Vardenafilo ratio 10 mg comprimidos recubiertos con pelicula efg

Prospect: information for the patient

Vardenafilo ratio 10 mg film-coated tablets EFG

vardenafilo

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Vardenafilo ratio and what it is used for

2. What you need to know before starting to take Vardenafilo ratio

3. How to take Vardenafilo ratio

4. Possible adverse effects

5. Storage of Vardenafilo ratio

6. Contents of the pack and additional information

This medication contains vardenafilo, an active ingredient in the group of medications known as phosphodiesterase 5 inhibitors, which are used to treat erectile dysfunction in adult men, a condition that consists of difficulty in achieving or maintaining an erection.

At least one in ten men has, at some point, problems achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and vascular alterations result in insufficient blood in the penis to achieve and maintain an erection.

Vardenafilo will only act when sexually stimulated. This medication reduces the action of a natural substance in the body that prevents an erection. Vardenafilo allows for an erection with a sufficient duration to maintain a satisfactory sexual relationship.

Do not take Vardenafilo ratio

- If you are allergic to vardenafil or any of the other components of this medication (listed in section 6). Signs of an allergic reaction include skin rash, itching, swelling on the face or lips, and difficulty breathing.

- If you are taking medications that contain nitrates, such as glyceryl trinitrate for angina, or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafil may severely affect your blood pressure.

- If you are taking ritonavir or indinavir, medications for the treatment of human immunodeficiency virus (HIV) infections.

- If you are over 75 years old and taking ketoconazole or itraconazole, antifungal medications.

- If you have a serious heart or liver problem.

- If you are undergoing renal dialysis.

- If you have recently experienced a stroke or heart attack.

- If you have low blood pressure, or if you have had it in the past.

- If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).

- If you have ever experienced vision loss due to a lack of blood supply to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy (NAION).

- If you are taking riociguat. This medication is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as vardenafil, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vardenafilo ratio.

Be especially careful with Vardenafilo ratio

- If you have heart problems, as having sex may pose a risk to you.

- If you have irregular heartbeats (arrhythmia) or any hereditary heart disease that alters your electrocardiogram.

- If you have any physical condition that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernous fibrosis.

- If you have a disease that may cause erections that do not go away (priapism). For example, sickle cell anemia, multiple myeloma, and leukemia.

- If you have a stomach ulcer (also known as a gastric or peptic ulcer).

- If you have bleeding disorders (such as hemophilia).

- If you are using any other treatment for erectile dysfunction, including vardenafil tablets (see the section: "Taking Vardenafilo ratio with other medications").

- If you have ever experienced sudden, temporary, or permanent loss of vision in one eye, do not take vardenafil and consult your doctor immediately.

Children and adolescents

Vardenafilo ratio should not be used in children or adolescents under 18 years old.

Taking Vardenafilo ratio with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may cause problems, especially the following:

- Nitrates, medications for angina or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafil may severely affect your blood pressure.

- Medications for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.

- Ritonavir or indinavir, medications for HIV.

- Ketoconazole or itraconazole, antifungal medications.

- Erythromycin or clarithromycin, macrolide antibiotics.

- Alpha-blockers, a group of medications used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia).

- Riociguat.

Do not take vardenafil tablets with another medication for erectile dysfunction, including vardenafil tablets.

Taking Vardenafilo ratio with food, drinks, and alcohol

- You can take vardenafil with or without food, but it is recommended not to do so after a large meal or with a high-fat content, as the effect may be delayed.

- Do not drink grapefruit juice while taking vardenafil, as it may interfere with the normal effect of the medication.

- Drinking alcoholic beverages may worsen erectile dysfunction.

Pregnancy and breastfeeding

Vardenafilo ratio should not be used in women.

Driving and operating machinery

In some people, Vardenafilo ratio may cause dizziness or affect vision. Do not drive or operate tools or machinery if you feel dizzy or have vision problems after taking Vardenafilo ratio.

Vardenafilo ratio contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per film-coated tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take a vardenafilo tablet 25 to 60 minutes before sexual activity. With sexual stimulation, you can obtain an erection from 25 minutes to four or five hours after taking vardenafilo.

- Swallow the tablet with a glass of water.

Do not take Vardenafilo ratio with any other vardenafilo formulation.

Do not take vardenafilo more than once a day.

If you estimate that the action of vardenafilo is too strong or weak, inform your doctor. They may suggest switching to another vardenafilo formulation with a different dose based on the effect it has on you.

If you take more Vardenafilo ratio than you should

Taking too many vardenafilo tablets can cause more side effects and produce intense back pain.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, vardenafil can cause side effects, although not everyone will experience them. Most of these side effects are mild or moderate.

Some patients have experienced a decrease in vision or partial loss of vision, sudden, temporary, or permanent, in one or both eyes. If you experience this, stop taking vardenafil and contact your doctor immediately.

Cases of sudden decrease or loss of hearing have also been reported.

Cases of sudden death, rapid or irregular heartbeats, heart attacks, chest pain, and cerebral circulation problems (including temporary decrease in blood flow to parts of the brain and cerebral hemorrhage) have been reported in men taking vardenafil. Most men who have experienced these side effects had pre-existing heart problems before taking this medication. It is not possible to determine if these events were directly related to vardenafil.

The possibility of presenting an adverse effect is described using the following categories:

Very common(may affect more than 1 in 10 people)

-Headache.

Common(may affect up to 1 in 10 people)

-Dizziness.

-Facial flushing.

-Nasal congestion or rhinorrhea.

-Indigestion.

Uncommon(may affect up to 1 in 100 people)

-Swelling of the skin and mucous membranes, including facial, lip, or throat swelling.

-Sleep disturbances.

-Numbness and alteration of tactile perception.

-Drowsiness.

-Effects on vision; subconjunctival hemorrhage, effects on color vision, eye pain, and photosensitivity.

-Tinnitus; vertigo.

-Palpitations or rapid pulse.

-Dyspnea.

-Blocked nose.

-Reflux, gastritis, abdominal pain, diarrhea, vomiting, nausea, dry mouth.

-Elevation of liver enzymes in blood.

-Skin eruptions, skin redness.

-Back pain or muscle pain; elevated creatine phosphokinase in blood; muscle rigidity.

-Prolonged erection.

-General malaise.

Rare(may affect up to 1 in 1,000 people)

-Ocular inflammation (conjunctivitis).

-Allergic reaction.

-Anxiety.

-Syncope.

-Amnesia (memory loss).

-Seizures.

-Glaucoma (increased intraocular pressure), watery eyes.

-Effects on the heart (such as myocardial infarction, tachycardia, or angina).

-Hypertension or hypotension.

-Nasal bleeding.

-Alterations in liver function test results in blood.

-Sensitivity to sunlight.

-Painful erection.

-Chest pain.

-Temporary decrease in blood flow to parts of the brain

Very rare(may affect fewer than 1 in 10,000 people)or unknown frequency(cannot be estimated from available data)

-Blood in urine (hematuria).

-Bleeding in the penis (hemorrhagic penile).

-Blood in semen (hematospermia).

-Sudden death.

-Cerebral hemorrhage.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not take this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Vardenafilo ratio 10 mg film-coated tablets EFG

• The active ingredient is vardenafil. Each film-coated tablet contains 10 mg of vardenafil (as vardenafil hydrochloride)
• The other excipients are:

Core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.

Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol/PEG 3350 (E1521), acrylate copolymer type A, yellow iron oxide (E172), sodium bicarbonate (E500 (ii)), red iron oxide (E172).

Appearance of the product and content of the packaging

Vardenafilo ratio 10 mg film-coated tablets EFG are yellowish clear tablets of 7 mm, marked with“A721”on one side.

The tablets are available in blisters containing 2, 4, 8, 12, 20, 24, 36or48 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid (Spain)

Responsible manufacturer

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000 Malta

Last review date of thisleaflet: November 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/