“You can’t beat a healthy heart.”
SCHEDULING STATUS S2
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
DYNA PENTOXIFYLLINE SR (400 mg, slow release film coated tablets)
Please read this information leaflet carefully before you start taking DYNA PENTOXIFYLLINE SR.
WHAT DYNA PENTOXIFYLLINE CONTAINS:
The active ingredient in DYNA PENTOXIFYLLINE SR is pentoxifylline 400 mg.
Carnauba wax, cellulose acetate, erythrosine dye (E127), hydroxypropylmethylcellulose, hypromellose, Indigo Carmine Lake (E132), lactose monohydrate, magnesium stearate, purified stearic acid, titanium dioxide (E171).
DYNA PENTOXIFYLLINE slow release tablets contain sugar in the form of lactose.
WHAT DYNA PENTOXIFYLLINE IS USED FOR:
- Symptomatic relief of intermittent claudication (pain caused by too little blood flow, usually during exercise) and ulcers caused by bad blood circulation
- Raynaud syndrome (decrease in blood circulation to your fingers and toes)
BEFORE YOU TAKE DYNA PENTOXIFYLLINE
Do not take DYNA PENTOXIFYLLINE:
- If you are allergic (hypersensitive) to pentoxyfylline or any of the other ingredients of DYNA PENTOXIFYLLINE (see WHAT DYNA PENTOXIFYLLINE CONTAINS).
- If you have suffered any acute heart condition, such as a heart attack.
- If you have suffered a brain haemorrhage (type of stroke resulting in bleeding into the brain tissue).
- If you have extensive retinal haemorrhage (disorder of the eye in which bleeding occurs into the light sensitive tissue on the back wall of the eye).
Take special care with DYNA PENTOXIFYLLINE:
- If you have a heart disorder such as hypotension (low blood pressure) or reduction of blood flow and oxygen to the heart muscle (ischaemic heart disease).
- If you have kidney failure, as the dose may need to be adjusted.
- If you have a liver disease such as cirrhosis (degeneration of the liver)
- If you are diabetic, on insulin and receive pentoxifylline intravenously
Taking DYNA PENTOXIFYLLINE with food and drink
DYNA PENTOXIFYLLINE should be swallowed whole with approximately half a glass of liquid, after meals.
Pregnancy and breastfeeding:
If you are pregnant, suspect that you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or healthcare professional for advice before taking DYNA PENTOXIFYLLINE.
Do not take DYNA PENTOXIFYLLINE if you are pregnant or breastfeeding your baby.
Driving and using machines:
DYNA PENTOXIFYLLINE can cause dizziness in certain individuals and may impair your ability to drive and use machinery. Do not drive, operate machinery, or do anything else that could be dangerous until you know how DYNA PENTOXIFYLLINE affects you.
Important information about some of the ingredients of DYNA PENTOXIFYLLINE:
DYNA PENTOXIFYLLINE contains lactose and should not be taken if you are lactose intolerant or have a rare hereditary problem, or a history of galactose intolerance (a simple sugar found in lactose), Lapp lactose deficiency or glucose–galactose malabsorption.
Taking other medicines with DYNA PENTOXIFYLLINE:
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines).
Simultaneous use of DYNA PENTOXIFYLLINE with the following medicine can have unwanted interactions. Please inform your doctor or pharmacist if you are taking or have taken any of the following:
- Medicine used to lower blood pressure, as DYNA PENTOXIFYLLINE may result in a stronger effect of the blood pressure medicine.
- Ketorolac (pain medication), as the use of DYNA PENTOXIFYLLINE with ketorolac, may increase the risk of bleeding.
HOW TO TAKE DYNA PENTOXIFYLLINE
Do not share medicines prescribed for you with any other person.Always take DYNA PENTOXIFYLLINE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The usual dose of DYNA PENTOXIFYLLINE is one tablet taken two to three times daily after meals.
Your doctor will adjust your dose if you have reduced kidney or liver function, or if you have low blood pressure.
If you take more DYNA PENTOXIFYLLINE than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and any remaining tablets with you, so the doctor knows what you have taken.
Symptoms of overdose may include fever, faintness, flushing, low blood pressure, drowsiness, feeling agitated and fits.
If you forget to take a dose of DYNA PENTOXIFYLLINE:
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take a double dose to make up for forgotten individual doses.
POSSIBLE SIDE EFFECTS
DYNA PENTOXIFYLLINE can have side effects. Not all side effects reported for DYNA PENTOXIFYLLINE are included in this leaflet. Should your general health worsen while taking DYNA PENTOXIFYLLINE please consult your doctor, pharmacist or other health care professional for advice.
If any of the following happens, stop taking DYNA PENTOXIFYLLINE and tell your doctor immediately or go to the casualty department at your nearest hospital:
- swelling of the hands, feet ankles, lips, mouth or throat which may cause difficulty in breathing
- rash or itching
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DYNA PENTOXIFYLLINE. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go the casualty department at your nearest hospital if you notice any of the following:
- Rapid heartbeat (palpitations)
- Angina (chest pain)
- Irregular heart rhythm
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
- Dizziness and headache
- Upset stomach
- Abnormal bleeding
STORING AND DISPOSING OF DYNA PENTOXIFYLLINE
Store at or below 25 °C.
Keep the container well closed.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not use after the expiry date printed on the label.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
PRESENTATION OF DYNA PENTOXIFYLLINE
White polypropylene securitainer with a white polyethylene tear-tab cap containing 30 or 100 tablets.
IDENTIFICATION OF DYNA PENTOXIFYLLINE
Pink oval film coated tablets.
South Africa Reg. No.: S2 36/8/0282
Namibia Reg. No.: NS2 08/8/0183
NAME AND ADDRESS OF REGISTRATION HOLDER
Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Cape Town, South Africa
DATE OF PUBLICATION
11 December 2004