Sildenafil Citrate 50, 100mg Film Coated Tablet
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or
pharmacist.
* This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
1-DESCRIPTION AND COMPOSITION:
HARDFORCE is a blue color, diamond shaped, biconvex film coated
tablets.
Each HARDFORCE film coated tablet contains:
-Sildenafil citrate BP Eq, to sildenafil 50mg
-Sildenafil citrate BP Eq, to sildenafil 100mg
Excipients: Micro Crystalline Cellulose pH-101, Di Basic Calcium
Phosphate, Sodium Starch Glycolate, Starch, Polysorbate-80
(Tween-80), PVPK-30,Talc,Magnesium Stearate, Micro Crystalline
Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide,
Hypromellose E, Titanium Dioxide, Color Brilliant Blue Lake, Isopropyl
Alcohol, Methylene Dichloride.
2-THERAPEUTIC INDICATIONS:
HARDFORCE is a prescription medicine used to treat erectile
dysfunction (ED). You will not get an erection just by taking this
medicine. HARDFORCE helps a man with erectile dysfunction get and
keep an erection only when he is sexually excited (stimulated).
HARDFORCE is not for use in women or children.
It is not known if HARDFORCE is safe and effective in women or
children under 18 years of age.
3- POSOLOGY:
•Take HARDFORCE exactly as your healthcare provider tells you to take
it.
•Your healthcare provider will tell you how much HARDFORCE to take
and when to take it.
•Your healthcare provider may change your dose if needed.
•Take HARDFORCE about 1 hour before sexual activity. You may take
HARDFORCE between 30 minutes to 4 hours before sexual activity if
needed.
•HARDFORCE can be taken with or without food. If you take HARDFORCE
after a high fat meal HARDFORCE may take a little longer to start
working
•Do not take HARDFORCE more than 1 time a day.
•If you accidentally take too much HARDFORCE, call your doctor or go
to the nearest hospital emergency room right away.
4-WARNINGS and PRECAUTIONS:
Do not take HARDFORCE if you:
•Take medicines called nitrates (such as nitroglycerin)
•Use street drugs called "poppers" such as amyl nitrate or amyl nitrite,
and butyl nitrate
•Take any medicines called guanylate cyclase stimulators such as
riociguat.
•Are allergic to sildenafil, as contained in HARDFORCE, or any of the
ingredients in HARDFORCE. See the list of excipients in HARDFORCE.
Before you take HARDFORCE, tell your healthcare provider if you:
•Have or have had heart problems such as a heart attack, irregular
heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure
•Have had heart surgery within the last 6 months
•Have pulmonary hypertension
•Have had a stroke
•Have low blood pressure, or high blood pressure that is not controlled
•Have a deformed penis shape
•Have had an erection that lasted for more than 4 hours
•Have problems with your blood cells such as sickle cell anemia,
multiple myeloma, or leukemia
•Have retinitis pigmentosa, a rare genetic (runs in families) eye
disease
•Have ever had severe vision loss, including an eye problem called
non-arteritic anterior ischemic optic neuropathy (NAION)
•Have bleeding problems
•Have or have had stomach ulcers
•Have liver problems
•Have kidney problems or are having kidney dialysis
•Have any other medical conditions
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and
herbal supplements.
HARDFORCE may affect the way other medicines work, and other
medicines may affect the way HARDFORCE works causing side effects.
Especially tell your healthcare provider if you take any of the following:
•Medicines called nitrates
•Medicines called guanylate cyclase stimulators, such as riociguat.
•Medicines called alpha blockers such as terazosin HCl, tamsulosin HCl,
doxazosin mesylate, prazosin HCl, alfuzosin HCl, dutasteride and
tamsulosin HCl or silodosin. Alpha-blockers are sometimes prescribed
for prostate problems or high blood pressure. In some patients, the use
of HARDFORCE with alpha-blockers can lead to a drop in blood
pressure or to fainting.
•Medicines called HIV protease inhibitors, such as ritonavir, indinavir
sulfate, saquinavir or atazanavir sulfate.
•Some types of oral antifungal medicines, such as ketoconazole and
itraconazole.
•Some types of antibiotics, such as clarithromycin, telithromycin, or
erythromycin
•Other medicines that treat high blood pressure
•Other medicines or treatments for ED
•HARDFORCE contains sildenafil, which is the same medicine found in
another drug called REVATIO. REVATIO is used to treat a rare disease
called pulmonary arterial hypertension (PAH). VIAGRA should not be
used with REVATIO or with other PAH treatments containing sildenafil or
any other PDE5 inhibitors (such as tadalafil).
Ask your healthcare provider or pharmacist for a list of these
medicines, if you are not sure.
Know the medicines you take. Keep a list of them to show to your
healthcare provider and pharmacist when you get a new medicine.
5-ADVERSE REACTIONS:
•HARDFORCE can cause serious side effects. Rarely reported side
effects include:
•An erection that will not go away (priapism). If you have an erection
that lasts more than 4 hours, get medical help right away. If it is not
treated right away, priapism can permanently damage your penis.
•Sudden vision loss in one or both eyes. Sudden vision loss in one or
both eyes can be a sign of a serious eye problem called non-arteritic
anterior ischemic optic neuropathy (NAION). It is uncertain whether
PDE5 inhibitors directly cause the vision loss. Stop taking HARDFORCE
and call your healthcare provider right away if you have sudden vision
loss in one or both eyes.
•Sudden hearing decrease or hearing loss. Some people may also
have ringing in their ears (tinnitus) or dizziness. If you have these
symptoms, stop taking HARDFORCE and contact a doctor right away.
The most common side effects of HARDFORCE are:
•Headache
•Flushing
•Upset stomach
•Abnormal vision, such as changes in color vision (such as having a
blue color tinge) and blurred vision
•Stuffy or runny nose
•Back pain
•Muscle pain
•Nausea
•Dizziness
•Rash
In addition, heart attack, stroke, irregular heartbeats and death have
happened rarely in men taking HARDFORCE. Most, but not all, of these
men had heart problems before taking HARDFORCE. It is not known if
HARDFORCE caused these problems.
Tell your healthcare provider if you have any side effect that bothers
you or does not go away.
These are not all the possible side effects of HARDFORCE. For more
information, ask your healthcare provider or pharmacist.
6-STORAGE CONDITIONS:
keep out of reach of children.
Store in a dry place below 30°C.
.Protect from light.
Manufacturer and MAH:
Date of Revision: May 5, 2025
PI015/01
4 Film Coated Tablets Reg. N°:
4 Film Coated Tablets Reg. N°:
This is a medicine:
- A medicine is a product which
affects your health and its consumption
contrary to instructions is dangerous for
you.
- Follow strictly the doctor's prescription,
the method of use and the instructions of
the pharmacist who dispensed the
medicine.
- The doctor and the pharmacist are the
experts in medicine, their benefits and
risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicines out of reach of
children.
Council of Arab Health Ministers
Union of Arab pharmacists
