Ferripel 3 syrup

Active Ingredients

Each 5 ml contains:

Iron (as Iron III Hydroxide Polymaltose Complex) 50 mg

Indications

Therapeutic class:

Iron replacement preparations.

Iron is an essential constituent of hemoglobin, myoglobin and iron-containing enzymes. Iron deficiency may cause the following general symptoms: excessive fatigue, impaired mental function, irritability, anxiety, headaches, loss of appetite, weakening of the immune system, conspicuous paleness, cracks in the corners of the mouth, dry skin, split hairs and brittle fingernails.

Ferripel 3 syrup is intended for prevention and treatment of anemia caused by iron deficiency.

Instructions

The generally accepted dosage is:

For adults and children above 12 years of age:

For prevention of anemia:

1-2 teaspoons per day.

For treatment of anemia:

2-4 teaspoons per day.

Dosage for children under 12 years of age:

For prevention of anemia:

1 mg (0.1 ml)/kg body weight per day.

Do not exceed a dosage of 15 mg per day in infants up to 2 years of age.

For treatment of anemia:

up to 2 mg (0.2 ml)/kg body weight, 3 times per day.

Do not exceed the recommended dose.

For accurate dosing, use the included measuring cup.

The medicine should be taken during or right after a meal. This medicine may be mixed before administration with fruit or vegetable juice or with baby food.

The daily dose may be taken as a single dose or in divided doses.

Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve after three weeks.

Before starting to use the medicine, the doctor will refer you for a blood test to check your blood iron and hemoglobin levels. If your symptoms are not caused by iron deficiency, this medicine will not be effective for you. During treatment with this medicine the doctor will carry out periodic examinations, and may also refer you for blood tests. This referral is normal and should not concern you.

After first opening, the product may be used for 1 month.

Warnings

Do not Ferripel 3 syrup if you are sensitive (allergic) to the active ingredient or any of the additional components the medicine contains.

Do not use this medicine if you have an excess of iron in your body (e.g., an excess of iron caused by a rare disease of iron build-up, which may lead to accumulation of iron in the tissues).

Do not use this medicine if you have problems with efficient utilization of iron (e.g., when anemia is caused by insufficient utilization of iron).

Do not use Ferripel 3 syrup in states of anemia that are not caused by iron deficiency (e.g., anemia caused by increased hemoglobin breakdown or due to vitamin B12 deficiency).

Before treatment with Ferripel-3 syrup, inform the doctor if:

• You have an infection or a tumor
• You have recently been treated or you might be treated in the future with injected iron preparations. Using this type of iron preparations during treatment with this medicine is not recommended
• You have received blood transfusions, since there is a risk for an excess of iron due to receiving additional iron

If you are taking or have recently taken other medicines including non-prescription medicines and food supplements, tell the physician or the pharmacist.

No adverse effects of Ferripel-3 syrup have been observed on the fetus or on women during pregnancy.

It is unknown whether iron passes into breast milk.

If you are pregnant, trying to become pregnant or breastfeeding, consult the doctor before using the medicine.

The preparation contains 2000 mg/5 ml of sorbitol solution 70%. Sorbitol is a source of fructose. If the doctor told you that you or your child have intolerance to certain types of sugar, or if you have a hereditary intolerance to fructose, a rare hereditary disease in which fructose does not break down, inform the doctor before you or your child use this medicine. Sorbitol may cause digestive system disturbances and has a slight laxative effect.

The syrup contains 1000 mg/5 ml sucrose. This should be noted for diabetic patients. Sucrose may harm your teeth.

The preparation contains ethanol 96%. Each 5 ml of the preparation contains 15.6 mg of ethanol. The ethanol content in the package is 343.2 mg. This small amount of alcohol in the medicine will not have any noticeable effects. The amount of ethanol in 10 ml of this preparation is lower than the amount in 1 ml of beer or 1 ml of wine.

The medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate. These may cause allergic reactions, which may also occur after some time.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.