PENTOHEXAL 600 mg. 30 tablets

WHAT PENTOHEXAL AND WHAT IT IS USED
PENTOHEXAL is administered for treatment of disturbances in blood circulation.
PENTOHEXAL used for induction and maintenance oral therapy of chronic peripheral arterial occlusive disease (poor circulation in the extremities) in Hb stage in Fontaine (intermittent claudication - muscle pain due to poor blood supply to the extremities), if impossible or contraindicated other therapeutic measures as an exercise of gait, opening the vascular clearance and / or restorative procedures.

2. BEFORE YOU TAKE PENTOHEXAL
Do not take PENTOHEXAL
if you are allergic (hypersensitive) to pentoxifylline, other methylxanthines or any of the excipients;
acute myocardial infarction;
in intracerebral hemorrhage or other clinically significant bleeding;
ulcers in the stomach and / or intestines;
in conditions with an increased tendency to bleed;
in retinal hemorrhage.
Ingestion of the product should be stopped immediately if there is a retinal hemorrhage during treatment with pentoxifylline.

Take special care with PENTOHEXAL
The following information describes when PENTOHEXAL can be used only under special conditions and special attention. This applies also if these data were important to you before.
Particularly careful monitoring is necessary in patients with arrhythmia, arterial hypotension (low blood pressure), coronary sclerosis (narrowing or wear and tear of the coronary arteries), severe cerebral sclerosis (impaired blood supply to the brain) after myocardial infarction or after surgical procedures.
When renal function (creatinine clearance below 30 ml / min) or severe hepatic impairment release of pentoxifylline may be delayed. In such cases it is necessary dose reduction and appropriate monitoring (see. Section 3 "How to take PentoHEKSAL").
Concomitant use of PENTOHEXAL medicinal products that inhibit blood clotting (oral anticoagulants) need careful monitoring and frequent coagulation monitoring (INR), due to a possible risk of bleeding.
Blood counts should be monitored at regular intervals during treatment with PENTOHEXAL

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken / used any other medicines, including medicines obtained without a prescription.

Drugs that lower blood pressure (antihypertensives)
PENTOHEXAL can enhance the effect of antihypertensive products and may increase the blood pressure lowering.

Medicinal products that inhibit blood clotting (oral anticoagulants)
PENTOHEXAL may enhance the effect of anticoagulants. In patients with increased bleeding tendency due to eg. concomitant anticoagulation is necessary especially carefully tracking (eg. regular monitoring of INR), as it may intensify bleeding haemorrhage.

Oral antidiabetic products (medicines to treat diabetes), insulin
It is enhanced lowering blood sugar (hypoglycaemic reactions).
Regulate blood sugar should be monitored at regular intervals and is determined individually.

Theophylline
It is possible that higher levels of theophylline in the blood, in which the treatment of respiratory diseases can increase the side effects of theophylline.

Pimetidin
It is possible that higher levels of pentoxifylline in the blood and strengthen the effect of
PENTOHEXAL

Pregnancy and lactation
Ask your doctor or pharmacist before taking / using other medicines.
PENTOHEXAL should not be taken during pregnancy, as there is insufficient data on safety in pregnant women.
Pentoxifylline passes into breast milk during lactation, but as newborn is taking very small amount of the substance is not expected effects. Due to lack of sufficient data can PENTOHEXAL be used during lactation only if necessary.

3. HOW TO TAKE PENTOHEXAL
Always take PENTOHEXAL exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the usual dose is 1 prolonged-release tablet PENTOHEXAL morning and evening (corresponding to 1200 mg pentoxifylline day).
In patients with low or unregulated blood pressure may require special dosage recommendations.
In patients with impaired renal function (creatinine clearance below 30 ml / min), the dose should be determined according to individual tolerance.
In patients with severe hepatic impairment require dose reduction, which is determined by the physician individually depending on the severity of the disease and tolerability.

Method of administration
Take the prolonged-release tablets without chewing with sufficient fluid after meals.

Duration of treatment
The duration of use is determined by your doctor.
Ask your doctor or pharmacist if you have the impression that the effect of PENTOHEXAL is too strong or too weak.

If you take more dose PENTOHEXAL
A suspected overdose PENTOHEXAL, please tell your doctor, he / she will consider the necessary measures, if possible, depending on the symptoms. Intoxications require immediate medical attention so that the patient may be hospitalized and to take appropriate therapeutic measures.

Symptoms of overdose
It is possible that these effects of overdose PENTOHEXAL - dizziness, nausea, drop in blood pressure, fast heart beat (tachycardia), flushing with warm feeling, unconsciousness, fever, agitation, loss of reflexes, tonic-clonic seizures ( severe seizures), vomiting of coffee, and arrhythmia (abnormal heart rhythm).

Therapeutic measures in overdose
Treatment is symptomatic. To avoid complications, you may need to be monitored in intensive care (especially blood pressure and breathing).

If you forget to take PENTOHEXAL
Do not take a double dose the next dose and resume treatment with the prescribed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, PENTOHEXAL can cause side effects, although not everybody gets them.

Adverse effects were assessed based on the following frequencies.
Very common: more than 1 in 10 treated patients;
Common: 1 to 10 of 100 patients treated;
Uncommon: 1 to 10 of 1000 patients treated;
Rare patients 1 to 10 of 10,000 patients treated;
Rare: less than 1 to 10 of 10,000 patients treated;
Not known: can not be estimated from the available data.
Possible side effects
Stomach, intestines, liver, bile ducts:
Common: gastrointestinal symptoms such as nausea, vomiting, feeling bloated stomach, heaviness in the stomach or diarrhea;
Not known: cholestasis (intrahepatic cholestasis) and increase in liver enzymes (transaminases, alkaline phosphatase).
Heart and blood vessels:
Uncommon: flushing of the face and a feeling of warmth;
Rare: arrhythmia (such as tachycardia), fall in blood pressure, pain in the heart, difficulty breathing (dyspnea) or fluid retention in the tissues (peripheral edema / angioedema);
Not known: high blood pressure (hypertension).
Hypersensitivity reactions:
Rare: hypersensitivity reactions with itching, redness of skin, hives (bubbles with redness);
Not known: severe hypersensitivity reactions (angioedema, bronchospasm, anaphylaxis) that appear within minutes after ingesting the product. At the first signs of hypersensitivity reactions the drug should be stopped immediately and notify your doctor.
Blood and blood cells:
Very rare: bleeding (eg. On skin and mucous membranes, stomach, intestine, urinary STDs), intracranial hemorrhage (bleeding in the brain) and retinal hemorrhages;
Not known: retinal detachment; thrombocytopenia (reduced platelet count) with cutaneous bleeding (thrombocytopenic purpura), and aplastic anemia, possibly fatal (reduced or stopped production of all blood cells, pancytopenia). For this reason blood counts should be monitored at regular intervals.
Others:
Uncommon: dizziness, shaking (tremor), headache, fever;
Not known: restlessness, sleep disturbances, increased sweating, abnormal sensation (paraesthesia), visual disorders, conjunctivitis, convulsions, severe skin reactions (epidermal necrolysis, and syndrome of Stevens-Johnson).
Emergency measures for adverse drug reactions
First signs of severe hypersensitivity reactions can be difficulty breathing, vomiting, sweating and dizziness. In these cases, immediately stop taking this drug and tell your doctor.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PENTOHEXAL
This medicinal product does not require any special storage conditions. Keep out of reach of children.
Do not use after the expiry date stated on the package after 'EXP'.

6. FURTHER INFORMATION
What PENTOHEXAL
The active substance is pentoxifylline. Each extended release tablet formulation contains 600 mg of pentoxifylline.
The other ingredients are copovidone, magnesium stearate (Ph.Eur.), Hypromellose, talc.

PENTOHEXAL looks like and contents of the pack
Packs contain 30, 50 and 100 prolonged-release tablets.