PARI 10MG TABLET

Manufacturer : IPC-IPCA LABORATORIES LTD
Composition : PAROXETINE-10MG
Dose Form : TABLET
Description : PARI 10MG TAB
Route Of Administration : ORAL
Pack : 10
₹123.20
In stock
SKU
PAR0033

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Manufacturer : IPC-IPCA LABORATORIES LTD
Composition : PAROXETINE-10MG
Dose Form : TABLET
Description : PARI 10MG TAB
Route Of Administration : ORAL
Pack : 10

Drug Ingredient Information

PAROXETINE-10MG

PAROXETINE

Information for patients
Drug Information Your medicine is available in bottles of 150 ml. Each 5 ml of the liquid contains 10 mg of paroxetine. The liquid is an orange suspension with a smell of oranges and a sweet taste. Paroxetine is a treatment for adults with depression and/or anxiety disorders. Paroxetine is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Paroxetine and other SSRIs work but they may help by increasing the level of serotonin in the brain. Other medicines or psychotherapy can also treat depression and anxiety. Treating depression or anxiety disorders properly is important to help you get better. If it’s not treated, your condition may not go away and may become more serious and more difficult to treat. You may find it helpful to tell a friend or relative that you are depressed or suffering from an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour
Drug Alert
Alert Do not take Paroxetine … •If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide), or have taken them at any time within the last two weeks. Your doctor will adviseyou how you should begin taking Paroxetine once you have stopped taking the MAOI •If you are taking a tranquilliser called thioridazine •If you are taking an anti-psychotic called pimozide •If you have previously had an allergic reaction to paroxetine or any of the other liquid ingredients. If any of these apply to you, tell your doctor without taking Paroxetine
Before Consuming the Medicine
Avoid Drug Do not take Paroxetine … •If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide), or have taken them at any time within the last two weeks. Your doctor will adviseyou how you should begin taking Paroxetine once you have stopped taking the MAOI •If you are taking a tranquilliser called thioridazine •If you are taking an anti-psychotic called pimozide •If you have previously had an allergic reaction to paroxetine or any of the other liquid ingredients. If any of these apply to you, tell your doctor without taking Paroxetine
Drug Special Care • Are you taking any other medicines (see Other medicines and Paroxetine, inside this leaflet)? • Do you have eye, kidney, liver or heart trouble? • Do you have epilepsy or have a history of fits? • Do you have episodes of mania (overactive behaviour or thoughts)? • Are you having electro-convulsive therapy (ECT)? • Do you have a history of bleeding disorders? • Are you taking tamoxifen to treat breast cancer or fertility problems? Paroxetine may make tamoxifen less effective, so your doctor may recommend you take another antidepressant. • Do you have diabetes? • Are you on a low sodium diet? • Do you have glaucoma (pressure in the eye)? • Are you pregnant or planning to get pregnant (see Pregnancy, breast-feeding and Paroxetine, inside this leaflet)? • Have you been told by your doctor that you have an intolerance to some sugars, as this medicine contains the sugar, sorbitol. If you answer YES to any of these questions, and you have not already discussed them with your doctor, go back to your doctor and ask what to do about taking Paroxetine.
Drug Drug Interactions •Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide). • Thioridazine or pimozide, which are anti-psychotics – see Do not take Paroxetine. • Aspirin, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib, etodolac and meloxicam, used for pain and inflammation • Tramadol and pethidine, painkillers, •Medicines called triptans, such as sumatriptan, used to treat migraine •Other antidepressants including other SSRIs, tryptophan and tricyclic antidepressants like clomipramine, nortriptyline and desipramine • Medicines such as lithium, risperidone, perphenazine (called anti-psychotics) used to treat some psychiatric conditions • Fentanyl, used in anaesthesia or to treat chronic pain • A combination of fosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection • St John’s Wort, a herbal remedy for depression • Phenobarbital, phenytoin, or carbamazepine, used to treat fits or epilepsy • Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD) • Procyclidine, used to relieve tremor, especially in Parkinson’s Disease • Warfarin or other medicines (called anticoagulants) used to thin the blood • Propafenone, flecainide and medicines used to treat an irregular heartbeat • Metoprolol, a beta-blocker used to treat high blood pressure and heart problems • Rifampicin, used to treat tuberculosis (TB) and leprosy •Linezolid, an antibiotic •Tamoxifen, which is used to treat breast cancer or fertility problems • Medicines such as cimetidine or omeprazole, which are used to reduce the amount of acid in your stomach. If you are taking any of the medicines in this list, and you have not already discussed these with your doctor, go back to your doctor and ask what to do. The dose may need to be changed or you may need to be given another medicine. If you are taking any other medicines, including ones you have bought yourself, check with your doctor or pharmacist before taking Paroxetine. They will know if it is safe for you to do so.
Drug Pregnancy Interaction . When taken during pregnancy, particularly late pregnancy, medicines like Paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and the lungs is too high. If you take Paroxetine during the last 3 months of pregnancy, your newborn baby might also have other conditions, which usually begin during the first 24 hours after birth. Symptoms include: •trouble with breathing • a blueish skin or being too hot or cold •blue lips • vomiting or not feeding properly • being very tired, not able to sleep or crying a lot • stiff or floppy muscles • tremors, jitters or fits. If your baby has any of these symptoms when it is born, or you are concerned about your baby’s health, contact your doctor or midwife who will be able to advise you.
Drug Breast feeding Interaction Paroxetine may get into breast milk in very small amounts. If you are taking Paroxetine, go back and talk to your doctor before you start breast-feeding. You and your doctor may decide that you can breast-feed while you are taking Paroxetine
Drug Machinery Interaction Possible side effects of Paroxetine include dizziness, confusion or changes in eyesight. If you do get these side effects, do not drive or use machinery
Drug More Information Do not drink alcohol while you are taking Paroxetine. Alcohol may make your symptoms or side effects worse
How to take the Medicine
Consumption Info • This medicine contains the sugar, sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Paroxetine. • Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible delayed). • Sunset yellow FCF is used as a colouring agent, and may cause allergic reactions. weeks or months – this should help reduce the chance of withdrawal effects. One way of doing this is to gradually reduce the dose of Paroxetine you take by 5 ml (10 mg of paroxetine) a week. Most people find that any symptoms on stopping Paroxetine are mild and go away on their own within two weeks. For some people, these symptoms may be more severe, or go on for longer. If you get withdrawal effects when you are coming off your medicine your doctor may decide that you should come off it more slowly. If you get severe withdrawal effects when you stop taking Paroxetine, please see your doctor. He or she may ask you to start taking your medicine again and come off it more slowly. If you do get withdrawal effects, you will still be able to stop Paroxetine. Possible withdrawal effects when stopping treatment Studies show that 3 in 10 patients notice one or more symptoms on stopping Paroxetine. Some withdrawal effects on stopping occur more frequently than others. Likely to affect up to 1 in 10 people: • Feeling dizzy, unsteady or off-balance • Feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head • Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take Paroxetine • Sleep disturbances (vivid dreams, nightmares, inability to sleep) • Feeling anxious • Headaches. Likely to affect up to 1 in every 100 people: • Feeling sick (nausea) • Sweating (including night sweats) • Feeling restless or agitated • Tremor(shakiness) • Feeling confused or disorientated • Diarrhoea (loose stools) • Feeling emotional or irritable • Visual disturbances • Fluttering or pounding heartbeat (palpitations). Please see your doctor if you are worried about withdrawal effects when stopping Paroxetine
Drug quanitty It is important to take your medicine as instructed by your doctor. The label will tell you how much medicine to take and how often. If you are unsure, ask your doctor or pharmacist. Your doctor will advise you what dose to take when you first start taking Paroxetine. Most people start to feel better after a couple of weeks. If you don’t start to feel better after this time, talk to your doctor, who will advise you. He or she may decide to increase the dose gradually, 5 ml (10 mg of paroxetine) at a time, up to a maximum daily dose The maximum dose for people over 65 is 20 ml (40 mg of paroxetine) per day. Patients with liver or kidney disease If you have trouble with your liver or kidneys your doctor may decide that you should have a lower dose of Paroxetine than usual. If you have severe liver or kidney disease the maximum dose is 10 ml (20 mg of paroxetine) per day.
Drug Dose
Excess Drug Consumption Never take more medicine than your doctor recommends. If you take too much Paroxetine oral suspension (or someone else does), tell your doctor or a hospital straight away. Show them the bottle of medicine
Forgot Drug Consumption Take your medicine at the same time every day. If you do forget a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose. You may possibly get withdrawal effects, but these should go away after you take your next dose at the usual time
Stop Drug Consumption Paroxetine will not relieve your symptoms straight away – all antidepressants take time to work. Some people will start to feel better within a couple of weeks, but for others it may take a little longer. Some people taking antidepressants feel worse before feeling better. If you don’t start to feel better after a couple of weeks, go back to your doctor who will advise you. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven’t started to feel better
Possible Side Effects
General Information • Increases in the level of cholesterol in the blood • Lack of appetite • Not sleeping well (insomnia) or feeling sleepy • Abnormal dreams (including nightmares) • Feeling dizzy or shaky (tremors) Headache Feeling agitated Blurred vision • Yawning, dry mouth • Diarrhoea or constipation •Vomiting Weight gain Feeling weak • A brief increase in blood pressure, or a brief decrease that may make you feel dizzy or faint when you stand up suddenly • A faster than normal heartbeat • Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue •Dilated pupils •Skin rashes Feeling confused • Having hallucinations (strange visions or sounds) • An inability to urinate (urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence). • Abnormal production of breast milk in men and women • A slow heartbeat • Effects on the liver showing up in blood tests of your liver function Paroxetine should not be used for children and adolescents under 18 years because it has not been proven to be an effective medicine for this age group. Also, patients under 18 have an increased risk of side effects such as suicidal thoughts and harming themselves when they take Paroxetine. If your doctor has prescribed Paroxetine for you (or your child) and you want to discuss this, please go back to your doctor. In studies of Paroxetine in under 18s, common side effects that affected less than 1 in 10 children/adolescents were: an increase in suicidal thoughts and suicide attempts, deliberately harming themselves, being hostile, aggressive or unfriendly, lack of appetite, shaking, abnormal sweating, hyperactivity (having too much energy), agitation, changing emotions (including crying and changes in mood) and unusual bruising or bleeding (such as nose bleeds). These studies also showed that the same symptoms affected children and adolescents taking sugar pills (placebo) instead of Paroxetine, although these were seen less often. Some patients in these studies of under 18s had withdrawal effects when they stopped taking Paroxetine. These effects were mostly similar to those seen in adults after stopping Paroxetine (see section 5, Stopping Paroxetine, inside this leaflet). In addition, patients under 18 also commonly (affecting less than 1 in 10) experienced stomach ache, feeling nervous and changing emotions (including crying, changes in mood, trying to hurt themselves, thoughts of suicide and attempting suicide)
Common Drug Side Effects •If you have unusual bruising or bleeding, including vomiting blood or passing blood in your stools, contact your doctor or go to a hospital straight away. •If you find that you are not able to pass water, contact your doctor or go to a hospital straight away.
Rare Drug Side Effects •If you experience seizures (fits), contact your doctor or go to a hospital straight away. •If you feel restless and feel like you can’t sit or stand still, you may have something called akathisia. Increasing your dose of Paroxetine may make these feelings worse. If you feel like this, contact your doctor. •If you feel tired, weak or confused and have achy, stiff or uncoordinated muscles this may be because your blood is low in sodium. If you have these symptoms, contact your doctor.
Very Rare Drug Side Effects •Allergic reactions to Paroxetine. If you develop a red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing or swallowing, contact your doctor or go to a hospital straight away. • If you have some or all of the following symptoms you may have something called serotonin syndrome. The symptoms include: feeling confused, feeling restless, sweating, shaking,shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat. If you feel like this contact your doctor. • Acute glaucoma. If your eyes become painful and you develop blurred vision, contact your doctor. •Feeling sick (nausea). Taking your medicine in the morning with food will reduce the chance ofthis happening. • Change in sex drive or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.
Drug Side Effects Symptoms Panic attacks • Overactive behaviour or thoughts (mania) • Feeling detached from yourself (depersonalisation) •Feeling anxious •Irresistible urge to move the legs (Restless Legs Syndrome) • Pain in the joints or muscles • Liver problems that make the skin or whites of the eyes go yellow • Fluid or water retention which may cause swelling of the arms or legs Sensitivity to sunlight • Painful erection of the penis that won’t go away • Unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins) Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take Paroxetine. An increased risk of bone fractures has been observed in patients taking this type of medicines. If you have any concerns while you are taking Paroxetine, talk to your doctor or pharmacist who will be able to advise you
How to Store the Medicine
How to Store the Medicine • Keep your medicine in the original bottle . Do not store above 25oC. • Keep your medicine out of the reach and sight of children. • Do not take your medicine after the expiry date shown on the label. • Your Paroxetine oral suspension keeps for one month after it is first opened. If you have any left after this time please give it back to your pharmacist who will dispose of it safely. If you need any more Paroxetine oral suspension, please see your doctor for a new prescription. • Never give this medicine to others, even if they have similar symptoms to yours. • Finish all your medicine as the doctor tells you to. • Keep this leaflet. You may need to read it again

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