PARAMAX 500MG/5MG EFFERVESCENT POWDER
Active substance: PARACETAMOL
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PACKAGE LEAFLET: INFORMATION FOR THE USER
You are elderly (65 years of age or older) If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Paramax
Paramax 500mg/5mg Effervescent Powder
Important information about some of the ingredients of Paramax Sodium: There is 387.7 mg of sodium per sachet. This may be harmful to people on a low sodium or low salt diet.
Paracetamol Metoclopramide hydrochloride
Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet: 1. What Paramax is and what it is used for 2. Before you take Paramax 3. How to take Paramax 4. Possible side effects 5. How to store Paramax 6. Further information
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Paramax can affect the way some other medicines work. Also, some other medicines can affect the way Paramax works. While taking Paramax you should not take any other medicines which contain paracetamol. This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops. Do not take this medicine, and tell your doctor, if you are taking: Levodopa - used for Parkinsons disease Tell your doctor if you are taking any of the following: Paramax may increase the effects of the following medicines: Medicines for mental illness known as antipsychotics Medicines to calm or reduce anxiety (hypnotics, anxiolytics) Medicines to help you sleep (sedatives, barbiturates) Some medicines used for depression such as mirtazapine or trazodone Chloramphenicol an antibiotic used for infections Medicines to prevent blood clotting (anti-coagulants) such as warfarin Ciclosporin - used to help prevent rejection of transplants. Your doctor may change your dose of ciclosporin Clonidine - used for high blood pressure, migraine or hot flushes in the menopause Some medicines for moderate to severe pain (morphine products) such as codeine, dihydrocodeine or dextropropoxyphene Medicines that can make you sleepy that are used for hay fever, rashes or other allergies called sedative antihistamines such as chlorphenamine or promethazine Paramax can make the following medicine work less well: Digoxin - used for heart problems. Your doctor may change your dose of digoxin The following medicine can increase the effects of Paramax: Domperidone (a similar medicine to metoclopramide) - used to stop you feeling sick (nausea) or being sick (vomiting) The following medicines can make Paramax work less well: Oral contraceptive pill Colestyramine - for lowering blood cholesterol levels Medicines used to treat muscle spasms (anticholinergics) for irritable bowel syndrome (IBS) such as mebeverine or hyoscine Medicines used to treat incontinence such as oxybutynin, propiverine or tolterodine Some medicines for moderate to severe pain (morphine products) such as codeine, dihydrocodeine or dextropropoxyphene Taking Paramax with food and drink You should not drink alcohol while you are taking these sachets. Drinking alcohol while taking Paramax may make you feel very sleepy. Pregnancy and breast-feeding Talk to your doctor before taking this medicine if: You are pregnant, think you may be pregnant or plan to get pregnant. You must not take Paramax during the first six months of pregnancy You are breast-feeding or planning to breast feed. Do not breast-feed if you are taking Paramax. This is because small amounts may pass into mothers milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
3.How to take Paramax
Always take Paramax exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine Take this medicine by mouth Pour the contents of the sachet into about a quarter of a glass of water mix well and drink straight away Do not take more than the recommended dose If you continue being sick (vomiting) after taking this medicine, tell your doctor If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor How much to take Adults (18 years and older) and the elderly: The usual dose is 2 sachets when you have the first warning of a migraine attack Wait at least 4 hours before taking another dose Do not take more than 6 sachets in a any 24 hour period Children Do not take if you are under 18 years of age If you take more Paramax than you should Tell your doctor or go to your nearest hospital casualty department straight away - even if you feel well. This is because of the risk of delayed, serious liver damage Remember to take any remaining sachets and the pack with you. This is so the doctor knows what you have taken The following effects may happen: Feeling sick (nausea) and being sick (vomiting); unusually pale complexion; loss of appetite; stomach pains. Other effects such as drowsiness, rapid uncontrollable shaking (convulsions), muscle spasms and jerks may also occur Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis You may also feel that your limbs are swollen (uid retention). This is a sign of changes in the way your kidneys are working In some cases an uneven heart beat; increased or heavy breathing and feeling weak. You may also develop liver problems that may cause the eyes or skin to go yellow and in severe cases lack of awareness (disorientation), confusion, loss of consciousness (coma) and death may occur If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
expression and/or lead to unnatural positioning of the head and shoulders Decreased level of consciousness, confusion, hallucination Rigid or sti muscles, trembling or shaking or difficulty moving You bruise more easily than usual. This could be because of a blood disorder (thrombocytopenia) You get infections more often and easier than normal. This could be because you have a low number of white blood cells (agranulocytosis) Depression
Tell your doctor as soon as possible if you have any of the following side effects: Diarrhoea Dizziness, lightheadedness and fainting. This could be because of low blood pressure Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: Abnormal production of breast milk in men and women Breast enlargement in men Loss of menstrual periods Feeling nervous (anxious), restless or confused Feeling drowsy Lack or loss of strength (weakness) Skin rash Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice side effects not listed in this leaflet.
Scale 100% PARAMAX Sachets - leaflet UK 148 x 315 mm code: 395574 Laetus: 61 Fonts: Ocean Sans Pro SAN 8 pt/text Color: 1/Pantone Reflex Blue Version n 3 Plant Rzeszow - Agnieszka Twardochleb Kamil Giecko Date: June 2011
1. What Paramax is and what it is used for
The name of your medicine is Paramax 500mg/5mg, Effervescent Powder (called Paramax in this leaflet). What Paramax contains Paramax contains two different medicines. These are called: Metoclopramide hydrochloride: this belongs to a group of medicines called anti-emetics It works on muscles in the upper part of the digestive system causing your stomach to empty. It also works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting) Paracetamol: this belongs to a group of medicines called painkillers (analgesics). It works by stopping substances that naturally occur in your body called prostaglandins from being made. Prostaglandins cause pain. If they are blocked, pain is relieved What Paramax is used for Paramax is used to treat the signs of migraine, such as headache, feeling sick (nausea) or being sick (vomiting) in adults 18 years and over.
5. How to store Paramax
Keep this medicine in a safe place where children cannot see or reach it. Do not use Paramax after the expiry date which is stated on the sachet and carton after EXP. The expiry date refers to the last day of that month. Store below 25C. Keep the sachets in the outer carton. 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.
6. Further information
What Paramax contains Each sachet contains 500mg paracetamol and 5mg metoclopramide hydrochloride (as anhydrous) as the active ingredients Paramax also contains gelatin, sodium carbonate, saccharin sodium, sodium dihydrogen citrate (anhydrous), sodium bicarbonate and lemon flavour What Paramax looks like and contents of the pack Paramax Sachets contain a white, soluble effervescent powder for oral solution. Paramax is presented in cartons containing 6, 30 or 42 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Zentiva, One Onslow Street Guildford, Surrey GU1 4YS, UK Manufacturer Sanofi-Aventis Sp. z o.o. ul. Lubelska 52 35-233 Rzeszw, Poland This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in June 2011. Zentiva 2011
2. Before you take Paramax
Do not take this medicine and tell your doctor if: You are allergic (hypersensitive) to: - Metoclopramide hydrochloride - Paracetamol - Any of the other ingredients of Paramax (listed in Section 6 below) Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have a blockage or bleeding in your stomach or intestine (gut) You have had movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs after taking metoclopramide or medicines used to calm emotional and mental problems You have epilepsy You have had an operation on your stomach or intestine (gut). Do not take during the first 3 to 4 days after your operation You have a tumour on the adrenal gland (called phaeochromocytoma) You are taking a medicine called levodopa used to treat Parkinsons disease (see Taking other medicines) The person going to take the sachets is under 18 years of age. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Paramax. Take special care with Paramax Check with your doctor or pharmacist before taking your medicine if: You have severe kidney problems You have severe liver problems including alcoholic liver disease
4. Possible side effects
Like all medicines, Paramax can cause side effects, although not everybody gets them. Stop taking Paramax and see a doctor or go to a hospital straight away if: You have an allergic reaction. Severe allergic reactions can occur very rarely and usually happen soon after taking Paramax. These can involve difficulty breathing, tightness in the throat, rapidly spreading rashes, dizziness, very fast heart beat or even loss of consciousness. You are short of breath, have bluish skin colouration, headache, tiredness, dizziness and loss of consciousness. These could be signs of a very rare but serious side effect called methaemoglobinaemia You are paler than normal, are sweating, have a high temperature, fast heartbeat, stiff muscles, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called neuroleptic malignant syndrome. Shortness of breath, slow heart beat and chest pain You have a t (seizure) Tell a doctor straight away if you notice any of the following serious side effects: Problems controlling certain muscles of the body or you have muscle spasms or jerks. The affected muscles may include your tongue, mouth, jaw, arms and legs. The spasms may cause unusual movements of the face, tongue, eyes, neck and affect speech,
Driving and using machines You may feel sleepy after taking this medicine. This is more likely if you have drunk alcohol or taken other medicines that cause drowsiness. If this happens, do not drive or use any tools or machines.
Turn Over
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26/10/2011 08:04 - VISTAlink folder 720687 - Page 1/2
You are elderly (65 years of age or older) If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Paramax
Paramax 500mg/5mg Effervescent Powder
Important information about some of the ingredients of Paramax Sodium: There is 387.7 mg of sodium per sachet. This may be harmful to people on a low sodium or low salt diet.
Paracetamol Metoclopramide hydrochloride
Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet: 1. What Paramax is and what it is used for 2. Before you take Paramax 3. How to take Paramax 4. Possible side effects 5. How to store Paramax 6. Further information
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Paramax can affect the way some other medicines work. Also, some other medicines can affect the way Paramax works. While taking Paramax you should not take any other medicines which contain paracetamol. This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops. Do not take this medicine, and tell your doctor, if you are taking: Levodopa - used for Parkinsons disease Tell your doctor if you are taking any of the following: Paramax may increase the effects of the following medicines: Medicines for mental illness known as antipsychotics Medicines to calm or reduce anxiety (hypnotics, anxiolytics) Medicines to help you sleep (sedatives, barbiturates) Some medicines used for depression such as mirtazapine or trazodone Chloramphenicol an antibiotic used for infections Medicines to prevent blood clotting (anti-coagulants) such as warfarin Ciclosporin - used to help prevent rejection of transplants. Your doctor may change your dose of ciclosporin Clonidine - used for high blood pressure, migraine or hot flushes in the menopause Some medicines for moderate to severe pain (morphine products) such as codeine, dihydrocodeine or dextropropoxyphene Medicines that can make you sleepy that are used for hay fever, rashes or other allergies called sedative antihistamines such as chlorphenamine or promethazine Paramax can make the following medicine work less well: Digoxin - used for heart problems. Your doctor may change your dose of digoxin The following medicine can increase the effects of Paramax: Domperidone (a similar medicine to metoclopramide) - used to stop you feeling sick (nausea) or being sick (vomiting) The following medicines can make Paramax work less well: Oral contraceptive pill Colestyramine - for lowering blood cholesterol levels Medicines used to treat muscle spasms (anticholinergics) for irritable bowel syndrome (IBS) such as mebeverine or hyoscine Medicines used to treat incontinence such as oxybutynin, propiverine or tolterodine Some medicines for moderate to severe pain (morphine products) such as codeine, dihydrocodeine or dextropropoxyphene Taking Paramax with food and drink You should not drink alcohol while you are taking these sachets. Drinking alcohol while taking Paramax may make you feel very sleepy. Pregnancy and breast-feeding Talk to your doctor before taking this medicine if: You are pregnant, think you may be pregnant or plan to get pregnant. You must not take Paramax during the first six months of pregnancy You are breast-feeding or planning to breast feed. Do not breast-feed if you are taking Paramax. This is because small amounts may pass into mothers milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
3.How to take Paramax
Always take Paramax exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine Take this medicine by mouth Pour the contents of the sachet into about a quarter of a glass of water mix well and drink straight away Do not take more than the recommended dose If you continue being sick (vomiting) after taking this medicine, tell your doctor If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor How much to take Adults (18 years and older) and the elderly: The usual dose is 2 sachets when you have the first warning of a migraine attack Wait at least 4 hours before taking another dose Do not take more than 6 sachets in a any 24 hour period Children Do not take if you are under 18 years of age If you take more Paramax than you should Tell your doctor or go to your nearest hospital casualty department straight away - even if you feel well. This is because of the risk of delayed, serious liver damage Remember to take any remaining sachets and the pack with you. This is so the doctor knows what you have taken The following effects may happen: Feeling sick (nausea) and being sick (vomiting); unusually pale complexion; loss of appetite; stomach pains. Other effects such as drowsiness, rapid uncontrollable shaking (convulsions), muscle spasms and jerks may also occur Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis You may also feel that your limbs are swollen (uid retention). This is a sign of changes in the way your kidneys are working In some cases an uneven heart beat; increased or heavy breathing and feeling weak. You may also develop liver problems that may cause the eyes or skin to go yellow and in severe cases lack of awareness (disorientation), confusion, loss of consciousness (coma) and death may occur If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
expression and/or lead to unnatural positioning of the head and shoulders Decreased level of consciousness, confusion, hallucination Rigid or sti muscles, trembling or shaking or difficulty moving You bruise more easily than usual. This could be because of a blood disorder (thrombocytopenia) You get infections more often and easier than normal. This could be because you have a low number of white blood cells (agranulocytosis) Depression
Tell your doctor as soon as possible if you have any of the following side effects: Diarrhoea Dizziness, lightheadedness and fainting. This could be because of low blood pressure Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: Abnormal production of breast milk in men and women Breast enlargement in men Loss of menstrual periods Feeling nervous (anxious), restless or confused Feeling drowsy Lack or loss of strength (weakness) Skin rash Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice side effects not listed in this leaflet.
Scale 100% PARAMAX Sachets - leaflet UK 148 x 315 mm code: 395574 Laetus: 61 Fonts: Ocean Sans Pro SAN 8 pt/text Color: 1/Pantone Reflex Blue Version n 3 Plant Rzeszow - Agnieszka Twardochleb Kamil Giecko Date: June 2011
1. What Paramax is and what it is used for
The name of your medicine is Paramax 500mg/5mg, Effervescent Powder (called Paramax in this leaflet). What Paramax contains Paramax contains two different medicines. These are called: Metoclopramide hydrochloride: this belongs to a group of medicines called anti-emetics It works on muscles in the upper part of the digestive system causing your stomach to empty. It also works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting) Paracetamol: this belongs to a group of medicines called painkillers (analgesics). It works by stopping substances that naturally occur in your body called prostaglandins from being made. Prostaglandins cause pain. If they are blocked, pain is relieved What Paramax is used for Paramax is used to treat the signs of migraine, such as headache, feeling sick (nausea) or being sick (vomiting) in adults 18 years and over.
5. How to store Paramax
Keep this medicine in a safe place where children cannot see or reach it. Do not use Paramax after the expiry date which is stated on the sachet and carton after EXP. The expiry date refers to the last day of that month. Store below 25C. Keep the sachets in the outer carton. 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.
6. Further information
What Paramax contains Each sachet contains 500mg paracetamol and 5mg metoclopramide hydrochloride (as anhydrous) as the active ingredients Paramax also contains gelatin, sodium carbonate, saccharin sodium, sodium dihydrogen citrate (anhydrous), sodium bicarbonate and lemon flavour What Paramax looks like and contents of the pack Paramax Sachets contain a white, soluble effervescent powder for oral solution. Paramax is presented in cartons containing 6, 30 or 42 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Zentiva, One Onslow Street Guildford, Surrey GU1 4YS, UK Manufacturer Sanofi-Aventis Sp. z o.o. ul. Lubelska 52 35-233 Rzeszw, Poland This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in June 2011. Zentiva 2011
2. Before you take Paramax
Do not take this medicine and tell your doctor if: You are allergic (hypersensitive) to: - Metoclopramide hydrochloride - Paracetamol - Any of the other ingredients of Paramax (listed in Section 6 below) Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have a blockage or bleeding in your stomach or intestine (gut) You have had movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs after taking metoclopramide or medicines used to calm emotional and mental problems You have epilepsy You have had an operation on your stomach or intestine (gut). Do not take during the first 3 to 4 days after your operation You have a tumour on the adrenal gland (called phaeochromocytoma) You are taking a medicine called levodopa used to treat Parkinsons disease (see Taking other medicines) The person going to take the sachets is under 18 years of age. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Paramax. Take special care with Paramax Check with your doctor or pharmacist before taking your medicine if: You have severe kidney problems You have severe liver problems including alcoholic liver disease
4. Possible side effects
Like all medicines, Paramax can cause side effects, although not everybody gets them. Stop taking Paramax and see a doctor or go to a hospital straight away if: You have an allergic reaction. Severe allergic reactions can occur very rarely and usually happen soon after taking Paramax. These can involve difficulty breathing, tightness in the throat, rapidly spreading rashes, dizziness, very fast heart beat or even loss of consciousness. You are short of breath, have bluish skin colouration, headache, tiredness, dizziness and loss of consciousness. These could be signs of a very rare but serious side effect called methaemoglobinaemia You are paler than normal, are sweating, have a high temperature, fast heartbeat, stiff muscles, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called neuroleptic malignant syndrome. Shortness of breath, slow heart beat and chest pain You have a t (seizure) Tell a doctor straight away if you notice any of the following serious side effects: Problems controlling certain muscles of the body or you have muscle spasms or jerks. The affected muscles may include your tongue, mouth, jaw, arms and legs. The spasms may cause unusual movements of the face, tongue, eyes, neck and affect speech,
Driving and using machines You may feel sleepy after taking this medicine. This is more likely if you have drunk alcohol or taken other medicines that cause drowsiness. If this happens, do not drive or use any tools or machines.
Turn Over
395574
26/10/2011 08:04 - VISTAlink folder 720687 - Page 1/2
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
