OLPAM 25 mg/100 mg TABLETS

Introduction

P

O

O

carbidopa/levodopa

Readtheentireleafletcarefullybeforeyoustarttakingthismedicine,asitcontainsimportantinformationforyou.

• Keep this 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 leaflet. See section 4.

Contentsoftheleaflet

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. Storage of Olpam
6. Contents of the pack 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

DonottakeOlpam

• 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 a sudden build-up of pressure 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, consult your doctor or pharmacist before taking this medicine.

Warningsandprecautions

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 a build-up of pressure in the eye. You will need regular eye pressure checks.
• If you sometimes have sudden attacks of sleep 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 addictive gambling, overeating or spending, an abnormally high desire for sex (libido) or an increase in sexual thoughts or feelings (hypersexuality). Your doctor may need to review your treatments.

Childrenandadolescents

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

OthermedicinesandOlpam

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. Other medicines can also 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, consult 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.

TestswhiletakingOlpam

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.

TakingOlpamwithfoodanddrinks

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,breast-feedingandfertility

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.

Drivingandusingmachines

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

If you have ever experienced excessive sleepiness or have had sudden episodes of falling asleep, 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 sudden sleep attacks. 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 have stopped.

3. How to take Olpam

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

Takingthismedicine

• 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 take effect 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 first consulting your doctor.
• Try to avoid taking your tablets with a heavy meal.
• The tablets can be divided into equal doses.

Ifyouhavenevertakenlevodopabefore

The usual starting dose is:

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

Ifyouhavealreadytakenlevodopabefore

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

IfyoutakemoreOlpamthanyoushould

If you take too many tablets, consult your doctor immediately.

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

IfyouforgettotakeOlpam

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

IfyoustoptakingOlpam

Do not stop taking this medicine or change your dose without first consulting your doctor. 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.

StoptakingOlpamimmediatelyandconsultyourdoctorifyouexperienceanyofthefollowingsideeffects:

• 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 can manifest as blood in the stool or dark 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.

Themostcommonsideeffectsare:

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

Othersideeffectsinclude:

• 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 episodes), tingling.
• Abnormal dreams, confusion, agitation, difficulty breathing, hair loss.

Youmayexperiencethefollowingsideeffects:

• Strong desire to take high doses of carbidopa/levodopa, beyond what is necessary to control motor symptoms, known as dopaminergic 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 shopping or spending.
  • Overeating (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger).

Tellyourdoctorifyouexperienceanyofthesebehaviors;he/shewilldiscusswaystomanageorreducethesymptoms.

Sideeffectsreportedwithmedicinescontaininglevodopa.

These may be experienced when taking carbidopa/levodopa.

Nervoussystem:

• 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

Digestivesystem:

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

Reproductivesystem:

• Priapism (abnormal persistent erection of the penis)

Urinarysystem:

• 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 tell your doctor or pharmacist. It will be helpful if you take note of what you experienced, when it started and how long it lasted.

Reportingofsideeffects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this 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. Storage of Olpam

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

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

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

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. Contents of the pack and further information

CompositionofOlpam

• 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 package contents

Olpam 25 mg/100 mg tablets

Round, flat, speckled tablets, pale yellow in color, with a notch 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 notch 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 some 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

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/