Olamide

Leaflet attached to the packaging: patient information

Olamide, 10 mg, tablets

Metoclopramide hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Olamide and what is it used for
• 2. Important information before taking Olamide
• 3. How to take Olamide
• 4. Possible side effects
• 5. How to store Olamide
• 6. Package contents and other information

1. What is Olamide and what is it used for

Olamide is an antiemetic medicine. It contains the active substance metoclopramide.
The medicine works on the part of the brain that prevents nausea and vomiting.
Adults:
Olamide is used in adults in the following cases:

• prevention of delayed nausea and vomiting that may occur after chemotherapy;
• prevention of nausea and vomiting associated with radiotherapy;
• treatment of nausea and vomiting, including nausea and vomiting associated with migraine. Metoclopramide may be used in combination with oral painkillers for migraine to enhance the pain-relieving effect.

Children and adolescents:
Olamide is indicated for use in children (aged 1-18 years) if other treatment methods
have been ineffective or cannot be used to prevent nausea and vomiting that may occur after chemotherapy.

2. Important information before taking Olamide

When not to take Olamide:

• if the patient is allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6);
• in case of bleeding, obstruction or perforation of the stomach or intestines;
• if the patient has a rare adrenal gland tumor located near the kidney (pheochromocytoma);
• if the patient has had involuntary muscle contractions (tardive dyskinesia) in the past while taking medicines;
• if the patient has epilepsy;
• if the patient has Parkinson's disease;
• if the patient is taking levodopa (a medicine for Parkinson's disease) or dopamine agonists (see "Olamide and other medicines" below);
• if the patient has ever had an abnormal pigment in the blood (methemoglobinemia) or a deficiency of NADH cytochrome b5 reductase (a type of enzyme).

Olamide should not be used in children under 1 year of age (see section "Children and adolescents" below).
Do not take Olamide if any of the above warnings apply to you.
In case of doubts, discuss with your doctor, pharmacist or nurse before taking Olamide.

Warnings and precautions

Before starting Olamide, discuss with your doctor, pharmacist or nurse:

• if the patient has had an irregular heartbeat (prolonged QT interval) or other heart problems;
• if the patient has electrolyte imbalances (potassium, sodium or magnesium) in the blood;
• if the patient is taking other medicines that affect the heart;
• if the patient has neurological disorders (brain disorders);
• if the patient has kidney or liver problems. Dose reduction may be necessary (see section 3).

Your doctor may order a blood test to check the blood pigment content. If the content is abnormal (methemoglobinemia), the medicine should be stopped immediately and permanently.
A minimum interval of 6 hours should be observed between doses, even in case of vomiting and expulsion of the dose, to avoid overdose.
The medicine should not be used for more than 3 months due to the risk of involuntary muscle contractions.

Children and adolescents

Uncontrolled movements (extrapyramidal symptoms) may occur in children and adolescents. This medicine should not be used in children under 1 year of age due to the increased risk of uncontrolled movements (see "When not to take Olamide" above).

Olamide and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or plan to take. This is important because some medicines may affect the action of Olamide or Olamide may affect the action of other medicines. In particular, inform your doctor about the use of the following medicines:

• levodopa or other medicines used to treat Parkinson's disease (see "When not to take Olamide");
• anticholinergic medicines (used to relieve stomach cramps);
• opioids (used to treat severe pain);
• sedatives;
• medicines used to treat mental disorders;
• digoxin (used to treat heart failure);
• cyclosporin (used to treat certain immune system disorders);
• mivacurium and suxamethonium (used to relax muscles);
• fluoxetine and paroxetine (used to treat depression);
• rifampicin (used to treat tuberculosis or other infections) may reduce the amount of metoclopramide in the blood if taken at the same time.

Olamide with alcohol

Do not drink alcohol while taking metoclopramide, as it increases the sedative effect of Olamide.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, consult your doctor before taking this medicine.
If necessary, Olamide may be used during pregnancy. The doctor will decide on the need to use the medicine.
Olamide is not recommended during breastfeeding, as metoclopramide passes into breast milk and may affect the baby.

Driving and using machines

After taking Olamide, you may feel drowsy, dizzy or have uncontrolled movements, and you may have difficulty driving or operating machines.

Olamide contains lactose.

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Olamide

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults
The recommended single dose is 10 mg and can be repeated up to three times a day.
The maximum recommended daily dose is 30 mg or 0.5 mg/kg body weight.
The maximum treatment duration is 5 days.
Prevention of delayed nausea and vomiting after chemotherapy (CINV) (children and adolescents aged 1-18 years)
The recommended dose of metoclopramide is 0.1-0.15 mg/kg body weight, repeated three times a day, given orally.
The maximum daily dose is 0.5 mg/kg body weight.
Dosing table
The maximum treatment duration is 5 days for the prevention of delayed nausea and vomiting after chemotherapy (CINV).
Olamide tablets are not a suitable form of the medicine for children with a body weight below 30 kg.

In this patient group, other pharmaceutical forms/strengths of the product should be used.

Method of administration

Swallow the tablet with a glass of water.
A minimum interval of 6 hours should be observed between doses, even in case of vomiting and expulsion of the dose.

Elderly patients

Dose reduction may be necessary depending on kidney and liver function and overall health.

Adults with kidney problems

Tell your doctor about kidney problems. In patients with moderate or severe kidney failure, the dose should be reduced.

Adults with liver problems

Tell your doctor about liver problems. In patients with severe liver failure, the dose should be reduced.

Children and adolescents

Metoclopramide should not be used in children under 1 year of age (see section 2).

Overdose of Olamide

Contact your doctor or pharmacist immediately. The patient may experience uncontrolled movements (extrapyramidal symptoms), drowsiness, altered consciousness, disorientation, hallucinations and heart problems. If necessary, the doctor will prescribe appropriate symptomatic treatment.

Missed dose of Olamide

Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olamide can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking this medicine and tell your doctor or pharmacist immediately:

• uncontrolled movements (often in the head and neck area). These can occur in children and adolescents, especially when using high doses. These reactions usually occur at the beginning of treatment and can occur even after a single dose. Proper treatment will stop the movements;
• high fever, high blood pressure, seizures (convulsions), sweating, excessive salivation. These may be symptoms of a condition called malignant neuroleptic syndrome;
• itching or skin rash, swelling of the face, lips or throat or tongue, difficulty breathing, shortness of breath, feeling of cold, moist skin, rapid heartbeat, dizziness, weakness or fainting. These may be symptoms of a severe allergic reaction (such as anaphylactic reaction, angioedema and urticaria).

Very common (occurring in more than 1 in 10 people):

• drowsiness

Common (occurring in less than 1 in 10 people):

• depression
• uncontrolled movements, such as tics, tremors, sudden movements or muscle contractions (stiffness, rigidity)
• symptoms similar to those of Parkinson's disease (stiffness, tremors)
• restlessness
• low blood pressure (especially after intravenous administration)
• diarrhea
• weakness

Uncommon (occurring in less than 1 in 100 people):

• increased levels of a hormone called prolactin in the blood, which can cause: milk production in non-breastfeeding women and men
• irregular menstrual periods
• hallucinations
• altered consciousness
• slow heartbeat (especially after intravenous administration)
• allergic reactions
• vision problems (eye problems) and involuntary deviation of the eyeball upwards

Rare (occurring in less than 1 in 1000 people):

• confusion
• seizures (convulsions) (especially in patients with epilepsy)

Frequency not known (cannot be estimated from the available data):

• presence of an abnormal pigment in the blood, which can cause a change in skin color
• abnormal breast growth (gynecomastia)
• involuntary muscle contractions after long-term treatment, especially in elderly patients
• high fever, high blood pressure, seizures (convulsions), sweating, excessive salivation. These may be symptoms of a condition called malignant neuroleptic syndrome.
• changes in heart function, which can be seen on an ECG
• cardiac arrest (especially after intravenous administration)
• shock (severe drop in blood pressure, especially after intravenous administration)
• fainting (especially after intravenous administration)
• very high blood pressure in patients with pheochromocytoma or without a tumor
• suicidal thoughts

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocides of the Office for Registration of Medicinal Products, Medical Devices and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olamide

• -Keep this medicine out of the sight and reach of children.
• Do not store above 30°C.
• Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Olamide contains

• The active substance is metoclopramide hydrochloride.
• Each tablet contains 10 mg of metoclopramide hydrochloride.
• The other ingredients are: lactose monohydrate, maize starch, corn starch, colloidal anhydrous silica, magnesium stearate.

What Olamide looks like and contents of the pack

Olamide is a white or almost white, round, biconvex tablet with the marking "BD" on one side and a score line on the other.
The tablet can be divided into equal doses.
The tablets are packed in PVC/PVDC/Aluminum blisters.
The packs contain: 20, 24, 28, 30, 40, 50, 60, 84, 100 or 500 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, Tel: +48 22 577 28 00.

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o., ul. Lutomierska 50, 95-200 Pabianice, Poland; Accord Healthcare Single Member S.A., 64th Km National Road Athens, 32009 Lamia, Greece.

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: December 2024