VENLAFAXINE RETARD KRKA 37.5 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Retard Krka37.5 mg Prolonged-Release Hard Capsules

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 and other information

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 it 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: generalised 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 may 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 abnormal 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 using 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 a family member has had, mania or bipolar disorder (feeling overexcited or irritable)
• If you have a history of aggressive behaviour

Venlafaxine Retard Krka may cause a sensation of restlessness or an inability to sit or stand 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 may increase the risk of side effects. Taking venlafaxine in combination with alcohol, as well as with certain other medicines, may increase the risk of side effects, including those that affect the rhythm of your heart.

Suicidal thoughts 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 start working, usually around 2 weeks, but sometimes up to 4 weeks or more. 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 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 approximately 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should pay attention to your dental hygiene.

Diabetes

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

Children and adolescents

Venlafaxine Retard Krka should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 in certain circumstances. If your doctor has prescribed this medicine to a patient under 18 and you want to discuss this, please contact your doctor. You should inform your doctor if any of the symptoms listed above occur when patients under 18 are taking Venlafaxine Retard Krka. Furthermore, the long-term safety of this medicine in terms of growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated.

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 will 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 and herbal products, before checking with your doctor or pharmacist.

• MAOIs (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. (See section “What you need to know before you take Venlafaxine Retard Krka”)
• Serotonin syndrome: a potentially life-threatening or severe reaction may occur with venlafaxine, particularly when taken with other medicines, (see section “Possible side effects”). 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 addiction to opioids or to treat 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, unclear reasoning and withdrawal)

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, diarrhoea, 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 heart rate.

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 that contain:

• 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. Taking venlafaxine with alcohol may also increase the risk of side effects, including those that affect the rhythm of your heart.

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 3 months of your pregnancy, you should be aware that the following effects may occur in your newborn baby: trouble sleeping and/or feeding, vomiting, hypoglycaemia (low blood sugar), tremors, agitation, jitteriness, fitting, fast or slow heart rate, breathing problems, bluish skin, or a high-pitched cry. If your baby develops any of these symptoms, contact your midwife or doctor as soon as possible.

Make sure your midwife and/or doctor know that you are taking Venlafaxine Retard Krka. When similar medicines (SSRIs) are taken during pregnancy, there is a risk of a condition called persistent pulmonary hypertension in the baby, which makes the baby breathe faster and may make the skin turn blue. These symptoms usually begin 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 breathing problems, your baby may have other symptoms such as difficulty feeding. If your baby has these symptoms when they are born and you are concerned, contact your doctor and/or midwife who will be able to advise you.

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

Driving and using machines

Do not drive or use any 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 depression, generalised anxiety disorder and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose, and if necessary 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 dose of 37.5 mg per day and then gradually increase the dose as necessary. The maximum dose for generalised 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 a drink of water, and not opened, crushed, chewed or dissolved.

Venlafaxine Retard Krka should be taken with food.

If you have liver or kidney problems, you may need to take a lower dose of Venlafaxine Retard Krka. Consult your doctor.

Do not stop taking Venlafaxine Retard Krka 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 should. You can also contact the national poison control centre at +34 91 562 04 20, indicating the medicine and the amount taken.

Taking more of this medicine than you should can be life-threatening, especially if taken with other medicines and/or alcohol (see the section “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, fits or seizures 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 time for your next dose, skip the missed dose and take only a single 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 a 24-hour period.

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, your dose may be reduced gradually over a period of time. When stopping Venlafaxine Retard Krka, you may experience side effects, especially if the treatment is stopped suddenly or the dose is reduced too quickly. Some patients have reported the following side effects when stopping this medicine: suicidal thoughts, aggression, dizziness, headache, insomnia, nausea, diarrhoea, anxiety, agitation, tremors, confusion, ringing in the ears, numbness or tingling, 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 on how to gradually reduce your dose and stop taking Venlafaxine Retard Krka. This may take several weeks or months. In some patients, the reduction may need to be more gradual and may take longer.

If you experience any of these or other symptoms that are troublesome, 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 red 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, 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, 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 (tarry) or blood in the stool
• Itching, yellow eyes or skin, dark urine, which may 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 may 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)

• Decreased appetite.
• Confusion, feeling separated (or detached) from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, a feeling of restlessness or inability to stay seated or still, tingling, altered taste, 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 (men), 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 separated (or detached) 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 (tarry) or blood in the stool, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.

• Stiffness, spasms and involuntary muscle movements.

• Mild changes in blood levels of liver enzymes, sodium or cholesterol.

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

• Seizures or convulsions.

• 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, rapid or irregular heartbeat, which can lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver or pancreas).
• Itching, yellow 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 discontinuation of treatment (see section 2. "What you need to know before taking Venlafaxine retard Krka").
• Severe postpartum hemorrhage (see "Pregnancy, breastfeeding and fertility" in section 2 for more information).
• Aggression.
• Vertigo.

Venlafaxine retard Krka sometimes produces unwanted effects of which you may not be aware, such as increased blood pressure or 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 37.5 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) and titanium dioxide (E171). See section 2 "Venlafaxine retard Krka contains sucrose".

Appearance of the product and package contents

Prolonged-release hard capsule.

Capsules are pinkish-brown and white (white body and pinkish-brown cap) containing white to off-white spheres.

Package sizes:

Boxes of 7, 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 with the following names:

Date of last revision of this prospectus: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