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TADALAFIL MILPHARM 10 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL

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P15XXXXX

Tadalafil 10 mg film-coated
tablets

P15XXXXX

Tadalafil 10 mg film-coated
tablets

Pharmacode position may change as per Supplier’s m/c requirement & additional
small pharma code may appear on the front / back panel

Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil.
Package leaflet: Information for the user

Tadalafil 10 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 is and what it is used for
2. What you need to know before you take Tadalafil
3. How to take Tadalafil
4. Possible side effects
5. How to store Tadalafil
6. Contents of the pack and other information
1. What Tadalafil is and what it is used for
Tadalafil 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 has been shown to significantly improve the
ability of obtaining a hard erect penis suitable for sexual activity.
Tadalafil contains the active substance tadalafil which belongs to
a group of medicines called phosphodiesterase type 5 inhibitors.
Following sexual stimulation tadalafil 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 will
not help you if you do not have erectile dysfunction.
It is important to note that tadalafil 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
Do not take Tadalafil:
• 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 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, have been shown to increase the hypotensive
effects of this medicine. If you are taking riociguat or are unsure
tell your doctor.

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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 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 and contact your doctor immediately.
Tadalafil is not intended for use by women.
Children and adolescents
Tadalafil is not intended for use by children and adolescents under
the age of 18.
Other medicines and Tadalafil
Tell your doctor if you are taking, have recently taken or might take
any other medicines
Do not take Tadalafil if you are already taking nitrates.
Some medicines may be affected by Tadalafil or they may affect
how well Tadalafil 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 with food, drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice
may affect how well Tadalafil 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 in clinical studies have reported
dizziness. Check carefully how you react to the tablets before driving
or using machines.
Tadalafil contains lactose monohydrate. If you have been told by
your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
3. How to take Tadalafil
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is one 10 mg tablet before
sexual activity. If the effect of this dose is too weak your doctor may
increase the dose to 20 mg. Tadalafil tablets are for oral use.
You may take a Tadalafil tablet at least 30 minutes before sexual
activity.
Tadalafil may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil more than once a day. Tadalafil 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 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, avoid excessive drinking (blood alcohol
level of 0.08 % or greater), since this may increase the risk of
dizziness when standing up.
If you take more Tadalafil than you should
Contact your doctor. You may experience side effects described in
section 4.
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
(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 (may affect up to 1 in 10 people)
- Headache, back pain, muscle aches, pain in arms and legs,
facial flushing, nasal congestion, indigestion and reflux.
Uncommon (may affect up to 1 in 100 people)
- Dizziness, stomach ache, blurred vision, eye pain, increased
sweating, difficulty in breathing, penile bleeding, presence of
blood in semen and/or urine, pounding heartbeat sensation, a
fast heart rate, high blood pressure, low blood pressure, nose
bleeds and ringing in the ears.
Rare (may affect up to 1 in 1,000 people)
- Fainting, seizures and passing memory loss, swelling of the
eyelids, red eyes, sudden decrease or loss of hearing and hives
(itchy red welts on the surface of the skin).
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 effects dizziness and diarrhoea have been reported more
frequently in men over 75 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
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 after EXP. The expiry date refers to the last day of that month.
The medicinal product does not require any special storage
conditions.
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 contains
- The active substance is tadalafil. Each film-coated tablet contains
10 mg of tadalafil.
- The other ingredient s are
Tablet core: Copovidone, macrogolglycerol hydroxystearate,
lactose monohydrate, silica, colloidal anhydrous, cellulose,
microcrystalline , croscarmellose sodium, magnesium stearate.
Tablet coating: Hypromellose , titanium dioxide (E 171), talc
(E553b), yellow iron oxide (E172), triacetin.
What Tadalafil looks like and contents of the pack
Film-coated tablet.
Light yellow colored, oval shaped, film-coated tablets debossed with
‘57’ on one side and ‘L’ on other side.
Tadalafil film-coated tablets are available in clear PVC/ PVdC
-Aluminium foil blister packs.
Blister pack sizes: 2, 4, 8, 12, 24, 28 and 56 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
or
Orion Corporation Orion Pharma
Orionintie 1, Espoo, FI-02200
Finland
This leaflet was last revised in 01/2016.

P15XXXXX

Tadalafil tablets are for oral use in men only. Swallow the tablet
whole with some water. The tablets can be taken with or without
food.

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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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