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Solpadeine Express 500 mg/65 mg effervescent tablets, 16 Tabs
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Solpadeine Express 500 mg/65 mg effervescent tablets, N16
Package leaflet: information for the user
Paracetamol/Caffeine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Do not throw this leaflet away as you may need to read it again.
If you want to know more or consult, ask your pharmacist.
If you experience side effects (even if they are not listed in this leaflet), contact your doctor or pharmacist. See Chapter 4.
If your condition has not improved or even worsened within 3 days, consult a doctor.
What is this leaflet about?
What Solpadeine Express is and what it is used for
What you need to know before you take Solpadeine Express
How to take Solpadeine Express
Possible side effects
How to store Solpadeine Express
Package contents and other information
1. What Solpadeine Express is and what it is used for
Solpadeine Express contains two active ingredients. Paracetamol relieves pain and also reduces temperature if you have a fever. Caffeine enhances the action of paracetamol. Due to the dual action of the active ingredients, this medicine provides quick and effective pain relief for headaches and migraines with or without warning signs (aura). The drug can also relieve back pain, muscle and joint pain, toothache, period pain, help with neuralgia, sore throat, fever, stinging and aches associated with colds and flu.
2. What you need to know before you take Solpadeine Express
Solpadeine Express should not be used:
- if you are allergic to paracetamol, caffeine or any of the excipients of this medicine (listed in section 6);
- if you are taking other medicines containing paracetamol.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solpadeine Express.
if you have liver or kidney disease, including alcoholic liver disease;
if you have asthma and are sensitive to acetylsalicylic acids;
If you have Gilbert's syndrome (non-hemolytic familial jaundice);
if your doctor has told you that you have an intolerance to some carbohydrates, in the case of glucose-6-phosphate dehydrogenase deficiency or glutathione deficiency;
if you suffer from hemolytic anemia, chronic malnutrition or dehydration;
if you are an adult or a teenager with a body weight of less than 50 kg;
if the amount of sodium in the food is controlled. Each tablet contains 427 mg of sodium.
For children and teenagers
This medicine should not be used in children under 12 years of age.
Other medicines and Solpadeine Express
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, especially if you are taking metoclopramide or domperidone (used to treat nausea or vomiting) or cholestyramine (used to lower blood cholesterol). If you are taking blood thinners (anticoagulants such as warfarin and coumarins) and you need to take pain relievers every day, talk to your doctor about the risk of bleeding, but you can occasionally take Solpadeine Express at the same time as anticoagulants. If you are taking probenecid, talk to your doctor as your dose of Solpadeine Express may need to be reduced. Tell your doctor if you are taking sedatives, tranquilizers and decongestants, as Solpadeine Express contains caffeine,
Pregnancy and breastfeeding
Because this medicine contains caffeine, it should not be used if you are pregnant or breast-feeding.
Driving and machine control
Solpadeine Express does not affect the ability to drive and use machines.
Solpadeine Express contains sodium
Each tablet contains 427 mg of sodium. Must be considered if dietary sodium is controlled.
Solpadeine Express contains sorbitol
If you have been told by your doctor that you have an intolerance to some carbohydrates, contact your doctor before taking this medicine.
3 . How to take Solpadeine Express
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If in doubt, ask your doctor or pharmacist.
Adults (including elderly patients) and adolescents 16 years of age and older
Dissolve 1 or 2 tablets in a glass of water and take as needed every 4-6 hours.
Do not take more than every 4 hours.
Do not take more than 8 tablets in 24 hours.
The maximum daily dose of paracetamol should not exceed 2 g per day, unless otherwise prescribed by the doctor:
if you have liver or kidney disease;
If you have Gilbert's syndrome;
if you have chronic alcoholism, chronic malnutrition or dehydration;
if you weigh less than 50 kg.
In patients with impaired renal or hepatic function and in patients with Gilbert's syndrome, the dose should be reduced and the duration of administration extended. Consult your doctor.
Elderly patients: If you are weak or immobile, you may be advised to reduce the dose.
Adolescents aged 12-15
Dissolve 1 tablet in a glass of water and take as needed every 4-6 hours.
Do not take more than every 4 hours.
Do not take more than 4 tablets in 24 hours.
Do not take more than the recommended dose.
Do not use in children under 12 years of age.
Avoid drinking too much caffeinated beverages such as coffee and tea.
High caffeine consumption can cause difficulty falling asleep, tremors, and chest discomfort.
Use in children and adolescents under 12 years of age
Solpadeine Express is not recommended for patients under 12 years of age.
What to do if you overdose on Solpadeine Express?
If you have taken too much of the medicine, contact your doctor immediately, even if you feel well, as paracetamol overdose can cause delayed, severe liver damage.
If you forget to take Solpadeine Express
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects have occurred in a small number of people.
Stop taking the medicine and contact your doctor immediately if you experience:
allergic reactions that can be severe, such as skin rash and itching, sometimes accompanied by swelling of the mouth or face or shortness of breath;
skin rash or peeling or sores in the mouth;
respiratory disorder. This symptom is more likely if you have experienced it in the past while taking other pain relievers such as ibuprofen and acetylsalicylic acid;
unexplained bruising or bleeding;
nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin;
cloudy urine.
Other side effects
nervousness and dizziness,
in very rare cases, the number of white blood cells may decrease (neutropenia and leukopenia).
Side effect reporting
If you get any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects to the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania by calling toll-free 8 800 73568 or fill out the form on the website www.vvkt.lt and submit it to the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania in one of the following ways : in writing (address Žirmūnų st. 139A, LT-09120 Vilnius), free fax number 8 800 20131, e-mail by mail [email protected] , as well as through the website of the State Drug Control Service under the Ministry of Health of the Republic of Lithuania (at http://www.vvkt.lt). By reporting side effects, you can help us get more information about the safety of this medicine.
5. How to store Solpadeine Express
Keep this medicine out of the sight and reach of children.
Store at a temperature not higher than 25 °C.
Store in the manufacturer's packaging to protect from moisture.
Do not use this medicine after the expiry date which is stated on the strip and carton after EXP/EXP. The drug is suitable for use until the last day of the indicated month.
Medicines must not be disposed of in the sewer or with household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help protect the environment.
6 . Package contents and other information
Composition of Solpadeine Express
The active substances are paracetamol and caffeine. Each tablet contains 500 mg of paracetamol and 65 mg of caffeine.
Excipients are sodium hydrogen carbonate, sorbitol (E420), saccharin sodium salt, sodium lauryl sulfate, anhydrous citric acid, anhydrous sodium carbonate, povidone K25, dimethicone 315/385.
What Solpadeine Express looks like and contents of the pack
Solpadeine Express are white, beveled-edge, scored (not designed to break the tablet into equal doses) effervescent tablets, packaged in laminated bilayer strips.
Pack sizes: 4, 6, 12, 16, 18 or 24 tablets.
Not all package sizes may be available.
Registrant and manufacturer
Registrant
Richard Bittner AG
Reisnerstraße 55-57
A-1030 Wien
Austria
Manufacturer
Famar AVE Anthoussa Plant
Anthoussa Avenue 7
Anthoussa Attiki 153 44
Greece
The picture is for illustration only. The packaging can be changed by the manufacturer. All packs include English informational leaflet.
DISCLAMER!!!! This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Package leaflet: information for the user
Paracetamol/Caffeine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Do not throw this leaflet away as you may need to read it again.
If you want to know more or consult, ask your pharmacist.
If you experience side effects (even if they are not listed in this leaflet), contact your doctor or pharmacist. See Chapter 4.
If your condition has not improved or even worsened within 3 days, consult a doctor.
What is this leaflet about?
What Solpadeine Express is and what it is used for
What you need to know before you take Solpadeine Express
How to take Solpadeine Express
Possible side effects
How to store Solpadeine Express
Package contents and other information
1. What Solpadeine Express is and what it is used for
Solpadeine Express contains two active ingredients. Paracetamol relieves pain and also reduces temperature if you have a fever. Caffeine enhances the action of paracetamol. Due to the dual action of the active ingredients, this medicine provides quick and effective pain relief for headaches and migraines with or without warning signs (aura). The drug can also relieve back pain, muscle and joint pain, toothache, period pain, help with neuralgia, sore throat, fever, stinging and aches associated with colds and flu.
2. What you need to know before you take Solpadeine Express
Solpadeine Express should not be used:
- if you are allergic to paracetamol, caffeine or any of the excipients of this medicine (listed in section 6);
- if you are taking other medicines containing paracetamol.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solpadeine Express.
if you have liver or kidney disease, including alcoholic liver disease;
if you have asthma and are sensitive to acetylsalicylic acids;
If you have Gilbert's syndrome (non-hemolytic familial jaundice);
if your doctor has told you that you have an intolerance to some carbohydrates, in the case of glucose-6-phosphate dehydrogenase deficiency or glutathione deficiency;
if you suffer from hemolytic anemia, chronic malnutrition or dehydration;
if you are an adult or a teenager with a body weight of less than 50 kg;
if the amount of sodium in the food is controlled. Each tablet contains 427 mg of sodium.
For children and teenagers
This medicine should not be used in children under 12 years of age.
Other medicines and Solpadeine Express
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, especially if you are taking metoclopramide or domperidone (used to treat nausea or vomiting) or cholestyramine (used to lower blood cholesterol). If you are taking blood thinners (anticoagulants such as warfarin and coumarins) and you need to take pain relievers every day, talk to your doctor about the risk of bleeding, but you can occasionally take Solpadeine Express at the same time as anticoagulants. If you are taking probenecid, talk to your doctor as your dose of Solpadeine Express may need to be reduced. Tell your doctor if you are taking sedatives, tranquilizers and decongestants, as Solpadeine Express contains caffeine,
Pregnancy and breastfeeding
Because this medicine contains caffeine, it should not be used if you are pregnant or breast-feeding.
Driving and machine control
Solpadeine Express does not affect the ability to drive and use machines.
Solpadeine Express contains sodium
Each tablet contains 427 mg of sodium. Must be considered if dietary sodium is controlled.
Solpadeine Express contains sorbitol
If you have been told by your doctor that you have an intolerance to some carbohydrates, contact your doctor before taking this medicine.
3 . How to take Solpadeine Express
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If in doubt, ask your doctor or pharmacist.
Adults (including elderly patients) and adolescents 16 years of age and older
Dissolve 1 or 2 tablets in a glass of water and take as needed every 4-6 hours.
Do not take more than every 4 hours.
Do not take more than 8 tablets in 24 hours.
The maximum daily dose of paracetamol should not exceed 2 g per day, unless otherwise prescribed by the doctor:
if you have liver or kidney disease;
If you have Gilbert's syndrome;
if you have chronic alcoholism, chronic malnutrition or dehydration;
if you weigh less than 50 kg.
In patients with impaired renal or hepatic function and in patients with Gilbert's syndrome, the dose should be reduced and the duration of administration extended. Consult your doctor.
Elderly patients: If you are weak or immobile, you may be advised to reduce the dose.
Adolescents aged 12-15
Dissolve 1 tablet in a glass of water and take as needed every 4-6 hours.
Do not take more than every 4 hours.
Do not take more than 4 tablets in 24 hours.
Do not take more than the recommended dose.
Do not use in children under 12 years of age.
Avoid drinking too much caffeinated beverages such as coffee and tea.
High caffeine consumption can cause difficulty falling asleep, tremors, and chest discomfort.
Use in children and adolescents under 12 years of age
Solpadeine Express is not recommended for patients under 12 years of age.
What to do if you overdose on Solpadeine Express?
If you have taken too much of the medicine, contact your doctor immediately, even if you feel well, as paracetamol overdose can cause delayed, severe liver damage.
If you forget to take Solpadeine Express
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects have occurred in a small number of people.
Stop taking the medicine and contact your doctor immediately if you experience:
allergic reactions that can be severe, such as skin rash and itching, sometimes accompanied by swelling of the mouth or face or shortness of breath;
skin rash or peeling or sores in the mouth;
respiratory disorder. This symptom is more likely if you have experienced it in the past while taking other pain relievers such as ibuprofen and acetylsalicylic acid;
unexplained bruising or bleeding;
nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin;
cloudy urine.
Other side effects
nervousness and dizziness,
in very rare cases, the number of white blood cells may decrease (neutropenia and leukopenia).
Side effect reporting
If you get any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects to the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania by calling toll-free 8 800 73568 or fill out the form on the website www.vvkt.lt and submit it to the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania in one of the following ways : in writing (address Žirmūnų st. 139A, LT-09120 Vilnius), free fax number 8 800 20131, e-mail by mail [email protected] , as well as through the website of the State Drug Control Service under the Ministry of Health of the Republic of Lithuania (at http://www.vvkt.lt). By reporting side effects, you can help us get more information about the safety of this medicine.
5. How to store Solpadeine Express
Keep this medicine out of the sight and reach of children.
Store at a temperature not higher than 25 °C.
Store in the manufacturer's packaging to protect from moisture.
Do not use this medicine after the expiry date which is stated on the strip and carton after EXP/EXP. The drug is suitable for use until the last day of the indicated month.
Medicines must not be disposed of in the sewer or with household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help protect the environment.
6 . Package contents and other information
Composition of Solpadeine Express
The active substances are paracetamol and caffeine. Each tablet contains 500 mg of paracetamol and 65 mg of caffeine.
Excipients are sodium hydrogen carbonate, sorbitol (E420), saccharin sodium salt, sodium lauryl sulfate, anhydrous citric acid, anhydrous sodium carbonate, povidone K25, dimethicone 315/385.
What Solpadeine Express looks like and contents of the pack
Solpadeine Express are white, beveled-edge, scored (not designed to break the tablet into equal doses) effervescent tablets, packaged in laminated bilayer strips.
Pack sizes: 4, 6, 12, 16, 18 or 24 tablets.
Not all package sizes may be available.
Registrant and manufacturer
Registrant
Richard Bittner AG
Reisnerstraße 55-57
A-1030 Wien
Austria
Manufacturer
Famar AVE Anthoussa Plant
Anthoussa Avenue 7
Anthoussa Attiki 153 44
Greece
The picture is for illustration only. The packaging can be changed by the manufacturer. All packs include English informational leaflet.
DISCLAMER!!!! This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
LT, Panevezys
