Paroxetine Pharma Combix 20 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paroxetina Pharma Combix 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Paroxetina Pharma Combix is and what it is used for
Before you take Paroxetina Pharma Combix
How to take Paroxetina Pharma Combix
Possible side effects
How to store Paroxetina Pharma Combix

Additional information

1. What Paroxetina Pharma Combix is and what it is used for

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 (obsessive, repetitive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by agoraphobia, which is fear of open spaces), social anxiety disorder (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling excessively anxious and nervous most of the time).

Paroxetina Pharma Combix belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). All of us have a substance in the brain called serotonin. People who are depressed or have anxiety have lower levels of this substance. The precise mechanism of action of Paroxetina Pharma Combix and other SSRIs is not fully understood, but they work by increasing the level of serotonin in the brain. Properly treating depression or anxiety disorders is important to help you feel better.

2. Before taking Paroxetina Pharma Combix

Do not take Paroxetina Pharma Combix

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

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

Take special care with Paroxetina Pharma Combix

Talk to your doctor:

if you are taking other medicines (see section Other medicines and Paroxetina Pharma Combix).
if you have any kidney, liver, or heart problems.
if you have epilepsy or experience seizures or epileptic fits.
if you have had manic episodes (excessively active thoughts or behavior).
if you are receiving electroconvulsive therapy (ECT).
if you are prone to bleeding or bruising, or if you are taking any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and inflammation medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam), or if you are pregnant (see "Pregnancy, breastfeeding").
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 you take another antidepressant.
if you have diabetes.
if you are on a low-sodium diet.
if you have glaucoma (increased eye pressure).
if you are pregnant or planning to become pregnant (see section Pregnancy, breastfeeding and paroxetine).
if you are under 18 years of age (see 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 about 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.

You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking Paroxetina Pharma Combix. Nevertheless, your doctor may prescribe Paroxetina Pharma Combix to patients under 18 years of age if they decide it is the most appropriate treatment. 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. You must inform your doctor if any of the symptoms listed above appear or begin while you or your child under 18 years of age are taking Paroxetina Pharma Combix. The long-term effects of paroxetine on safety with regard to growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

In clinical studies with paroxetine in patients under 18 years of age, the following common adverse effects (affecting less than 1 in 10 children or adolescents) were reported: increased suicidal thoughts and suicide attempts, self-harm attempts, hostile, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional lability (including crying and mood swings), and occurrence of unexplained bruising or bleeding (such as nosebleeds). These effects were also observed, although less frequently, in patients included in these studies who did not take paroxetine.

When discontinuing treatment with paroxetine, some patients under 18 years of age in these studies reported adverse effects. These effects were very similar to those observed in adults discontinuing paroxetine treatment (see 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 emotional lability (including crying, mood swings, self-harm attempts, suicidal thoughts, and suicide attempts).

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 medicines take some time to work—usually about two weeks, but sometimes longer.

You are more likely to experience this:

If you have previously had suicidal thoughts or thoughts of self-harm.
If you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to 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 may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Important adverse effects observed with paroxetine

Some patients taking paroxetine develop a condition called akathisia, and feel restless and unable to sit still or remain motionless. Other patients develop a condition known as "serotonin syndrome", and may experience one or more of the following symptoms: confusion, restlessness, sweating, tremor, chills, hallucinations (strange visions or sounds), sudden jerky movements, or increased heart rate. Contact your doctor if you experience 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 medicines in the same class as Paroxetina Pharma Combix (known as SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Paroxetina Pharma Combix

Some medicines may alter the effect of Paroxetina Pharma Combix or make it more likely that certain adverse effects will occur. Paroxetina Pharma Combix may also alter the effect of some medicines. For example:

Medicines known as monoamine oxidase inhibitors (MAOIs, including moclobemide). See section Do not take Paroxetina Pharma Combix.
Medicines called thioridazine or pimozide, which are antipsychotics. See section Do not take Paroxetina Pharma Combix.
Acetylsalicylic acid, ibuprofen, and other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
Tramadol and pethidine, analgesics.
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 supplement called tryptophan.
Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat certain psychiatric disorders.
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 used to treat 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 conditions.
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, inform 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 using or have recently used any other medicines, including those obtained 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 adverse 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 medicine.

Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning to become pregnant. Some studies have shown an increased risk of birth defects, 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 is born with a heart defect. This rate increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in agreement with you, may switch you to another treatment or gradually discontinue Paroxetina Pharma Combix during pregnancy. However, depending on your individual circumstances, your doctor may recommend continuing Paroxetina Pharma Combix.

Ensure your doctor or midwife knows that you are taking Paroxetina Pharma Combix. Medicines like Paroxetina Pharma Combix may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN) when taken during pregnancy, particularly in the later stages. Blood vessel pressure between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

If you are taking Paroxetina Pharma Combix during the third trimester of pregnancy, your newborn may also experience other symptoms, usually beginning within the first 24 hours after birth. These symptoms may include:

difficulty breathing
bluish skin or appearance of being too hot or too cold
bluish lips
vomiting or feeding difficulties
extreme tiredness, difficulty sleeping, or frequent crying
muscle stiffness or floppiness
tremors, irritability, or seizures.

Taking Paroxetina Pharma Combix late in pregnancy may increase the risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Paroxetina Pharma Combix so they can advise you appropriately.

If your baby shows 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 breastfeeding. Your doctor, in agreement with you, may advise continuing 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 adverse effects caused by Paroxetina Pharma Combix include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

3. How to take Paroxetina Pharma Combix

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

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

Dosage	Number of tablets to take
10 mg	Half a tablet
20 mg	One tablet
30 mg	One and a half tablets
40 mg	Two tablets
50 mg	Two and a half tablets
60 mg	Three tablets

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

	Initial daily dose	Recommended daily dose	Maximum daily dose
Depression	20 mg	20 mg	50 mg
Obsessive-compulsive disorder	20 mg	40 mg	60 mg
Panic disorder	10 mg	40 mg	60 mg
Social phobia disorder	20 mg	20 mg	50 mg
Post-traumatic stress disorder	20 mg	20 mg	50 mg
Generalized anxiety disorder	20 mg	20 mg	50 mg

Your doctor will tell you what dose to take when starting treatment with Paroxetina Pharma Combix. Most people begin to feel better after a couple of weeks. If you do not start to feel better after this time, consult your doctor, who will advise you on what to do. Your doctor may decide to gradually increase your 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 must not be chewed.

Your doctor will determine how long your treatment should last. This period may extend for several months or even longer.

Elderly patients:

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

Patients with kidney or liver disease:

If you have severe hepatic or renal impairment, 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 prescribed. If you or someone else takes more Paroxetina Pharma Combix than recommended, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken.

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

If you forget to take Paroxetina Pharma Combix

Take your medication at the same time each day.

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

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

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

What to do if you do not feel better

Paroxetina Pharma Combix will not improve your symptoms immediately, as all antidepressants take time to work. Some people begin to feel better after a couple of weeks, but others may require more time. Some people taking antidepressants may feel worse before they start to feel better. If you do not start to feel better after a couple of weeks, inform your doctor, who will advise you on what to do. Your doctor may have scheduled a follow-up appointment approximately 2 weeks after you started treatment.

If you stop taking Paroxetina Pharma Combix

Do not stop treatment until your doctor tells you to do so.

When stopping treatment with Paroxetina Pharma Combix, your doctor will instruct you on 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 by gradually reducing your dose of Paroxetina Pharma Combix by 10 mg each week. Most people find that any withdrawal symptoms that occur when stopping Paroxetina Pharma Combix are mild and resolve on their own within two weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal effects while stopping treatment, your doctor may decide to taper the medication more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may recommend restarting treatment and then discontinuing it more gradually.

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

Possible withdrawal effects when stopping treatment

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

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

Dizziness, unsteadiness, or balance disturbances
Tingling, burning sensations, and less frequently, electric shock-like sensations, even in the head; ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus)
Sleep disturbances (very vivid dreams, nightmares, inability to sleep)
Anxiety
Headaches

Uncommon adverse effects, which may affect up to 1 in 100 people:

Nausea (vomiting)
Sweating (including night sweats)
Restlessness or agitation
Tremor
Confusion or disorientation
Diarrhea (loose stools)
Feeling overly sensitive or irritable
Visual disturbances
Rapid or very strong palpitations

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

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

4. Possible adverse effects

Like all medicines, Paroxetina Pharma Combix may produce adverse effects, although not everyone experiences them. Adverse effects are more likely to occur during the first weeks of treatment with Paroxetina Pharma Combix.

Inform your doctor if you experience any of the adverse effects listed below during treatment with Paroxetina Pharma Combix.

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

Uncommon adverse effects, which may affect less than 1 in 100 people:

If you have bruising or unusual bleeding, such as blood in vomit or stools, contact your doctor or go to hospital immediately.
If you are unable to urinate, contact your doctor or go to hospital immediately.

Rare adverse effects, which may affect less than 1 in 1,000 people:

If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless, unable to sit still or remain still, a condition known as akathisia. Increasing the dose of Paroxetina Pharma Combix may worsen your symptoms. If you feel this way, consult your doctor.
Tiredness, weakness, confusion, and muscle pain, stiffness, and lack of coordination. This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

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

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

Symptoms are: confusion, restlessness, sweating, tremor, chills, hallucinations (strange sounds or visions), sudden jerky movements, or rapid heartbeat. If you feel this way, consult your doctor.

Acute glaucoma.

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

Frequency not known

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

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

Other possible adverse effects during treatment:

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

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

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

Increased blood cholesterol levels
Decreased appetite
Difficulty sleeping (insomnia) or drowsiness
Abnormal dreams (including nightmares)
Dizziness, tremors
Headache
Agitation
Unusual weakness
Blurred vision
Yawning, dry mouth
Diarrhoea or constipation
Vomiting
Weight gain
Sweating

Uncommon adverse effects, which may affect up to 1 in 100 people:

Transient increases in blood pressure, or transient decreases in blood pressure which may cause dizziness or fainting when standing up quickly.
Faster than normal heartbeat
Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue
Pupil dilation
Skin 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 adverse effects, which may affect less than 1 in 1,000 people:

Abnormal breast milk secretion in men and women
Slowed heart rate
Liver effects seen in laboratory tests indicating liver function
Panic attacks
Very active behaviour or thoughts (mania)
Depersonalisation
Anxiety
Irresistible urge to move the legs (Restless Legs Syndrome)
Joint or muscle pain.

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

Liver disorders causing yellowing of the skin or whites of the eyes
Water or fluid retention causing swelling of arms or legs
Sensitivity to sunlight
Painful and prolonged penile erection
Decreased platelet count in blood.

Frequency not known

Aggression.
Teeth grinding.
Inflammation of the colon (causing diarrhoea).

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

It has been observed that people taking medicines such as Paroxetina Pharma Combix have an increased risk of bone fractures.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

If you are taking half a tablet, take care to store it safely in the container.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of Paroxetina Pharma Combix

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

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

Appearance of the medicinal product and contents of the container

Paroxetina Pharma Combix is presented as white, capsule-shaped, film-coated tablets, scored on one side and smooth on the other. Each pack of Paroxetina Pharma Combix contains 14, 28 or 56 tablets.

The tablet can be divided into equal halves.

Only certain 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

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