Esofold "Esomeprazole" a product of PharmAlliance International Labs Private Limited

 

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What is in this Post?

1-            What Esofold is and what it is used for.?

2-            What you need to know before you take Esofold?

3-            How to take Esofold?

4-            Possible side effects of Esofold?

5-            How to store Esofold?

6-            Contents of the pack and other information

What Esofold is and what it is used for.?

            Esofold contains a medicine called Esofold. This belongs to a group of medicines called ‘proton pump inhibitors. They work by reducing the amount of acid that your stomach produces.

    Esofold is used to treat the following conditions:

    Adults and young people aged 12 years and above.

 

‘Gastro-esophageal reflux disease (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation, and heartburn.

 

Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults.

Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esofold can also be used to stop stomach ulcers from forming if you are taking NSAIDs.

 

Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

Prolonged treatment after prevention of rebleeding of ulcers with intravenous Esofold.

What you need to know before you take Esofold?

Do not take Esofold:

      If you are allergic to Esomeprazole or any of the other ingredients of this medicine.

      If you are taking a medicine containing nelfinavir (used to treat HIV infection).

      If you are allergic to the group of medicines called ‘benzimidazoles’, which includes other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole) as well as other different types of medicine.

      Do not take Esofold if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Esofold.

Warnings and Precautions:

Talk to your doctor or pharmacist before taking Esofold:

      If you have severe liver problems.

      If you have severe kidney problems.

      If you have ever had a skin reaction after treatment with a medicine similar to Esofold 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 Esofold. Remember to also mention any other ill effects like pain in your joints.

 

Taking a proton pump inhibitor like Esofold, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist, or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Esofold may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking this medicine or while you are taking it, talk to your doctor straight away:

      You lose a lot of weight for no reason and have problems swallowing.

      You get stomach pain or indigestion.

      You begin to vomit food or blood.

      You pass black stools (blood-stained faeces).

Other medicines and Esofold:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Esofold can affect the way some medicines work and some medicines can have an effect on Esofold.

Do not take Esofold if you are taking a medicine containing nelfinavir (used to treat HIV).

Tell your doctor or pharmacist if you are taking any of the following medicines:

      Atazanavir (used to treat HIV).

      Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).

      Erlotinib (used to treat cancer).

      Citalopram, imipramine, or clomipramine (used to treat depression).

      Diazepam (used to treat anxiety, relax muscles, or in epilepsy).

      Phenytoin (used in epilepsy). If you are taking phenytoin, the doctor will need to monitor you when you start or stop taking Esofold.

      Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esofold.

      Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply).

      If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Esofold to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Pregnancy and breast-feeding:

If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esofold during this time.

It is not known if Esofold passes into breast milk. Therefore, you should not take Esofold if you are breast-feeding

Driving and using machines:

Esofold can cause side effects such as dizziness and blurred vision. If you are affected by these you should not drive, use tools or operate machinery.

Esofold contains sucrose:

If you have been told by your doctor that you have an intolerance to some sugars, such as sucrose, talk to your doctor before taking this medicine.

How to take Esofold?

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

      Esofold is not recommended for children less than 12 years old.

      If you are taking this medicine for a long time, your doctor will want to monitor you (particularly if you are taking it for more than a year).

      If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

Taking this medicine:

      You can take your capsules at any time of the day.

      You can take your capsules with food or on an empty stomach.

      Swallow your capsules whole with a drink of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets that stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have trouble swallowing the capsules:

If you have trouble swallowing the capsules:

Open the capsule and empty the pellets into half a glass of still (non-fizzy) water. Do not use any other liquid. Drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it. To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

 

If you cannot swallow at all, the capsule can be mixed with some water and put into a syringe. It can then be given to you through a tube directly into your stomach ("gastric tube").

How much to take:

Your doctor will tell you how many capsules to take and how long to take them. This will depend on your condition; how old you are and how well your liver works. If you have severe liver problems, your doctor may give you a lower dose.

The recommended doses are given below:

To treat heartburn caused by gastro-oesophagal reflux disease (GRD):

Adults and children aged 12 or above:

      If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Esofold 40 mg Capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.

      The recommended dose once the gullet has healed is one Esofold 20 mg Capsule once a day.

      If your gullet has not been damaged, the recommended dose is one Esofold 20 mg Capsule each day.

      Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Esofold 20 mg Capsule each day.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

Adults and young people aged 12 or above:

      the recommended dose is one Esofold 20 mg Capsule twice a day for one week.

      Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

Adults aged 18 and above:

      the recommended dose is one Esofold 20 mg Capsule once a day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

Adults aged 18 and above:

      the recommended dose is one Esofold 20 mg Capsule once a day.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

Adults aged 18 and above:

      the recommended dose is one Esofold “Esofold” 40 mg Capsule twice a day.

Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine. The maximum dose is 80 mg twice a day.

To be used as prolonged treatment after prevention of rebleeding of ulcers with intravenous Esofold:

Adults aged 18 and above:

      the recommended dose is one Esofold 40 mg Capsule once daily for 4 weeks.

If you take more Esofold then you should:

If you take more Esofold than your doctor has told you to, talk to your doctor or pharmacist straight away.

If you forget to take Esofold:

      If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose.

      Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

      If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects of Esofold?

If you notice any of the following serious side effects, stop taking Esofold and contact a doctor immediately:

Common (may affect up to 1 in 10 people).

      Diarrhoea, stomach pain, constipation, wind (flatulence).

      Feeling sick (nausea) or being sick (vomiting).

      Benign polyps in the stomach.

      Headache.

Uncommon (may affect up to 1 in 100 people):

      Swelling of the feet and ankles.

      Disturbed sleep (insomnia).

      Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.

      Spinning feeling (vertigo).

      Dry mouth.

      Changes in blood tests that check how the liver is working.

      Skin rash, lumpy rash (hives), and itchy skin.

Reporting of side effects:

      If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via e-mail to info@pharmalliance.pk

How to store Esofold?

      Keep this medicine out of the sight and reach of children.

      Do not use this medicine after the expiry date which is stated on the pack label, carton, or blister foil after EXP. The expiry date refers to the last day of that month.

      Blister: Do not store above 25º C. Store in the original package to protect from moisture.

      Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

 Contents of the pack and other information

Esofold is available in 20mg and 40mg in capsules form.

Alu Alu two blisters of 14 capsules