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TADALAFIL ARISTO 10 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL

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Tadalafil Aristo 10 mg film-coated tablets
Tadalafil Aristo 20 mg film-coated tablets
Tadalafil
Read all of this 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. 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.
What is in this leaflet:
1. What Tadalafil Aristo is and what it is used for
2. What you need to know before you take Tadalafil Aristo
3. How to take Tadalafil Aristo
4. Possible side effects
5. How to store Tadalafil Aristo
6. Contents of the pack and other information
1. What Tadalafil Aristo is and what it is used for
Tadalafil Aristo is a treatment for adult men with erectile dysfunction. This is when a man cannot get,
or keep a hard, erect penis suitable for sexual activity. Tadalafil Aristo has been shown to significantly
improve the ability of obtaining a hard erect penis suitable for sexual activity.
Tadalafil Aristo contains the active substance tadalafil which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Following sexual stimulation Tadalafil Aristo works by helping the blood vessels in your penis to relax,
allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil Aristo
will not help you if you do not have erectile dysfunction.
It is important to note that Tadalafil Aristo does not work if there is no sexual stimulation. You and your
partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile
dysfunction.
2. What you need to know before you take Tadalafil Aristo
Do not take Tadalafil Aristo if you:
- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil Aristo has been
shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure
tell your doctor.
- have serious heart disease or recently had a heart attack within the last 90 days.
- recently had a stroke within the last 6 months.
- have low blood pressure or uncontrolled high blood pressure.
- ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
- are taking riociguat. This drug 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 secondary to blood clots). PDE5 inhibitors, such as Tadalafil Aristo, have been
shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure
tell your doctor.
Warnings and precautions
Talk to your doctor before taking Tadalafil Aristo.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an
extra strain on your heart. If you have a heart problem you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
- sickle cell anaemia (an abnormality of red blood cells).
- multiple myeloma (cancer of the bone marrow).
- leukaemia (cancer of the blood cells).
- any deformation of your penis.
- a serious liver problem.
- a severe kidney problem.
It is not known if Tadalafil Aristo is effective in patients who have had:
- pelvic surgery.
- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non- nerve-sparing prostatectomy).
If you experience sudden decrease or loss of vision, stop taking Tadalafil Aristo and contact your
doctor immediately.
Tadalafil Aristo is not intended for use by women.
Children and adolescents
Tadalafil Aristo is not intended for use by children and adolescents under the age of 18.
Other medicines and Tadalafil Aristo
Tell your doctor if you are taking, have recently taken or might take any other medicines Do not take
Tadalafil Aristo if you are already taking nitrates.
Some medicines may be affected by Tadalafil Aristo or they may affect how well Tadalafil Aristo will
work. Tell your doctor or pharmacist if you are already taking:
- an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign
prostatic hyperplasia).
- other medicines to treat high blood pressure.
- riociguat.
- a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
- medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
- phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
- rifampicin, erythromycin , clarithromycin or itraconazole.
- other treatments for erectile dysfunction.
Tadalafil Aristo with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil Aristo
will work and should be taken with caution. Talk to your doctor for further information.
Fertility
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm
was seen in some men. These effects are unlikely to lead to a lack of fertility.
Driving and using machines
Some men taking Tadalafil Aristo in clinical studies have reported dizziness. Check carefully how you
react to the tablets before driving or using machines.
Tadalafil Aristo contains lactose:
If you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Tadalafil Aristo
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Tadalafil Aristo tablets are for oral use in men only. Swallow the tablet whole with some water. The
tablets can be taken with or without food.
The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been
given the dose of one 20mg tablet as your doctor has decided that the recommended dose of 10mg
is too weak.
You may take a Tadalafil Aristo tablet at least 30 minutes before sexual activity. Tadalafil Aristo may still
be effective up to 36 hours after taking the tablet.
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Do not take Tadalafil Aristo more than once a day. Tadalafil Aristo 10 mg and 20 mg is intended for use
prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Aristo does not work if there is no sexual stimulation. You and your
partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile
dysfunction.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure.
If you have taken or are planning to take Tadalafil Aristo, avoid excessive drinking (blood alcohol level of

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Produkt

Tadalafil Aristo, 10 u. 20 mg
Tabletten

Artikel-Nr.

XXXXXXX/X

Druck-Nr.

GIXXXXXX-XX/UK/XXXX

L-Code

wird nachereicht

Packung

10 mg = 4, 8, 12, 20 or 30
film-coated tablets.
20 mg = 2, 4, 8, 12, 20 or
30 film-coated tablets

Land

UK

Größe

180 x 610 mm

Datum

16.06.2017

Titel

Helvetika Neue Bold 21 pt

Schrift

Helvetika Neue (Roman,
Bold) 10 pt

0.08 % or greater), since this may increase the risk of dizziness when standing up.
If you take more Tadalafil Aristo than you should
Contact your doctor. You may experience side effects described in section 4.
If you forget to take Tadalafil Aristo
Take your dose as soon as you remember but do not take a double dose to make up for a forgotten
tablet. You should not take Tadalafil Aristo more than once a day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These
effects are normally mild to moderate in nature.
If you experience any of the following side effects stop using the medicine and seek medical
help immediately:
- allergic reactions including rashes (frequency uncommon).
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
- prolonged and possibly painful erection after taking Tadalafil Aristo (frequency rare). If you have
such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (frequency rare). Other side effects have been reported:
Common (seen in 1 to 10 in every 100 patients)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and
indigestion.
Uncommon (seen in 1 to 10 in every 1,000 patients)
- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty
in breathing, presence of blood in urine, pounding heartbeat sensation, a fast heart rate, high blood
pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles
and feeling tired.
Rare (seen in 1 to 10 in every 10,000 patients)
- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or
loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood
in semen and increased sweating.
Heart attack and stroke have also been reported rarely in men taking Tadalafil. Most of these men had
known heart problems before taking this medicine.
Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
Some additional rare side effects have been reported in men taking Tadalafil that were not seen in clinical
trials. These include:
- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat,
serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and
sudden cardiac death.
The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil.
Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.
mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety
of this medicine.
5. How to store Tadalafil Aristo
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 ‘EXP’. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Tadalafil Aristo contains
- The active substance is tadalafil. Each film-coated tablet contains 10 mg or 20 mg of tadalafil.
- The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium,
hydroxypropylcellulose, cellulose, microcrystalline, sodium laurilsulfate, magnesium stearate.
Film-coat Opadry II Yellow 32K220019: hydroxypropyl methyl cellulose, lactose monohydrate,
titanium dioxide (E171), triacetin, iron oxide yellow (E172), talc
What Tadalafil Aristo looks like and contents of the pack
Tadalafil Aristo 10 mg is a yellow coloured, oval shaped, one side scored and other side debossed with
“T 10” biconvex film coated tablet of 11.50 x 5.90 mm. The score line is only there to help you break
the tablet if you have difficulty swallowing it whole.
Tadalafil Aristo 20 mg is a yellow coloured, oval shaped, one side scored and other side debossed with
“T 20” biconvex film coated tablet of 13.90 x 7.20 mm. The tablet can be divided into equal doses.
Tadalafil Aristo 10 mg is available in blister packs containing 4, 8, 12, 20 or 30 film-coated tablets.
Tadalafil Aristo 20 mg is available in blister packs containing 2, 4, 8, 12, 20 or 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8–10
13435 Berlin
Germany

This leaflet was last revised in May 2017
Detailed information on this medicine is available on the European Medicines Agency web site: http://
www.ema.europa.eu

GIXXXXXX-XX/UK/XXXX

Code xxx

XXXXXXXX/X

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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