Package Leaflet: Information for the User

Sertraline Cinfa 100 mg Film-Coated Tablets

Sertraline Hydrochloride

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

sertraline cinfa contains sertraline as the active ingredient. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

sertraline cinfa can be used to treat:

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 diseases 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 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:

Warnings and precautions

Consult your doctor or pharmacist before starting to take sertralina cinfa. Medicines are not always suitable for everyone.

Before starting treatment with sertralina cinfa, 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 (convulsions), 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").
• If you have serotonin syndrome. In rare cases, this syndrome can occur when you are taking certain medicines at the same time as sertralina. (To see the symptoms, read section 4. Possible side effects). Your doctor will tell you if you have had this syndrome before.
• If you have low sodium levels in your blood, as this condition may occur as a result of treatment with sertralina. Also, inform your doctor if you are taking any medicine for high blood pressure, as these medicines can also alter sodium levels in the blood.
• If you are elderly, as you may be at greater risk of having low sodium levels in your blood (see previous section).
• If you have liver disease: your doctor may consider that you should take a lower dose of sertralina.
• If you have diabetes; sertralina 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, breastfeeding and fertility").
• If you are a child or adolescent under 18 years old. Sertralina 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 monitor you closely (see "Children and adolescents").
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorder, 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 sertralina has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still (acatisia). This occurs 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 sertralina, the dose be 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 sometimes longer.

This is more likely to happen

• If you have had thoughts of suicide or self-harm before.
• 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 were 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 an anxiety disorder, and ask them to read this leaflet. You may 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 ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Normally, sertralina 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 have a higher risk of side effects such as suicidal thoughts, thoughts of self-harm or suicide (suicidal ideas) and hostility (mainly aggression, confrontational behavior, and irritable reaction) when treated with this class of medicines. However, it is possible that your doctor may decide to prescribe sertralina cinfa to a patient under 18 years old if they consider it to be the most suitable option for the patient. If your doctor has prescribed sertralina cinfa and you are under 18 years old and want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen when you are taking sertralina. At the same time, the long-term effects on safety and related to growth, maturity, and learning (cognitive development) and behavioral development of sertralina 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 sertralina cinfa works, or sertralina cinfa itself may reduce the effectiveness of other medicines you are taking at the same time.

The use of sertralina cinfa 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 methemoglobin in the blood). Do not take sertralina with these medicines.
• Medicines to treat mental disorders such as psychosis (pimozide). Do not take sertralina with pimozide.

Inform your doctor if you are taking the following medicines:

• Medicines that contain 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 that contain 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 or aspirin.
• 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).

Taking sertralina cinfa with food, drinks, and alcohol

Sertralina can be taken with or without food.

Alcohol should be avoided while taking sertralina.

Do not take sertralina with grapefruit juice, as it may increase the levels of sertralina in your body.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The safety of sertralina in pregnant women has not been fully established. If you are pregnant, sertralina 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 sertralina cinfa. If you take sertralina during pregnancy, especially during the last three months of pregnancy, certain medicines like sertralina cinfa 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.

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

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,
• shaking, restlessness, or convulsions,
• increased reflexes,
• irritability,
• low blood sugar levels.

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.

There is evidence that sertralina passes into breast milk. Therefore, sertralina can only be used in women who are breastfeeding if your doctor considers that the benefits outweigh any possible risk to the baby.

In animal studies, some medicines like sertralina have been shown to reduce the quality of sperm. Theoretically, this could affect fertility, but it has not yet been determined in humans.

Driving and operating machinery

During treatment with sertralina, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how sertralina cinfa affects you.

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.

Sertralina cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication 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 commonly effective dose for depression and OCD is 50 mg per day. The daily dose can be increased by 50 mg at intervals of at least one week, and thus for several weeks. The maximum recommended dose is 200 mg 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 25 mg per day and increased to 50 mg per day after one week. The daily dose can be increased at intervals of 50 mg over a period of several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents:

Sertraline 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 25 mg per day. After one week, your doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.

Adolescents aged 13 to 17 years:

The recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.

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

Administration form:

Sertraline tablets can be taken with or without food.

Take your medication once a day, either in the morning or at night. The tablet can be divided into equal doses.

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 may take several weeks for your symptoms to improve. Treatment of depression usually should continue for 6 months after improvement.

If you take more sertraline cinfa than you should

If you accidentally take an excessive amount of sertraline, contact your doctor or go to the nearest hospital emergency service. Always carry the medication packaging with you, even if it is empty.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or 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 sertraline 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 sertraline cinfa

Do not stop treatment with sertraline unless your doctor tells you to. Your doctor will want to gradually reduce the dose of sertraline over several weeks before stopping treatment completely. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these side effects or any other during the interruption of your treatment with sertraline, 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 interrupt treatment.
• Allergic reaction or allergy, which may present symptoms such as skin rash with itching, breathing problems, ringing, swelling of the eyelids, face, or lips.
• If you experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and rapid pulse. 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 interrupt 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 feeling restless and are unable to sit or stand after starting treatment with sertraline cinfa. Inform your doctor if you start feeling restless.
• If you experience a seizure (convulsions).
• If you experience 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,
• Tremor, muscle movement problems (such as constant movements, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, increased muscle tone, lack of concentration, abnormal taste,
• Visual disturbances,
• Tinnitus 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, neglect, 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 pulse, heart problems,
• Bleeding problems (such as stomach bleeding)*, high blood pressure, angina, hematuria,
• Shortness of breath, nasal bleeding, possible noisy breathing,

• Black stools, dental disorders, esophageal inflammation, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,

• Swollen eyes, urticaria, hair loss, itching, purple spots on the skin, skin disorders with blisters, dry skin, swollen face, cold sweat,
• Arthritis, muscle spasms, muscle cramps*, muscle weakness,
• Increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased urine volume, nocturia,
• Female sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction,
• Swollen legs, chills, difficulty walking, thirst,
• Increased liver enzymes, weight loss,
• Cases of suicidal thoughts and behavior have been reported during treatment with sertraline or shortly after its discontinuation (see section 2).

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

• Diverticulitis, swollen lymph nodes, low platelet count*, low white blood cell count*,
• Severe allergic reaction,
• Endocrine problems*,
• High cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels*,
• Physical symptoms due to stress or emotions, abnormal nightmares*, medication dependence, somnambulism, premature ejaculation,
• Coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS)*, sensory disturbances,
• Seeing spots in front of the eyes, glaucoma, double vision, photophobia (light sensitivity), eye bleeding, irregular pupils*, visual disturbances*, eye disorders,

• Heart 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 lung tissue scars (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
• Mouth ulceration, pancreatitis*, blood in stool, tongue ulceration, mouth sores,
• Liver function problems, severe liver function problems*, yellow skin and eyes (jaundice)*,
• Sun sensitivity reaction*, skin swelling*, abnormal hair texture, abnormal skin odor, capillary eruption,
• Muscle tissue rupture*, bone disorders,
• Intermittent urination, decreased urine volume,
• Milk secretion, vaginal dryness, genital secretion, penile and preputial pain and redness, breast enlargement*, prolonged erection,
• Hernia, decreased tolerance to the medication,
• Increased cholesterol levels, abnormal laboratory results*, abnormal semen, coagulation problems*,
• Relaxation of blood vessel procedure.

Frequency not known (cannot be estimated from available data):

-Trigeminal nerve block*,

-Nocturnal urinary incontinence*

-Partial vision loss.

-Colitis (which causes diarrhea)

-Excessive vaginal 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 interrupted

If you interrupt treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3. If you interrupt treatment with sertraline).

A higher risk of bone fractures has been observed in patients taking this type of medication.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date, which appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of sertraline cinfa

• The active ingredient of sertraline cinfa is sertraline (hydrochloride). Each tablet contains 100 mg of sertraline.
• The other components are: microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, copovidone, magnesium stearate (E-470b) and anhydrous colloidal silica. Coating: Opadry white Y-5-7068: hypromellose (E-464), hydroxypropylcellulose (E-463), titanium dioxide (E-171) and macrogol 400.

Appearance of the product and content of the packaging

Sertraline cinfa 100 mg is presented in coated, oblong, biconvex tablets, white or almost white in color, with the logo “ST” on one face and scored on the other face.

Sertraline cinfa is available in packaging of: 30, 60 and 500 (clinical packaging) tablets.

Only some sizes of packaging may be commercially marketed.

The tablets are presented in a PVC-PVDC-Aluminium blister.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: January 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/66058/P_66058.html

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