5 mg, 20 mg modified-release tablets
What Plenadren is and what it is used for
Plenadren contains a substance called hydrocortisone (sometimes called cortisol ). Hydrocortisone is a glucocorticoid. Plenadren belongs to a group of medicines called corticosteroids. Glucocorticoids are found naturally in the body and help keep you in good health.
Plenadren is used in adults to treat a condition called adrenal insufficiency, or cortisol deficiency. Adrenal insufficiency occurs when the adrenal glands (located just above the kidneys) do not produce enough of the hormone et cortisol. Patients who have long-term ( chronic ) adrenal insufficiency need replacement therapy to survive.
Plenadren replaces the natural cortisol that is lacking in adrenal insufficiency. The drug gives hydrocortisone to the body during the day. The level of cortisol in the blood increases rapidly and reaches a maximum level about 1 hour after you take the tablet in the morning. Then the cortisol level gradually decreases during the day until it is almost zero late in the evening and at night when it should be low.
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 cautions
Talk to your doctor or pharmacist before taking Plenadren
- if you have a disease that prevents you from taking the medicine or if the medicine is not absorbed from the stomach properly. This can happen if you have a stomach upset with vomiting or diarrhea. In this case, you should immediately seek medical attention for treatment with cortisone injections and fluid administration.
- if you have a short-term or temporary illness such as infection or fever or severe physical stress, e.g. surgery, dose one of hydrocortisone must be increased temporarily. Ask your doctor immediately to explain what to do in these situations. If you are going to have an operation, tell your doctor/dentist before the operation that you are taking Plenadren.
- if your general state of health deteriorates even though you are taking the medicine as prescribed, you should seek medical attention immediately.
- if your thyroid gland is not functioning normally, tell your doctor; dose one of Plenadren may need to be adjusted.
Children and young people
The use of Plenadren is not recommended in children and adolescents under 18 years of age as 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. For long-term treatment with anti-infective drugs ( antibiotics ), the dose of one of Plenadren may need to be adjusted. If Plenadren is used at the same time as mifepristone, an abortion treatment, the effect of Plenadren may be reduced.
You should also tell your doctor or pharmacist if you are taking any of the following medicines, as one dose of Plenadren may need to be changed:
- Phenytoin, carbamazepine, and barbiturates – are used to treat epilepsy.
- Rifampicin or rifabutin – is used to treat tuberculosis.
- Ritonavir, efavirenz and nevirapine – used to treat HIV infection .
- St. John’s wort – is used to treat depression and other diseases.
- Ketoconazole , itraconazole, posaconazole and voriconazole – used to treat fungal infections.
- Erythromycin, telithromycin, and clarithromycin – used to treat bacterial infections
Plenary with food and drink
Do not take this medicine with grapefruit juice as the juice may affect the way the medicine works.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You must continue to take Plenadren during pregnancy. It is unlikely that the treatment will harm the mother or child when treating pregnant women. You should tell your doctor if you become pregnant as the dose of one of Plenadren may need to be adjusted.
You can breastfeed while taking Plenadren. Hydrocortisone is excreted in breast milk. The dose of hydrocortisone used in replacement therapy is unlikely to have any effect on the child. However, you should still consult your doctor if you plan to breastfeed your baby.
Fertility can be reduced in women with adrenal insufficiency or cortisol deficiency. There are no indications that Plenadren, in doses used for substitution treatment, affects fertility.
Driving and using machines
This medicine has a minor effect on the ability to drive and use machines. Severe fatigue and short-term dizziness have been reported. Inadequately treated, or untreated, adrenal insufficiency reduces the ability to concentrate and affects the ability to drive and use machines. Therefore, you must take Plenadren according to your doctor’s instructions when driving or using machines. If you are affected, do not drive or use machines until you have consulted your doctor.
How to take Plenadren
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Dose one is specially tailored for you by your doctor.
- When you wake up in the morning, swallow the whole Plenadrent tablets with a glass of water, at least 30 minutes before eating breakfast and preferably between 6.00 and 8.00 in the morning.
- You should preferably take the tablets in an upright position.
- Do not split, crush or chew the tablets. The tablets release hydrocortisone to the body during the day. If you split, crush or chew the tablets, hydrocortisone may not be enough all day long.
The need for extra dose is of Plenadren
In case of a short-term or temporary illness such as infection or fever and in case of physical stress, e.g. In connection with surgery, you need more hydrocortisone because the body can not produce the extra cortisol needed in these situations. Therefore, the dose should be increased temporarily. Your doctor may prescribe other hydrocortisone tablets instead of Plenadren or as a supplement to Plenadren. Consult your doctor and follow the instructions on what to do in these situations.
You may need to take twice or three times as much Plenadren per day for milder illnesses as mild infections and moderate stress. Then you should take the second dose of this medicine 6-10 hours after the morning dose. If it is not enough to double the daily dose, take a third dose 6-10 hours after the second dose (wait 6-10 hours between each dose ). Once the temporary illness has passed, you should return to your usual maintenance dose of this medicine.
The following signs and symptoms may indicate that you need to take additional doses of Plenadren or other forms of hydrocortisone: fatigue, weight loss, stomach upset, dizziness when getting up from a sitting to standing position, darker skin, especially in folds of skin or exposed areas. Contact a doctor immediately for advice if you notice any of this.
However, see a doctor immediately if you notice any of the following: severe weakness, fainting, abdominal pain, nausea, vomiting, back pain, confusion, decreased consciousness, and delirium (very confused condition).
If you take more Plenadren than you should
Too high a dose of this drug for a period longer than a few days can be detrimental to health. Blood pressure may increase, you may gain weight and your blood sugar may become too high. A higher dose may sometimes be needed for the body to cope with increased stress, e.g. fever. If an extra dose is needed often and regularly, contact your doctor for a new assessment of your normal maintenance dose.
If you forget to take Plenadren
If you forget to take the tablet in the morning, take it as soon as possible afterward. Do not take a double dose to make up for a forgotten dose. If you experience any of the signs and symptoms listed in the section “Need an extra dose of Plenadren”, contact your doctor immediately.
If you stop taking Plenadren
It can be life-threatening to stop taking Plenadren. Therefore, you must continue to take this medicine exactly as your doctor has told you. Do not stop taking it without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you switch from other hydrocortisone tablets to Plenadren, you may experience side effects during the first few weeks. These side effects can include stomach pain, nausea, and fatigue. Normally, they disappear over time. If they do not, contact your doctor.
The side effects of this drug are as follows:
Very common (may affect more than 1 user in 10)
Common (may affect up to 1 in 10 of 100 users)
- Stomach/heartburn, nausea, or nausea
- Joint pain
Additional side effects have been reported with other drugs containing hydrocortisone. These drugs have also been given for indications other than as replacement therapy for adrenal insufficiency, often in higher doses. The frequency of these possible side effects is unknown (it can not be calculated from the available data). Tell your doctor if you experience any of these side effects.
- Increased susceptibility to infection.
- Diabetes or problems with blood sugar (seen in blood tests).
- Salt and fluid are retained in the body and cause swelling and high blood pressure (noticeable on medical examination) and low potassium content in the blood.
- Mood swings such as excessive elation or lost perception of reality.
- Hard to sleep.
- Increased pressure in the eye ( glaucoma ), clouding of the lens of the eye ( cataract, also called a cataract).
- Heartburn, worsening of existing stomach ulcer.
- Osteoporosis can lead to bone fractures.
- Stretch marks, bruises, acne-like rashes, increased facial hair growth, and slow wound healing.
How to store Plenadren
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the can label after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
- The active substance 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 (maize), colloidal anhydrous silicon (E551), and magnesium stearate. The casing system is a mixture of macrogol (3350), polyvinyl alcohol, talc (E553b), and titanium oxide (E171). The tablets containing 5 mg hydrocortisone also contain iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172).
What the medicine looks like and the contents of the pack
The tablets are round (diameter 8 mm) and convex.
The 5 mg tablets are pink. The 20 mg tablets are white.
Plenadren is sold in jars with screw caps. One jar contains 50 tablets.
Carton containing a jar of 50 modified-release tablets.
Carton containing 2 cans of 50 modified-release tablets (100 tablets).
Not all pack sizes may be available in your country.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50-58 Baggot Street Lower
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50-58 Baggot Street Lower
Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50 – 58 Baggot Street Lower