Elorgan 400 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Elorgan 400 mg prolonged-release tablets

Pentoxifylline

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

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. How to store Elorgan 400 mg tablets
6. Contents of the pack and other information

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

Pentoxifylline is a medicine that belongs to a 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 starting Elorgan 400 mg tablets

Do not take Elorgan 400 mg tablets:

• if you are allergic to pentoxifylline or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction to another medicine in this group (xanthines).
• if you have massive bleeding or a 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 disorders,
• if you have previously had a myocardial infarction,
• if you have low blood pressure (hypotension),
• if you have severe impairment of kidney function (creatinine clearance less than 30 ml/min),
• if you have severe liver function impairment,
• if you are at high risk of bleeding, for example, patients being treated with anticoagulant medicines (which inhibit blood coagulation) or patients with coagulation disorders receiving 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 advise you on the dose to take.

Patients with hepatic impairment

Your doctor will advise you on the dose to take.

Taking Elorgan 400 mg tablets with other medicines

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

Especially if you are being treated with oral anticoagulants or antiplatelet agents, since their use together with Elorgan increases the risk of bleeding. For this reason, your doctor may carry out periodic monitoring.

Concomitant administration of Elorgan with antihypertensive drugs (medicines that lower blood pressure) may enhance the effect of these drugs; therefore, your doctor may need to adjust your dose.

Treatment with Elorgan in patients receiving antidiabetic medicines (insulin or oral antidiabetics) may also enhance the effect of these medicines. For this reason, you must undergo periodic monitoring.

Concomitant treatment with Elorgan and theophylline (a medicine used to treat asthma) may lead to increased theophylline levels and, consequently, an increase in its adverse effects.

Likewise, concomitant treatment with Elorgan and ciprofloxacin (a medicine used to treat bacterial infections) may lead to increased levels of pentoxifylline and, consequently, an increase in its adverse effects.

Concomitant treatment with Elorgan and antiplatelet agents (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, other non-steroidal anti-inflammatory drugs that are non-selective COX-2 inhibitors, acetylsalicylates (acetylsalicylic acid/lysine acetylsalicylate), ticlopidine, dipyridamole) may enhance the anticoagulant effect and increase the risk of bleeding.

Concomitant administration of Elorgan with cimetidine (a medicine used to treat gastric ulcers) may increase pentoxifylline and active Metabolite I levels.

Taking Elorgan 400 mg tablets with food and drink

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

Pregnancy, breastfeeding and fertility

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

Pregnancy

Elorgan must not be administered during pregnancy.

Breastfeeding

There are insufficient data to establish the safety of using Elorgan during breastfeeding. Therefore, your doctor will assess whether or not it is advisable to continue treatment while you are nursing your child.

Driving and operating machinery

The ability to drive and operate machinery may be impaired due to possible adverse reactions.

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

3. How to take Elorgan 400 mg tablets

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

If you think that the effect 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 condition and your tolerance to this medicine.

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

If you experience a severe allergic reaction (anaphylactic or anaphylactoid) with swelling of the mouth and airways causing difficulty in breathing and drop in blood pressure, stop treatment with Elorgan immediately and inform your doctor.

Your doctor will advise you on the duration of your treatment with Elorgan. Do not stop treatment prematurely.

If you take more Elorgan than you should

Contact your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you.

If you take too high a dose of Elorgan, you may initially experience nausea, dizziness, palpitations, or a sudden drop in blood pressure. In addition, fever, restlessness, hot flushes, loss of consciousness, loss of reflexes, seizures, skin rashes, and vomiting resembling coffee grounds (a sign indicating gastrointestinal bleeding) may occur.

In case of overdose or accidental ingestion, contact 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 missed doses.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Additional investigations:

Increased transaminases (liver enzymes), decreased blood pressure.

Gastrointestinal disorders:

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

Cardiac disorders:

Heart rhythm disturbances with increase or decrease in heart rate (e.g. palpitations), angina pectoris.

Vascular disorders:

Hot flushes, haemorrhages (e.g. of the skin and/or mucous membranes located in the stomach and/or intestine), especially in patients with a high tendency to bleed.

Nervous system disorders:

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

Hepatobiliary disorders:

Liver function disorders such as, for example: intrahepatic cholestasis (obstruction of bile flow within the liver).

Skin and subcutaneous tissue disorders:

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

Immune system disorders:

Severe allergic-type reactions (anaphylactic or anaphylactoid) with inflammation of the mouth and airways causing breathing difficulties and drop in blood pressure. Angioedema (fluid accumulation in tongue and throat that may cause asphyxiation), bronchospasms (bronchial spasms making normal breathing difficult).

Psychiatric disorders:

Agitation and sleep disturbances.

Blood and lymphatic system disorders:

Thrombocytopenia (decrease in platelet count), leucopenia/neutropenia (decrease in white blood cells).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 time of taking, to ensure they remain well protected.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Elorgan

• The active substance 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 contents of the pack

Elorgan 400 mg prolonged-release tablets are pink oval 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 most recent review of this leaflet: October 2022

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/.