CETEBE

CETEBE Vitamin C sustained release capsules 500 mg

Important notes (mandatory information)

Cetebe Vitamin C Retard 500, 500 mg hard capsule, retarded. Active ingredient: Ascorbic acid (vitamin C). Areas of application: for the prevention of vitamin C deficiency, if sufficient intake through diet is not ensured and for the treatment of vitamin C deficiency diseases.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetebe Vitamin C Retard 500, 500 mg hard capsule, retarded
Active ingredient: Ascorbic acid (vitamin C)

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 14 days, contact your doctor.

What this package leaflet contains

1. WHAT IS CETEBE VITAMIN C RETARD 500 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CETEBE VITAMIN C RETARD 500?
3. HOW TO TAKE CETEBE VITAMIN C RETARD 500?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CETEBE VITAMIN C RETARD 500?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CETEBE VITAMIN C RETARD 500 AND WHAT IS IT USED FOR?

Cetebe Vitamin C Retard 500 is a vitamin C preparation. Vitamin C is vital for the human body and influences a variety of metabolic processes. It must be supplied regularly and in sufficient quantities because it cannot be produced by the body itself. Cetebe Vitamin C Retard 500 is a medicine for the prevention of vitamin C deficiency, if sufficient intake through diet is not ensured and for the treatment of vitamin C deficiency diseases.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CETEBE VITAMIN C RETARD 500?

Cetebe Vitamin C Retard 500 must not be taken:

• if you are allergic to ascorbic acid (vitamin C) or any of the other ingredients of this medicine listed in section 6.
• if you suffer or have suffered from oxalate-containing bladder or kidney stones (oxalate urolithiasis).
• if you suffer from a disease in which too much iron is stored in the body (thalassemia, hemochromatosis, sideroblastic anemia).
• if you know that you tend to store more iron.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Cetebe Vitamin C Retard 500:

• if you have suffered from kidney stones in the past or are currently suffering from kidney stones. In this case, you should avoid excessive intake of vitamin C and consult your doctor for advice.
• if you suffer from a very rare metabolic disorder known as erythrocyte glucose-6-phosphate dehydrogenase deficiency. In this case, you must not exceed the specified dosage, as in individual cases, doses of 4 g or more have been observed to cause partial dissolution of red blood cells (severe hemolysis). Please consult your doctor about this.
• if you suffer from impaired kidney function. In this case, you must not exceed the specified minimum dosage of one capsule per day.
• if you suffer from severe renal impairment and are on dialysis: You should not take more than 50 - 100 mg of vitamin C per day, as otherwise high oxalate concentrations in the blood (hyperoxalatemia) and consequently kidney stones (oxalate crystals in the kidneys) may occur. In this case, Cetebe Vitamin C Retard 500 is not suitable for you and you should use a lower-dose vitamin C preparation.

Children and adolescents

Children and adolescents under 13 years of age need less vitamin C than adults. Cetebe Vitamin C Retard 500 is therefore not suitable for them. Your doctor will decide whether Cetebe Vitamin C Retard 500 should be taken by adolescents aged 13 and over. Keep Cetebe Vitamin C Retard 500 out of the sight and reach of children.

Taking Cetebe Vitamin C Retard 500 with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Interactions are possible with:

• Agents for the treatment of iron deficiency: Vitamin C increases the absorption of iron from the gastrointestinal tract. This should be taken into account when using medicines for the treatment of iron deficiency at the same time.
• aluminium-containing agents for stomach hyperacidity (antacids): Taking them together can lead to increased aluminium levels in the blood and thus to poisoning. Co-administration should therefore be avoided, especially in the case of impaired renal function.
• medicines for the treatment of iron overload (deferoxamine): Cardiac function may be impaired. Therefore, consult your doctor before taking it.
• Acetylsalicylic acid (e.g. aspirin): The absorption of vitamin C may be impaired.

Effects of taking Cetebe Vitamin C Retard 500 on laboratory tests

The determination of sugar, uric acid, creatinine and inorganic phosphate in the urine can be influenced. Similarly, the detection of blood in the stool can give false-negative results. In general, chemical detection methods based on color reactions can be impaired.

Taking Cetebe Vitamin C Retard 500 with food, drink and alcohol

No interactions are known.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. The need for vitamin C is increased during pregnancy and breast-feeding. If there is a vitamin C deficiency, it should be compensated. However, the recommended dose should not be exceeded, as vitamin C passes into the circulation of the unborn child and into breast milk.

Driving and using machines

Cetebe Vitamin C Retard 500 has no influence on the ability to drive and use machines.

Cetebe Vitamin C Retard 500 contains sucrose

Please only take Cetebe Vitamin C Retard 500 after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars and do not exceed the recommended dosage.

3. HOW TO TAKE CETEBE VITAMIN C RETARD 500?

Always take Cetebe Vitamin C Retard 500 exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults 1 - 2 capsules daily.

Use in children and adolescents

Children and adolescents under 13 years of age need less vitamin C than adults. Cetebe Vitamin C Retard 500 is therefore not suitable for them. Your doctor will decide whether Cetebe Vitamin C Retard 500 should be taken by adolescents aged 13 and over.

Method of administration

For oral use. Swallow the capsules whole with water. The duration of use depends on your symptoms and the laboratory values determined by your doctor. Do not take for more than six months without medical advice.

If you have taken more Cetebe Vitamin C Retard 500 than you should

If you have taken more Cetebe Vitamin C Retard 500 than recommended, consult your doctor immediately for advice. This applies in particular to pain in the kidney area or difficulty urinating. For the risk of hemolysis and kidney stones: see section 2 (Warnings and precautions). Diarrhea may occur after taking excessive amounts of Cetebe Vitamin C Retard 500, accompanied by corresponding gastrointestinal symptoms. The intake of Cetebe Vitamin C Retard 500 is then interrupted. Other measures are generally not necessary.

If you forget to take Cetebe Vitamin C Retard 500

Do not take double the amount if you have forgotten to take the previous dose.

If you stop taking Cetebe Vitamin C Retard 500

No special measures are necessary if treatment is interrupted. If treatment is discontinued prematurely, the deficiency symptoms may persist or recur. In this case, you should consult a doctor if necessary.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and consult your doctor if you experience any of the following side effects

Very rare side effects (may affect up to 1 in 10,000 people):

• Hypersensitivity reactions such as difficulty breathing or allergic skin reactions in the form of rash, itching or swelling of the lips, tongue, face or throat.
• Headache and dizziness.
• Nausea, vomiting, diarrhea, heartburn and abdominal pain.
• Fatigue.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CETEBE VITAMIN C RETARD 500?

Do not store above 25°C. Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "Use by". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cetebe Vitamin C Retard 500 contains

The active ingredient is: 500 mg ascorbic acid (vitamin C). The other ingredients are: sucrose, corn starch, stearic acid, shellac, talc, tartaric acid (Ph. Eur.), dye riboflavin (E 101), sodium dodecyl sulfate, gelatin.

Note for diabetics

1 retard capsule contains 40.6 mg sucrose (sugar) corresponding to approx. 0.004 bread units (BE).

What Cetebe Vitamin C Retard 500 looks like and contents of the pack

Hard capsules with yellowish-transparent main part and yellowish-opaque cap. Blister packs of 30, 60, 120 or 180 retard capsules.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich

Address

Barthstraße 4
80339 Munich

Tel.: (089) 78 77-209
Fax: (089) 78 77-304
E-mail: medical.contactcenter@gsk.com

Manufacturer

Omega Pharma Manufacturing GmbH & Co. KG
Benzstraße 25
D-71083 Herrenberg

This package leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 04/2018
Active ingredient: Ascorbic acid (vitamin C). Areas of application: for the prevention of vitamin C deficiency, if sufficient intake through diet is not ensured and for the treatment of vitamin C deficiency diseases.