Olamide

Package leaflet: Information for the patient

Olamide, 10 mg, tablets
Metoclopramidi hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Olamide is and what it is used for
2. Important information before taking Olamide
3. How to take Olamide
4. Possible side effects
5. How to store Olamide
6. Contents of the pack and other information

1. What Olamide is and what it is used for

Olamide is an antiemetic medicine. It contains an active substance called metoclopramide.
Olamide acts on the part of the brain that controls 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 analgesics in migraine to enhance the pain-relieving effect.

Children and adolescents:
Olamide is indicated for use in children (aged 1–18 years) when other treatment methods have proven ineffective or cannot be used, for the prevention of nausea and vomiting that may occur after chemotherapy.

2. Important information before using Olamide

When not to use Olamide:

• if the patient is allergic to metoclopramide or to 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 tumour located near the kidney (pheochromocytoma);
• if the patient has previously experienced involuntary muscle spasms (tardive dyskinesia) 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 section "Olamide with other medicines" below);
• if the patient has ever had abnormal pigment in the blood (methemoglobinemia), or deficiency of NADH-cytochrome b5 reductase (a type of enzyme).

Olamide must not be used in children under 1 year of age (see section "Children and adolescents" below).
Do not use Olamide if any of the above warnings apply to the patient.
If in doubt, discuss this with a doctor, pharmacist, or nurse before using Olamide.

Warnings and precautions

Before starting treatment with Olamide, discuss with a doctor, pharmacist, or nurse:

• if the patient has previously had irregular heartbeat (QT prolongation) or other heart problems;
• if the patient has disturbances in blood levels of potassium, sodium, or magnesium;
• if the patient is taking other medicines that affect heart function;
• if the patient has neurological disorders (brain disorders);
• if the patient has kidney or liver problems. A dose reduction may be necessary (see section 3).

The doctor may order blood tests to check blood pigment levels. If abnormal levels are detected (methemoglobinemia), the medicine must be discontinued immediately and permanently.
At least a six-hour interval must be maintained between doses, even if vomiting and expulsion of the dose occur, to avoid overdose.
This medicine should not be used for longer than 3 months due to the risk of developing involuntary muscle spasms.

Children and adolescents

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

Olamide with other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is important because certain medicines may affect the action of Olamide, or Olamide may affect the action of other medicines. In particular, inform the doctor if the patient is taking any of the following medicines:

• levodopa or other medicines used to treat Parkinson's disease (see section "When not to use Olamide");
• anticholinergic medicines (medicines used to relieve stomach cramps);
• morphine derivatives (medicines used to treat severe pain);
• sedatives;
• medicines used to treat psychiatric disorders;
• digoxin (a medicine used to treat heart failure);
• cyclosporine (a medicine used to treat certain immunological disorders);
• mivacurium and suxamethonium (medicines used to relax muscles);
• fluoxetine and paroxetine (medicines used to treat depression);
• rifampicin (a medicine used to treat tuberculosis or other infections) may reduce the amount of metoclopramide in the blood when administered simultaneously.

Olamide and alcohol

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

Pregnancy, breastfeeding, and effects on fertility

If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
If necessary, Olamide may be used during pregnancy. The doctor will decide whether treatment is required.
Olamide is not recommended during breastfeeding, as metoclopramide passes into breast milk and may affect the infant.

Driving and operating machinery

After taking Olamide, the patient may experience drowsiness, dizziness, involuntary tremors, sudden or twisting movements, and unusual muscle tension causing distorted body posture. These effects may impair vision and the ability to drive or operate machinery.

Olamide contains lactose.

If the doctor has informed the patient of an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to take Olamide

This medicine should always be taken exactly as directed by the doctor or pharmacist.
If in doubt, consult the doctor or pharmacist.
Adults
The recommended single dose is 10 mg, which may be repeated up to three times daily.
The maximum recommended daily dose is 30 mg, or 0.5 mg/kg body weight.
The maximum duration of treatment 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 daily, administered orally.
The maximum daily dose is 0.5 mg/kg body weight.
Dosing table

The maximum duration of treatment is 5 days for the prevention of delayed nausea and vomiting after chemotherapy (CINV).
Olamide tablets are not the appropriate dosage form for use in children with body weight below 30 kg.
In this patient group, other pharmaceutical forms/strengths of the product should be used.
Method of administration
The tablet should be swallowed with a glass of water.
A minimum interval of at least six hours must be maintained between doses, even if vomiting and expulsion of the dose occurs.
Elderly patients
Dose reduction may be necessary depending on renal and hepatic function and general health status.
Adults with renal impairment
Inform your doctor about any kidney problems. The dose should be reduced in patients with moderate or severe renal impairment.
Adults with hepatic impairment
Inform your doctor about any liver problems. The dose should be reduced in patients with severe hepatic impairment.
Children and adolescents
Metoclopramide must not be used in children under 1 year of age (see section 2).
Use of a higher than recommended dose of Olamide
Contact your doctor or pharmacist immediately. The patient may experience uncontrolled movements (extrapyramidal symptoms), drowsiness, disturbances of consciousness, disorientation, hallucinations, and cardiac disturbances. If necessary, the doctor will recommend appropriate symptomatic treatment.
Missed dose of Olamide
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If any of the following adverse effects occur, stop using this medicine immediately and inform your doctor or pharmacist without delay:

• Uncontrolled movements (often in the head and neck area). These may occur in children and adolescents, especially when high doses are used. These reactions usually occur at the beginning of treatment and may appear even after a single dose. Appropriate treatment will stop these movements;
• High fever, high blood pressure, seizures (convulsions), sweating, salivation. These may be symptoms of a disorder called neuroleptic malignant syndrome;
• Itching or skin rash, swelling of the face, lips, tongue or throat, breathing difficulties, shortness of breath, feeling cold, clammy 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 out of 10 people):

• Drowsiness

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

• Melancholy (depression)
• Uncontrolled movements such as tics, tremors, sudden movements or muscle spasms (stiffness, rigidity)
• Parkinson-like symptoms (stiffness, tremor)
• Restlessness
• Low blood pressure (especially after intravenous administration)
• Diarrhea
• Weakness

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

• Increased blood levels of a hormone called prolactin, which may cause: milk production in women who are not breastfeeding and in men
• Irregular menstruation
• Hallucinations
• Reduced level of consciousness
• Slow heart rate (especially after intravenous administration)
• Hypersensitivity
• Vision disturbances (vision problems) and involuntary upward deviation of the eyeball

Rare (occurring in less than 1 out of 1,000 people):

• Confusion
• Seizures (convulsions) (especially in patients with epilepsy)

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

• Presence of an abnormal pigment in the blood, which may cause skin discoloration
• Abnormal breast enlargement (gynaecomastia)
• Involuntary muscle contractions after long-term treatment, particularly in elderly patients
• High fever, high blood pressure, seizures (convulsions), sweating, excessive salivation. These may be symptoms of a disorder called neuroleptic malignant syndrome.
• Changes in heart function that may be visible on an ECG recording
• 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 or without a pheochromocytoma
• Suicidal thoughts

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Olamide

• Keep the medicine out of 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 stated month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Olamide contains

• The active substance is metoclopramide hydrochloride.
• Each tablet contains 10 mg of metoclopramide hydrochloride.
• The other ingredients are: monohydrate lactose, pregelatinized 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 imprint “BD” on one side and a division line on the other.
The tablet can be divided into equal doses.
The tablets are packed in blisters made of PVC/PVDC/Aluminium foil.
Pack sizes contain: 20, 24, 28, 30, 40, 50, 60, 84, 100 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warszawa
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 authorised in the countries of the European Economic Area and the United Kingdom (Northern Ireland) under the following names: