10 mg, 20 mg film-coated tablets
escitalopram

What Premalex is and what it is used for

Premalex contains the active substance escitalopram, Premalex belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ). These drugs act on the serotonin system in the brain by increasing serotonin levels.

Premalex is used to treat the premenstrual dysphoric syndrome. Premenstrual dysphoric syndrome is a condition in which one suffers from increased irritability and depression (and often also other symptoms) during the week or weeks before menstruation but is completely problem-free during the period after menstruation. To treat this condition, your symptoms should be so severe that they affect your quality of life, social life, and/or ability to work. Your doctor can assess if your condition is severe enough.

Escitalopram, the active substance in Premalex, may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Premalex

Do not use Premalex

  • if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking medicines that belong to a group called MAO inhibitors, including selegiline (used to treat Parkinson’s disease ), moclobemide (used to treat depression), and linezolid (an antibiotic ).
  • if you have been born with or have had a period of abnormal heart rhythm (as observed with ECG, a method that examines how the heart works).
  • if you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 “Take special care with Premalex”).

Warnings and cautions

Talk to your doctor or pharmacist before taking Premalex. Tell your doctor if you have other diseases. This is especially true if you:

  • have epilepsy. Treatment with Premalex should be discontinued if you experience seizures for the first time or if the seizures occur at more frequent intervals (see section 4 “Possible side effects”).
  • have impaired liver or kidney function (your doctor may need to adjust the dose of Premalex).
  • have diabetes. Treatment with Premalex may affect your blood sugar level. The dose of one of the insulin and/or blood glucose-lowering tablets may need to be changed.
  • have decreased levels of sodium in the blood.
  • tend to easily get bleeding or bruising.
  • have coronary heart disease.
  • have or previously had problems with increased pressure in the eyes (such as certain types of glaucoma or glaucoma ).
  • suffers from or has suffered from heart problems or recently had a heart attack.
  • have a low resting heart rate and/or know that you have a salt deficiency due to prolonged severe diarrhea and vomiting or use diuretics ( diuretics ).
  • experiencing a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate abnormal heart rhythm function.

Note

Some patients with depressive disorder taking Premalex may have manic symptoms. This is characterized by unusual and rapidly changing thoughts, unmotivated joy, and excessive physical activity. Contact your doctor if you experience these symptoms.

Symptoms such as restlessness and difficulty sitting or standing still may occur during the first weeks of treatment. However, these symptoms appear to be uncommon in the treatment of the premenstrual dysphoric syndrome. Contact your doctor immediately if you experience these symptoms.

Drugs such as Premalex (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Premenstrual disorders associated with depression/anxiety disorder

Premalex should only be used for the treatment of premenstrual dysphoric syndrome, ie for the condition that means that you suffer from increased irritability and depression (and often also other symptoms) during the week or weeks before menstruation, but is completely problem-free during the period after menstruation. Some patients with depression or anxiety disorders may experience symptoms that worsen during the period before menstruation, but they are still not completely free of problems during the period between menstruation and ovulation. Such conditions should not be misinterpreted as a premenstrual dysphoric syndrome, and should not be treated with Premalex. Should you be depressed and/or have anxiety symptoms also during the period between menstruation and ovulation, or if you are unsure whether your symptoms only occur during the week or weeks before menstruation,

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

The active substance in Premalex, ie escitalopram, is also used in other medicines to treat depression and anxiety disorders. You who are depressed and/or suffer from worry/anxiety can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for a drug of this type 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 go to the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It can 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.

Children and young people

Premalex should not normally be used in 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. Despite this, Premalex can be prescribed by a doctor to patients under the age of 18, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you received this medicine, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for children and adolescents under 18 years of age.

Other medicines and Premalex

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

Be especially careful to tell your doctor about the following medications:

  • “Non-selective monoamine oxidase inhibitors” (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, you must wait 14 days before starting Premalex. After stopping treatment with Premalex, you must wait 7 days before taking any of these medicines.
  • “Reversible, selective MAO-A inhibitors” containing moclobemide (antidepressant).
  • “Irreversible MAO-B inhibitors” containing selegiline (medicines for Parkinson’s disease ). These increase the risk of side effects.
  • Linezolid, an antibiotic .
  • Lithium (medicine for manic-depressive illness) and tryptophan.
  • Imipramine and desipramine (antidepressants).
  • Triptans eg sumatriptan (medicine for migraines ) and opioids er eg tramadol (medicine for severe pain). These medicines increase the risk of serotonergic syndrome (see section 4 “Possible side effects”).
  • Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections), and fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of blood clots). These can cause increased levels of escitalopram in the blood.
  • St. John’s wort (Hypericum perforatum – an herbal remedy for depression).
  • Acetylsalicylic acid and NSAIDs (analgesics or blood thinners, so-called anticoagulants ). They may increase the tendency to bleed.
  • Warfarin, dipyridamole, and phenprocoumon (blood thinners, called anticoagulants ). When starting and stopping Premalex treatment, your doctor will probably check your blood clotting time to make sure your dose of anticoagulants is appropriate.
  • Mefloquine (malaria medicine), bupropion (medicine for depression), and tramadol (medicine for severe pain) due to a possible risk of lowering the seizure threshold.
  • Neuroleptics (medicines for schizophrenia, and psychosis ) and antidepressants (tricyclics and SSRIs) due to a possible risk of lowering the seizure threshold.
  • Metoprolol, flecainide, and propafenone (used in various cardiovascular diseases) clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose one of Premalex may need to be adjusted.
  • Drugs that lower blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take Premalex if you are taking medicines for heart rhythm problems or medicines that can affect your heart rhythm, such as Class 1A and III antiarrhythmics, antipsychotics (eg phenothiazines, pimozide, haloperidol ), tricyclic antidepressants, certain antimicrobial medicines (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial drugs, especially halofantrine ), certain antihistamines (astemizole, mizolastine). If you have any further questions on the use of this product, ask your doctor.

Premalex with food, drink, and alcohol

Premalex can be taken with or without food (see section 3 “How to use Premalex”).

As with many other medicines, the use of alcohol during treatment with Premalex is not recommended, although Premalex is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or planning to become pregnant. As premenstrual symptoms stop in connection with pregnancy, there is never a reason to take Premalex during pregnancy, and treatment should be stopped.

In pregnancies where medicines containing escitalopram, the active substance of Premalex, have been used during the last three months until delivery, the following symptoms have been reported in the newborn: difficulty breathing, bluish skin, cramps, difficulty regulating body temperature, difficulty breastfeeding, vomiting, low blood sugar, tense or slack muscles, overactive reflexes, tremors, jerky, irritability, listlessness, persistent crying, increased sleepiness and difficulty sleeping. If your child gets any of these symptoms, contact your doctor or midwife as soon as possible.

Tell your midwife or doctor that you are using Premalex. When medicines containing escitalopram, the active substance in Premalex, are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). 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 a midwife or doctor immediately.

Premalex is expected to be excreted in human milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Premalex may impair the ability to react in some people, which should be kept in mind at times when increased attention is required, e.g. while driving and precision work.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform risky work. 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Premalex

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

Adults

Premalex tablets are taken in recurring periods. The optimal dose is usually 20 mg daily, but some patients may have sufficient effect at 10 mg daily. Discuss with your treating physician how you experience the treatment effect and any side effects so that the dose can be adjusted if necessary. The first tablet is taken on the same day as the estimated day of ovulation. You can calculate this by taking the length of your normal menstrual cycle, ie the time between one menstruation and the next, minus 14 days. This gives the number of days between the first day of menstruation and the next ovulation.

Treatment cycle 1 + 2

The usual starting dose is 10 mg taken on the same day as the estimated ovulation. After 2-3 days, the dose can be increased to 20 mg daily if you have not experienced troublesome side effects. If you experience side effects, keep taking 10 mg daily. Continue taking the desired dose (10 mg or 20 mg daily) until the first day of menstruation. Then take a break until the next expected ovulation, when the same dosage is repeated.

Treatment cycle 3 and onwards

You can continue to take Premalex according to Treatment Cycle 1 + 2 if this worked for you. If you are not bothered by side effects, you can start with the full dose (20 mg daily) already on the day of your expected ovulation and then take 20 mg daily throughout the treatment cycle until the first day of menstruation. Then take a break until the next ovulation, when the next treatment period begins.

Use for children and adolescents

Premalex should not be given to children and adolescents under 18 years of age. For further information, see section 2 “Before using Premalex”.

Premalex can be taken with or without food. Swallow the tablet with water. Do not chew the tablet due to its bitter taste.

If needed, the tablets can be divided. Place the tablet on a flat surface with a notch up. Press each end of the tablet with your index fingers, as shown in the sketch.

If you use more Premalex than you should  

If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Do this even if you / the child does not notice any symptoms.

Signs of overdose can include dizziness, tremors, anxiety, seizures, unconsciousness, nausea, vomiting, disturbed heart rhythm, decreased blood pressure, and effects on the body’s salt and fluid balance. Take the Premalex pack with you when contacting your doctor or hospital.

If you forget to use Premalex

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and you remember this before you go to bed, take one dose at a time. Continue as usual the next day. If you forget during the night or the next day that you forgot a dose, then let the missed dose be one and continue as usual.

If you stop using Premalex

In patients with depression or anxiety disorders who have been medicated continuously and for a long time with SSRIs, discontinuation of these agents, especially if they occur suddenly, may give rise to withdrawal symptoms. However, the risk of withdrawal symptoms is considered to be significantly less as the medication, as in the treatment of premenstrual dysphoric syndrome, never lasts longer than about 2 weeks at a time. Should you still experience any of the following symptoms in connection with stopping taking tablets at the beginning of your period, there may be reasons to take half a dose for a few days before stopping taking tablets completely. However, if you experience severe withdrawal symptoms, you should always contact your doctor.

Symptoms reported in connection with discontinuation include dizziness (feeling of instability or balance difficulties), sensory disturbances such as ant crawling, burning sensation, and, less commonly, feeling of electric shock (including such sensations in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, nausea, sweating (including night sweats) feeling of restlessness or agitation, tremor (tremors), feeling of being confused or disoriented, emotional instability or irritability, diarrhea, visual disturbances, palpitations.

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

4. Possible side effects

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

The side effects are most common during the first days of the first treatment cycle and usually decrease during the following treatment cycles.

If you experience any of the following side effects during treatment, see your doctor or hospital:

Uncommon (may affect up to 1 in 100 people):

  • Uncommon bleeding, including gastrointestinal bleeding.

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

  • Swelling of the skin, tongue, lips, or face, or having difficulty breathing or swallowing ( allergic reaction ), contact your doctor or go to the hospital immediately.
  • High fever, anxiety, feeling confused, trembling, and having sudden muscle contractions, can be signs of a rare condition called serotonergic syndrome.

If you experience the following side effects, contact your doctor or go to the hospital immediately:

  • Difficulty urinating
  • Seizures, see also section “Take special care with Premalex”
  • Yellowish skin and yellowish whites of the eyes (signs of hepatic impairment/hepatitis).
  • Rapid, irregular heartbeat, and fainting, may be symptoms of a life-threatening condition known as Torsade de Pointes.
  • Thoughts of self-harm or suicide (see also section 2 “Warnings and precautions”).

In addition, the following side effects have been reported:

Very common (may affect up to 1 in 10 people):

  • Nausea
  • Headache

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

  • Clogged or runny nose ( sinusitis )
  • Decreased or increased appetite
  • Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, stinging sensation in the skin
  • Diarrhea, constipation, vomiting, dry mouth
  • Increased sweating
  • Pain in muscles and joints ( arthralgia and myalgia )
  • Sexual disorders (decreased sexual desire and difficulty in reaching orgasm)
  • Fatigue, fever
  • Weight gain

Uncommon (may affect up to 1 in 100 people):

  • Hives ( urticaria ), skin rash, itching
  • Tooth grinding, anxiety, nervousness, panic attacks, states of confusion
  • Sleep disturbance, taste change, fainting ( syncope )
  • Enlarged pupils ( mydriasis ), visual disturbances, earrings ( tinnitus )
  • Hair loss
  • Abundant menstrual bleeding
  • Irregular menstruation
  • Weight loss
  • Palpitation
  • Swollen arms and legs
  • Nasal blood

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

  • Aggression, personality changes, hallucinations
  • Slow heartbeat

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

  • Decreased sodium levels in the blood (symptoms are nausea and malaise with muscle weakness or confusion)
  • Dizziness in a standing position due to low blood pressure ( orthostatic hypotension )
  • Abnormal liver function values ​​(elevated levels of liver enzymes in the blood)
  • Movement disorders (involuntary muscle movements)
  • Increased tendency to bleed e.g. skin and mucous membranes ( ecchymosis ) and low platelet levels ( thrombocytopenia )
  • Sudden swelling of the skin and mucous membranes ( angioedema )
  • Increased urine output (poorly functioning ADH secretion)
  • The flow of breast milk in women who are not breastfeeding
  • Mania
  • An increased risk of bone fractures has been seen in patients taking this type of drug
  • Changes in heart rate (” QT prolongation”, observed with ECG, measurement of the electrical activity of the heart).

In addition to the above, several side effects have been observed with the use of drugs that act in a similar way to Premalex. These are:

  • Motor restlessness ( akathisia )
  • Loss of appetite

How to store Premalex

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 label or carton after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

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.

Contents of the pack and other information

Content declaration

The active substance is escitalopram. Each Premalex tablet contains 10 mg or 20 mg of escitalopram (as escitalopram oxalate).

The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 400, and titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Premalex is available as 10 mg and 20 mg film-coated tablets. The tablets have the following appearance:

10 mg – oval, white, scored, film-coated tablets marked with “E” and “L” on each side of the notch on one side of the tablet.

20 mg – oval, white, scored, film-coated tablets marked with “E” and “N” on each side of the notch on one side of the tablet.

Printing package (transparent) with outer carton:

10 and 20 mg: 28 and 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

H. Lundbeck AB

Hyllie Boulevard 34

215 32 Malmö

Tel: 040-699 82 00

Manufacturer:

H. Lundbeck A / S

Ottiliavej 9

2500 Valby

Denmark

Muhammad Nadeem

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