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MRP 517

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FORMOFLO FORTE TRANS ROTACAPS

Formoflo forte trans rotacaps
Uses and Benefits

Uses and Benefits

Formoflo forte trans rotacaps is a combination medicine used for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by preventing and reducing swelling and inflammation in lungs. Asthma is a condition in which airways narrow, swell and create excess mucus, making breathing difficult and trigger coughing, wheezing and shortness of breath while breathing out. This medication is used only for the maintenance treatment of asthma and won’t help for treating an acute and severe attack. It is helpful especially in patients experiencing frequent symptoms and suffering from frequent exacerbations of COPD. However, the uses mentioned here are not comprehensive, there may be other conditions for which the medication may be used upon your doctor’s discretion.

Composition

Composition

The active ingredients of Formoflo forte trans 30S rotacaps are Fluticasone propionate (500Mcg) and Formoterol (12Mcg)/CAP

Mechanism of Action of Drugs

Mechanism of Action of Drugs

Fluticasone propionate is an anti-inflammatory corticosteroid that works by blocking chemical messengers to relieve symptoms associated with inflammation and allergic rhinitis such as stuffy or runny nose, sneezing, watery eyes. Formoterol, a bronchodilator works by relaxing the muscles in the airways leading to lungs, making breathing easier.

Contraindications and Cautions

Contraindications and Caution

Patients with following conditions are suggested to seek advice from their healthcare professionals before using Formoflo forte trans rotacaps:

  • Hypersensitivity to any of the ingredients used in the formulation
  • Acute episodes of asthma or COPD
  • Caution:
  • High blood pressure
  • Seizures and depression
  • Osteoporosis
  • Increased intraocular pressure, glaucoma, cataracts
  • Gastrointestinal ulcers
  • Myasthenia gravis
  • Diabetes mellitus
  • Infection due to parasites
  • Hyperthyroidism
  • Hepatic and renal impairment
  • Children
  • Pregnancy and lactation
Side Effects

Side and Adverse Effects

Formoflo forte trans rotacaps is usually well tolerated when used in the prescribed dosage guidelines. Most side effects are temporary and usually subsides on their own. However, consult your doctor if they persist for a longer duration. You may experience one or more of the following symptoms:

  • Difficulty in swallowing
  • Dry mouth
  • Headache
  • Fungal infection of mouth
  • Blurred vision
  • Respiratory tract infection
  • Hoarseness of voice
  • Dizziness or drowsiness
  • Sneezing
  • Bone pain
  • Throat infection
  • Nausea and vomiting
  • Sore throat
  • Cough

Rare but more serious adverse effects may include:

  • Angioedema
  • Hypertension
  • Psychomotor hyperactivity
  • Arrhythmias
  • Sleep disorders
  • Nasopharyngitis
How to Use

How to Use

Take Formoflo forte trans rotacaps as instructed by your doctor. Do not use this medicine for durations shorter or longer than suggested by your doctor. Avoid missing or forgetting the dose, if you do, take the medicine as soon as remember, however if it’s almost time for your next dose, skip the previous dose and take it according to your normal scheduled time. Continue to use this drug until completion of the maximum amount suggested.
Do not swallow the medicine as it is to be inhaled using roto haler. Follow all the instructions carefully as mentioned on the label. The capsule should be placed at the base of rotohaler, not in the mouthpiece. Completely twist the mouth piece until you hear a click, then breathe in deeply through the mouthpiece. For up to 10 seconds, hold your breath. If there is still powder in the rotohaler, repeat the procedure.
Take the medicine with or without food. Increase the intake of fluids and maintain oral hygiene to avoid excessive dry mouth caused by the medicine, as continued dry mouth can lead to dental disease (gum disease, tooth decay, fungal infection).

Overdosage

Avoid taking medicine more than the prescribed dosage. If you notice any unusual or abnormal reactions after taking the medicine, promptly seek medical attention. Depending on the dosage of Formoflo forte trans rotacaps, symptoms vary in individuals, you may experience one or more of the following symptoms:

  • Decreased consciousness
  • Convulsions
  • Acute adrenal crisis
  • Hypoglycaemia
  • Decreased bone mineral density
  • Oral candidiasis
Warnings and Precautions

Warnings and Precautions

Use this Nasal spray only on the advice of medical practitioner. Dose adjustments or complete avoidance of the Formoflo forte trans rotacaps may be required in the following conditions:

Kidney:

Since there is not enough reliable information about the safety of taking this medicine for renal patients, consult your doctor if you an impairment of normal kidney function and stay on the safe side.

Liver:

Caution is advised among people with liver problems. Dose adjustments of the medicine may be needed. If you have any hepatic problems, it is recommended that you consult doctor before the consumption of this medicine.

Pregnancy:

This medicine is not considered safe to use in pregnant women unless the potential benefits outweigh the risks involved. Despite the fact that there are limited studies in human beings, animal studies have shown effects on the developing baby. It is recommended that you consult your doctor before consuming this medicine.

Lactation:

This medicine is not considered safe to use in nursing mothers unless the potential benefits outweigh the risks involved. Since the effect of the medicine on infants is not clearly established, we recommend that you to consult your doctor before consuming the medicine.

Alcohol:

Interaction of alcohol with this medicine is unknown. Any symptoms of abnormal reactions after taking the medicine should be reported to your doctor immediately.

Driving:

This medicine does not cause drowsiness or dizziness. If you notice any abnormal reactions after taking the medicine do not drive, operate heavy machinery or involve in any works which may demand your attention or physical strength.

Food:

There are no known food interactions with this medicine.

Drug Interactions:

Inform your doctor or pharmacist if you are taking any other medicines which includes over-the-counter drugs, herbal tonics, supplements and medicines that you buy without a prescription. Alert your doctor if you are taking Formoflo forte trans rotacaps with CYP3A4 inhibitors ritonavir, atazanavir, clarithromycin, itraconazole, saquinavir, monoamine oxidase inhibitors used in treating depression, amitriptyline, alprazolam, carbamazepine, brompheniramine, arpiprazole, cardiac glycosides.

Precautions
  • Do not use the medicine post the expiry date
  • Do not use this medication for durations longer than suggested by your doctor
  • Store at room temperature (20-30 degree Celsius)
FDA Pregnancy Category

FDA Pregnancy Category

Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.


Drug Composition information
What is Fluticasone Propionate for:

This medication is a synthetic glucocorticoid, prescribed for preventing asthma and chronic obstructive pulmonary disease. It reduces inflammatory reactions in the airways. Topical: Topical preparation is used for certain types of skin conditions such as allergic reactions, eczema and psoriasis.

How does Fluticasone Propionate work:

Fluticasone stops or lowers irritation and swelling. It lowers or stops the bodys reaction to the allergen.

How should Fluticasone Propionate be used:

Asthma- Adult- Dose is based on asthma severity. The recommended dose is 1 inhalation twice daily. The maximum recommended dosage is 50050 twice daily. Chronic Obstructive Pulmonary Disease- The recommended dose is 1 inhalation (25050) twice daily. Skin Inflammation: Cream, Lotion, and Ointment- Apply as directed by your physician. It comes as an aerosol to inhale by mouth. It also comes as a cream, lotion and ointment to apply over the affected area.

Common side effects of Fluticasone Propionate :

Skin Irritation

What do I do if I miss a dose

Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. Do not change the dose or stop this drug. Talk with the doctor.

What precautions should I take when taking Fluticasone Propionate :

If you have an allergy to fluticasone or any other part of this drug. If you have an allergy to formaldehyde. Tell your doctor if you are allergic to any drugs. Make sure to tell about the allergy and what signs you had. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. If you have a skin infection.

When do I need to seek medical help

If you think there was an overdose, call your local poison control center or ER right away. Signs of a very bad reaction to the drug. These include wheezing; chest tightness; fever; itching; bad cough; blue or gray skin color; seizures; or swelling of face, lips, tongue, or throat. Very bad skin irritation. Any rash. Side effect or health problem is not better or you are feeling worse.

Can I take Fluticasone Propionate with other medicines:

Sometimes drugs are not safe when you take them with certain other drugs and food. - Taking them together can cause bad side effects. - Be sure to talk to your doctor about all the drugs you take.

Are there any food restrictions

Avoid Alcohol

How do I store Fluticasone Propionate :

Store it in controlled room temperature (4 and 30°C), and in an airtight container.

Pregnancy Category

Category C : Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Therapeutic Classification

Antiasthmatic & COPD Preparations, Nasal Decongestants & Other Nasal Preparations, Topical Corticosteroids


Frequently Asked Questions

Frequently Asked Questions
Q1. What is the use of the Formoflo forte trans rotacaps?

It is a combination medicine used for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by preventing and reducing swelling and inflammation in lungs. Asthma is a condition in which airways narrow, swell and create excess mucus, making breathing difficult and trigger coughing, wheezing and shortness of breath while breathing out. This medication is used only for the maintenance treatment of asthma and won’t help for treating an acute and severe attack. It is helpful especially in patients experiencing frequent symptoms and suffering from frequent exacerbations of COPD.

Q2. What are the side effects of the Formoflo forte trans rotacaps?

The medicine is well tolerated when taken in prescribed dosage guidelines. Most common side effects include difficulty in swallowing, dry mouth, headache, fungal infection of mouth, respiratory tract infection, blurred vision, burning in the nose, dizziness or drowsiness, sneezing, hoarseness of voice, bone pain, nausea and vomiting, sore throat, cough. Its use may also lead to extreme but uncommon side effects such as angioedema, hypertension, psychomotor hyperactivity, arrhythmias, sleep disorders, nasopharyngitis.

Q3. Should we use Formoflo forte trans rotacaps with food or without food?

Take the medicine with or without food. Increase the intake of fluids and maintain oral hygiene to avoid excessive dry mouth caused by the medicine, as continued dry mouth can lead to dental disease.

Q4. What are the precautions to be followed while taking the Formoflo forte trans rotacaps?

If you ever had impaired kidney function, severe liver impairment or heart disease, let your doctor know before taking this medicine. Inform your doctor about all the medicines you take to ensure that you are healthy. This medicine is contraindicated in patients with to hypersensitivity to any of the ingredients used in the formulation, acute episodes of asthma or COPD. Caution is advised among patients with status asthmaticus, high blood pressure, osteoporosis, increased intraocular pressure, glaucoma, cataracts, myasthenia gravis, gastrointestinal ulcers, diabetes mellitus, infection due to parasites, hyperthyroidism, hepatic and renal impairment, children, pregnancy and lactation.

Q5. Does Formoflo forte trans rotacaps make you sleepy?

This medicine does not cause drowsiness or dizziness. If you notice any abnormal reactions after taking the medicine do not drive, operate heavy machinery or involve in any works which may demand your attention or physical strength.

Q6. Is Formoflo forte trans rotacaps harmful? What does an overdose of Formoflo forte trans rotacaps lead to?

It is usually well tolerated when taken in the recommended dosage guidelines. Over dose of the medicine may lead to decreased consciousness, convulsions, acute adrenal crisis, hypoglycaemia, decreased bone mineral density, oral candidiasis.

Q7. Can I use Formoflo forte trans rotacaps during pregnancy?

It is not considered safe to use in pregnant women unless the potential benefits outweigh the risks involved. Despite the fact that there are limited studies in human beings, animal studies have shown harmful effects on the developing baby. It is recommended that you consult your doctor before consuming this medicine.

Q8. Can Formoflo forte trans rotacaps be used without a doctor’s prescription?

No, do not take the medicine without doctor’s prescription.

Q9. Is it okay to drink alcohol while I am on the Formoflo forte trans rotacaps?

Interaction of alcohol with this medicine is unknown. Any symptoms of abnormal reactions after taking the medicine should be reported to your doctor immediately.

Q10. How to store Formoflo forte trans rotacaps?

Store the medicine at room temperature (20-30 degree Celsius) in a cool and dry place. Keep the tablet according to the instructions mentioned on the pack or label. Store the medicine in the container or the pack it came in, tightly closed.

Q12. Can we give Formoflo forte trans rotacaps to children?

This medicine is not recommended for children below 12 years of age since the safety and efficacy of use are not clinically established.

Q13. By when should I start seeing the results of the Formoflo forte trans rotacaps?

The amount of time required for this medicine to show its action in the body is 20-30 minutes after administration.

Q14. How long does the effect of Formoflo forte trans rotacaps last?

The amount of time for which this medicine remains active in the body is for about 12 hours.

Q15. Can we take Formoflo forte trans rotacaps daily?

Medicines should always be taken under medical supervision. Take the medicine exactly as prescribed by your doctor: for dosage and duration.

Q16. For how many days should I use the Formoflo forte trans rotacaps?

The number of days that any medicine must be taken varies from patient to patient; and case to case. So always stick to your doctor’s suggestion about how many days to take this medicine.

Q17. When should I use Formoflo forte trans rotacaps?

Use the medicine exactly as prescribed by your doctor for the dosage and duration.

Note: All of the above information is for reference purpose only. It is always recommended that you consult a medical professional.

Seller Information
Manufactured By

LUPIN LTD

a-28/1, m.i.d.c, chikalthana,aurangabad - 431210, india

Packed By

LUPIN LTD

a-28/1, m.i.d.c, chikalthana,aurangabad - 431210, india

Applicable Offers

  • 20% Discount
    On prescription medicines, orders above Rs 1000 T & C
  • 10% Discount
    On prescription medicines, orders above Rs 200 T & C

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