VENLAFAXINE RETARD KRKA 75 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Retard Krka 75 mg Prolonged-Release Hard Capsules EFG

venlafaxine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Venlafaxine Retard Krka and what is it used for

Venlafaxine Retard Krka contains the active substance venlafaxine.

Venlafaxine Retard Krka 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 thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. The way that Venlafaxine Retard Krka works is not fully understood but is believed to help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine Retard Krka is used to treat adults with depression. Venlafaxine Retard Krka is also used to treat adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), and panic disorder (panic attacks). Treating depression and anxiety disorders effectively is important to help you feel better. If left untreated, your condition may not improve or may get worse and become more difficult to treat.

2. What you need to know before you take Venlafaxine Retard Krka

Do not take Venlafaxine Retard Krka

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking or have taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease. Taking an irreversible MAOI with Venlafaxine Retard Krka can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine Retard Krka before you take any irreversible MAOI (see also the section “Other medicines and Venlafaxine Retard Krka” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before taking Venlafaxine Retard Krka:

• If you are taking other medicines that, when taken with Venlafaxine Retard Krka, may increase the risk of developing serotonin syndrome (see the section “Other medicines and Venlafaxine Retard Krka”)
• 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 you have an irregular heart rhythm
• If you have a history of seizures (fits)
• If you have a history of low sodium levels in your blood (hyponatraemia)
• If you have a tendency to develop bruises or have a tendency to bleed easily (a history of bleeding disorders), if you are pregnant (see Pregnancy, breast-feeding and fertility) or if you are taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots)
• If your cholesterol levels increase
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or irrationally happy)
• If you have a history of aggressive behaviour

Venlafaxine Retard Krka may cause a sensation of restlessness or difficulty sitting or standing still during the first few weeks of treatment. You should consult your doctor if this happens to you.

Do not drink alcohol while you are taking venlafaxine, as this can increase the risk of side effects. Taking venlafaxine with certain medicines or alcohol may make your depression or anxiety worse, or may cause other serious side effects, such as serious allergic reactions, severe rash, or seizures.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you can sometimes have thoughts of harming yourself or suicide. These thoughts may be more likely to occur when you first start taking antidepressants, since these medicines all take time to work, usually about 2 weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or when you stop taking Venlafaxine Retard Krka.

This is more likely to happen if:

• You have previously had thoughts about killing or harming yourself.
• You are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Sexual dysfunction

Some medicines like Venlafaxine Retard Krka (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases these symptoms have persisted after stopping treatment.

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 be careful with your dental hygiene.

Diabetes

Blood glucose levels may be altered due to Venlafaxine Retard Krka. Therefore, you may need to adjust the dosage of your diabetes medicines.

Children and adolescents

Venlafaxine Retard Krka should not normally be used in the treatment of children and adolescents under 18 years old. Also, you should know that in patients under 18 years, there is an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger) when they take this type of medicine. Despite this, your doctor may prescribe this medicine to patients under 18 years when he decides that it is in their best interest. If your doctor has prescribed this medicine to a patient under 18 years and you want to discuss this, please contact your doctor. You should inform your doctor if any of the symptoms listed above occur when these patients under 18 years are taking Venlafaxine Retard Krka. Also, long-term safety data on this medicine in children and adolescents concerning growth, maturation, and cognitive and behavioural development are not available.

Other medicines and Venlafaxine Retard Krka

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

Your doctor should decide whether you can take Venlafaxine Retard Krka with other medicines.

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

• Irreversible MAOIs, which are used to treat depression or Parkinson’s disease, should not be taken with Venlafaxine Retard Krka. Tell your doctor if you have taken these medicines within the last 14 days. (MAOI: see section “What you need to know before you take Venlafaxine Retard Krka”)
• Serotonin syndrome: a potentially life-threatening or fatal syndrome (see section “Possible side effects”) may occur with venlafaxine treatment, particularly when taken with other medicines. Examples of these medicines include:

• triptans (used for migraine)
• other medicines for treating 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 opioids (such as buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain
• medicines containing dextromethorphan (used to treat coughs)
• medicines containing methadone (used to treat opioid addiction or severe pain)
• medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• products containing St John’s Wort (also known as Hypericum perforatum, a herbal remedy used to treat mild depression)
• products containing tryptophan (used for problems such as sleep and depression)
• antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that are not there, mistaken beliefs, unusual suspiciousness, and unclear reasoning, and withdrawal syndrome)

The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, rigid muscles, confusion, and changes in breathing and blood circulation.

Tell your doctor immediately, or go to the casualty department of your nearest hospital, if you think you are experiencing serotonin syndrome.

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

Some examples of these medicines include:

• anti-arrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart rhythms)
• antipsychotics such as thioridazine (see also serotonin syndrome above)
• antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• antihistamines (used to treat allergies)

The following medicines may also interact with Venlafaxine Retard Krka and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:

• ketoconazole (an antifungal medicine)
• haloperidol or risperidone (for treating psychiatric conditions)
• metoprolol (a beta-blocker for treating high blood pressure and heart problems)

Taking Venlafaxine Retard Krka with food, drinks, and alcohol

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

Do not drink alcohol while you are taking venlafaxine. Drinking alcohol while taking venlafaxine may cause drowsiness or unconsciousness and may worsen the side effects of venlafaxine, including depression and anxiety disorders.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take Venlafaxine Retard Krka after discussing the potential benefits and risks with your doctor.

If you take Venlafaxine Retard Krka during the last month of pregnancy, you may experience an increased risk of excessive bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Venlafaxine Retard Krka so that they can advise you.

Make sure your midwife and/or doctor knows you are taking Venlafaxine Retard Krka. When similar medicines (SSRIs) are taken during pregnancy, there is a potential increased risk of a condition called persistent pulmonary hypertension in the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, in addition to problems with breathing, other symptoms your baby may have when they are born are problems with feeding. If your baby has these symptoms when they are born and you are worried, contact your doctor and/or midwife who can advise you.

Venlafaxine Retard Krka passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the case with your doctor and he will decide whether you should stop breast-feeding or stop the treatment with this medicine.

Driving and using machines

Do not drive or use tools or machines until you know how Venlafaxine Retard Krka affects you.

Venlafaxine Retard Krka contains sucrose

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

3. How to take Venlafaxine Retard Krka

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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, even up to a maximum dose of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start you on 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 per day.

Take Venlafaxine Retard Krka at approximately the same time each day, either in the morning or in the evening. The capsules should be swallowed whole with fluids and should not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard Krka should be taken with food.

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

Do not stop taking this medicine without talking to your doctor (see the section “If you stop taking Venlafaxine Retard Krka”).

If you take more Venlafaxine Retard Krka than you should

Contact your doctor or pharmacist immediately if you take more of this medicine than you were told to. You can also contact the national poison control center at 91 562 04 20, stating the medicine and the amount taken.

Overdose can be life-threatening, especially when taken with certain other medicines and/or alcohol (see “Other medicines and Venlafaxine Retard Krka”).

Symptoms of overdose may include fast heart beat, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Venlafaxine Retard Krka

If you miss 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 one dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily dose of Venlafaxine Retard Krka that has been prescribed for you in one day.

If you stop taking Venlafaxine Retard Krka

Do not stop taking your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor thinks that you no longer need Venlafaxine Retard Krka, he may ask you to reduce the dose gradually before stopping treatment completely. It is known that side effects can occur when people stop using this medicine, especially when it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, tiredness, dizziness, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, electric shock sensations, weakness, sweating, seizures, or symptoms similar to flu, vision problems, and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you how to gradually stop taking Venlafaxine Retard Krka. This may take several weeks or months. In some patients, the withdrawal may need to be very gradual over several months or longer. If you experience any of these or other symptoms that are troublesome for you, contact your doctor for further advice.

If you have any further questions on 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 all people suffer from them.

If any of the following effects occur, do not take more Venlafaxine retard Krka. Tell 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 swollen rash with itching, difficulty swallowing or breathing.

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

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching or hives (elevated areas of reddened or pale skin, which often itch).
• Signs and symptoms of serotonin syndrome that may include restlessness, hallucinations, lack 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 resemble neuroleptic malignant syndrome (NMS).

The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, acute muscle stiffness, confusion, and increased muscle enzymes (determined 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 can lead to the formation of severe blisters and skin peeling.
• Unexplained muscle pain, discomfort 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" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

Other side effects that you should tell your doctor aboutare (the frequency of these adverse effects is included in the list below "Other side effects that may occur"):

• Cough, breathing noise and difficulty breathing that may be accompanied by an increased temperature.
• Black stools (tar-like) or blood in the stool
• Itching, yellowing of the eyes or skin, dark urine, which can be 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 disorder (muscle spasms and stiffness), convulsions or seizures
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Venlafaxine Retard Krka", "If you stop treatment with Venlafaxine retard Krka").
• Prolonged bleeding time: if you cut or damage yourself, bleeding could take longer than usual to stop.

Other side effects that 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)

• Confusion, feeling detached (or disconnected) from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, a feeling of 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 change focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• 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 irregular bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, accelerated thoughts and decreased need for sleep (mania).
• Hallucinations, feeling detached (or disconnected) from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, altered coordination and balance.
• Feeling dizzy (especially when getting up too quickly), decreased blood pressure.
• Vomiting blood, black stools (deposits) or blood in the stool, which can be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urine.

• Stiffness, spasms and involuntary muscle movements.

• Mild changes in blood levels of liver enzymes.

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

• Seizures or fits.

• Cough, breathing noise and shortness of breath that may be accompanied by a high temperature.
• Disorientation and confusion often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heartbeat, rapid or irregular, which can lead to fainting.
• Severe abdominal or back pain (which can 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.

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

• 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 bruising or broken blood vessels (broken veins).

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

• Suicidal thoughts and behavior; cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. "What you need to know before taking Venlafaxine retard Krka").
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding and fertility" in section 2 for more information.
• Aggression.
• Dizziness.

Venlafaxine retard Krka sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium or cholesterol. Less frequently, Venlafaxine retard Krka may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to perform occasional blood tests, especially if you have been taking Venlafaxine retard Krka for a long time.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine retard Krka

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

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Venlafaxine retard Krka

• The active ingredient is venlafaxine. Each prolonged-release hard capsule contains 75 mg of venlafaxine as venlafaxine hydrochloride.
• The other ingredients are: sugar spheres (sucrose, corn starch), hydroxypropylcellulose (E463), povidone K30 (E1201), ethylcellulose, dibutyl sebacate and talc (E553B).
• The ingredients of the capsule are: gelatin, red iron oxide (E172), titanium dioxide (E171) and yellow iron oxide (E172). See section 2 "Venlafaxine retard Krka contains sucrose".

Appearance of the product and package contents

Prolonged-release hard capsule.

Pink capsules containing white to off-white spheres.

Package sizes:

Boxes of 10, 14, 20, 28, 30, 50, 60, 98, 100 and 112 prolonged-release hard capsules, in blisters.

HDPE child-resistant bottles with 50, 100 or 250 prolonged-release hard capsules.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the Local Representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:May 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.