Package leaflet: Information for the patient

C-Tard 500 mg prolonged-release hard capsules

ASCORBIC ACID
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What C-Tard is and what it is used for
What you need to know before taking C-Tard
How to take C-Tard
Possible side effects
How to store C-Tard
Contents of the pack and other information

1. What C-Tard is and what it is used for

C-Tard contains the active substance acidum ascorbicum (Vitamin C).
C-Tard is indicated:

for the prevention and treatment of conditions in which the body has a deficiency of Vitamin C:
- pregnancy
- breastfeeding
- tendency to bleeding caused by capillary fragility.
as adjunctive therapy in case of inflammation of the mouth (stomatitis) and gums (gingivitis).

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking C-Tard

Do not take C-Tard

If you are allergic to ascorbic acid (Vitamin C) or to any of the other ingredients of this medicine (listed in section 6).
If you suffer from oxalate urolithiasis or hyperoxaluria (kidney stones).
If you have severe impairment of renal function or renal failure.
If you are a child under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking C-Tard.
Ascorbic acid must not be taken in doses higher than or for longer periods than recommended,
as overdose may cause calcium oxalate deposits and acute tubular necrosis and/or
renal failure.
Vitamin C should be used with caution in individuals who currently have or have previously had
nephrolithiasis (kidney stones), and in those affected by:

G6PD (Glucose-6-phosphate dehydrogenase) deficiency, anemia due to destruction of red blood cell membranes;
Haemochromatosis (a disease caused by excessive accumulation of iron in various organs and tissues);
Thalassaemia (a genetic blood disorder caused by reduced or absent haemoglobin synthesis);
Sideroblastic anaemia (anaemia caused by the body's inability to incorporate iron into red blood cells).

Other medicines and C-Tard
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Specifically inform your doctor if you are taking:

Iron, as vitamin C increases gastric and intestinal absorption of iron;
Deferoxamine (a medicine used to remove excess iron from the body), as cardiac dysfunction may occur in patients with haemochromatosis (a disease caused by excessive accumulation of iron in various organs and tissues) or thalassaemia (a genetic blood disorder caused by reduced or absent haemoglobin synthesis);
Aluminium-containing antacids (medicines used to counteract stomach acidity), as in patients with renal failure, aluminium may accumulate in body tissues;
Acetylsalicylic acid, as it may interfere with the absorption of vitamin C.

Laboratory tests
Ascorbic acid may alter blood and urine glucose levels. Therefore, it is advisable to discontinue
ascorbic acid intake a few days before undergoing such tests.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
C-Tard may be used during pregnancy and breastfeeding. Do not exceed the recommended doses during
pregnancy and breastfeeding. Ascorbic acid crosses the placenta and is excreted in breast milk.
Driving and using machines
C-Tard does not affect the ability to drive or operate machinery.
C-Tard contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this
medicine.

3. How to take C-Tard

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule in the morning and 1 capsule in the evening.
Do not exceed the recommended doses and take C-Tard only for short-term treatment.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment, if the condition recurs repeatedly, or if you have noticed any recent changes in its characteristics.

Special populations:
Use in the paediatric population
Do not use in children under six years of age.
Use in patients with renal impairment
C-Tard should be taken with caution in patients with renal impairment (see section Warnings and Precautions).

If you take more C-Tard than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Transient diarrhoea may occasionally occur when taking doses exceeding 3 g; this occurs more frequently at doses above 10 g.
High doses of ascorbic acid increase the risk of haemolysis and kidney stone formation.
General therapeutic measures should be implemented. Further treatment should be based on clinical indications or recommendations from the national poison control centre.

If you forget to take C-Tard
Do not take a double dose to make up for the forgotten dose.

If you stop taking C-Tard
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following adverse reactions have been observed with the use of C-Tard and are based on spontaneous reports:
Not known (frequency cannot be estimated from the available data):

Allergic reactions, including hypersensitivity reactions (such as shortness of breath, facial swelling, and skin rashes);
Headache;
Nausea, vomiting, diarrhoea, dyspepsia (indigestion), abdominal pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store C-Tard

Do not store above 25 °C. Keep in the original packaging.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, keep both the carton and the package leaflet.

6. Package contents and other information

What C-Tard contains

The active substance is ascorbic acid. Each capsule contains 500 mg of ascorbic acid in prolonged-release microbeads.
The other ingredients are sucrose, shellac, talc, starch, tartaric acid, gelatin, titanium dioxide, yellow iron oxide, erythrosine, quinoline yellow.

Description of the appearance of C-Tard and package contents
Each C-Tard package contains
20 capsules in blister packs
or
60 capsules in a bottle.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milano
Manufacturer
Haleon Italy Manufacturing S.r.l., Via Nettunense, 90 - 04011, Aprilia (LT), Italy