ADDITIVA

ADDITIVA Vitamin C 1 g effervescent tablets

Important notes (mandatory information)

Additiva Vitamin C Lemon Lemon, 1000 mg, effervescent tablets. Active ingredient: ascorbic acid. Field of application: for the treatment of vitamin C deficiency diseases.

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


Patient information: Information for users
Additiva Vitamin C Lemon Lemon, 1000 mg, effervescent tablets
Ascorbic acid

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 leaflet or exactly as directed by your doctor, pharmacist or healthcare professional.
. 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, pharmacist or healthcare professional. This also applies to side effects not listed in this leaflet. See section 4.
. If you do not feel better or even worse, talk to your doctor.

What this leaflet contains

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

1. WHAT IS Additiva Vitamin C Lemon LEMON AND WHAT IS IT USED FOR?

Additiva Vitamin C Lemon effervescent tablets are used to treat vitamin C deficiency diseases (e.g. scurvy).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING Additiva Vitamin C Lemon LEMON?

Additiva Vitamin C Lemon Lemon must not be taken
- if you are allergic to ascorbic acid or any of the other ingredients of this medicine listed in section 6.
- if you suffer from kidney stones (oxalate), unless your doctor recommends otherwise.
- if you suffer from certain diseases in which too much iron is stored in the body (thalassemia, hemochromatosis, sideroblastic anemia).

Warnings and precautions
Please talk to your doctor, pharmacist or healthcare professional before taking Additiva Vitamin C Lemon Lemon.

Special care should be taken when taking Additiva Vitamin C Lemon if
- you suffer from a hereditary disorder of red blood cell metabolism (e.g. erythrocyte glucose-6-phosphate dehydrogenase deficiency); do not take more than the recommended dosage (1000 mg daily).
- taking increased doses of vitamin C over a prolonged period of time can lead to vitamin C deficiency after discontinuation of treatment. Increased intake can lead to increased excretion of vitamin C via the kidneys.
- if you are at risk of developing kidney stones, you should not take more than 100 to 200 mg of vitamin C (see section 2 "Additiva Vitamin C Lemon should not be taken"). If you are prone to kidney stones, there is a risk of forming calcium oxalate kidney stones when taking high doses of vitamin C.
- if you suffer from severe kidney disease (dialysis patients), you should not take more than 50 to 100 mg of vitamin C daily, as otherwise there is a risk of high oxalate concentrations in the blood (hyperoxalatemia) and the formation of oxalate crystals in the kidneys. Please consult your doctor about this.
- Avoid high vitamin C doses if you have kidney failure and if you are taking medicines that can have a negative effect on kidney function (see also "Taking Additiva Vitamin C Lemon with other medicines").
- After administration of gram doses, the ascorbic acid concentration in the urine may increase to such an extent that the measurement of various clinical-chemical parameters (glucose, uric acid, creatinine, inorganic phosphate) is disturbed. Similarly, after gram doses, false negative results may occur when attempting to detect occult blood in the stool. In general, chemical detection methods based on color reactions can be impaired.

Children and adolescents
Additiva Vitamin C Lemon is not intended for children and adolescents under 18 years of age. Medicines with a lower ascorbic acid content are available for these.

Taking Additiva Vitamin C Lemon with other medicines

Tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines. Although the following interactions between vitamin C and other active ingredients are described, it is not certain whether they are significant when Additiva Vitamin C Lemon is used as directed

- Vitamin C in doses of 1 g per day increases the absorption of oral contraceptives (contraceptives/estrogen preparations).
- Corticosteroids and calcitonin increase vitamin C consumption.
- Salicylic acid salts such as acetylsalicylic acid inhibit the absorption of vitamin C from the intestinal tract.
- Antibiotics such as tetracyclines inhibit the utilization of vitamin C in the body cells.
- Acetylsalicylic acid, barbiturates such as phenobarbital and antibiotics such as tetracyclines increase the excretion of vitamin C in the urine.
- Vitamin C can reduce the effectiveness of blood-thinning medicines (e.g. warfarin) and phenothiazine antipsychotics such as fluphenazine.
- Taking high doses of vitamin C over a prolonged period of time can affect the interaction of disulfiram and alcohol when taken at the same time.
- Taking high doses of vitamin C together with iron preparations increases iron absorption and can thus lead to an increased iron level.
- Taking high doses of vitamin C together with aluminum (e.g. antacids such as aluminum hydroxide, magaldrate) can cause increased aluminum absorption.
- Vitamin C can reduce the amount of cyclosporin A, an immunosuppressant, in the blood.

Taking Additiva Vitamin C Lemon with food, drink and alcohol
Alcohol reduces plasma ascorbic acid levels.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking/using this medicine. Do not take Additiva Vitamin C Lemon until after consulting your doctor if you are pregnant or breastfeeding. There are insufficient data on the use of high doses of vitamin C in pregnant women. It is not clear whether higher vitamin C doses for nutrient intake (DRI; Dietary Reference Intake) than recommended are safe or beneficial. Vitamin C passes into breast milk and crosses the placental barrier. The effect of high doses on the fetus/newborn is not known.

Driving and using machines
Not applicable.

Additiva Vitamin C Lemon contains sodium and sorbitol.

This medicine contains 299.3 mg sodium per effervescent tablet and should be taken with caution by people on a low-sodium/low-salt diet (e.g. patients with high blood pressure). Please do not take Additiva Vitamin C Lemon until after consulting your doctor if you know that you have an intolerance to certain sugars.

3. HOW TO TAKE Additiva Vitamin C Lemon LEMON?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor, pharmacist or healthcare professional. Check with your doctor, pharmacist or healthcare professional if you are unsure.

The recommended dose is

Adults take 1 effervescent tablet (equivalent to 1000 mg vitamin C (ascorbic acid)) once a day until symptoms subside. The maximum dose of 1000 mg vitamin C (1 effervescent tablet daily) should not be exceeded.

Use in children and adolescents
Additiva Vitamin C Lemon is not intended for children and adolescents under 18 years of age. Medicines with a lower ascorbic acid content are available for these.

Patients with kidney disease
Additiva Vitamin C Lemon is not intended for patients with kidney disease. Medicines with a lower ascorbic acid content are available for these (see section "Warnings and precautions").

Method of administration
Dissolve the effervescent tablets in a glass of drinking water and drink the contents of the glass completely. If there are still residues in the glass after drinking, rinse with a little liquid.

Duration of use
In general, it is recommended to continue therapy until symptoms disappear. Ask your doctor for advice if you are unsure.

If you have taken more Additiva Vitamin C Lemon than you should
See section 2 under "Warnings and precautions" for the risk of hemolysis (dissolution of red blood cells) and kidney stones. If you experience pain in the kidney area or difficulty urinating after a high dose of Additiva Vitamin C Lemon, consult a doctor immediately. Diarrhea may occur temporarily after taking a single dose of 3 g and almost always after taking 10 g of vitamin C, accompanied by corresponding gastrointestinal symptoms. The intake of Additiva Vitamin C Lemon must then be interrupted. Other measures are generally not necessary.

If you forget to take Additiva Vitamin C Lemon
Do not take double the amount if you have forgotten the previous dose,

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can have side effects, although not everybody gets them.
Stop taking Additiva Vitamin C Lemon and tell your doctor immediately or go to the nearest emergency room if you notice the following symptoms.
Medical attention may be necessary.

Frequency not known (frequency cannot be estimated from the available data):
Hypersensitivity reactions such as
- Difficulty breathing
- allergic skin reactions have been observed.

Reporting side effects
If you experience any side effects, talk to your doctor or, pharmacist or healthcare professional. This also applies to side effects not listed in this 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: http://www.bfarm.de.

By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE Additiva Vitamin C Lemon LEMON?

Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is stated on the bottom of the container or carton. The expiry date refers to the last day of the month indicated.
After opening, Additiva Vitamin C Lemon is usable for 6 months. Do not store above 30°C. Keep the container tightly closed to protect the contents from moisture. Store in the outer carton to protect the contents from light.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Additiva Vitamin C Lemon contains

- The active ingredient is 1000 mg ascorbic acid (vitamin C).
- The other ingredients are: Anhydrous citric acid (Ph. Eur.), sodium hydrogen carbonate, sorbitol (Ph. Eur.), lemon flavor, corn starch, sodium cyclamate, saccharin sodium, riboflavin phosphate sodium.

What Additiva Vitamin C Lemon looks like and contents of the pack

Additiva Vitamin C Lemon are light yellow effervescent tablets with yellowish specks and a lemon scent. 10 or 20 effervescent tablets are available in tubes (polypropylene) with closures (polyethylene) equipped with desiccant (silica gel). Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer
Dr. B. Scheffler Nachf. GmbH & Co. KG
Senefelderstrasse 44
D-51469 Bergisch Gladbach

This leaflet was last revised in August 2014.

Source: Information from the package leaflet
Status: 08/2015
Active ingredient: ascorbic acid. Field of application: for the treatment of vitamin C deficiency diseases.