Cialis 5 mg Daily - Patient Information Leaflet (PIL)
{arrow_up} Back to top
About Medicine
{medical_services}
Prescription only medicine
My Account Area
{arrow_down}
{arrow_left}
{arrow_right}
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
{info_black}
Last updated on emc: 13 Sep 2023
CIALIS® 5 mg film-coated tablets
tadalafil
- 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 signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What CIALIS is and what it is used for
2. What you need to know before you take CIALIS
3. How to take CIALIS
4. Possible side effects
5. How to store CIALIS
6. Contents of the pack and other information
CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
CIALIS 5 mg is used to treat adult men with:
-
erectile dysfunction. This is a condition where a man is unable to achieve or maintain a satisfying erection for sexual activity. Cialis has demonstrated significant efficacy in facilitating the ability to maintain an erection suitable for intercourse.
Upon sexual stimulation, Cialis enables the relaxation of blood vessels in the penis, facilitating increased blood flow. This results in enhanced erectile performance. It is important to emphasize that Cialis does not work in the absence of sexual arousal. Both partners should engage in foreplay, just as they would without medication assistance for erectile dysfunction. -
urinary symptoms associated with a prevalent condition referred to as benign prostatic hyperplasia (BPH).
This condition arises as the prostate gland enlarges with advancing age, leading to symptoms such as difficulty initiating urination, the sensation of incomplete bladder emptying, and an increased frequency of urination, including during nighttime hours. The action of Cialis promotes enhanced blood circulation to the prostate and bladder, potentially alleviating the symptoms associated with benign prostatic hyperplasia. Clinical evidence suggests that Cialis can yield improvements in urinary symptoms within as little as 1 to 2 weeks post initiation of treatment.
- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- are concurrently taking any form of organic nitrates or nitric oxide donors such as amyl nitrite. This group of medicines, known as “nitrates,” is utilized in the management of angina pectoris (“chest pain”). The combination of Cialis with nitrates may amplify their effects. If you are on nitrate therapy or are uncertain, consult your doctor.
- have a history of severe heart disease or have experienced a heart attack in the past 90 days.
- have suffered a stroke within the last 6 months.
- suffer from low blood pressure or uncontrolled hypertension.
- have experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye.”
- are prescribed riociguat. This medication is used in the management of pulmonary arterial hypertension (i.e., elevated blood pressure in the pulmonary arteries). PDE5 inhibitors like Cialis can heighten the hypotensive effects of riociguat. If you are taking riociguat or are unsure, inform your doctor.
Consult your doctor before initiating treatment with CIALIS.
Be aware that engaging in sexual activity can pose additional risks for individuals with heart disease as it adds extra strain to the heart. If you have cardiac issues, it's imperative to notify your doctor.
As benign prostatic hyperplasia and prostate cancer may present with similar symptoms, your healthcare provider will likely conduct screenings for prostate cancer prior to starting treatment with CIALIS for benign prostatic hyperplasia. CIALIS is not intended for the treatment of prostate cancer.
Prior to commencing treatment with the tablets, disclose any of the following conditions to your doctor:
- sickle cell anaemia (a blood disorder characterized by abnormal hemoglobin).
- multiple myeloma (a type of cancer affecting bone marrow).
- leukaemia (a hematological cancer).
- anomalies of your penis.
- significant liver impairment.
- severe renal dysfunction.
It remains unclear whether CIALIS is effective in individuals with:
- pelvic surgeries.
- total or partial prostate gland removal involving nerve cutting (radical non-nerve-sparing prostatectomy).
If you experience a sudden decrease or loss of vision, or if your vision is altered or dimmed while on CIALIS, discontinue use immediately and consult your doctor.
CIALIS has been associated with reports of decreased or sudden hearing loss; although the causal link to tadalafil remains uncertain, if you experience such changes, cease use and inform your doctor without delay.
CIALIS is contraindicated for use in women.
CIALIS is also not indicated for patients under the age of 18.
Inform your doctor if you are currently taking, have recently taken, or may take any other medications
Avoid using CIALIS concurrently with nitrates.
Certain medications may influence the effects of CIALIS or vice versa. Disclose to your doctor or pharmacist if you are currently on:
- an alpha-blocker (common in the treatment of hypertension or urinary symptoms related to benign prostatic hyperplasia).
- other antihypertensives.
- riociguat.
- a 5-alpha reductase inhibitor (utilized for benign prostatic hyperplasia management).
- drugs such as ketoconazole (antifungal agents) and protease inhibitors (for the treatment of HIV/AIDS).
- anticonvulsants like phenobarbital, phenytoin, and carbamazepine.
- rifampicin, erythromycin, clarithromycin, or itraconazole.
- other remedies for erectile dysfunction.
Consult section 3 for insights on the interaction of alcohol. Be cautious with grapefruit juice, as it may impact the efficacy of CIALIS. Speak to your doctor for further information.
Experimental studies in canines indicated a reduction in sperm production within the testes. A decrease in sperm count has been documented in certain men. Such effects are unlikely to impact fertility.
Some participants in CIALIS clinical research reported experiencing dizziness. It is advisable to assess your response to the medication prior to operating vehicles or machinery.
If your doctor has informed you of an intolerance to specific sugars, consult them prior to taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, effectively rendering it ‘sodium-free’.
Always adhere to your doctor's instructions regarding the use of this medicine. Verify with your healthcare professional if you have uncertainties.
CIALIS tablets are intended for oral administration in men only. The tablet should be swallowed whole with water. The tablets may be ingested with or without food.
Excessive alcohol consumption may temporarily lower blood pressure. If you have taken or intend to take CIALIS, limit alcohol intake (blood alcohol concentration of 0.08% or more), as this may increase the likelihood of dizziness upon standing.
The recommended dosage is one 5 mg tablet taken once daily at approximately the same time each day. Your physician may adjust the dosage to 2.5 mg based on your response to CIALIS. This lower dose will be provided as a 2.5mg tablet.
Do not exceed one dose of CIALIS per day.
When taken daily, CIALIS enables you to achieve an erection when sexually stimulated, at any point throughout the 24-hour period. Once-a-day dosing of CIALIS may be beneficial for men who expect to engage in sexual activity two or more times weekly.
It is essential to note that CIALIS is ineffective without sexual arousal. Engaging in foreplay is requisite, consistent with non-medicated sexual activity.
Increased alcohol consumption may impair your ability to achieve an erection.
The dosage is one 5 mg tablet taken once daily at approximately the same time of the day.
For patients dealing with benign prostatic hyperplasia and erectile dysfunction, the dosage remains a single 5 mg tablet once per day.
Do not take CIALIS more than once daily.
Contact your doctor. You may encounter side effects as described in section 4.
Take your dose as soon as you recall, but do not take a double dose to compensate for a missed tablet. Do not exceed once-a-day dosing of CIALIS.
If you have additional inquiries concerning the use of this medicine, consult your physician or pharmacist.
As with all medications, this drug may induce side effects, although not all individuals experience them. Such side effects are generally mild to moderate.
- allergic reactions such as rashes (reported as uncommon).
- chest pain - avoid nitrates, seek immediate medical assistance (reported as uncommon).
- priapism, a prolonged and potentially painful erection following CIALIS use (reported as rare). If experiencing an erection lasting continuously for more than 4 hours, consult a healthcare professional without delay.
- sudden vision loss (reported as rare), distorted, dimmed, blurred central vision, or sudden decline in vision (frequency not established).
Other side effects have been noted:
Common (observed in 1 to 10 out of every 100 patients)
- headaches, back pain, muscle soreness, pain in arms and legs, facial flushing, nasal congestion, and digestive discomfort.
Uncommon (observed in 1 to 10 out of every 1,000 patients)
- dizziness, abdominal discomfort, nausea, vomiting, reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, rapid heartbeat, hypertension, hypotension, nosebleeds, tinnitus, swelling of extremities, and fatigue.
Rare (observed in 1 to 10 out of every 10,000 patients)
- fainting, seizures, amnesia, eyelid swelling, conjunctival suffusion, sudden hearing loss, hives (urticaria), penile bleeding, presence of blood in semen, and increased perspiration.
Reports of heart attack and stroke have been documented rarely in men using CIALIS; nearly all such individuals had pre-existing cardiac conditions.
Partial, transient, or permanent vision loss in one or both eyes has been recorded infrequently.
Additional rare side effects reported in men using CIALIS that were not observed in clinical trials include:
- migraine, facial swelling, severe allergic reactions leading to facial or throat swelling, severe dermatological reactions, various disorders affecting ocular blood flow, arrhythmias, angina episodes, and sudden cardiac arrest.
- distorted, dimmed, blurred central vision, or sudden decline in vision (frequency unknown).
Reports indicate that dizziness has been more prevalent in men aged over 75 years taking CIALIS. Similarly, diarrhea has been reported more frequently in men aged above 65 years using CIALIS.
If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not mentioned in this leaflet. You may also report side effects directly via the Yellow Card Scheme, accessible through the website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Store this medicine out of the sight and reach of children.
Do not utilize this medication after the expiration date mentioned on the package and blister after ‘EXP’. The expiration date pertains to the final day of that month.
Maintain in the original packaging to safeguard against moisture. Do not store above 25°C.
Do not discard any medications via wastewater or household waste. Consult your pharmacist regarding the proper disposal of unused medications. These actions will aid in protecting the environment.
- The active ingredient is tadalafil. Each tablet comprises 5 mg of tadalafil.
- The other components include:
Tablet core: lactose monohydrate (refer to the end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Refer to section 2 "CIALIS contains lactose".
Coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
CIALIS 5 mg is a light yellow, almond-shaped film-coated tablet marked with "C 5" on one side.
CIALIS 5 mg is accessible in blister packs containing 14, 28, or 84 tablets.
Not all packaging 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 further inquiries regarding this medicine, please reach out to the local representative of the Marketing Authorisation Holder:
United Kingdom (Great Britain)
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
This leaflet was last revised in August 2023.
CI047