NORMON Normofludil 600Mg 20 Dispersible Tablets
NORMON Normofludil 600Mg 20 Dispersible Tablets
NORMON Normofludil 600Mg 20 Dispersible Tablets
Normofludil ® 600 mg dispersible tablets
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- If you need advice or more information, ask your pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects that are not listed in this leaflet. See section 4.
- You must see a doctor if you do not feel better or if you feel worse after 5 days.
Package leaflet content:
- What Normofludil is and what it is used for
- What you need to know before you take Normofludil
- How to take Normofludil
- Possible side effects
- How to store Normofludil
- Package contents and additional information
1. What is Normofludil and what is it used for
Acetylcysteine, the active ingredient in this medicine, belongs to a group of medicines called mucolytics, which act by reducing the viscosity of mucus, making it thinner and facilitating its elimination.
This medicine is indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, for adults.
You must see a doctor if you do not feel better or if you feel worse after 5 days.
2. What you need to know before you take Normofludil
Do not take Normofludil
- If you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
- Do not administer to children under 2 years of age.
Warnings and cautions
Talk to your doctor or pharmacist before taking Normofludil.
- If you are asthmatic or have a severe respiratory disease, you should consult your doctor before taking this medicine.
- The possible sulfur odor (rotten eggs) of the medicine is typical of the active ingredient, but does not indicate that the medicine is in poor condition.
- If you notice stomach discomfort when taking the medicine, you should stop the treatment and consult your doctor or pharmacist. Caution is advised in patients with a peptic ulcer or a history of peptic ulcer.
- During the first days of treatment you may observe an increase in mucus and phlegm, which will decrease throughout the treatment.
Children and adolescents
Children and adolescents should not take this medicine. There are other more suitable presentations for this population.
Other medicines and Normofludil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Joint therapy with nitroglycerin can cause headache and the occurrence of hypotension, which can be severe, should be monitored.
Co-administration with the antiepileptic carbamazepine may cause a decrease in the effectiveness of carbamazepine.
Do not administer together with antitussive (cough) medications or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as an accumulation of fluidized mucus may occur.
When you are taking any medicine that contains minerals such as iron or calcium, or some type of antibiotic medicine (amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin and some tetracyclines) you must separate your taking from taking Normofludil at least 2 hours. Normofludil dissolution with other medications is not recommended.
Taking Normofludil with food and drink
Taking food and drink does not affect the effectiveness of this medicine.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It should be avoided during lactation.
Driving and using machines
There is no evidence of effects on the ability to drive and use machines.
Normofludil contains aspartame
This medicine contains 35 mg of aspartame in each tablet.
Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (NCF), a rare genetic disease in which phenylalanine accumulates because the body is not able to eliminate it correctly.
3. How to take Normofludil
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
In adults: One tablet, once a day. Do not exceed the dose of one tablet a day.
Normofludil is taken by mouth.
Dissolve 1 dispersible tablet in a glass of water. Stir with a spoon before administration. The solution obtained is taken directly from the glass.
It is recommended to drink plenty of fluids during the day.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days of treatment.
Use in children and adolescents
Children and adolescents cannot take this medicine. There are other more suitable presentations for this population.
If you take more Normofludil than you should
If you take more acetylcysteine than you should, you may notice: nausea, vomiting, heartburn and stomach pain, diarrhea or any other side effect described in section 4.
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20 indicating the medicine and the amount ingested.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you forget to take Normofludil
Do not take a double dose to make up for a forgotten dose. If you miss a dose, wait for the next one.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people): hypersensitivity, headache, ringing in the ears, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, hives, rash, angioedema, itching, increased body temperature , hypotension.
Rare (may affect up to 1 in 1,000 people): drowsiness, bronchospasm, shortness of breath, digestive discomfort.
Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, bleeding, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with at least one other drug simultaneously.
Not known (cannot be estimated from the available data): swelling of the face.
In the event of any alteration to the skin or mucous membranes, the administration of acetylcysteine should be stopped immediately and medical attention should be sought.
Communication of adverse effects
If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are 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 Normofludil
Keep this medicine out of the sight and reach of children.
Store below 25ºC.
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.
Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines you do not need at the SIGRE point 
of the pharmacy. Ask your pharmacist how to dispose of medicines that you no longer need. This way you will help to protect the environment.
6. Package contents and additional information
- The active substance is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.
- The other ingredients (excipients) are: microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, aspartame (E-951), calcium carbonate, lemon essence, orange essence and magnesium stearate.
| Brand: | NORMON |
| Isin: | I94KHHQVQCOD |
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Normofludil ® 600 mg dispersible tablets
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- If you need advice or more information, ask your pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects that are not listed in this leaflet. See section 4.
- You must see a doctor if you do not feel better or if you feel worse after 5 days.
Package leaflet content:
- What Normofludil is and what it is used for
- What you need to know before you take Normofludil
- How to take Normofludil
- Possible side effects
- How to store Normofludil
- Package contents and additional information
1. What is Normofludil and what is it used for
Acetylcysteine, the active ingredient in this medicine, belongs to a group of medicines called mucolytics, which act by reducing the viscosity of mucus, making it thinner and facilitating its elimination.
This medicine is indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, for adults.
You must see a doctor if you do not feel better or if you feel worse after 5 days.
2. What you need to know before you take Normofludil
Do not take Normofludil
- If you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
- Do not administer to children under 2 years of age.
Warnings and cautions
Talk to your doctor or pharmacist before taking Normofludil.
- If you are asthmatic or have a severe respiratory disease, you should consult your doctor before taking this medicine.
- The possible sulfur odor (rotten eggs) of the medicine is typical of the active ingredient, but does not indicate that the medicine is in poor condition.
- If you notice stomach discomfort when taking the medicine, you should stop the treatment and consult your doctor or pharmacist. Caution is advised in patients with a peptic ulcer or a history of peptic ulcer.
- During the first days of treatment you may observe an increase in mucus and phlegm, which will decrease throughout the treatment.
Children and adolescents
Children and adolescents should not take this medicine. There are other more suitable presentations for this population.
Other medicines and Normofludil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Joint therapy with nitroglycerin can cause headache and the occurrence of hypotension, which can be severe, should be monitored.
Co-administration with the antiepileptic carbamazepine may cause a decrease in the effectiveness of carbamazepine.
Do not administer together with antitussive (cough) medications or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as an accumulation of fluidized mucus may occur.
When you are taking any medicine that contains minerals such as iron or calcium, or some type of antibiotic medicine (amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin and some tetracyclines) you must separate your taking from taking Normofludil at least 2 hours. Normofludil dissolution with other medications is not recommended.
Taking Normofludil with food and drink
Taking food and drink does not affect the effectiveness of this medicine.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It should be avoided during lactation.
Driving and using machines
There is no evidence of effects on the ability to drive and use machines.
Normofludil contains aspartame
This medicine contains 35 mg of aspartame in each tablet.
Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (NCF), a rare genetic disease in which phenylalanine accumulates because the body is not able to eliminate it correctly.
3. How to take Normofludil
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
In adults: One tablet, once a day. Do not exceed the dose of one tablet a day.
Normofludil is taken by mouth.
Dissolve 1 dispersible tablet in a glass of water. Stir with a spoon before administration. The solution obtained is taken directly from the glass.
It is recommended to drink plenty of fluids during the day.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days of treatment.
Use in children and adolescents
Children and adolescents cannot take this medicine. There are other more suitable presentations for this population.
If you take more Normofludil than you should
If you take more acetylcysteine than you should, you may notice: nausea, vomiting, heartburn and stomach pain, diarrhea or any other side effect described in section 4.
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20 indicating the medicine and the amount ingested.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you forget to take Normofludil
Do not take a double dose to make up for a forgotten dose. If you miss a dose, wait for the next one.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people): hypersensitivity, headache, ringing in the ears, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, hives, rash, angioedema, itching, increased body temperature , hypotension.
Rare (may affect up to 1 in 1,000 people): drowsiness, bronchospasm, shortness of breath, digestive discomfort.
Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, bleeding, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with at least one other drug simultaneously.
Not known (cannot be estimated from the available data): swelling of the face.
In the event of any alteration to the skin or mucous membranes, the administration of acetylcysteine should be stopped immediately and medical attention should be sought.
Communication of adverse effects
If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are 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 Normofludil
Keep this medicine out of the sight and reach of children.
Store below 25ºC.
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.
Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines you do not need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of medicines that you no longer need. This way you will help to protect the environment.
6. Package contents and additional information
- The active substance is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.
- The other ingredients (excipients) are: microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, aspartame (E-951), calcium carbonate, lemon essence, orange essence and magnesium stearate.
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:
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- 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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