Venlafaxine prolonged-release Cinfamed 75 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

venlafaxine retard cinfamed 75 mg prolonged-release hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What venlafaxine retard cinfamed is and what it is used for

venlafaxine retard cinfamed is an antidepressant that belongs 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 suffer from anxiety have lower levels of serotonin and noradrenaline in the brain. The way antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

venlafaxine retard cinfamed 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 avoidance of social situations), and panic disorder (panic attacks). Properly treating depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not go away or may worsen and become more difficult to treat.

2. What you need to know before taking venlafaxine retard cinfamed

Do not take venlafaxine retard cinfamed

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are currently taking or have taken at any time within the last 14 days a medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with other medicines such as venlafaxine may cause serious or even potentially life-threatening adverse effects. In addition, you must wait at least 7 days after stopping venlafaxine before starting any MAOI (see also sections “Serotonin syndrome” and “Other medicines and venlafaxine retard cinfamed”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take venlafaxine retard cinfamed

• If you are taking other medicines that, when taken together with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Other medicines and venlafaxine retard cinfamed”).
• If you have eye problems, such as certain types 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 been told that your heart rhythm is abnormal.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in the blood (hyponatremia).
• 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, e.g. warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy and breastfeeding”).
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overly excited or euphoric).
• If you have a history of aggressive behavior.

Some medicines in the same group as venlafaxine (called SSRIs/SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Venlafaxine may cause a feeling of restlessness or an inability to sit or stay still during the first few weeks of treatment. You should consult your doctor if this happens to you.

Do not drink alcohol during treatment with venlafaxine retard cinfamed, as it may cause extreme tiredness and unconsciousness. Taking it together with certain medicines and/or alcohol may worsen symptoms of depression and other conditions such as anxiety disorders.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or of suicide. This risk may increase when you first start taking antidepressants, because all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of treatment with venlafaxine.

This is more likely to happen:

• If you have previously had thoughts of suicide or of harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years of age) with psychiatric disorders who were treated with antidepressants.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to a hospital immediately.

It may be helpful to tell a close friend or family member that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of dental caries. Therefore, you should take care with your dental hygiene.

Diabetes

Your blood glucose levels may be altered by venlafaxine. Therefore, the doses of your diabetes medications may need to be adjusted.

Children and adolescents

Venlafaxine should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. You should inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking venlafaxine. In addition, the long-term safety regarding growth, maturation, and cognitive and behavioral development has not been established.

Other medicines and venlafaxine retard cinfamed

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor must decide whether you can take venlafaxine with other medicines.

Do not start or stop taking any medicine, including those available without a prescription, natural remedies, or herbal products, before checking with your doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease must not be taken with venlafaxine. Tell 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 retard cinfamed”).
• Serotonin syndrome:

A potentially life-threatening condition or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”) may occur during treatment with venlafaxine, particularly when taken with other medicines.

Examples of these medicines include:

• triptans (used for migraine),
• other medicines to treat depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium,
• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], narcolepsy, and obesity),
• medicines containing the antibiotic linezolid (used to treat infections),
• medicines containing moclobemide, a reversible MAOI (used to treat depression),
• medicines containing sibutramine (used for weight loss),
• medicines containing tramadol, fentanyl, tapentadol, meperidine, or pentazocine (used to treat severe pain),
• medicines containing dextromethorphan (used to treat cough),
• medicines containing methadone (used for opioid addiction treatment or for treating severe pain),
• medicines containing methylene blue (used to treat elevated methemoglobin levels in blood),
• 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),
• antipsychotics (used to treat a condition with symptoms such as hearing, seeing, or feeling things that are not there, false beliefs, unusual suspiciousness, unclear thinking, and tendency to withdraw).

Signs and symptoms of serotonin syndrome may include a combination of the following:

restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes 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 heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by a blood test).

Contact your doctor immediately or go to the nearest hospital emergency department if you think you are experiencing serotonin syndrome.

Tell your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of these 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 allergy).

The following medicines may also interact with venlafaxine and should be used with caution. It is especially important to inform 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 used to treat high blood pressure and heart problems).

Taking venlafaxine retard cinfamed with food, drinks, and alcohol

Venlafaxine should be taken with food (see section 3).

Do not drink alcohol during treatment with venlafaxine retard cinfamed. Taking it together with alcohol may cause extreme tiredness and unconsciousness, and may worsen symptoms of depression and other conditions such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should only take venlafaxine after discussing with your doctor the possible benefits and possible risks to the unborn child.

Make sure your midwife and/or doctor knows that you are taking venlafaxine. When similar medicines (SSRIs) are taken during pregnancy, they may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, in addition to breathing problems, another symptom your baby might have at birth is feeding difficulties. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can advise you.

If you take venlafaxine retard in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking venlafaxine so they can advise you.

Venlafaxine passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss this with your doctor, who will decide whether you should stop breastfeeding or stop treatment with this medicine.

Driving and using machines

During treatment with venlafaxine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this treatment affects you.

venlafaxine retard cinfamed contains sucrose.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take venlafaxine retard cinfamed

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual 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, further increase it 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 lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Take venlafaxine at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine should be taken with food.

If you have liver or kidney problems, speak with your doctor, as your dose of this medicine may need to be different.

Do not stop taking this medicine without consulting your doctor (see section “If you stop taking venlafaxine retard cinfamed”).

If you take more venlafaxine retard cinfamed than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see Taking venlafaxine retard cinfamed with other medicines).

Symptoms of a possible overdose may include rapid heartbeat, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take venlafaxine retard cinfamed

If you have missed a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only your next single dose as usual. Do not take a double dose to make up for missed doses. Do not take more than the daily amount of venlafaxine prescribed for you in one day.

If you stop taking venlafaxine retard cinfamed

Do not stop your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need venlafaxine, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop using this medicine, especially when it is stopped suddenly or when the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, lack of coordination, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with venlafaxine. This may take several weeks or months. In some patients, discontinuation may need to be very gradual over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for advice.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

If you experience any of the following effects, stop taking venlafaxine immediately and contact your doctor right away 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 or feet and/or swollen itchy rash, difficulty swallowing or breathing.

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

• Chest tightness, noisy breathing, difficulty swallowing or breathing.
• Severe skin rash, itching or hives (raised red or pale areas of skin that often itch).
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes 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 heartbeat, sweating, severe muscle stiffness, confusion, and increased muscle enzymes (detected by a blood test).
• Signs of infection such as increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can lead to an increased risk of infection.
• Severe rash, which may progress to the formation of serious blisters and peeling of the skin.
• Unexplained muscle pain, discomfort or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

• Signs and symptoms of a condition called “stress cardiomyopathy,” which may include chest pain, difficulty breathing, dizziness, fainting, or irregular heartbeats.

Other adverse effects you should report to your doctor (the frequency of these adverse effects is included in the list below, “Other adverse effects”):

• Cough, noisy breathing, and difficulty breathing, which may be accompanied by increased temperature.
• Tarry stools or blood in the stool.
• Itching, yellowing of the eyes or skin, dark urine, which are symptoms 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 and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of over-excitement).
• Withdrawal effects (see section “How to take venlafaxine retard cinfamed. If you stop taking venlafaxine retard cinfamed”).
• Prolonged bleeding; if you cut yourself or sustain a wound, it may take slightly longer than normal for the bleeding to stop.

Do not be concerned if you notice small granules or white beads in your stools after taking this medicine. Inside the venlafaxine capsules are spheroids or small white beads that contain the active substance (venlafaxine). These spheroids are released from the capsule in the stomach. As they pass through the stomach and intestines, venlafaxine is slowly released. The “shell” of the spheroid does not dissolve and is eliminated in the stools. Therefore, even though you may see spheroids in your stools, the full dose of the medicine has been absorbed.

Other adverse effects that may occur:

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

• Dizziness, headache, drowsiness.
• Insomnia.
• Nausea, dry mouth, constipation.
• Excessive sweating (including night sweats).

Common (may affect up to 1 in 10 patients)

• Decreased appetite.
• Confusion, feeling strange, anorgasmia, decreased libido, agitation, restlessness, abnormal dreams.
• Tremor, feeling of inner restlessness or inability to remain seated or still, tingling, altered taste perception, increased muscle tone.
• Visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flushes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased bleeding or increased irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or weight loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 patients)

• Hyperactivity, racing thoughts, and reduced need for sleep (mania).
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, disturbance in coordination and balance.
• Feeling dizzy (especially when getting up too quickly), decreased blood pressure.
• Vomiting blood, tarry stools (faeces) or blood in the stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Muscle stiffness, spasms, and involuntary muscle movements.
• Slight changes in blood levels of liver enzymes.

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

• Seizures or fits.
• Cough, noisy breathing, 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 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 in the intestine, liver, or pancreas).
• Itching, yellowing of the eyes or skin, dark urine, 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 due to a reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding.
• Abnormal production of breast milk.
• Unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or the appearance of unexpected bruising or broken blood vessels (broken veins).

Frequency not known (cannot be estimated from available data)

• Suicidal thoughts and suicidal behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2 “What you need to know before starting to take venlafaxine retard cinfamed”).
• Aggression.
• Vertigo.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy and breastfeeding” in section 2 for more information.

Venlafaxine sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or an abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium or cholesterol. Less frequently, venlafaxine may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to carry out occasional blood tests, particularly if you have been taking venlafaxine for a long time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of venlafaxine retard cinfamed

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Keep in a dry place.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of venlafaxine retard cinfamed

• The active substance is venlafaxine (as hydrochloride). Each capsule contains 75 mg of venlafaxine (as venlafaxine hydrochloride).
• The other components are sugar spheres 20 (sucrose and maize starch), stearic acid, ethylcellulose and talc. The components of the capsule shell are: gelatin and titanium dioxide (E-171).

Appearance of the product and contents of the container

venlafaxine retard cinfamed is presented as prolonged-release hard capsules. The capsules have a white opaque cap and body made of hard gelatin and contain white or almost white pellets.

venlafaxine retard cinfamed is available in Al/PVDC-PVC/PVDC blisters.

Each pack contains 30 or 500 capsules (clinical pack) of prolonged-release hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Farmalider S.A.

Aragoneses, 2

28108 (Alcobendas) Madrid

Spain

Or

Starpharma Ltd.

Industrial State

Half Far - Malta

Or

VALPHARMA INTERNATIONAL S.p.A.

Via G. Morgagni, 2

61016 Pennabilli (Pesaro-Urbino)

Italy

Or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10.

Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: May 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69162/P_69162.html

QR code link: https://cima.aemps.es/cima/dochtml/p/69162/P_69162.html