20 mg film-coated tablets
paroxetine
What Paroxiflex is and what it is used for
Paroxiflex is used for treating depression and/or anxiety disorders in adults. The anxiety states that Paroxiflex is used for are: obsessive-compulsive disorder (repeated obsessive-compulsive disorder), panic disorder (attacks of panic disorder, including those that occur with agoraphobia, ie fear of open spaces), social phobia (fear of or avoidance of social situations), post-traumatic stress disorder. stress syndrome (anxiety after a traumatic experience) and generalized anxiety disorder (general severe anxiety or worry).
Paroxiflex belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ). All people have a neurotransmitter in the brain called serotonin. People with depression or anxiety have lower levels of serotonin than others. It is not completely known how Paroxiflex and other SSRIs work, but it could be because they increase the levels of serotonin in the brain. Proper treatment of your depression or anxiety is important to help you improve.
Paroxetine contained in Paroxiflex may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Paroxiflex
Do not take Paroxiflex
- If you are taking medicines called monoamine oxidase inhibitors ( MAOIs, including moclobemide, linezolid, and methylthioninium chloride (methylene blue) or have taken them at any time during the last two weeks, your doctor will advise you on how to start taking Paroxiflex after you have stopped taking MAO inhibitors.
- If you are taking a medicine for psychosis that contains either thioridazine or pimozide.
- If you are allergic to paroxetine, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).
- If any of the above applies to you, tell your doctor before taking Paroxiflex.
Warnings and cautions
Talk to your doctor or pharmacist or nurse before taking Paroxiflex and ask yourself the following questions:
- Are you taking any other medicines (see section Other medicines and Paroxiflex )?
- Do you have kidney, liver, or heart problems?
- Do you have epilepsy or have had seizures or seizures in the past?
- Have you ever had manic episodes (overactive behavior or thoughts)?
- Do you receive electroconvulsive therapy (ECT)?
- Have you had a bleeding disorder or are you taking any other medicine that may increase the risk of bleeding (blood thinners such as warfarin, antipsychotics such as phenazine or clozapine, tricyclic antidepressants, painkillers, and anti-inflammatory drugs, so-called NSAIDs ) ) such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam or if you are pregnant (see section Pregnancy, breast-feeding and fertility )?
- Do you have diabetes?
- Are you on a salt-reduced diet?
- Do you have glaucoma ( glaucoma, increased pressure in the eye)?
- Are you pregnant or planning to become pregnant (see section Pregnancy, breastfeeding, and fertility )?
- Are you under 18 (see Children and adolescents under 18 in this leaflet)?
If you answer YES to any of these questions and have not previously discussed this with your doctor, consult your doctor again and ask how to apply Paroxiflex.
If you start to feel worse and have thoughts of harming yourself
You who are depressed and/or suffer from worry/anxiety can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for a drug of this type to take effect, usually about 2 weeks, sometimes longer.
These thoughts may be common:
- if you have previously had thoughts of harming yourself or committing suicide,
- if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide.
It can be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.
Children and young people under 18 years of age
Paroxiflex should not be used by children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age using Paroxiflex. If your doctor has prescribed Paroxiflex for you (or your child) and you want to discuss this, you should see your doctor again. You should tell your doctor if any of the above symptoms occur or if such symptoms worsen while you (or your child) are taking Paroxiflex. The long-term effects on growth, maturity, and cognitive and behavioral development have not been established for children and adolescents under 18 years of age.
In studies with paroxetine in patients under 18 years of age, the following common side effects occurred in less than 1 in 10 children/adolescents: Increased suicidal ideation and suicide attempts, self-harming behavior, hostile, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity ( excess energy), agitation, emotional changes (including crying and mood swings). The studies showed that the same symptoms also occurred in children and adolescents who received a placebo (an inactive substance) instead of paroxetine, but less often.
Some patients in these studies with people under the age of 18 experienced withdrawal symptoms when they stopped taking paroxetine. These symptoms are mostly similar to those seen in adults after discontinuation of paroxetine treatment (see section 3. How to take Paroxiflex in this leaflet). In addition, patients under 18 years of age usually experienced (less than 1 in 10) abdominal pain, nervousness, and emotional changes (including crying, mood swings, attempted self-harm, thoughts of suicide, and suicide attempts).
Drugs such as Paroxiflex (so-called SSRIs ) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Important side effects have been seen with Paroxiflex
Some patients taking Paroxiflex develop something called akathisia, which means that they feel restless and can not sit or standstill. Others may develop something called serotonergic syndrome when they have some or all of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (seeing or hearing strange things), sudden muscle twitching, or rapid heartbeat. If you experience any of these symptoms, consult a doctor. For more information on these and other side effects of Paroxiflex, see section 4. Any side effects are listed in this leaflet.
Other medicines and Paroxiflex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the way Paroxiflex works or increase the risk of side effects. Paroxiflex may also affect the way other medicines work. This applies to the following medicines and substances contained in medicines:
- Medicines called MAO inhibitors, including moclobemide and methylthioninium chloride (methylene blue) – see section Do not take Paroxiflex in this leaflet
- Thioridazine or pimozide, which are available in medicines for psychosis – see section Do not take Paroxiflex in this leaflet.
- Linezolid, which is found in antibiotics – see section Do not take Paroxiflex in this leaflet.
- Acetylsalicylic acid, ibuprofen, or other so-called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam are used in pain and inflammation.
- Tramadol and pethidine are used for pain.
- Fentanyl, used in anesthesia or for the treatment of chronic pain
- Drugs called triptans, such as sumatriptan, are used to treat migraines.
- Other antidepressants include other SSRIs and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
- A dietary supplement called tryptophan.
- Drugs such as lithium, risperidone, perphenazine, and clozapine (so-called antipsychotics) are used to treat certain psychiatric illnesses.
- A combination of fosamprenavir and ritonavir is used to treat HIV infection.
- St. John’s wort is a natural remedy for depression.
- Phenobarbital, phenytoin, sodium valproate, or carbamazepine for the treatment of seizures or epilepsy.
- Atomoxetine is a drug used to treat ADHD (Attention Deficit Hyperactivity Disorder).
- Procyclidine is used to relieve tremors, especially in Parkinson’s disease.
- Warfarin or other blood thinners (so-called anticoagulants ).
- Propafenone, flecainide, and medicines are used to treat an irregular heartbeat.
- Metoprolol is a beta-blocker used to treat high blood pressure and heart problems.
- Pravastatin is used to treat high cholesterol
- Rifampicin is used to treat tuberculosis and leprosy.
- Tamoxifen (used to treat breast cancer).
If you are taking or have recently taken any of the medicines listed above and have not already discussed these with your doctor, see your doctor again and ask for advice. Your dose may need to be changed or you may need another medicine.
Paroxiflex with food, drink, and alcohol
Do not use alcohol while taking Paroxiflex. Alcohol can worsen your symptoms or side effects. Taking Paroxiflex in the morning with food reduces the risk of nausea.
Pregnancy, breastfeeding, and fertility
If you are taking Paroxiflex and have recently learned that you are pregnant, talk to your doctor immediately. If you are planning to become pregnant, you should also talk to your doctor about this as some studies have shown an increased risk of heart defects in children of mothers who used paroxetine during the first months of pregnancy. In these studies, it was found that 2 children out of 100 (2%) or less, whose mothers used paroxetine early in pregnancy, were born with heart defects, compared with 1 child out of 100 (1%) in the general population. Regarding the total incidence of various malformations, there is no difference between children and mothers who used paroxetine during pregnancy compared to newborns in the general population. You and your doctor can decide together whether it is better to switch to another treatment or whether to gradually phase out Paroxiflex treatment while you are pregnant. However, depending on the circumstances, your doctor may decide that continued treatment with Paroxiflex is better for you.
Tell your midwife or doctor that you are using Paroxiflex When medicines such as Paroxiflex are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.
If you are taking Paroxiflex during the last 3 months of pregnancy, tell your midwife, as your baby may experience some postpartum symptoms. Such symptoms usually begin during the first 24 hours after birth and include the baby having difficulty sleeping or eating properly, difficulty breathing, bluish skin, the baby being too hot or too cold, vomiting, crying persistently, having tense or limp muscles, has decreased alertness, tremors, twitching or cramps. If your baby gets any of these symptoms after birth, consult a doctor or midwife for advice.
If you take Paroxiflex at the end of your 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 be informed that you are taking Paroxiflex so that they can advise you on this.
Paroxiflex can be excreted in milk in very small amounts. If you are taking Paroxiflex, talk to your doctor before breastfeeding.
In animal studies, it has been shown that paroxetine reduces the quality of semen. In theory, this could affect fertility, but no such reducing effect of paroxetine on fertility has yet been demonstrated in humans.
Driving and using machines
Possible side effects of Paroxiflex include dizziness, confusion, drowsiness, or blurred vision. If you get these side effects, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Paroxiflex contains soy lecithin and sodium
If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. next to “sodium-free”.
How to use Paroxiflex
Always take Paroxiflex exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Sometimes you may need to take more than one tablet or just half a tablet. This table shows you the number of tablets to take.
| Dose | Number of tablets to be taken |
|---|---|
| 10 mg | Half a tablet |
| 20 mg | A pill |
| 30 mg | One and a half tablets |
| 40 mg | Two tablets |
| 50 mg | Two and a half tablets |
| 60 mg | Three tablets |
The usual dosage for different conditions is given in the table below
| Starting dose | Recommended daily dose | Maximum daily dose | |
| Depression | 20 mg | 20 mg | 50 mg |
|---|---|---|---|
| Obsessive-compulsive disorder | 20 mg | 40 mg | 60 mg |
| Panic syndrome | 10 mg | 40 mg | 60 mg |
| Social Phobia | 20 mg | 20 mg | 50 mg |
| Posttraumatic stressyndrome | 20 mg | 20 mg | 50 mg |
| Generalized anxiety disorder | 20 mg | 20 mg | 50 mg |
Your doctor will advise you on which dose of Paroxiflex to start with. Most people start to feel better after a couple of weeks. If you do not feel better after this time, consult your doctor for advice. Your doctor may decide to increase your dose gradually, by 10 mg at a time, up to the highest daily dose.
Take your tablets in the morning with food.
Swallow the tablets with a glass of water.
Do not chew them.
The tablet can be divided into equal doses.
Doctors will discuss with you how long you need to continue taking Paroxiflex. It can be for several months or even longer.
Elderly patients
The maximum dose for patients over 65 years of age is 40 mg per day.
Patients with liver or kidney disease
If you have liver problems or severe kidney disease, your doctor may decide that you should take a lower dose of Paroxiflex than recommended.
If you take more Paroxiflex than you should
Never take more tablets than your doctor recommends. If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Show the medicine package. A person taking an overdose of Paroxiflex may experience the symptoms listed in section 4. Possible side effects, or the following symptoms: vomiting, dilated pupils, fever, headache, uncontrollable muscle contraction.
If you forget to take Paroxiflex
Take Paroxiflex at the same time each day.
If you forget to take a dose and think about it before going to bed at night, take a dose immediately. Continue as usual the next day.
If you forget to take a dose and only remember to take it overnight or the next day, do not take any extra dose. Take the next dose at the usual time. You may experience some withdrawal symptoms, but these will disappear after the next dose.
Do not take a double dose to make up for a forgotten dose.
If you do not feel any improvement
Paroxiflex will not relieve your symptoms immediately – all antidepressants require time to work. Some patients start to feel better after a couple of weeks while for others it may take a little longer. Some people who take antidepressants experience a worsening before they start to feel better. If you do not start to feel better after a couple of weeks, contact your doctor for advice. Your doctor should suggest a return visit a few weeks after you start treatment. Tell your doctor if you do not notice any improvement.
If you stop taking Paroxiflex
Do not stop taking Paroxiflex until your doctor tells you to.
When stopping Paroxiflex, your doctor will help you slowly reduce your dose over several weeks or months to reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce your Paroxiflex dose by 10 mg per week. Most people experience that the withdrawal symptoms are mild and go away on their own within 2 weeks. For some patients, the symptoms may be more severe or more prolonged.
If you experience withdrawal symptoms when you end your treatment, your doctor may decide that you should stop at a slower pace. Contact your doctor if you experience severe withdrawal symptoms. Your doctor may ask you to start taking Paroxiflex again and then end the treatment more slowly.
Even if you experience withdrawal symptoms, it will be possible for you to stop taking Paroxiflex.
Withdrawal symptoms that may occur when treatment is stopped
Studies show that 3 out of 10 patients experience one or more withdrawal symptoms when treatment with paroxetine is stopped. Some withdrawal symptoms occur more often than others.
Common withdrawal symptoms may affect up to 1 in 10 people
- Dizziness (feeling of instability, balance difficulties)
- Sensory disturbances such as ant crawling burning sensation, and, less commonly, a sensation of electric shock (including in the head), as well as buzzing, hissing, whistling, ringing, or other persistent sounds in the ears ( tinnitus )
- Sleep disorders (vivid dreams, nightmares, difficulty sleeping).
- Anxiety
- Headache
Uncommon withdrawal symptoms may affect up to 1 in 100 people
- Nausea
- Sweating (including night sweats)
- Restlessness or agitation
- Tremor (shaking)
- Confusion or disorientation
- Diarrhea
- Emotional instability or irritability
- Visual disturbances
- Fluttering or throbbing heartbeat (palpitations)
Contact a doctor if you are worried about withdrawal symptoms when treatment with Paroxiflex is stopped.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects occur more often during the first weeks of treatment with Paroxiflex.
If you get any of the following side effects during treatment, contact your doctor immediately or consult a hospital
Uncommon side effects may affect up to 1 in 100 people:
- If you get unusual bruising or bleeding, bloody vomiting, or blood in the stool, consult a doctor or see a hospital immediately.
- If you have difficulty urinating, consult a doctor or go to a hospital immediately.
Rare side effects may affect up to 1 in 1,000 people:
- If you have a seizure, contact your doctor or hospital immediately.
- If you feel restless and have difficulty sitting or standing still, it may be something called akathisia. Increasing the Paroxiflex dose may worsen these symptoms. Contact a doctor if you experience these symptoms.
- If you feel tired, weak, or confused and have sore, stiff, or uncoordinated muscles, this may be due to too low a level of sodium in the blood. Contact a doctor if you get these symptoms.
Very rare side effects may affect up to 1 in 10,000 people:
- Allergic reactions (which may be severe) to Paroxifle x. If you develop red and lumpy skin rash, swelling of eyelids, face, lips, mouth or tongue, itching or difficulty breathing (shortness of breath), or swallowing and feeling weak or dizzy resulting in fainting or unconsciousness, consult a doctor or see a hospital immediately.
- If you have one or more of these symptoms, it may be a so-called serotonergic syndrome. Symptoms include confusion, restlessness, sweating, tremors, chills, hallucinations (hearing or seeing strange things), sudden muscle twitching, or palpitations. Contact a doctor if you experience this.
- Acute glaucoma. If you get pain in your eyes and you have blurred vision, consult a doctor.
- Severe rash (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis ), which is potentially life-threatening and requires immediate medical attention.
- These first appear as round spots often with central blisters usually on the arms and hands or legs and feet, more severe skin rashes may include blisters on the chest and back. Severe forms of skin rash can develop into widespread skin rash that can be life-threatening.
- If you get a rash or these skin symptoms, stop taking Paroxiflex and contact your doctor immediately.
Has been reported (occurs in the unknown number of users):
- Thoughts of harming yourself or committing suicide (see section 2. Warnings and precautions).
- Aggression.
Other possible side effects are during the treatment
Very common side effects may affect more than 1 in 10 people.
- Nausea. Taking Paroxiflex in the morning with food reduces the risk of nausea.
- Change in sexual drive or function e.g. missed orgasm and, in men, erectile dysfunction and ejaculation.
- Concentration problems
Common side effects may affect up to 1 in 10 people
- Loss of appetite
- Difficulty sleeping or drowsiness
- Abnormal dreams (including nightmares)
- Dizziness or tremors ( tremor )
- Headache
- Indignation
- Unusual weakness
- Dimsyn
- Yawning, dry mouth
- Diarrhea or constipation
- Vomiting
- Weight gain
- Sweating
- Increased cholesterol levels
Uncommon, may affect up to 1 in 100 people
- Short-term increase or decrease in blood pressure, faster pulse than normal
- Movement retardation, stiffness, shaking, or abnormal movements in the mouth or tongue
- Rash
- Itching
- Confusion
- A short-term drop in blood pressure when you get up can make you feel dizzy or faint
- Hallucinations (seeing or hearing strange things)
- Dilated pupils ( mydriasis )
- Difficulty urinating ( urinary retention ) or uncontrollable, involuntary urination (urinary incontinence)
- If you are a diabetic patient, you may experience a loss of control of your blood sugar levels while taking Paroxiflex. Talk to your doctor about adjusting the dose of your insulin or your diabetes medicine.
Rare side effects may affect up to 1 in 1,000 people
- Abnormal production of breast milk in men and women
- Slow pulse
- Liver effects seen in blood tests when testing your liver function
- Panic attacks
- Overactive behavior or thoughts (mania)
- The feeling of being outside your own body (depersonalization)
- Anxiety
- Pain in joints or muscles
- Increase of hormone and prolactin in the blood
- Need to move the legs (or other parts of the body) to stop restless legs.
Very rare side effects may affect up to 1 in 10,000 people
- Yellowing of the skin or whites of the eyes due to liver problems,
- Retention of fluid or water in the body, which can cause swelling in the arms or legs
- Sensitivity to sunlight
- Painful and persistent erection of the penis
- Decreased number of platelets in the blood
Has been reported (occurs in an unknown number of users):
- Tooth grinding
- Inflammation of the colon (which causes diarrhea).
- Severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see Pregnancy, breastfeeding, and fertility in section 2 for more information.
Other possible side effects:
An increased risk of bone fractures has been seen in patients taking this type of drug.
Some patients have experienced buzzing, hissing, whistling, ringing, or other persistent sounds in their ears ( tinnitus ) when using paroxetine.
If you have any worries about using Paroxiflex, talk to your doctor or pharmacist for advice.
How to store Paroxiflex
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or jar and the carton. The expiration date is the last day of the specified month.
No special storage instructions.
If you use half tablets, be sure to store them safely in the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is paroxetine (20 mg).
Other ingredients are:
- Tablet core: magnesium stearate, sodium starch glycollate (type A), mannitol, microcrystalline cellulose
- Tablet coating: basic butylated methacrylate copolymer, polyvinyl alcohol, talc, soy lecithin, xanthan gum, and titanium dioxide (E171)
What the medicine looks like and the contents of the pack
Paroxiflex 20 mg film-coated tablet is white/off-white, biconvex, round, film-coated, scored, and marked with “P” on one side and “20” on the other. The tablet has a score line on both sides. The tablet can be divided into two equal doses.
Paroxiflex 20 mg is available in
Blister packs (Al / Al) containing 20, 50, 60 and 100 tablets, 5 x 20 and 10 x 20 tablets or
jars containing (Polypropylene with LDPE lid) with desiccants 100, 200, and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers:
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark
It can also be helpful for you to contact a self-help or patient organization support group to find out more about your illness. Your doctor can give you the detailed information.