Mylan-Rabeprazole: Uses, Side Effects and Dosage

What is Mylan-Rabeprazole used for?

MYLAN-RABEPRAZOLE is used in adults to:

• relieve symptoms and heal duodenal ulcers;
• relieve symptoms and heal stomach ulcers;

• heal gastroesophageal reflux disease (GERD) and relieve its symptoms such as:

  • the burning feeling that rises from the chest to the throat (heartburn)
  • the flow of bitter/sour juice into the mouth (regurgitation);
• treat symptoms of non-erosive reflux disease (NERD) such as heartburn and regurgitation.
• maintain longer term healing of gastroesophageal reflux disease (GERD).
• treat rare conditions where excess acid is produced in the stomach (eg. Zollinger-Ellison syndrome.

• treat ulcers caused by infection with the bacterium, Helicobacter pylori (H. pylori), and prevent these ulcers from coming back by:

  • taking Mylan-Rabeprazole with antibiotics such as amoxicillin and clarithromycin, as directed by your doctor.
  • following the information on the antibiotics provided to you by the pharmacist.

.

How does Mylan-Rabeprazole work?

Mylan-Rabeprazole is a medicine called a proton pump inhibitor (PPI). Mylan-Rabeprazole works by reducing the amount of acid made in your stomach.

What are the ingredient in Mylan-Rabeprazole?

Medicinal Ingredient: rabeprazole sodium

Nonmedicinal ingredients:

diacetylated mono-glycerides, ethyl cellulose, hydroxy propyl cellulose, hypromellose phthalate, iron oxide red, iron oxide yellow, low substituted hydroxy propyl cellulose, magnesium oxide heavy, magnesium stearate, mannitol, talc, and titanium dioxide.

Coating ingredients: acetylated monoglycerides, hypromellose 6cP, iron oxide (red or yellow), and titanium dioxide.

Imprinting ingredients: industrial methylated spirit, iron oxide black, propylene glycol, and shellac glaze.

Mylan-Rabeprazole comes in the following dosage forms:

Tablets of 10 mg and 20 mg.

Do not use Mylan-Rabeprazole if you are allergic to:

• rabeprazole or other medications in this class
• the “nonmedicinal” ingredients in Mylan-Rabeprazole tablets (see What the ingredients are in Mylan-Rabeprazole?)
• the antibiotics amoxicillin or clarithromycin if these are used with Mylan-Rabeprazole to treat ulcers caused by H. pylori.

Do not use Mylan-Rabeprazole if you are:

• taking rilpivirine

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Mylan-Rabeprazole. Talk about any health conditions or problems you may have, including:

• all health problems you have now or have had in the past.
• any liver problems
• if you experience symptoms including palpitations (rapid heartbeat), dizziness, seizures, twitching, spasms, muscle weakness, cramps and convulsions. These may be signs of low magnesium levels in your blood.
• if you are taking methotrexate.

• if you are pregnant, or planning to become pregnant.

• If you are breast-feeding or planning to breastfeed.

Other warnings you should know about:

Long-term use of Mylan-Rabeprazole may prevent normal absorption of vitamin B₁₂ from the diet and could lead to vitamin B₁₂ deficiency. Talk to your doctor.

Using Mylan-Rabeprazole for a long period of time (a year or longer) may increase the risk of fractures of the hip, wrist or spine. Talk to your doctor about your risk.

Tell your healthcare professional about all the medicines you take, including any drugs (prescription and non-prescription), vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Mylan-Rabeprazole:

• ketoconazole
• digoxin
• warfarin
• antiretroviral drugs such as atazanavir, nelfinavir, saquinavir
• methotrexate

How to take Mylan-Rabeprazole:

• Take Mylan-Rabeprazole exactly as prescribed by your doctor, usually for a specific number of weeks.
• Use the lowest dose and shortest time as determined by your doctor.
• Do not stop taking Mylan-Rabeprazole even when you start to feel better. If you stop taking Mylan-Rabeprazole too soon your symptoms may return.
• Take Mylan-Rabeprazole with or without meals.
• Swallow tablets whole with a liquid. Do not chew or crush the tablets.
• Talk to your doctor if you have any concerns.

Usual dose:

^*If you are given MYLAN-RABEPRAZOLE in combination with antibiotic drugs, it is important that you take all medications at the correct time of day and for the entire treatment period, to ensure they will work properly. Studies have shown that patients who take their medications as prescribed have better ulcer healing rates and greater success in getting rid of their H. pylori infection.

Overdose:

Missed Dose:

If you forget to take one dose of Mylan-Rabeprazole medication, take a tablet as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed tablet at all. Never double-up on a dose to make up for the one you have missed; just go back to your regular schedule.

What are the possible side effects from using Mylan-Rabeprazole?

Like all medicines, Mylan-Rabeprazole tablets can cause side effects.

Headache and diarrhea are the most common side effects experienced with Mylan-Rabeprazole. Less common side effects are rash, itchiness and dizziness. If any of these become troublesome, consult your doctor.

Treatment in combination with antibiotics:

If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking Mylan-Rabeprazole. and contact your health care professional immediately.

If you experience symptoms of low magnesium levels in your body, your doctor may stop Mylan-Rabeprazole.

Tell your doctor right away if you have any of these symptoms:

• seizures
• dizziness
• abnormal or fast heart beat
• jitteriness
• jerking movements or shaking (tremors)
• muscle weakness
• spasms of the hands and feet
• cramps or muscle aches
• spasm of the voice box
• fracture (broken bone)

Stopping your PPI therapy after taking it for a long time, may cause your symptoms to get worse and your stomach may increase acid production. Carefully follow your doctor’s instructions when discontinuing your PPI therapy.

Reporting Side Effects

Storage:

Keep your tablets stored at room temperature (15° to 30°C) and protect from moisture. Keep out of the sight and reach of children. more information about Mylan-Rabeprazole:

• Talk to your healthcare professional.
• For questions or concerns contact the sponsor, Mylan Pharmaceuticals ULC. (www.mylan.ca).
• The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379 or by visiting the website at www.mylan.ca.

Etobicoke, Ontario M8Z 2S6

Last revised: June 05, 2017.

Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca