MENELRI 50 MG CAPSULES SOFT - patient leaflet, side effects, dosage

Patient leaflet - MENELRI 50 MG CAPSULES SOFT

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, ask your doctor or 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.

What is in this leaflet

1. What Menelri is and what it is used for

2. What you need to know before you take Menelri

3. How to take Menelri

4. Possible side effects

5. How to store Menelri

6. Contents of the pack and other information

1. what menelri is and what it is used for

The name of your medicine is Menelri. It contains the active substance ciclosporin. This belongs to a group of medicines known as immunosuppressive agents. These medicines are used to lower the body’s immune reactions.

What Menelri is used for and how Menelri works

If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Menelri is to control your body’s immune system. Menelri prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue.
If you have an autoimmune disease, in which your body’s immune response attacks your body’s own cells, Menelri stops this immune reaction. Such diseases include eye

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problems which threaten your vision (endogenous uveitis, including Behcet's uveitis), severe cases of certain skin diseases (atopic dermatitis, or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease called nephrotic syndrome.

2. what you need to know before you take

If you are taking Menelri following a transplant it will only be prescribed for you by a doctor with experience in transplants and/or autoimmune diseases.

The advice in this leaflet may vary depending on whether you are taking the medicine for a transplant or for an autoimmune disease.

Follow all your doctor’s instructions carefully. They may differ from the general information contained in this leaflet.

Do not take Menelri:

– if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
– with products containing Hypericum perforatum (St John's Wort).
– with products containing dabigatran etexilate (used to avoid blood clots after surgery) or
– bosentan and aliskiren (used to reduce high blood pressure).

Do not take Menelri and tell your doctor if the above applies to you. If you are not sure, talk to your doctor before taking Menelri.

Warnings and precautions

Talk to your doctor before taking Menelri.

Before and during treatment with Menelri, tell your doctor straight away:

if you have any signs of infection, such as fever or a sore throat. Menelri suppresses the immune system and may also affect your body’s ability to fight against infection.
if you have liver problems.
if you have kidney problems. Your doctor will carry out regular blood tests and may change your dose if necessary.
if you develop high blood pressure. Your doctor will check your blood pressure regularly and may give you a medicine to lower blood pressure if necessary.
if you have low levels of magnesium in your body. Your doctor may give you magnesium supplements to take, especially just after your operation if you have had a transplant.
if you have high levels of potassium in your blood
if you have gout.
if you need to have a vaccination.

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If any of the above applies to you before or during treatment with Menelri, tell your doctor straight away.

Sunlight and sun protection

Menelri suppresses your immune system. This increases your risk of developing cancers, particularly of the skin and lymphoid system. You should limit your exposure to sunlight and UV light by:

Wearing appropriate protective clothing.
Often applying a sunscreen with a high protection factor.

Talk to your doctor before taking Menelri:

if you have or have had alcohol-related problems.
if you have epilepsy.
if you have any liver problems.
if you are pregnant.
if you are breast-feeding.
if this medicine is being prescribed for a child.

If any of the above apply to you (or you are not sure), tell your doctor before Menelri. This is because this medicine contains alcohol (see section below “Menelri contains ethanol”).

Monitoring during your treatment with Menelri

Your doctor will check:

the levels of ciclosporin in your blood, especially if you have had a transplant,
your blood pressure before the start of your treatment and regularly during treatment,
how well your liver and kidneys are working,
your blood lipids (fats).

If you have any questions about how Menelri works or why this medicine has been prescribed for you, ask your doctor.

In addition if you are taking Menelri for a non-transplant disease (intermediary or posterior uveitis and Behcet's uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Menelri:

if you have kidney problems (except for nephrotic syndrome).
if you have an infection which is not under control with medication.
if you have any type of cancer.
if you have high blood pressure (hypertension) which is not under control with medication. If you get high blood pressure during treatment and it cannot be controlled, Menelri should be stopped by your doctor.

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

If you are being treated for Behcet's uveitis, your doctor will monitor you particularly carefully if you have neurological symptoms (for example: increased forgetfulness, personality changes noticed over time, psychiatric or mood disorders, burning sensation in limbs, decreased sensation in limbs, tingling sensation in limbs, weakness of limbs, walking disturbances, headache with or without nausea and vomiting, vision disturbances including restricted movement of eyeball).

Your doctor will closely monitor you if you are elderly and are being treated for psoriasis or atopic dermatitis. If you have been prescribed Menelri to treat your psoriasis or atopic dermatitis, you must not be exposed to any UVB-rays or phototherapy during treatment.

Children and adolescents

Menelri should not be given to children for a non-transplant disease, except for treatment of nephrotic syndrome.

Elderly population (65 years of age and older)

There is limited experience with Menelri in elderly patients. Your doctor should monitor how well your kidneys work. If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Menelri if your condition is particularly severe.

Other medicines and Menelri

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

In particular tell your doctor or pharmacist if you are taking any of the following medicines before or during Menelri treatment:

Medicines that may affect your potassium levels. These include medicines which contain potassium, potassium supplements, water tablets (diuretics) called potassium-sparing diuretics and some medicines which lower your blood pressure.
Methotrexate. This is used to treat tumours, severe psoriasis and severe rheumatoid arthritis.
Medicines which may increase or decrease the level of ciclosporin (the active substance of Menelri) in your blood. Your doctor might check the level of ciclosporin in your blood when starting or stopping treatment with other medicines.
Medicines which may increase the level of ciclosporin in your blood include: antibiotics (such as erythromycin or azythromycin), anti-fungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop sickness), oral contraceptives, danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol),

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cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukaemia or tumours), colchicine, telaprevir (used to treat hepatitis C).

Medicines which may decrease the level of ciclosporin in your blood include: barbiturates (used to help you to sleep), some anti-convulsant medicines (such as carbamazepine or phenytoine), octreotide (used to treat acromegaly or neuroendocrine tumours in the gut), anti-bacterial medicines used to treat tuberculosis, orlistat (used to help weight loss), herbal medicines containing St. John’s wort, ticlopidine (used after a stroke), certain medicines which lower blood pressure (bosentan), and terbinafine (an anti-fungal medicine used to treat infections of the toes and nails).
Medicines which may affect your kidneys. These include: anti-bacterial medicines (gentamycin, tobramycin, ciprofloxacin), anti-fungal medicines which contain amphotericin B, medicines used for urinary tract infections which contain trimethoprim, medicines for cancer which contain melphalan, medicines used to lower the amount of acid in your stomach (acid secretion inhibitors of the H2-receptor antagonist type), tacrolimus, pain killers (non-steroid antiinflammatory medicines such as diclofenac), fibric acid medicines (used to lower the amount of fat in the blood).
Nifedipine. This is used to treat high blood pressure and heart pain. You might get swollen gums that might grow over your teeth if you are taking nifedipine during your treatment with ciclosporin.
Digoxin (used to treat heart problems), medicines which lower cholesterol (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (oral anti-diabetic medicine), immunosuppressives (everolimus, sirolimus), ambrisentan and specific anti-cancer medicines called anthracyclines (such as doxorubicin).

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Menelri.

Menelri with food and drink

Do not take Menelri with grapefruit or grapefruit juice. This is because these can affect how Menelri works.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Menelri during pregnancy.

Tell your doctor if you are pregnant or intend to become pregnant. Experience with Menelri in pregnancy is limited. In general, Menelri should not be taken during pregnancy. If it is necessary for you to take this medicine, your doctor will discuss with you the benefits and potential risks of taking it during pregnancy.

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Tell your doctor if you are breast-feeding. Breast-feeding is not recommended during treatment with Menelri. This is because ciclosporin, the active substance, passes into breast milk. This may affect your baby.

If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

Driving and using machines

Menelri contains alcohol. This may affect your ability to drive and use machines.

Menelri contains ethanol

Menelri contains approximately 12.0 vol. % ethanol (alcohol), which corresponds to up to 500 mg per dose used in transplant patients. This is equivalent to nearly 15 ml beer or 5 ml wine per dose.

Alcohol may be harmful if you have alcohol-related problems, epilepsy, brain injury, liver problems or if you are pregnant or breast-feeding. It may also be harmful if this medicine is given to children.

Menelri contains macrogolglycerol hydroxystearate

Menelri contains macrogolglycerol hydroxystearate, which may cause stomach discomfort and diarrhoea.

Menelri 10 mg capsules, soft contains propylene glycol

This medicine contains 10 mg propylene glycol in each capsule. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

Menelri 25 mg capsules, soft contains propylene glycol

This medicine contains 25 mg propylene glycol in each capsule. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

Menelri 50 mg capsules, soft contains propylene glycol

This medicine contains 50 mg propylene glycol in each capsule. If your child is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

Menelri 100 mg capsules, soft contains propylene glycol

This medicine contains 100 mg propylene glycol in each capsule. If your child is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

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3. how to take menelri

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

Do not take more than the recommended dose.

The dose of this medicine will be carefully adjusted to your individual needs by your doctor. Too much of the medicine can affect your kidneys. You will have regular blood tests and visits to the hospital, especially after a transplant. This will give you the chance to talk to your doctor about your treatment and talk about any problems you may be having.

How much Menelri to take

Your doctor will work out the correct dose of Menelri for you. This depends on your body weight and what you are taking the medicine for. Your doctor will also tell you how often to take your medicine.

If your doctor switches you from one oral formulation of ciclosporin to another

After you change from one oral formulation of ciclosporin to another:

Your doctor will monitor you more closely for a short time.
You may have some side effects. If this happens, tell your doctor or pharmacist. Your dose may need to be changed. Never change your dose yourself, unless a doctor has told you to.

When to take Menelri

Take Menelri at the same time every day. This is very important if you have had a transplant.

How to take Menelri

Your daily doses should always be taken in 2 divided doses.

Remove the capsules from the blister. Swallow the capsules whole with water.

How long to take Menelri

Your doctor will tell you how long you need to take Menelri for. This depends on whether you are taking it after a transplant or for the treatment of a severe skin condition, rheumatoid arthritis, uveitis or nephrotic syndrome. For severe rash, the treatment usually lasts for 8 weeks.

Keep taking Menelri for as long as your doctor tells you.

If you have questions about how long to take Menelri, talk to your doctor or your pharmacist.

If you take more Menelri than you should

If you accidentally take too much of your medicine, tell your doctor immediately or go to your nearest hospital emergency unit. You may need medical attention.

If you forget to take Menelri

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Then go on as before.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Menelri

Do not stop taking Menelri unless your doctor tells you to.

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Keep taking Menelri even if you feel well. Stopping your treatment with Menelri may increase the risk of your transplanted organ being rejected.

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.

Some side effects could be serious

Tell your doctor straight away if you notice any of the following serious side effects:

Like other medicines that act on the immune system, ciclosporin may influence your body’s ability to fight against infection and may cause tumours or other cancers, particularly of the skin. Signs of infection might be fever or sore throat.
Changes in your sight, loss of coordination, being clumsy, memory loss, difficulty speaking or understanding what others say, and muscle weakness. These might be signs of an infection of the brain called progressive multifocal leukoencephalopathy.
Brain problems with signs such as seizures, confusion, feeling disorientated, being less responsive, personality changes, feeling agitated, sleeplessness, changes to your sight, blindness, coma, paralysis of part or all of the body, stiff neck, loss of coordination with or without unusual speech or eye movements.
Swelling at the back of the eye. This may be associated with blurred vision. It may also affect your sight because of the higher pressure inside your head (benign intracranial hypertension).
Liver problems and damage with or without yellow skin and eyes, nausea, loss of appetite and dark urine.
Kidney problems which may greatly reduce the amount of urine you produce.
Low level of red blood cells or platelets. The signs include pale skin, feeling tired, being breathless, having dark urine (this is a sign of the breakdown of red blood cells), bruising or bleeding with no obvious reasons, feeling confused, feeling disorientated, being less alert and having kidney problems.

Other side effects include:

Very common side effects: These side effects may affect more than 1 in 10 people.

Kidney problems.
High blood pressure.
Headache.
Shaking of your body which you cannot control.
Excessive growth of body and facial hair.

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High level of lipids in your blood.