REMIDIA 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Remidia, 20 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Remidia and what is it used for
4. Important information before taking Remidia
   1. When not to take Remidia:
   2. Warnings and precautions
   3. Children
   4. Remidia and other medicines
   5. Remidia with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Remidia contains lactose monohydrate and sodium
5. How to take Remidia
   1. Use in children and adolescents
   2. Taking a higher dose of Remidia than recommended
   3. Missing a dose of Remidia
   4. Stopping treatment with Remidia
6. Possible side effects
   1. Reporting side effects
7. How to store Remidia
8. Contents of the pack and other information
   1. What Remidia contains
   2. What Remidia looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

Remidia, 20 mg, Film-Coated Tablets

Sildenafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Remidia and what is it used for
• 2. Important information before taking Remidia
• 3. How to take Remidia
• 4. Possible side effects
• 5. How to store Remidia
• 6. Contents of the pack and other information

1. What is Remidia and what is it used for

Remidia contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5).
Remidia lowers blood pressure in the lungs by relaxing blood vessels.
Remidia is used to treat high blood pressure in the pulmonary arteries (pulmonary arterial hypertension) in adults, children, and adolescents from 1 to 17 years of age.

2. Important information before taking Remidia

When not to take Remidia:

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates or medicines that release nitric oxide, such as amyl nitrite. These medicines are used to treat chest pain (angina pectoris). Remidia may enhance the effects of these medicines, and therefore, you should inform your doctor about taking them. In case of doubt, consult your doctor or pharmacist.
• 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 Remidia, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, inform your doctor.
• If you have recently had a stroke, heart attack, or have severe liver disease, or very low blood pressure (<90>
• If you are taking medicines used to treat fungal infections, such as ketoconazole, itraconazole, or ritonavir (used to treat HIV).
• If you have ever had a loss of vision due to a condition called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before taking Remidia, discuss it with your doctor.
Tell your doctor about:

• disease related to blockage or narrowing of a vein in the lungs, rather than blockage or narrowing of an artery;
• severe heart disease;
• abnormal blood flow through the heart chambers;
• increased blood pressure in the pulmonary blood vessels;
• decreased blood pressure at rest;
• loss of large amounts of fluid (dehydration), which may occur due to excessive sweating or insufficient fluid intake. This may also occur in case of fever, vomiting, or diarrhea.
• rare, inherited eye disease (retinitis pigmentosa);
• abnormalities related to red blood cells (sickle cell anemia), blood cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease of the penis or its anatomical deformity;
• peptic ulcer disease, bleeding disorders (such as hemophilia), or frequent nosebleeds;
• taking medicines used to treat erectile dysfunction.

During treatment with phosphodiesterase type 5 inhibitors, including sildenafil, the following side effects have been reported, with unknown frequency, related to vision disorders: partial, unexpected, transient, or permanent loss of vision, or decreased vision in one or both eyes.
In case of sudden loss of vision, stop taking Remidia and immediately consult a doctor(see also section 4).
In men taking sildenafil, prolonged and sometimes painful erections have been observed. In case of an erection lasting longer than 4 hours, stop taking Remidia and immediately consult a doctor(see also section 4).
Taking the medicine in patients with kidney or liver disease
Tell your doctor if you have kidney or liver disease, as it may be necessary to adjust the dose of the medicine.

Children

Remidia should not be used in children under 1 year of age.

Remidia and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• Medicines containing nitrates or nitric oxide-releasing medicines, such as amyl nitrite (so-called poppers). These medicines are used to treat angina pectoris or chest pain (see section 2 "Important information before taking Remidia").
• Riociguat.
• Other treatments for pulmonary hypertension (e.g., bosentan, iloprost) used at the same time.
• Medicines containing St. John's Wort, rifampicin (an antibiotic), carbamazepine, phenytoin, or phenobarbital (used, among other things, to treat epilepsy).
• Blood-thinning medicines (e.g., warfarin), although they did not cause side effects.
• Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics), saquinavir (used to treat HIV), or nefazodone (used to treat depression), as it may be necessary to adjust the dose.
• Alpha-adrenergic blockers (e.g., doxazosin), used to treat high blood pressure or enlarged prostate, as taking these medicines together may cause symptoms that lead to low blood pressure (e.g., dizziness, feeling of emptiness in the head).
• Medicines containing sacubitril with valsartan, used to treat heart failure.

Remidia with food and drink

Do not drink grapefruit juice while taking Remidia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Remidia should only be used during pregnancy if it is absolutely necessary.
It is not recommended to use Remidia in women of childbearing age unless they use appropriate contraceptive methods.
Remidia passes into breast milk in very small amounts and is not expected to harm the baby.

Driving and using machines

Remidia may cause dizziness and vision disturbances. Check your reaction to the medicine before driving or operating machinery.

Remidia contains lactose monohydrate and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking the medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially sodium-free.

3. How to take Remidia

Always take this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor or pharmacist.
The recommended dose for adults is 20 mg three times a day (taken every 6-8 hours), with or without food.

Use in children and adolescents

For children and adolescents from 1 to 17 years of age, the recommended dose is 10 mg three times a day for children and adolescents with a body weight of ≤20 kg or 20 mg three times a day for children and adolescents with a body weight of >20 kg, with or without food. Do not use higher doses in children. This medicine should only be used when a dose of 20 mg three times a day is given. For patients with a body weight of ≤20 kg and other younger patients who cannot swallow tablets, another medicinal product containing sildenafil in an appropriate pharmaceutical form - suspension - is available.

Taking a higher dose of Remidia than recommended

Do not take more than the recommended dose of the medicine.
If you have taken more than the recommended dose of the medicine, contact your doctor immediately. Taking more than the recommended dose of Remidia may increase the risk of side effects.

Missing a dose of Remidia

If you miss a dose of Remidia, take it as soon as possible and continue taking the medicine as scheduled. Do not take a double dose to make up for a missed dose.

Stopping treatment with Remidia

Sudden withdrawal of Remidia may worsen your condition. Do not stop taking the medicine without consulting your doctor. Your doctor may decide to gradually reduce the dose of the medicine over several days before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Remidia can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Remidia and consult a doctor immediately(see also section 2):

• sudden loss of vision (frequency unknown),
• erection lasting longer than 4 hours. In men taking sildenafil, prolonged and sometimes painful erections have been observed (frequency unknown).

Adults
Very common (affecting more than 1 in 10 people) side effects include: headache, sudden reddening of the face, indigestion, diarrhea, and pain in the arms or legs.
Common (affecting less than 1 in 10 people) side effects include:
subcutaneous infections, flu-like symptoms, sinusitis, decreased red blood cell count (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremors, tingling, burning sensation, decreased skin sensitivity, bleeding in the back of the eye, vision disturbances, blurred vision, increased sensitivity to light, color vision disturbances, eye irritation, conjunctival congestion (red eyes), dizziness, bronchitis, nosebleeds, runny nose, cough, inflammation of the stomach and intestines, heartburn, hemorrhoids, bloating, dry mouth, hair loss, skin reddening, night sweats, muscle pain, back pain, and increased body temperature.
Uncommon (affecting less than 1 in 100 people) side effects include:
decreased visual acuity, double vision, abnormal eye sensations, penile bleeding, blood in semen and/or urine, and breast enlargement in men.
Also reported with unknown frequency (frequency cannot be estimated from available data): skin rash, sudden hearing loss, and decreased blood pressure.

Children and adolescents
The following serious side effects have been reported: pneumonia, heart failure, right ventricular failure, cardiogenic shock, increased pulmonary arterial pressure, chest pain, syncope, respiratory tract infections, bronchitis, viral gastroenteritis, urinary tract infections, and tooth decay.
Serious side effects considered to be related to treatment and reported with unknown frequency (affecting less than 1 in 100 people) include:
allergic reactions (such as skin rash, face, lips, tongue, or throat swelling, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, gastrointestinal inflammation, wheezing due to airway obstruction.
Very common (affecting more than 1 in 10 people) side effects include: headache, vomiting, throat infections, fever, diarrhea, flu, and nosebleeds.
Common (affecting less than 1 in 10 people) side effects include:
nausea, increased frequency of erections, pneumonia, and runny nose.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Remidia

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Remidia contains

• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as sildenafil citrate).
• The other ingredients are:
• Tablet core: mannitol, crospovidone (type A), povidone (K30), colloidal anhydrous silica, corn starch, magnesium stearate, sodium lauryl sulfate.
• Coating: hypromellose (type 2910), macrogol 3350, lactose monohydrate, titanium dioxide (E 171), triacetin.

What Remidia looks like and contents of the pack

Remidia is a white, round, biconvex, film-coated tablet with a diameter of 5 mm, in a cardboard box.
The pack contains 90 film-coated tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Date of last revision of the leaflet:June 2022