Cialis 5mg Film-Coated Tablets - Patient Information Leaflet (PIL) - (emc)

CIALIS^® 5 mg Film-Coated Tablets

Active ingredient: tadalafil

CIALIS contains tadalafil, a drug that is classified as a phosphodiesterase type 5 inhibitor, utilized for specific therapeutic applications.

CIALIS 5 mg is indicated for adult men diagnosed with:

• Erectile dysfunction: a condition where a male is unable to achieve or maintain a firm, erect penis sufficient for sexual activity. CIALIS significantly enhances the capability to achieve an erection. Upon sexual stimulation, CIALIS promotes relaxation of the blood vessels within the penis, facilitating increased blood flow and enhancing erectile function. It is essential to note that CIALIS is ineffective without sexual stimulation, and foreplay with your partner is necessary.
• Urinary symptoms stemming from benign prostatic hyperplasia (BPH): This condition is characterized by an enlarged prostate gland with age. Symptoms may include difficulty initiating urination, the sensation of incomplete bladder emptying, and an increased frequency of urination, particularly at night. CIALIS fosters better blood circulation and muscle relaxation in the prostate and bladder, potentially alleviating the symptoms of BPH, with noticeable improvements seen as early as 1-2 weeks post initiation of treatment.

• If you are allergic to tadalafil or any other ingredients present in this medication (refer to section 6).
• If you are using any form of organic nitrates or nitric oxide donors such as amyl nitrite, which are medications prescribed for angina (chest pain). CIALIS may amplify the effects of these substances. Consult your physician if you are currently on nitrates or have any uncertainties.
• Individuals with significant heart disease or who have recently suffered a heart attack (within the past 90 days).
• Those who have experienced a stroke within the last 6 months.
• Individuals with low blood pressure or poorly controlled hypertension.
• If you have a medical history of vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
• You should not use riociguat concurrently, as it treats pulmonary arterial hypertension and may heighten the hypotensive effects when combined with PDE5 inhibitors like CIALIS. Inform your doctor if you are taking riociguat or are unsure.

Prior to taking CIALIS, consult with your healthcare provider.

Be advised that sexual activity poses a potential risk for those with pre-existing heart conditions due to added stress on the heart. Disclosure of any heart-related issues to your physician is essential.

Given that benign prostatic hyperplasia and prostate cancer can present similar symptoms, your doctor will perform checks for prostate cancer before prescribing CIALIS for BPH treatment. Note that CIALIS does not treat prostate cancer.

Before commencing therapy, inform your physician if you have:

• Sickle cell anemia (a blood disorder).
• Multiple myeloma (a type of blood cancer).
• Leukemia (cancer affecting blood cells).
• Any structural deformities of the penis.
• Severe liver impairment.
• Severe renal impairment.

The efficacy of CIALIS in patients who have undergone:

• Pelvic surgery.
• Radical non-nerve-sparing prostatectomy (partial or complete removal of the prostate where nerves are also cut).

If you experience sudden vision loss or distorted vision while on CIALIS, cease use immediately and contact your healthcare provider without delay.

Some patients on tadalafil have reported sudden hearing loss. Although causation remains unclear, should you experience such symptoms, discontinuation is warranted and consult your doctor promptly.

CIALIS is not approved for use in women.

CIALIS is contraindicated for children and adolescents under 18 years of age.

Notify your healthcare provider if you are currently taking, have recently taken, or anticipate taking any other medications.

CIALIS should not be taken if you are already on nitrates.

Be aware that certain drugs may interact with CIALIS or potentially affect its efficacy. Inform your healthcare professional or pharmacist if you are currently taking:

• Alpha blockers (used for treating high blood pressure or urinary issues tied to BPH).
• Other antihypertensive medications.
• Riociguat.
• 5-alpha reductase inhibitors (for BPH treatment).
• Antifungal medications, such as ketoconazole, and protease inhibitors for HIV treatment.
• Anticonvulsants like phenobarbital, phenytoin, or carbamazepine.
• Antibiotics like rifampicin, erythromycin, or clarithromycin, and antifungals such as itraconazole.
• Other erectile dysfunction medications.

For information regarding the impact of alcohol, please refer to section 3. Grapefruit juice may alter the functionality of CIALIS and should be consumed with care. Consult your physician for further details.

Research on animals has shown that treatment may result in reduced sperm production in the testes. Among some males, a decrease in sperm count has been noted, although these effects are unlikely to result in infertility.

Dizziness has been reported by some males in clinical studies involving CIALIS. It is recommended to assess your reaction to the medication before engaging in activities requiring mental alertness, such as driving or operating machinery.

If your doctor has indicated an intolerance to certain sugars, please consult your healthcare provider before using this medication.

This medication contains less than 1 mmol sodium (23 mg) per tablet, essentially rendering it ‘sodium-free’.