Cialis 20mg film-coated tablets - Patient Information Leaflet (PIL) - (emc)

• Keep this leaflet for future reference as you may need to read it again.
• If you have more questions or concerns, consult your doctor or pharmacist.
• This medication has been specifically prescribed for you. It is important not to share it with others, as it could potentially harm them—even if they exhibit similar symptoms.
• Should you experience any side effects, please inform your healthcare provider. This includes side effects not detailed in this leaflet. Consult section 4 for more information.

This leaflet covers 1. What CIALIS is and its indicated uses, 2. Necessary precautions prior to using CIALIS, 3. Guidance on how to properly take CIALIS, 4. Potential side effects associated with its use, 5. Instructions on storing CIALIS, and 6. Detailed contents of the pack along with additional information.

• If you have a known allergy to tadalafil or any other components of this medication (refer to section 6 for a complete list of ingredients).
• If you are currently using any type of organic nitrate or nitric oxide donors—such as amyl nitrite—commonly used for treating angina pectoris (chest pain), as CIALIS can enhance the effects of these medicines. Consult your physician if you are unsure of your current medications.
• If you have a history of severe heart disease or have experienced a heart attack within the last 90 days.
• If you have had a stroke in the last 6 months.
• If you suffer from low blood pressure or poorly controlled hypertension.
• If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye."
• If you are taking riociguat, which is utilized for treating pulmonary arterial hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension. PDE5 inhibitors like CIALIS may amplify the hypotensive effects of riociguat.

Prior to using CIALIS, it is crucial to discuss any pre-existing conditions with your doctor. Engaging in sexual activities may pose risks for individuals with heart disease due to the additional strain it may place on the heart. Inform your doctor if you have:

• Sickle cell anemia (a red blood cell disorder).
• Multiple myeloma (a type of blood cancer).
• Leukemia (cancer affecting blood cells).
• Any anatomical deformity of the penis.
• Serious liver issues.
• Severe renal conditions.

Moreover, the effectiveness of CIALIS in patients who have undergone:

• Pelvic surgery.
• Radical non-nerve-sparing prostatectomy (removal of the prostate gland including nerve damage) has not been established.

If you experience a sudden decrease or loss of vision while taking CIALIS, discontinue use and consult your doctor immediately.

Some patients have noted decreased or sudden hearing loss while taking tadalafil. It's unclear whether this is directly related to the medication, but if you experience such symptoms, stop taking CIALIS and seek medical advice right away.

It is important to note that CIALIS is not approved for use by women.

CIALIS is also not approved for use in individuals under the age of 18.

Inform your doctor regarding any accompanying prescriptions or medications you are currently taking, have recently taken, or might potentially take in the future. Do not consume CIALIS if you are prescribed nitrates.

Interactions with other medications can alter the effectiveness of CIALIS or lead to potential side effects. Advise your healthcare provider if you are already taking:

• An alpha blocker (used for high blood pressure or urinary symptoms related to benign prostatic hyperplasia).
• Other hypertensive agents.
• Riociguat.
• A 5-alpha reductase inhibitor (medications used for benign prostatic hyperplasia).
• Antifungals like ketoconazole or protease inhibitors for managing HIV/AIDS.
• Anticonvulsants such as phenobarbital, phenytoin, and carbamazepine.
• Antibiotics like rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other erectile dysfunction treatments.

Refer to section 3 for information concerning the effects of alcohol. Additionally, grapefruit juice may interfere with the efficacy of CIALIS and should be consumed with caution. For further advice, consult your doctor.

Studies on canine subjects indicated a reduction in sperm production. Some men may also experience similar effects, although these are unlikely to lead to infertility.

In clinical evaluations, a few men reported dizziness while taking CIALIS. It is advisable to assess your reaction to the tablets before attempting to drive or operate heavy machinery.

If you have been advised by a healthcare professional regarding an intolerance to certain sugars, please consult your doctor before using this medication.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, essentially categorizing it as 'sodium-free.'

Contact your healthcare provider if you notice side effects as mentioned in section 4.

• Allergic reactions, including skin rashes (uncommon).
• Chest pain – refrain from using nitrates and seek immediate medical help (uncommon).
• Priapism, characterized by a prolonged and potentially painful erection post CIALIS consumption (rare). If such an erection persists for over 4 hours, seeking medical attention is critical.
• Sudden vision loss (rare), distortion, dimming, blurring of central vision, or a sudden decrease in vision (uncommon).

Other side effects that have been reported include:

Common (observable in 1 to 10 out of every 100 patients)

• Headaches, back pain, muscle aches, discomfort in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (observable in 1 to 10 out of every 1,000 patients)

• Dizziness, abdominal pain, nausea, vomiting, acid reflux, blurred vision, ocular pain, breathing difficulties, blood in urine, prolonged erections, rapid heartbeat, fluctuating blood pressure, nose bleeds, tinnitus, swelling in hands, feet, or ankles, and fatigue.

Rare (observable in 1 to 10 out of every 10,000 patients)

• Fainting, seizures, transient memory loss, eyelid swelling, conjunctival redness, sudden hearing loss, hives, penile bleeding, blood in semen, and increased perspiration.

Instances of heart attack and stroke have been reported infrequently among men using CIALIS, most of whom had pre-existing heart conditions prior to treatment.

Rare cases of temporary, partial, or complete vision loss in one or both eyes have been noted.

Additional rare side effects not identified in clinical trials but reported by patients taking CIALIS include:

• Migraine, facial swelling, severe allergic reactions causing swelling of the face or throat, serious skin rashes, certain blood flow disorders to the eyes, irregular heartbeats, angina, and sudden cardiac death.
• Distortion, dimming, blurring of central vision, or sudden decrease in vision (exact frequency not established).

The occurrence of dizziness has been more frequently reported among men over the age of 75 taking CIALIS. Diarrhea has also been reported more often in men aged over 65.

If you experience any side effects, connect with your healthcare provider or pharmacist. This encompasses any potential side effects not mentioned in this leaflet. Additionally, you may report side effects directly through the Yellow Card Scheme, visit the website: www.mhra.gov.uk/yellowcard, or search for the MHRA Yellow Card app in the Google Play or Apple App Store.

• The active ingredient is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are:
  Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate (for formulation details, refer to section 2 “CIALIS contains lactose”).
  Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.

CIALIS 20 mg is a yellow film-coated tablet, almond-shaped, with "C 20" imprinted on one side.

Available packaging includes blister packs containing 2, 4, 8, 10, or 12 tablets.

Note that not all pack sizes may be commercially available.

Marketing Authorisation Holder:

Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Manufacturer:

Lilly S.A.
Avda. de la Industria 30
28108 Alcobendas
Madrid
Spain

For inquiries regarding this medication, please contact the local representative of the Marketing Authorisation Holder: