PATIENT INFORMATION LEAFLET

Paroxetine Pharma Combix 20 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Additional information

Paroxetina Pharma Combix is used for the treatment of depression and/or anxiety disorders in adults.The anxiety disorders for which Paroxetina Pharma Combix is indicated are: obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrolled behavior), anxiety disorder (panic crises, including those caused by agoraphobia, which is the fear of open spaces), social anxiety disorder (fear or avoidance of social contact situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling normally a lot of anxiety and nervousness).

Paroxetina Pharma Combix belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). We all have a substance called serotonin in our brain. People who are depressed or have anxiety have lower levels of this substance. The exact mechanism of action of Paroxetina Pharma Combix and other SSRIs is not precisely known, but they exert their action by increasing the level of serotonin in the brain. Properly treating depression or anxiety is important to help you feel better.

Do not takeParoxetina Pharma Combix

• if you are being treated with medications called monoamine oxidase inhibitors(MAOIs, including moclobemide), or if you have been treated with any of these medications in the past 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 medicationcalled thioridazine or the antipsychotic called pimozide.
• if you are allergic (hypersensitive)to paroxetine or to any of the other components of Paroxetina Pharma Combix (see the sectionAdditional Information).

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

Be especially careful withParoxetina Pharma Combix

Consult your doctor:

• if you are taking other medications (see the section Use of other medications and ParoxetinaPharma Combix).
• if you have any kidney, liver, or heart problems.
• if you have epilepsy or if you experience seizures or convulsions.
• if you have had manic episodes (excessively active thoughts or behaviors).
• if you are being treated with electroconvulsive therapy (ECT).
• if you have a tendency to bleed or bruise easily, or if you are being treated with any medication that may increase the risk of bleeding (including medications such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and anti-inflammatory medications called nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam), or if you are pregnant (see «Pregnancy, breastfeeding»).
• if you are taking tamoxifen for breast cancer (or fertility problems). Paroxetina Pharma Combix may make tamoxifen less effective, so your doctor should recommend 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 if you think you may become pregnant (see the section Pregnancy, breastfeeding 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 them 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, be aware that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking Paroxetina Pharma Combix. Despite this, your doctor may prescribe Paroxetina Pharma Combix to patients under 18 years of age when they decide it is best for the patient. If your doctor has prescribed Paroxetina Pharma Combix to you or your child under 18 years of age and you wish to discuss this decision, consult your doctor. Inform your doctor if any of the symptoms listed 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, the most common adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in thoughts and attempts of suicide, self-mutilation, 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 fortuitous cardinals or bleeding (such as nasal bleeding). These effects were also observed in patients included in these studies who did not take paroxetine, although less frequently.

When stopping treatment with paroxetine, some of the patients under 18 years of age reported adverse effects. These effects were very similar to those observed in adults who stopped taking paroxetine (see the section How to takeParoxetina 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-mutilation, thoughts and attempts of suicide).

Suicidal thoughts and worsening of depression or anxiety disorder

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

This is more likely to happen:

• if you have previously had thoughts of suicide or self-harm.
• if you are ayoung adult.There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were being treated with some antidepressant.

If you have thoughts of harming yourself or committing 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 friend that 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 adverse effects observed with paroxetine

Some patients who take paroxetine develop a disorder called akathisia, andfeelrestless and unable to sit or stay still. Other patients develop the so-called“serotonin syndrome”,and may have any or all of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), sudden, abrupt movements, or an increase in heart rate.Consult your doctorif you have any of these symptoms. For more information on this or other adverse effects of Paroxetina Pharma Combix, see section 4. Possible adverse effects, in this leaflet.

Some medications 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.

Use of other medications and Paroxetina Pharma Combix

Some medications may modify the effect of Paroxetina Pharma Combix or make it more likely for adverse effects to occur. Paroxetina Pharma Combix may also modify the effect of some medications. For example:

• Medications calledmonoamine oxidase inhibitors(MAOIs, including moclobemide). See the sectionDo not take Paroxetina Pharma Combix.
• Medications called thioridazine or pimozide, which areantipsychotics. See the sectionDo not takeParoxetinaPharma Combix.
• Aspirin, ibuprofen, and other medications called nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treatpain and inflammation.
• Tramadol and petidina,analgesics.
• Medications called triptans, such as sumatriptan, used to treatmigraine.
• Otherantidepressants, including other selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• Adietary supplementcalled tryptophan.
• Medications such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat somepsychiatric disorders.
• Fentanil, used in anesthesia or to treatchronic pain.
• A combination of fosamprenavir and ritonavir, used to treathuman immunodeficiency virus (HIV) infection.
• St. John's Wort, a medicinal herb to treatdepression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treatseizures or epilepsy.
• Atomoxetine, a medication used to treatattention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to alleviate tremor, especially inparkinson's disease.
• Warfarin and other medications (called anticoagulants) used tothin the blood.
• Propafenone, flecainide, and medications used to treatheart rhythm disorders.
• Metoprolol, a beta-blocker used to treathigh blood pressure and heart disorders.
• Rifampicin, used to treattuberculosis (TB) and leprosy.
• Linezolid, anantibiotic.
• Tamoxifen, used totreat breast cancer(orfertility problems).

If you are taking or have recently taken any of these medications, inform your doctor and consult what to do.Your doctor may decide to change the dose or prescribe another medication.

Inform your doctor or pharmacist if you are using or have recently used other medications,including those purchased without a prescription.

Taking Paroxetina Pharma Combix with food and drinks

Do not consume 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, breastfeeding

Consult your doctor or pharmacist before using any medication.

Inform your doctor immediately if you are pregnant, if you think you may be pregnant, or if you are planning to become pregnant.In some studies, there was an increased risk of malformations, particularly those affecting the heart, in newborns whose mothers took paroxetine during the first months of pregnancy. In the general population, approximately 1 in 100 newborns are born with a heart defect. This proportion increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in consultation with you, may change your medication or gradually stop Paroxetina Pharma Combix while you are pregnant. However, depending on your circumstances, your doctor may recommend that you continue taking Paroxetina Pharma Combix.

Make sure your doctor or midwife knows that you are taking Paroxetina Pharma Combix.Medications like Paroxetina Pharma Combix may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN), when taken during pregnancy and particularly towards the end of it. The pressure in the blood vessels 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 experience other symptoms that usually begin within the first 24 hours after birth. These symptoms include:

• difficulty breathing
• blue skin or appearance of being too hot or cold
• blue lips
• vomiting or difficulty feeding
• feeling very tired, difficulty sleeping, or frequent crying
• muscle stiffness or flaccidity
• tremors, irritability, or seizures.

If you take Paroxetina Pharma Combix in the final stage of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Paroxetina Pharma Combix to be able to advise you.

If your baby has any of these symptoms at birth, or if you are concerned about your baby'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 consultation with you, may advise you to continue breastfeeding while taking Paroxetina Pharma Combix.

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

Driving and operating machinery

Some of the adverse effects that Paroxetina Pharma Combix may cause are dizziness, confusion, feeling drowsy, or blurred vision. If you experience any of these effects, do not drive vehicles or operate machinery.

Follow exactly the administration instructions for Paroxetina Pharma Combix indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

Your doctor will tell you what dose to take when starting treatment with Paroxetina Pharma Combix.Most people start to feel better after a couple of weeks. If you don't start to feel better after this time, 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 must be swallowed whole with water.

The tablets should not be chewed.

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

Seniors:

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

Patients with kidney or liver disease:

If you have severe liver or kidney disease, 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, take more Paroxetina Pharma Combix than you should, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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

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 remember before bedtime, take it immediately. Take the next dose at the usual time.

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

Do not take a double dose to compensate for the missed doses.

What to do if you don't feel better

Paroxetina Pharma Combix will not improve your symptoms immediately, all antidepressants take time to act. Some people start to feel better after a couple of weeks, but others may need more time. Some people who take antidepressants feel worse before they start to notice the improvement. If you don't start to feel better after a couple of weeks, tell your doctor, who will tell you what to do. Your doctor may have scheduled a follow-up appointment after 2 weeks of starting treatment.

If you interrupt treatment with Paroxetina Pharma Combix

Do not stop treatment until your doctor tells you to.

When stopping treatment with Paroxetina Pharma Combix,your doctor will tell you how to gradually reduce the dose over a period of several weeks or months, which will help reduce the risk of 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 withdrawal symptoms that occur when stopping treatment with Paroxetina Pharma Combix to be mild and disappear on their own in two weeks. For some people, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms while stopping treatment, your doctor may decide to stop treatment more gradually. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then stop it more gradually.

Although you may experience withdrawal symptoms, you can still be able to stop treatment with Paroxetina Pharma Combix.

Withdrawal symptoms when stopping treatment

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

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

- Feeling dizzy, unstable, or having balance problems

- Tingling, burning sensations, and, less frequently, a feeling of electric shock, even in the head, buzzing, ringing, beeping, or other persistent sounds in the ears (tinnitus)

- Sleep disturbances (vivid dreams, nightmares, inability to sleep)

- Anxiety

- Headaches

Less common side effects, which can affect 1 in 100 people:

- Nausea (vomiting)

- Sweating (including night sweats)

- Restlessness or agitation

- Tremors

- Confusion or disorientation

- Diarrhea (soft stools)

- Feeling very sensitive or irritable

- Visual disturbances

- Rapid or strong heart palpitations

Consult your doctor if you are concerned about withdrawal symptoms from Paroxetina Pharma Combix

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

Like all medications,ParoxetinePharma Combix may cause side effects, although not everyone will experience them. It is more likely that side effects will occur during the first weeks of treatment with Paroxetine Pharma Combix.

Inform your doctor if you experience any of the following side effects during treatment with Paroxetine Pharma Combix.

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

Side effects that are infrequent, affecting less than 1 person in 100:

-If you have unusual bruising or 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..

Side effects that are rare, affecting less than 1 person in 1,000:

-If you experience seizures(epileptic crises),contact your doctor or go to the hospital immediately.

-If you have a feeling of restlessness, inability to sit or stay still,known as akathisia. Increasing the dose of Paroxetine Pharma Combix may worsen your symptoms. If you feel this way,consult your doctor..

-Fatigue, 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..

Side effects that are very rare, affecting less than 1 person in 10,000:

-Allergic reactions to Paroxetine Pharma Combix

- If you develop a skin rash with redness and blisters, 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 aSerotonin Syndrome..

The symptoms are: confusion, restlessness, sweating, tremors, chills, hallucinations (strange sounds or visions), sudden, rapid 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..

Unknown frequency:

Some people have experienced thoughts of self-harm or suicide while taking paroxetine or shortly after stopping treatment (see section 2, Before taking Paroxetine Pharma Combix).

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

Other possible side effects during treatment:

Very common side effects, affecting more than 1 person in 10:

- Vomiting (nausea). This effect may 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, affecting up to 1 person in 10:

- Increase in blood cholesterol levels

- Decreased appetite

- Difficulty sleeping (insomnia) or drowsiness

- Abnormal dreams (including nightmares)

- Dizziness, tremors

- Headache

- Restlessness

- Unusual weakness

- Blurred vision

- Yawning, dry mouth

- Diarrhea or constipation

- Vomiting

- Weight gain

- Sweating

Infrequent side effects, affecting up to 1 person in 100:

- Transient increases in blood pressure, or transient decreases that may cause dizziness or fainting when standing up quickly.

- Rapid heartbeats

- Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue

- Dilated pupils

- Skin rash

- Confusion

- Hallucinations (strange sounds or visions)

- Inability to urinate (urinary retention) or involuntary urination (incontinence)

- Decreased white blood cell count

Rare side effects, affecting less than 1 person in 1,000:

- Abnormal milk secretion in men and women

- Decreased heart rate

- Liver effects that are seen in laboratory tests indicating liver function

- Panic attacks

- Very active behaviors or thoughts (mania)

- Depersonalization

- Anxiety

- Irresistible need to move legs (Restless Legs Syndrome)

- Joint or muscle pain.

Very rare side effects, affecting less than 1 person in 10,000:

- Liver damage that turns the skin or the white of the eyes yellow

- Water or fluid retention causing swelling of the arms or legs

- Sensitivity to sunlight

- Prolonged and painful erection of the penis

- Decreased platelet count in the blood.

Unknown frequency:

- Aggression.

- Grinding of teeth.

- Inflammation of the colon (causing diarrhea).

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

People taking medications like Paroxetine Pharma Combix have a higher risk of bone fractures.

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

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 Medicines 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 out of 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 packagingafter “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 through drains or inthe trash. Disposeof the packaging and unused medicines at the SIGREcollection pointof the pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Paroxetina Pharma Combix

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

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

Appearance of the product and contents of the package

Paroxetina Pharma Combix is presented in the form of coated tablets with a white film, in the shape of a capsule, with a groove 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.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix, S.L.U.

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/