Leaflet: information for theuser

Sertraline cinfa 150mg film-coated tablets

Sertraline cinfa 200 mg film-coated tablets

Sertraline hydrochloride

Read this leaflet carefully before you start taking thismedicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you,and you must not give it to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceside effects, consultyour doctor or pharmacist, even if the side effects are not listed in this leaflet.See section 4.

1.What isSertraline cinfa and what is it used for

2.What you need to know before starting to take Sertraline cinfa

3.How to take Sertraline cinfa

4.Possible side effects

5.Storage of Sertraline cinfa

6.Contents of the pack and additional information

Sertralina cinfa contains sertraline as the active ingredient. Sertralinebelongs to a group of medicines calledSelective Serotonin Reuptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertralinecan be used to treat:

• Depression and prevention of depression relapse (in adults).
• Social anxiety disorder (in adults).
• Post-traumatic stress disorder (PTSD) (in adults).
• Generalized anxiety disorder (in adults).
• Obsessive-compulsive disorder (OCD) (in adults and in children and adolescents aged 6-17 years).

Depression is a clinical disease with symptoms such as feelings of sadness, inability to sleep well or to enjoy life as one used to.

OCD and anxiety disorders are linked to anxiety, with symptoms such as being constantly preoccupied with repeated ideas (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that may occur after a very emotionally traumatic experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety disorder. It is characterized by feeling intense anxiety or anguish in social situations (for example: speaking to strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in a shameful manner).

Your doctor has considered that this medicine is suitable for treating your condition.

If you are unsure why you have been prescribed sertraline, you should consult your doctor.

Do not take Sertralina cinfa:

• If you are allergic to sertraline or any of the other ingredients in this medicine (including those listed in section 6).
• If you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other similar medicines (such as linezolid). If you stop taking sertraline, you should wait at least one week before starting treatment with an MAOI.After stopping treatment with an MAOI, you should wait at least two weeks before starting treatment with sertraline.
• If you are taking another medicine called pimozide(a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take sertraline.

Medicines are not always suitable for everyone. Before starting treatment with sertraline, tell your doctor if you have or have had any of the following circumstances:

• If you have epilepsy (seizures) or a history of convulsions.If you have a seizure (convulsion), call your doctor immediately.
• If you have manic-depressive illness (bipolar disorder), or schizophrenia. If you have a manic episode, call your doctor immediately.
• If you have or have had thoughts of harming yourself or suicidal thoughts (see "Thoughts of suicide and worsening of your depression or anxiety" below).
• If you have Serotonin Syndrome. In rare cases, this syndrome can occur when you are taking certain medicines at the same time as sertraline. (See "Possible side effects" for symptoms. Your doctor will tell you if you have had this syndrome before.
• If you have low sodium levelsin your blood, as this situation can occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicines for high blood pressure, as these medicines can also alter sodium levels in your blood.
• If you are elderly, as you may be at greater risk of having low sodium levels in your blood (see above).
• If you have liver disease; your doctor may consider that you should take a lower dose of sertraline.
• If you have diabetes; sertraline may alter your blood sugar levels, so you may need to adjust the dose of your diabetes medicines.
• If you have had bleeding disorders or have been taking medicines that reduce blood clotting (such as aspirin, or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy, Breast-feeding and Fertility").
• If you are a child or adolescent under 18 years old. Sertraline should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are to be treated for this disorder, your doctor will want to keep a close eye on you (see "Children and adolescents" below).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorders, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told that you have an abnormal heart rhythm that is shown on an electrocardiogram (ECG), known as QT prolongation.
• If you have heart disease, low potassium or magnesium levels, a family history of QT prolongation, low heart rate, or are taking medicines that prolong the QT interval.

Restlessness/Acatisia:

The use of sertraline has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still (acatisia). This happens more often during the first few weeks of treatment. Increasing the dose may be harmful, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms:

Side effects related to stopping treatment (withdrawal symptoms) are common, particularly if treatment is stopped abruptly (see section 3. If you stop taking Sertralina cinfa and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients, they can be severe. These symptoms usually occur during the first few days after stopping treatment. In general, these symptoms usually resolve on their own and usually resolve within two weeks. In some patients, they may last longer (2-3 months or more). It is recommended that when stopping treatment with sertraline, the dose is gradually reduced over a period of several weeks or even months, and you should always agree with your doctor on the best way to stop treatment.

Thoughts of suicide and worsening of your depression or anxiety:

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicidal thoughts. This may increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually two weeks but can be longer.

You are more likely to experience this:

• If you have previously had thoughts of suicide or harming yourself.
• If you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders, who are being treated with an antidepressant.

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

It may be helpful for you to explain to a close family member or friend that you are depressed or have anxiety, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Sexual problems

Some medicines in the group to which Sertralina cinfa belongs (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Normally, sertraline should not be used to treat children and adolescents under 18 years old,except in the case of patients with obsessive-compulsive disorder (OCD). Young patients are at greater risk of side effects such as suicidal thoughts,thoughts of harming themselves or suicidal thoughts(suicidal ideas) and hostility (mainly aggression, confrontational behavior, and irritable reaction) when treated with this class of medicines.However, your doctor may decide to prescribe sertraline to a patient under 18 years old if they consider it to be the best option for the patient. If your doctor has prescribed sertraline and you are under 18 years old and want to discuss this decision, please contact your doctor.

You should inform your doctor if any of the symptoms listed above appear or worsen while you are taking sertraline. At the same time, the long-term safety effects and those related to growth, maturity, and learning (cognitive development) and behavioral development of sertraline in this age group have not yet been demonstrated.

Taking Sertralina cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Some medicines may affect how sertraline works, or sertraline itself may reduce the effectiveness of other medicines you are taking at the same time.

The use of sertraline with the following medicines may cause serious side effects:

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (to treat depression), selegiline (to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (to treat high levels of methaemoglobin in the blood). Do not take sertraline with these medicines.
• Medicines to treat mental disorders such as psychosis (pimozide).Do not take sertraline with pimozide.

Inform your doctor if you are taking the following medicines:

• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Medicines based on plants that contain St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medicines to treat severe pain (such as tramadol).
• Medicines used in anesthesia or to treat chronic pain (such as fentanyl, mivacurium, and suxamethonium).
• Medicines to treat migraines (such as sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines to treat pain/arthritis [non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin (acetylsalicylic acid)].
• Sedatives (diazepam).
• Diuretics.
• Medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines to treat diabetes (tolbutamide).
• Medicines to treat acid reflux, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines to treat mania and depression (lithium).
• Other medicines to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines to treat high blood pressure, chest pain, or to regulate heart rate (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines known to increase the risk of changes in heart rhythm (such as some antipsychotics and antibiotics).
• A medicine used to treat pain and fever (metamizole).

Taking Sertralina cinfa with food, drink, and alcohol

Sertraline tablets can be taken with or without food.

You should avoid drinking alcohol while taking sertraline.

You should not take sertraline with grapefruit juice, as this may increase the levels of sertraline in your body.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of sertraline in pregnant women has not been fully established. If you are pregnant, sertraline will only be given to you if your doctor considers that the benefits for you outweigh any possible risk to the developing baby.

Make sure your midwife and/or doctor know that you are taking sertraline. If you take sertraline during pregnancy, especially in the last three months of pregnancy, medicines like sertraline may increase the risk of a serious condition in newborn babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Your newborn baby may have other conditions, which usually occur within the first 24 hours after birth. The symptoms include:

• difficulty breathing,

• blue skin or too hot or cold,

• blue lips,

• vomiting or feeding problems,

• excessive tiredness, unable to sleep, or crying a lot,

• stiffness or decreased muscle tone,

• tremors, restlessness, or convulsions,

• increased reflexes,

• irritability,

• low blood sugar.

If your baby has any of these symptoms at birth, or you are concerned about your baby's health, consult your doctor or midwife for advice.

If you take sertraline in the final stages of pregnancy, there may be a higher risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking sertraline so they can advise you.

There is some indication that sertraline passes into breast milk. Therefore, sertraline can only be used by women who are breast-feeding if your doctor considers that the benefits outweigh any possible risk to the baby.

In animal studies, some medicines like sertraline have been shown to reduce the quality of sperm. This could theoretically affect fertility, but the impact on human fertility has not yet been determined.

Driving and operating machinery

Medicines like sertraline can affect your ability to drive or operate machinery. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to do these activities.

Sertralina cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult them before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

The usually effective dose for depression and OCD is 50mg per day. The daily dose can be increased by 50mg at intervals of at least one week, and thus overseveral weeks. The maximum recommended dose is 200mg per day.

Anxiety Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder:

For anxiety disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should begin with a dose of 25mg per day, and increased to 50mg per day after one week.

The daily dose can be increased at intervals of 50mg over a period of several weeks. The maximum recommended dose is 200mg per day.

Use in children and adolescents:

Sertralina should only be used to treat children and adolescents aged 6 to 17 years with OCD.

Obsessive-Compulsive Disorder:

Children aged 6 to 12 years:The recommended starting dose is 25mg per day. After one week, your doctor may increase the dose to 50mg per day. The maximum dose is 200mg per day.

Adolescents aged 13 to 17 years:The recommended starting dose is 50mg per day. The maximum dose is 200mg per day.

If you have liver or kidney problems, inform your doctor and follow the instructions they give you..

Administration form:

Sertralina tablets can be taken with or without food.

Take your medication once a day, either in the morning or at night.

Your doctor will indicate the duration of treatment with this medication. The duration will depend on the nature of your illness and your response to treatment. It will take several weeks for your symptoms to improve. Treatment of depression should continue for 6 months after improvement.

If you take more Sertralina cinfa than you should:

If you accidentally take an excess ofsertralina, contact your doctor or go to the nearest hospital emergency department. Always carry the medication packaging with you, even if it is empty.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose may include drowsiness, nausea, and vomiting, rapid heart rate, tremors, agitation, dizziness, and in rare cases, unconsciousness.

If you forget to take Sertralina cinfa:

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, do not take it when you remember.Take the next dose when it is due.

If you interrupt treatment with Sertralina cinfa:

Do not stop treatment withsertralina unless your doctor tells you to. Your doctor will want to gradually reduce the dose ofsertralina over several weeks before stopping treatment completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these adverse effects, or any other during the interruption of your treatment withsertralina, please inform your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most common side effect is nausea. Side effects depend on the dose and often disappear or decrease as treatment continues.

Inform your doctor immediately:

If you experience any of the following symptoms after taking this medicine, as these symptoms can be serious.

• If you develop a severe skin rash that causes blisters (erythema multiforme), (which can affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In these cases, your doctor will stop treatment.
• Allergic reaction or allergy, which may present symptoms such as skin rash with itching, breathing problems, ringing in the ears, swelling of the eyelids, face, or lips.
• If you experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and rapid heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur when taking certain medications at the same time as sertraline. Your doctor may decide to stop treatment.
• If you experience yellowing of the skin and eyes, which may indicate liver damage.
• If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If you start to feel restless and are unable to sit or stand after starting treatment with sertraline. Inform your doctor if you start to feel restless.
• If you have a seizure (convulsions).
• If you have a manic episode (see section 2. Warnings and precautions).

The following side effects were observed in clinical trials in adults and after marketing.

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

Insomnia, dizziness, drowsiness, headache, diarrhea, feeling unwell, dry mouth, ejaculation problems, and fatigue.

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

• Common cold (of the chest), sore throat, coughing,
• Loss of appetite, increased appetite,
• anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• shaking, muscle movement disorders(such as constant movements, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*,numbness and tingling, muscle tension, lack of concentration, abnormal taste,
• Visual disturbances,
• Ringling in the ears,
• Palpitations,
• Angina,
• Yawns,
• Uncomfortable stomach, constipation, abdominal pain, vomiting, gas,
• Increased sweating, rash,
• Back pain, joint pain, muscle pain,
• Irregular menstrual cycle, erectile dysfunction,
• Uncomfortable, chest pain, weakness, fever,
• Weight gain,
• Lesion.

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

• Gastroenteritis, ear infection,
• Tumor,
• Hypersensitivity, seasonal allergy,
• Low levels of thyroid hormones,
• Suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thoughts, lack of care, hallucinations, aggression, excessive happiness, paranoia,
• Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, convulsions, dizziness when standing, abnormal coordination, speech disorders,
• Dilated pupils,
• Ear pain,
• Rapid heart rate, heart problems,
• Problems with bleeding (such as stomach bleeding)*, high blood pressure, angina, blood in urine,
• Shortness of breath, nasal bleeding, possible noisy breathing,
• Black stools, dental disorders, esophageal inflammation, tongue problems, hemorrhoids, excessive salivation, difficulty swallowing, belching, tongue disorders,
• Swollen eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, facial swelling, cold sweat,
• Arthritis, muscle spasms, muscle cramps*, muscle weakness,
• Increased frequency of urination, urinary disorders, urinary retention, incontinence, increased urine volume, need to urinate at night,
• Sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,
• Swollen legs, chills, difficulty walking, thirst,
• Weight loss,
• There have been reports of suicidal thoughts and behavior during treatment with sertraline or shortly after stopping treatment (see section 2).

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

• Diverticulitis, swollen lymph nodes, low platelet count*, low white blood cell count*,
• Severe allergic reaction,
• Endocrine disorders*,
• Elevated cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar,high blood sugar*, low sodium levels in the blood*,
• Symptoms due to stress or emotions,abnormal nightmares*, dependence on medication, somnambulism, premature ejaculation,
• Coma, abnormal movements, difficulty moving, increased sensitivity,severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*,sensorial disturbances,
• Seeing spots in front of the eyes, glaucoma, double vision, photophobia (sensitivity to light), eye hemorrhages, irregular pupils*, visual disturbances*, eye disordersHeart attack,dizziness, fainting, or chest discomfort that may be signs of changes in electrical activity (seen on the electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• Problems with circulation in the arms and legs,
• Accelerated breathing,progressive formation of scars in lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
• Ulceration of the mouth, pancreatitis*, blood in stool, ulceration of the tongue, mouth sores,
• Problems with liver function,severe liver dysfunction*, yellow skin and eyes (jaundice)*,
• Sun sensitivity*, skin swelling*, abnormal hair texture, abnormal skin odor,capillary eruption,
• Muscle tissue rupture*, bone disorders,
• Intermittent urination, decreased urine volume,
• Breast secretion, vaginal dryness,genital secretion, pain and redness of thepene and foreskin, breast enlargement*, prolonged erection,
• Hernia, decreased tolerance to the medication,
• Increased cholesterol levels,abnormal analytical tests*, abnormal semen, coagulation disorders*,
• Relaxation of blood vessel procedure.

Frequency not known: cannot be estimated from available data:

• Trigeminal nerve block*,
• Nocturnal urinary incontinence*,
• Partial loss of vision,,
• Colitis (which causes diarrhea)
• Bleeding after childbirth (postpartum hemorrhage), see «Pregnancy, lactation, and fertility» in section 2 for more information.

*Side effects reported after marketing.

Other side effects in children and adolescents

In clinical trials in children and adolescents, side effects were generally similar to those reported in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhea, and nausea.

Symptoms that may appear when treatment is stopped

If you stop treatment abruptly, you may experience side effects such asdizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors(see section 3. If you stop treatment with Sertralina cinfa).

There has been an increased risk of bone fractures in patients taking this type of medication.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout ofsight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Askyour pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Sertraline cinfa

Each film-coated tablet contains sertraline hydrochloride equivalent to 150mg of sertralina.

Each film-coated tablet contains sertraline hydrochloride equivalent to 200mg of sertralina.

The other components in sertraline 150 mg tablets are: anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, copovidone, lactose monohydrate, stearic acid, magnesium stearate, hypromellose 2910, titanium dioxide, macrogol.

The other components in sertraline 200 mg tablets are: anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, copovidone, lactose monohydrate, stearic acid, magnesium stearate, hypromellose 2910, titanium dioxide, macrogol, yellow iron oxide.

Appearance of the product and contents of the package

Sertraline 150 mg film-coated tablets are oblong and biconvex, white or almost white, 13 x 6 mm.

Sertraline 200 mg film-coated tablets are oblong and biconvex, yellow, 17 x 7 mm.

Sertraline film-coated tablets are available in aluminum/PVC/PVDC blisters containing 15, 30 and 60 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Manufacturer responsible:

Ferrer Internacional, S.A

Joan Buscallà 1-9

08173 Sant Cugat del Vallès

Spain

This medicine is authorized in the member states of the European Economic Area, with the following names:

Last review date of this leaflet:May 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/84732/P_84732.html

https://cima.aemps.es/cima/dochtml/p/84733/P_84733.html

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