CLOPIDOGREL DERMOGEN 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel Dermogen 75 mg Film-Coated Tablets EFG

Clopidogrel, besylate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Clopidogrel Dermogen and what is it used for
2. What you need to know before taking Clopidogrel Dermogen
3. How to take Clopidogrel Dermogen
4. Possible side effects
5. Storage of Clopidogrel Dermogen
6. Package Contents and Additional Information

1. What is Clopidogrel Dermogen and what is it used for

Clopidogrel Dermogen belongs to a group of medications called antiplatelet agents. Platelets are very small cells found in the blood, smaller than red or white blood cells, and they aggregate when the blood clots. Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process called thrombosis) forming.

Clopidogrel Dermogen is administered to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as cerebral infarction, myocardial infarction, or death). You have been prescribed Clopidogrel Dermogen to help prevent the formation of blood clots and reduce the risk of these serious events, as:

• You suffer from a process that causes the hardening of the arteries (also called atherosclerosis), and
• You have previously suffered a myocardial infarction, a cerebral infarction, or suffer from a disease called peripheral arteriopathy.

2. What you need to know before taking Clopidogrel Dermogen

Do not take Clopidogrel Dermogen:

• if you are allergic to clopidogrel or any of the other components of this medication (listed in section 6).
• if you have an active bleeding disorder, such as a stomach ulcer or bleeding in the brain.
• if you have a severe liver disease.

If you think any of these may apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Clopidogrel Dermogen

Before starting treatment with Clopidogrel Dermogen, inform your doctor if you are in any of the following situations:

• If you are at risk of bleeding (bleeding) because:
  • You have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
  • You have a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body).
  • You have recently had a serious injury.
  • You have recently undergone surgery (including dental surgery).
  • You are scheduled to undergo surgery (including dental surgery) within the next seven days.
• If you have had a blood clot in a brain artery (ischemic cerebral infarction) in the last 7 days.
• If you are taking other medications (see "Use of other medications").
• If you have liver or kidney disease.

During treatment with Clopidogrel Dermogen

• Inform your doctor if you are scheduled to undergo surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder that includes fever and bruising (bruises) under the skin that may appear as localized red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "POSSIBLE SIDE EFFECTS")
• If you cut or injure yourself, the bleeding may take longer than usual to stop. This is related to the way the medication works, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be especially careful with Clopidogrel").
• Your doctor may ask you to have blood tests.
• Inform your doctor or pharmacist if you notice any side effects not mentioned in section 4 of "POSSIBLE SIDE EFFECTS" or if you notice that any side effect worsens.

Children and Adolescents

Clopidogrel Dermogen should not be administered to children or adolescents.

Taking Clopidogrel Dermogen with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Some medications may affect the use of Clopidogrel or vice versa.

Concomitant administration of Clopidogrel with oral anticoagulants (medications used to decrease blood clotting) is not recommended.

You must explicitly inform your doctor if you are taking ticlopidine, another antiplatelet agent, non-steroidal anti-inflammatory drugs, medications commonly used to treat pain and/or inflammation of muscles or joints, or if you are taking heparin, or any other medication used to decrease blood clotting, or if you are taking a proton pump inhibitor (e.g., omeprazole) for stomach discomfort, or if you are taking antiretrovirals (medications to treat HIV infection).

A dose of acetylsalicylic acid administered occasionally (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use in other circumstances should be consulted with your doctor.

Taking Clopidogrel Dermogen with food and beverages

Clopidogrel Dermogen can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is preferable not to use this medication during pregnancy and breastfeeding.

Driving and Using Machines

It is unlikely that Clopidogrel will affect your ability to drive or operate machinery.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Clopidogrel Dermogen

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one 75 mg tablet of Clopidogrel Dermogen per day, administered orally, with or without food, and at the same time every day.

You should take Clopidogrel Dermogen for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Dermogen than you should

Contact your doctor or go to the nearest hospital emergency department, as there is a higher risk of bleeding. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested)

If you forget to take Clopidogrel Dermogen

If you forget to take a dose of Clopidogrel Dermogen, but remember before 12 hours have passed since the time you should have taken the medication, take the tablet immediately and the next one at the usual time.

If you forget for more than 12 hours, simply take the next dose at the usual time. Do not take a double dose to make up for the forgotten doses.

In the 7, 14, 28, and 84 tablet formats, you can check the last day you took a Clopidogrel tablet by looking at the calendar printed on the blister pack.

If you interrupt treatment with Clopidogrel Dermogen

Do not interrupt your treatment. Contact your doctor or pharmacist before stopping this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Clopidogrel Dermogen can have side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

• Fever, signs of infection, or severe fatigue. These symptoms may be due to a rare decrease in some blood cells.
• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), associated or not with bleeding that appears under the skin as red spots and/or confusion (see section 2 "Be especially careful with Clopidogrel").
• Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin.

These may be signs of an allergic reaction.

The most common side effect reported with Clopidogrel(affecting 1 to 10 patients out of 100) is bleeding. Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in the urine. A reduced number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Dermogen

If you cut or injure yourself, the bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medication, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be especially careful with Clopidogrel").

Other side effects reported with Clopidogrel are

Common side effects (affecting 1 to 10 people out of 100): Diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon side effects (affecting 1 to 10 people out of 1,000): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, tingling, and numbness.

Rare side effects (affecting 1 to 10 people out of 10,000): vertigo.

Very rare side effects (affecting less than 1 person out of 10,000): jaundice, severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions; swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mouth mucosa (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste, eosinophilic pneumonia, acquired hemophilia A.

Side effects of unknown frequency: hypersensitivity reactions.

In addition, your doctor may observe changes in the results of your blood or urine tests.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Clopidogrel Dermogen

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medication if you observe any visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Clopidogrel Dermogen

• The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besylate).

• The other components are: microcrystalline cellulose, spray-dried mannitol, hydroxypropylcellulose, crospovidone, citric acid, PEG 6,000, stearic acid, talc, hypromellose, lactose monohydrate, red iron oxide (E172), triacetin, and titanium dioxide (E171)

Appearance of the Product and Package Contents

The Clopidogrel Dermogen tablets are round, biconvex, pink, and film-coated

They are available in packages of 28, 50, and 100 tablets in PVC/PE/PVDC-Aluminum or Aluminum/Aluminum blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

DERMOGEN FARMA, S.A.

San Rafael, 3

28108 Alcobendas - Madrid - Spain

Manufacturer

FARMALIDER S.A.

Aragoneses 2

28108 Alcobendas - Madrid - Spain

Or

PHARMATHEN S.A.

6, Dervenakion Str (Pallini Attikis)

• GR-16351 - Greece

Local Representative

Allenda Pharma S.L.

Segundo Mata nº1

Pozuelo de Alarcón (Madrid) 28224

Spain

Date of the Last Revision of this Package Leaflet: April 2021

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