CAMIQUA 30 MG TABLETS - patient leaflet, side effects, dosage

What is in this leaflet:

• 1. What Camiqua is and what it is used for

• 2. What you need to know before you take Camiqua

• 3. How to take Camiqua

• 4. Possible side effects

• 5. How to store Camiqua

• 6. Contents of the pack and other information

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1. what camiqua is and what it is used for

The name of your medicine is Camiqua 30 mg Tablets (called Camiqua throughout this leaflet). Camiqua contains the active substance deflazacort, which is a steroid medicine. Their full name is glucocorticoids or corticosteroids.

How Camiqua works

• Corticosteroids occur naturally in the body, and help to maintain health and wellbeing.
• Boosting your body with extra corticosteroid (such as Camiqua) is an effective way to treat various illnesses involving inflammation in the body.
• Camiqua works by reducing this inflammation, which could otherwise go on making your condition worse.
• Camiqua also works by stopping reactions known as autoimmune reactions. These reactions happen when your body’s immune system attacks the body itself and causes damage.
• You must take this medicine regularly to get maximum benefit from it.

Camiqua can be used to:

• Treat inflammation including asthma, arthritis and allergies.
• Treat problems with your skin, kidneys, heart, digestive system, eyes or blood.
• Treat problems where your body has growths (tumours).
• Suppress the immune system in transplant operations.

2. what you need to know before you take camiqua

Do not take this medicine and tell your doctor if:

• You are allergic (hypersensitive) to deflazacort or any of the other ingredients in these tablets (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have an infection that affects your whole body (systemic infection), which is not already being treated.
• You are having or have recently had any vaccinations with live viruses (see “vaccinations” below).

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Camiqua.

Warnings and precautions

Take special care and check with your doctor before you take Camiqua if:

• You have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Camiqua.
• Any of your close family has had these illnesses.
• You have or ever had mental health problems such as depression or psychoses.

If any of the above applies to you, talk to a doctor before taking Camiqua.

Mental health problems while taking Camiqua

Mental health problems can happen while taking steroids like Camiqua (see also section 4: Possible Side Effects).

• These illnesses can be serious.
• 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 happen, they might need treatment.

Talk to a doctor if you (or someone taking this medicine) show 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.

Check with your doctor before taking this medicine if:

• You have epilepsy (fits).
• You or anyone in your family has diabetes.
• You have high blood pressure.
• You have kidney, liver or heart problems.
• You have brittle or weak bones called osteoporosis.
• You have an eye disease that causes detachment of your retina and bulging eyes.
• You or anyone in your family has an eye problem called glaucoma.
• You have an underactive thyroid gland.
• You have problems with your digestive system, including your food pipe (oesophagitis), gut (ulcerative colitis, diverticulitis) or stomach (peptic ulcer).
• You have ever had a bad reaction such as muscle weakness to any steroid.
• You have or ever had an infection caused by a virus or fungus. This includes infections such as athlete’s foot, thrush and cold sores (that may also affect the eye).
• You have or ever had tuberculosis (TB).
• You have any problems with your blood vessels such as a blood clot.
• You have a pheochromocytoma (a tumour of adrenal gland tissue. The adrenal glands are located above the kidneys).

Camiqua may cause inflammation of tendons and easy tearing especially when given together with antibiotics such as ciprofloxacin.

Irregular periods in women and blood problems such as leukocytosis (increase in white blood cells count) may also occur.

If any of the above apply to you, your doctor may want to see you more often during your treatment.

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

Other medicines and Camiqua

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes medicines you obtain without a prescription, including herbal medicines.

This is because Camiqua and other medicines can affect the way some other medicines work.

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

In particular, check with your doctor if you are taking any of the following medicines. Your doctor may want to change the dose of Camiqua, or the other medicine.

• Painkillers such as aspirin.
• Aminoglutethimide – used for some types of cancer.
• Ketoconazole – used to treat infections.
• Water tablets (diuretics) such as spironolactone, triamterene or amiloride.
• Medicines for thinning your blood (such as warfarin).
• Medicines for diabetes.
• Medicines for epilepsy such as phenobarbitone, primidone, phenytoin, carbamazepine, acetazolamide.
• Medicines which contain oestrogens including oral contraceptives.
• Medicines for tuberculosis (TB) such as rifampicin or rifabutin.
• Medicines for high blood pressure.
• Medicines for indigestion and heartburn (antacids). If you are taking an antacid leave at least 2 hours between taking it and Camiqua.
• Medicines for asthma such as salbutamol and theophylline.

Vaccinations

If you have just had any injections or vaccinations, tell your doctor before you take Camiqua. If you are going to have any injections or vaccinations, tell your doctor or nurse you are taking Camiqua. This includes those needed for a foreign holiday. Some vaccines should not be given to patients taking Camiqua. This is because Camiqua can affect the way some vaccines work.

Operations

If you are going to have an operation, tell your doctor you are taking Camiqua. Muscle relaxants are sometimes used during an operation or in the intensive care unit. Camiqua and muscle relaxants can affect one another.

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.

Driving and using machines

These tablets may make you feel dizzy, feel like everything around you is spinning, or feel disorientated (vertigo). If this happens, do not drive or use any tools or machines.

Camiqua and infections

Taking Camiqua can mean that you get infections more easily than usual, and these infections can be more serious.

Chickenpox, measles or shingles

If you get chickenpox, measles or shingles while taking Camiqua, you can become seriously ill:

• Keep away from people who have chickenpox, measles or shingles, if you have never had them. They could affect you severely. If you do come into contact with chickenpox, measles or shingles, see your doctor straight away. Your doctor may want to give you a vaccination to help you from getting these infections.
• If you do catch chickenpox, measles or shingles, tell your doctor straight away. Your doctor will advise you on how to take Camiqua. You may be told to increase the number of tablets that you use.

Blue steroid card:

• If you take this medicine for more than three weeks, you will be given a blue ‘steroid card’ by your doctor or pharmacist.
• It contains information about your medicine, including dose instructions. This is important if you fall ill or are in an accident.
• You should carry the card with you at all times.

Camiqua contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOWTO TAKE CAMIQUA

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

The dose will depend on the illness being treated and any other medicines you are taking. Your doctor may change you to a different strength of deflazacort tablets during the course of your illness, depending on the dose you need. You must follow the specific instructions for the particular strength you have been prescribed.

Taking this medicine

• Take this medicine by mouth.
• Swallow your tablets whole with a glass of water. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
• It is important to take your medicine at the right times.

Adults

• The dose for severe asthma may be up to three 30 mg tablets each day. This dose may be gradually reduced once the asthma attack has been controlled.
• For some problems up to 4 tablets may be needed each day for several days.

Elderly

Your doctor may need to check you more carefully for side effects.

Children and adolescents

• Camiqua may be given every day or every other day.
• The doctor will work out the dose based on your child’s age and weight.
• Your child will be given the lowest possible dose.
• The usual dose for chronic arthritis is between 0.25 mg and 1 mg of the medicine for each kg of your child’s bodyweight, each day.
• The usual dose for kidney problems (nephrotic syndrome) is 1.5 mg of the medicine for each kg of your child’s bodyweight, each day. Depending on how well the medicine works for your child, this dose may then be slowly lowered.
• The usual dose for asthma is between 0.25 mg and 1 mg of the medicine for each kg of your child’s bodyweight, every other day.
• In infants, an echocardiogram (ultrasound) should be performed by the doctor to monitor the structure and function of the muscular tissue of the heart.

If you take more Camiqua than you should

Tell your doctor or go to the nearest hospital casualty department straight away. Remember to take with you any tablets that are left and the pack. This is so the doctor knows what you have taken.

If you forget to take Camiqua

If you forget to take a dose take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Camiqua

• You need to take Camiqua regularly to get the maximum benefit.
• Do not stop taking this medicine without talking to your doctor – you may need to lower the dose gradually.
• Stopping the treatment suddenly can sometimes cause problems such as a high temperature, a runny nose, sore, red, sticky eyes, aching muscles and joints, itchy skin and weight loss. Also, sickness (vomiting), headaches and drowsiness – this is more likely to happen in children.

You may also notice the following symptoms if you stop treatment with Camiqua. If this happens, tell a doctor straight away as these could be signs of a serious illness:

• Sudden, severe pain in the back, stomach and legs.
• Being sick (vomiting) and diarrhoea.
• Feeling faint or dizzy, this could be a sign of low blood pressure.

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.

Stop taking your medicine and see a doctor or go to a hospital straight away if:

Uncommon (affects 1 to 10 users in 1,000):

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Camiqua.
• You pass black tarry stools or notice fresh or clotted blood in your stools (faeces). You may also notice dark bits that look like coffee grounds in your vomit. These could be signs of a stomach ulcer.

Not known (frequency cannot be estimated from the available data):

• You get severe stomach pain which may reach through to your back. This could be a sign of pancreatitis.

Serious effects: Tell a doctor straight away if you notice any of the following side effects:

Common (affects about 5 in every 100 users):

• Steroids including Camiqua can cause serious mental health problems. These are common in both adults and children.

Uncommon (affects 1 to 10 users in 1,000):

• Feeling depressed, including thinking about suicide.

Not known (frequency cannot be estimated from the available data):

• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
• Pheochromocytoma crisis (symptoms can include an awareness of your heartbeat, increase in heart rate (palpitations), excessive sweating, high blood pressure, severe headaches or tremor (feeling shaky)).
• Avery sore throat. You may also have difficulty in swallowing and the inside of your mouth may have white areas on the surface.
• Headache, which is usually worse in the morning, on coughing or straining, and feeling sick (nausea). Also, fits, fainting, eyesight problems, painful eyes or confusion can occur.
• In infants with a low birth weight being treated with Camiqua, the doctor will monitor the infant’s heart structure and function because a heart muscle disease (hypertrophic cardiomyopathy) may occur.

If you notice any of these problems talk to a doctor straight away.

Other side effects:

Please tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

Uncommon (affects 1 to 10 users in 1,000):

• Stomach or bowel problems such as feeling full or bloated, indigestion, heartburn or stomach pain.
• Increase in appetite and weight gain including around your face. Or, you may lose weight or feel weak.
• Hair, including body or facial hair, grows more than normal.
• Increased thirst and needing to pass water more often than usual. These could be signs of diabetes. If you are already diabetic, your doctor may prescribe more of your diabetes medicine to balance the effects of deflazacort. You should discuss this with your doctor.
• Raised blood pressure and increased water retention.
• Tiredness, confusion, muscle weakness or muscle cramps. This may be due to low levels of potassium in your body.
• Mood changes, difficulty in sleeping.
• If you have had tuberculosis (TB) in the past it may return.
• Skin problems such as acne, appearance of stretch marks.
• You may get infections more easily than usual.

Rare (affects 1 to 10 users in 10,000):

• Bleeding under the skin, redness
• General muscle weakness or tiredness

Not known (frequency cannot be estimated from the available data):

• Bones and tendons may break or tear more easily than usual. Also tendons may get inflamed and become painful.
• Irregular periods in women of they may stop altogether.
• Becoming dependent on deflazacort (also called psychological dependence).
• If you have schizophrenia your symptoms may get worse.
• Fungal infections such as thrush.
• Eye disease that causes detachment of the retina and bulging eyes.
• Eye problems such as glaucoma and cataracts can happen if you take this medicine for a long time.
• Eye infections (viral) may spread or return if you have had them in the past.
• Blurred vision.
• Increase in the risk of clots forming in your blood.
• Blood problems such as leukocytosis.
• Wounds and cuts do not heal as quickly as usual.
• Noticeable blood vessels, thinning of the skin.
• Sudden or severe muscle weakness or tiredness following an operation.

Some of the side effects are more likely to happen if you are elderly.

Additional side effects in children and adolescents

Children and adolescents (teenagers) taking this medicine may grow less than normal. (Not known: frequency cannot be estimated from the available data). If you think this is happening to a child, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

6. contents of the pack and other information

What Camiqua 30 mg Tablets contain

• Each tablet contains 30 mg of the active substance, deflazacort.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, maize starch and magnesium stearate.

What Camiqua 30 mg Tablets look like and contents of the pack

Camiqua 30 mg tablets are round, ivory white uncoated tablets, 11 mm in diameter, scored with a cross, they are available in cardboard cartons containing 10 tablets packed in blister packs of polyvinylchloride and aluminium foil.

Marketing Authorisation Holder

Veriton Pharma Ltd., Unit 16, Trade City, Avro Way, Brooklands Business Park, Weybridge, Surrey, KT13 0YF, United Kingdom.

Manufacturer

Lacer S.A., C/Boters 5, Parc Tecnoldgic del Valles, 08290 Cerdanyola del Valles, Barcelona, Spain.

This leaflet was last revised in 08/2020.

5. HOW TO STORE CAMIQUA

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.

This medicine does not require any special storage conditions. Keep the medicine in the pack in which it was given to you.

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.