Glandacet tablets contain the active substance Cinacalcet hydrochloride which a positive modulator of the calcium sensing receptor used for :

·        Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.

Limitations of Use:

Glandacet tablets are not indicated for use in patients with CKD who are not on dialysis

·        Hypercalcemia in adult patients with Parathyroid Carcinoma (PC).

·        Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.

Secondary Hyperparathyroidism

Glandacet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis .

Limitations of Use:

Glandacet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

Parathyroid Carcinoma

Glandacet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma.

Primary Hyperparathyroidism

·        Glandacet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy

Do not take Glandacet tablet:

If you are allergic to cinacalcet or any of the other ingredients of this medicine

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before taking Glandacet.

Before you start taking Glandacet , tell your doctor if you have or have ever had:

·        seizures The risk of having seizures is higher if you have had them before;

·        liver problems;

·        heart failure.

Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in patients treated with Glandacet.

Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an unusually fast or pounding heart beat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking Glandacet.

For additional information see section 4.

During treatment with Glandacet, tell your doctor:

·        if you start or stop smoking, as this may affect the way Glandacet works.

Children and adolescents

Children under the age of 18 must not take Glandacet.

Other medicines and Glandacet

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

Tell your doctor if you are taking the following medicines.

Medicines such as these can affect how Glandacet works:

·        medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole);

·        medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin);

·        a medicine used to treat HIV infection and AIDS (ritonavir);

·        a medicine used to treat depression (fluvoxamine).

Glandacet may affect how medicines such as the following work:

·        medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine);

·        a medicine used to relieve cough (dextromethorphan);

·        medicines used to treat changes in heart rate (flecainide and propafenone);

·        a medicine used to treat high blood pressure (metoprolol).

Glandacet with food and drink

Glandacet should be taken with or shortly after food.

Pregnancy, breast-feeding and fertility

·        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.

·        Glandacet has not been tested in pregnant women. In case of pregnancy, your doctor may decide to modify your treatment, as Glandacet might harm the unborn baby.

·        It is not known whether Glandacet is excreted in human milk. Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Glandacet .

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Dizziness and seizures have been reported by patients taking Glandacet . If you experience these, your ability to drive or operate machinery may be affected.

Glandacet 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure. Your doctor will tell you how much Glandacet you must take.

Glandacet must be taken orally, with or shortly after food. The tablets must be taken whole and are not to be divided.

Your doctor will take regular blood samples during treatment to monitor your progress and will adjust your dose if necessary.

If you are being treated for secondary hyperparathyroidism

The usual starting dose for Glandacet is 30 mg (one tablet) once per day.

If you take more Glandacet than you should

If you take more Glandacet than you should you must contact your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.

If you forget to take Glandacet

·        Do not take a double dose to make up for a forgotten dose.

·        If you have forgotten a dose of Glandacet, you should take your next dose as normal.

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

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

If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures you should tell you doctor immediately. These may be signs that your calcium levels are too low (hypocalcaemia).

Very common: may affect more than 1 in 10 people

·        nausea and vomiting, these side effects are normally quite mild and do not last for long.

Common: may affect up to 1 in 10 people

·        dizziness

·        numbness or tingling sensation (paraesthesia)

·        loss (anorexia) or decrease of appetite

·        muscle pain (myalgia)

·        weakness (asthenia)

·        rash

·        reduced testosterone levels.

·        high potassium levels in the blood (hyperkalaemia)

·        allergic reactions (hypersensitivity)

·        headache

·        seizures (convulsions or fits)

·        low blood pressure (hypotension)

·        upper respiratory infection

·        breathing difficulties (dyspnoea)

·        cough

·        indigestion (dyspepsia)

·        diarrhoea

·        abdominal pain, abdominal pain – upper

·        constipation

·        muscle spasms

·        back pain

·        low calcium levels in the blood (hypocalcaemia).

Not known: frequency cannot be estimated from available data

·        Hives (urticaria)

·        Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)

·        Unusually fast or pounding heart beat which may be associated with low levels of calcium in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).

After taking Glandacet a very small number of patients with heart failure had worsening of their condition and/or low blood pressure (hypotension).

Children and adolescents

Reported in an adolescent clinical trial patient with very low calcium levels in the blood (hypocalcaemia).

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.

·        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.

·        Store below 30 °C.

·        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