Men’s Health

“A man too busy to take care of his health is like a mechanic too busy to take care of his tools.”

- Spanish Proverb

Erectile Dysfunction Medication

PDE-5 inhibitors

dynafilSMOptimsed

Scheduling Status S4

Proprietary name, Strength and Pharmaceutical Form
DYNAFIL 25 mg (coated tablets)
DYNAFIL 50 mg (coated tablets)
DYNAFIL 100 mg (coated tablets)

Please read this patient information leaflet carefully before taking DYNAFIL tablets

  • Keep this leaflet.  You may need to read it again.
  • If you have any further questions, please ask your doctor or your pharmacist.
  • This medicine has been prescribed for you personally and you should not share your medicine with other people.  It may harm them, even if their symptoms are the same as yours.

WHAT DYNAFIL 25/50/100 mg TABLETS CONTAINS

Active ingredients:
DYNAFIL 25 mg: Each coated tablet contains sildenafil citrate equivalent to 25 mg sildenafil.
DYNAFIL 50 mg: Each coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.
DYNAFIL 100 mg: Each coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.

Inactive ingredients:
Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry 03F20404 Blue, Povidone K29-32.

WHAT DYNAFIL IS USED FOR

DYNAFIL is used for the treatment of erection problems in men.
DYNAFIL IS NOT AN APHRODISIAC
DYNAFIL offers NO protection against sexually transmitted diseases. You should use protective measures necessary to guard against sexually transmitted diseases, including the human immunodeficiency virus (HIV/AIDS).

BEFORE YOU TAKE DYNAFIL

Do not take DYNAFIL:

  • If you are hypersensitive (allergic) to any of the ingredients of DYNAFIL (see “WHAT DYNAFIL CONTAINS”).
  • If you are female.
  • If you have a heart, liver or severe kidney disorder.
  • If you are taking medication for high blood pressure or heart medication (e.g. nitrates). Please inform your doctor.
  • If you are taking other medications for erection problems or any other diseases. Please consult your doctor or pharmacist.

Take special care with DYNAFIL:

  • If you had a heart attack or stroke or other life threatening heart problems within the last 6 months.
  • If you have high or low blood pressure.
  • If you have any heart disorders such as angina.
  • If you have eye disorders. Please consult your doctor.
  • If you are an elderly patient. Follow the dose precisely as prescribed to you.
  • If you have a stomach ulcer or a bleeding disorder.

You should seek immediate medical assistance in the event of an erection that persists longer than 4 hours after taking DYNAFIL.  Painful erections longer than 6 hours (priapism) should be treated immediately, as damage to the penis and permanent loss of potency could result.

DYNAFIL should be used with caution if your have an anatomical deformation of the penis.  Please consult your doctor.

Your doctor will examine you and determine the probable cause of your disorder before starting treatment.

Do not take other aids or medicines for erection problems with DYNAFIL as this may cause side-effects.

Pregnancy and breastfeeding:
Do not use DYNAFIL if you are female.

Driving and using machinery:
DYNAFIL can lead to dizziness and influence your vision and you should exercise caution before driving, operating hazardous machinery or performing hazardous tasks.

Using other medicines with DYNAFIL:
DYNAFIL may influence the effects of other medicines.  Other medicines may on the other hand influence the effect of DYNAFIL.  If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of DYNAFIL simultaneously with these medicines may cause undesirable interactions.

Please consult your doctor, pharmacist or other healthcare professional for advice. Tell your doctor or pharmacist if you are taking any other medicines, including any you have bought at your pharmacy, supermarket or health food shop. 

Medicines known to influence the effects of DYNAFIL are certain anti-fungal medication (ketoconazole, fluconazole), certain antacid / ulcer medication (cimetidine), certain antibiotics (erythromycin, clarithromycin) and certain antiviral HIV medicines. These medicines may enhance the effects of DYNAFIL.  Consult your doctor.

DYNAFIL should be used with caution if you have any bleeding disorders or active peptic ulceration.  Consult your doctor.

HOW TO USE DYNAFIL

The dose of DYNAFIL will be different for different patients and may depend on the seriousness of your disorder and whether or not you are taking other medicines.

Do not take more DYNAFIL than was prescribed to you or take DYNAFIL more frequently.

Adults:
The recommended dose is one 50 mg tablet per day when needed one hour before sexual intercourse. The dose can be increased or reduced the next day depending on the response.  The maximum single dose per day is 100 mg.   

Elderly, patients with liver, kidney disorders and concomitant use with certain medications that enhance the effect of DYNAFIL:

The dose prescribed to you will be one 25 mg tablet per day when needed to be taken one hour before sexual intercourse.

If you take more DYNAFIL than you should:
In event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

POSSIBLE SIDE EFFECTS

DYNAFIL can have side effects.  Not all side effects reported for DYNAFIL are included in this leaflet.  Should your general health worsen while taking DYNAFIL, please consult your doctor, pharmacist or other health care professional for advice. 

The following side-effects may occur frequently:

  • Increased heart rate, low blood pressure, pain in the chest (angina pain).
  • Loss of vision of one or both eyes.  Consult your doctor immediately.
  • Prolonged or painful erection.  Consult your doctor immediately.
  • Headache, dizziness.
  • Gastrointestinal discomfort, stomach pain.
  • Muscle pain.
  • Nasal congestion.
  • Flushing.
  • Nausea.

The following side-effects may occur less frequently:

  • Tinnitus, deafness, ear pain.
  • Anaphylaxis (including low blood pressure, skin rash, hives, trouble breathing).

STORAGE AND DISPOSING OF DYNAFIL

  • Store below 25 °C.
  • Do not remove from outer carton until required for use.
  • KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
  • Return all unused medicine to your pharmacist
  • Do not use the tablets after the expiry date printed on the blisters and containers
  • Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

PRESENTATION OF DYNAFIL

DYNAFIL 25 mg is packed into hard, silver-coloured aluminium foil / transparent PVC/PVDC film blister strips.

DYNAFIL 50 mg is packed into hard, silver-coloured aluminium foil / transparent PVC/PVDC film blister strips.

DYNAFIL 100 mg is packed into hard, silver-coloured aluminium foil / transparent PVC/PVDC film blister strips.

IDENTIFICATION OF DYNAFIL

DYNAFIL 25 mg: Blue, elliptical, biconvex, 10,0 x 5,0 mm film-coated tablets, with SL25 engraved on one side. (DYNAFIL 25 mg is not currently marketed in South Africa).

DYNAFIL 50 mg: Blue, elliptical, biconvex, 13,0 x 6,5 mm film-coated tablets, with SL50 engraved on one side.

DYNAFIL 100 mg: Blue, elliptical, biconvex, 17,0 x 8,5 mm film-coated tablets, with SL100 engraved on one side.

REGISTRATION NUMBERS

DYNAFIL 25 mg: 42/7.1.5/1070

DYNAFIL 50 mg: 42/7.1.5/1071

DYNAFIL 100 mg: 42/7.1.5/1072

NAME AND ADDRESS OF REGISTRATION HOLDER

Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Silverwood Close
Westlake, 7945
Cape Town, South Africa

DATE OF PUBLICATION

14 September 2012
Version: PD9018A

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