Cemill

• If you have an allergy to ascorbic acid or any other part of Cemill (ascorbic acid (vitamin C) controlled-release caps & controlled-release tabs).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Cemill. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• If you have high blood sugar (diabetes), talk with your doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• Kidney stones may rarely happen.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Cemill while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take with a full glass of water.
• Swallow whole. Do not chew, break, or crush.
• To gain the most benefit, do not miss doses.
• Keep taking Cemill as you have been told by your doctor or other health care provider, even if you feel well.

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.

Applies to ascorbic acid: oral capsule, oral capsule extended release, oral capsule liquid filled, oral granule, oral liquid, oral lozenge/troche, oral powder, oral powder for solution, oral powder for suspension, oral solution, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release, oral wafer

Along with its needed effects, ascorbic acid (the active ingredient contained in Cemill) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking ascorbic acid:

• Side or lower back pain

Some side effects of ascorbic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• dizziness or faintness (with the injection only)
• flushing or redness of skin
• headache
• increase in urination (mild)
• nausea or vomiting
• stomach cramps

Applies to ascorbic acid: compounding powder, injectable solution, oral capsule, oral gum, oral liquid, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release

Renal

Renal side effects have included oxalate and urate kidney stones.[Ref]

Hyperoxaluria appears to be dose-related.[Ref]

Nervous system

Migraine headache has been reported with a daily dose of 6 grams.

The manufacturer reports temporary dizziness and faintness may be associated with too rapid of a rate during intravenous administration.[Ref]

Nervous system side effects have included dizziness, faintness, fatigue, and headache in less than 1% of patients. Migraine headache has also been reported.[Ref]

Other

Conditional scurvy is reported to occur following excessive doses of ascorbic acid (the active ingredient contained in Cemill) over a prolonged period of time. The mechanism of action for this condition is thought to be that large doses of ascorbic acid condition the patient over time for rapid clearance of ascorbic acid resulting in scurvy. The plasma levels of ascorbic acid appear to remain within normal limits. The actual existence of conditional scurvy remains controversial.[Ref]

Other side effects have included flank pain in less than 1% of patients. Conditional scurvy has also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, abdominal cramps, and esophagitis.[Ref]

Nausea, diarrhea, and abdominal cramps appears to be associated with doses exceeding 2 g per day, although there have been some reports with as little as 1 g per day.

Esophagitis appears to be associated with prolonged or increased contact of ascorbic acid tablets with the esophageal mucosa.[Ref]

Hematologic

The majority of hemolysis reports have been associated with patients who have concurrent glucose-6-phosphate dehydrogenase deficiency.[Ref]

Hematologic side effects have included hemolysis.[Ref]

Local

Local side effects have included transient mild soreness at the site of injection.[Ref]

Some side effects of Cemill may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.