Activra

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Package leaflet: information for the patient

Actigra, 25 mg, film-coated tablets
Actigra Forte, 50 mg, film-coated tablets
Sildenafilum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, please consult a pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after using the medicine, or if the patient feels worse, medical advice should be sought.

Table of contents

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 pack 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 (PDE5) inhibitors. These medicines work by helping to relax blood vessels in the penis, thereby increasing blood flow during sexual stimulation. Actigra and Actigra Forte help achieve an erection only when sexual stimulation is present.
Actigra and Actigra Forte are used to treat erectile dysfunction in adult men, i.e. impotence. This refers to the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Actigra and Actigra Forte medicines

When not to use Actigra and Actigra Forte medicines:

• If the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking nitrates, as their concomitant use may lead to a dangerous decrease in blood pressure. The patient should inform the doctor if taking any medicines from this group. These medicines are often used to relieve symptoms of angina (chest pain). In case of doubt, consult a doctor or pharmacist.
• If the patient is taking drugs that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concomitant use may also lead to a dangerous decrease in blood pressure.
• If the patient is 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). PDE5 inhibitors such as Actigra and Actigra Forte have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.
• If the patient has severe heart or liver disease.
• If the patient has recently had a stroke or heart attack, or has low blood pressure.
• If the patient has inherited degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Actigra or Actigra Forte, discuss this with a doctor or pharmacist if:

• The patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• The patient has anatomical deformity of the penis or Peyronie's disease.
• The patient has heart problems. In such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
• The patient has peptic ulcer disease or bleeding disorders (such as hemophilia).
• If sudden worsening of vision or sudden vision loss occurs, the patient should stop taking Actigra or Actigra Forte and contact a doctor immediately.

Actigra and Actigra Forte medicines should not be used simultaneously with other orally or locally administered treatments for erectile dysfunction.
Actigra and Actigra Forte medicines should not be used simultaneously with arterial pulmonary hypertension (PAH) therapies using sildenafil or other PDE5 inhibitors.
Actigra and Actigra Forte should not be taken if erectile dysfunction has not been diagnosed.
Actigra and Actigra Forte medicines are not intended for use by women.

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. Patients with impaired kidney or liver function should not take a dose higher than 25 mg of sildenafil (should not use Actigra Forte).

Children and adolescents
Actigra and Actigra Forte should not be used in individuals under 18 years of age.

Actigra and Actigra Forte with other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Actigra and Actigra Forte may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and immediate medical attention is required, inform the doctor, pharmacist, or nurse about taking Actigra or Actigra Forte and the time of administration.
Do not take Actigra or Actigra Forte with other medicines without a doctor's recommendation.
Do not take Actigra or Actigra Forte if the patient is taking nitrates, as their concomitant use may lead to a dangerous decrease in blood pressure.
Always inform the doctor or pharmacist if the patient is taking nitrates used to treat angina (chest pain).
Do not take Actigra or Actigra Forte if the patient is taking drugs that release nitric oxide (such as amyl nitrite), as their concomitant use may also cause a dangerous decrease in blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
If the patient is taking protease inhibitors used in the treatment of HIV infection, consult a doctor before taking Actigra or Actigra Forte; in such cases, treatment should start with a lower dose (25 mg - Actigra).
In some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting up. Such symptoms have been reported in some patients taking Actigra or Actigra Forte together with alpha-blockers. These symptoms are most likely to occur within 4 hours after taking Actigra or Actigra Forte. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Actigra or Actigra Forte. The doctor may decide to start with a lower initial dose (25 mg - Actigra).
If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit until symptoms subside. Drinking water, getting fresh air, and crossing the legs may also help. Avoid rapid standing or sitting up.
If the patient is taking medicines containing sacubitril with valsartan (used in the treatment of heart failure), they should inform their doctor or pharmacist.

Actigra and Actigra Forte with food, drink, and alcohol
Actigra or Actigra Forte may be taken with or without food. However, taking Actigra or Actigra Forte with a heavy meal may delay the onset of the medicine's effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of Actigra or Actigra Forte, significant alcohol intake should be avoided 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. Patients should assess how they react to Actigra and Actigra Forte before driving or operating machinery.

Actigra and Actigra Forte contain less than 1 mmol (23 mg) of sodium per recommended dose unit, meaning 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 information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 25 mg of sildenafil – Actigra medicine.
If the patient has previously taken medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg – Actigra Forte medicine. Otherwise, Actigra Forte at a dose of 50 mg should only be used if the patient did not achieve the desired effect (i.e. did not obtain an erection sufficient for sexual intercourse) after taking sildenafil at a dose of 25 mg.
If treatment with a lower dose of sildenafil (25 mg) enabled an erection sufficient for sexual intercourse, a 50 mg dose should not be used.
Actigra and Actigra Forte must not be taken more than once a day.
Do not take Actigra and Actigra Forte together with other medicines containing sildenafil, including sildenafil tablets that dissolve in the mouth.
Take Actigra or Actigra Forte approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If you feel the effect of Actigra or Actigra Forte is too strong or too weak, consult your doctor or pharmacist.
Actigra and Actigra Forte enable an erection only in the presence of sexual stimulation. The time it takes for Actigra or Actigra Forte to take effect varies between patients, usually between half an hour and one hour. The effect may occur later if the medicine is taken after a heavy meal.
Contact your doctor if, after taking Actigra or Actigra Forte, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Actigra and Actigra Forte
Adverse effects may occur more frequently and may be more severe.
Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than indicated in the patient information leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with the use of Actigra and Actigra Forte medicines are
usually mild or moderate in intensity and short-lived.
If any of the following adverse reactions occur, stop taking Actigra or Actigra Forte and seek
immediate medical help:

• Allergic reaction – occurs uncommonly (may occur in 1 out of 100 patients). Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs uncommonly. If chest pain occurs during or after sexual intercourse:
  • adopt a semi-sitting position and try to relax,
  • do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (may occur in 1 out of 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden decrease or loss of vision – occurs rarely
• Severe skin reactions – occur rarely. Symptoms may include severe skin peeling and swelling, formation of blisters in the mouth, on the genitals and around the eyes, fever.
• Seizures or fits – occur rarely

Other adverse reactions:
Very common (may occur in more than 1 out of 10 patients): headache.
Common (may occur in 1 out of 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of warmth in the upper part of the body), indigestion, coloured vision, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may occur in 1 out of 100 patients): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, watery eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, reduced sense of touch, dizziness, tinnitus, dry mouth, blocked or stuffy sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or feet, nosebleeds, feeling of warmth and feeling of fatigue.
Rare (may occur in 1 out of 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of tightness in the throat, numbness of the lips, bleeding into the back of the eye, double vision, reduced visual acuity, abnormal sensations inside 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 discolouration of the white part of the eye, rectal bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden weakness or loss of hearing.
Since 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 adverse reactions, heart problems were already present before taking sildenafil-containing medicines. It is not possible to determine whether these adverse reactions were related to the use of Actigra or Actigra Forte.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Actigra and Actigra Forte medicines

Keep the medicine out of the sight and reach of children.
There are no special storage requirements for this medicine.
Do not use the medicine after the expiry date stated on the blister and the cardboard
package after EXP:
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Actigra and Actigra Forte medicines contain

• The active substance is sildenafil.
  Actigra 25 mg: Each coated tablet contains 25 mg of sildenafil (as sildenafil citrate).

Actigra Forte 50 mg: Each coated tablet contains 50 mg of sildenafil (as sildenafil citrate).

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

What Actigra and Actigra Forte medicines look like and contents of the pack
Actigra 25 mg
Actigra 25 mg coated tablets are blue, elongated, biconvex, with a width of 5.1 mm ± 0.5 mm and length of 10.2 mm ± 1.0 mm, imprinted with the number "25" on one side.
Pack sizes available
Aluminium/PVC blisters in cardboard packaging containing 2, 4 or 8 coated tablets.

Actigra Forte 50 mg
Actigra Forte 50 mg coated tablets are blue, elongated, biconvex, with a width of 7.7 mm ± 0.8 mm and length of 12.9 mm ± 1.3 mm, imprinted with the number "50" on one side.
Pack sizes available
Aluminium/PVC blisters in cardboard packaging containing 2 or 4 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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