Venlafaxine Combix 75 mg tablets EFG

Package Leaflet: Information for the User

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Venlafaxine Combix 75 mg Tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if the adverse effects are not listed in this leaflet.

Package leaflet

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

1. What Venlafaxina Combix is and what it is used for

Venlafaxina Combix is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or suffer from anxiety have lower levels of serotonin and norepinephrine in the brain. The way antidepressants work is not fully understood, but they may help increase the levels of serotonin and norepinephrine in the brain.

Venlafaxina Combix is a treatment for depression in adults. Properly treating depressive disorders is important to help you feel better. If left untreated, your condition may not resolve or may worsen and become more difficult to treat.

2. What you need to know before taking Venlafaxine Combix

Do not take Venlafaxine Combix

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Venlafaxine Combix.

• If you are using other medicines that, when taken together with Venlafaxine Combix, could increase the risk of developing serotonin syndrome (see section “Use of Venlafaxine Combix with other medicines”).
• 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 a history of seizures (fits).
• If you have a history of low sodium levels in the blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
• If your cholesterol levels increase.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or elated).
• If you have a history of aggressive behaviour.
• Diabetes: your blood glucose levels may be affected by venlafaxine. Therefore, the doses of your diabetes medicines may need to be adjusted.

Venlafaxine Combix may cause a feeling of restlessness or difficulty sitting or staying still. You should consult your doctor if this occurs.

Some medicines in the group to which Venlafaxine Combix belongs (called SSRIs/SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

If any of these conditions apply to you, consult your doctor before taking Venlafaxine Combix.

Do not drink alcohol during treatment with Venlafaxine Combix, as it may cause extreme drowsiness 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 anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. This risk may increase when you first start taking antidepressants, because these medicines take time to work, usually about two weeks, but sometimes longer.

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 behaviour 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.

You may find it 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 could ask them whether they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Dry mouth

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

Use in children and adolescents under 18 years of age

Venlafaxine Combix 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 behaviour, 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 the most appropriate for the patient. If your doctor prescribes this medicine to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed above develop or worsen when these patients under 18 years of age are taking Venlafaxine Combix. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development have not yet been established for this medicine.

Use of Venlafaxine Combix with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine. Your doctor must decide whether you can take Venlafaxine Combix with other medicines.

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

• Monoamine oxidase inhibitors used to treat depression or Parkinson’s disease must not be taken with Venlafaxine Combix. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOIs: see section “What you need to know before taking Venlafaxine Combix”)

• 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)
• medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
• 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 (a painkiller)
• products containing St. John’s wort (also known as “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 suspicion, 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, diarrhoea, coma, nausea, and 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.

The following medicines may also interact with Venlafaxine Combix and should be used with caution. It is especially important to tell 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 Combix with food, drinks and alcohol

Venlafaxine Combix should be taken with food (see section 3 “How to take Venlafaxine Combix”).

Do not drink alcohol during treatment with Venlafaxine Combix. Taking it together with alcohol may cause extreme drowsiness and unconsciousness, and may worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should only take Venlafaxine Combix 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 Combix. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborn babies 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 take this medicine during pregnancy, other symptoms your baby may have at birth include feeding difficulties and breathing problems. 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 Combix 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 know you are taking Venlafaxine Combix so they can advise you.

Venlafaxine Combix passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss the situation 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 medicine affects you.

Venlafaxine Combix contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Venlafaxine Combix

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

The usual recommended starting dose is 75 mg per day in divided doses, taken two or three times daily. Your doctor may gradually increase the dose, and if necessary, even up to a maximum dose of 375 mg per day for depression.

Take Venlafaxine Combix at approximately the same time each day, either in the morning or at night.

Venlafaxine Combix 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 adjusted.

Do not stop taking this medicine without consulting your doctor (see section “If you stop treatment with Venlafaxine Combix”).

If you take more Venlafaxine Combix than you should

Call your doctor or pharmacist immediately if you take more Venlafaxine Combix than prescribed by your doctor. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

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

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

If you forget to take Venlafaxine Combix

If you have missed 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 more than the daily amount of Venlafaxine Combix prescribed for you in one day.

If you stop treatment with Venlafaxine Combix

Do not stop taking this medicine or reduce the dose without the advice of your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine Combix, 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 if treatment is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, 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 Combix. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

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

4. Possible adverse effects

Like all medicines, Venlafaxine Combix may cause adverse effects, although not everyone will experience them.

Allergic reactions

If any of the following occur, do not take any more Venlafaxine Combix. Tell your doctor immediately or go to the nearest hospital emergency department:

• Chest tightness, wheezing, difficulty swallowing or breathing
• Swelling of the face, throat, hands or feet
• Feeling nervous or anxious, dizziness, prickling sensations, sudden reddening of the skin and/or a sensation of warmth
• Severe rash, itching or hives (raised areas of red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heart rate, 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).

Other adverse effects you should report to your doctor include:

• Cough, wheezing, shortness of breath and high temperature.
• Tarry stools (faeces) or blood in stools.
• Yellowing of the eyes or skin, itching, or 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, seizures or fits.
• Psychiatric problems such as hyperactivity and euphoria (unusual feeling of over-excitement).

Withdrawal effects (see section “How to take Venlafaxine Combix, If you stop taking Venlafaxine Combix”).

• Prolonged bleeding – if you cut yourself or sustain an injury, it may take slightly longer than normal for the bleeding to stop.

Complete list of adverse effects

Very common (affects more than 1 in 10 people)

• Dizziness; headache;
• Nausea; dry mouth.
• Sweating (including night sweats).

Common (affects between 1 and 10 in 100 people)

• Decreased appetite.
• Confusion; feeling detached from oneself; inability to reach orgasm; decreased libido; restlessness; insomnia; abnormal dreams.
• Drowsiness.
• Tremor; tingling; 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).
• Palpitations.
• Increased blood pressure; hot flushes.
• Yawning.
• Vomiting; constipation; diarrhoea.
• Increased frequency of urination; difficulty urinating.
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (in men); erectile dysfunction (impotence).
• Weakness (asthenia); fatigue; chills.
• Increased cholesterol.

Uncommon (affects between 1 and 10 in 1,000 people)

• Hallucinations; feeling detached from reality; agitation; abnormal orgasm (in women); lack of feelings or emotions; feeling over-excited.
• Teeth grinding.
• A sensation of restlessness or inability to sit still or remain still; fainting; involuntary muscle movements; disturbance in coordination and balance; altered taste perception.
• Rapid heartbeat; feeling dizzy (especially when standing up too quickly).
• Vomiting blood, tarry stools (faeces) or blood in stools, which may be a sign of internal bleeding.
• Generalised swelling of the skin, especially of the face, mouth, tongue, throat area or hands and feet and/or raised itchy rash (urticaria); sensitivity to sunlight; bruising;
• skin rash; abnormal hair loss.
• Inability to urinate.
• Weight gain or weight loss.

Rare (affects between 1 and 10 in 10,000 people)

• Seizures or fits.
• Inability to control urination.
• Hyperactivity, racing thoughts and decreased need for sleep (mania).

Frequency not known

• Reduced number of platelets in the blood leading to an increased risk of bruising or bleeding; blood disorders, e.g. bleeding gums, blood in urine or vomit, or unexpected bruising or broken blood vessels (broken veins), which may lead to an increased risk of infection.

• Swelling of the face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a severe allergic reaction).

• Excessive water intake (known as SIADH).

• Decreased levels of sodium in the blood.

• Suicidal thoughts and suicidal behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2 “Before taking Venlafaxine Combix”).

• Disorientation and confusion often accompanied by hallucinations (delirium); aggression.

• High temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky, uncontrolled muscle movements, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movements, clumsiness, restlessness, feeling drunk, sweating or rigid muscles, which are symptoms of serotonin syndrome; rigidity; spasms and involuntary muscle movements.

• Severe eye pain and reduced or blurred vision.

• Dizziness.

• Decreased blood pressure; abnormal, rapid or irregular heartbeat, which may lead to fainting.

• Cough, difficulty breathing, shortness of breath and high temperature, which are symptoms of lung inflammation associated with an increase in white blood cells (pulmonary eosinophilia).

• 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 symptoms of liver inflammation (hepatitis), mild changes in blood levels of liver enzymes.

• Skin rash which may lead to severe blistering and peeling of the skin; itching; mild rash.

• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis).

• Abnormal production of breast milk.

• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Venlafaxine Combix sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or an abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium or cholesterol. Less frequently, Venlafaxine Combix 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, especially if you have been taking Venlafaxine Combix for a long time.

Reporting of adverse reactions

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

5. Storage of Venlafaxine Combix

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.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Venlafaxine Combix

The active substance is venlafaxine. Each tablet contains 84.84 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine.

The other components (excipients) are: microcrystalline cellulose (E460i), lactose monohydrate, sodium starch glycolate from potato, magnesium stearate (E470b), yellow iron oxide (E172), and brown iron oxide (E172).

Appearance of Venlafaxine Combix and contents of the pack

Venlafaxine Combix 75 mg is presented as beige, speckled, oblong tablets, scored on one side and smooth on the other.

Venlafaxine Combix 75 mg is available in packs containing 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.
C/ Badajoz 2. Edificio 2.
28223 Pozuelo de Alarcón (Madrid)
Spain

Manufacturer

Combino Pharm S.L.
Fructuós Gelabert 6-8
08970 Sant Joan Despí
Barcelona
SPAIN

OR

Combino Pharm (Malta) Ltd.
HF 60, Hal Far Industrial Estate
BBG07 Hal Far
MALTA

OR

ZYDUS FRANCE
Zac Les Hautes Pâtures
Parc d'Activités des Pleupliers
25 rue des Pleupliers
92000 Nanterre (France)

OR

Centre Spécialités Pharmaceutiques
ZAC des Suzots
35 rue de la Chapelle
63450 Saint Amant Tallende
France

This leaflet was approved in May 2023.

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”