PAROXETINE DAVURGAMA 20 mg FILM-COATED TABLETS

2. What you need to know before you take Paroxetina Davurgama

Do not take Paroxetina Davurgama

• If you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue),or if you have been treated with any of these medicines in the last two weeks. Your doctor will advise you how you should begin taking paroxetine after you have stopped taking the MAOI.
• If you are taking an antipsychotic medicine called thioridazine or the antipsychotic pimozide.
• If you are allergicto paroxetine, soya or peanuts or to any of the other ingredients of this medicine (listed in section 6).

If you are in any of these situations,tell your doctor and do not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take paroxetine

• If you are taking other medicines (see the section ‘Other medicines and Paroxetina Davurgama’),
• If you are taking tamoxifen for breast cancer treatment (or fertility problems). Paroxetine may make tamoxifen less effective, so your doctor should recommend that you take another antidepressant.
• If you have any kidney, liver or heart problems.
• If you have a heart condition known as prolongation of the QT interval (seen on an electrocardiogram, ECG).
• If you have a family history of QT interval prolongation, heart disease such as heart failure, slow heart rate or low levels of potassium or magnesium.
• If you have epilepsy or have fits (seizures).
• If you have had manic episodes (excessive mood elevation).
• If you are being treated with electroconvulsive therapy (ECT).
• If you have a history of bleeding disorders or have been told you have a tendency to bleed more than usual, or if you are taking any other medicines that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines to treat pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
• If you have diabetes.
• If you are on a low sodium diet.
• If you have glaucoma (increased pressure in the eye).
• If you are pregnant or think you might be pregnant (see the section ‘Pregnancy, breast-feeding and fertility’).
• If you are under 18 years old (see the section ‘Children and adolescents under 18 years of age’).

If your answer is YES to any of these questionsand you have not talked to your doctor, go and see your doctor before taking paroxetine.

Children and adolescents under 18 years of age

Paroxetine should not be used in the treatment of children and adolescents under 18 years of age.

You should also know that in patients under 18 years, there is an increased risk of adverse effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger) when taking paroxetine. If your doctor has prescribed paroxetine to you (or your child) and you want to discuss this decision, go and see your doctor. You should inform your doctor if any of the symptoms listed above occur or worsen when you (or your child) are taking this medicine. The long-term safety of paroxetine in terms of growth, maturation, and cognitive and behavioural development in this age group has not yet been demonstrated.

In studies of paroxetine in patients under 18 years, common adverse effects (affecting less than 1 in 10 children/adolescents) were: an increase in suicidal thoughts and attempts, self-harm behaviours, hostility, aggression or unfriendly behaviour, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes), and unexplained bruising or bleeding. These effects were also seen in children/adolescents included in these studies who were taking placebo, rather than paroxetine, although with a lower frequency.

When stopping treatment with paroxetine, in these studies some of the patients under 18 years reported withdrawal effects. These effects were very similar to those seen in adults who stopped treatment with paroxetine (see section 3). Additionally, patients under 18 years frequently (affecting less than 1 in 10) experienced stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm behaviours, suicidal thoughts, and attempts).

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment with antidepressants, as all these medicines take time to work, usually about two weeks, but sometimes longer.

You are more likely to experience these thoughts:

• If you have previously had thoughts about killing or harming yourself.
• If you are a young adult.Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital straight away.

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Important side effects seen with paroxetine

Some patients who take paroxetine develop a condition called akathisia, and feel restless and unable to sit or stand still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and may have some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling of heat, sweating, shaking, shivering, hallucinations (seeing or hearing things that are not there), stiff muscles, sudden jerky movements or increased heart rate. The severity can increase, leading to loss of consciousness. Consult your doctorif you experience any of these symptoms. For more information on this or other side effects of paroxetine, see section 4.

Some medicines of the same group as paroxetine (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Other medicines and Paroxetina Davurgama

Some medicines may affect the action of paroxetine or make side effects more likely. Paroxetine may also affect the action of some other medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue).See the section ‘Do not take Paroxetina Davurgama’.
• Medicines known to increase the risk of changes in heart activity (e.g. the antipsychotics thioridazine or pimozide).See the section ‘Do not take Paroxetina Davurgama’.
• Aspirin, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• Tramadol, buprenorphine, and pethidine, analgesics.
• Buprenorphine combined with naloxone, substitution treatment for opioid addiction.
• Medicines called triptans, such as sumatriptan, used to treat migraine.
• Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplementcalled tryptophan.
• Mivacurium and suxamethonium (used in anaesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat some psychiatric diseases.
• Fentanyl, used in anaesthesiaor to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat HIV infection.
• St John’s Wort, a herbal remedy used to treat depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizuresor epilepsy.
• Atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve tremors, especially in Parkinson’s disease.
• Warfarin and other medicines (called anticoagulants) used to thin the blood.
• Propafenone, flecainide, and medicines used to treat heart rhythm disorders.
• Metoprolol, a beta-blocker used to treat high blood pressure and heart problems.
• Pravastatin, used to treat high cholesterol.
• Rifampicin, used to treat tuberculosis (TB) and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, used to treat breast cancer(or fertility problems).

If you are taking or have recently taken any of these medicines, tell your doctor and ask what you should do.Your doctor may decide to change your dose or prescribe another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,including those obtained without a prescription.

Taking Paroxetina Davurgama with food, drinks, and alcohol

Do not drink alcohol while you are taking this medicine. Alcohol may make your symptoms or side effects worse.

Taking this medicine in the morning with food may reduce the chance of you feeling sick.

Pregnancy, breast-feeding, and fertility

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

In some studies, an increased risk of malformations has been observed in newborns whose mothers took paroxetine during the first months of pregnancy. In the general population, about 1 in 100 newborns is born with a heart malformation. This increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in agreement with you, may decide to change your treatment or gradually stop your treatment with paroxetine while you are pregnant. However, depending on your circumstances, your doctor may recommend that you continue taking this medicine.

Make sure your doctor or midwife knows you are taking paroxetine.If you take this medicine in the last 3 months of your pregnancy, you may be more likely to get vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife need to know that you are taking this medicine so they can advise you. Medicines like paroxetine may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), when taken during pregnancy, particularly in the last few months. The blood pressure in the blood vessels that supply the lungs is very high in newborns with PPHN. If you are taking this medicine at the end of your pregnancy, your newborn may also have other symptoms which usually start during the first 24 hours after birth. These include:

• Difficulty breathing
• Blue-tinged skin or looking too hot or cold
• Blue lips
• Vomiting or feeding difficulties
• Feeling very tired, having difficulty sleeping, or crying frequently
• Stiff or floppy muscles
• Shakiness, tremors, or seizures
• Overactive reflexes.

If your baby has any of these symptoms when they are born, or if you are worried about your baby’s health, contact your doctor or midwife, who will advise you.

Paroxetine passes into breast milk in very small amounts.Ask your doctor for advice before taking this medicine if you are breast-feeding. Your doctor, in agreement with you, may recommend that you continue breast-feeding while taking this medicine.

Animal studies have shown that paroxetine reduces sperm quality. This could theoretically affect fertility in humans, but this effect has not been observed in people yet.

Driving and using machines

Some of the side effects of this medicine, such as dizziness, confusion, drowsiness, or blurred vision, may affect your ability to drive or operate machinery. If you experience any of these effects, do not drive or operate machinery.

Paroxetina Davurgama contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially ‘sodium-free’.

Paroxetina Davurgama contains soya lecithin

This medicine contains soya lecithin (derived from soya oil). Do not take this medicine if you are allergic to peanuts or soya.

3. How to Take Paroxetine Davurgama

Follow your doctor's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

Sometimes it may be necessary to take more than one tablet or half a tablet. The following table will show you how many tablets you should take:

The normal doses for the different indications are detailed in the following table:

Your doctor will indicate what dose you should take when starting treatment with paroxetine.Most people start to feel better after a couple of weeks. If after this time you do not start to feel better, consult your doctor who will indicate how to proceed. Your doctor may decide to gradually increase the dose, in increments of 10 mg, up to the maximum daily dose.

Take the tablets in the morning, with food.

The tablets should be swallowed with water.

The tablets should not be chewed.

The score line is used to divide the tablet into equal doses.

Your doctor will indicate the duration of the treatment. This period may be extended for several months or even longer.

Elderly Patients

The maximum dose for people over 65 years old is 40 mg per day.

Patients with Kidney or Liver Problems

If you have severe liver or kidney failure, your doctor may advise you to take smaller doses of paroxetine than usual.

If You Take More Paroxetine Than You Should

Never take more tablets than your doctor has recommended. If you take too many paroxetine tablets (or someone else does), consult your doctor or go to the hospital immediately. Show them the package of tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

A person who has taken an overdose of paroxetine may experience some of the symptoms that appear in section 4, Possible Adverse Effects,or some of the following symptoms: fever, involuntary muscle contraction.

If You Forget to Take Paroxetine Davurgama

Take your medication at the same time every day.

If you forget to take a dose and remember before going to bed, take it immediately. Take the next dose at the usual time.

If you remember during the night or the next day, skip the missed dose. You may experience some withdrawal symptoms, but they should disappear after taking the next dose at the usual time.

Do not take a double dose to make up for missed doses.

What to Do If You Do Not Feel Better

Paroxetine will not improve your symptoms immediately.All antidepressants take time to work. Some people start to feel better after a couple of weeks, but others may require more time. Some people who take antidepressants feel worse before starting to notice improvement. If you do not start to feel better after a couple of weeks, tell your doctor, who will indicate what to do. It is possible that your doctor has scheduled a follow-up appointment after two weeks of starting your treatment. Consult your doctor if you have not started to feel better.

If You Stop Treatment with Paroxetine

Do not stop treatment until your doctor indicates it.

When You Stop Treatment with Paroxetine, your doctor will indicate how to gradually reduce the doses over a period of several weeks or months. This will help reduce the risk of experiencing withdrawal symptoms. One way to do this is to gradually reduce the dose of paroxetine you are taking by 10 mg each week. Most people consider the possible symptoms that occur when stopping treatment with this medication to be mild and to disappear on their own within two weeks. For others, these symptoms can be more severe or last longer.

If You Experience Withdrawal Effectswhile stopping your treatment, your doctor may decide to stop it more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then stop it more slowly.

Although You May Experience Withdrawal Effects, You Will Be Able to Stop Your Treatment with Paroxetine.

Possible Withdrawal Effects When Stopping Treatment

Studies have shown that 3 out of 10 patients experience one or more symptoms when stopping their treatment with paroxetine. Some of these effects occur more frequently than others.

Common Adverse Effects

May affect up to 1 in 10 people

• Feeling dizzy, unsteady, or having balance problems.
• Numbness, tingling, and, less frequently, electric shock sensations, even in the head, buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus).
• Sleep disturbances (vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

Uncommon Adverse Effects

May affect up to 1 in 100 people

• Vomiting (nausea).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Rapid or very strong heartbeats.

Consult your doctor if you are concerned about the withdrawal effects of paroxetine.

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

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them. It is more likely that adverse effects will appear during the first few weeks of treatment with this medication.

Tell your doctor if you experience any of the adverse effects described below during treatment

You may need to consult your doctor or go to the hospital immediately

Uncommon Adverse Effects

May affect up to 1 in 100 people

• If you have bruising or unusual bleeding,such as blood in your vomit or stools, contact your doctor or go to the hospital immediately.
• If you experience difficulty urinating, contact your doctor or go to the hospital immediately.

Rare Adverse Effects

May affect up to 1 in 1,000 people

• If you experience seizures(epileptic fits), contact your doctor or go to the hospital immediately.
• If you feel restless, unable to sit still or stay still,called akathisia. Increasing the dose of this medication may worsen your symptoms. If you feel this way, consult your doctor.
• Weakness, confusion, and pain, stiffness, and lack of muscle coordination.This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Very Rare Adverse Effects

May affect up to 1 in 10,000 people

• Severe allergic reactions to paroxetine.

If you develop a skin rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching or difficulty breathing (difficulty breathing) or swallowing, and a feeling of weakness or fainting that can cause collapse or loss of consciousness, contact your doctor or go to the hospital immediately.

• If you notice any of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome.The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange sounds or visions), muscle stiffness, sudden jerky movements or rapid heartbeats. The severity can increase and lead to loss of consciousness. If you feel this way, consult your doctor.
• Acute glaucoma.

If you experience eye pain and blurred vision, consult your doctor.

Frequency Not Known

The frequency cannot be estimatedfrom the available data

• Some people have experienced thoughts of self-harm or suicide while taking this medication or shortly after stopping treatment (see Thoughts of Suicide and Worsening of Your Depression or Anxiety Disorderin section 2).
• Some people have experienced aggression while taking this medication.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, Breastfeeding, and Fertilityin section 2 for more information.

If you experience these adverse effects, contact your doctor.

Other Possible Adverse Effects During Treatment:

Very Common Adverse Effects

May affect more than 1 in 10 people

• Feeling sick (nausea). This effect can be reduced by taking your medication in the morning after breakfast.
• Change in sexual desire or function, for example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common Adverse Effects

May affect up to 1 in 10 people

• Increased cholesterol levels in the blood.
• Decreased appetite.
• Difficulty sleeping (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness, tremors.
• Headaches.
• Difficulty concentrating.
• Agitation.
• Unusual weakness.
• Blurred vision.
• Diarrhea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Uncommon Adverse Effects

May affect up to 1 in 100 people

• Transient increases in blood pressure, or transient decreases in blood pressure that can cause dizziness or fainting when standing up quickly.
• Faster than normal heartbeats.
• Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue.
• Dilated pupils.
• Skin rash.
• Itching.
• Confusion.
• Hallucinations (strange sounds or visions).
• Decreased white blood cell count.
• Inability to urinate (urinary retention) or uncontrolled urination (involuntary urination).
• If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking this medication. Consult your doctor about how to adjust your insulin or diabetes medication dose.

Rare Adverse Effects

May affect up to 1 in 1,000 people

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver effects that appear in laboratory tests that indicate liver function.
• Panic attacks.
• Very active behavior or thoughts (mania).
• Feeling detached from oneself (depersonalization).
• Anxiety.
• Irresistible urge to move the legs (Restless Legs Syndrome).
• Pain in joints or muscles.
• Increased levels of a hormone called prolactin in the blood.
• Menstrual disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very Rare Adverse Effects

May affect up to 1 in 10,000 people

• Skin rash, in which blisters appear with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around) called erythema multiforme.
• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash over a large area of the body with blisters and skin peeling (toxic epidermal necrolysis).
• Liver disorders that turn the skin or the whites of the eyes yellow.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), which is a condition in which the body develops an excess of water and a decrease in sodium (salt) concentration as a result of inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms.
• Water or fluid retention (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased platelet count in the blood.

Frequency Not Known

The frequency cannot be estimatedfrom the available data

• Inflammation of the colon (causing diarrhea).
• Teeth grinding.

Some patients have experienced buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus) when taking paroxetine.

It has been observed that people taking this type of medication have a higher risk of bone fractures.

Reporting Adverse Effects

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

5. Conservation of Paroxetine Davurgama

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack or bottle and on the packaging after CAD. The expiration date is the last day of the month indicated.

If you are taking half a tablet, be careful to store it safely in the packaging

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Paroxetina Davurgama

• The active ingredient is paroxetine.

Each 20 mg tablet contains 20 mg of paroxetine (as paroxetine hydrochloride).

• The other ingredients are mannitol, microcrystalline cellulose, sodium carboxymethyl starch Type A (from potato), magnesium stearate.
• The coating contains: methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent, partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soybean lecithin (E322), and xanthan gum (E415)

Appearance of the Product and Packaging Contents

The tablets are white, round, film-coated, biconvex, 10 mm in diameter, scored on one side and printed with P20 on the other.

The score line serves to divide the tablet into equal doses.

It is available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 film-coated tablets and in unit dose blister packs of 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 98x1 or 100x1 film-coated tablets and in bottles of 28, 56, 100 or 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Local Representative

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 - Madrid

Spain

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Denmark: Paroxetin Teva B.V.

Spain: Paroxetina Davurgama 20 mg film-coated tablets EFG

Portugal: Paroxetina Refta

Date of last revision of this leaflet: February 2024

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/