PAROXETINE PHARMA COMBIX 20 mg FILM-COATED TABLETS

2. Before taking Paroxetina Pharma Combix

Do not takeParoxetina Pharma Combix

• if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide), or if you have been under treatment with any of these medicines in the last two weeks.Your doctor will advise you on how to start taking Paroxetina Pharma Combix once you have stopped taking the MAOI.
• if you are taking an antipsychotic medicinecalled thioridazine or the antipsychotic called pimozide.
• if you are allergic (hypersensitive)to paroxetine or any of the other ingredients of Paroxetina Pharma Combix (see the section Additional Information).

If you are in any of these situations,tell your doctor and do not take Paroxetina Pharma Combix.

Be especially careful withParoxetina Pharma Combix

Consult your doctor:

• if you are taking other medicines(see the section Using other medicines and Paroxetina Pharma Combix).
• if you have any kidney, liver, or heart problems.
• if you have epilepsy or have had seizures or epileptic fits.
• if you have had manic episodes (excessively active thoughts or behavior).
• if you are being treated with electroconvulsive therapy (ECT).
• if you have a tendency to bleed or bruise, or are being treated with a medicine that may increase the risk of bleeding(including medicines such as warfarin, antipsychotics like 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), or if you are pregnant(see Pregnancy, breast-feeding).
• if you are taking tamoxifen for the treatment of breast cancer(or fertility problems). Paroxetina Pharma Combix may make tamoxifen less effective, so your doctor should recommend taking another antidepressant.
• if you have diabetes.
• if you are on a low-sodium diet.
• if you have glaucoma(high eye pressure).
• if you are pregnant or think you may be pregnant(see the section Pregnancy, breast-feeding and paroxetine).
• if you are under 18 years of age(see the section Children and adolescents under 18 years of age).

If you are in any of these situations and have not yet consulted your doctor, ask your doctor how to take Paroxetina Pharma Combix.

Children and adolescents under 18 years of age

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

Also, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking Paroxetina Pharma Combix. Nevertheless, your doctor may prescribe Paroxetina Pharma Combix to patients under 18 years of age when they decide it is most convenient for the patient. If your doctor has prescribed Paroxetina Pharma Combix to you or your child under 18 years of age and you want to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms mentioned above appear or start when you or your child under 18 years of age are taking Paroxetina Pharma Combix. The long-term effects of paroxetine on safety, related to growth, maturity, and cognitive and behavioral development in this age group, have not yet been demonstrated.

In studies conducted with paroxetine in patients under 18 years of age, frequent adverse effects that affected less than 1 in 10 children or adolescents were: an increase in suicidal thoughts and attempts, self-harm behaviors, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes), and the appearance of bruises or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take paroxetine, although with less frequency.

When stopping treatment with paroxetine, some of the patients under 18 years of age in these studies reported having adverse effects. These effects were very similar to those observed in adults who stopped treatment with paroxetine (see the section How to take Paroxetina Pharma Combix).

Additionally, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm behaviors, suicidal thoughts, and attempts).

Suicidal thoughts and worsening of your depression or anxiety disorder

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

It is more likely to happen to you:

• If you have previously had thoughts of suicide or self-harm.
• 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 of age with psychiatric illnesses who were being treated with some antidepressant.

If you have thoughts of self-harm or suicide at any time, consult your doctor or go to the hospital immediately.

It may be helpful for you to explain to a family member or close friendthat you are depressed or have anxiety disorders, 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.

Important side effects seen with paroxetine

Some patients taking paroxetine develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop a condition called “serotonin syndrome”,and may have some or all of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), sudden jerky movements, or increased heart rate. Consult your doctorif you have any of these symptoms. For more information on this or other side effects of Paroxetina Pharma Combix, see the section 4. Possible side effects, in this leaflet.

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

Using other medicines and Paroxetina Pharma Combix

Some medicines may change the effect of Paroxetina Pharma Combix or make it more likely that some side effects will appear. Paroxetina Pharma Combix may also change the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide).See the section Do not take Paroxetina Pharma Combix.
• Medicines called thioridazine or pimozide, which are antipsychotics.See the section Do not take Paroxetina Pharma Combix.
• 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 and pethidine, painkillers.
• 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.
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat some psychiatric illnesses.
• Fentanyl, used in anesthesia or to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
• St. John's Wort, a herbal remedy for depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or 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 disorders.
• 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 consult what to do.Your doctor may decide to change the dose or prescribe another medicine.

Tell your doctor or pharmacist if you are using or have recently used other medicines,even those bought without a prescription.

Taking Paroxetina Pharma Combix with food and drinks

Do not drink alcohol while taking Paroxetina Pharma Combix.Alcohol may worsen your symptoms or side effects.

Taking Paroxetina Pharma Combix in the morning with food may reduce the likelihood of nausea.

Pregnancy, breast-feeding

Consult your doctor or pharmacist before using any medicine.

Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to become pregnant.In some studies, an increased risk of malformations, particularly those affecting the heart, has been observed in newborns whose mothers took paroxetine during the first months of pregnancy. In the general population, approximately 1 in 100 newborns is born with a heart malformation. This proportion increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in agreement with you, may change your treatment to another or gradually stop treatment with Paroxetina Pharma Combix while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take Paroxetina Pharma Combix.

Make sure your doctor or midwife knows that you are taking Paroxetina Pharma Combix.Medicines like Paroxetina Pharma Combix may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN) when taken during pregnancy, particularly at the end of it. The pressure in the blood vessels that go between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

If you are taking Paroxetina Pharma Combix in the last trimester of pregnancy,your newborn may also have other symptoms that usually start during the first 24 hours after birth. These symptoms include:

• breathing difficulties
• blue-tinged skin or looking too hot or cold
• blue-tinged lips
• vomiting or difficulty feeding
• feeling very tired, difficulty sleeping, or frequent crying
• muscle stiffness or floppiness
• tremors, irritability, or seizures

If you take Paroxetina Pharma Combix in the final stage of pregnancy, there may be a greater 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 Paroxetina Pharma Combix to advise you.

If your baby has any of these symptoms at birth, or if you are concerned about your newborn's health, contact your doctor or midwife, who will advise you.

Paroxetina Pharma Combix passes into breast milk in very small amounts.Consult your doctor if you are taking Paroxetina Pharma Combix before starting to breastfeed. Your doctor, in agreement with you, may advise you to continue breastfeeding while taking Paroxetina Pharma Combix.

Medicines like Paroxetina Pharma Combix may reduce sperm quality.Although the effect of this on fertility is unknown, the fertility of some men may be affected while taking Paroxetina Pharma Combix.

Driving and using machines

Some of the side effects that Paroxetina Pharma Combix can cause are dizziness, confusion, drowsiness, or blurred vision.If you experience any of these effects, do not drive vehicles or use machines.

3. How to take Paroxetina Pharma Combix

Follow your doctor's instructions for taking Paroxetina Pharma Combix exactly. Consult your doctor or pharmacist if you have any doubts.

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 usual doses for different indications are detailed in the following table:

Your doctor will tell you what dose you should take when you start treatment with Paroxetina Pharma Combix.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 tell you what to do. 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 whole with water.

The tablets should not be chewed.

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

Elderly:

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

Patients with kidney or liver disease:

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

If you take more Paroxetina Pharma Combix than you should

Never take more tablets than your doctor has recommended.If you or someone else takes more Paroxetina Pharma Combix than they should, consult your doctor or pharmacist immediately or go to the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

A person who has taken an overdose of Paroxetina Pharma Combix may experience some of the symptoms that appear in section 4, Possible side effects, or some of the following symptoms: fever, involuntary muscle contraction.

If you forget to take Paroxetina Pharma Combix

Take your medication at the same time every day.

If you forget to take a dose, and you 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

Paroxetina Pharma Combix 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 they start to feel better. If you do not start to feel better after a couple of weeks, tell your doctor, who will tell you what to do. It is possible that your doctor has scheduled a follow-up appointment after 2 weeks of starting your treatment.

If you stop treatment with Paroxetina Pharma Combix

Do not stop treatment until your doctor tells you to.

When you stop treatment with Paroxetina Pharma Combix, your doctor will tell you how to gradually reduce the dose 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 Paroxetina Pharma Combix you are taking by 10 mg each week. Most people consider the possible symptoms that occur when stopping treatment with Paroxetina Pharma Combix to be mild and to disappear on their own within two weeks. For other people, these symptoms can be more severe or last longer.

If you experience withdrawal effects while stopping your treatment, your doctor may decide to stop it more slowly. If you experience severe withdrawal symptoms, please consult your doctor. He or she may advise you to start treatment again and then stop it more slowly.

Even if you experience withdrawal effects, you may be able to stop your treatment with Paroxetina Pharma Combix.

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 side effects, which may affect up to 1 in 10 people:

• Feeling dizzy, unsteady, or having balance problems
• Numbness, tingling, and, less frequently, electric shock sensation, 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 side effects, which 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

Tell your doctor if you are concerned about the withdrawal effects of Paroxetina Pharma Combix

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

4. Possible side effects

Like all medicines, Paroxetina Pharma Combix can cause side effects, although not everyone gets them. It is more likely that side effects will appear during the first few weeks of treatment with Paroxetina Pharma Combix.

Tell your doctor if you experience any of the side effects described below during treatment with Paroxetina Pharma Combix.

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

Uncommon side effects, which may affect less than 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 are unable to urinate, contact your doctor or go to the hospital immediately.

Rare side effects, which may affect less than 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 or stand still, called akathisia. Increasing the dose of Paroxetina Pharma Combix 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 side effects, which may affect less than 1 in 10,000 people:

• Allergic reactions to Paroxetina Pharma Combix
• If you develop a rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing or swallowing, contact your doctor or go to the hospital immediately.
• If you notice any or all of the following symptoms, you may be experiencing Serotonin Syndrome.

The symptoms are: confusion, restlessness, sweating, tremors, chills, hallucinations (strange sounds or visions), sudden jerky movements, or rapid heartbeats. If you feel this way, consult your doctor.

• Acute glaucoma.

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

Frequency not known

Some people have experienced thoughts of harming themselves or suicidal thoughts while taking paroxetine or shortly after stopping treatment (see section 2, Before taking Paroxetina Pharma Combix).

Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding" in section 2 for more information.

Other possible side effects during treatment:

Very common side effects, which may affect more than 1 in 10 people:

• Vomiting (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 side effects, which 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
• Agitation
• Unusual weakness
• Blurred vision
• Diarrhea or constipation
• Vomiting
• Weight gain
• Sweating

Uncommon side effects, which 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
• Rash
• Confusion
• Hallucinations (strange sounds or visions)
• Inability to urinate (urinary retention) or Urinary incontinence (uncontrolled and involuntary urination)
• Decreased white blood cell count

Rare side effects, which may affect less than 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)
• Depersonalization
• Anxiety
• Irresistible urge to move the legs (Restless Legs Syndrome)
• Pain in joints or muscles.

Very rare side effects, which may affect less than 1 in 10,000 people:

• Liver disorders that turn the skin or the whites of the eyes yellow
• Fluid retention or swelling of arms or legs
• Sensitivity to sunlight
• Painful and prolonged erection of the penis
• Decreased platelet count in the blood.

Frequency not known

• Aggression.
• Teeth grinding.
• Inflammation of the colon (which causes diarrhea).

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 medications like Paroxetina Pharma Combix have a higher risk of bone fractures.

If you have any doubts while taking Paroxetina Pharma Combix, consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paroxetina Pharma Combix

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Paroxetina Pharma Combix after the expiration date that appears 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.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Paroxetina Pharma Combix

The active ingredient is paroxetine. Each Paroxetina Pharma Combix tablet contains 22.80 mg of paroxetine hydrochloride hemihydrate, equivalent to 20 mg of paroxetine base.

The other ingredients are: calcium phosphate anhydrous (E341), sodium starch glycolate (type A), magnesium stearate (E470b), coating agent (hypromellose (E464), titanium dioxide (E171), and macrogol 400).

Appearance of the product and packaging contents

Paroxetina Pharma Combix is presented in the form of white, film-coated tablets with a capsule shape, scored on one side and smooth on the other. Each package of Paroxetina Pharma Combix contains 14, 28, or 56 tablets.

The tablet can be divided into two equal halves.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

25, parc d’activités des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

This leaflet was approved in December 2023

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