NORMON Difenatil 1G 10 Tablets
NORMON Difenatil 1G 10 Tablets
NORMON Difenatil 1G 10 Tablets
Difenatil ® 1 g tablets
Paracetamol
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.
This medication can be purchased without a prescription. However, for best results, it must be used with care.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, ask your pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
- You should consult your doctor if fever worsens or persists after 3 days of treatment or pain for more than 5 days.
Content of the leaflet
- What Difenatil is and what it is used for
- What you need to know before you take Difenatil
- How to take Difenatil
- Possible adverse effects.
- How to store Difenatil
- Contents of the pack and Additional information
1. What Difenatil is and what it is used for
Difenatil contains paracetamol as the active ingredient. Paracetamol belongs to the group of medicines called analgesics and antipyretics.
Paracetamol is used for the treatment of pain of moderate intensity and febrile states in adults and adolescents from 16 years of age (or body weight greater than 50 kg).
2. What you need to know before you take Difenatil
Do not take Difenatil
- If you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and Cautions
Talk to your doctor or pharmacist before taking Difenatil.
- Do not take more medication than recommended in section 3. How to take Difenatil.
- The simultaneous use of this medicine with other medicines containing paracetamol, for example medicines for flu and cold, should be avoided, since high doses can lead to liver damage. Do not use more than one medication that contains acetaminophen without consulting your doctor.
- In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
- If you suffer from kidney, liver, heart or lung disease or have anemia (decreased level of hemoglobin in the blood, due or not to a decrease in red blood cells), you should consult your doctor before taking this medicine.
- When you are being treated with any medication to treat epilepsy, you should consult your doctor before taking this medication, because when they are used at the same time, the efficacy of paracetamol is decreased and hepatotoxicity is enhanced, especially in treatments with high doses of paracetamol.
- In chronic alcoholics, they should be careful not to take more than 2 grams in 24 hours of paracetamol.
- If the pain persists for more than 5 days, the fever lasts for more than 3 days, or the pain or fever worsens or other symptoms appear, a doctor should be consulted and the clinical situation reassessed.
- In adolescents under 16 years of age, consult your doctor or pharmacist as there are other presentations with doses that are adapted to this group of patients.
Other medicines and Difenatil
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Acetaminophen may interact with the following medications:
- Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
- Drugs to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
- Drugs to treat tuberculosis: (isoniazid, rifampicin)
- Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives and anticonvulsants)
- Drugs to lower blood cholesterol levels: (cholestyramine)
- Medicines used to increase urine output (loop diuretics such as those of the furosemide group)
- Drugs used for the treatment of gout (probenecid and sulfinpyrazone)
- Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
- Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disturbances (cardiac arrhythmias): Propranolol.
Tell your doctor or pharmacist if you are taking:
-flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (high anion gap metabolic acidosis) which must be treated urgently and which can occur particularly in severe renal failure, sepsis (when bacteria and its toxins circulate in the blood resulting in organ damage), malnutrition, chronic alcoholism, and if maximum daily doses of paracetamol are used.
Do not use with other analgesics (medicines that reduce pain) without consulting a doctor.
As a general rule for any medication, it is advisable to systematically inform the doctor or pharmacist if you are being treated with another medication. In case of treatment with oral anticoagulants it can be administered occasionally as an analgesic of choice.
Interferences with analytical tests:
If you are going to have any analytical test (including blood tests, urine tests, skin tests that use allergens, etc...) tell your doctor that you are taking/using this medicine, as it can alter the results of these tests.
Difenatil with food, drink and alcohol
The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor,... per day) can cause liver damage.
Taking this medicine with food does not affect its effectiveness.
Pregnancy and Lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor before taking this medicine.
If necessary, this medicine can be used during pregnancy. You should use the lowest possible dose that will reduce pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever do not subside or if you need to take the medicine more often.
Small amounts of paracetamol may appear in breast milk, therefore it is recommended that you consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Paracetamol has no or negligible influence on the ability to drive and use machines.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet; that is, essentially "sodium-free."
3. How to take Difenatil
Follow these instructions unless your doctor has given you other directions.
Remember to take your medicine. Paracetamol should be taken orally.
The normal dose is:
Adults and adolescents over 16 years of age: the usual dose is 1 tablet (1 gram of paracetamol) 3 times a day. The drinks must be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.
The use of high daily doses of paracetamol for prolonged periods of time should be avoided as the risk of adverse effects such as liver damage is increased.
If the pain persists for more than 5 days, the fever lasts for more than 3 days, or the pain or fever worsens or other symptoms appear, you should stop treatment and consult your doctor.
Patients with liver diseases : before taking this medicine you have to consult your doctor. They must take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose.
They should not take more than 2 paracetamol tablets in 24 hours, divided into 2 doses.
Patients with kidney diseases : before taking this medicine you have to consult your doctor. Take a maximum of 500 mg per dose.
Due to the dose, 1 gram of paracetamol, is not indicated for this group of patients.
Elderly patients : should consult their doctor.
Use in children and adolescents : Do not use in children and adolescents under 16 years of age.
If the action of paracetamol is considered to be too strong or weak, tell your doctor or pharmacist. When the administration of doses of less than 1 gram of paracetamol per dose is required, other presentations of paracetamol should be used that adapt to the required dosage.
If you take more Difenatil than you should
You should immediately consult your doctor or pharmacist.
Overdose symptoms may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
If you have ingested an overdose, you should immediately go to a medical center even if you do not notice the symptoms, since these often do not appear until 3 days after ingesting the overdose, even in cases of severe poisoning.
Treatment of overdose is most effective if started within 4 hours of taking the drug.
Patients being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of an overdose of acetaminophen.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.
If you forget to take Difenatil
Do not take a double dose to make up for a forgotten dose, just take the forgotten dose when you remember, taking the following doses with the separation between doses indicated in each case (at least 4 hours).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Rare side effects that may occur (between 1 and 10 in 10,000 people) are: malaise, drop in blood pressure (hypotension), and increased levels of transaminases in the blood.
Very rare side effects that may occur (in less than 1 in 10,000 people) are: Kidney disease, cloudy urine, allergic dermatitis (rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, haemolytic anemia) and hypoglycaemia (low blood sugar). Cases of serious skin reactions have been reported very rarely.
Paracetamol can damage the liver when taken in high doses or in long-term treatments.
Reporting of adverse effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Difenatil
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.
Medications should not be disposed of down the drain or in the trash. Deposit the containers and medications that you do not need at the SIGRE Point 
of the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way you will help to protect the environment.
6. Contents of the pack and other information
Composition of Difenatil
- The active substance is paracetamol. Each tablet contains 1 gram of paracetamol.
- The other ingredients (excipients) are sodium potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570) and crospovidone (E-1202).
What the product looks like and contents of the pack
Difenatil is presented as tablets for oral administration.
The tablets are oblong, biconvex, white, scored on one side and marked PC on the other side. The compressed can be divided into equal halves.
In packages of 10 tablets, packaged in PVC/PVDC/Aluminium blister packs.
| Brand: | NORMON |
| Isin: | IJXQEGM8E15T |
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Difenatil ® 1 g tablets
Paracetamol
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.
This medication can be purchased without a prescription. However, for best results, it must be used with care.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, ask your pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
- You should consult your doctor if fever worsens or persists after 3 days of treatment or pain for more than 5 days.
Content of the leaflet
- What Difenatil is and what it is used for
- What you need to know before you take Difenatil
- How to take Difenatil
- Possible adverse effects.
- How to store Difenatil
- Contents of the pack and Additional information
1. What Difenatil is and what it is used for
Difenatil contains paracetamol as the active ingredient. Paracetamol belongs to the group of medicines called analgesics and antipyretics.
Paracetamol is used for the treatment of pain of moderate intensity and febrile states in adults and adolescents from 16 years of age (or body weight greater than 50 kg).
2. What you need to know before you take Difenatil
Do not take Difenatil
- If you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and Cautions
Talk to your doctor or pharmacist before taking Difenatil.
- Do not take more medication than recommended in section 3. How to take Difenatil.
- The simultaneous use of this medicine with other medicines containing paracetamol, for example medicines for flu and cold, should be avoided, since high doses can lead to liver damage. Do not use more than one medication that contains acetaminophen without consulting your doctor.
- In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
- If you suffer from kidney, liver, heart or lung disease or have anemia (decreased level of hemoglobin in the blood, due or not to a decrease in red blood cells), you should consult your doctor before taking this medicine.
- When you are being treated with any medication to treat epilepsy, you should consult your doctor before taking this medication, because when they are used at the same time, the efficacy of paracetamol is decreased and hepatotoxicity is enhanced, especially in treatments with high doses of paracetamol.
- In chronic alcoholics, they should be careful not to take more than 2 grams in 24 hours of paracetamol.
- If the pain persists for more than 5 days, the fever lasts for more than 3 days, or the pain or fever worsens or other symptoms appear, a doctor should be consulted and the clinical situation reassessed.
- In adolescents under 16 years of age, consult your doctor or pharmacist as there are other presentations with doses that are adapted to this group of patients.
Other medicines and Difenatil
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Acetaminophen may interact with the following medications:
- Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
- Drugs to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
- Drugs to treat tuberculosis: (isoniazid, rifampicin)
- Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives and anticonvulsants)
- Drugs to lower blood cholesterol levels: (cholestyramine)
- Medicines used to increase urine output (loop diuretics such as those of the furosemide group)
- Drugs used for the treatment of gout (probenecid and sulfinpyrazone)
- Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
- Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disturbances (cardiac arrhythmias): Propranolol.
Tell your doctor or pharmacist if you are taking:
-flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (high anion gap metabolic acidosis) which must be treated urgently and which can occur particularly in severe renal failure, sepsis (when bacteria and its toxins circulate in the blood resulting in organ damage), malnutrition, chronic alcoholism, and if maximum daily doses of paracetamol are used.
Do not use with other analgesics (medicines that reduce pain) without consulting a doctor.
As a general rule for any medication, it is advisable to systematically inform the doctor or pharmacist if you are being treated with another medication. In case of treatment with oral anticoagulants it can be administered occasionally as an analgesic of choice.
Interferences with analytical tests:
If you are going to have any analytical test (including blood tests, urine tests, skin tests that use allergens, etc...) tell your doctor that you are taking/using this medicine, as it can alter the results of these tests.
Difenatil with food, drink and alcohol
The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor,... per day) can cause liver damage.
Taking this medicine with food does not affect its effectiveness.
Pregnancy and Lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor before taking this medicine.
If necessary, this medicine can be used during pregnancy. You should use the lowest possible dose that will reduce pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever do not subside or if you need to take the medicine more often.
Small amounts of paracetamol may appear in breast milk, therefore it is recommended that you consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Paracetamol has no or negligible influence on the ability to drive and use machines.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet; that is, essentially "sodium-free."
3. How to take Difenatil
Follow these instructions unless your doctor has given you other directions.
Remember to take your medicine. Paracetamol should be taken orally.
The normal dose is:
Adults and adolescents over 16 years of age: the usual dose is 1 tablet (1 gram of paracetamol) 3 times a day. The drinks must be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.
The use of high daily doses of paracetamol for prolonged periods of time should be avoided as the risk of adverse effects such as liver damage is increased.
If the pain persists for more than 5 days, the fever lasts for more than 3 days, or the pain or fever worsens or other symptoms appear, you should stop treatment and consult your doctor.
Patients with liver diseases : before taking this medicine you have to consult your doctor. They must take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose.
They should not take more than 2 paracetamol tablets in 24 hours, divided into 2 doses.
Patients with kidney diseases : before taking this medicine you have to consult your doctor. Take a maximum of 500 mg per dose.
Due to the dose, 1 gram of paracetamol, is not indicated for this group of patients.
Elderly patients : should consult their doctor.
Use in children and adolescents : Do not use in children and adolescents under 16 years of age.
If the action of paracetamol is considered to be too strong or weak, tell your doctor or pharmacist. When the administration of doses of less than 1 gram of paracetamol per dose is required, other presentations of paracetamol should be used that adapt to the required dosage.
If you take more Difenatil than you should
You should immediately consult your doctor or pharmacist.
Overdose symptoms may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
If you have ingested an overdose, you should immediately go to a medical center even if you do not notice the symptoms, since these often do not appear until 3 days after ingesting the overdose, even in cases of severe poisoning.
Treatment of overdose is most effective if started within 4 hours of taking the drug.
Patients being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of an overdose of acetaminophen.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.
If you forget to take Difenatil
Do not take a double dose to make up for a forgotten dose, just take the forgotten dose when you remember, taking the following doses with the separation between doses indicated in each case (at least 4 hours).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Rare side effects that may occur (between 1 and 10 in 10,000 people) are: malaise, drop in blood pressure (hypotension), and increased levels of transaminases in the blood.
Very rare side effects that may occur (in less than 1 in 10,000 people) are: Kidney disease, cloudy urine, allergic dermatitis (rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, haemolytic anemia) and hypoglycaemia (low blood sugar). Cases of serious skin reactions have been reported very rarely.
Paracetamol can damage the liver when taken in high doses or in long-term treatments.
Reporting of adverse effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Difenatil
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.
Medications should not be disposed of down the drain or in the trash. Deposit the containers and medications that you do not need at the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way you will help to protect the environment.
6. Contents of the pack and other information
Composition of Difenatil
- The active substance is paracetamol. Each tablet contains 1 gram of paracetamol.
- The other ingredients (excipients) are sodium potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570) and crospovidone (E-1202).
What the product looks like and contents of the pack
Difenatil is presented as tablets for oral administration.
The tablets are oblong, biconvex, white, scored on one side and marked PC on the other side. The compressed can be divided into equal halves.
In packages of 10 tablets, packaged in PVC/PVDC/Aluminium blister packs.
Shipping Summary:
- Packages are shipped from Monday to Friday.
- The usual time for processing an order is 1 to 3 business days, but may vary depending on the availability of products ordered. This period excludes delivery times, which depend on your geographic location.
- We provide tracking for every order. Tracking will be available once your product is shipped. Each individual product may be shipped from different fulfillment centers across the globe as our product research team spends the time to source quality yet affordable products.
Estimated delivery times:
- Standard Shipping: 3-7 business days
- Expedited Shipping: 2-5 business days
- International Shipping: 10 - 15 business days
Please note that these are estimates, not guarantees. Delivery time depends on a number of variables, and there may be delays such as bad weather affecting air transport, or a package being held for inspection by Customs. ibspot is not liable for any delays in international transportation or customs clearance.
Shipments can be delivered directly to most addresses, except post office boxes. However, in certain remote areas, there may be an additional delivery charge or you may need to pick up your package from the closest service location of ibspot's shipping partner.
Shipping Status:
As soon as your order ships, you'll receive a shipping confirmation email that includes your tracking number.
If you don't receive a shipping confirmation email right away, don't worry! We know the delivery date or date range provided at checkout and we'll be sure to deliver the items within that timeframe.
Order changes:
Please contact our customer support if the order needs to be canceled or modified.
Item not received:
If you've successfully placed an order and haven't received it yet while the tracking status shows it's delivered. you'd wish to contact the carrier to hunt out your Cover as once the item is Covered we have control over it (once it’s by the carrier), but if still persists kindly email us
Damaged Parcel
If your package has been delivered in a PO Box, please note that we are not responsible for any damage that may result (consequences of extreme temperatures, theft, etc.).
If you have any questions regarding shipping or want to know about the status of an order, please contact us or email to support@ibspot.com.
Please Read Our Return & Refund Policy Carefully:
Return:
You may return most items within 30 days of delivery for a full refund.
To be eligible for a return, your item must be unused and in the same condition that you received it. It must also be in the original packaging.
Several types of goods are exempt from being returned. Perishable goods such as food, flowers, newspapers or magazines cannot be returned. We also do not accept products that are intimate or sanitary goods, hazardous materials, or flammable liquids or gases.
Additional non-returnable items:
- Gift cards
- Downloadable software products
- Some health and personal care items
To complete your return, we require a tracking number, which shows the items which you already returned to us.
There are certain situations where only partial refunds are granted (if applicable)
- Book with obvious signs of use
- CD, DVD, VHS tape, software, video game, cassette tape, or vinyl record that has been opened
- Any item not in its original condition, is damaged or missing parts for reasons not due to our error
- Any item that is returned more than 30 days after delivery
Items returned to us as a result of our error will receive a full refund,some returns may be subject to a restocking fee of 7% of the total item price, please contact a customer care team member to see if your return is subject. Returns that arrived on time and were as described are subject to a restocking fee.
Items returned to us that were not the result of our error, including items returned to us due to an invalid or incomplete address, will be refunded the original item price less our standard restocking fees.
You should expect to receive your refund within four weeks of giving your package to the return shipper, however, in many cases you will receive a refund more quickly. This time period includes the transit time for us to receive your return from the shipper (5 to 10 business days), the time it takes us to process your return once we receive it (3 to 5 business days), and the time it takes your bank to process our refund request (5 to 10 business days).
If you need to return an item, please Contact Us with your order number and details about the product you would like to return. We will respond quickly with instructions for how to return items from your order.
Shipping Cost
We'll pay the return shipping costs if the return is a result of our error (you received an incorrect or defective item, etc.). In other cases, you will be responsible for paying for your own shipping costs for returning your item. Shipping costs are non-refundable. If you receive a refund, the cost of return shipping will be deducted from your refund.
Depending on where you live, the time it may take for your exchanged product to reach you, may vary.
If you are shipping an item over $75, you should consider using a trackable shipping service or purchasing shipping insurance. We don’t guarantee that we will receive your returned item.
Refund:
- Purchases may be returned within 30 days of the shipping date for a refund.
- Refund will be issued to your original form of payment.
- Refunds for orders purchased with IBSPOT Gift Cards and/or IBSPOT Notes will be issued as a IBSPOT Gift Card and mailed to the original billing address. Gift cards cannot be redeemed for cash unless required by law.
Refund Processing
• Returns to a IBSPOT store will be refunded to the original form of payment or gift card. • Mail-in returns with our prepaid return label will be refunded back to the original form of payment within 3-5 business days after we receive your return. Please allow 5-7 business days for your return to arrive at our Returns Center.
• Note: It may take a few days until your bank posts the refund to your account.
Claims:
Claims related to the product. Be sure to check the details of your purchase carefully before you make the payment, and check the contents of the package(s) promptly upon receipt. If you have a problem with the product, visit our Support Center to find out about return shipping arrangements.
WHICH CIRCUMSTANCES WE OFFER RETURND & REFUND:
WRONG PRODUCT:
If you discover your order is flawed please contact us Mail: support@ibspot.com. With photos of the wrong product we will providing a return shipping label. Once it is tracking we will ship a replacement a product immediately.
Damages and issues
Please inspect your order upon reception and contact us immediately if the item is defective, damaged or if you receive the wrong item, so that we can evaluate the issue and make it right.
Exceptions / non-returnable items
Certain types of items cannot be returned, like perishable goods (such as food, flowers, or plants), custom products (such as special orders or personalized items), and personal care goods (such as beauty products). We also do not accept returns for hazardous materials, flammable liquids, or gases. Please get in touch if you have questions or concerns about your specific item. Unfortunately, we cannot accept returns on sale items or gift cards.
Exchanges
The fastest way to ensure you get what you want is to return the item you have, and once the return is accepted, make a separate purchase for the new item.
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