Actigra

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Leaflet attached to the packaging: patient information

Actigra, 25 mg, film-coated tablets

Actigra Forte, 50 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not experience improvement after taking the medicine or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What are Actigra and Actigra Forte medicines and what are they used for
• 2. Important information before taking Actigra and Actigra Forte medicines
• 3. How to take Actigra and Actigra Forte medicines
• 4. Possible side effects
• 5. How to store Actigra and Actigra Forte medicines
• 6. Contents of the packaging and other information

1. What are Actigra and Actigra Forte medicines and what are they used for

Actigra and Actigra Forte medicines contain the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). The medicines work by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Actigra and Actigra Forte help achieve an erection only if there is prior sexual stimulation.

Actigra and Actigra Forte medicines are used to treat erectile dysfunction in adult men, which is the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Actigra and Actigra Forte medicines

When not to take Actigra and Actigra Forte medicines:

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates, as their simultaneous intake may lead to a dangerous decrease in blood pressure. You should inform your doctor if you are taking any medicines from this group. These medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, you should consult your doctor or pharmacist.

If you are taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their simultaneous intake may also lead to a dangerous decrease in blood pressure.

• If you are taking riociguat. This is a medicine used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors, such as Actigra and Actigra Forte, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.
• If you have severe heart or liver disease.
• If you have recently had a stroke or heart attack, and in cases of low blood pressure.
• If you have hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If you have ever experienced loss of vision due to non-inflammatory anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take Actigra or Actigra Forte medicine, you should discuss it with your doctor or pharmacist in case of:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), multiple myeloma (a bone marrow cancer).
• If you have anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, your doctor should assess whether your heart condition allows for the additional effort associated with sexual activity.
• Ulcer disease or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden loss of vision, you should stop taking Actigra or Actigra Forte medicine and immediately contact your doctor.

You should not take Actigra and Actigra Forte medicines at the same time as other orally or locally administered types of erectile dysfunction therapy.

You should not take Actigra and Actigra Forte medicines at the same time as therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

You should not take Actigra and Actigra Forte medicines if you have not been diagnosed with erectile dysfunction.

Actigra and Actigra Forte medicines are not intended for women.

Special considerations for patients with kidney or liver function disorders

Patient with kidney or liver function disorders should inform their doctor. Patients with kidney or liver function disorders should not take a dose higher than 25 mg of sildenafil (should not take Actigra Forte medicine).

Children and adolescents

Actigra and Actigra Forte medicines should not be taken by persons under 18 years of age.

Actigra and Actigra Forte medicine and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Actigra and Actigra Forte medicines may interact with some medicines, especially those used to treat chest pain. If your condition worsens, requiring immediate medical attention, you should inform your doctor, pharmacist, or nurse about taking Actigra or Actigra Forte medicine and the time of its intake.

You should not take Actigra or Actigra Forte medicine at the same time as other medicines without your doctor's recommendation.

You should not take Actigra or Actigra Forte medicine if you are taking nitrate medicines, as their simultaneous use may lead to a dangerous decrease in blood pressure.

You should always inform your doctor or pharmacist if you are taking nitrates, which are used to treat angina pectoris ("chest pain").

You should not take Actigra or Actigra Forte medicine if you are taking medicines that release nitric oxide (such as amyl nitrite), as their simultaneous use may also cause a dangerous decrease in blood pressure.

If you are already taking riociguat, you should inform your doctor or pharmacist.

In the case of taking protease inhibitor medicines used to treat HIV infection, you should consult your doctor before taking the medicine; in such a case, it is recommended to start treatment with a lower dose (25 mg - Actigra medicine).

In some patients who are taking alpha-adrenergic blockers due to high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure, caused by a decrease in blood pressure when standing up or sitting down quickly. Such symptoms occurred in some patients taking Actigra or Actigra Forte medicine and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours after taking Actigra or Actigra Forte medicine. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Actigra or Actigra Forte medicine. The doctor may decide to use a lower initial dose (25 mg - Actigra medicine).

In case of low blood pressure symptoms (dizziness, lightheadedness, feeling of impending faint), you should first lie down or sit and wait for the symptoms to pass; drinking water, taking fresh air, or crossing your legs may also help.

You should avoid standing up or sitting down quickly.

If you are taking medicines containing sacubitril with valsartan (used to treat heart failure), you should inform your doctor or pharmacist.

Actigra and Actigra Forte medicine with food, drink, and alcohol

Actigra or Actigra Forte medicine can be taken with or without food. However, taking Actigra or Actigra Forte medicine while eating large meals may prolong the time needed for the medicine to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Actigra or Actigra Forte medicine, you should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Actigra and Actigra Forte medicines are not intended for use by women.

Driving and using machines

Actigra and Actigra Forte medicines may cause dizziness and vision disturbances.

Before driving or operating machines, patients should find out how they react to Actigra and Actigra Forte medicines.

Actigra and Actigra Forte medicine contains less than 1 mmol (23 mg) of sodiumin the recommended dose, which means the medicine is considered "sodium-free".

3. How to take Actigra and Actigra Forte medicines

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.

The recommended dose is 25 mg of sildenafil - Actigra medicine.

If you have previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg - Actigra Forte medicine. Otherwise, Actigra Forte medicine in a dose of 50 mg should only be used if you did not experience the desired effect after taking sildenafil in a dose of 25 mg (i.e., you did not achieve an erection sufficient for sexual intercourse).

If taking a lower dose of sildenafil (25 mg) allowed you to achieve an erection that enabled you to have sexual intercourse, you should not take a dose of 50 mg.

Actigra and Actigra Forte medicines should not be taken more than once a day.

You should not take Actigra or Actigra Forte medicine at the same time as other medicines containing sildenafil, including tablets containing sildenafil that dissolve in the mouth.

Actigra or Actigra Forte medicine should be taken about an hour before planned sexual activity. The tablet should be swallowed whole, with a glass of water.

If you feel that the effect of Actigra or Actigra Forte medicine is too strong or too weak, you should consult your doctor or pharmacist.

Actigra and Actigra Forte medicines allow you to achieve an erection only if there is prior sexual stimulation. The time after which the effect of Actigra or Actigra Forte medicine occurs varies from person to person, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a large meal.

You should contact your doctor if you do not experience an erection after taking Actigra or Actigra Forte medicine or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Actigra and Actigra Forte medicines than recommended

The patient may experience more frequent side effects, and they may be more severe.

Taking a dose higher than 100 mg does not mean an increase in the effectiveness of the medicine.

You should not take more tablets than indicated in the patient leaflet.

You should contact your doctor in case of taking more tablets than recommended.

In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects reported in connection with the use of Actigra and Actigra Forte medicines are usually mild or moderate and short-term.

In case of experiencing any of the following side effects, you should stop taking Actigra or Actigra Forte medicine and seek medical attention immediately:

• Allergic reaction - occurs uncommonly(may occur in 1 in 100 patients) Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonlyIf they occur during or after sexual intercourse:
• you should sit half-up and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in 1 in 1000 patients). If the erection lasts for more than 4 hours, you should contact your doctor immediately.
• Sudden vision loss or sudden loss of vision - occur rarely
• Severe skin reactions - occur rarelySymptoms may include severe peeling and swelling of the skin, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur rarely

Other side effects:

Very common(may occur in more than 1 in 10 patients): headache.

Common(may occur in 1 in 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of heat in the upper part of the body), indigestion, colored vision, blurred vision, visual disturbances, stuffy nose, dizziness.

Uncommon(may occur in 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctival hyperemia, eye pain, flashes of light, bright vision, sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, stuffy or congested sinuses, nasal inflammation (symptoms include runny nose, sneezing, and stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of heat, and feeling of fatigue.

Rare(may occur in 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of compression in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensations in the eye, swelling of the eyes or eyelids, small particles or spots in the field of vision, seeing halos around light sources, pupil dilation, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden loss of hearing.

After the introduction of sildenafil-containing medicine to the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important to note that in most, but not all, men who experienced these side effects, heart function disorders occurred before taking the sildenafil-containing medicine. It is not possible to determine whether these side effects were related to the use of Actigra or Actigra Forte medicines.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Actigra and Actigra Forte medicines

The medicine should be stored in a place that is out of sight and reach of children.

There are no special recommendations for storing the medicine.

You should not use this medicine after the expiry date stated on the blister pack and carton after EXP:

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Actigra and Actigra Forte medicines contain

• The active substance of the medicine is sildenafil. Actigra, 25 mg Each film-coated tablet contains 25 mg of sildenafil (as sildenafil citrate).

Actigra Forte, 50 mg

Each film-coated tablet contains 50 mg of sildenafil (as sildenafil citrate).

• Other ingredients are:
• Core: Calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium
• Coating: Hypromellose 6 mPa·s, titanium dioxide (E171), macrogol 6000, talc, indigo carmine (E132), lacquer

What Actigra and Actigra Forte medicines look like and what the pack contains

Actigra, 25 mg

Actigra 25 mg film-coated tablets are blue, elongated, biconvex, 5.1 mm ± 0.5 mm in width and 10.2 mm ± 1.0 mm in length, with the inscription "25" on one side.

Packaging available

Aluminum/PVC blisters in a carton containing 2, 4, or 8 film-coated tablets.

Actigra Forte, 50 mg

Actigra Forte 50 mg film-coated tablets are blue, elongated, biconvex, 7.7 mm ± 0.8 mm in width and 12.9 mm ± 1.3 mm in length, with the inscription "50" on one side.

Packaging available

Aluminum/PVC blisters in a carton containing 2 or 4 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Biofarm Sp. z o.o.

ul. Wałbrzyska 13

60-198 Poznań

Tel. +48 61 66 51 500

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo 6

28760 Tres Cantos, Madrid

Spain

Biofarm Sp. z o.o.

ul. Wałbrzyska 13

60-198 Poznań

Date of last revision of the leaflet: 15.04.2025