainly
aggression, hostile behavior and anger) when using this class of drugs. However, the
doctor may prescribe Zaredrop to patients under 18 years of age if they believe that this
is best for them. If your doctor has prescribed Zaredrop to a patient under 18 years of age, and you wish to discuss it, please contact him. If any of the above symptoms
should occur or worsen in patients under 18 years of age treated with Zaredrop, you should
inform your doctor. Furthermore, the long-term effects of
Zaredrop on physical development, maturation and cognitive and behavioral development in this
age group have not yet been evaluated.

Other medicines and Zaredrop
Please tell your doctor or pharmacist if you are taking, have recently taken or might
take other medicines.
The doctor will need to decide whether you can take Zaredrop with other medicines.
Do not start or stop taking any medicine, including over-the-counter medicines, herbal or natural products, before consulting your doctor or pharmacist.

• Monoamine oxidase inhibitors, used in the treatment of depression or Parkinson's disease must not be taken with Zaredrop. Tell your doctor if you have taken these medicines in the last 14 days (MAOIs: see the section “What you need to know before taking Zaredrop”).
• Serotonin syndrome, a potentially life-threatening condition or reactions similar to neuroleptic malignant syndrome (NMS) (see the section “Possible side effects”), may occur following treatment with venlafaxine, particularly if taken in combination with other medicines. Examples of these medicines are:
• Triptans (used for migraine)
• Medicines for the treatment of depression, such as serotonin and noradrenaline reuptake inhibitors (SNRIs), or serotonin reuptake inhibitors (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, medicines containing buprenorphine or pentazocine (used to treat severe pain)
• Medicines containing dextromethorphan (used to treat cough)
• Medicines containing methadone (used to treat opioid substance dependence or severe pain)
• Medicines containing methylene blue (used to treat high levels of methemoglobin in the blood)
• Products containing St. John's wort (also called Hypericum

Perforatum, a herbal or natural remedy used to treat
mild depression)

• Products containing tryptophan (used for problems such as sleep disorders and depression)
• Antipsychotics (used to treat symptoms such as hearing, seeing or perceiving non-existent things, having false beliefs, unusual suspicions or confused thinking, or estrangement).

The signs and symptoms of serotonin syndrome may include a combination of the
following manifestations: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood
pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can manifest as
neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, accelerated heartbeat, sweating, severe muscle rigidity,
confusion and increased muscle enzymes (evaluated through a blood test).

Seek immediate help from your doctor or go to the nearest hospital emergency room if you think you have serotonin syndrome.
The following medicines can interact with venlafaxine and alter the heart rhythm, and therefore their co-administration should be avoided:

• Antiarrhythmics (medicines such as quinidine, amiodarone, sotalol or dofetilide)
• Some medicines used to treat psychiatric conditions (thioridazine).(See also above: “Serotonin syndrome”)
• Some antibiotics such as erythromycin or moxifloxacin
• Some antihistamines

Cases of unintended pregnancies have been reported in subjects taking contraceptives
during treatment with venlafaxine.
There is no clear evidence that these pregnancies were the result of a pharmacological interaction
with venlafaxine. Tell your doctor if you are taking oral contraceptives.
The following medicines can interact with Zaredrop and must be used with caution. It is
particularly important to tell your doctor or pharmacist if you are taking medicines containing:

• ketoconazole, itraconazole, voriconazole, posaconazole (antifungal medicines)
• clarithromycin, telithromycin (antibiotics used to treat infections)
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used in the treatment of HIV infections)
• haloperidol, risperidone, diazepam or imipramine (for the treatment of psychiatric disorders)
• metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Zaredrop with food, drinks and alcohol
Zaredrop must be taken with food and the solution must be diluted with water before
administration (see section 3 “How to take Zaredrop”).
Do not drink alcohol during treatment with Zaredrop. Concomitant use with alcohol may cause
extreme fatigue and loss of consciousness and worsen the symptoms of depression and other
conditions, such as anxiety disorders.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before taking this medicine.
You should only use Zaredrop after discussing the potential benefits and potential
risks to the fetus with your doctor.
Make sure your midwife and/or doctor know that you are taking Zaredrop. If used in
pregnancy, similar medicines (SSRIs) can increase the risk of a serious illness in the
baby, called persistent pulmonary hypertension of the newborn (PPHN), which causes
accelerated breathing in the baby, which thus takes on a bluish tinge. These
symptoms usually start during the first 24 hours after the baby's birth. If this happens to
your baby, contact your midwife and/or doctor immediately.
If you are taking Zaredrop during pregnancy, tell your midwife and/or doctor, as
your baby may experience other symptoms after birth. These include difficulty
feeding and breathing problems.
In most cases, these symptoms are observed immediately or within 24 hours of birth.
If your baby presents these symptoms at birth and you are concerned, contact the
doctor and/or midwife who will be able to advise you.
Zaredrop is excreted in breast milk. There is a risk of side effects in the breastfed baby, which may cause crying, irritability and sleep disturbances. Withdrawal symptoms have been observed in newborns after discontinuation of breastfeeding. Therefore, you should
discuss this with your doctor, who will decide whether to stop breastfeeding or discontinue therapy
with Zaredrop.
If you take Zaredrop near the end of pregnancy, there may be an increased risk of
heavy vaginal bleeding shortly after delivery, especially if you suffer from bleeding disorders
(easy bleeding). Tell your doctor or midwife/obstetrician that you are
taking Zaredrop, so they can advise you on what to do.

Driving and using machines
Do not drive vehicles or use tools or machinery until you know how Zaredrop affects
you.

Zaredrop contains sorbitol
This medicine contains 300 mg of sorbitol per ml.
Sorbitol is a source of fructose. If your doctor has told you (or your child) that you are intolerant to
certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic
disease in which patients cannot metabolize fructose, talk to your doctor before you (or your
child) take this medicine.
This medicine contains 1 mg of sodium benzoate per ml.

Zaredrop contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘sodium-free’.

Zaredrop contains ethanol
This medicine contains 15.8 mg / ml of ethanol (anise flavoring agent) which is
equivalent to 1.58% p / v. Therefore, a dose of 1 ml of Zaredrop is equivalent to less than 1 ml of beer
or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Zaredrop

Always take this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
The bottle is equipped with a graduated adapter syringe and is closed with a child-resistant
screw cap.
0.5 ml of solution is equivalent to 37.5 mg of venlafaxine base.
To draw the prescribed dose of solution, insert the syringe into the adapter.
Holding the syringe attached to the bottle, rotate the bottle upside down.
Gently pull the plunger down and draw the prescribed dose.
Eliminate any air bubbles present by gently tapping the body of the syringe and
slowly pressing the plunger.
The recommended initial dose for the treatment of depression is 75 mg/day, divided into two
daily administrations. The dose may be gradually increased by your doctor, if
necessary, up to a maximum dose for the treatment of depression of 375 mg per
day.
Take Zaredrop at approximately the same time each day, in the morning and in the evening. Zaredrop must be taken with
a full stomach.
The solution must be diluted with water before use.
For oral use.
If you have liver or kidney problems, tell your doctor, as a different dose of Zaredrop may be necessary.
Do not stop taking Zaredrop without discussing it with your doctor (see the section “If
you stop taking Zaredrop”).

If you take more Zaredrop than you should
If you should take an amount of Zaredrop greater than that prescribed by your doctor, call
your doctor or pharmacist immediately.
Overdosage can be life-threatening, especially with concomitant use of alcohol
and/or certain medicines (see “Other medicines and Zaredrop”).
Symptoms of a possible overdose may include rapid heartbeat, changes in
level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or epileptic
attacks, and vomiting.

If you forget to take Zaredrop
If you miss a dose, take it as soon as you remember. However, if it is time to take the next one,
do not make up for the missed dose and take only a single dose as usual. Do not take in
a single day more than the daily amount of Zaredrop that has been prescribed to you.

If you stop taking Zaredrop
Do not stop treatment and do not reduce the dose without the advice of your doctor, even if you
feel better. If your doctor believes that it is no longer necessary to take Zaredrop, they may ask you to
reduce the dose slowly, before stopping treatment completely. It is known that stopping
treatment with Zaredrop causes the appearance of side effects, especially when
Zaredrop is stopped abruptly or if its dosage is reduced too quickly. Some
patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness,
lightheadedness, headache, insomnia, nightmares, dry mouth, loss of appetite,
nausea and/or vomiting, tremor, diarrhea, nervousness, agitation, confusion, ringing in the
ears (tinnitus), tingling or, rarely, electric shock sensations, weakness, sweating,
seizures or flu-like symptoms, vision problems and increased blood pressure
(which can cause headache, dizziness, ringing in the ears, sweating, etc.).
Your doctor will advise you on how to gradually stop treatment with Zaredrop.
This operation may take several weeks or months. In some patients, it may be necessary
that the discontinuation occurs very gradually over months or longer periods.
If you experience any of these symptoms or other bothersome symptoms, consult your doctor for
further advice.
If you have any further doubts regarding the use of the product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following manifestations occur, stop taking Zaredrop. Inform your doctor immediately, or go to the emergency room of the nearest hospital:

Uncommon (may affect up to 1 in 100 people)
Swelling of the face, mouth, tongue, throat, hands or feet and/or a raised, itchy rash
(urticaria), difficulty swallowing or breathing.
Rare (may affect up to 1 in 1,000)

• Feeling of tightness in the chest, wheezing, difficulty swallowing or breathing
• Nervousness or anxiety, dizziness, feeling of palpitations, sudden flushing of the skin and/or hot flushes
• Intense rash, itching or urticaria (raised, red or pale skin patches that often itch)
• Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, increased heart rate, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting. In its most severe form, serotonin syndrome can manifest as Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, increased heart rate, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (assessed through a blood test).
• Signs of infection, such as high fever, chills, tremors, headache, sweating, flu-like symptoms. This may be due to a blood disorder that causes an increased risk of infection.
• Severe rash, which may lead to severe blisters and peeling of the skin;
• Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.

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

• Signs and symptoms of a condition called "stress cardiomyopathy" which may include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Other side effects, about which you should inform your doctor, include: (The frequency of these
side effects is included in the list "Other side effects that may occur" below)

• Cough, wheezing, difficulty breathing and fever
• Black (tarry) stools or blood in the stools
• Yellowing of the skin or eyes, itching, dark urine, which may be symptoms of liver inflammation (hepatitis)
• Heart disorders, such as rapid or irregular heartbeat, increased blood pressure
• Eye disorders, such as blurred vision, dilated pupils
• Nervous disorders, such as dizziness, tingling, movement disorders (muscle spasms or stiffness), convulsions or seizures
• Psychiatric disorders, such as hyperactivity and euphoria (feeling unusually excited)
• Withdrawal symptoms from treatment (see the paragraph “How to take Zaredrop - If you stop taking Zaredrop”)
• Prolonged bleeding - if you cut or injure yourself, it may take longer than usual for the bleeding to stop.

Other side effects may occur:
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)

• reduced appetite
• confusion; feeling of separation (or detachment) from oneself
• lack of orgasm; reduced sexual desire
• agitation; nervousness; abnormal dreams
• tremor; feeling of restlessness or inability to sit or stand still; tingling; altered taste; increased muscle tension
• vision disorders, including blurred vision; dilated pupils; inability of the eye to focus on objects, from far to near
• ringing in the ears (tinnitus)
• fast heartbeat; palpitations
• increased blood pressure; hot flushes
• shortness of breath; yawning
• vomiting; diarrhea
• mild rash; itching;
• increased frequency of urination; inability to urinate; difficulty urinating
• menstrual irregularities such as increased bleeding or irregular and increased bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
• weakness (asthenia); fatigue; chills
• increased cholesterol levels
• weight gain, weight loss
• drowsiness

Uncommon (may affect up to 1 in 100 people)

• hallucinations; feeling of separation or detachment from reality; abnormal orgasm; lack of feelings or emotions; feeling of overstimulation or euphoria; teeth grinding;
• Hyperactivity, racing thoughts and decreased need for sleep (mania);
• fainting; involuntary muscle movements; alterations in coordination and balance; feeling of dizziness (especially when getting up too quickly) decreased blood pressure;
• vomiting blood; black stools or presence of blood in the stools, which may be a sign of internal bleeding
• hypersensitivity to daylight; bruising; rash; abnormal hair loss
• involuntary loss of urine
• rigidity, spasms and involuntary movements of the muscles
• mild changes in blood levels of liver enzymes.

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

• convulsions or seizures
• cough, wheezing and shortness of breath which may be accompanied by a high temperature
• disorientation and confusion often accompanied by hallucinations (delirium)
• excessive intake of water (known as SIADH)
• decreased levels of sodium in the blood
• 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 intestines, liver or pancreas)
• itching, yellowing of the skin or eyes, dark urine or flu-like symptoms, which are symptoms of liver inflammation (hepatitis)

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

• Prolonged bleeding, which may be a sign of a reduced number of platelets in the blood, resulting in an increased risk of bruising or bleeding;
• Abnormal production of breast milk
• Unexpected bleeding, e.g. bleeding gums, blood in the urine or vomit, or the appearance of unexpected bruises or rupture of blood vessels (rupture of veins)

Not known (frequency cannot be estimated from the available data)

• thoughts of self-harm or suicide; cases of suicidal ideation and suicidal behavior have been reported during therapy with venlafaxine or immediately after discontinuation of treatment (see paragraph 2, “What you need to know before taking Zaredrop”);
• aggression;
• vertigo;
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see paragraph 2 “Pregnancy, breastfeeding and fertility” for more information.

Zaredrop sometimes causes side effects that you may not notice, such as increased
blood pressure or abnormal heartbeat; mild changes in the levels of liver enzymes,
sodium and cholesterol in the blood. Less frequently, Zaredrop can reduce the function of
platelets in the blood, leading to an increased risk of bruising and bleeding. Therefore, the
doctor may occasionally want to perform blood tests, especially if you have taken
Zaredrop for a long period of time.
If any of the side effects should worsen, or if you notice any concerning or unusual effects
tell your doctor, pharmacist or nurse.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Zaredrop

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad”. The expiry
date refers to the last day of that month.
Store in the original package and keep the bottle in its outer cardboard box.
After first opening, the solution is valid for 4 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zaredrop contains
The active ingredient is venlafaxine hydrochloride. Each ml of oral solution contains 84.86 mg of
venlafaxine hydrochloride corresponding to 75 mg of venlafaxine.
The other ingredients are:
Liquid sorbitol E420, sodium saccharin E954, sodium benzoate E211, anise flavour (anethole,
water, ethanol), sodium hydroxide, concentrated hydrochloric acid, purified water.

Description of the appearance of Zaredrop and contents of the pack
Zaredrop is a clear and colourless or slightly yellowish oral solution. It is supplied in
a bottle containing 60 ml of solution equipped with an adapter syringe and a graduated syringe
for administering the medicine.

Marketing Authorisation Holder
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milano
Italy
Tel: +39.02.64431
Fax: +39.02.644346
e-mail: [email protected]
Manufacturer
Italfarmaco S.A.
28108 Alcobendas (Madrid) (E), San Rafael, 3 Polig. Industrial Alcobendas
Tel: +34.916572323
Fax: +34. 916572361
E-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: ZAREDROP 75 mg/ml Oral solution
Greece: ZAREDROP 75 mg/ml Πόσιμο διάλυμα
Spain: ZAREDROP 75 mg/ml Solución oral
Portugal: ZAREDROP 75 mg/ml Solução oral