PATIENT INFORMATION LEAFLET

Sildenafil Maxmind 25 mg, 50 mg and 100 mg film-coated tablets

Sildenafil
Generic medicine
Please 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 questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Sildenafil tablets are and what they are used for
What you need to know before taking Sildenafil tablets
How to take Sildenafil tablets
Possible side effects
How to store Sildenafil tablets
Contents of the pack and other information

1. What Sildenafil tablets are and what they are used for

Sildenafil tablets contain the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing blood flow to this organ when sexually stimulated. Sildenafil tablets will help you achieve an erection only if you are sexually stimulated.
Sildenafil tablets are a treatment for adult men who have erectile dysfunction, sometimes called impotence. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse.

2. What you need to know before taking Sildenafil tablets

Do not take Sildenafil tablets

If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
If you are taking medicines called nitrates, because this combination can cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina attacks (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
If you are using medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination may also cause a dangerous reduction in blood pressure.
If you are taking riociguat. This medicine 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 due to blood clots). PDE5 inhibitors, such as Sildenafil tablets, have been shown to increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.
If you have a serious heart or liver problem.
If you have recently had a stroke or heart attack, or if you have low blood pressure.
If you have a rare inherited eye disease (such as retinitis pigmentosa).
If you have previously experienced vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil tablets

If you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell tumor), or multiple myeloma (a bone marrow tumor).
If you have a penile deformity or Peyronie's disease.
If you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual activity.
If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
If you experience a sudden decrease or loss of vision, stop taking Sildenafil tablets and contact your doctor immediately.

You must not use Sildenafil tablets together with other oral or topical treatments for
erectile dysfunction.
You must not use Sildenafil tablets together with treatments for pulmonary arterial
hypertension (PAH) containing sildenafil or with any other phosphodiesterase type
5 (PDE5) inhibitors.
You must not take Sildenafil tablets if you do not have erectile dysfunction.
You must not take Sildenafil tablets if you are a woman.
Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to
prescribe a lower dose.
Children and adolescents
Sildenafil tablets must not be given to individuals under 18 years of age.
Other medicines and Sildenafil tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines.
Sildenafil tablets may interact with certain medicines, particularly those used
to treat chest pain. In case of a medical emergency, you must inform your doctor, pharmacist, or nurse that you have taken Sildenafil tablets and when you took them. Do not take Sildenafil tablets with other medicines unless authorized by your doctor.
Do not take Sildenafil tablets if you are taking medicines called nitrates,
because the combination of these medicines can cause a dangerous drop in blood
pressure.
Always inform your doctor, pharmacist, or nurse if you are taking any of these
medicines, which are often used to relieve angina pectoris attacks (or "chest
pain").
Do not take Sildenafil tablets if you are using medicines known as
nitric oxide donors, such as amyl nitrite ("poppers"), because this combination
may cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, such as those used in the treatment
of HIV, your doctor may initially prescribe the lowest dose of Sildenafil tablets (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness, which may be due to low blood pressure when sitting down or standing up quickly. Some patients have experienced these symptoms while taking Sildenafil tablets together with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil tablets. To reduce the likelihood of these symptoms, you should be on a stable dose of an alpha-blocker before starting treatment with Sildenafil tablets. Your doctor may start you on a lower dose of Sildenafil tablets (25 mg).
Medicines containing sacubitril/valsartan, used to treat heart failure.
Sildenafil tablets with food, drinks, and alcohol
Sildenafil tablets can be taken with or without food. However, you may notice that
the onset of action of Sildenafil tablets is slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from this medicine, it is advisable to avoid excessive alcohol consumption before taking Sildenafil tablets.
Pregnancy, breastfeeding, and fertility
Sildenafil tablets are not indicated for use in women.
Driving and using machines
Sildenafil tablets may cause dizziness and affect vision. Before driving or operating machinery, you should be aware of how you react to Sildenafil tablets.

3. How to take Sildenafil tablets

Always take Sildenafil tablets exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Do not take Sildenafil tablets more than once a day.
Do not take Sildenafil film-coated tablets in combination with Sildenafil orodispersible tablets.
Take Sildenafil tablets approximately one hour before anticipated sexual activity.
Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil tablets is too strong or too weak, consult your doctor or pharmacist.
Sildenafil tablets will help you achieve an erection only if you are sexually stimulated. The time required for Sildenafil tablets to take effect varies from person to person, but generally ranges from half an hour to one hour. You may notice that the onset of action of Sildenafil tablets is slower if taken after a heavy meal.
If Sildenafil tablets do not help you achieve an erection, or if the erection does not last long enough to complete sexual intercourse, inform your doctor.
If you take more Sildenafil tablets than you should:
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than prescribed by your doctor.
Contact your doctor if you take more tablets than prescribed.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects reported with Sildenafil tablets are usually mild to moderate in intensity and
short-lived.
If you experience any of the following serious side effects, stop taking Sildenafil tablets
immediately and contact your doctor straight away:

Allergic reaction – occurs with uncommon frequency (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pain – occurs with uncommon frequency: If this occurs during or after sexual intercourse:
- Sit semi-reclined and try to relax.
- Do not use nitrates to treat chest pain.
Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people). If this type of erection lasts more than 4 hours, contact your doctor immediately.
Sudden decrease or loss of vision – occurs rarely.
Severe skin reactions – occur rarely. Symptoms may include severe skin peeling and swelling, blisters in the mouth, genital area or around the eyes, fever.
Seizures or convulsions – occur rarely.

Other side effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (symptoms include a sudden feeling of warmth in the upper part of the body), indigestion, increased intensity of colours in vision, blurred vision, visual disturbances, nasal congestion, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, light flashes, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, sensation of throat tightness, numbness of the mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or particles in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability, sudden decrease or loss of hearing.

Rare cases of unstable angina (a heart condition) and sudden death have been reported after the medicine was marketed. It should be noted that most, but not all, of the men who experienced these side effects already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events are directly related to the use of Sildenafil tablets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions regarding temperature.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sildenafil tablets contain
The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate
equivalent to 25 mg, 50 mg or 100 mg of sildenafil.
The excipients are
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate,
sodium croscarmellose, hypromellose and magnesium stearate.
Film coating: Hypromellose 6 cP, titanium dioxide (E171), triacetin and aluminium lake with indigo carmine (E132).
Description of the appearance of Sildenafil tablets and contents of the pack
25 mg: film-coated tablets, rhomboid-shaped, blue in colour, marked "CL 35" on one
side and smooth on the other.
50 mg: film-coated tablets, rhomboid-shaped, blue in colour, marked "CL 36" on one
side and smooth on the other.
100 mg: film-coated tablets, rhomboid-shaped, blue in colour, marked "CL 37" on one
side and smooth on the other.
The tablets are supplied in blisters.
Pack sizes:
25 mg: 2, 4, 8, 12, 24 tablets.
50 mg: 2, 4, 8, 12, 20, 24, 48, 60 tablets.
100 mg: 2, 4, 8, 10, 12, 20, 24, 30, 36, 48, 60, 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Maxmind Pharmaceutical GmbH
Dorotheenstrasse 48
22301 Hamburg, Germany
Manufacturer
Macleods Pharma UK Limited
Wynyard Park House, Wynyard Avenue,
Wynyard, Billingham, TS22 5TB, United Kingdom
Synoptis Industrial Sp. z o.o
ul. Rabowicka 15
Swarzędz, 62-020, Poland
This patient information leaflet was last revised in 02/2026