OLPAM 25 MG/250 MG TABLETS

Introduction

Package Leaflet: Information for the User

Olpam 25 mg/100 mg Tablets EFG

Olpam 25 mg/250 mg TabletsEFG

Carbidopa/Levodopa

Readtheentirepackageleafletcarefullybeforeyoustarttakingthismedicine,asitcontainsimportantinformationforyou.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contentsofthepackageleaflet

1. What is Olpam and what is it used for
2. What you need to know before you take Olpam
3. How to take Olpam
4. Possible side effects
5. Storing Olpam
6. Package contents and further information

1. What is Olpam and what is it used for

Olpam improves the symptoms of Parkinson's disease. Parkinson's disease is a long-term disease in which:

• you experience slowness and unsteadiness.
• your muscles feel stiff.
• You may develop tremors (called 'tremor').

If left untreated, Parkinson's disease can make it difficult for you to continue with your normal daily activities.

Olpam contains two different medicines called: levodopa and carbidopa.

• Levodopa is converted into a substance called 'dopamine' in the brain. Dopamine helps to improve the symptoms of Parkinson's disease.
• Carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing down the speed at which levodopa breaks down in your body.

2. What you need to know before you take Olpam

Do not take Olpam

• If you are allergic to carbidopa, levodopa, or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had skin cancer or have suspicious lesions that have not been examined by your doctor.
• If you are taking certain medicines called 'MAOIs' (Monoamine Oxidase Inhibitors) used for depression. You need to stop taking these medicines at least two weeks before starting to take carbidopa/levodopa (see also “Other medicines and Olpam” below).
• If you have a condition called narrow-angle glaucoma that can cause sudden pressure build-up in the eye.
• If you have a severe mental disorder.
• If you are pregnant, could become pregnant, or are breastfeeding.

Do not take Olpam if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Olpam:

• If you have a history of seizures.
• If you have had stomach ulcers (called duodenal or peptic ulcer) or have vomited blood.
• If you have had a heart attack, heart rhythm problems, circulation, or breathing problems.
• If you have had kidney, liver, or hormonal problems.
• If you have had depression or other mental problems.
• If you have a condition called 'wide-angle glaucoma' that can cause pressure build-up in the eye. You will need regular eye pressure checks.
• If you sometimes have sudden sleep attacks or feel very drowsy.
• If you are going to have surgery.
• If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Tell your doctor if you or your family/caregiver notice that you are developing symptoms similar to addiction that make you want to take high doses of carbidopa/levodopa and other medicines used to treat Parkinson's disease.

Tell your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in ways that are unusual for you, or if you cannot resist the impulse, desire, or temptation to carry out certain activities that could harm you or others. These behaviors are called impulse control disorders and include pathological gambling, excessive eating or spending, an abnormally high sex drive (libido), or an increase in sexual thoughts or feelings (hypersexuality). Your doctor may need to review your treatments.

Children and adolescents

Olpam is not suitable for children under 18 years of age.

Other medicines and Olpam

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because carbidopa/levodopa can affect how other medicines work. Also, some other medicines can affect how carbidopa/levodopa works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines for Parkinson's disease that contain levodopa:
• If they are 'slow-release', you should wait 24 hours after your last dose before starting to take Olpam.
• If they are 'normal release', you should wait 12 hours after your last dose before starting to take Olpam.
• Tell your doctor or pharmacist even if you have only taken them in the past.

Medicines for Parkinson's disease that do not contain levodopa are usually continued. However, your dose may be changed.

• Medicines for mental problems (including depression), tuberculosis (TB), high blood pressure, muscle spasms, epilepsy, or other diseases related to involuntary movements. Your dose may need to be changed.
• Medicines to treat iron deficiency. Your dose may need to be changed.
• Medicines called 'MAOIs' (see also 'Do not take Olpam').
• Anticholinergic medicines (such as orphenadrine, trihexyphenidyl, benzatropine, and procyclidine).

Your dose may need to be changed.

• Phenytoin used to treat seizures (fits).
• Papaverine used to treat impotence in men.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine. Your doctor or pharmacist has a more complete list of medicines that you should avoid while taking Olpam.

Tests while taking Olpam

This medicine may affect some laboratory tests that your doctor may perform on blood or urine samples. Please remind your doctor if you are taking carbidopa/levodopa and are going to have tests.

Taking Olpam with food and drinks

Try to avoid taking your tablets with a heavy meal. If your diet contains too much protein (meat, eggs, milk, cheese), carbidopa/levodopa may not work as well as it should.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take carbidopa/levodopa if you are pregnant, could become pregnant, or are breastfeeding. Levodopa, one of the substances in this medicine, passes into breast milk.

Driving and using machines

When taking carbidopa/levodopa, be extra careful when driving or using machines.

If you have ever experienced excessive sleepiness or have had sudden sleep attacks, you should avoid driving and using machines and talk to your doctor.

Carbidopa/levodopa affects people in different ways. Some people have side effects that affect their ability to drive or use tools or machines (see section 4). Do not drive or use tools or machines if you experience these effects.

This medicine can also cause drowsiness or make you fall asleep suddenly. If this happens to you, do not drive or use tools or machines. Your doctor will tell you if you can start driving again when these attacks stop.

3. How to take Olpam

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

Taking this medicine

• Remove the tablet from the blister pack gently to avoid breaking it.
• If the tablet breaks when you remove it from the blister pack, make sure you have all the pieces of the tablet (the full dose). If you do not have all the pieces of a broken tablet, discard the pieces and take another tablet from the blister pack.
• Taking only part of a tablet (a partial dose) may worsen your symptoms.
• Take this medicine by mouth.
• Although your medicine may work after one day, it may take up to seven days to take effect.
• Take them at regular intervals as instructed by your doctor.
• Do not change the times at which you take your tablets or take other medicines for Parkinson's disease without talking to your doctor first.
• Try to avoid taking your tablets with a heavy meal.
• The tablets can be divided into equal doses.

If you have never taken levodopa before

The usual starting dose is:

• for Olpam 25 mg/100 mg: one tablet three times a day.

If you have taken levodopa before

• your doctor will ask you to stop taking your Parkinson's disease medicine before starting to take carbidopa/levodopa.

The usual starting dose is:

• one tablet three or four times a day.

Your doctor may prescribe more than one Olpam for you to take. If you have been given different Olpam tablets to take, make sure you are taking the correct one at the right time.

If you take more Olpam than you should

If you take too many tablets, talk to your doctor immediately.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Olpam

Do not take a double dose to make up for a forgotten dose.

If you stop taking Olpam

Do not stop taking this medicine or change your dose without talking to your doctor first. When you stop taking carbidopa/levodopa, the following may occur: muscle stiffness, high fever, and mental changes.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Olpam immediately and talk to your doctor if you experience any of the following side effects:

• Allergic reaction, characterized by symptoms such as hives, itching, skin rash, swelling of the face, lips, tongue, or throat, which can cause difficulty breathing or swallowing.
• Chest pain.
• Irregular heartbeat or palpitations.
• Dizziness when standing up quickly.
• Gastrointestinal bleeding, which may appear as blood in the stool or black stools.
• Blood disorders, including pale skin, tiredness, fever, sore throat, easy bruising, or prolonged bleeding after an injury.
• Severe muscle stiffness and high fever.
• Mental changes such as delirium, hallucinations, or depression.
• Seizures.

The most common side effects are:

• Abnormal movements such as spasms or tremors, which may or may not resemble the symptoms of your Parkinson's disease.
• Nausea.

Other side effects include:

• Fainting, loss of appetite, high blood pressure.
• Inflammation of veins, vomiting, diarrhea, change in urine color, sweat, or saliva.
• "On-off" phenomenon, characteristic of some people with chronic Parkinson's disease. It is characterized by unpredictable changes between periods of mobility ("on") and sudden inability to move ("off"). The "off" to "on" switch can occur with the same speed.
• Dizziness, drowsiness (including excessive drowsiness or sudden sleep attacks), tingling.
• Abnormal dreams, confusion, agitation, difficulty breathing, hair loss.

You may experience the following side effects:

• Strong desire to take high doses of carbidopa/levodopa, beyond what is necessary to control motor symptoms, known as dopamine dysregulation syndrome. Some patients may experience severe abnormal involuntary movements (dyskinesias), mood changes, or other side effects after taking high doses of carbidopa/levodopa.
• Inability to resist the impulse to perform an action that could be harmful, such as:
• • Strong impulse to gamble excessively despite serious personal or family consequences.
  • Altered or increased sexual interests or behaviors of significant concern to you or others, for example, an increased sex drive.
  • Uncontrollable excessive shopping or spending.
  • Eating excessively (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors; he/she will discuss ways to manage or reduce the symptoms.

Side effects reported with medicines containing levodopa.

These may be experienced when taking carbidopa/levodopa.

Nervous system:

• Loss of control over voluntary movements of daily life
• Numbness, increased tremor of the hands, muscle spasms, muscle cramps, irregular movement of the jaw muscles resulting in difficulty opening the mouth
• Difficulty sleeping, feeling anxious or euphoric, falls, and abnormal gait patterns
• Headache

Eyes:

• Ptosis (drooping eyelid) and mydriasis (pupil dilation)
• Changes in vision, irregular eye movements

Digestive system:

• Dyspepsia (indigestion), dry mouth, bitter taste
• Swelling of the salivary glands, difficulty swallowing, teeth grinding
• Hiccup, abdominal pain, and discomfort, constipation, flatulence
• Burning sensation on the tongue

Reproductive system:

• Priapism (persistent abnormal erection of the penis)

Urinary system:

• Difficulty urinating or urinary incontinence (inability to control urine flow)

Skin:

• Changes in pigmented skin spots, including irritated or irregular moles, or moles in which you have noticed changes (melanoma)

General:

• Weight gain or loss, swelling in the limbs
• Flushing, hot flashes, excessive sweating
• Feeling weak, fainting, or fatigue
• Hoarseness, general feeling of discomfort
• Increased energy or activity, unusual breathing pattern

If any symptom persists or you experience other side effects, please talk to your doctor or pharmacist. It will be helpful if you make a note of what you experienced, when it started, and how long it lasted.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Olpam

Keep this medicine out of the sight and reach of children.

This medicine does not require any special temperature storage conditions. Keep it in the original package to protect it from light.

Do not use this medicine after the expiry date which is stated on the package and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. They will dispose of it in an environmentally friendly way. This will help to protect the environment.

6. Package contents and further information

Composition of Olpam

• The active substances are carbidopa and levodopa.

Each Olpam 25 mg/100 mg tablet contains 25 mg of carbidopa as carbidopa monohydrate and 100 mg of levodopa.

Each Olpam 25 mg/250 mg tablet contains 25 mg of carbidopa as carbidopa monohydrate and 250 mg of levodopa.

• The other ingredients are:

Olpam 25 mg/100 mg tablets: microcrystalline cellulose PH 101, pregelatinized maize starch, crospovidone type B, hydroxypropylcellulose, yellow iron oxide (E172), microcrystalline cellulose PH 102, magnesium stearate.

Olpam 25 mg/250 mg tablets: microcrystalline cellulose PH 101, pregelatinized maize starch, crospovidone type B, hydroxypropylcellulose, indigo carmine (E132), microcrystalline cellulose PH 102, magnesium stearate.

Appearance of the product and packaging contents

Olpam 25 mg/100 mg tablets

Round, flat, speckled tablets, pale yellow in color, with a score line on one side and the Medochemie logo embossed on the other side, with a diameter of 9 mm.

Olpam 25 mg/250 mg tablets

Round, flat, speckled tablets, pale blue in color, with a score line on one side and "MC" embossed on the other side, with a diameter of 10.5 mm.

OPA/Al/PVC-Al blisters and opaque PVC/PE/PVDC-Al blisters.

Boxes of 20, 60, 100, and 120 tablets.

Only certain pack sizes may be marketed.

Marketing authorization holder

Medochemie Limited

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer

Medochemie Ltd, Central Factory,

1-10 Constantinoupoleos Street,

3011 Limassol,

Cyprus

Date of the last revision of this leaflet: June 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/