Kamagra Oral Jelly Side Effects

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Answer the side-effect intent for kamagra oral jelly without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Kamagra Oral Jelly?

Kamagra-Oral-Jelly contains the active ingredient Sildenafil.

• Active ingredient — Sildenafil
• Registration number — 47/7.1.5/0676; 47/7.1.5/0677; 47/7.1.5/0678
• Registration holder — Zydus Healthcare SA (Pty) Ltd

It is approved for:

• ZYFORMA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors
• ZYFORMA works by relaxing the blood vessels in your penis when you are sexually excited
• This allows blood to flow into your penis, allowing you to get an erection in the natural way
• ZYFORMA is used to treat erectile dysfunction, sometimes known as impotence, in men

Common side effects of Kamagra Oral Jelly

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Less frequent side effects

• vomiting
• skin rash
• eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes
• pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure
• muscle pain
• feeling sleepy, reduced sense of touch
• vertigo, ringing in the ears
• dry mouth
• blocked or stuffy sinuses, inflammation of the lining of the nose, nosebleed
• upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn)
• presence of blood in urine
• pain in the arms or legs
• feeling hot, feeling tired
• fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain
• feeling of tightening of the throat, numb mouth
• bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye
• penile bleeding, presence of blood in semen
• dry nose, swelling of the inside of the nose, feeling irritable
• sudden decrease or loss of hearing

Frequent side effects

• headache, dizziness
• nausea, indigestion
• facial flushing, hot flush
• colour tinge to vision, blurred vision, visual disturbance, stuffy nose

Frequency unknown side effects

• unstable angina (a heart condition)
• sudden death

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to sildenafil or any of the other ingredients of ZYFORMA (listed in section 6)
• If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist
• If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure
• If you are taking riociguat. Riociquat is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as ZYFORMA have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor
• If you are using cimetidine (used to treat ulcers), ketoconazole or itraconazole (used to treat fungal infections), erythromycin or rifampicin (used to treat infections) or ritonavir or saquinavir (used to treat HIV infections)
• If you have severe problems with your heart (such as unstable angina or heart failure)
• If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION)
• If you have a severe kidney or liver problem
• If you have recently had a stroke or a heart attack, or if you have low blood pressure
• If you have certain rare inherited eye diseases (such as retinitis pigmentosa)

Use with care, and tell your doctor, if

• If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex
• If you have a deformity of your penis or Peyronie’s disease
• If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow)
• If you currently have a stomach ulcer, or a bleeding problem (such as haemophilia)
• If you experience sudden decrease or loss of vision, stop taking ZYFORMA and contact your doctor immediately
• You should not use ZYFORMA with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors
• You should not use ZYFORMA with any other oral or local treatments for erectile dysfunction
• You should not take ZYFORMA if you do not have erectile dysfunction. Children and adolescents
• ZYFORMA should not be given to individuals under the age of 18

Pregnancy and breastfeeding

• ZYFORMA is not indicated for use in women

Interactions and medicines to check

The approved leaflet names these interactions.

• Always tell your health care provider if you are taking any other medicine
• (This includes all complementary or traditional medicines.) ZYFORMA tablets may interfere with some medicines, especially those used to treat chest pain
• In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken ZYFORMA and when you did
• Do not take ZYFORMA with other medicines unless your doctor tells you that you can
• You should not take ZYFORMA if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure
• Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”)
• You should not take ZYFORMA if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure
• Tell your doctor or pharmacist if you are already taking riociguat
• If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of ZYFORMA
• Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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