10 mg, 20 mg film-coated tablets
paroxetine
What Paroxetine Hexal is and what it is used for
Paroxetine Hexal is used in the treatment of adults with depression and/or anxiety. The anxiety states that Paroxetine Hexal is used for are: obsessive-compulsive disorder (repeated obsessive-compulsive disorder), panic disorder (attacks of panic disorder, including those caused by agoraphobia, ie fear of open spaces), social phobia (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety after a traumatic experience) and generalized anxiety (general severe anxiety or worry).
Paroxetine Hexal belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ). All people have a neurotransmitter in the brain called serotonin. Those who suffer from depression or anxiety have abnormally low levels of serotonin. How Paroxetine Hexal and other SSRIs work is not completely known but it could be because they raise the levels of serotonin in the brain. Proper treatment of your depression or anxiety is important to help you improve.
Paroxetine contained in Paroxetine Hexal 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 you use Paroxetine Hexal
Do not use Paroxetine Hexal
- if you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthionine 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 Paroxetine Hexal after you have stopped taking MAOIs.
- if you are taking an antipsychotic medicine that contains either thioridazine or pimozide
- if you are allergic to paroxetine 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 Paroxetine Hexal.
Warnings and cautions
Talk to your doctor or pharmacist before using Paroxetine Hexal
- Are you taking any other medicines (see ‘Other medicines and Paroxetine Hexal’ in this leaflet)?
- Are you taking tamoxifen for the treatment of breast cancer or fertility problems? Paroxetine Hexal may reduce the effect of tamoxifen and doctors may therefore recommend that you use other antidepressant medicines.
- Do you have kidney, liver, or heart problems?
- Do you have epilepsy or have you ever had seizures or seizures?
- 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 medication that may increase the risk of bleeding (blood thinners such as warfarin, antipsychotics such as perfenazine or clozapine, tricyclic antidepressants, painkillers, and anti-inflammatory drugs, so-called NSAIDs ) ), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
- Are you pregnant or planning to become pregnant (see ‘Pregnancy, breastfeeding and fertility in this leaflet)?
- Do you have diabetes?
- Are you on a salt-reduced diet?
- Do you have glaucoma ( glaucoma, increased pressure in the eye)?
- 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 Paroxetine Hexal.
Children and young people under 18 years of age
Paroxetine Hexal 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 Paroxetine Hexal. If your doctor has prescribed Paroxetine Hexal for you (or your child) and you want to discuss this, you should see your doctor again. You should tell your doctor if you notice any of the above symptoms or if such symptoms worsen while you (or your child) are taking Paroxetine Hexal. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been determined for children and adolescents under 18 years of age.
In studies with paroxetine in patients under 18 years of age, common side effects that occurred in less than 1 in 10 children/adolescents were the following: increased suicidal ideation and suicide attempts, intentional 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) and unusual bruising or bleeding (eg nosebleeds). 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 studies with people under 18 years of age experienced withdrawal symptoms when they stopped taking paroxetine. These symptoms are similar to those that occur in adults after discontinuation of paroxetine (see section 3 “How to use Paroxetine Hexal” in this leaflet). In addition, it was common (in less than 1 in 10) that patients under the age of 18 experienced abdominal pain, nervousness, and emotional changes (including crying, mood swings, attempted self-harm, thoughts of suicide, and suicide attempts).
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 more 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.
Important side effects have been seen with Paroxetine Hexal
Some patients taking Paroxetine Hexal develop something called akathisia, which means that they feel restless and can not sit or standstill. Others may develop something called serotonergic syndrome or malignant neuroleptic syndrome. This is meant some or all of the following symptoms: feeling very aroused or irritated, confusion, restlessness, feeling hot, sweating, shaking, chills, hallucinations (seeing or hearing strange things), muscle stiffness, sudden muscle twitching, or rapid heartbeat. The severity can increase and lead to unconsciousness. If you experience any of these symptoms, consult a doctor. For more information on these or other side effects of Paroxetine Hexal, see section 4 “Possible side effects” in this leaflet.
Drugs such as Paroxetine Hexal (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Other medicines and Paroxetine Hexal
Some medicines may affect the way Paroxetine Hexal works or increase the risk of side effects. Paroxetine Hexal may also affect the way other medicines work. Drugs affected are:
- Medicines called MAO inhibitors, including moclobemide and methylthionine chloride (methylene blue) – see ‘ Do not use Paroxetine Hexal ‘ in this leaflet.
- Thioridazine or pimozide, which are antipsychotics – see ‘ Do not use Paroxetine Hexal ‘ 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 for pain and inflammation.
- Tramadol and pethidine are painkillers.
- Drugs called triptans, such as sumatriptan, are used to treat migraines.
- Other antidepressant drugs include other SSRIs, tryptophan, and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
- A dietary supplement called tryptophan.
- Mivacurium and suxamethonium (used in anesthesia).
- Drugs such as lithium, risperidone, perfenazine, and clozapine (so-called antipsychotics ), are used to treat certain psychiatric illnesses.
- Fentanyl is used in anesthesia and anesthesia or the treatment of chronic pain.
- 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 anticoagulants, ie blood-thinning drugs.
- 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.
- Linezolid is an antibiotic.
- Tamoxifen is used to treat breast cancer or fertility problems.
- If you are taking or have recently taken any of the medicines listed above and have not already discussed this with your doctor, talk to your doctor again and ask for advice. Your dose may need to be changed or you may need another medicine.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Paroxetine Hexal with food, drink, and alcohol
Do not use alcohol while taking Paroxetine Hexal. Alcohol can worsen your symptoms or side effects. Taking Paroxetine Hexal in the morning with food may reduce the risk of nausea.
Pregnancy, breastfeeding, and fertility
Pregnancy :
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are reports of an increased risk of malformations, especially heart malformations in children whose mothers took paroxetine during the first months of pregnancy. In the general population, about 1 in 100 children is born with heart malformations. The risk is higher in children whose mothers have taken paroxetine, where the risk is 2 out of 100 children.
You and your doctor can decide together if you should switch to another treatment or if you should gradually reduce Paroxetine Hexal while you are pregnant. Depending on the circumstances, your doctor may decide that continued treatment with Paroxetine Hexal is better for you.
Tell your midwife or doctor that you are using Paroxetine Hexal. When drugs such as Paroxetine Hexal are used during pregnancy, especially late in pregnancy, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and lungs is too high. If you are taking Paroxetine Hexal during the last 3 months of pregnancy, your newborn baby may also have other symptoms that usually start within the first 24 hours after birth and include:
- difficulty breathing
- bluish skin or that the baby is too hot or cold
- blue lips
- vomiting or that the child does not eat properly
- that the child is very tired, has difficulty sleeping, or cries persistently
- tense or slack muscles
- tremors, twitches, or cramps
- excessive reflexes.
- If your baby has any of these symptoms after birth, or if you are worried about your baby’s health, consult a doctor or midwife for advice.
If you are taking Paroxetine Hexal 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 Paroxetine Hexal so that they can advise you on this.
Breastfeeding :
Paroxetine Hexal can be excreted in human milk in very small amounts. Consult your doctor before breastfeeding. You and your doctor can decide together if you can breastfeed while taking Paroxetine Hexal.
Fertility :
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 Paroxetine Hexal 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.
Paroxetine Hexal contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Paroxetine Hexal
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Sometimes you may need to take more than one tablet or just half a tablet.
The table indicates the recommended dose for different conditions.
| Introductory dose | Recommended daily dose | Maximum daily dose | |
| Depression | 20 mg | 20 mg | 50 mg |
| Obsessive-compulsive disorder (obsessive-compulsive disorder) | 20 mg | 40 mg | 60 mg |
| Panic Syndrome (Panic Anxiety Attacks) | 10 mg | 40 mg | 60 mg |
| Social phobia (fear or avoidance of social situations) | 20 mg | 20 mg | 50 mg |
| Posttraumatic stressyndrome | 20 mg | 20 mg | 50 mg |
| General severe anxiety or worry | 20 mg | 20 mg | 50 mg |
Your doctor will advise you on which dose of Paroxetine Hexal to start with. Most people start to feel better after a few weeks. If you have not noticed any improvement 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 Paroxetine Hexal in the morning with food.
Swallow the tablets with a glass of water.
Do not chew them.
The 20 mg film-coated tablets can be divided into two equal doses if needed.
Your doctor will discuss with you how long you need to continue taking Paroxetine Hexal. It can be many 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 problems with your liver or kidneys, your doctor may decide that your dose of Paroxetine Hexal should be lower than what is normally recommended.
If you use more Paroxetine Hexal than you should
Never take more Paroxetine Hexal than your doctor advised. If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Show the medicine package. A person who has overdosed on Paroxetine Hexal may experience side effects listed in section 4. Possible side effects or the following symptoms: fever, uncontrollable muscle contraction.
If you forget to take Paroxetine Hexal
Take Paroxetine Hexal 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 do so overnight or the next day, do not take any extra dose. You may experience some withdrawal symptoms, but these should go away after you take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you do not feel any improvement
Paroxetine Hexal will not relieve your symptoms immediately. All antidepressant drugs require time to work. Some patients improve after a couple of weeks while for others it may take longer. Some people who take antidepressants experience a worsening before they start to feel better. If you have not started to get better after a few 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 using Paroxetine Hexal
Do not stop taking Paroxetine Hexal until your doctor tells you to.
When stopping Paroxetine Hexal, 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 dose of Paroxetine Hexal 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 stop your treatment, your doctor may recommend that you discontinue Paroxetine Hexal more slowly. Contact your doctor if you experience severe withdrawal symptoms. Your doctor may ask you to start taking Paroxetine Hexal again, then discontinue the medicine more slowly. Even if you experience withdrawal symptoms, it will be possible for you to stop taking Paroxetine Hexal.
Withdrawal symptoms that may occur when treatment is stopped
According to studies, 3 out of 10 patients experience one or more withdrawal symptoms when treatment with paroxetine is stopped. Some 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 even in the head
- some patients have experienced buzzing, whistling, ringing, or another persistent ringing in the ears ( tinnitus ) when using paroxetine
- sleep disorders (vivid dreams, nightmares, difficulty falling asleep)
- 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 and throbbing heartbeat (palpitations).
- Contact a doctor if you are worried about withdrawal symptoms when treatment with Paroxetine Hexal 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 Paroxetine Hexal.
If you get any of the following side effects during treatment, contact your doctor immediately or consult a hospital.
Uncommon (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 (throwing water), consult a doctor or see a hospital immediately.
Rare (may affect up to 1 in 1,000 people):
- If you have a seizure, consult a doctor or see a hospital immediately.
- If you feel restless and have difficulty sitting or standing still, it may be something called akathisia. Elevating the Paroxetine Hexal dose may worsen the 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 (may affect up to 1 in 10,000 people):
- Allergic reactions to Paroxetine Hexal may be serious.
- If you develop red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, itching or difficulty breathing (shortness of breath) or swallowing as well as feelings of weakness and dizziness leading to collapse and unconsciousness, contact a doctor or see a hospital immediately.
- If you have one or all of the following symptoms, it could be a so-called serotonergic syndrome or malignant neuroleptic syndrome. The symptoms consist of feeling very aroused or irritated, confusion, restlessness, feeling hot, sweating, shaking, chills, hallucinations (hearing and seeing strange things), muscle stiffness, sudden muscle twitching, or palpitations. The severity can increase and lead to unconsciousness. Contact a doctor if you experience this.
- Acute glaucoma.
If it hurts in your eyes and you get blurred vision, consult a doctor.
Has been reported (occurs in the unknown number of users):
- Some people have had thoughts of harming themselves or taking their own lives while taking paroxetine or shortly after stopping treatment (see section 2).
- Some people have experienced aggression while taking paroxetine.
If you experience these side effects, consult your doctor.
Other possible side effects are during the treatment
Very common (may affect more than 1 user in 10):
- nausea. Taking Paroxetine Hexal with food in the morning reduces the risk of this.
- changes in sexual drive or function e.g. missed orgasm, and in men erectile dysfunction and ejaculation.
Common (may affect up to 1 in 10 people):
- elevated blood cholesterol levels
- loss of appetite
- poor sleep (difficulty falling asleep) or drowsiness
- abnormal dreams (including nightmares)
- dizziness or tremor ( tremor )
- headache
- concentration difficulties
- indignation
- unusual weakness
- dimsyn
- yawning, dry mouth
- diarrhea or constipation
- vomiting
- weight gain
- sweating.
Uncommon (may affect up to 1 in 100 people):
- a short-term increase in blood pressure, or a short-term decrease that may make you feel dizzy or faint when you get up quickly
- faster pulse than normal
- movement inhibition, stiffness, shaking, or abnormal movements of the mouth or tongue
- dilated pupil is
- rash
- itching
- confusion
- hallucinations (seeing and hearing strange things)
- inability to urinate ( urinary retention ) or uncontrollable, involuntary urination (urinary incontinence)
- If you have diabetes, you may find it difficult to control your blood sugar while taking Paroxetine Hexal. Talk to your doctor about a dose adjustment of your insulin or diabetes medicine.
Rare ( may affect up to 1 in 1,000 people):
- abnormal production of breast milk in men and women
- slow pulse
- liver effects in the form of elevated liver function values in blood
- panic attacks
- overactive behavior or overactive thoughts (mania)
- the feeling of being outside your own body (depersonalization)
- anxiety
- the uncontrollable need to move the legs (Restless Legs syndrome)
- pain in joints and muscles
- increase of hormone et prolactin in the blood
- menstrual disorders (including heavy or irregular menstrual bleeding, menstrual bleeding, and absence or delayed menstruation).
Very rare (may affect up to 1 in 10,000 people):
- skin rash that can cause blisters and look like small “targets” (a central dark spot surrounded by a paler area, with a dark ring around the edge). This is called erythema multiforme.
- extensive skin rash with blisters and flaky skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome)
- extensive skin rash with blisters and scales that occupy a large part of the body surface ( toxic epidermal necrolysis )
- liver problems that cause the skin or whites of the eyes to turn yellow
- syndrome with disturbed production of antidiuretic hormone (SIADH), a condition that causes excess water and decreased sodium (salt) concentration in the body, this is due to incorrect chemical signals. Patients with SIADH may become seriously ill or may be completely asymptomatic.
- fluid or water accumulation (which may cause swelling of the arms and legs)
- sensitivity to sunlight
- painful and persistent erection of the penis
- decreased number of platelets in the blood.
Has been reported (occurs in the unknown number of users):
- gnashing of teeth
- buzzing, whistling, ringing, or another persistent ringing in the ears ( tinnitus )
- inflammation of the colon (which causes diarrhea)
- severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy” in section 2 for more information.
An increased risk of bone fractures has been seen in patients taking this type of drug.
How to store Paroxetine Hexal
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 carton and the blister or can after EXP. The expiration date is the last day of the specified month.
Blister (Al / PVC):
10 mg: Do not store above 30 ° C.
20 mg: No special storage instructions.
HDPE can:
Do not store above 30 ° C.
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 (as hydrochloride).
One film-coated tablet contains 10 mg paroxetine (as hydrochloride).
One film-coated tablet contains 20 mg paroxetine (as hydrochloride).
Other ingredients are:
Tablet core:
Mannitol
Microcrystalline cellulose
Kopovidon K28
Sodium starch glycolate (type A)
Anhydrous colloidal silica
Magnesium stearate
Tablet cover:
Hypromellose 5 cps
Talc
Titanium dioxide (E 171)
What the medicine looks like and the contents of the pack
10 mg film-coated tablets:
White or almost white, round film-coated tablet, marked “PX 10”.
20 mg film-coated tablets:
White, round, two-part film-coated tablet with pressure-sensitive brake notch, marked with “PX 20”.
The film-coated tablets are packaged in PVC / ALU blisters in a carton or packaged in an HDPE jar with an LDPE screw cap.
Pack sizes:
10 mg: 7, 10, 14, 20, 28, 30, 50, 60, 100 and 250 film-coated tablets.
20 mg: 7, 10, 14, 15, 20, 28, 30, 40, 50, 50×1, 60, 100, 200 and 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany