Tadalafil Cipla 20 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tadalafil Cipla 20 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Tadalafil Cipla is and what it is used for
- What you need to know before taking Tadalafil Cipla
- How to take Tadalafil Cipla
- Possible side effects
- How to store Tadalafil Cipla
- Contents of the pack and other information
1. What Tadalafilo Cipla is and what it is used for
Tadalafilo Cipla contains the active substance tadalafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors, which work by helping the blood vessels around your lungs to relax, thereby improving blood flow in the lungs. This results in improved ability to perform physical activity.
Tadalafilo Cipla is indicated for the treatment of pulmonary arterial hypertension in adults.
2. What you need to know before taking Tadalafilo Cipla
Do not take Tadalafilo Cipla if you:
- are allergic to tadalafil or any of the other components (see section 6).
- are taking any type of nitrates, such as amyl nitrite, which are used to relieve "chest pain." Tadalafil may increase the effects of these medicines. If you are taking any nitrates or are unsure, consult your doctor.
- have previously experienced vision loss due to a condition known as "eye stroke" (non-arteritic anterior ischemic optic neuropathy - NAION).
- have had a heart attack within the last 3 months.
- have low blood pressure.
- are taking riociguat. This medicine is used to treat pulmonary arterial 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). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
Warnings and precautions
Talk to your doctor before starting Tadalafilo Cipla if you have:
- any heart problems other than your pulmonary hypertension
- problems with your blood pressure
- any hereditary eye disease
- a red blood cell disorder (sickle cell anemia)
- bone marrow cancer (multiple myeloma)
- blood cell cancer (leukemia)
- any deformity of the penis, or unexpected and unwanted erections lasting more than 4 hours
- severe liver problems
- severe kidney problems.
If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking tadalafil, contact your doctor immediately.
Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, contact your doctor immediately.
Children and adolescents
Tadalafil must not be used in children and adolescents under 18 years of age.
Taking Tadalafilo Cipla with other medicines
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. Do not take these tablets if you are being treated with nitrates.
Some medicines may be affected by tadalafil or may affect how tadalafil works properly. Tell your doctor or pharmacist if you are taking:
- bosentan (another treatment for pulmonary arterial hypertension)
- nitrates (for chest pain)
- alpha-blockers for treating high blood pressure or prostate problems
- riociguat
- rifampicin (for treating bacterial infections)
- ketoconazole tablets (for treating fungal infections)
- ritonavir (for treating HIV/AIDS)
- tablets for treating erectile dysfunction (PDE5 inhibitors)
Taking Tadalafilo Cipla with alcohol
Drinking alcohol can temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (more than 5 units of alcohol), as this may increase the risk of dizziness upon standing.
Pregnancy, breast-feeding and fertility
If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Do not take Tadalafilo during pregnancy unless strictly necessary and discussed with your doctor.
Do not breast-feed while taking these tablets, as it is unknown whether the medicine passes into breast milk. Consult your doctor or pharmacist before taking any medicine if you are pregnant or breast-feeding.
In treated dogs, a decrease in sperm production by the testes has been observed. Some men have shown reduced sperm count. It is unlikely that these effects would lead to infertility.
Driving and using machines
Dizziness has been reported. Carefully assess how you react to the medicine before driving or operating machinery.
Tadalafilo Cipla contains lactose and sodium
If you know you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially "sodium-free".
3. How to take Tadalafil Cipla
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
The usual dose is 2 tablets of 20 mg taken once daily. Both tablets should be taken at the same time, one after the other. If you have mild to moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet per day.
Method of administration
Swallow the tablets whole with a glass of water. The tablets may be taken with or without food.
If you take more Tadalafil Cipla than you should
If you or someone else takes more tablets than prescribed, contact your doctor or go immediately to a hospital, taking the medicine or its packaging with you, or contact the Toxicology Information Service, telephone 915 620 420. You may experience any of the adverse effects described in section 4.
If you forget to take Tadalafil Cipla
Take your dose as soon as you remember, provided it is within 8 hours of the time you were supposed to take it. DO NOT take a double dose to make up for a forgotten dose.
If you stop taking Tadalafil Cipla
Do not stop taking your tablets unless advised by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. These effects are generally mild to moderate in intensity.
If you experience any of the following adverse effects, stop using the medicine and seek immediate medical help:
Frequent (may affect up to 1 in 10 people)
- allergic reactions, including skin rashes.
- chest pain – do not use nitrates, but seek immediate medical help.
Uncommon (may affect up to 1 in 100 people)
- priapism, a prolonged and possibly painful erection after taking tadalafil. If you experience this type of erection lasting continuously for more than 4 hours, you must contact a doctor immediately.
Rare (may affect up to 1 in 1,000 people)
- sudden loss of vision
Frequency not known (cannot be estimated from available data)
- distorted vision, reduced vision, blurred central vision, or sudden decrease in vision
The following adverse effects have been reported very frequently in patients taking tadalafil (may affect more than 1 in 10 people):
- headache,
- flushing,
- nasal and sinus congestion (stuffy nose),
- nausea,
- indigestion (including abdominal pain and discomfort),
- muscle aches,
- back pain and limb pain (including limb discomfort)
Other adverse effects that have been reported:
Frequent (may affect up to 1 in 10 people)
- blurred vision,
- low blood pressure,
- nosebleeds,
- vomiting,
- increased or abnormal uterine bleeding,
- facial swelling,
- reflux,
- migraine,
- irregular heartbeat, and
- fainting.
Uncommon (may affect up to 1 in 100 people)
- seizures,
- transient memory loss,
- hives,
- excessive sweating,
- bleeding in the penis,
- presence of blood in semen and/or urine,
- high blood pressure,
- rapid pulse,
- sudden cardiac death, and
- ringing in the ears.
PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. The following adverse effects have been rarely reported: - Decrease or partial, temporary or permanent loss of vision in one or both eyes, and severe allergic reaction causing swelling of the face or throat. Cases of sudden decrease or loss of hearing have also been reported.
Some adverse effects have been reported in men who were taking tadalafil for the treatment of erectile dysfunction. These effects were not observed during clinical studies for pulmonary arterial hypertension, and therefore their frequency is unknown:
- eyelid swelling,
- eye pain,
- red eyes,
- heart attack, and
- stroke
- distorted vision, reduced vision, blurred central vision, or sudden decrease in vision.
Most of the men who reported rapid pulse, irregular heartbeat, heart attack, stroke, and sudden cardiac death had previously had some cardiac problems before taking tadalafil. It is not possible to determine whether these events were directly related to tadalafil.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tadalafil Cipla
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “CAD” and “EXP”, respectively. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Tadalafil Cipla
The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
The other components are:
- Tablet core: Monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate.
- Film coating: Opadry II brown 32K565010 containing HPMC 2910/hypromellose, monohydrate lactose, titanium dioxide (E171), yellow iron oxide (E172), triacetin, red iron oxide (E172).
Appearance of the product and contents of the pack
Tadalafil Cipla 20 mg is presented as brown, film-coated tablets, capsule-shaped, marked with “T20” on one side and smooth on the other. The length of each tablet is 14.10 ± 0.20 mm and the thickness is 6.10 ± 0.20 mm.
Tadalafil Cipla is available in aluminum/PVC/PE/PVDC blister packs in cartons containing 28 or 56 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer Responsible
Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Cipla Europe NV, Spanish branch
C/ Guzmán el Bueno, 133, Edif. Britannia, 28003 Madrid, Spain
Tel: 91 534 16 73
Date of the most recent review of this leaflet: November 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es