PLENADREN 5 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Plenadren 5 mg modified-release tablets, 20 mg modified-release tablets
   1. What is Plenadren and what is it used for
   2. What you need to know before taking Plenadren
   3. How to take Plenadren
   4. Possible side effects
   5. How to store Plenadren
   6. Package contents and other information

Plenadren 5 mg modified-release tablets, 20 mg modified-release tablets

hydrocortisone

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Plenadren is and what it is used for
• 2. What you need to know before you take Plenadren
• 3. How to take Plenadren
• 4. Possible side effects
• 5. How to store Plenadren
• 6. Contents of the pack and other information

1. What is Plenadren and what is it used for

Plenadren contains a substance called hydrocortisone (sometimes referred to as cortisol). Hydrocortisone is
a glucocorticoid that belongs to a group of medicines called corticosteroids. Glucocorticoids
are found naturally in our body and contribute to our well-being and overall state of
health.
Plenadren is used in adults for the treatment of a condition known as adrenal insufficiency, or cortisol deficiency. Adrenal insufficiency occurs when the adrenal glands
(located above the kidneys) do not produce enough cortisol hormone. Patients
with long-term (chronic) adrenal insufficiency need replacement therapy
to survive.
Plenadren replaces the natural cortisol that is lacking in adrenal insufficiency. The medicine
provides hydrocortisone to the body throughout the day. Blood cortisol levels increase
rapidly to reach a maximum level, approximately 1 hour after taking the tablet in the
morning, to gradually decrease over the day and reach a very low or zero blood level
late in the evening and at night when levels should be low.

2. What you need to know before taking Plenadren

Do not take Plenadren

• if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Plenadren

• if your condition prevents you from taking this medicine or when the medicine is not absorbed properly by the stomach. This can occur if there are problems with your stomach

which include vomiting and/or diarrhoea. In these situations, you should consult a doctor immediately to undergo treatment with hydrocortisone injections and supplemental fluid administration.

• In the case of short-term or transient illnesses such as infections, fever, or situations that cause significant physical stress, such as surgery: the dose of hydrocortisone must be temporarily increased. Immediately ask your doctor for information on the most appropriate way to manage such situations. In the event of surgery, inform your doctor/dentist before the procedure about taking this medicine.
• If for any reason you notice a worsening of your general health condition despite taking the medicine as prescribed by your doctor, consult a doctor immediately.
• If you suffer from pheochromocytoma (a rare tumour of the adrenal glands).
• If your thyroid gland is not functioning normally, inform your doctor, as it may be necessary to adjust the dose of Plenadren.

Children and adolescents
The use of Plenadren is not recommended in children or adolescents under the age of 18, because it has not been studied in these patients.

Other medicines and Plenadren
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. During long-term treatment with medicines for the treatment of infections (antibiotics), your doctor may consider it appropriate to adjust the dose of Plenadren. If taken with mifepristone, a medicine used to terminate a pregnancy, the effect of Plenadren may be reduced.
Also inform your doctor or pharmacist if you are using any of the following medicines, because it may be necessary to modify the dose of Plenadren:

• Phenytoin, carbamazepine and barbiturates - for the treatment of epilepsy
• Rifampicin or rifabutin - for the treatment of tuberculosis
• Ritonavir, efavirenz and nevirapine - for the treatment of HIV infections
• St John's Wort - for the treatment of depression and other conditions
• Ketoconazole, itraconazole, posaconazole, voriconazole - for the treatment of fungal infections
• Erythromycin, telithromycin, clarithromycin - for the treatment of bacterial infections

Plenadren with food and drink
Do not take this medicine with grapefruit juice as the juice affects the action of this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is important to continue treatment during pregnancy. It is unlikely that treatment with Plenadren in pregnant women with adrenal insufficiency will cause adverse effects on the mother and/or the baby. Inform your doctor if you are pregnant, as it may be necessary to adjust the dose of Plenadren.
Breastfeeding is possible during treatment with Plenadren. Hydrocortisone is excreted in breast milk. It is unlikely that the doses of hydrocortisone used for replacement therapy will have effects on the baby. However, inform your doctor if you intend to breastfeed.
Fertility in women with adrenal insufficiency or cortisol deficiency may be reduced. There is no indication of an effect of Plenadren on fertility at the doses used for replacement therapy.

Driving and using machines
This medicine may have a mild effect on the ability to drive and operate machines. Episodes of brief dizziness and extreme fatigue have been reported. Untreated or inadequately treated adrenal insufficiency reduces the ability to concentrate and affects the ability to drive and operate machines. It is therefore important to take this medicine according to your doctor's instructions when driving or operating machinery. If you suffer from this condition, do not drive or use machines before consulting a doctor.

3. How to take Plenadren

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist. The indicated dose is specific to your needs and is
decided by your doctor.

• In the morning, immediately after waking up, take the Plenadren tablets whole with a glass of water at least 30 minutes before breakfast, preferably between 6:00 and 8:00 am.
• It is preferable to take the medicine while in an upright position.
• The tablet must be swallowed whole, without dividing, breaking or crushing it. These tablets release hydrocortisone into the body throughout the day. If the tablet is divided, broken or crushed, the dose of hydrocortisone contained in the tablet may not cover the entire day.

Need for supplementary doses of Plenadren
In the case of short-term or transient illnesses such as infections, fever or situations that cause
significant physical stress, such as surgery, the body cannot produce the additional amount of cortisol needed in these situations and therefore it will be necessary to take more
hydrocortisone. The dose must therefore be temporarily increased and your doctor will tell you whether to take
other hydrocortisone tablets rather than Plenadren, or in addition to Plenadren itself. Consult your
doctor and follow the instructions given.
It may be necessary to double or triple the daily dose of Plenadren in milder conditions such as a mild infection or mild stress. In this case, it is necessary to take the second
dose of this medicine 6 to 10 hours after the morning dose. If doubling
the daily dose is not sufficient, it is necessary to take a third dose 6 to 10 hours after the second dose (with 6-
10 hours between doses). At the end of the illness, return to the normal maintenance dose of
this medicine.
The following signs and symptoms may indicate the need to take supplementary doses of Plenadren or
other forms of hydrocortisone: fatigue, weight loss, stomach discomfort, feeling lightheaded when moving from a sitting to an upright position, or dizziness when standing up,
darkening of the skin, especially skin folds and exposed areas. Consult your doctor immediately
if you notice any of these signs and symptoms.
However, seek immediate medical attentionif you notice any of the following signs and symptoms:
severe weakness, fainting, abdominal pain, nausea, vomiting, back pain, confusion, reduced
level of consciousness, delirium (a state of great confusion).

If you take more Plenadren than you should
An overdose of this medicine for more than a few days can be dangerous to your health.
You may experience an increase in blood pressure, weight gain and an excessive level of glucose in the blood. Occasionally it is necessary to increase the dose because the body
can cope with situations of greater stress, due to fever for example. If supplementary doses are
required frequently and regularly, you should contact your doctor to redefine the maintenance dose.

If you forget to take Plenadren
If you have forgotten to take the tablet in the morning, take it as soon as possible. Do not take a
double dose to make up for the forgotten dose. If any of the signs or symptoms
listed in the paragraph “Need for supplementary doses of Plenadren” appear, contact your doctor immediately.

If you stop taking Plenadren
Stopping treatment with Plenadren could be fatal. It is therefore important
to continue taking this medicine as prescribed by your doctor. Do not stop the
treatment without consulting your doctor.
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.
If you change treatment, switching from other hydrocortisone tablets to Plenadren, you may experience
side effects during the first few weeks. These may include stomach pain, nausea
and fatigue. These effects usually disappear over time; if not, consult
your doctor.
List of side effects of this medicine:
Very common (may affect more than 1 in 10 people)

• Dizziness
• Headache
• Diarrhoea
• Fatigue

Common (may affect up to 1 in 10 people)

• Stomach pain/heartburn, feeling unwell or nausea
• Joint pain
• Skin rash
• Itching

Other side effects have been reported for other medicines containing hydrocortisone. These medicines
have also been given for indications other than replacement therapy for adrenal
insufficiency, often with higher doses. The frequency of these side effects is unknown (cannot be
defined based on available data). If you notice any of these side effects
occurring, consult your doctor.

• Increased susceptibility to infections
• Diabetes or problems with blood glucose levels (based on blood count data)
• Fluid and salt retention, causing swelling and increased blood pressure (highlighted during medical examination) and low potassium levels in the blood
• Mood changes, for example, overexcitement or loss of contact with reality
• Sleep disturbances
• Increased eye pressure (glaucoma), clouding of the lens (cataract)
• Heartburn, worsening of any gastric ulcers
• Weakening of the bones, which can cause bone fractures
• Stretch marks, bruising, acne-like rash, excessive hair growth on the face, delayed wound healing.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Plenadren

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 label of the bottle and on the
pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Plenadren contains

• The active ingredient is hydrocortisone. Plenadren 5 mg: Each modified-release tablet contains 5 mg of hydrocortisone. Plenadren 20 mg: Each modified-release tablet contains 20 mg of hydrocortisone.
• The other ingredients are hypromellose (E464), microcrystalline cellulose (E460), pregelatinized starch (corn), anhydrous colloidal silica (E551) and magnesium stearate. The coating system is a mixture of macrogol (3350), polyvinyl alcohol, talc (E553b) and titanium dioxide (E171). The 5 mg tablets also contain red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172).

Description of Plenadren and package contents
The modified-release tablets are round (diameter 8 mm) and convex.
The 5 mg tablets are pink. The 20 mg tablets are white.
Plenadren is supplied in screw-cap bottles containing 50 tablets.
Package size:
Box containing one bottle of 50 modified-release tablets.
Box containing 2 bottles of 50 modified-release tablets (100 tablets).
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland

Manufacturer
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland
Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Lietuva
Takeda, UAB
Tel: +370 521 09 070
[email protected]

България
Такеда България ЕООД
Тел.: +359 2 958 27 36
[email protected]

Luxembourg/Luxemburg
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Česká republika
Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722
[email protected]

Magyarország
Takeda Pharma Kft.
Tel.: +36 1 270 7030
[email protected]

Danmark
Takeda Pharma A/S
Tlf: +45 46 77 10 10
[email protected]

Malta
Τakeda HELLAS S.A.
Tel: +30 210 6387800
[email protected]

Deutschland
Takeda GmbH
Tel: +49 (0)800 825 3325
[email protected]

Nederland
Takeda Nederland B.V.
Tel: +31 20 203 5492
[email protected]

Eesti
Takeda Pharma AS
Tel: +372 6177 669
[email protected]

Norge
Takeda AS
Tlf: +47 800 800 30
[email protected]

Ελλάδα
Τakeda ΕΛΛΑΣ Α.Ε.
Τηλ: +30 210 6387800
[email protected]

Österreich
Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 50
[email protected]

España
Takeda Farmacéutica España S.A.
Tel: +34 917 90 42 22
[email protected]

Polska
Takeda Pharma Sp. z o.o.
Tel.: +48223062447
[email protected]

France
Takeda France SAS
Tél: + 33 1 40 67 33 00
[email protected]

Portugal
Takeda Farmacêuticos Portugal, Lda.
Tel: + 351 21 120 1457
[email protected]

Hrvatska
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
[email protected]

România
Takeda Pharmaceuticals SRL
Tel: +40 21 335 03 91
[email protected]

Ireland
Takeda Products Ireland Ltd
Tel: 1800 937 970
[email protected]

Slovenija
Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: + 386 (0) 59 082 480
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600
[email protected]

Italia
Takeda Italia S.p.A.
Tel: +39 06 502601
[email protected]

Suomi/Finland
Takeda Oy
Puh/Tel: 0800 774 051
[email protected]

Κύπρος
Τakeda ΕΛΛΑΣ Α.Ε.
Τηλ: +30 210 6387800
[email protected]

Sverige
Takeda Pharma AB
Tel: 020 795 079
[email protected]

Latvija
Takeda Latvia SIA
Tel: +371 67840082
[email protected]

United Kingdom (Northern Ireland)
Takeda UK Ltd
Tel: +44 (0) 2830 640 902
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu. Also, links to other websites on rare diseases and
related therapeutic treatments are provided.