ELORGAN 400 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Elorgan 400 mg prolonged-release tablets

Pentoxifylline

L

• Keep this leaflet, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What Elorgan 400 mg tablets are and what they are used for
2. What you need to know before taking Elorgan 400 mg tablets
3. How to take Elorgan 400 mg tablets
4. Possible side effects
5. Storage of Elorgan 400 mg tablets
6. Contents of the pack and further information

1. What Elorgan 400 mg tablets are and what they are used for

Pentoxifylline is a medicine that belongs to the group of medicines called peripheral vasodilators.

Always under the prescription of your doctor, Elorgan tablets are indicated for the treatment of peripheral circulatory disorders due to arteriosclerosis, diabetes, inflammation, or other causes such as leg ulcers and gangrene.

2. What you need to know before taking Elorgan 400 mg tablets

Do not take Elorgan 400 mg tablets:

• if you are allergic to pentoxifylline or any of the other ingredients of this medicine (listed in section 6).
• if you have ever experienced an allergic reaction to another medicine of this group (xanthines).
• if you have a massive hemorrhage or a significant retinal hemorrhage.

Warnings and Precautions

Consult your doctor or pharmacist before taking Elorgan 400 mg tablets.

• if you have severe heart rhythm disorders,
• if you have had a previous myocardial infarction,
• if you have low blood pressure (hypotension),
• if you have a renal function disorder (creatinine clearance less than 30 ml/min),
• if you have a severe liver function disorder,
• if you are at high risk of bleeding, such as in patients being treated with anticoagulant medicines (which inhibit blood clotting) or patients with coagulation disorders, being treated with antiplatelet agents (see "Taking Elorgan 400 mg tablets with other medicines"),
• if you are taking antidiabetic medicines (medicines used to lower blood glucose levels),

- if you are taking ciprofloxacin,

• if you are taking theophylline.

Children and Adolescents

There is no experience with the use of Elorgan 400 mg tablets in children.

Patients with Renal Impairment

Your doctor will indicate the dose you should take at each moment.

Patients with Hepatic Impairment

Your doctor will indicate the dose you should take at each moment.

Taking Elorgan 400 mg tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Especially if you are being treated with oral anticoagulants or antiplatelet agents, as their use with Elorgan increases the risk of bleeding. For this reason, your doctor may subject you to periodic checks.

The concomitant administration of Elorgan with blood pressure-lowering medicines (antihypertensives) may potentiate the effect of these latter, so your doctor may need to adjust your dose.

Treatment with Elorgan in patients receiving medicines for diabetes (insulin or oral treatment) may also potentiate the effect of these. For this reason, you should undergo periodic checks.

Concomitant treatment with Elorgan and theophylline (a medicine for the treatment of asthma) may cause an increase in theophylline levels and thus an increase in its adverse effects.

Similarly, concomitant treatment with Elorgan and ciprofloxacin (a medicine for the treatment of bacterial infections) may cause an increase in pentoxifylline levels and thus an increase in its adverse effects.

Concomitant treatment with Elorgan and antiplatelet agents (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, other non-selective non-steroidal anti-inflammatory drugs, acetylsalicylic acid/lysine acetylsalicylate, ticlopidine, dipyridamole), may potentiate the anticoagulant effect and increase the risk of bleeding.

The concomitant administration of Elorgan with cimetidine (a medicine for the treatment of gastric ulcers) may increase pentoxifylline levels and the active Metabolite I.

Taking Elorgan 400 mg tablets with food and drinks

The tablets can be swallowed whole during or immediately after meals with the help of a sufficient amount of liquid (approximately half a glass of water).

Pregnancy, Breast-feeding, and Fertility

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

Pregnancy

Elorgan should not be administered during pregnancy.

Breast-feeding

There is not enough data to establish the safety of using Elorgan during breast-feeding. Therefore, your doctor will assess the convenience of continuing or not continuing treatment while you are nursing your child.

Driving and Using Machines

The ability to drive and use machines may be altered due to possible adverse reactions.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Elorgan 400 mg tablets

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

Remember to take your medicine.

If you think the effect of Elorgan is too strong or too weak, tell your doctor or pharmacist.

The recommended dose is 1 tablet (400 mg of pentoxifylline) 2 or 3 times a day.

If you have a severe kidney or liver disease, your doctor may reduce the dose, adjusting it according to your disease and tolerance to this medicine.

If you have low blood pressure, unstable circulation, or suffer from a disease for which a decrease in blood pressure could be harmful (severe coronary heart disease or narrowing of the blood vessels that supply the brain), your doctor will prescribe a low initial dose that will be gradually increased according to your response to treatment.

If you observe a severe allergic reaction (anaphylactic or anaphylactoid) with inflammation of the mouth and respiratory tract that causes difficulty breathing and a drop in blood pressure, stop your treatment with Elorgan immediately and inform your doctor.

Your doctor will indicate the duration of your treatment with Elorgan. Do not stop your treatment before.

If you take more Elorgan than you should

Consult your doctor or go to the nearest hospital emergency department immediately, accompanied by this leaflet.

If you take a dose of Elorgan that is too high, you may initially experience nausea, dizziness, palpitations, or a sudden drop in blood pressure. Additionally, fever, agitation, hot flashes, loss of consciousness, loss of reflexes, convulsions, skin rashes, and signs of gastrointestinal bleeding, such as coffee ground vomit, may appear.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Elorgan

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

4. Possible Side Effects

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

Side effects of unknown frequency (cannot be estimated from the available data):

Complementary Tests:

Increased transaminases (liver enzymes), decreased blood pressure.

Gastrointestinal Disorders:

Stomach discomfort, gastrointestinal disorders, feeling of fullness, nausea, vomiting, diarrhea, constipation, hypersalivation (increased saliva production).

Cardiac Disorders:

Heart rhythm disorders with increased or decreased heart rate (e.g., palpitations), angina pectoris.

Vascular Disorders:

Hot flashes, bleeding (e.g., skin and/or mucous membrane bleeding localized in the stomach and/or intestine), especially in patients with a high risk of bleeding.

Nervous System Disorders:

Dizziness, headache, benign inflammation of the meninges (aseptic meningitis).

Hepatobiliary Disorders:

Liver function disorders, such as intrahepatic cholestasis (bile obstruction in the liver).

Skin and Subcutaneous Tissue Disorders:

Erythema (skin redness), itching, skin rash or urticaria (hives, skin irritation, and itching), rash.

Immune System Disorders:

Severe allergic reactions (anaphylactic or anaphylactoid) with inflammation of the mouth and respiratory tract that cause difficulty breathing and a drop in blood pressure. Angioedema (fluid accumulation in the tongue and throat that can cause asphyxia), bronchospasm (bronchial spasms that make normal breathing difficult).

Psychiatric Disorders:

Agitation and sleep disturbances.

Blood and Lymphatic System Disorders:

Thrombocytopenia (decreased platelet count), leucopenia/neutropenia (decreased white blood cell count).

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Elorgan 400 mg tablets

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

Do not remove the tablets from the blister pack until the moment of taking them, so they will be well protected.

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

Do not use this medicine if you notice that the tablet is deteriorated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Elorgan

• The active ingredient is pentoxifylline. Each prolonged-release tablet contains 400 mg of pentoxifylline.
• The other ingredients (excipients) are: hydroxyethylcellulose, povidone, talc, magnesium stearate, hypromellose, titanium dioxide E171, polyethylene glycol 8000, erythrosine E127.

Appearance of the Product and Contents of the Pack

Elorgan 400 mg prolonged-release tablets are oval, pink tablets with the letters "ATA" on one side and smooth on the other.

Each pack contains 60 tablets.

Marketing Authorization Holder and Manufacturer

The marketing authorization holder is:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69,

08970 Sant Joan Despí (Barcelona)

Spain

The manufacturer is:

Sanofi S.r.l.

Strada Statale 17 km 22

Scoppito (AQ) I-67019 (Italy)

Date of the Last Revision of this Leaflet: October 2022

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