Elitan 10 mg. / 2 ml. 25 ampules

What Elitan is and what it is used for
Elitan is an anti-emetic. It contains a medicine called "metoclopramide." It acts on the part of the brain that prevents vomiting (vomiting) and vomiting.

Adults
Elitan is used in adults:

to prevent nausea and vomiting after surgery;
for the treatment of nausea and vomiting, including nausea and vomiting, which may occur in migraine;
to prevent nausea and vomiting caused by radiation therapy.
Children and adolescents
Elite is used in children (aged 1-18 years) only if other treatments do not help or can not be given:

to prevent nausea and vomiting after chemotherapy;
for treatment of nausea and vomiting after surgery.
2. What you need to know before using Elite
Do not use Elitan:

if you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6);
if you have bleeding, obstruction or tearing of the stomach or intestines;
if you have or may have a rare tumor of the adrenal gland close to the kidneys (pheochromocytoma);
if you have ever had involuntary muscle spasms (tardive dyskinesia) during treatment with medicines;
if you have epilepsy;
if you suffer from Parkinson's disease;
if you are taking levodopa (a medicine for Parkinson's disease) or dopaminergic antagonists (see section "Other medicines and Elitan" below);
if you have ever had abnormal levels of blood pigment (methaemoglobinaemia) or NADH cytochrome-b5 deficiency.
Elitane should not be used in children under 1 year of age (see section "Children and adolescents" below).
Do not use Elite if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before using Elite.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Elite if:

have a history of abnormal heart rhythm (prolonged QT interval) or other heart problems;
if you have problems with salt levels in your blood, such as potassium, sodium and magnesium;
take other medicines that affect heart rhythm;
you have neurological (brain) problems;
if you have liver or kidney problems. The dose may be reduced (see section 3).
Your doctor may do blood tests to check your blood pigment levels. In case of abnormalities (methaemoglobinaemia), treatment should be discontinued immediately and permanently.

Children and adolescents
Uncontrolled movements (extrapyramidal symptoms) may occur in children and young adults. This medicine should not be used in children younger than 1 year due to an increased risk of uncontrolled movements (see section "Do not use Elitan" above).

Other medicines and Elitan
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Elitan or Elitan works can affect the way other medicines work.
These medicines include:

levodopa or other medicines used to treat Parkinson's disease (see section "Do not take Elitan");
anticholinergics (medicines used to relieve stomach cramps or spasms);
morphine derivatives (medicines used to treat severe pain);
sedatives (sedatives);
any medicines used to treat mental problems;
digoxin (a medicine used to treat heart failure);
ciclosporin (a medicine used to treat certain problems with the immune system);
mycobacterium and sucamethonium (medicines used to relax the muscles);
fluoxetine and paroxetine (medicines used to treat depression).
Elite with alcohol
You should not consume alcohol during treatment with metoclopramide as it increases the sedative effect of Elitan.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Epitamine may be given during pregnancy. Your doctor will decide whether or not to use the medicine.
It is not recommended if you are breast-feeding because metoclopramid passes into breast milk and may affect your baby.

Driving and using machines
After taking Elite, you may feel drowsiness, dizziness, or have uncontrolled twitching, sudden or writhing movements and disturbed muscle tone that causes a distortion of the body. This may impair vision and affect your ability to drive and use machines.

Elite contains benzyl alcohol. Benzyl alcohol can cause toxicity and allergic reactions in babies and children up to the age of 3 years.

3. How to use Elitan
Usually, this medicine will be given to you by a doctor or a nurse. It will be given as a slow injection into a vein
Elderly patients
Dose reduction may be necessary in the presence of kidney, liver, and poor overall health conditions.

Adults with kidney problems
Talk to your doctor if you have kidney problems. The dose should be decreased if you suffer from moderate or severe kidney problems.

Adults with liver problems
Talk to your doctor if you have liver problems. The dose should be reduced if you suffer from severe liver problems.

Children and adolescents
Metoclopramide should not be used in children less than 1 year of age (see section 2).

If you use more than the required dose of Elite
Contact your doctor or pharmacist immediately. You may experience uncontrollable movements (extrapyramidal disorders), drowsiness, consciousness problems, confusion, hallucinations, or heart problems. Your doctor will give you treatment for these signs if necessary.

If you forget to use Elitan
Do not take a double dose to make up for the missed dose.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop treatment and talk to your doctor, pharmacist or nurse immediately if you experience any of the following while taking this medicine:

Uncontrollable movements (often head or neck). These may occur in children and young adults, especially when using high doses. These signs usually occur at the beginning of treatment and may also occur after a single administration. These movements will stop when properly treated;
High temperature, high blood pressure, convulsions, sweating, salivation. These may be signs of a condition called "neuroleptic malignant syndrome";
Itching or skin rash, swelling of the face, lips or throat, difficulty in breathing. These may be signs of an allergic reaction, which may be severe.
Very common (may affect more than 1 in 10 people):

drowsiness.
Common (may affect up to 1 in 10 people):

depression;
uncontrollable movements such as tics, trembling, twisting movements or muscle contraction (stiffness, rigidity);
symptoms resembling Parkinson's disease (rigidity, tremor);
anxiety;
decreased blood pressure (especially when given intravenously);
diarrhea;
feeling weak.
Uncommon (may affect up to 1 in 100 people):

elevated levels of a hormone called prolactin in the blood that may cause: milk to be excreted in non-breast-fed men and women;
irregular menstruation;
hallucinations;
decreased level of consciousness;
slow pulse (especially when given intravenously);
alergy.
Rare (may affect up to 1 in 1,000 people):

state of confusion;
convulsions (especially in patients with epilepsy).
Not known (frequency can not be estimated from the available data):

Deviation in blood pigment levels: this may change the color of your skin;
abnormal breast enlargement (gynecomastia);
involuntary muscle spasms after prolonged use, especially in the elderly;
high blood pressure, high blood pressure, convulsions, sweating, salivation. These may be signs of a condition called "neuroleptic malignant syndrome";
changes in heart rhythm that may be visible in ECG research;
cardiac arrest (especially when given as an injection);
shock (severe lowering of blood pressure) (especially when given as an injection);
seizures (especially when given as an injection);
an allergic reaction that may be severe (especially when given as an injection);
very high blood pressure.
How to Store Elitan
Keep out of the reach and sight of children.
Store below 25 ° C in the original package.
Use this medicine after the expiry date which is stated on the carton and the label of each ampoule. The expiry date refers to the last day of that month.
From a microbiological point of view, the product should be used immediately. If not used immediately, storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2 ° C to 8 ° C unless reconstitution is performed under controlled and validated aseptic conditions.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Elitan contains
The active substance is metoclopramide hydrochloride 5 mg / ml.
The other ingredients are: edetate disodium, citric acid, sodium chloride, benzyl alcohol and water for injections.

What Elitan looks like and what the pack contains
Elitan are ampoules with a clear colorless solution for intramuscular or intravenous use.
Each ampoule of 2 ml contains 10 mg of anhydrous metoclopramide hydrochloride as metoclopramide hydrochloride monohydrate.
Ampoules of dark glass in a PVC / PE foil insert, placed in cardboard packaging.
Cartons of 5, 10 and 100 ampoules are available.
Not all pack sizes may be marketed.

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