Prospecto: information for the user

Elorgan 400 mg prolonged-release tablets

Pentoxifilina

Read the entire prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect:

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

Pentoxifilina is a drug that belongs to the group of medications called peripheral vasodilators.

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

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 in this group (xanthines).
• if you have a massive or significant retinal hemorrhage.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Elorgan 400 mg tablets.

- if you have severe heart rhythm disturbances,

- if you have had a previous myocardial infarction,

- if your blood pressure is low (hypotension),

- if you have a severe kidney function disorder (creatinine clearance less than 30 ml/min),

- if you have a severe liver function disorder,

- if you have a high risk of bleeding, such as patients taking anticoagulant medications (that inhibit blood coagulation) or patients with coagulation problems, on treatment with antiplatelet agents (see “Taking Elorgan 400 mg tablets with other medicines”),

- if you are taking antidiabetic medications (medicines used to lower blood glucose levels),

- if you are taking ciprofloxacin,

- if you are taking theophylline.

Children and adolescents

No experience of use of Elorgan 400 mg tablets in children is available.

Patients with renal insufficiency

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

Patients with hepatic insufficiency

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

Taking Elorgan 400 mg tablets with other medicines

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

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 concurrent administration of Elorgan with antihypertensive medications (anti-hypertensive drugs) may potentiate the effect of these latter, so your doctor may need to adjust your dose.

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

The simultaneous treatment of Elorgan with theophylline (medication for the treatment of asthma) may cause an increase in the levels of theophylline and thus an increase in the adverse effects of this.

Similarly, the simultaneous treatment of Elorgan with ciprofloxacin (medication for the treatment of bacterial infections) may cause an increase in the levels of pentoxifylline and thus an increase in the adverse effects of this.

The simultaneous treatment of Elorgan with antiplatelet agents (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelida, other non-steroidal anti-inflammatory drugs not selective COX-2 inhibitors, acetylsalicylic acid/lysine acetylsalicylate, ticlopidine, dipyridamole), may potentiate the anticoagulant effect and increase the risk of bleeding.

The concurrent administration of Elorgan with cimetidine (medication for the treatment of gastric ulcers) may increase the levels of pentoxifylline 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 a sufficient amount of liquids (approximately half a glass of water).

Pregnancy, breastfeeding and fertility

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

Pregnancy

Elorgan should not be administered during pregnancy.

Breastfeeding

No sufficient data are available to establish the safety of the use of Elorgan during the breastfeeding period. Therefore, your doctor will evaluate the convenience of continuing or not the treatment while breastfeeding.

Driving and operating machinery

Your ability to drive and use machines may be impaired, due to the possible adverse reactions.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

If you estimate that the action of Elorgan is too strong or too weak, inform 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 your tolerance to this medication.

If you have low blood pressure, unstable circulation, or have 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 airways that produce difficulty breathing and a drop in blood pressure, stop taking 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 immediately or go to the nearest hospital emergency service, accompanied by this prospectus.

If you take too much Elorgan, you may initially experience nausea, dizziness, palpitations, or a sudden drop in blood pressure. In addition, fever, agitation, hot flashes, loss of consciousness, loss of reflexes, seizures, skin eruptions, and, as an indicative sign of gastrointestinal hemorrhage, coffee-ground vomit may appear.

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

If you forgot to take Elorgan

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Unknown frequency side effects (frequency cannot be estimated from available data):

Additional diagnostic tests:

Increased transaminases (liver enzymes), decreased blood pressure.

Gastrointestinal disorders:

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

Cardiac disorders:

Arrhythmias with increased or decreased heart rate (e.g. palpitations), angina pectoris.

Vascular disorders:

Hot flashes, hemorrhages (e.g. skin and/or mucous membrane bleeding in the stomach and/or intestine), especially in patients with a high tendency for 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), pruritus, 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 causing breathing difficulties and hypotension. Angioedema (fluid accumulation in the tongue and throat that can cause asphyxiation), bronchospasm (bronchial spasms that make normal breathing difficult).

Psychiatric disorders:

Agitation and sleep disturbances.

Blood and lymphatic system disorders:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not remove the tablets from the blister until it is time to take them, in this way they will be well protected.

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

Do not use this medication if you observe that the tablet is deteriorated.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help to protect the environment.

Composition of Elorgan

-The active ingredient is pentoxifylline. Each prolonged-release tablet contains 400 mg of pentoxifylline.

-The other components (excipients) are: hydroxyethylcellulose, polyvinylpyrrolidone, talc, magnesium stearate, hypromellose, titanium dioxide E171, polyethylene glycol 8000, erythrosine E127.

Appearance of the product and content of the packaging

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

Each package contains 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

The holder of the marketing authorization is:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69,

08970 Sant Joan Despí (Barcelona)

Spain

The responsible for manufacturing is:

Sanofi S.r.l.

Strada Statale 17 km 22

Scoppito (AQ) I-67019 (Italy)

Last review date of this leaflet: October 2022

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.