Oralin 50 mg film-coated tablets, Oralin 100 mg film-coated tablets
( Sertraline )
What Oralin is and what it is used for
The active substance in Oralin is sertraline. Oralin belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). These drugs are used to treat depression and/or anxiety disorders.
Oralin can be used to treat
– depression and prevention of recurrent depression (in adults)
– social phobia (in adults)
– post-traumatic stress disorder (PTSD) (in adults)
– panic disorder (in adults)
obsessive-compulsive disorder (OCD) (in adults, as well as children and adolescents in the age group 6-17 years).
Depression is a clinical illness with symptoms such as feeling sad, unable to sleep properly, or enjoying life as usual.
Obsessive-compulsive disorder and panic disorder are diseases that are linked to anxiety with symptoms such as constant discomfort from fixations (obsessions), which means that you have to repeat different rituals (compulsion).
Post-traumatic stress disorder is a condition that can occur after a very emotionally traumatic experience, with some symptoms similar to depression and anxiety. Social phobia (social anxiety syndrome) is a disease that is linked to anxiety. The disease is characterized by feelings of intense anxiety or anguish in social situations (eg, talking to strangers, speaking in front of groups of people, eating or drinking in front of other people, or worrying about perhaps behaving embarrassingly).
Your doctor has decided that this medicine is suitable for treating your illness.
Ask your doctor if you are not sure why you have been given Oralin.
Sertraline contained in Oralin may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Oralin
Do not take Oralin:
- if you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
- if you are taking or have taken medicines called monoamine oxidase inhibitors ( MAOIs ) (eg selegiline , moclobemide) or medicines similar to MAOIs (eg linezolid). If you stop taking sertraline , you must wait at least 1 week before starting treatment with an MAOI . If you stop taking an MAOI , you must wait at least 2 weeks before you can start treatment with sertraline .
- if you are taking a medicine called pimozide (a medicine for mental illness such as psychosis ).
Warnings and cautions
Talk to your doctor or pharmacist before taking Oralin.
Not all medicines are suitable for everyone. Tell your doctor before taking Oralin if you have or have ever had any of the following:
- If you have epilepsy (seizures) or if you have had seizures in the past. If you have a seizure, contact your doctor immediately.
- If you have a history of mania and depression ( bipolar disorder ) or schizophrenia. If you have a manic period, contact your doctor immediately.
- If you have or have previously had thoughts of harming yourself or committing suicide (see below “Suicidal thoughts and worsening of your depression or anxiety disorder”).
- If you have serotonergic syndrome. In rare cases, this syndrome may occur when you take certain other medicines at the same time as sertraline . (The symptoms of serotonergic syndrome are described in section 4, “Possible side effects”). Your doctor has told you if you have had this before.
- If you are taking medicines containing buprenorphine. If these medicines are used together with Oralin, this can lead to serotonergic syndrome, a condition that can be life-threatening (see “Other medicines and Oralin”).
- If you have low sodium levels in your blood, as this may occur when treated with Oralin. Also tell your doctor if you are taking certain medicines for high blood pressure , as such medicines can also change the levels of sodium in your blood.
- If you are older, because you may be at higher risk of getting low sodium levels in your blood (see above).
- If you have liver disease. Your doctor may decide that you should take a lower dose of Oralin.
- If you have diabetes . Blood sugar levels may be affected due to Oralin and your diabetes medicine may need to be adjusted.
- If you have a history of bleeding disorders or if you are pregnant (see ‘Pregnancy, breast-feeding and fertility’, or if you have taken medicines that thin the blood (eg acetylsalicylic acid or warfarin ) or that may increase the risk of bleeding.
- If you are a child or young person under 18 years of age. Oralin should only be given to children and adolescents aged 6-17 years if they suffer from obsessive-compulsive disorder (OCD). If you are being treated for this disease, your doctor will want to monitor you closely (see “Children and Adolescents” below).
- If you receive electrical treatment (so-called electroconvulsive treatment, ECT).
- If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
- If you have been told by an examination of your heart that you have an abnormal ECG ( electrocardiogram ) called an extended QT interval .
- If you have heart disease, low potassium or low magnesium levels in the blood, cases of prolonged QT interval in the family, low heart rate or at the same time using drugs that prolong QT interval .
Drugs such as Oralin (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
The use of sertraline has been linked to a painful restlessness and need to move, often unable to sit or stand still ( akathisia ). This usually occurs during the first weeks of treatment. Increasing dose one can be harmful, so if you develop such symptoms, you should consult your doctor.
reactions Adverse reactions associated with discontinuation of treatment (discontinuation reactions) are common, especially if treatment is stopped abruptly (see section 3 If you stop taking Oralin and section 4, Possible side effects ). The risk of getting withdrawal symptoms depends on how long you have been treated, dosage one, and how quickly dose one is stepped down. In general, these symptoms are mild to moderate, but for some patients, they can be severe. The symptoms usually appear within the first few days after stopping treatment and usually disappear on their own or subside within 2 weeks. In some patients, they may sit for longer (2-3 months or more). About the treatment with sertraline should be discontinued it is recommended that the dose be reduced gradually over several weeks or months, you should always discuss with your doctor how you can discontinue treatment in the best way.
If you start to feel worse and have thoughts of harming yourself
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 adolescents
Sertraline should not normally be used in the treatment of children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). The risk of side effects such as suicide attempts, thoughts of harming or committing suicide (suicidal thoughts) and hostility (mainly aggression, defiance, and anger) are greater in people under the age of 18 when they take drugs of this type. Despite this, Oralin can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If a doctor has prescribed Oralin for you and you are under 18 and you want to discuss this, contact your doctor. You should also tell your doctor if you notice any of the above symptoms or if these symptoms worsen when you take Oralin. In addition, the long-term effects of Oralin on the growth, maturation, and development of learning ability (cognitive ability) and behavior have not yet been established in this age group.
Other medicines and Oralin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the effect of Oralin, or Oralin may reduce the effect of other medicines taken at the same time.
Taking Oralin with the following medicines can cause serious side effects:
- Drugs called monoamine oxidase inhibitors ( MAOIs ) such as moclobemide (for depression) and selegiline (for Parkinson’s disease ), antibiotic et linezolid and methylene blue (for the treatment of high levels of methemoglobin in the blood). Do not use Oralin with these medicines.
- Medicines for mental illnesses such as psychosis (pimozide). Do not use Oralin with pimozide.
- Some medicines can aggravate the side effects of Oralin and in some cases can cause very serious reactions. Do not take any other medicines while you are taking Oralin without first talking to your doctor, especially:
medicines containing buprenorphine. These medicines can affect or be affected by Oralin and you may experience symptoms such as involuntary rhythmic muscle twitching, even in the muscles that control eye movements, agitation, hallucinations, coma , heavy sweating, tremors, increased reflexes, tense muscles and body temperature above 38 ° C. Contact your doctor if you experience such symptoms.
Talk to your doctor if you are taking any of the following medicines:
- Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder, narcolepsy and obesity).
- Herbal medicine that contains St. John’s wort ( Hypericum perforatum ). The effect of St. John’s wort can be for 1-2 weeks.
- Products that contain the amino acid tryptophan.
- Medicines for severe pain (eg tramadol) and opioid dependence (buprenorphine).
- Medicines used in anesthesia or to treat chronic pain ( fentanyl , mivacurium and suxamethone).
- Medicines for migraine (eg sumatriptan).
- Blood thinners ( warfarin ).
- Drugs for pain / joint inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ), eg ibuprofen , acetylsalicylic acid ).
- Sedatives ( diazepam ).
- Diuretics (also called diuretics ).
- Medicines for epilepsy ( phenytoin , phenobarbital, carbamazepine).
- Medicines for diabetes (tolbutamide).
- Medicines for strong stomach acid, stomach ulcers and heartburn (cimetidine, omeprazole, lanzoprazole, pantoprazole, rabeprazole).
- Medicines for mania and depression (lithium).
- Other antidepressants (eg amitriptyline, nortriptyline, nefazodone, fluoxetine , fluvoxamine).
- Medicines for schizophrenia and other mental illnesses (eg perfenazine, levomepromazine and olanzapine).
- Drugs used to treat high blood pressure , chest pain or to regulate heart rate and rhythm (eg verapamil, diltiazem flecainide , propafenone ).
- Medicines used to treat bacterial infections (eg rifampicin, clarithromycin, telithromycin, erythromycin)
- Medicines used to treat fungal infections (eg fluconazole , ketoconazole , itraconazole, posaconazole, voriconazole)
- Drugs used to treat HIV / AIDS and Hepatitis C ( protease inhibitors such as ritonavir, telaprevir)
- Medicines used to prevent nausea and vomiting after chemotherapy (chemotherapy) (aprepitant).
- Drugs that are known to increase the risk of changes in the electrical activity of the heart (eg certain antipsychotics and antibiotics ).
- Metamizole, a medicine used for pain and fever.
Oralin with food, drink and alcohol
Oralin tablets can be taken with or without food.
Alcohol should be avoided when treated with Oralin.
Sertraline should not be taken with grapefruit juice, as this may increase the levels of sertraline in the body.
Pregnancy, breastfeeding and fertility
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.
The safety of sertraline in pregnant women has not been established. Sertraline will only be given to you when you are pregnant if your doctor considers that the benefit to you outweighs the potential risks to the baby.
If you take Oralin at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Oralin so that they can advise you on this. When drugs such as Oralin 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.
Your newborn baby may also have other symptoms that usually appear within the first 24 hours after birth. These symptoms include:
– Difficulty breathing
– A bluish skin or the baby is too hot or too cold
– Blue lips
– The child vomits or does not eat enough
– The child is very tired, has difficulty sleeping, or cries a lot
Tense or relaxed muscles
Tremors, twitches, or cramps
– Reinforced reflexes
– Low blood sugar.
If your baby has any of these symptoms at birth, or if you are worried about your baby’s health, contact your doctor or midwife for advice.
There is evidence that sertraline is excreted in human breast milk. Sertraline should only be given to breastfeeding women if your doctor considers that the benefit to the mother outweighs the potential risks to the baby.
In animal studies, it has been shown that certain drugs such as sertraline can reduce the quality of semen. In theory, this could affect fertility, but no such reducing effect of sertraline on fertility has yet been demonstrated in humans.
Driving and using machines
Psychotropic drugs such as sertraline may affect your ability to drive or use machines. Therefore, you should not drive or use machines until you know how this medicine affects your ability to perform these activities.
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.
Oralin contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
3. How to use Oralin
Always take this medicine exactly as your doctor or pharmacist has told you.
Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Depression and obsessive-compulsive disorder
The usual effective dose is 50 mg daily. Dose one can then be increased by 50 mg at a time at intervals of at least one week for several weeks. The maximum recommended dose is 200 mg daily.
Panic disorder, social phobia, and post-traumatic stress disorder
Treatment should start with 25 mg daily, then increase to 50 mg daily after one week. Dose one can then be increased by 50 mg at a time for several weeks. The maximum recommended dose is 200 mg daily.
Children and young people
Oralin should only be given to children and adolescents aged 6-17 years who suffer from obsessive-compulsive disorder (OCD).
Children 6-12 years of age: The recommended starting dose is 25 mg daily. After one week, the doctor may increase the dose from one to 50 mg daily. The maximum dose is 200 mg daily.
Adolescents 13-17 years: The recommended starting dose is 50 mg daily. The maximum dose is 200 mg daily.
If you have liver or kidney problems, tell your doctor and follow the instructions.
Method of administration :
Oralin tablets can be taken with or without food.
Take the medicine once a day, either in the morning or in the evening.
Your doctor will tell you how long to take this medicine. It depends on the nature of the disease and how well you respond to the treatment. It may take several weeks before your symptoms improve. Treatment for depression should usually continue for 6 months after you notice an improvement.
If you use more Oralin than you should
If you accidentally ingest too much Oralin, contact your doctor immediately or go to the nearest emergency room. Always carry the medicine package with the label on it, regardless of whether there is any medicine left or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and, in rare cases, unconsciousness.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.
If you forget to use Oralin
If you forget to take a tablet, do not take the missed tablet. Take the next tablet at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop using Oralin
Do not stop taking Oralin unless your doctor tells you to. Your doctor wants you to gradually reduce the dose of one of Oralin for several weeks before you completely stop taking the medicine. If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep problems, upset or anxiety, headache, nausea, vomiting, and tremors. If you experience any of these side effects or any other side effects while stopping Oralin, contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nausea is the most common side effect. The side effects depend on dose one and often go away or decrease after continued treatment.
Talk to your doctor immediately :
If you experience any of the following symptoms after taking this medicine. The symptoms can be severe.
- If you get severe rash with blisters (erythema multiforme) (this can affect the mouth and tongue). It could be a sign of a disease called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In this case, your doctor will stop the treatment.
- Allergic reaction or allergy , which can cause symptoms such as itchy skin rash, breathing problems, wheezing, swelling of the eyelids, face or lips.
- If you get upset or confused or have diarrhea, fever and high blood pressure , heavy sweating and rapid heartbeat. These are symptoms of serotonergic syndrome. In rare cases, this syndrome may occur when you take certain other medicines at the same time as sertraline . Your doctor may want to stop the treatment.
- If you get yellowish skin and yellowish eyes, which may indicate liver damage.
- If you experience symptoms of depression with thoughts of harming yourself or committing suicide (suicidal thoughts).
- If you start to feel restless and cannot sit or stand still after taking Oralin. Talk to your doctor if you start to feel restless.
- If you have a seizure.
- If you have a manic period (see section 2 “Warnings and precautions”).
The following adverse reactions have been observed in clinical trials in adults and post-marketing experience.
Very common (may affect more than 1 user in 10):
- insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth , missed ejaculation, fatigue.
Common (may affect up to 1 in 10 people):
- trachea , sore throat, runny nose
- decreased appetite, increased appetite
- anxiety, depression, agitation, decreased sexual interest, anxiety, feeling weird, nightmares, gnashing of teeth
- tremors, effects on the muscles (such as overactivity, muscle tension, difficulty walking and stiffness, spasms and involuntary muscle movements) *, numbness and tingling, muscle strain, lack of attention, abnormal taste
- visual disturbances
- hot flashes
- upset stomach, constipation, stomach pain, vomiting, gas
- increased sweating, rash
- back pain, joint pain, muscle aches
- irregular menstruation, potency problem
- malaise, chest pain, weakness, fever
- weight gain
Uncommon (may affect up to 1 in 100 people):
- gastrointestinal catarrh , ear infection
- hypersensitivity, seasonal allergy
- low levels of thyroid hormone
- suicidal thoughts, suicidal behavior *, psychotic disorder, abnormal thoughts, indifference, hallucinations, aggression, euphoria , persecution mania
- memory loss, decreased emotions, involuntary muscle contractions, fainting spells, inability to be still, migraines , cramps, dizziness when standing up, abnormal coordination, speech difficulties
- enlarged pupil er
- fast heartbeat, heart problems
- problems with bleeding (eg stomach bleeding) *, high blood pressure , flushing , blood in the urine
- shortness of breath, nosebleeds, difficulty breathing (possibly with wheezing)
- tar-like stools, dental problems, inflammation of the esophagus, tongue problems, hemorrhoids , increased salivation, difficulty swallowing, belching, disorders of tongue movements
- eye swelling, hives, hair loss, itching , dark purple spots on the skin, skin problems with blisters, dry skin, facial swelling, cold sweats
- inflammation of joints and bones, muscle twitching, muscle cramps *, muscle weakness
- need to urinate more often, difficulty urinating, inability to urinate, urinary incontinence, increased urine output, need to urinate at night
- sexual problems, heavy vaginal bleeding, vaginal bleeding, sexual problems in women
- leg swelling, chills, difficulty walking, thirst
- increased liver values, weight gain.
- Cases of suicidal ideation and behavior have been reported during treatment with sertraline or early after discontinuation of treatment (see section 2).
Rare (may affect up to 1 in 1,000 people):
- inflammation of the abdomen ( diverticulitis ), swollen lymph nodes , decreased number of platelets *, decreased number of white blood cells *
- severe allergic reaction
- hormonal ( endocrine ) disorders *
- high cholesterol , problems controlling blood sugar ( diabetes ), low blood sugar, high blood sugar *, low blood levels *
- physical symptoms due to stress or emotion, nightmares *, drug addiction, sleep deprivation, premature ejaculation
- coma , abnormal movements, difficulty moving, increased sensation, sudden severe headache (which may be a sign of a serious condition called reversible cerebral vasoconstriction syndrome) *, disturbed sensation
- spots in front of eyes *, glaucoma *, double vision *, light in the eyes *, eye bleeding *, various large pupils *, abnormal vision *, problems with tear flow *
- heart attack, dizziness, fainting, or chest discomfort that may be a sign of changes in the electrical activity of the heart (seen on ECG ) or abnormal heart rhythm *, slow heartbeat
- poor circulation in arms and legs
- rapid breathing, increasing scarring of the lung tissue (interstitial lung disease) *, feeling of tightness in the throat, difficulty speaking, slow breathing, hiccups
- cold sores, inflammation of the pancreas *, blood in the stool, sores on the tongue, sore mouth
- problems with liver function, severe effects on liver function *, yellowing of the skin and eyes (jaundice) *
- skin reaction to the sun *, skin edema *, abnormal hair structure, abnormal skin odor, rash on the scalp
- degradation of muscle tissue *, bone disease
- difficulty urinating, decreased urine output
- secretion from the breasts, dry vagina , abdominal discharge, redness and pain in the penis and foreskin, breast enlargement *, prolonged erection
- hernia , decreased drug tolerance
- increased cholesterol levels in the blood, abnormal laboratory values *, abnormal semen, problems with coagulation *
- vasodilation surgery.
Has been reported (occurs in an unknown number of users):
- locked jaw
- bed wetting *
- partial vision loss *
- inflammation of the colon (which causes diarrhea)
- severe vaginal bleeding shortly after delivery ( postpartum haemorrhage ), see ‘Pregnancy, breast-feeding and fertility’ in section 2 for more information.
* Side effect reported after marketing.
Additional side effects in children and adolescents :
In clinical trials in children and adolescents, similar side effects were generally seen as in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhea, and nausea.
Symptoms that may occur when treatment is stopped
If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, upset or anxiety, headache, nausea, vomiting, and tremors (see section 3, “If you stop taking Oralin”).
An increased risk of bone fractures has been seen in patients taking this type of drug.
How to store Oralin
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 after EXP and on the carton after EXP. The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
Store in the original package.
Do not use Oralin if you notice any visible signs of deterioration.
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
The active substance is sertraline.
Oralin 50 mg film-coated tablets
Each film-coated tablet contains 50 mg of sertraline (as sertraline hydrochloride).
Oralin 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of sertraline (as sertraline hydrochloride).
Other ingredients are:
Microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropyl cellulose, calcium hydrogen phosphate dihydrate, magnesium stearate.
Hypromellose, macrogol 400, polysorbate 80, and titanium dioxide (E171).
What the medicine looks like and contents of the pack
Oralin 50 mg film-coated tablets are white, capsule-shaped, film-coated tablets marked with “A” on one side and scored between “8” and “1” on the other side. The tablet can be divided into two equal parts.
Oralin 100 mg film-coated tablets are white, capsule-shaped, film-coated tablets marked with “A” on one side and “82” on the other side.
Oralin film-coated tablets are available in packs of 10, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 98 and 100 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orion Corporation Orion Pharma
Orion Corporation Orion Pharma
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Orion Pharma AB
This medicinal product is authorized under the European Economic Area under the names:
|Name of Member State||The name of the drug|
|CZ:||Sertraline Vipharm 50 mg tabletsSertraline Vipharm100 mg tablets|
|THE:||Sertraline Aurobindo 50 Mg Film TabletsSertraline Aurobindo 100 Mg Film Tablets|
|DK:||Sertraline Orion50 mg film-coated tablets sertraline Orion 100 mg film-coated tablets|
|IT:||Sertraline Aurobindo 50 mg compresses rivestite with filmSertralina Aurobindo 100 mg compresses rivestite with film|
|NL:||Sertraline Aurobindo 50 mg film-coated tablets sertraline Aurobindo 100 mg film-coated tablets|
|PT:||Sertraline Aurobindo 50 mg compressed by the pill Sertralina Aurobindo 100 mg compressed by the pill|
|SEE:||Oralin 50 mg film-coated tablets rain 100 mg film-coated tablets|
|UK:||Sertraline Aurobindo 50 mg film-coated tablets sertraline Aurobindo 100 mg film-coated tablets|