75 mg & 150 mg prolonged-release capsules, hard 
venlafaxine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet you will find information about: 
1. What Efastad is and what it is used for 
2. What you need to know before you use Efastad 
3. How to use Efastad 
4. Possible side effects 
5. How to store Efastad 
6. Contents of the packaging and other information 

1. What Efastad is and what it is used for

Efastad contains the active substance venlafaxine.

Efastad is an antidepressant drug that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors ( SNRIs ). This group of drugs is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or have anxiety have lower levels of serotonin and norepinephrine in the brain. It is not completely clear how antidepressants work, but they can help by increasing the levels of serotonin and norepinephrine in the brain.

Efastad is a treatment for adults with depression. Efastad is also a treatment for adults with the following anxiety disorders: generalized anxiety, social phobia (fear of or avoidance of social situations), and panic disorder (panic attacks). It is important to treat depression or anxiety disorders properly to help you feel better. If the condition is not treated, it may not go away, but becomes more serious and more difficult to treat.

Venlafaxine contained in Efastad may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Efastad

Do not use Efastad

  • 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 at any time within the last 14 days have taken any medicine called irreversible monoamine oxidase inhibitors ( MAOIs ) used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Efastad can cause serious or even life-threatening side effect s. Also, you must wait at least 7 days after stopping Efastad before taking an MAOI (see also the section entitled “Other medicines and Efastad” and the information in that section on “serotonergic syndrome”).

Warnings and cautions

Talk to a doctor before taking Efastad if you:

  • use other medicines as if taken with Efastad may increase the risk of developing serotonergic syndrome (see section “Other medicines and Efastad”)
  • have eye problems, such as certain types of glaucoma (increased pressure in the eye)
  • previously had high blood pressure
  • previously had heart problems
  • have been informed that you have an abnormal heart rhythm
  • previously had seizures (epileptic seizures)
  • previously had low sodium levels in the blood ( hyponatremia )
  • are prone to bruising or if you bleed easily (if you have had bleeding disorders)
  • take other medicines that may increase the risk of bleeding e.g. warfarin (used to prevent blood clots)
  • have or someone in your family has had mania or bipolar disorder (feeling of excessive excitement or euphoria )
  • previously had aggressive behavior.

Efastad may cause a feeling of restlessness or inability to stand or sit still during the first weeks of treatment. Tell your doctor if this happens to you.

Drugs such as Efastad (so-called SSRIs ) can cause symptoms of sexual dysfunction(see section 4). In some cases, these symptoms persist after discontinuation of treatment.

If you start to feel worse and have thoughts of harming yourself

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

  • if you have previously had thoughts of harming yourself or committing suicide
  • if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This can increase the risk of caries (holes in the teeth). You should therefore be extra careful with dental hygiene.

Diabetes

Efastad may alter your blood sugar levels. Does one of your drugs for diabetes may need to be adjusted.

Children and young people

Efastad should not normally be used for the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking drugs of this type. Nevertheless, this medicine can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you were given this medicine, consult your doctor again. You should also inform your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Efastad. The long-term effects of this drug on growth, maturation, and cognitive and behavioral development have not yet been established for this age group.

Other medicines and Efastad

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

Your doctor will decide if you can take Efastad with other medicines.

You should not start or stop taking any medicines, including those that you have bought without a prescription, natural and herbal medicines, before asking your doctor or pharmacist.

  • Monoamine oxidase inhibitors, which are used to treat depression or Parkinson’s disease, must not be used with Efastad. Tell your doctor if you have taken any such medicine in the last 14 days. (MAO inhibitors: see section “What you need to know before taking Efastad”)
  • Serotonergic syndrome :
  • a potentially life-threatening condition or reactions that in the case of the neuroleptic malignant syndrome (NMS), (see section “Possible side effects”) may occur during treatment with venlafaxine, especially when taken with other medicines. Examples of such include drugs that contain:
    • triptans (used for migraines )
    • lithium and other medicines to treat depression, for instance, SNRI -preparat, SSRIs -preparat, tricyclic antidepressant drugs
    • linezolid, an antibiotic (used to treat infections )
    • moclobemide, an MAOI (used to treat depression)
    • sibutramine (used for weight loss)
    • tramadol, fentanyl , tapentadol, pethidine and pentazocine (used to treat severe pain)
    • dextromethorphan (used to treat cough)
    • methadone (used to treat opioid abuse or severe pain)
    • methylene blue (used to treat high levels of methemoglobin in the blood)
    • St. John’s wort (also known as Hypericum perforatum, a traditional herbal medicine used to treat mild depression and mild anxiety)
    • tryptophan (used for sleep problems and depression)
    • antipsychotic drugs (used to treat symptoms when you hear, see or feel things that do not exist, delusions, abnormal suspicion, confusion, n, and withdrawal).

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

restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, the serotonergic syndrome can resemble malignant neuroleptic syndrome (NMS).

Signs and symptoms of NMS may include a combination of fever, rapid pulse, sweating, severe muscle stiffness, confusion, elevated levels of muscle enzymes (determined by blood tests).

Tell your doctor immediately, or go to the nearest emergency room, if you think you have serotonergic syndrome.

You must tell your doctor if you are taking medicines that may affect your heart rhythm.

Examples of these drugs are:

  • antiarrhythmics e.g. quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythms)
  • antipsychotic drugs e.g. thioridazine (see also Serotonergic syndrome above)
  • antibiotics e.g. erythromycin and moxifloxacin (used to treat infections caused by bacteria)
  • antihistamines (used to treat allergies ).

The following medicines may also affect or be affected by ( interact ) with Efastad and should be used with caution. You must tell your doctor or pharmacist if you are taking medicines that contain:

  • ketoconazole (an antifungal )
  • haloperidol or risperidone (to treat psychiatric conditions)
  • metoprolol (a beta-blocker to treat high blood pressure and heart problems).

Efastad with food, drink, and alcohol

Efastad should be taken with a meal (see section 3 “How to take Efastad”).

Avoid alcohol while taking Efastad.

Pregnancy, breastfeeding, and fertility

Pregnancy

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. Do not take Efastad until you have discussed the potential benefits and risks of your unborn baby with your doctor.

Tell your midwife and/or doctor that you are taking Efastad. When similar drugs ( SSRIs ) are used during pregnancy, the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN) may increase. This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact your midwife and/or doctor immediately.

Other symptoms besides having difficulty breathing, which your baby may have when it is born if you take this medicine during pregnancy are that the baby does not eat properly. If your baby has these symptoms when it is born and you are worried, contact your doctor and/or midwife who can advise you.

Breast-feeding

Efastad passes into breast milk. There is a risk that the child will be affected. You should therefore talk to your doctor who will decide if you should stop breast-feeding or stop treatment with this medicine.

Driving and using machines

Do not drive or use machines until you know how Efastad affects you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Efastad contains Efastad 150 mg contains sodium and the color para-orange (E110) and Allura red AC (E129)

This medicine contains less than 1 mmol sodium (23 mg) per capsule, ie essentially ‘ sodium-free’. is next to “sodium-free”.

Para-orange (E110) and Allura red AC (E129) may cause allergic reactions.

3. How to use Efastad

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

Depression

The recommended starting dose is 75 mg daily. The dose can be increased gradually by your doctor and, if necessary, up to a maximum of 375 mg daily.

Panic disorder

Your doctor will start with a lower dose (37.5 mg) and then increase the dose one step at a time. The highest dose is 225 mg daily.

Generalized anxiety or social phobia

The recommended starting dose is 75 mg daily. The highest dose is 225 mg daily.

Liver or kidney problems

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

Method of administration

Take Efastad at about the same time each day, either in the morning or in the evening.

The capsules should be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Efastad should be taken with a meal.

Do not stop taking this medicine without first consulting your doctor (see section “If you stop taking Efastad”).

If you use more Efastad than you should 

Contact your doctor or pharmacist immediately if you take more of this medicine than your doctor advised.

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

If you have taken too much of this medicine or if, for example, If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.

If you forget to use Efastad

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 only take one dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the amount of Efastad that you have been prescribed per day.

If you stop using Efastad

You should not stop taking the treatment or reduce the dose without first consulting your doctor, even if you feel better. If your doctor thinks you no longer need Efastad, he/she may ask you to reduce the dose slowly before stopping treatment altogether.

It is known that you may experience side effects when you stop taking this medicine, especially if you stop suddenly or if your dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, intoxication, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, anxiety, confusion, ringing in the ears, and crawls or, in rare cases, feeling electric shock, weakness, sweating. , seizures or flu-like symptoms.

Your doctor will tell you how to gradually stop taking Efastad. If you get any of these or other symptoms that bother you, consult your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

If any of the following occur, do not take Efastad again. Tell your doctor immediately, or go to the nearest emergency room.

Uncommon (may affect up to 1 in 100 people)

  • swelling of the face, throat, hands, or feet.

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

  • chest tightness, wheezing, difficulty swallowing or breathing
  • severe skin rash, itching or hives (raised spots of red or pale skin that often itch)
  • signs and symptoms of a serotonergic syndrome such as restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma nausea, vomiting. In its most severe form, the serotonergic syndrome can resemble malignant neuroleptic syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid pulse, sweating, severe muscle stiffness, confusion, elevated levels of muscle enzymes (determined by blood tests)
  • signs of infection, such as fever, chills, tremors, headache, sweating, flu-like symptoms. This may be due to a blood disease that leads to an increased risk of infection
  • severe rash, which can lead to severe blisters and dandruff
  • unexplained muscle aches, tenderness or weakness. This may be a sign of rhabdomyolysis.

Other side effects that you should tell your doctor are (the frequency of these side effects is included in the list of ‘Other side effects that may occur’ below):

  • cough, wheezing, and shortness of breath, which may occur along with fever
  • black (tar-like) stool or blood in the stool
  • itching, yellowish skin or yellow eyes, or dark urine, which may be symptoms of an inflammation of the liver ( hepatitis )
  • heart problems, such as fast or irregular heart rate, high blood pressure
  • eye problems such as blurred vision, dilated pupil s
  • nerve problems, such as dizziness, tingling and numbness, movement disorders (muscle spasms or stiffness), seizures
  • mental problems, such as hyperactivity and a feeling of unusual elation
  • withdrawal symptoms (see section 3 “How to take Efastad, If you stop taking Efastad”)
  • prolonged bleeding – if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Other side effects may occur

Very common (may affect more than 1 user in 10):

  • dizziness, headache, drowsiness
  • insomnia
  • nausea, dry mouth  constipation
  • sweating (even at night).

Common (may affect up to 1 in 10 people):

  • loss of appetite
  • confusion, feeling of being separated from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams
  • tremors, a feeling of restlessness or an inability to sit or stand still, numbness and tingling, altered taste sensation, increased muscle tension
  • visual disturbances including blurred vision, dilated pupils, the inability of the eye to automatically change focus from distant to near objects
  • ringing in the ears ( tinnitus )
  • fast heartbeat, palpitations
  • high blood pressure, redness
  • shortness of breath, yawning
  • vomiting, diarrhea
  • mild rash, itching
  • need to urinate more often than usual, inability to urinate, difficulty urinating
  • irregular periods such as increased bleeding or more irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction ( impotence )
  • weakness ( asthenia ), fatigue, chills
  • weight gain, weight loss
  • elevated cholesterol.

Uncommon (may affect up to 1 in 100 people)

  • overactivity, thoughtlessness, and reduced need for sleep (mania)
  • hallucinations, feeling detached from reality, abnormal orgasm, lack of emotion, feeling of excessive arousal, gnashing of teeth
  • fainting, involuntary muscle movements, impaired coordination, and balance
  • dizziness (especially if you get up too fast), decreased blood pressure
  • bloody vomiting, black tar-like stools, or blood in the stools, which may indicate internal bleeding
  • sensitivity to sunlight, bruising, abnormal hair loss
  • inability to control urine
  • stiffness, spasms, and involuntary muscle movements
  • some change in liver enzyme levels in the blood.

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

  • seizures
  • cough, wheezing, shortness of breath, which may occur along with fever
  • altered perception of space and confusion, often in combination with hallucinations ( delirium ).
  • excessive fluid intake (so-called SIADH)
  • decreased sodium levels in the blood
  • severe pain in the eyes and impaired vision or blurred vision
  • abnormal, fast, or irregular heartbeat, which can lead to fainting
  • severe pain in the abdomen or back (which may indicate a serious illness in the abdomen, life,r or pancreas)
  • itching, yellow skin or eyes, dark urine, or flu-like symptoms, which are signs of liver inflammation ( hepatitis ).

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

  • prolonged bleeding which may be a sign of decreased platelet count in the blood, leading to an increased risk of bruising or bleeding
  • abnormal production of breast milk
  • unexpected bleeding, e.g. bleeding gums, blood in the urine or bloody vomiting, or the appearance of unexpected bruising or ruptured blood vessels.

Has been reported (occurs in an unknown number of users):

  • suicidal ideation and suicidal ideation, cases of suicidal ideation and suicidal ideation have been reported during treatment with venlafaxine or immediately after stopping treatment (see section 2, What you need to know before taking Efastad)
  • aggression
  • dizziness.

Blood sample

Efastad sometimes causes side effects that you may not be aware of, such as high blood pressure or abnormal heartbeats, small changes in your blood levels of liver enzymes, sodium, or cholesterol. In rarer cases, Efastad may affect the function of the platelets in the blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to take blood samples from time to time, especially if you have been taking Efastad for a long time.

5. How to store Efastad

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Do not take this medicine if the capsules appear to be significantly discolored or show any other signs of damage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is venlafaxine .

Efastad 75 mg prolonged-release hard capsule :

Each prolonged-release capsule contains 84.9 mg venlafaxine hydrochloride equivalent to 75 mg venlafaxine .

Efastad 150 mg prolonged-release hard capsule :

Each prolonged-release capsule contains 169.8 mg of venlafaxine hydrochloride equivalent to 150 mg of venlafaxine .

Other ingredients are:

Core: microcrystalline cellulose (E460), povidone, talc (E553b), colloidal anhydrous silica (E551), magnesium stearate (E572).

Film coating: ethylcellulose, copovidone.

For the strength 75 mg:

Capsule cap: black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin.

Capsule body: black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin, red ink (composition: shellac, propylene glycol, strong ammonia solution and red iron oxide (E 172)).

For the strength of 150 mg:

Capsule cap: brilliant blue FCF (E133), allura red AC (E129), para-orange (E110), titanium dioxide (E171), gelatin.

Capsule body: brilliant blue FCF (E133), allura red AC (E129), para-orange (E110), titanium dioxide (E171), gelatin, white ink (composition: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171)).

What the medicine looks like and contents of the pack

Efastad 75 mg prolonged-release hard capsule :

Opaque peach colored, size 1 hard gelatin capsules approx. 18.90 mm to 19.70 mm with thick and thin radial circular bands on the body in red ink and thick and thin radial circular bands on the lid in red ink. The capsule contains 6 white to off-white, round, biconvex, film-coated mini-tablets of 12.5 mg each.

Efastad 150 mg prolonged-release hard capsule :

Dark orange / opaque dark orange size 0 hard gelatin capsules approx. 21.00 mm to 21.80 mm with thick and thin radial circular bands on the body in white ink and thick and thin radial circular bands on the lid in white ink. The capsule contains 12 white to off-white, round, biconvex, film-coated mini-tablets of 12.5 mg each.

Efastad 75 mg prolonged-release hard capsule :

7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 105 and 120 capsules packed in blisters (PVC / ACLAR film and aluminum foil or aluminum foil and white, opaque PVC / PVdC film).

Efastad 150 mg prolonged-release hard capsule :

10, 14, 20, 28, 30, 50, 56, 98, 100, 105 and 120 capsules packed in blisters (PVC / ACLAR film and aluminum foil or aluminum foil and white, opaque PVC / PVdC film).

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

Bad Vilbel

Germany

Other manufacturers

Centrafarm Services BV

New Donk 9

NL- 4879 AC Etten-Leur

Netherlands

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

Sanico NV

Veedijk 59

2300 Turnhout

Belgium

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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