Patient Information Leaflet

Jelnu 0.5 mg/0.4 mg hard capsules

Dutasteride/tamsulosin hydrochloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Jelnu is and what it is used for
What you need to know before taking Jelnu
How to take Jelnu
Possible side effects
How to store Jelnu
Contents of the pack and other information

1. What Jelnu is and what it is used for

Jelnu is used to treat men with an enlarged prostate ( benign prostatic hyperplasia ) – a non-malignant increase in prostate size caused by excessive production of a hormone called dihydrotestosterone.
Jelnu is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines known as 5-alpha reductase inhibitors, and tamsulosin belongs to a group of medicines called alpha blockers.
When the prostate enlarges, it can cause urinary problems such as difficulty passing urine and the need to urinate frequently. This may also result in a weaker and slower urinary stream. If left untreated, there is a risk that urine flow may become completely blocked ( acute urinary retention ), which requires immediate medical treatment. In some cases, surgery may be necessary to remove or reduce the size of the prostate.
Dutasteride reduces the production of a hormone called dihydrotestosterone, thereby helping to shrink the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscle of the prostate gland, making it easier for urine to pass and rapidly improving symptoms.

2. What you should know before taking Jelnu

Do not take Jelnu

if you are a woman (because this medicine is intended only for men)
if you are a child or adolescent under 18 years of age
if you are allergic to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6)
if you have low blood pressure causing dizziness, lightheadedness, or fainting ( orthostatic hypotension )
if you have severe liver disease.

If you think any of the above apply to you, do not take this medicine until you have consulted your doctor.

Warnings and precautions
Talk to your doctor before taking Jelnu.

In some clinical studies, more patients taking dutasteride and another medicine called an alpha blocker such as tamsulosin developed heart failure compared to patients treated only with dutasteride or only with an alpha blocker. Heart failure means that the heart does not pump blood as well as it should.
Ensure your doctor is aware of any liver problems you have. If you have had any liver disease, additional monitoring may be needed while you are taking Jelnu.
Ensure your doctor is aware if you have severe kidney problems.
Cataract surgery (cloudy lens). If you are scheduled to undergo cataract removal surgery, your doctor may ask you to stop taking Jelnu for a period before the operation. Inform your ophthalmologist before surgery if you are taking Jelnu or tamsulosin (or have taken them previously). The specialist will need to take appropriate precautions to help prevent complications during surgery.
Women, children, and adolescents must avoid contact with damaged Jelnu capsules, as the active ingredient can be absorbed through the skin. In case of skin contact, wash the affected area immediately with water and soap.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men being treated with Jelnu. If your partner is pregnant or could become pregnant, you must avoid exposing her to your semen, as dutasteride may impair the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce your fertility.
Jelnu affects a blood test for PSA ( prostate-specific antigen ), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still recommend the test to check for prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking Jelnu. Men taking Jelnu should have regular PSA tests.
In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride developed a higher frequency of aggressive forms of prostate cancer compared to men not taking dutasteride. The effect of dutasteride on this aggressive form of prostate cancer is not clear.
Jelnu may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, you should discuss these changes with your doctor, as they could be signs of a serious condition, such as breast cancer.
Ask your doctor or pharmacist if you have any questions about taking Jelnu.

Other medicines and Jelnu
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Do not take Jelnu with the following medicines:

other alpha blockers (used for enlarged prostate or high blood pressure).

Jelnu is not recommended with the following medicines:

ketoconazole (used to treat fungal infections).

Some medicines may interact with Jelnu and increase the risk of side effects. These include:

PDE5 inhibitors (used to help achieve or maintain an erection), such as vardenafil, sildenafil citrate, and tadalafil
verapamil or diltiazem (for high blood pressure)
ritonavir or indinavir (for HIV)
itraconazole or ketoconazole (for fungal infections)
nefazodone (an antidepressant)
cimetidine (for stomach ulcers)
warfarin (for blood clotting)
erythromycin (an antibiotic used to treat infections)
paroxetine (an antidepressant)
terbinafine (used to treat fungal infections)
diclofenac (used to treat pain and inflammation)

Tell your doctor if you are taking any of these medicines.

Jelnu with food and drink
Jelnu should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility
Jelnu must not be taken by women.
Pregnant women (or women who may become pregnant) must not handle damaged capsules.
Dutasteride is absorbed through the skin and may interfere with the normal development of a male fetus.
This is particularly risky during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Jelnu. If your partner is pregnant or could become pregnant, you must avoid exposing her to your semen.
Jelnu has been shown to reduce sperm count, seminal fluid volume, and sperm motility. Therefore, male fertility may be reduced.
Consult your doctor if a pregnant woman has been exposed to Jelnu.

Driving and using machines
Jelnu may cause dizziness in some people and therefore may affect your ability to drive or operate machinery safely.
Do not drive or operate machinery if you feel dizzy.

Important information about some of the excipients in Jelnu
Jelnu contains sunset yellow (E110), a dye that may cause allergic reactions.
Jelnu contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Jelnu

Take Jelnu exactly as your doctor or pharmacist has told you. If you do not take it
regularly, monitoring of PSA levels may be affected. If you are unsure, consult your doctor or
pharmacist.
How much Jelnu to take
The recommended dose is one capsule taken once daily, 30 minutes after the same meal, every day.
How to take Jelnu
Swallow the capsules whole with water. Do not chew or open the capsules. Contact with the capsule contents
may irritate the mouth or throat.
If you take more Jelnu than you should
Contact your doctor or pharmacist for advice if you have taken more capsules than prescribed.
If you forget to take Jelnu
Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.
Do not stop Jelnu without medical advice
Do not stop taking Jelnu without first consulting your doctor.
If you have further questions about 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.
Allergic reaction
Signs of allergic reactions may include:

rash (which may be itchy)
hives
swelling of the eyelids, face, lips, arms or legs.
Contact your doctor immediately if you experience any of these symptoms and stop taking Jelnu.

Dizziness, lightheadedness and fainting
Jelnu may cause dizziness, lightheadedness and, in rare cases, fainting. Be cautious when moving from a lying or sitting position to a sitting or standing position, especially if you wake up at night, until you know how this medicine affects you. If you feel dizzy or lightheaded at any time during treatment, sit or lie down until these symptoms pass.
Severe skin reactions
Signs of severe skin reactions may include:
widespread rash with blisters and peeling of the skin, particularly around the
mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Contact your doctor immediately if you experience these symptoms and stop taking Jelnu.

Common side effects
These may affect up to 1 in 10 people treated with Jelnu:
impotence (inability to achieve or maintain an erection)*
decreased sexual desire (libido)*
ejaculation disorders, such as reduced amount of semen released during sexual intercourse*
breast enlargement or tenderness (gynecomastia)
dizziness.
* In a small number of people, some of these side effects may continue after stopping Jelnu.

Uncommon side effects
These may affect up to 1 in 100 people:
heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include shortness of breath, extreme tiredness and swelling of the ankles and legs)
low blood pressure when standing
fast heartbeat (palpitations)
constipation, diarrhoea, vomiting, nausea
weakness or loss of strength
headache
itchy, blocked or runny nose (rhinitis)
rash, hives, itching
hair loss (usually from the body) or excessive hair growth.

Rare side effects
These may affect up to 1 in 1,000 people:
swelling of the eyelids, face, lips, arms or legs (angioedema)
fainting.

Very rare side effects
These may affect up to 1 in 10,000 people:
persistent painful erection of the penis (priapism)
severe skin reactions (Stevens-Johnson syndrome).

Other side effects
Other side effects have occurred in a small number of patients, but their exact frequency is unknown (frequency cannot be estimated from the available data):
abnormal or fast heartbeat (arrhythmia or tachycardia or atrial fibrillation)
shortness of breath (dyspnoea)
depression
pain and swelling of the testicles
nosebleeds
severe skin rash
changes in vision (blurred vision or impaired vision)
dry mouth.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jelnu

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial. The expiry date refers to the
last day of that month.
Do not store Jelnu above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Jelnu contains
The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
The other components are:

capsule shell coating: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), sunset yellow (E110), carnauba wax, corn starch.
contents of the hard capsule: mono- and diglycerides of caprylic/capric acid, butylated hydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), medium-chain triglycerides, lecithin (may contain soybean oil), microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (containing polysorbate 80 and sodium lauryl sulfate), talc, triethyl citrate.
black ink (SW-9010 or SW-9008): varnish, propylene glycol, iron oxide black (E172), potassium hydroxide (only in black ink SW-9008).

Description of the appearance of Jelnu and pack sizes
This medicine is an oblong, hard capsule with a brown body and an orange cap, printed with "GS 7CZ" in black ink. The capsules are available in packs of 7, 30 and 90 capsules. Not all pack sizes may be marketed.
Marketing Authorization Holder:
GlaxoSmithKline S.p.A.
Via A. Fleming, 2
Verona
Italy
Manufacturer:
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2
73614 Schorndorf
Germany
Dutasteride-tamsulosin GSK – Germany
Juteo – Portugal
Jelnu – Italy