HYDVENTIA 5 MG TABLETS - patient leaflet, side effects, dosage

RES Hydventia® 5mg OcXia PIL V2 - Created 26.04.21 -

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Package leaflet – Information for the patient

Hydventia® 5 mg Tablets

Hydrocortisone

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, please ask your doctor or your 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.
• Hydventia®Tablets are a steroid medicine, prescribed for many different conditions, including serious illnesses.
• You need to take it regularly to get the maximum benefit.
• Do not stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually.
• Hydventia® can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed, or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor as soon as possible.
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information).
• If you take this medicine for more than 3 weeks, you will get a blue ‘Steroid Treatment Card': always keep it with you and show it to any doctor or nurse treating you.
• Keep away from people who have chicken-pox or shingles, even if you have had them previously (read Section 2 for additional information). If you do come into contact with chicken pox or shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.

What is in this leaflet:

• 1. What Hydventia ® Tablets are and what they are used for

2. What you need to know before you take Hydventia

® Tablets

3. How to take Hydventia

® Tablets

4. Possible side effects

5. How to store Hydventia

® Tablets

6. Contents of the pack and other information

• 1. What Hydventia ® Tablets are and what they are used for

Hydventia® Tablets contain an active ingredient called hydrocortisone. This belongs to a group of medicines called steroids. Their full name is corticosteroids. These medicines are used to replace the adrenal hormones in your body, which may be lacking.

These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Hydventia® Tablets) is an effective way to treat various illnesses involving inflammation in the body. Hydventia® Tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

Hydventia® Tablets are used:

• As replacement therapy for children with congenital adrenal hyperplasia which affects your body’s natural production of steroids.
• To treat severe asthma and allergic reactions in adults and children.

2. what you need to know before you take hydventia® tablets

Do not take Hydventia ® Tablets if:

• you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6);
• you have an infection, especially thrush, candida or any other fungal infection;
• you have been vaccinated recently or are going to have any vaccinations.

If you are not sure talk to your doctor or pharmacist before taking Hydventia® Tablets.

Warnings and Precautions:

Talk to your doctor before taking Hydventia® Tablets if:

• you have ever had severe depression or manic-depression (bipolar disorder). This includes having had symptoms of depression in the past while taking steroid medicines like Hydventia® Tablets;
• any of your close family has had these illnesses.

Also, check with your doctor before taking this medicine if you have had any of the following:

• you have recently had heart problems including heart attacks;
• you have tuberculosis (TB);
• you have liver problems;
• you have kidney problems;
• you have high blood pressure;
• you have diabetes (or a family history of diabetes);
• you have thinning of the bones (osteoporosis);
• you have glaucoma (increased pressure in the eye) or a family history of the condition;
• you have epilepsy;
• you have stomach ulcers or other digestive problems;
• you have had muscle weakness after taking steroids in the past;
• you have a type of muscle weakening problem called ‘myasthenia gravis';
• you have an existing or previous history of severe mood-related disorders;
• you have thyroid problems;
• you have metastatic carcinoma (cancer that has spread from one part of the body to another);
• you have chicken pox, shingles or measles;
• you have exanthematous disease (disease affecting the skin, rash);
• you have thrombophlebitis (swelling and redness along a vein which is extremely tender when touched);
• you have a herpes infection in the eye called ocular herpes simplex;
• you have an HIV infection;
• you have recently visited a tropical country;
• you have amoebic dysentery and an infestation of a gut worm (strongyloidiasis), it may be activated or become worse
• you have bowel problems such as ulcerative colitis.

Contact your doctor if you experience blurred vision or other visual disturbances.

You should see your doctor if you develop any new infections whilst taking these tablets. Taking hydrocortisone for extended periods of time increases the chance that you will get an infection. These may be worse than normal and may very rarely be fatal.

If you are taking or have taken Hydventia®Tablets within the last 3 months and you become ill, (particularly important in cases of gastroenteritis or----

vomiting/diarrho­ea), suffer stress, get injured or are about to have a surgical procedure you must tell your doctor immediately that you have undergone treatment with Hydventia®Tablets as your dose may need to be increased (or you may have to start taking it again for a short period) to prevent a sharp fall in blood pressure.

If for any other reason your general health is declining although you take your medicine as prescribed; seek medical advice immediately.

Particular care should be taken by patients on long-term treatment as there is an increased risk of side effects.

If you have been on Hydventia®Tablets for longer than 3 weeks and wish to stop taking them, do not stop suddenly as this could result in a severe drop in blood pressure which could be fatal.Your doctor will advise on how to reduce the number of tablets you are taking.

It is important to avoid exposure to people who have chicken-pox, measles or shingles , especially if you have not already had these illnesses or are not sure if you have had them. Hydrocortisone increases the risk of a severe bout of chicken-pox. If exposed you must contact your doctor immediately.

Children

If the patient is a child, it is important that the doctor monitors growth and development at intervals during treatment. If hydrocortisone is given to a prematurely born baby, monitoring of heart function may be needed.

Elderly

Hydventia®Tablets should be used with caution in the elderly as side effects can be more pronounced in this age group.

Mental Health Problems while taking Hydventia ® Tablets

• Mental health problems can occur while taking steroids like hydrocortisone (see also section 4). These illnesses can be severe.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped.

However, if problems do occur they might need treatment.

Talk to a doctor if you (or someone taking this medicine), shows any signs of mental health problems.This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental health problems have happened when doses are being lowered or stopped altogether.

Important – Steroid Treatment Card

All patients taking steroids for more than 3 weeks should carry a ‘Steroid Treatment Card’ , which is available from your doctor or pharmacist. These cards have details of the medicine you are taking. Always keep it with you and show it to any doctor or nurse treating you.

Other Medicines and Hydventia ® Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without a prescription. This includes herbal medicines. This is because Hydventia® Tablets can affect the way some medicines work. Also, some other medicines can affect the way Hydventia® Tablets work.

Some medicines may increase the effects of Hydventia® Tablets and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

In particular do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:

• medicines used to thin the blood such as warfarin;
• aspirin or other salicylates;
• medicines for pain and inflammation called

NSAIDs such as ibuprofen, diclofenac or naproxen;

• calcium supplements;
• medicines for diabetes (including insulin);
• erythromycin, telithromycin or clarithromycin (used to treat bacterial infections);
• oral contraceptive pills and hormone replacement therapy (HRT);
• somatropin (a type of growth hormone);
• ritonavir, efavirenz or nevirapine (medicines used in the treatment of HIV infections);
• acetazolamide (for the treatment of glaucoma);
• some medicines for fungal infections such as amphotericin, ketoconazole, itraconazole, posaconazole or voriconazole;
• mifepristone (a medicine used to assist medical termination in pregnancy);
• water tablets (diuretics);
• a medicine for urea cycle disorder called sodium phenylbutyrate (usually started by a specialist doctor or consultant);
• carbenoxolone (a medicine used to treat ulcers);
• methotrexate (a medicine used to treat rheumatoid arthritis);
• St. John's Wort (a herbal medicine used for treating depression);
• medicines for fits (epilepsy) such as phenytoin, phenobarbital, carbamazepine and primidone;
• medicines used forTB (tuberculosis) called rifabutin or rifampicin;
• a medicine for cancer called aminoglutethimide;
• digoxin and other cardiac glycosides (used to treat heart failure and irregular heartbeats);
• theophylline and sympathomimetics such as bambuterol, fenotorol, formoterol, ritrodrine, salbutamol, salmeterol and terbutaline (used singly or in combination in the treatment of asthma and other breathing problems);
• antihypertensives (medicines for treating high blood pressure).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hydventia®Tablets.

Having vaccines or tests while you are taking Hydventia® Tablets

Tell your doctor that you are taking Hydventia® Tablets if you are to receive any vaccinations. Hydventia®Tablets could also affect the results of some tests performed by your doctor or in hospital, so tell your doctor or nurse that you are taking these tablets before any tests are carried out.

Having surgery while you are taking Hydventia® Tablets

If you are having surgery requiring an anaesthetic tell your doctor you are taking Hydventia® Tablets.

Hydventia® Tablets with food and drink

Hydventia® Tablets can be taken with or without food. Do not take this medicine with grapefruit juice as it may affect the action of this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Small amounts of hydrocortisone may pass into breast milk, therefore you should talk to your doctor before taking Hydventia® Tablets if you are breast-feeding or intend to breast-feed. Your doctor will decide if you should take Hydventia® Tablets during this time.

Driving and using machines

Steroids such as hydrocortisone may cause changes to vision and/or muscle weakness. If you experience any of these symptoms you should not drive or operate machinery.

Hydventia Tablets contain sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium- free’.

Hydventia Tablets are suitable for those with an intolerance to lactose or gluten and for vegans.

3. how to take hydventia® tablets

Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

You should take this medicine by mouth. The amount you take each day will depend on your illness. The number of tablets to be taken will be on the label of your medicine. If you are unsure about the dose you should take, you must talk to your doctor or pharmacist. The usual doses of Hydventia® Tablets are:

Dosage for Acute Emergencies

The usual dose for adults is 60–80mg every 4–6 hours for 24 hours then gradually lowering over several days.

Use as replacement therapy in children

When used in replacement therapy, the usual dose for children is 10–30mg divided into two doses each day. The first dose taken in the morning may be larger than the second dose taken in the evening.

If you take more Hydventia® Tablets than you should If you take too many tablets by mistake, contact your doctor as soon as possible. Overdosage can cause symptoms such as nausea (feeling sick), vomiting (being sick), sodium and water retention and occasional gastrointestinal bleeding.

If you forget to take Hydventia® Tablets

• If you forget to take your dose, skip the missed dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Hydventia® Tablets

DO NOT STOP taking this medicine just because you feel better. You should follow your doctor’s instruc­tions on stopping this medicine. Your doctor may want you to reduce the dose gradually; taking fewer tablets over a period of time. Never let your tablets run out before receiving the next prescription. It may be dangerous to go without treatment (see section 2).

If you stop taking Hydventia® Tablets it may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as fever, muscle and joint pain, blocked/runny nose, swelling of the eye, painful itchy skin rash and weight loss.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Digestive System: Burst or bleeding ulcers (indicated by stomach pain, bleeding from the back passage, black stools or being sick with blood present), inflammation of the pancreas causing abdominal pain, stomach pain and discomfort, a bloated feeling, ulceration or thrush in the gullet (discomfort on swallowing, which can cause chest pain), indigestion, hiccups, feeling sick and being sick, tooth decay.

Nervous System: Fits (convulsions), worsening of epilepsy, sleepiness, dizziness/spinning sensation, headache (sometimes severe).

Bone, Muscle and Joints: Muscle weakness or wasting, thinning of bones (osteoporosis) which makes fracture more likely, broken bones or fractures, hip or shoulder pain due to poor blood circulation, risk of torn tendons, joint inflammation in the knee and groin (aseptic necrosis) or other joints.

Eyes: Changes in vision as a result of cataracts or glaucoma (increased pressure inside the eye), blurred vision, dry eye, thinning of the surface of the eye, existing eye infections may get worse.

Blood and lymphatic system: Increased number of white blood cells.

Psychiatric disorders: Psychological dependence, worsening schizophrenia.

Reproductive System:

In Women: Irregular or lack of periods.

Endocrine System: Development of Cushingoid faces (round or moon shaped), increased appetite and weight gain, loss of calcium and nitrogen (shown on medical tests), salt and water retention (causing swelling and raised blood pressure), low adrenal gland function which reduces the production of steroids in your body (particularly after surgery, an accident or illness).

Skin: Slow healing of cuts or wounds, thin or delicate skin, redness, sweating, rashes, acne, bruising, stretch marks, growth of body hair.

General: Feeling generally unwell (malaise), tiredness.

Investigations: Changes in the levels of various chemicals in the blood which are usually detected by blood and urine tests, intolerance to carbohydrates, decrease in cholesterol (good cholesterol) in the blood (shown in blood tests), high blood glucose levels (may be seen as excessive thirst and increased passing of urine), breakdown of protein stores (loss of weight and loss of muscle in arms and legs), loss of calcium and nitrogen. A loss or reduction of potassium salts from the body may result in irregular beating of the heart (palpitations), fainting due to low blood pressure, muscle weakness, cramps and spasms. Weight increased.

Additional side effects in children

Suppression of normal growth in children.

Raised pressure within the skull (pseudotumour cerebri, indicated by headaches with vomiting, listlessness and drowsiness) has been reported in children; this usually occurs after treatment has stopped.

Stopping Hydventia® Tablets too quickly may cause withdrawal symptoms such as fever, muscle and joint pain, blocked/runny nose, swelling of the eyes, painful itchy skin rash and weight loss. Reducing the dose too quickly following long-term treatment can lead to kidney failure, low blood pressure and potentially death. You should follow your doctor's instruc­tions on stopping this medicine.

Because of these potential side effects, your doctor may want to monitor you at intervals during your treatment.

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 Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

4. Possible side effects

5. How to store Hydventia

® Tablets

Like all medicines, this medicine can cause side effects, although not everybody gets them.

People taking steroids to replace similar naturally occurring hormones, should be less likely to get side effects than people taking steroids for other illnesses. Side effects are likely to be more pronounced when this medicine is used by elderly patients.

Tell the doctor immediately if you notice:

• Itching or skin rashes;
• Swelling of the face, lips or throat;
• Difficulty breathing or wheeziness.

These may be signs of an allergic reaction

Severe Side Effects:

Steroids including hydrocortisone can cause severe mental health problems. These side effects are common in both adults and children. They can affect about five in every 100 people taking medicines like hydrocortisone.

Tell your doctor immediately if you are:

• depressed, including thinking about suicide;
• high (mania) or having moods that go up and down;
• anxious, having problems sleeping, having difficulty in thinking or being confused and losing your memory;
• feeling, seeing or hearing things that do not exist;
• having strange and frightening thoughts, changing how you act or having feelings of being alone.

Other Side Effects

Tell your doctor if you experience any of the following:

The frequency of the following side effects is not known, it cannot be estimated from the available data.

Heart Problems: Increased damage to the heart in the event of a heart attack, heart failure, high blood pressure, formation of blood clots (which may go to the lung, symptoms of which are sudden chest pain and coughing up blood), difficulty in breathing and irregular beating of the heart, very slow or very fast heartbeat. Thickening of the heart muscle (hypertrophic cardiomyopathy) in prematurely born babies.

Infections: Taking Hydventia® Tablets may make it easier for you to pick up infections which may very rarely be fatal. Infections such as chicken-pox and measles can be made worse and TB may recur.

Some fungal and viral infections, including herpes, may be activated. Diarrhoea and vomiting, sore throat/cold, flu-like illness caused by a viral infection.

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store in the original package in order to protect from light.
• Do not put your tablets into another container, in case they get mixed up.
• Do not use this medicine after the expiry date, which is stated on the carton. 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 Hydventia® Tablets contain

The active substance is hydrocortisone. Each tablet contains 5 mg of hydrocortisone. The other ingredients are Prosolv 90, sodium starch glycolate, magnesium stearate and talc (E553b).

What Hydventia® Tablets look like and contents of the pack

Hydventia® 5 mg Tablets are white oval tablets marked “F2” on one side and “5” on the reverse, with dimensions of approximately 7.5 × 4 mm. The tablets are scored so that they can easily be broken into halves. This can allow you take a lower dose of half of a tablet (2.5mg).

Hydventia® Tablets are packaged in blister packs containing 30 tablets.

Marketing authorisation holder:

Resolution Chemicals Ltd.,

Wedgwood Way, Stevenage, Herts, SG1 4QT, United Kingdom

Distributor: OcXia, 4 WintonLea,

Monument Way West, Woking, Surrey, GU21 5EN, United Kingdom

Manufacturer:

Surepharm Services Limited,

Bretby Business Park, Ashby Road, Bretby, Burton-on-Trent, DE15 0YZ. UK

This leaflet was last revised in April 2021.