Protopan DSR Capsule 10'S

INTRODUCTION

PROTOPAN DSR CAPSULE is a combination of Domperidone and Pantoprazole which belongs to the group of medicines called Prokinetic Drugs and Proton pump inhibitors respectively. It is used to treat peptic ulcers, gastroesophageal reflux disease (GERD) and reflux esophagitis.

Peptic ulcers are painful sores that develop on the linings of the stomach, esophagus or intestines. It causes severe stomach pain with sensation of flatulence, indigestion, vomiting and fatigue.

GERD is a chronic digestive disease in which the acid from the stomach frequently flows into the esophagus leading to irritation of lining of food pipe. Symptoms include heartburn, chest pain, nausea, sensation of lump in throat and stomach discomfort.

Reflux esophagitis can be defined as the inflammation of the food pipe accompanied with acid reflex.

PROTOPAN DSR CAPSULE acts by reducing the production of gastric acid. It also speeds up the movement of food from the stomach to the intestines, thereby reducing the signs of nausea, vomiting and acid reflux. Due to these actions, it can also reduce the unpleasant signs of GI tract such as nausea, vomiting, indigestion, burping, bloating, acidity or heartburn.

PROTOPAN DSR CAPSULE is suitable for use both in adults and in children (aged 12 years or above weighing 35 kg or more). It should be taken at least 15-30 minutes before meals. During treatment with PROTOPAN DSR CAPSULE your doctor will closely monitor your kidney functions, liver functions and blood magnesium levels to avoid the risk of unwanted side effects.

Before taking PROTOPAN DSR CAPSULE inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have any blockage or tears in the gut or have weak bones.

PROTOPAN DSR CAPSULE is not recommended for use in patients having bleeding from the gut. Consult your doctor before taking PROTOPAN DSR CAPSULE if you are pregnant or breastfeeding. The most common side effects of taking PROTOPAN DSR CAPSULE are dryness of mouth, constipation and flatulence. Consult your doctor if any of these side effect bothers you.

You must also inform your doctor immediately if you experience any signs of low magnesium levels in blood (such as tiredness, abnormal muscle movements, dizziness, confusion, disorientation, irregular heartbeat).

USES OF PROTOPAN DSR CAPSULE

It is used in adults and in children (aged 12 years or older weighing 35 kg or more) to treat:

• Peptic ulcer
• Gastrointestinal Reflux disease (GERD)
• Reflux esophagitis (inflammation of the esophagus)
• Nausea and Vomiting
• Acidity, Heartburn
• Signs of indigestion (such as burping, bloating)

HOW PROTOPAN DSR CAPSULE WORKS

PROTOPAN DSR CAPSULE contains two medicines namely domperidone and pantoprazole. Domperidone is a prokinetic medicine with anti-emetic properties. It works by blocking the actions of a chemical messenger called dopamine in the gut and across the brain and spinal cord.

This action stimulates the gut, reduces acid reflux and speeds up the movements of food from the stomach into the intestines. It also blocks the transmission of nerve signals between the vomiting centers and brain which reduces the onset of nausea and vomiting.

Pantoprazole is a proton pump inhibitor. It reduces gastric acid secretion by the blocking the actions of a protein membrane called H+K+Atpase (proton pump) present in the lining of the stomach.

By reducing stomach acid production, PROTOPAN DSR CAPSULE it prevents the worsening of ulcers, heals the existing ulcers and esophageal lesions and provides relief from the unpleasant symptoms of GI tract (such as acidity, bloating, burping and indigestion).

DIRECTIONS FOR USE

Take PROTOPAN DSR CAPSULE 15-30 minutes before meals or as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking PROTOPAN DSR CAPSULE unless your doctor advice you to stop.

SIDE EFFECTS OF PROTOPAN DSR CAPSULE

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try to take PROTOPAN DSR CAPSULE with or just after meals. Stick to simple meals and avoid oil rich or spicy foods. Consult your doctor if nausea worsens.

Headache:  

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Constipation:

Taking PROTOPAN DSR CAPSULE with meals may reduce the chances of constipation. However, if you experience constipation, eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

WARNING & PRECAUTIONS

PREGNANCY

PROTOPAN DSR CAPSULE should be used in pregnant women only if it is considered necessary by the physician. Therefore, consult your doctor before taking it.

BREASTFEEDING

PROTOPAN DSR CAPSULE may pass through breast milk. Therefore, it should be used in breastfeeding women only if it is considered necessary by the physician. Consult your doctor for advice.

DRIVING AND USING MACHINES

PROTOPAN DSR CAPSULE does not affect your ability in driving or handling heavy tools or machines. However, do not drive or handle heavy tools or machines if your ability is affected by PROTOPAN DSR CAPSULE.

ALCOHOL

Avoid consumption of alcohol while taking PROTOPAN DSR CAPSULE, as it could aggravate your existing condition.

KIDNEY

PROTOPAN DSR CAPSULE should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.

LIVER

PROTOPAN DSR CAPSULE is not recommended for use in patients with moderate or severe liver impairment. It should be used with caution in patients with other mild liver problems. Therefore, consult your doctor before taking it.

ALLERGY

Do not take PROTOPAN DSR CAPSULE if you are allergic to Domperidone, Pantoprazole or to any other proton pump inhibitors (such as rabeprazole, omeprazole).

HEART DISEASE

PROTOPAN DSR CAPSULE is not recommended for use in patients with heart problems such as prolongation of QT interval or congestive heart failure. Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug interactions:

Before taking PROTOPAN DSR CAPSULE inform your doctor if you are taking any of the following medicines such as:

• other medicines used to treat gastrointestinal problems (Ex. cisapride, dolasetron, prucalopride, diphemanil)
• medicines used to treat heart problems or hypertension (Ex. digoxin, apomorphine, disopyramide, hydroquinidine, quinidine, amiodarone, dofetilide, dronedarone, ibutilide, sotalol, diltiazem or verapamil)
• medicines used to treat HIV infection (Ex. atazanavir, nelfinavir, saquinavir)
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole)
• medicines used for blood thinning (Ex. warfarin and phenprocoumon)
• medicines used to treat hepatitis C (Ex. telaprevir)
• antipsychotics (used to treat mental illness) Ex. haloperidol, pimozide, sertindole
• antidepressants (used to treat depression) Ex. escitalopram or citalopram, fluvoxamine, St John’s wort
• antibiotics (used to treat bacterial infections) Ex. moxifloxacin, erythromycin, levofloxacin, clarithromycin, telithromycin or amoxicillin
• medicines used to treat malaria (Ex. halofantrine, lumefantrine)
• antihistamines (used to treat allergies) Ex. mizolastine, mequitazine
• medicines used to treat cancer (Ex. toremifene, vandetanib, vincamine, erlotinib, dasatinib, nilotinib)
• methotrexate (used to treat cancer and auto-immune disease)
• bepridil (used to treat hypertension)
• methadone (used to relieve pain)
• iron salts (used to treat iron deficiency anemia)
• tacrolimus or mycophenolate mofetil (used to prevent graft rejection)
• pentamidine (used to treat parasite infections)
• rifampicin (a medicine used to treat tuberculosis)

Overdosage:

If you or anyone else accidentally took more PROTOPAN DSR CAPSULE, contact your doctor immediately or go to a hospital straight away. Symptoms of overdosage might include sleepiness, confusion, uncontrollable body movements (including eye and tongue), twisted neck and abnormal body posture.

SYNOPSIS

MORE INFORMATION

• Keep PROTOPAN DSR CAPSULE out of the sight and reach of children
• Store PROTOPAN DSR CAPSULE at room temperature

FAQs ABOUT PROTOPAN DSR CAPSULE

What is PROTOPAN DSR CAPSULE used for?

PROTOPAN DSR CAPSULE is used to treat peptic ulcers, GERD and reflux esophagitis. It can also be used to treat nausea, vomiting, bloating, burping, acidity and heartburn.

How and when to take PROTOPAN DSR CAPSULE?

Take PROTOPAN DSR CAPSULE at least 15-30 minutes before meals. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight and disease condition.

How long should I take PROTOPAN DSR CAPSULE?

You need to take PROTOPAN DSR CAPSULE for the stipulated duration prescribed by your doctor. Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight and disease condition

What is the best time to take PROTOPAN DSR CAPSULE?

PROTOPAN DSR CAPSULE must be taken before meals to avoid gastrointestinal side effects.

What to do if I forgot to take a dose of PROTOPAN DSR CAPSULE?

If you forgot to take a dose of PROTOPAN DSR CAPSULE, take it as soon as you remember. However, if it is time for the next dose of PROTOPAN DSR CAPSULE, skip the missed dose and take the next one regularly. Do not take a double dose of PROTOPAN DSR CAPSULE to compensate for the missed ones.

What are the most common side effects of taking PROTOPAN DSR CAPSULE?

The most common side effects of taking PROTOPAN DSR CAPSULE are dryness of mouth, constipation and flatulence. Consult your doctor if any of these side effects bother you.

Can I stop taking PROTOPAN DSR CAPSULE without consulting your doctor?

No. You should not stop taking PROTOPAN DSR CAPSULE without consulting your doctor because it may lead to a reversal of symptoms. If you feel better after using PROTOPAN DSR CAPSULE, consult your doctor for advice.

Will taking a higher dose of PROTOPAN DSR CAPSULE be more effective?

No, taking a higher dose of PROTOPAN DSR CAPSULE will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.

What precautions do I need to follow while taking PROTOPAN DSR CAPSULE?

Make sure to take PROTOPAN DSR CAPSULE 30 minutes before meals. Before taking PROTOPAN DSR CAPSULE inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have any blockage or tears in the gut or have weak bones. Consult your doctor before taking PROTOPAN DSR CAPSULE if you are pregnant or breastfeeding. Regularly visit your doctor and take all the blood tests recommended by your doctor without fail.

Can I take medication for high blood pressure along with PROTOPAN DSR CAPSULE?

It is not advisable to take medicines to control blood pressure while taking PROTOPAN DSR CAPSULE without consulting your doctor as they have known interactions with PROTOPAN DSR CAPSULE.

Can PROTOPAN DSR CAPSULE be used in pregnant women?

PROTOPAN DSR CAPSULE should be used in pregnant women only if it is considered necessary by the physician. Therefore, consult your doctor before taking it.

How to take PROTOPAN DSR CAPSULE?

You must take PROTOPAN DSR CAPSULE as advised by your physician. Try to take PROTOPAN DSR CAPSULE 30 minutes before and swallow it with a glass of water. Do not crush or chew the medicine.

How much PROTOPAN DSR CAPSULE should I take?

PROTOPAN DSR CAPSULE should be used only under medical supervision. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body condition and severity of the disease condition.

Can PROTOPAN DSR CAPSULE cause constipation?

Yes. Constipation is a common side effect of using PROTOPAN DSR CAPSULE. Eat plenty of fibre-rich foods such as fresh fruits, vegetables, cereals as well as drink plenty of water and exercise more regularly when taking this medicine. Contact your doctor if this side effect bothers you.

Can PROTOPAN DSR CAPSULE cause dry mouth?

Yes. Dry mouth is a common side effect of using PROTOPAN DSR CAPSULE. Contact your doctor if this side effect bothers you.

REFERENCES

1. KD. Tripathi. Antiemetic, Prokinetic and Digestant drugs & Drugs for Peptic Ulcer and Gastroesophageal Reflux Disease. Essentials of medical pharmacology. Seventh edition. 2013. Page – 666 & 653.

2. Nur Fathurah Zamani, Afifah Sjamun Sjahid, Tuan Hairulnizam Tuan Kamauzaman, Yeong Yeh Lee and Md Asiful Islam. Efficacy and Safety of Domperidone in Combination with Proton Pump Inhibitors in Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Journal of Clinical Medicine. August 2022. [Accessed on 21st October 2022]. https://www.mdpi.com/2077-0383/11/18/5268/htm

3. Cipla Ltd. NEW PANTOSEC D SR Capsules (Pantoprazole Gastro-resistant + Domperidone Prolonged Release Capsules IP). Ciplamed.com. [Revised in April 2020]. [Accessed on 21st October 2022]. https://www.ciplamed.com/content/new-pantosec-d-sr-capsules

4. Panacea Biotec Limited. OD-PEP-D CAPSULES. [Revised in July 2019]. [Accessed on 21st October 2022]. https://media.panaceabiotec.com/documents/2019/7/27/ProductMonograph-OP-PEP-D.pdf

5. Milpharm Limited. Electronic Medicines Compendium (EMC). [Revised in March 2021]. [Accessed on 21st October 2022]. https://www.medicines.org.uk/emc/files/pil.556.pdf

6. Takeda GmbH. Electronic Medicines Compendium (EMC). [Revised in April 2022]. [Accessed on 21st October 2022]. https://www.medicines.org.uk/emc/files/pil.483.pdf

7. Milpharm Limited. Electronic Medicines Compendium (EMC). [Revised in November 2021]. [Accessed on 21st October 2022]. https://www.medicines.org.uk/emc/files/pil.7090.pdf

8. Leeford Healthcare Ltd. Pantafol-D. [Accessed on 21st October 2022]. https://www.leeford.in/product/775/pantafol-d

9. Hetero Healthcare Ltd. Pantin RD Tablet. [Accessed on 21st October 2022]. https://www.heterohealthcare.com/pantin-rd-tablet

10. Central Drugs Standard Control Organization. Pantoprazole+Domperidone SR. [Revised in December 2004]. [Accessed on 21st October 2022]. https://cdscoonline.gov.in/CDSCO/Drugs

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 09 Jan 2023 | 11:49 AM(IST)