TOPCID-DSR Capsules

Category:

TOPCID-DSR: Each capsule contains Pantoprazole 40mg and Domperidone 30mg.

TOPCID DSR is used to treat adults and adolescents 12 years of age and above for

  • Reflux oesophagitis with nausea. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.
  • An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.
  • Stomach and duodenal ulcers with nausea and vomiting.
  • Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.

Description

TOPCID DSR Capsules contains two active substance pantoprazole and domperidone. Pantoprazole is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. Domperidone belongs to a group of medicines called ‘dopamine antagonists’.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

Take the Capsule 1 hour before a meal without chewing or breaking them and swallow them whole with some water.

The recommended dose is:

Adults and adolescents 12 years of age and above

  • The usual dose is one Capsule a day.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

This is because Pantoprazole & Domperidone may influence the effectiveness of other medicines, so tell your doctor if you are taking:

  • Medicines such as ketoconazole, itraconazole and posaconazole or erlotinib because Pantoprazole may stop these and other medicines from working properly.
  • Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.
  • Medicines used to treat HIV-infection, such as atazanavir.
  • Methotrexate
  • if you are taking methotrexate your doctor may temporarily stop your Pantoprazole treatment because pantoprazole can increase levels of methotrexate in the blood.
  • Fluvoxamine, if you are taking fluvoxamine your doctor may reduce the dose.
  • Rifampicin (used to treat infections).

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following side effects, stop taking these tablets and tell your doctor immediately, or contact the casualty department at your nearest hospital:

  • Serious allergic reactions: swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling, severe dizziness with a very fast heartbeat and heavy sweating.
  • Serious skin conditions: blistering of the skin and rapid deterioration of your general condition, erosion of eyes, nose, mouth/lips or genitals, Lyell-Syndrome, and sensitivity to light.
  • Other serious conditions: yellowing of the skin or whites of the eyes or fever, rash, and enlarged kidneys sometimes with painful urination, and lower back pain, possibly leading to kidney failure.
  • A severe hypersensitivity reaction that may occur soon after administration that is characterized by hives, itching, flushing, fainting, and difficulty in breathing among other possible symptoms
  • Disorders of the cardiovascular system: heart rhythm disorders (rapid or irregular heartbeat) have been reported; if this happens, you should stop the treatment immediately.

Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day.

Other side effects are:

  • Common: Benign polyps in the stomach, Dry mouth
  • Uncommon: Headache, dizziness, diarrhoea, feeling sick, vomiting; bloating and flatulence, constipation, abdominal pain and discomfort; skin rash, exanthema, eruption, Anxiety, Agitation, Nervousness, Loss of interest in sex or diminished interest in sex, Headache, Sleepiness, Itchiness, Hives, Painful or tender breasts, Milk discharge from breasts, A general feeling of weakness, Feeling dizzy
  • Rare: Distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; high fever; swelling of the extremities; allergic reactions; depression; breast enlargement in males.
  • Very Rare: Disorientation.
  • Not known: Hallucination, confusion; decreased sodium level in the blood, decreased magnesium level in the blood, feeling of tingling, prickling, pins and needles, burning sensation ,Upward movement of the eyes, Stopped menstrual periods in women, Enlarged breasts in men, Inability to urinate, Changes in certain laboratory test results, Restless legs syndrome (uncomfortable feeling, with an irresistible urge to move your legs, and sometimes arms and other parts of your body).

Side effects identified through blood tests:

  • Uncommon: an increase in liver enzymes.
  • Rare: Increase in bilirubin; increased fat levels in the blood; a sharp drop in circulating granular white blood cells, associated with a high fever.
  • Very Rare: a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets.

Do not take TOPCID DSR

  • If you are allergic to pantoprazole or Domperidone
  • If you are allergic to medicines containing other proton pump inhibitors

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Topcid DSR

  • If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently, especially when you are taking Pantoprazole as a long-term treatment. In the case of a rise of liver enzymes, the treatment should be stopped.
  • If you have reduced body stores or risk factors for reduced vitamin B12 and receive long-term treatment with pantoprazole. As with all acid-reducing agents, pantoprazole may lead to reduced absorption of vitamin B12.
  • If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
  • Taking a proton pump inhibitor like pantoprazole, especially over more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. 
  • If you are on Pantoprazole for more than three months the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly.
  • Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30mg per day. The risk also increases when domperidone is given together with some drugs.
  • If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole that reduces stomach acid.
  • If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pantoprazole. Remember to also mention any other ill-effects like pain in your joints.
  • if you are due to have a specific blood test (Chromogranin A)
  • You have a blockage or tear in your intestines
  • You have a tumor of the pituitary gland called a prolactinoma.

Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease:

  • An unintentional loss of weight, Vomiting, particularly if repeated , Vomiting blood; this may appear as dark coffee grounds in your vomit
  • You notice blood in your stools; which may be black or tarry in appearance
  • Difficulty in swallowing or pain when swallowing
  • You look pale and feel weak (anaemia)
  • Chest pain , Stomach pain, Severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.

Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause a delay in diagnosing it. If your symptoms continue despite your treatment, further investigations will be considered. 

If you take Pantoprazole on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

Domperidone should be used at the lowest effective dose. While taking domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, and loss of consciousness. Treatment with domperidone should be stopped.

Children and adolescents: TOPCID DSR is not recommended for use in children as it has not been proven to work in children below 12 years of age.

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TOPCID DSR is used to treat adults and adolescents 12 years of age and above for

  • Reflux oesophagitis with nausea. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.
  • An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.
  • Stomach and duodenal ulcers with nausea and vomiting.
  • Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.

Description

TOPCID DSR Capsules contains two active substance pantoprazole and domperidone. Pantoprazole is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. Domperidone belongs to a group of medicines called ‘dopamine antagonists’.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

Take the Capsule 1 hour before a meal without chewing or breaking them and swallow them whole with some water.

The recommended dose is:

Adults and adolescents 12 years of age and above

  • The usual dose is one Capsule a day.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

This is because Pantoprazole & Domperidone may influence the effectiveness of other medicines, so tell your doctor if you are taking:

  • Medicines such as ketoconazole, itraconazole and posaconazole or erlotinib because Pantoprazole may stop these and other medicines from working properly.
  • Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.
  • Medicines used to treat HIV-infection, such as atazanavir.
  • Methotrexate
  • if you are taking methotrexate your doctor may temporarily stop your Pantoprazole treatment because pantoprazole can increase levels of methotrexate in the blood.
  • Fluvoxamine, if you are taking fluvoxamine your doctor may reduce the dose.
  • Rifampicin (used to treat infections).

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following side effects, stop taking these tablets and tell your doctor immediately, or contact the casualty department at your nearest hospital:

  • Serious allergic reactions: swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling, severe dizziness with a very fast heartbeat and heavy sweating.
  • Serious skin conditions: blistering of the skin and rapid deterioration of your general condition, erosion of eyes, nose, mouth/lips or genitals, Lyell-Syndrome, and sensitivity to light.
  • Other serious conditions: yellowing of the skin or whites of the eyes or fever, rash, and enlarged kidneys sometimes with painful urination, and lower back pain, possibly leading to kidney failure.
  • A severe hypersensitivity reaction that may occur soon after administration that is characterized by hives, itching, flushing, fainting, and difficulty in breathing among other possible symptoms
  • Disorders of the cardiovascular system: heart rhythm disorders (rapid or irregular heartbeat) have been reported; if this happens, you should stop the treatment immediately.

Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day.

Other side effects are:

  • Common: Benign polyps in the stomach, Dry mouth
  • Uncommon: Headache, dizziness, diarrhoea, feeling sick, vomiting; bloating and flatulence, constipation, abdominal pain and discomfort; skin rash, exanthema, eruption, Anxiety, Agitation, Nervousness, Loss of interest in sex or diminished interest in sex, Headache, Sleepiness, Itchiness, Hives, Painful or tender breasts, Milk discharge from breasts, A general feeling of weakness, Feeling dizzy
  • Rare: Distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; high fever; swelling of the extremities; allergic reactions; depression; breast enlargement in males.
  • Very Rare: Disorientation.
  • Not known: Hallucination, confusion; decreased sodium level in the blood, decreased magnesium level in the blood, feeling of tingling, prickling, pins and needles, burning sensation ,Upward movement of the eyes, Stopped menstrual periods in women, Enlarged breasts in men, Inability to urinate, Changes in certain laboratory test results, Restless legs syndrome (uncomfortable feeling, with an irresistible urge to move your legs, and sometimes arms and other parts of your body).

Side effects identified through blood tests:

  • Uncommon: an increase in liver enzymes.
  • Rare: Increase in bilirubin; increased fat levels in the blood; a sharp drop in circulating granular white blood cells, associated with a high fever.
  • Very Rare: a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets.

Do not take TOPCID DSR

  • If you are allergic to pantoprazole or Domperidone
  • If you are allergic to medicines containing other proton pump inhibitors

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Topcid DSR

  • If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently, especially when you are taking Pantoprazole as a long-term treatment. In the case of a rise of liver enzymes, the treatment should be stopped.
  • If you have reduced body stores or risk factors for reduced vitamin B12 and receive long-term treatment with pantoprazole. As with all acid-reducing agents, pantoprazole may lead to reduced absorption of vitamin B12.
  • If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
  • Taking a proton pump inhibitor like pantoprazole, especially over more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. 
  • If you are on Pantoprazole for more than three months the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly.
  • Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30mg per day. The risk also increases when domperidone is given together with some drugs.
  • If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole that reduces stomach acid.
  • If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pantoprazole. Remember to also mention any other ill-effects like pain in your joints.
  • if you are due to have a specific blood test (Chromogranin A)
  • You have a blockage or tear in your intestines
  • You have a tumor of the pituitary gland called a prolactinoma.

Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease:

  • An unintentional loss of weight, Vomiting, particularly if repeated , Vomiting blood; this may appear as dark coffee grounds in your vomit
  • You notice blood in your stools; which may be black or tarry in appearance
  • Difficulty in swallowing or pain when swallowing
  • You look pale and feel weak (anaemia)
  • Chest pain , Stomach pain, Severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.

Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause a delay in diagnosing it. If your symptoms continue despite your treatment, further investigations will be considered. 

If you take Pantoprazole on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

Domperidone should be used at the lowest effective dose. While taking domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, and loss of consciousness. Treatment with domperidone should be stopped.

Children and adolescents: TOPCID DSR is not recommended for use in children as it has not been proven to work in children below 12 years of age.

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