Information for the patient 

VALBIT 24 mg/26 mg film-coated tablets

VALBIT 49 mg/51 mg film-coated tablets

VALBIT 97 mg/103 mg film-coated tablets

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, pharmacist or nurse.

· 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.

What is in this leaflet

1. What VALBIT is and what it is used for

2. What you need to know before you take VALBIT

3. How to take VALBIT

4. Possible side effects

5. How to store VALBIT

6. Contents of the pack and other information 

1. What VALBIT is and what it is used for

VALBIT is a heart medicine containing an Angiotensin Receptor Neprilysin Inhibitor. It delivers two active substances, Sacubitril and Valsartan.

VALBIT is used to treat a type of long-term heart failure in adults, children and adolescents (one year and older).

This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body. The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.

2. What you need to know before you take VALBIT

 Do not take VALBIT

· If you are allergic to Sacubitril, Valsartan or any of the other ingredients of this medicine.

· If you are taking another type of medicine called an Angiotensin Converting Enzyme (ACE) inhibitor (for example Enalapril, Lisinopril or Ramipril), which is used to treat high blood pressure or heart failure. If you have been taking an ACE inhibitor, wait for 36 hours after taking the last dose before you start to take VALBIT.

· If you have ever had a reaction called Angioedema (rapid swelling under the skin in areas such as the face, throat, arms and legs which can be life-threatening if throat swelling blocks the airway) when taking an ACE inhibitor or an Angiotensin receptor blocker (ARB) (such as Valsartan, Telmisartan or Irbesartan).

· If you have a history of angioedema which is hereditary or for which the cause is unknown (idiopathic).

· If you have diabetes or impaired kidney function and you are being treated with a blood pressure lowering medicine containing Aliskiren

· If you have severe liver disease.

· If you are more than 3 months pregnant

· If any of the above applies to you, do not take VALBIT and talk to your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before or when taking VALBIT:

· If you are being treated with an Angiotensin receptor blocker (ARB) or Aliskiren

· If you have ever had angioedema

· If you have low blood pressure or are taking any other medicines that reduce your blood pressure (for example, a medicine that increases urine production (diuretic)) or are suffering from vomiting or diarrhoea, especially if you are aged 65 years or more, or if you have kidney disease and low blood pressure.

· If you have kidney disease.

· If you are suffering from dehydration.

· If your kidney artery has narrowed.

· If you have liver disease.

· If you experience hallucinations, paranoia or changes in sleeping pattern while taking VALBIT.

· If you have hyperkalemia (high levels of potassium in the blood).

· If you suffer from heart failure classified as NYHA class IV (unable to carry on any physical activity without discomfort and may have symptoms even when resting).

If any of the above applies to you, tell your doctor, pharmacist or nurse before you take VALBIT.

Your doctor may check the amount of potassium and sodium in your blood at regular intervals during VALBIT treatment. In addition, your doctor may check your blood pressure at the start of treatment and when the doses are increased.

Children and adolescents

Do not give this medicine to children aged below 1 year because it has not been studied in this age group.

Other medicines and VALBIT

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. It may be necessary to change the dose, to take other precautions, or even to stop taking one of the medicines. This is particularly important for the following medicines:

· ACE inhibitors. Do not take VALBIT with ACE inhibitors. If you have been taking an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting to take VALBIT. If you stop taking VALBIT, wait 36 hours after taking your last dose of VALBIT before starting an ACE inhibitor.

· Other medicines used to treat heart failure or lower blood pressure, such as Angiotensin receptor blockers or Aliskiren.

· Some medicines known as statins that are used to lower high cholesterol levels (for example atorvastatin).

· Sildenafil, Tadalafil, Vardenafil or Avanafil, which are medicines used to treat erectile dysfunction or lung hypertension.

· Medicines that increase the amount of potassium in the blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines and heparin.

· Painkillers of the type called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase -2 (COX-2) inhibitors. If you are taking one of these, your doctor may want to check your kidney function when starting or adjusting treatment.

· Lithium, a medicine used to treat some types of Psychiatric illness.

· Furosemide, a medicine belonging to the type known as diuretics, which are used to increase the amount of urine you produce.

· Nitroglycerine, a medicine used to treat Angina pectoris.

· Some types of antibiotics (Rifamycin group), Ciclosporin (used to prevent rejection of transplanted organs) or Antivirals such as Ritonavir (used to treat HIV/AIDS).

· Metformin, a medicine used to treat diabetes.

If any of the above applies to you, tell your doctor or pharmacist before you take VALBIT. 

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.

Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of VALBIT. 

This medicine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.

Breast-feeding

VALBIT is not recommended for mothers who are breast-feeding. Tell your doctor if you are breast- feeding or about to start breast-feeding.

Driving and using machines

Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how VALBIT affects you. If you feel dizzy or very tired while taking this medicine, do not drive a vehicle, cycle or use any tools or machines.

3. How to take VALBIT

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

Adults

You will usually start by taking a 24 mg/26 mg or 49 mg/51 mg tablet twice a day (one tablet in the morning and one tablet in the evening). Your doctor will decide your exact starting dose based on which medicines you have been taking previously and your blood pressure. Your doctor will then adjust the dose every 2-4 weeks depending on how you respond to the treatment until the best dose for you is found.

The usual recommended target dose is 97 mg/103 mg twice a day (one tablet in the morning and one tablet in the evening).

Children and adolescents (one year and older)

Your (or your child’s) doctor will decide the starting dose based on body weight and other factors including previously taken medicines. The doctor will adjust the dose every 2-4 weeks until the best dose is found.

VALBIT should be given twice a day (one tablet in the morning and one tablet in the evening).

VALBIT film-coated tablets are not meant to be used in children who weigh less than 40 kg.

Patients taking VALBIT can develop low blood pressure (dizziness, light-headedness), a high level of potassium in the blood (which would be detected when your doctor performed a blood test) or decreased kidney function. If this happens, your doctor may reduce the dose of any other medicine you are taking, temporarily reduce the VALBIT dose, or stop VALBIT treatment completely.

Swallow the tablets with a glass of water. You can take VALBIT with or without food. Splitting or crushing of the tablets is not recommended.

If you take more VALBIT than you should

If you have accidentally taken too many VALBIT tablets, or if someone else has taken your tablets, contact your doctor immediately. If you experience severe dizziness and/or fainting, tell your doctor as quickly as possible and lie down.

If you forget to take VALBIT

It is advisable to take your medicine at the same time each day. However, If you forget to take a dose, you should simply take the next one at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If you stop taking VALBIT

Stopping your treatment with VALBIT may cause your condition to get worse. Do not stop taking your medicine unless your doctor tells you to.

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 may be serious.

· Stop taking VALBIT and seek immediate medical attention if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulties in breathing or swallowing. These may be signs of angioedema (an uncommon side effect which may affect up to 1 in 100 people).

Other possible side effects:

If any of the side effects listed below becomes severe, tell your doctor or pharmacist.

Very common (may affect more than 1 in 10 people)

· Low blood pressure, which can cause symptoms of dizziness and light-headedness (hypotension)

· High level of potassium in the blood, shown in a blood test (hyperkalaemia)

· Decreased kidney function (renal impairment)

Common (may affect up to 1 in 10 people)

· Cough

· Dizziness

· Diarrhoea

· Low level of red blood cells, shown in a blood test (Anaemia)

· tiredness (fatigue)

· Acute inability of the kidney to work properly (Renal failure)

· Low level of potassium in the blood, shown in a blood test (Hypokalaemia)

· Headache

· Fainting (Syncope)

· Weakness (Asthenia)

· Feeling sick (Nausea)

· Low blood pressure (Dizziness, Light-Headedness) when switching from sitting or lying to standing position

· Gastritis (Stomach pain, Nausea)

· Spinning sensation (Vertigo)

· Low level of sugar in the blood, shown in a blood test (Hypoglycaemia)

Uncommon (may affect up to 1 in 100 people)

· Allergic reaction with rash and itching (Hypersensitivity)

· Dizziness when switching from sitting to standing position (Dizziness postural)

· Low level of sodium in the blood, shown in a blood test (Hyponatraemia)

Rare (may affect up to 1 in 1000 people)

· Seeing, hearing or feeling things that are not there (Hallucinations)

· Changes in sleeping pattern (Sleep disorder)

Very rare (may affect up to 1 in 10000 people)

· Paranoia

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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VALBIT

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 and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater. 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 VALBIT contains

The active substances are Sacubitril and Valsartan.

VALBIT 50

Each film-coated tablet contains:

24 mg Sacubitril and 26 mg Valsartan as sodium salt complex

Colours: Tartrazine Lake & Titanium Dioxide

VALBIT 100

Each film-coated tablet contains:

49 mg Sacubitril and 51 mg Valsartan as sodium salt complex

Colours: Tartrazine Lake & Titanium Dioxide

VALBIT 200

Each film-coated tablet contains:

97 mg Sacubitril and 103 mg Valsartan as sodium salt complex

Colours: Tartrazine Lake & Titanium Dioxide

What VALBIT looks like and contents of the pack

VALBIT 50 tablets are Yellow, Round, biconvex, film-coated tablets with “Q” logo scored on one side. Tablets are packed into Alu-Alu Blister. The pack size is 10 x l0 tablets in a printed paper carton.

VALBIT 100 tablets are Yellow, Round, biconvex, film-coated tablets with “Q” logo scored on one side. Tablets are packed into Alu-Alu Blister. The pack size is 10 x l0 tablets in a printed paper carton.

VALBIT 200 tablets are Yellow, Round, biconvex, film-coated tablets with “Q” logo scored on one side. Tablets are packed into Alu-Alu Blister. The pack size is 10 x l0 tablets in a printed paper carton.

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