ACTIGRA 50 mg Tablets

Contents of the leaflet

1. Before taking the medicine, use the included diagnostic tool!
2. Leaflet attached to the packaging: patient information
3. Actigra, 25 mg, film-coated tablets
4. Actigra Forte, 50 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What are Actigra and Actigra Forte and what are they used for
6. Important information before taking Actigra and Actigra Forte
   1. When not to take Actigra and Actigra Forte:
   2. Warnings and precautions
   3. Children and adolescents
   4. Actigra and Actigra Forte with other medicines
   5. Actigra and Actigra Forte with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
7. How to take Actigra and Actigra Forte
   1. Actigra and Actigra Forte should not be taken more than once a day.
   2. Taking a higher dose of Actigra and Actigra Forte than recommended
   3. You should not take more tablets than indicated in the patient leaflet.
8. Possible side effects
   1. In case of any of the following side effects, you should stop taking Actigra or Actigra Forte and seek medical attention immediately:
   2. Other side effects:
   3. Reporting side effects
9. How to store Actigra and Actigra Forte
10. Contents of the packaging and other information
    1. What Actigra and Actigra Forte contain
    2. What Actigra and Actigra Forte look like and what the pack contains
    3. Marketing authorization holder and manufacturer
    4. Date of last revision of the leaflet: 15.04.2025

Before taking the medicine, use the included diagnostic tool!

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 consult a pharmacist.
• If you experience any side effects, including any 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 and what are they used for
• 2. Important information before taking Actigra and Actigra Forte
• 3. How to take Actigra and Actigra Forte
• 4. Possible side effects
• 5. How to store Actigra and Actigra Forte
• 6. Contents of the packaging and other information

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

Actigra and Actigra Forte 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 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

When not to take Actigra and Actigra Forte:

• 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 concurrent use 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 a doctor or pharmacist.

If you are taking medicines that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concurrent use 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 changes in the retina, 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 treatment with Actigra or Actigra Forte, you should discuss it with your doctor or pharmacist if you have:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• 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.
• Ulcers or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden blindness, you should stop taking Actigra or Actigra Forte and immediately consult a doctor.

Actigra and Actigra Forte should not be taken concurrently with other oral or topical treatments for erectile dysfunction.

Actigra and Actigra Forte should not be taken concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

Actigra and Actigra Forte should not be taken if you have not been diagnosed with erectile dysfunction.

Actigra and Actigra Forte are not intended for women.

Special considerations for patients with kidney or liver function disorders

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

Children and adolescents

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

Actigra and Actigra Forte with 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 may interact with certain 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 and the time of its administration.

You should not take Actigra or Actigra Forte concurrently with other medicines without a doctor's recommendation.

You should not take Actigra or Actigra Forte if you are taking nitrate medicines, as their concurrent 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 if you are taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent 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 inhibitors used to treat HIV infections, you should consult a doctor before taking the medicine; in such cases, it is recommended to start treatment with a lower dose (25 mg - Actigra).

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

In case of symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending fainting), 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 with food, drink, and alcohol

Actigra or Actigra Forte can be taken with or without food. However, taking Actigra or Actigra Forte during a large meal 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, you should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Actigra and Actigra Forte may cause dizziness and visual disturbances.

Before driving or operating machinery, patients should be aware of how they react to Actigra and Actigra Forte.

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

3. How to take Actigra and Actigra Forte

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 a doctor or pharmacist.

The recommended dose is 25 mg of sildenafil - Actigra.

If you have previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg - Actigra Forte. Otherwise, Actigra Forte in a dose of 50 mg should only be taken 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 should not be taken more than once a day.

You should not take Actigra or Actigra Forte concurrently with other medicines containing sildenafil, including tablets that dissolve in the mouth.

Actigra or Actigra Forte 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 is too strong or too weak, you should consult a doctor or pharmacist.

Actigra and Actigra Forte enable an erection only if there is prior sexual stimulation. The time it takes for Actigra or Actigra Forte to work 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 or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Actigra and Actigra Forte 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 a 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 are usually mild or moderate and short-term.

In case of any of the following side effects, you should stop taking Actigra or Actigra Forte 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 an erection lasts for more than 4 hours, you should contact your doctor immediately.
• Sudden vision loss or blindness - occurs rarely
• Severe skin reactions - occur rarelySymptoms may include severe skin peeling and swelling, 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, hot flashes (symptoms include a feeling of heat in the upper body), indigestion, colored vision, blurred vision, visual disturbances, stuffy nose, dizziness.

Uncommon(may occur in 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, flashes of light, bright vision, sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, weakened sense of touch, 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 constriction 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 medicines 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 existed 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.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

The medicine should be stored out of sight and reach of children.

There are no special recommendations for storing the medicine.

Do not use this medicine after the expiration date stated on the blister pack and carton after EXP:

The expiration date means the last day of the specified month.

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 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 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 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